Trial Outcomes & Findings for Information With or Without Numbers For Optimizing Reasoning About Medical Decisions (NCT NCT02477553)
NCT ID: NCT02477553
Last Updated: 2019-07-29
Results Overview
Completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening test within 6 months of enrollment, based on documentation in the participants' electronic health record. If a patient completed both screening tests and the colonoscopy was a follow-up to a positive FIT, they were considered having completed a FIT only. If the FIT was negative and the patient still had a colonoscopy, they were considered to have completed both tests.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
728 participants
Primary outcome timeframe
6 months post intervention
Results posted on
2019-07-29
Participant Flow
Participants were recruited from primary care practices between June 2015 and December 2016.
Participant milestones
| Measure |
Verbal
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
Decision Aid (DA) - Verbal
|
Quantitative
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
Decision Aid (DA) - Quantitative
|
|---|---|---|
|
Overall Study
STARTED
|
364
|
364
|
|
Overall Study
COMPLETED
|
344
|
344
|
|
Overall Study
NOT COMPLETED
|
20
|
20
|
Reasons for withdrawal
| Measure |
Verbal
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
Decision Aid (DA) - Verbal
|
Quantitative
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
Decision Aid (DA) - Quantitative
|
|---|---|---|
|
Overall Study
Screening up-to-date
|
12
|
13
|
|
Overall Study
No MD visit
|
1
|
1
|
|
Overall Study
Workup consistent w/CRC
|
1
|
1
|
|
Overall Study
Technical issues with intervention
|
2
|
0
|
|
Overall Study
Elevated risk for CRC
|
2
|
2
|
|
Overall Study
MD advised against screening
|
1
|
3
|
|
Overall Study
patient deceased
|
1
|
0
|
Baseline Characteristics
Information With or Without Numbers For Optimizing Reasoning About Medical Decisions
Baseline characteristics by cohort
| Measure |
Verbal
n=344 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Verbal
|
Quantitative
n=344 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Quantitative
|
Total
n=688 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.71 years
STANDARD_DEVIATION 6.49 • n=5 Participants
|
58.83 years
STANDARD_DEVIATION 6.66 • n=7 Participants
|
58.77 years
STANDARD_DEVIATION 6.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
206 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
404 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
284 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
317 Participants
n=5 Participants
|
329 Participants
n=7 Participants
|
646 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
98 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
205 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
437 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
16 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Education
Less than high school
|
25 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Education
High school graduate/GED
|
75 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Education
Some college/technical school/trade school
|
92 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Education
Associate's degree
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Education
Bachelor's degree
|
58 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Education
Professional or graduate degree
|
44 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Education
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Relationship
Single
|
71 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Relationship
Married/living with partner
|
170 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
338 Participants
n=5 Participants
|
|
Relationship
Seperated
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Relationship
Divorced
|
61 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Relationship
Widowed
|
19 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Relationship
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Employed?
Yes
|
158 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
346 Participants
n=5 Participants
|
|
Employed?
No
|
170 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
316 Participants
n=5 Participants
|
|
Employed?
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Health Insurance?
Yes
|
315 Participants
n=5 Participants
|
317 Participants
n=7 Participants
|
632 Participants
n=5 Participants
|
|
Health Insurance?
No
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Health Insurance?
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Insurance Lapse over past 12 months?
Yes
|
51 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Insurance Lapse over past 12 months?
No
|
278 Participants
n=5 Participants
|
286 Participants
n=7 Participants
|
564 Participants
n=5 Participants
|
|
Insurance Lapse over past 12 months?
