Information With or Without Numbers For Optimizing Reasoning About Medical Decisions

Completed · Not applicable

Conditions studied: Colorectal Cancer Screening

In brief

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.

Key facts

Study ID

NCT02477553

Run by

Indiana University

People needed

728

Starts

2015-06-01

Expected to finish

2017-08-25

Last updated by the study team

2019-07-29

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• undergoing workup for symptoms consistent with colon cancer, such as weight loss or rectal bleeding
• 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
• are unable to speak and read English.

Where it is running

• Indiana University — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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