INFORM: Information With or Without Numbers For Optimizing Reasoning About Medical Decisions

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02477553
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 728
• Location: 1
• Arms: 2
• Duration (Months): 26.8
• Patients Per Site Per Month: 27.2

Study Details

Study Description

Brief Summary

Experts believe that increasing the low uptake of screening for colorectal cancer (CRC) requires educating patients about all approved tests and helping them choose one that fits their preferences. As one motto puts it: "The best test is the one that gets done." Screening tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less invasive and less sensitive (e.g., fecal immunochemical testing (FIT)). But it is unclear how best to educate patients about the options and the tradeoffs involved. Some guidelines recommend that decision aids, a promising tool in this area, provide patients with detailed quantitative information, including baseline risk, risk reduction, and chance of negative outcomes. But this sort of "comparative effectiveness" data can confuse patients, especially those with limited mathematical ability. Previous studies have not measured the effect of providing quantitative information to patients with varying levels of ability or interest or asked them whether such data is essential for their decision-making.

The investigators will conduct a clinical trial to determine the impact on patients who view a decision aid (DA) that includes quantitative information versus a DA without such data. The investigators will also seek to determine whether numeracy moderates the effect of quantitative information.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Screening	Behavioral: DA - Quantitative; Behavioral: DA - Verbal	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 728 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Describing the Comparative Effectiveness of Colorectal Cancer Screening Tests: The Impact of Quantitative Information
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Aug 25, 2017
• Actual Study Completion Date: Aug 25, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Quantitative Subjects view: 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. 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.	Behavioral: DA - Quantitative
Active Comparator: Verbal Subjects view: 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. 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.	Behavioral: DA - Verbal

Outcome Measures

Primary Outcome Measures

1. Colorectal Cancer (CRC) Screening Completion [6 months post intervention]

   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.

2. Colorectal Cancer (CRC) Screening Intention: Change From Baseline to Post-intervention [1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])]

   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.

Secondary Outcome Measures

1. Perceived Risk of Colorectal Cancer (CRC): Change From Baseline to Post-intervention [1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])]

   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.

2. Perceived Benefits of Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) and Colonoscopy: Change From Baseline to Post-intervention [1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])]

   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.

3. Perceived Barriers to Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) or Colonoscopy: Change From Baseline to Post-intervention [1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])]

   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.

4. Knowledge of Colorectal Cancer (CRC) and Colorectal Cancer Screening: Change in Number of Correct Answers From Baseline to Post-intervention [1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])]

   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.

5. Decision Conflict: Change in Conflict From Baseline to Post-intervention [1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])]

   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.

6. Number of Patients With High and Low Subjective Numeracy [1 day]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Have not had colonoscopy performed in last 10 years, sigmoidoscopy in last 5 years, or fecal occult blood testing (including FIT) in last 1 year and

2. have a scheduled appointment or due to schedule an appointment with a healthcare practitioner at our performance sites.

Exclusion Criteria:

1. undergoing workup for symptoms consistent with colon cancer, such as weight loss or rectal bleeding

2. have a diagnosis or medical history conferring elevated risk for CRC including polypectomy or colon cancer, inflammatory bowel disease, certain inherited syndromes, or a significant family history of CRC

3. are unable to speak and read English.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University	Indianapolis	Indiana	United States	462020

Sponsors and Collaborators

• Indiana University
• Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Peter H Schwartz, M.D., Ph.D, Indiana University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 31, 2015

More Information

Publications

None provided.

• Responsible Party: Peter Schwartz, Assistant Professor of Medicine, Indiana University
• ClinicalTrials.gov Identifier: NCT02477553
• Other Study ID Numbers: 1502774679; CDR-1403-11040
• First Posted: Jun 23, 2015
• Last Update Posted: Jul 29, 2019
• Last Verified: Jul 1, 2019

• Keywords provided by Peter Schwartz, Assistant Professor of Medicine, Indiana University: decision aid; cancer screening; colorectal neoplasm; decision making; risk communication; numeracy; health literacy
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

Participant Flow

Recruitment Details	Participants were recruited from primary care practices between June 2015 and December 2016.

Arm/Group Title	Verbal	Quantitative
Arm/Group Description	Subjects view: 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. 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	Subjects view: 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. 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
Period Title: Overall Study
STARTED	364	364
COMPLETED	344	344
NOT COMPLETED	20	20

Baseline Characteristics

Arm/Group Title	Verbal	Quantitative	Total
Arm/Group Description	Subjects view: 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. 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	Subjects view: 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. 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 of all reporting groups
Overall Participants	344	344	688
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.71 (6.49)	58.83 (6.66)	58.77 (6.57)
Sex: Female, Male (Count of Participants)
Female	206 59.9%	198 57.6%	404 58.7%
Male	138 40.1%	146 42.4%	284 41.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	12 3.5%	5 1.5%	17 2.5%
Not Hispanic or Latino	317 92.2%	329 95.6%	646 93.9%
Unknown or Not Reported	15 4.4%	10 2.9%	25 3.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.3%	1 0.3%	2 0.3%
Asian	3 0.9%	4 1.2%	7 1%
Native Hawaiian or Other Pacific Islander	1 0.3%	1 0.3%	2 0.3%
Black or African American	98 28.5%	86 25%	184 26.7%
White	205 59.6%	232 67.4%	437 63.5%
More than one race	16 4.7%	5 1.5%	21 3.1%
Unknown or Not Reported	20 5.8%	15 4.4%	35 5.1%
Education (Count of Participants)
Less than high school	25 7.3%	15 4.4%	40 5.8%
High school graduate/GED	75 21.8%	89 25.9%	164 23.8%
Some college/technical school/trade school	92 26.7%	80 23.3%	172 25%
Associate's degree	35 10.2%	31 9%	66 9.6%
Bachelor's degree	58 16.9%	68 19.8%	126 18.3%
Professional or graduate degree	44 12.8%	51 14.8%	95 13.8%
Unknown or Not Reported	15 4.4%	10 2.9%	25 3.6%
Relationship (Count of Participants)
Single	71 20.6%	75 21.8%	146 21.2%
Married/living with partner	170 49.4%	168 48.8%	338 49.1%
Seperated	12 3.5%	10 2.9%	22 3.2%
Divorced	61 17.7%	73 21.2%	134 19.5%
Widowed	19 5.5%	8 2.3%	27 3.9%
Unknown or Not Reported	11 3.2%	10 2.9%	21 3.1%
Employed? (Count of Participants)
Yes	158 45.9%	188 54.7%	346 50.3%
No	170 49.4%	146 42.4%	316 45.9%
Unknown or Not Reported	16 4.7%	10 2.9%	26 3.8%
Health Insurance? (Count of Participants)
Yes	315 91.6%	317 92.2%	632 91.9%
No	13 3.8%	17 4.9%	30 4.4%
Unknown or Not Reported	16 4.7%	10 2.9%	26 3.8%
Insurance Lapse over past 12 months? (Count of Participants)
Yes	51 14.8%	46 13.4%	97 14.1%
No	278 80.8%	286 83.1%	564 82%
Unknown or Not Reported	15 4.4%	12 3.5%	27 3.9%
Self-reported health status at baseline (Count of Participants)
Excellent	23 6.7%	33 9.6%	56 8.1%
Very good	87 25.3%	111 32.3%	198 28.8%
Good	144 41.9%	133 38.7%	277 40.3%
Fair	63 18.3%	51 14.8%	114 16.6%
Poor	11 3.2%	6 1.7%	17 2.5%
Unknown or Not Reported	16 4.7%	10 2.9%	26 3.8%
Income Level (yearly) (Count of Participants)
Less than $20,000	95 27.6%	80 23.3%	175 25.4%
$20,000 - $39,999	59 17.2%	73 21.2%	132 19.2%
$40,000 - $59,000	37 10.8%	40 11.6%	77 11.2%
$60,000 - $99,999	67 19.5%	63 18.3%	130 18.9%
More than $100,000	47 13.7%	56 16.3%	103 15%
Unknown or Not Reported	39 11.3%	32 9.3%	71 10.3%
Income Level Subjective (Count of Participants)
Are comfortable	129 37.5%	145 42.2%	274 39.8%
Have just enough to make ends meet	117 34%	125 36.3%	242 35.2%
Do not have enough to make ends meet	80 23.3%	59 17.2%	139 20.2%
Unknown or Not Reported	18 5.2%	15 4.4%	33 4.8%

