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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Cancer Screening

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The participants will be healthcare system primary care patients, and health system leadership, clinicians, and staff involved in primary care.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthcare system leadership, providers, and staff; Leadership, providers, and staff at the project team's affiliated healthcare system
Patients due for colorectal cancer screening; Patients who are considered due for colorectal cancer screening prior to a scheduled appointment with a primary care provider at the project team's affiliated healthcare system and completed the appointment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shared decision making	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.	18 months
Implementation of decision aid	Interviews with healthcare system leadership, clinicians, staff and patients	18 months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Indiana University Health; Eskenazi Health
• Investigators: Principal Investigator: Peter H. Schwartz, MD, PhD, Indiana University; Principal Investigator: Teresa M. Damush, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: colorectal cancer; shared decision making; implementation; decision aid; electronic health record
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 22517; SDM-2022C2-28397 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No