Trial Outcomes & Findings for Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening (NCT NCT04683731)
NCT ID: NCT04683731
Last Updated: 2024-12-13
Results Overview
Patients' completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening within 6 months, based on documentation in the participants' electronic health record.
COMPLETED
NA
1111 participants
6 months after patient enrollment
2024-12-13
Participant Flow
Patients were recruited from primary care practices between January 2021 and November 2022.
Participant milestones
| Measure |
Group 1
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 2
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, advanced colorectal neoplasm (ACN) risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 3
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 4
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
294
|
265
|
262
|
290
|
|
Overall Study
COMPLETED
|
290
|
262
|
247
|
285
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
15
|
5
|
Reasons for withdrawal
| Measure |
Group 1
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 2
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, advanced colorectal neoplasm (ACN) risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 3
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 4
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
2
|
|
Overall Study
Determined patient was not eligible
|
3
|
3
|
12
|
3
|
Baseline Characteristics
Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening
Baseline characteristics by cohort
| Measure |
Group 1
n=290 Participants
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 2
n=262 Participants
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 3
n=247 Participants
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 4
n=285 Participants
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Total
n=1084 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 5.9 • n=93 Participants
|
56.8 years
STANDARD_DEVIATION 6.5 • n=4 Participants
|
56.5 years
STANDARD_DEVIATION 6.2 • n=27 Participants
|
56.4 years
STANDARD_DEVIATION 6.2 • n=483 Participants
|
56.5 years
STANDARD_DEVIATION 6.2 • n=36 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=93 Participants
|
155 Participants
n=4 Participants
|
140 Participants
n=27 Participants
|
179 Participants
n=483 Participants
|
647 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=93 Participants
|
107 Participants
n=4 Participants
|
107 Participants
n=27 Participants
|
106 Participants
n=483 Participants
|
437 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Consolidated Race · Black
|
76 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
77 Participants
n=483 Participants
|
290 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Consolidated Race · Hispanic
|
13 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
34 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Consolidated Race · Other
|
17 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
53 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Consolidated Race · White
|
171 Participants
n=93 Participants
|
165 Participants
n=4 Participants
|
148 Participants
n=27 Participants
|
180 Participants
n=483 Participants
|
664 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Consolidated Race · Unknown or Not Reported
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
43 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
290 participants
n=93 Participants
|
262 participants
n=4 Participants
|
247 participants
n=27 Participants
|
285 participants
n=483 Participants
|
1084 participants
n=36 Participants
|
|
Education - highest level
Less than high school
|
9 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
45 Participants
n=36 Participants
|
|
Education - highest level
High school graduate/GED
|
45 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
55 Participants
n=483 Participants
|
209 Participants
n=36 Participants
|
|
Education - highest level
Some college or technical school/trade school
|
79 Participants
n=93 Participants
|
67 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
68 Participants
n=483 Participants
|
273 Participants
n=36 Participants
|
|
Education - highest level
Associates degree
|
28 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
110 Participants
n=36 Participants
|
|
Education - highest level
Bachelors degree
|
69 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
68 Participants
n=483 Participants
|
232 Participants
n=36 Participants
|
|
Education - highest level
Professional or graduate degree
|
38 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
145 Participants
n=36 Participants
|
|
Education - highest level
Prefer not to answer
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
|
Education - highest level
Unknown or Not Reported
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
44 Participants
n=36 Participants
|
|
Relationship
Divorced
|
69 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
62 Participants
n=483 Participants
|
231 Participants
n=36 Participants
|
|
Relationship
Married or living with a partner
|
140 Participants
n=93 Participants
|
141 Participants
n=4 Participants
|
128 Participants
n=27 Participants
|
144 Participants
n=483 Participants
|
553 Participants
n=36 Participants
|
|
Relationship
Never married
|
43 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
169 Participants
n=36 Participants
|
|
Relationship
Separated
|
14 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
40 Participants
n=36 Participants
|
|
Relationship
Widowed
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
49 Participants
n=36 Participants
|
|
Relationship
Unknown or Not Reported
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
42 Participants
n=36 Participants
|
|
Employed?
Yes
|
183 Participants
n=93 Participants
|
165 Participants
n=4 Participants
|
147 Participants
n=27 Participants
|
172 Participants
n=483 Participants
|
667 Participants
n=36 Participants
|
|
Employed?
No
|
95 Participants
n=93 Participants
|
85 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
105 Participants
n=483 Participants
|
374 Participants
n=36 Participants
|
|
Employed?
Unknown or Not Reported
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
43 Participants
n=36 Participants
|
|
Health Insurance?
Yes
|
268 Participants
n=93 Participants
|
241 Participants
n=4 Participants
|
228 Participants
n=27 Participants
|
264 Participants
n=483 Participants
|
1001 Participants
n=36 Participants
|
|
Health Insurance?
No
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
41 Participants
n=36 Participants
|
|
Health Insurance?
Unknown or Not Reported
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
42 Participants
n=36 Participants
|
|
Insurance Lapse over 12 Months?
Yes
|
27 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
87 Participants
n=36 Participants
|
|
Insurance Lapse over 12 Months?
No
|
238 Participants
n=93 Participants
|
227 Participants
n=4 Participants
|
200 Participants
n=27 Participants
|
239 Participants
n=483 Participants
|
904 Participants
n=36 Participants
|
|
Insurance Lapse over 12 Months?
Unknown or Not Reported
|
25 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
93 Participants
n=36 Participants
|
|
Self-reported Health Status at Baseline
Excellent
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
46 Participants
n=36 Participants
|
|
Self-reported Health Status at Baseline
Very Good
|
59 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
70 Participants
n=483 Participants
|
231 Participants
n=36 Participants
|
|
Self-reported Health Status at Baseline
Good
|
121 Participants
n=93 Participants
|
117 Participants
n=4 Participants
|
104 Participants
n=27 Participants
|
114 Participants
n=483 Participants
|
456 Participants
n=36 Participants
|
|
Self-reported Health Status at Baseline
Fair
|
74 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
258 Participants
n=36 Participants
|
|
Self-reported Health Status at Baseline
Poor
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
49 Participants
n=36 Participants
|
|
Self-reported Health Status at Baseline
Missing or Not Reported
|
14 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
44 Participants
n=36 Participants
|
|
Subjective Income Level
Are comfortable
|
124 Participants
n=93 Participants
|
134 Participants
n=4 Participants
|
114 Participants
n=27 Participants
|
126 Participants
n=483 Participants
|
498 Participants
n=36 Participants
|
|
Subjective Income Level
Have just enough to make ends meet
|
109 Participants
n=93 Participants
|
93 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
108 Participants
n=483 Participants
|
396 Participants
n=36 Participants
|
|
Subjective Income Level
Do NOT have enough to make ends meet
|
41 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
42 Participants
n=483 Participants
|
142 Participants
n=36 Participants
|
|
Subjective Income Level
Missing or Not Reported
|
16 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
48 Participants
n=36 Participants
|
|
Subjective Numeracy
|
4.2 units on a scale
STANDARD_DEVIATION 1.3 • n=93 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 1.2 • n=4 Participants
|
4.2 units on a scale
STANDARD_DEVIATION 1.3 • n=27 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 1.2 • n=483 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 1.3 • n=36 Participants
|
|
Health Literacy
|
2.1 units on a scale
STANDARD_DEVIATION 2.4 • n=93 Participants
|
1.9 units on a scale
STANDARD_DEVIATION 2.2 • n=4 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 2.2 • n=27 Participants
|
1.9 units on a scale
STANDARD_DEVIATION 2.2 • n=483 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 2.3 • n=36 Participants
|
|
Perceived Comparative Risk for Colorectal Cancer
Lower than other women/men your age
|
68 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
73 Participants
n=483 Participants
|
248 Participants
n=36 Participants
|
|
Perceived Comparative Risk for Colorectal Cancer
About the same as other women/men your age
|
111 Participants
n=93 Participants
|
101 Participants
n=4 Participants
|
101 Participants
n=27 Participants
|
110 Participants
n=483 Participants
|
423 Participants
n=36 Participants
|
|
Perceived Comparative Risk for Colorectal Cancer
Higher than other women/men your age
|
13 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
44 Participants
n=36 Participants
|
|
Perceived Comparative Risk for Colorectal Cancer
Don't know
|
88 Participants
n=93 Participants
|
92 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
86 Participants
n=483 Participants
|
338 Participants
n=36 Participants
|
|
Perceived Comparative Risk for Colorectal Cancer
Unknown or Not Reported
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
31 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 6 months after patient enrollmentPatients' completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening within 6 months, based on documentation in the participants' electronic health record.
Outcome measures
| Measure |
Group 2
n=262 Participants
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 1
n=290 Participants
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 3
n=247 Participants
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 4
n=285 Participants
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
|---|---|---|---|---|
|
Number of Participants Who Completed Colorectal Cancer Screening
|
95 Participants
|
110 Participants
|
113 Participants
|
113 Participants
|
PRIMARY outcome
Timeframe: 6 months after participant enrollmentDecision quality will be assessed using the multi-dimensional measure of informed consent (MMIC), where a high-quality decision is one where the individual has adequate knowledge regarding the available options and undergoes the screening test that he or she has chosen or that fits his or her values ("values concordance"). Patient knowledge of colorectal cancer and screening will be assessed by a 12-item test made up of 6 multiple choice questions and 6 true-false questions. Adequate knowledge = 9 correct. Concordance will be measured between the patient's test choice at the post-provider survey and the screening test underwent, if any, within 6 months after patient enrollment.
Outcome measures
| Measure |
Group 2
n=262 Participants
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 1
n=290 Participants
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 3
n=247 Participants
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 4
n=285 Participants
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
|---|---|---|---|---|
|
Number of Participants Who Made a High Quality Decision Using the Multi-dimensional Measure of Informed Consent (MMIC) Which Incorporates Knowledge, Intent, and Behavior.
|
92 Participants
|
90 Participants
|
91 Participants
|
103 Participants
|
SECONDARY outcome
Timeframe: 6 months after participant enrollmentColorectal cancer (CRC) screening uptake and type of screening test completed within 6 months of enrolled was assessed, as documented in the electronic health record (EHR).
Outcome measures
| Measure |
Group 2
n=262 Participants
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 1
n=290 Participants
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 3
n=247 Participants
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 4
n=285 Participants
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
|---|---|---|---|---|
|
Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test Completed
Completed a stool test (FIT or Cologuard)
|
56 Participants
|
51 Participants
|
61 Participants
|
62 Participants
|
|
Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test Completed
Completed a colonoscopy
|
39 Participants
|
59 Participants
|
52 Participants
|
51 Participants
|
|
Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test Completed
Did not complete a CRC screening test
|
167 Participants
|
180 Participants
|
134 Participants
|
172 Participants
|
SECONDARY outcome
Timeframe: 1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)Population: Only participants who completed the item at each time point under comparison were used in the analysis.
Patients' intention to be screened for CRC with any CRC screening test will be measured with 1 item: "Do you plan to get any type of colon cancer screening test within the next 6 months?". The response options were: 5=Definitely; 4=Probably; 3=May or may not; 2=Probably not; and 1=Definitely not. Higher positive change means CRC screening intention increased. Increased intention to be screened is a better outcome.
Outcome measures
| Measure |
Group 2
n=262 Participants
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 1
n=290 Participants
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 3
n=247 Participants
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 4
n=285 Participants
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
|---|---|---|---|---|
|
Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
Change from baseline (T0) to post-intervention (T1)
|
0.68 score on a scale
Standard Deviation 0.86
|
0.59 score on a scale
Standard Deviation 0.79
|
0.55 score on a scale
Standard Deviation 0.84
|
0.63 score on a scale
Standard Deviation 0.83
|
|
Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
Change from post-intervention (T1) to post-provider visit (T2)
|
0.24 score on a scale
Standard Deviation 0.74
|
0.23 score on a scale
Standard Deviation 0.93
|
0.24 score on a scale
Standard Deviation 0.82
|
0.20 score on a scale
Standard Deviation 0.79
|
|
Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
Change from baseline (T0) to post-provider visit (T2)
|
0.94 score on a scale
Standard Deviation 1.01
|
0.85 score on a scale
Standard Deviation 1.18
|
0.80 score on a scale
Standard Deviation 1.15
|
0.82 score on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: 1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)For those patients who answer the screening intent item with "definitely not," "probably not," or "may or may not", test choice will be categorized as "no screening". Those who answer Screening Intent with "Probably" or "Definitely" have Test Choice categorized based on their answer to a single item: "If you have a colon test, which one would you choose?" Response options are: Stool test (FIT or Cologuard), Colonoscopy, Another test, or Don't know.