Outcome Measures

1. Primary Outcome

Title	Colorectal Cancer (CRC) Screening Completion
Description	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.
Time Frame	6 months post intervention

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Verbal	Quantitative
Arm/Group Description	Subjects view: 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. 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	Subjects view: 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. 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
Measure Participants	332	340
Count of Participants [Participants]	99 28.8%	99 28.8%

2. Primary Outcome

Title	Colorectal Cancer (CRC) Screening Intention: Change From Baseline to Post-intervention
Description	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.
Time Frame	1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Verbal	Quantitative
Arm/Group Description	Subjects view: 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. 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	Subjects view: 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. 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
Measure Participants	342	342
Mean (Standard Deviation) [units on a scale]	0.37 (0.84)	0.47 (0.84)

3. Secondary Outcome

Title	Perceived Risk of Colorectal Cancer (CRC): Change From Baseline to Post-intervention
Description	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.
Time Frame	1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])

Outcome Measure Data

Analysis Population Description

All participants with baseline (T0) and post-intervention (T1) perceived risk items. Missing responses were not used.

Arm/Group Title	Verbal	Quantitative
Arm/Group Description	Subjects view: 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. 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	Subjects view: 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. 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
Measure Participants	333	336
Mean (Standard Deviation) [units on a scale]	-0.08 (0.70)	0.08 (0.81)

4. Secondary Outcome

Title	Perceived Benefits of Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) and Colonoscopy: Change From Baseline to Post-intervention
Description	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.
Time Frame	1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Verbal	Quantitative
Arm/Group Description	Subjects view: 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. 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	Subjects view: 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. 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
Measure Participants	324	332
Colonoscopy Benefits	0.44 (0.62)	0.47 (0.62)
FIT Benefits	0.44 (0.76)	0.52 (0.73)

5. Secondary Outcome

Title	Perceived Barriers to Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) or Colonoscopy: Change From Baseline to Post-intervention
Description	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.
Time Frame	1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Verbal	Quantitative
Arm/Group Description	Subjects view: 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. 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	Subjects view: 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. 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
Measure Participants	322	330
Colonoscopy Barriers	-0.18 (0.47)	-0.13 (0.45)
FIT Barriers	-0.18 (0.55)	-0.21 (0.54)

6. Secondary Outcome

Title	Knowledge of Colorectal Cancer (CRC) and Colorectal Cancer Screening: Change in Number of Correct Answers From Baseline to Post-intervention
Description	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.
Time Frame	1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])

Outcome Measure Data

Analysis Population Description

All participants who completed at least 7 knowledge questions at both baseline (T0) and post-intervention (T1).

Arm/Group Title	Verbal	Quantitative
Arm/Group Description	Subjects view: 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. 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	Subjects view: 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. 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
Measure Participants	342	342
Mean (Standard Deviation) [correct answers]	3.13 (2.99)	3.66 (2.82)

7. Secondary Outcome

Title	Decision Conflict: Change in Conflict From Baseline to Post-intervention
Description	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.
Time Frame	1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])

Outcome Measure Data

Analysis Population Description

All participants with at least 11 responses to the 16-item Decision Conflict Scale at both baseline (T0) and post-intervention (T1).

Arm/Group Title	Verbal	Quantitative
Arm/Group Description	Subjects view: 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. 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	Subjects view: 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. 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
Measure Participants	316	326
Mean (Standard Deviation) [units on a scale]	-19.3 (17.77)	-22.0 (19.25)

8. Secondary Outcome

Title	Number of Patients With High and Low Subjective Numeracy
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Subjects who completed the Subjective Numeracy Scale.

Arm/Group Title	Verbal	Quantitative
Arm/Group Description	Subjects view: 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. 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	Subjects view: 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. 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
Measure Participants	336	337
Low Subjective Numeracy	172 50%	160 46.5%
High Subjective Numercy	164 47.7%	177 51.5%

Adverse Events

Time Frame	2 years
Arm/Group Title	Quantitative		Verbal
Arm/Group Description	Subjects view: 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. 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		Subjects view: 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. 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
All Cause Mortality
	Quantitative		Verbal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/364 (0%)		0/364 (0%)
Serious Adverse Events
	Quantitative		Verbal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/364 (0%)		0/364 (0%)
Other (Not Including Serious) Adverse Events
	Quantitative		Verbal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/364 (0%)		0/364 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.