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

Indiana University

Status: Completed

Conditions: Colorectal Cancer Screening

Treatments: Behavioral: DA - Verbal; Behavioral: DA - Quantitative

Study type: Interventional

Funder types: Other

Identifiers

NCT02477553

1502774679

CDR-1403-11040 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 728 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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728 participants in 2 patient groups

Quantitative

Experimental group

Description:

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.

Treatment:

Behavioral: DA - Quantitative

Verbal

Active Comparator group

Description:

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.

Treatment:

Behavioral: DA - Verbal