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

NCT ID: NCT06597955

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-28
• Study Completion Date: 2026-07-31

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.

Conditions

Colorectal Cancer Screening

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Healthcare system leadership, providers, and staff

Leadership, providers, and staff at the project team's affiliated healthcare system

No interventions assigned to this group

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University Health

OTHER

Sponsor Role: collaborator

Eskenazi Health

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Peter Schwartz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter H. Schwartz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Teresa M. Damush, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

SDM-2022C2-28397

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

22517

Identifier Type: -

Identifier Source: org_study_id