Outcome measures
| Measure |
Group 2
n=262 Participants
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 1
n=290 Participants
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 3
n=247 Participants
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 4
n=285 Participants
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
|---|---|---|---|---|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at baseline (T0) · Intends to be screened with colonoscopy
|
58 Participants
|
70 Participants
|
56 Participants
|
79 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at baseline (T0) · Intends to be screened with a stool test (FIT or Cologuard)
|
53 Participants
|
62 Participants
|
55 Participants
|
70 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at baseline (T0) · Intends to be screened with another test
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at baseline (T0) · Intends to be screened and don't know which test
|
37 Participants
|
37 Participants
|
35 Participants
|
32 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at baseline (T0) · Does not intend to be screened
|
105 Participants
|
111 Participants
|
95 Participants
|
99 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at baseline (T0) · Unknown or not reported
|
6 Participants
|
8 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at post-intervention (T1) · Intends to be screened with colonoscopy
|
82 Participants
|
106 Participants
|
93 Participants
|
86 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at post-intervention (T1) · Intends to be screened with a stool test (FIT or Cologuard)
|
106 Participants
|
85 Participants
|
74 Participants
|
133 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at post-intervention (T1) · Intends to be screened with another test
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at post-intervention (T1) · Intends to be screened and don't know which test
|
18 Participants
|
25 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at post-intervention (T1) · Does not intend to be screened
|
40 Participants
|
52 Participants
|
39 Participants
|
31 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at post-intervention (T1) · Unknown or not reported
|
16 Participants
|
22 Participants
|
21 Participants
|
16 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at post-provider (T2) · Intends to be screened with colonoscopy
|
90 Participants
|
104 Participants
|
83 Participants
|
89 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at post-provider (T2) · Intends to be screened with a stool test (FIT or Cologuard)
|
84 Participants
|
92 Participants
|
89 Participants
|
117 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at post-provider (T2) · Intends to be screened with another test
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at post-provider (T2) · Intends to be screened and don't know which test
|
5 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at post-provider (T2) · Does not intend to be screened
|
25 Participants
|
26 Participants
|
25 Participants
|
27 Participants
|
|
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Intended screening behavior at post-provider (T2) · Unknown or not reported
|
57 Participants
|
61 Participants
|
48 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: 1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)Population: Only participants who completed the item at each time point under comparison were used in the analysis.
Knowledge was assessed with six multiple choice and six true/false questions regarding general information (including risk factors, screening test options, and test frequency) of CRC and CRC screening. Knowledge scores were derived by summing correct responses to the 12 individual knowledge questions (range, 0-12), and change was calculated from baseline (T0) to post-intervention (T1), post-intervention (T1) to post-provider visit (T2), and from baseline (T0) to post-provider (T2) by using the knowledge score at the later time point minus the knowledge score of the former time point. The range for change could be -12 to 12 with higher values meaning an increase in knowledge which is a better outcome.
Outcome measures
| Measure |
Group 2
n=262 Participants
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 1
n=290 Participants
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 3
n=247 Participants
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 4
n=285 Participants
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
|---|---|---|---|---|
|
Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.
Change in correct responses from baseline (T0) to post-intervention (T1)
|
3.70 units on a scale-number correct
Standard Deviation 2.74
|
3.65 units on a scale-number correct
Standard Deviation 2.68
|
3.75 units on a scale-number correct
Standard Deviation 2.82
|
3.76 units on a scale-number correct
Standard Deviation 2.90
|
|
Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.
Change in correct responses from post-intervention (T1) to post-provider visit (T2)
|
-0.58 units on a scale-number correct
Standard Deviation 1.31
|
-0.60 units on a scale-number correct
Standard Deviation 1.40
|
-0.60 units on a scale-number correct
Standard Deviation 1.60
|
-0.43 units on a scale-number correct
Standard Deviation 1.45
|
|
Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.
Change in correct responses from baseline (T0) to post-provider visit (T2)
|
3.10 units on a scale-number correct
Standard Deviation 2.79
|
3.03 units on a scale-number correct
Standard Deviation 2.71
|
3.02 units on a scale-number correct
Standard Deviation 3.02
|
3.31 units on a scale-number correct
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: 1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)Population: Only participants who completed the item at each time point under comparison were used in the analysis.
Multiple choice questions assessing the patients' perception of how likely they are to get colon cancer in the next 5 years, in the next 10 years, and sometime during their lifetime. Each has response options: 4=very likely, 3=somewhat likely, 2=somewhat unlikely, and 1=very unlikely. The mean of the 3 questions was calculated (each combined score has a range of 1 to 4) at each time point. We calculated the change from baseline (T0) to post-intervention (T1), post-intervention (T1) to post-provider visit (T2), and from baseline (T0) to post-provider (T2) by using the mean of the later time point minus the mean of the former time point. The range for change could be from -3 to 3 with higher values meaning an increase in perceived risk.
