Describing the Comparative Effectiveness of Colorectal Cancer Screening Tests: The Impact of Quantitative Information
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer Screening
- Sponsor
- Indiana University
- Enrollment
- 728
- Locations
- 1
- Primary Endpoint
- Colorectal Cancer (CRC) Screening Intention: Change From Baseline to Post-intervention
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Peter Schwartz
Assistant Professor of Medicine
Indiana University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Colorectal Cancer (CRC) Screening Intention: Change From Baseline to Post-intervention
Time Frame: 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.
Colorectal Cancer (CRC) Screening Completion
Time Frame: 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.
Secondary Outcomes
- 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]))
- 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]))
- 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]))
- 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]))
- 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]))
- Number of Patients With High and Low Subjective Numeracy(1 day)