Information With or Without Numbers For Optimizing Reasoning About Medical Decisions

NCT02477553 | Completed Results

• 2 other identifiers: 1502774679CDR-1403-11040
• Study Type: interventional
• Target: 728
• Locations: 1 country
• Sites: 1

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

Keywords

decision aid; cancer screening; colorectal neoplasm; decision making; risk communication; numeracy; health literacy

Outcome Measures

Primary Outcomes (2)

• Colorectal Cancer (CRC) Screening Completion

  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.

  6 months post intervention

• Colorectal Cancer (CRC) Screening Intention: Change From Baseline to Post-intervention

  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.

  1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])

Secondary Outcomes (6)

• 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])

• 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])

• 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])

Study Arms (2)

Quantitative

EXPERIMENTAL

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.

Behavioral: DA - Quantitative

Verbal

ACTIVE COMPARATOR

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.

Behavioral: DA - Verbal

Interventions

DA - Quantitative BEHAVIORAL

Quantitative

DA - Verbal BEHAVIORAL

Verbal

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Indiana University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 462020, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Peter H. Schwartz, M.D., Ph.D.
• Organization: Indiana University

phschwar@iu.edu

317-278-4037

Study Officials

• Peter H Schwartz, M.D., Ph.D

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 23, 2015
• Study Start: June 1, 2015
• Primary Completion: August 25, 2017
• Study Completion: August 25, 2017
• Last Updated: July 29, 2019
• Results First Posted: July 29, 2019

Record last verified: 2019-07

Locations

US (1)