Information With or Without Numbers For Optimizing Reasoning About Medical Decisions

NCT ID: NCT02477553

Last Updated: 2019-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 728 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-08-25

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.

Conditions

Colorectal Cancer Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

DA - Quantitative

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

DA - Verbal

Intervention Type: BEHAVIORAL

Interventions

DA - Quantitative

Intervention Type: BEHAVIORAL

DA - Verbal

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Peter Schwartz

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter H Schwartz, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CDR-1403-11040

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1502774679

Identifier Type: -

Identifier Source: org_study_id