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Self-reported health status at baseline
Excellent
|
23 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Self-reported health status at baseline
Very good
|
87 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Self-reported health status at baseline
Good
|
144 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Self-reported health status at baseline
Fair
|
63 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Self-reported health status at baseline
Poor
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Self-reported health status at baseline
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Income Level (yearly)
Less than $20,000
|
95 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Income Level (yearly)
$20,000 - $39,999
|
59 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Income Level (yearly)
$40,000 - $59,000
|
37 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Income Level (yearly)
$60,000 - $99,999
|
67 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Income Level (yearly)
More than $100,000
|
47 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Income Level (yearly)
Unknown or Not Reported
|
39 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Income Level Subjective
Are comfortable
|
129 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Income Level Subjective
Have just enough to make ends meet
|
117 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Income Level Subjective
Do not have enough to make ends meet
|
80 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Income Level Subjective
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post interventionPopulation: All participants who agreed to having their electronic health record (EHR) checked by the researchers. There were 12 participants in the Verbal arm and 4 participants in the Quantitative arm who would not agree for their EHRs to be checked by the researchers; therefore, assessment of uptake was not performed with those participants.
Completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening test within 6 months of enrollment, based on documentation in the participants' electronic health record. If a patient completed both screening tests and the colonoscopy was a follow-up to a positive FIT, they were considered having completed a FIT only. If the FIT was negative and the patient still had a colonoscopy, they were considered to have completed both tests.
Outcome measures
| Measure |
Verbal
n=332 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Verbal
|
Quantitative
n=340 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Quantitative
|
|---|---|---|
|
Colorectal Cancer (CRC) Screening Completion
|
99 Participants
|
99 Participants
|
PRIMARY outcome
Timeframe: 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])Population: All participants with both baseline and post-intervention responses to CRC screening intent items. There were 2 participants in each arm who did not respond to at least one of the intent items.
Multiple choice question assessing subject's intention in getting a CRC screening test in the next 6 months. The response options were: 5=Definitely, 4=Probably, 3=May or may not, 2=Probably not, and 1=Definitely not. Higher positive change means CRC screening intention increased. Increased intention to be screened is a better outcome.
Outcome measures
| Measure |
Verbal
n=342 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Verbal
|
Quantitative
n=342 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Quantitative
|
|---|---|---|
|
Colorectal Cancer (CRC) Screening Intention: Change From Baseline to Post-intervention
|
0.37 units on a scale
Standard Deviation 0.84
|
0.47 units on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])Population: All participants with baseline (T0) and post-intervention (T1) perceived risk items. Missing responses were not used.
Multiple choice questions assessing subject's 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 had 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 baseline and post-intervention and then change from baseline was calculated using the mean at post-intervention minus the mean at baseline. The range for change could be from -3 to 3 with higher values meaning an increase in perceived risk which is a better outcome.
Outcome measures
| Measure |
Verbal
n=333 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Verbal
|
Quantitative
n=336 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Quantitative
|
|---|---|---|
|
Perceived Risk of Colorectal Cancer (CRC): Change From Baseline to Post-intervention
|
-0.08 units on a scale
Standard Deviation 0.70
|
0.08 units on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])Population: Participants who completed both the baseline and post-intervention benefit questions. For colonoscopy, it was 324 in Verbal and 332 in Quantitative. For FIT, it was 320 in Verbal and 330 in Quantitative.
Assessed separately for colonoscopy (4 questions) and FIT (4 questions), using items drawn from validated scales for measuring benefits and self-efficacy of colonoscopy and FIT. All items had Likert-type response options where 5=strongly agree to 1=strongly disagree. Mean values were calculated within each set of questions (each combined score has a range of 1 to 5) at baseline and post-intervention and then change from baseline was calculated using the mean at post-intervention minus the mean at baseline. The range for change could be -4 to 4 with higher values meaning perceived benefits increased which is a better outcome.
Outcome measures
| Measure |
Verbal
n=324 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Verbal
|
Quantitative
n=332 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Quantitative
|
|---|---|---|
|
Perceived Benefits of Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) and Colonoscopy: Change From Baseline to Post-intervention
Colonoscopy Benefits
|
0.44 units on a scale
Standard Deviation 0.62
|
0.47 units on a scale
Standard Deviation 0.62
|
|
Perceived Benefits of Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) and Colonoscopy: Change From Baseline to Post-intervention
FIT Benefits
|
0.44 units on a scale
Standard Deviation 0.76
|
0.52 units on a scale
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])Population: Participants who completed both the baseline and post-intervention barrier questions. For colonoscopy, it was 322 in Verbal and 330 in Quantitative. For FIT, it was 321 in Verbal and 327 in Quantitative.