Outcome measures
| Measure |
Group 2
n=244 Participants
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 1
n=267 Participants
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 3
n=223 Participants
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 4
n=264 Participants
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
|---|---|---|---|---|
|
Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
Change from baseline (T0) to post-intervention (T1)
|
0.15 score on a scale
Standard Deviation 0.78
|
0.21 score on a scale
Standard Deviation 0.74
|
0.14 score on a scale
Standard Deviation 0.81
|
0.08 score on a scale
Standard Deviation 0.77
|
|
Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
Change from post-intervention (T1) to post-provider visit (T2)
|
0.12 score on a scale
Standard Deviation 0.82
|
-0.10 score on a scale
Standard Deviation 0.86
|
0.10 score on a scale
Standard Deviation 0.87
|
0.05 score on a scale
Standard Deviation 0.83
|
|
Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
Change from baseline (T0) to post-provider visit (T2)
|
0.28 score on a scale
Standard Deviation 0.87
|
0.14 score on a scale
Standard Deviation 0.79
|
0.21 score on a scale
Standard Deviation 0.98
|
0.14 score on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: 1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)Population: Only participants who completed the item at each time point under comparison were used in the analysis.
Patients' decision conflict is assessed using the low literacy version of the Decision Conflict Scale, a ten-item instrument that assesses patients' subjective feeling regarding the decision process over five areas. Each item has three response categories (yes, no, unsure). Scores are summed; divided by 10; and multiplied by 25. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\]. Negative change means decision conflict decreased. A decrease in decision conflict is a better outcome.
Outcome measures
| Measure |
Group 2
n=244 Participants
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 1
n=267 Participants
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 3
n=222 Participants
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 4
n=263 Participants
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
|---|---|---|---|---|
|
Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
Change from baseline (T0) to post-provider visit (T2)
|
-41.6 score on a scale
Standard Deviation 28.8
|
-39.0 score on a scale
Standard Deviation 29.2
|
-37.9 score on a scale
Standard Deviation 29.2
|
-39.3 score on a scale
Standard Deviation 29.2
|
|
Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
Change from baseline (T0) to post-intervention (T1)
|
-42.4 score on a scale
Standard Deviation 27.6
|
-36.6 score on a scale
Standard Deviation 28.9
|
-37.1 score on a scale
Standard Deviation 27.7
|
-40.3 score on a scale
Standard Deviation 28.4
|
|
Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
Change from post-intervention (T1) to post-provider visit (T2)
|
-0.76 score on a scale
Standard Deviation 9.53
|
-1.60 score on a scale
Standard Deviation 12.1
|
-2.32 score on a scale
Standard Deviation 11.6
|
-0.27 score on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]Patients answered four items assessing the extent to which they were involved in the decision-making process. Each item had response options: 1= A lot; 2=Some; 3=A little; 4=Not at all. Each item was analyzed separately and responses "A lot", "Some" and "A little" were considered "enough" and received 1 point. The response "Not at all" was considered "not enough" and received 0 points.
Outcome measures
| Measure |
Group 2
n=262 Participants
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 1
n=290 Participants
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 3
n=247 Participants
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 4
n=285 Participants
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
|---|---|---|---|---|
|
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4
How much did you and your provider talk about the reasons you might want to have a colonoscopy? · Enough
|
178 Participants
|
203 Participants
|
164 Participants
|
201 Participants
|
|
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4
How much did you and your provider talk about the reasons you might want to have a colonoscopy? · Not enough
|
28 Participants
|
26 Participants
|
35 Participants
|
35 Participants
|
|
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4
How much did you and your provider talk about the reasons you might want to have a colonoscopy? · Unknown or not reported
|
56 Participants
|
61 Participants
|
48 Participants
|
49 Participants
|
|
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4
How much did you and your provider talk about the reasons you might not want to have a colonoscopy? · Enough
|
89 Participants
|
106 Participants
|
91 Participants
|
119 Participants
|
|
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4
How much did you and your provider talk about the reasons you might not want to have a colonoscopy? · Not enough
|
117 Participants
|
123 Participants
|
108 Participants
|
117 Participants
|
|
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4
How much did you and your provider talk about the reasons you might not want to have a colonoscopy? · Unknown or not reported
|
56 Participants
|
61 Participants
|
48 Participants
|
49 Participants
|
|
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4
How much did you and your provider talk about the reasons you might want to do a stool test? · Enough
|
146 Participants
|
160 Participants
|
146 Participants
|
173 Participants
|
|
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4
How much did you and your provider talk about the reasons you might want to do a stool test? · Not enough
|
60 Participants
|
69 Participants
|
52 Participants
|
63 Participants
|
|
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4
How much did you and your provider talk about the reasons you might want to do a stool test? · Unknown or not reported
|
56 Participants
|
61 Participants
|
49 Participants
|
49 Participants
|
|
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4
How much did you and your provider talk about the reasons you might not want to do a stool test? · Enough
|
92 Participants
|
108 Participants
|
93 Participants
|
111 Participants
|
|
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4
How much did you and your provider talk about the reasons you might not want to do a stool test? · Not enough
|
114 Participants
|
121 Participants
|
106 Participants
|
124 Participants
|
|
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4
How much did you and your provider talk about the reasons you might not want to do a stool test? · Unknown or not reported
|
56 Participants
|
61 Participants
|
48 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]A single-item measure taken from the Colon Cancer Testing Decision Quality Worksheet v.2.0 assessing if the patients' primary care provider asked them which type of colon cancer screening test they wanted.
Outcome measures
| Measure |
Group 2
n=262 Participants
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 1
n=290 Participants
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 3
n=247 Participants
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 4
n=285 Participants
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
|---|---|---|---|---|
|
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality Instrument
Yes
|
134 Participants
|
152 Participants
|
130 Participants
|
159 Participants
|
|
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality Instrument
No
|
72 Participants
|
76 Participants
|
69 Participants
|
77 Participants
|
|
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality Instrument
Unknown or not reported
|
56 Participants
|
62 Participants
|
48 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]A 3-item measure assessing how much effort was made by their provider to: explain colon cancer screening, ask for screening preferences, and incorporate those preferences into the decision. Response options ranged from 0="No effort was made" to 9="Every effort was made". The three items were summed and a mean was calculated. Scores can range from 0-9. A higher score indicates more perceived shared decision making. Higher perceived shared decision making is a better outcome.
Outcome measures
| Measure |
Group 2
n=262 Participants
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 1
n=290 Participants
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 3
n=247 Participants
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 4
n=285 Participants
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
|---|---|---|---|---|
|
Participant's Average Perception of Shared-Decision Making as Assessed by CollaboRATE
|
6.3 score on a scale
Standard Deviation 3.2
|
6.4 score on a scale
Standard Deviation 3.1
|
6.3 score on a scale
Standard Deviation 3.2
|
6.5 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 6 months after patient enrollmentA FIT, colonoscopy, or other CRC screening test ordered within 6 months of each participants' enrollment based on documentation in the electronic health record (EHR).
Outcome measures
| Measure |
Group 2
n=262 Participants
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 1
n=290 Participants
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 3
n=247 Participants
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 4
n=285 Participants
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
|---|---|---|---|---|
|
Number of Participants With Orders for a Colorectal Cancer Screening (CRC) Test
NO order for CRC screening test
|
84 Participants
|
89 Participants
|
79 Participants
|
84 Participants
|
|
Number of Participants With Orders for a Colorectal Cancer Screening (CRC) Test
YES order for CRC screening test
|
178 Participants
|
201 Participants
|
168 Participants
|
201 Participants
|
SECONDARY outcome
Timeframe: 6 months after patient enrollmentOpening the provider notification sent for each patient was assessed by reviewing the electronic health record (EHR).
Outcome measures
| Measure |
Group 2
n=262 Participants
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 1
n=290 Participants
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification without personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
|
Group 3
n=247 Participants
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Decision aid without personalized message: The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
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Group 4
n=285 Participants
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Decision aid with personalized message: The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification with personalized message: Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
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Number of Providers Who Open Their Provider Notification
Provider notification was opened
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161 Participants
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181 Participants
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153 Participants
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175 Participants
|
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Number of Providers Who Open Their Provider Notification
Provider notification was not opened
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33 Participants
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34 Participants
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29 Participants
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28 Participants
|
|
Number of Providers Who Open Their Provider Notification
Provider notification was not sent
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4 Participants
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7 Participants
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7 Participants
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2 Participants
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Number of Providers Who Open Their Provider Notification
Unable to determine if provider notification was opened
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64 Participants
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68 Participants
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58 Participants
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80 Participants
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Adverse Events
Group 1
Group 2
Group 3
Group 4
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Peter H. Schwartz, MD, PhD
Trustees of Indiana University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place