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Clinical Trials/NCT06597955
NCT06597955
Enrolling By Invitation
Not Applicable

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

Indiana University1 site in 1 country400 target enrollmentAugust 28, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer Screening
Sponsor
Indiana University
Enrollment
400
Locations
1
Primary Endpoint
Shared decision making
Status
Enrolling By Invitation
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 28, 2024
End Date
July 1, 2026
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Peter Schwartz

Principal Investigator

Indiana University

Eligibility Criteria

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.

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

Outcomes

Primary Outcomes

Shared decision making

Time Frame: 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

Time Frame: 18 months

Interviews with healthcare system leadership, clinicians, staff and patients

Study Sites (1)

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