Assessed separately for colonoscopy (11 questions) and FIT (9 questions), using items drawn from validated scales for measuring barriers and self-efficacy of colonoscopy and FIT. All items had Likert-type response options where 5=strongly agree to 1=strongly disagree. Mean values were calculated within each set of questions (each combined score has a range of 1 to 5) at baseline and post-intervention and then change from baseline was calculated using the mean at post-intervention minus the mean at baseline. The range for change could be -4 to 4 with lower values meaning perceived barriers decreased which is a better outcome.
Outcome measures
| Measure |
Verbal
n=322 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Verbal
|
Quantitative
n=330 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Quantitative
|
|---|---|---|
|
Perceived Barriers to Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) or Colonoscopy: Change From Baseline to Post-intervention
Colonoscopy Barriers
|
-0.18 units on a scale
Standard Deviation 0.47
|
-0.13 units on a scale
Standard Deviation 0.45
|
|
Perceived Barriers to Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) or Colonoscopy: Change From Baseline to Post-intervention
FIT Barriers
|
-0.18 units on a scale
Standard Deviation 0.55
|
-0.21 units on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])Population: All participants who completed at least 7 knowledge questions at both baseline (T0) and post-intervention (T1).
Qualitative knowledge is assessed with five multiple choice and five 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 10 individual knowledge questions (range, 0-10), and change from baseline was calculated using the knowledge score at post-intervention minus the knowledge score at baseline. The range for change could be 0 to 10 with higher values meaning an increase in knowledge which is a better outcome.
Outcome measures
| Measure |
Verbal
n=342 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Verbal
|
Quantitative
n=342 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Quantitative
|
|---|---|---|
|
Knowledge of Colorectal Cancer (CRC) and Colorectal Cancer Screening: Change in Number of Correct Answers From Baseline to Post-intervention
|
3.13 correct answers
Standard Deviation 2.99
|
3.66 correct answers
Standard Deviation 2.82
|
SECONDARY outcome
Timeframe: 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])Population: All participants with at least 11 responses to the 16-item Decision Conflict Scale at both baseline (T0) and post-intervention (T1).
Decision conflict is assessed using the16-item Decision Conflict Scale. Scores will range from 0 (low decision conflict) to 100 (high decision conflict). Negative change means decision conflict decreased. A decrease in decision conflict is a better outcome.
Outcome measures
| Measure |
Verbal
n=316 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Verbal
|
Quantitative
n=326 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Quantitative
|
|---|---|---|
|
Decision Conflict: Change in Conflict From Baseline to Post-intervention
|
-19.3 units on a scale
Standard Deviation 17.77
|
-22.0 units on a scale
Standard Deviation 19.25
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Subjects who completed the Subjective Numeracy Scale.
Subjective numeracy was determined using the Subjective Numeracy Scale (SNS), a validated instrument that involves 8 Likert-type questions regarding the participant's preference for or dislike of numeric information and their perception of their ability to understand it. Each item has a six-point response option from 1-6. The higher the number, the higher the subjective numeracy. All participants were divided into two groups: above (high numeracy) and below (low numeracy) the median for their total subjective numeracy score.
Outcome measures
| Measure |
Verbal
n=336 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Verbal
|
Quantitative
n=337 Participants
Subjects view:
1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
DA - Quantitative
|
|---|---|---|
|
Number of Patients With High and Low Subjective Numeracy
Low Subjective Numeracy
|
172 Participants
|
160 Participants
|
|
Number of Patients With High and Low Subjective Numeracy
High Subjective Numercy
|
164 Participants
|
177 Participants
|
Adverse Events
Quantitative
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Verbal
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place