Clinical trial NCT02477553: Information With or Without Numbers For Optimizing Reasoning About Medical Decisions
Official title: Describing the Comparative Effectiveness of Colorectal Cancer Screening Tests: The Impact of Quantitative Information
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Keywords: decision aid
cancer screening
colorectal neoplasm
decision making
risk communication
numeracy
health literacy
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-06-23
Enrollment: 728
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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.

Primary outcomes:
measure: Colorectal Cancer (CRC) Screening Completion
timeFrame: 6 months post intervention
measure: Colorectal Cancer (CRC) Screening Intention: Change From Baseline to Post-intervention
timeFrame: 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])
Secondary outcomes:
measure: Perceived Risk of Colorectal Cancer (CRC): Change From Baseline to Post-intervention
timeFrame: 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])
measure: Perceived Benefits of Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) and Colonoscopy: Change From Baseline to Post-intervention
timeFrame: 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])
measure: Perceived Barriers to Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) or Colonoscopy: Change From Baseline to Post-intervention
timeFrame: 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])
measure: Knowledge of Colorectal Cancer (CRC) and Colorectal Cancer Screening: Change in Number of Correct Answers From Baseline to Post-intervention
timeFrame: 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])
measure: Decision Conflict: Change in Conflict From Baseline to Post-intervention
timeFrame: 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])
measure: Number of Patients With High and Low Subjective Numeracy
timeFrame: 1 day
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Peter H Schwartz, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: