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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1111 participants

Primary outcome timeframe

6 months after patient enrollment

Results posted on

2024-12-13

Participant Flow

Patients were recruited from primary care practices between January 2021 and November 2022.

Participant milestones

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

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

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 enrollment

Patients' 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

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 enrollment

Decision 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

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 enrollment

Colorectal 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

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

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

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

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

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

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

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

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

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 enrollment

A 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

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 enrollment

Opening the provider notification sent for each patient was assessed by reviewing the electronic health record (EHR).

Outcome measures

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 Providers Who Open Their Provider Notification
Provider notification was opened
161 Participants
181 Participants
153 Participants
175 Participants
Number of Providers Who Open Their Provider Notification
Provider notification was not opened
33 Participants
34 Participants
29 Participants
28 Participants
Number of Providers Who Open Their Provider Notification
Provider notification was not sent
4 Participants
7 Participants
7 Participants
2 Participants
Number of Providers Who Open Their Provider Notification
Unable to determine if provider notification was opened
64 Participants
68 Participants
58 Participants
80 Participants

Adverse Events

Group 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group 3

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group 4

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 317-278-4037

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place