Large-Scale Implementation of a Decision Aid About Colorectal Cancer Screening

• Conditions: Colorectal Cancer Screening

• Registration Number: NCT06597955
• Lead Sponsor: Indiana University

Brief Summary

The goal of the project is to improve shared decision making and increase uptake of colorectal cancer (CRC) screening by facilitating the implementation of a decision aid about CRC and screening options in two healthcare systems in Indiana.

Detailed Description

This implementation project is putting a shared decision making approach into routine practice to help patients make informed decisions about colorectal cancer(CRC) screening. Regular screening is recommended for adults ages 45 - 75 years old, and there are multiple approved tests for individuals at average risk for colorectal cancer. A video-based decision aid about CRC screening was developed and tested in a previous study by the project team. The study showed that viewing the decision aid had positive effects on measures directly related to shared decision making (knowledge, decision conflict) as well as intent to undergo CRC screening. The project team is working with two healthcare systems to provide patients who are eligible for CRC screening access to the decision aid, training staff and clinicians how to use the decision aid to support shared decision making for CRC screening, working with healthcare system leaders to support the staff and clinicians, and providing support for the ongoing use of the decision aid.

Study Timeline

• Study Start: 2024-08-28
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04
• Primary Completion: 2026-04
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Healthcare system participants will be eligible if they are employed by one of the project team's partner healthcare systems
• Patient participants will be eligible if they are considered due for colorectal cancer screening by the healthcare systems' criteria.

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Exclusion Criteria

Patient participants will be excluded if they:

• are not between ages of 45 - 75 years old
• self-report that they no longer receive primary care at either of the project team's partner healthcare systems
• self-report that they are not due for colorectal cancer screening (had colonoscopy within the past 10 years, sigmoidoscopy in the last 5 years, FIT in the past year, or Cologuard in the past 3 years)
• are unable to speak or read English or Spanish

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shared decision making	18 months	Shared decision making will be assessed using the CollaboRATE scale. CollaboRATE is a three-item measure that assesses three key areas of shared decision making; 1) explaining the health issue; 2) asking for patient preferences; and 3) incorporating patient preferences into the decision. Each item uses 0 - 9 likert response options ranging from 0 = "no effort was made" to 9 = "every effort was made". The higher the score the better the shared decision making.
Implementation of decision aid	18 months	Interviews with healthcare system leadership, clinicians, staff and patients

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States