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

NCT06597955 | Enrolling By Invitation

• 2 other identifiers: 22517SDM-2022C2-28397
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Screening

Keywords

decision aid; implementation; colorectal cancer; shared decision making; electronic health record

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator
• Eskenazi Health: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, 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

Study Officials

• Peter H. Schwartz, MD, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Teresa M. Damush, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: August 28, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

US (1)