Use of a Colorectal Cancer Screening Decision Support Tool in Primary Care

Not Applicable

Recruiting

• Conditions: Colorectal Cancer Control and Prevention; Colorectal Cancer Screening; Shared Decision Making; Decision Aid
• Interventions: Other: CRC decision tool

• Registration Number: NCT06625983
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The research question we pose is, Does a colorectal cancer (CRC) screening decision support tool offered in advance of primary care visits increase CRC screening completion rates? Our work aims to answer this question by evaluating the effectiveness of an MGB decision support tool to 1) promote informed decisions about CRC screening for average risk patients ages 45-75, 2) deploy a decision support tool as part of a primary care bundle questionnaire, and 3) support patients in completing their preferred method of CRC screening.

Detailed Description

As part of usual care, a CRC screening electronic decision support tool developed by Mass General Brigham has been integrated into Epic. This decision support tool is part of routine clinical care and is sent electronically to patients aged 45-75 who receive the Annual Visit Primary Care Screening Bundled Questionnaire in advance of their annual visit. Patients complete the tool on Patient Gateway prior to the visit or via an iPad at the visit. The decision support tool guides patients through the CRC screening options (e.g., FIT, colonoscopy, Cologuard) to help them select their preferred screening method. As part of routine care, the patient will be prompted to complete the tool as part of the bundled questionnaire, and the results will be available in the Epic encounter in the Screenings tab with the other screening bundle responses. The primary care clinician can then discuss the options and/or screening preference with the patient. Depending on what the patient and clinician decide, a CRC screening test may be ordered for the patient. As a secondary outcome, a random sample of 1000 patients will be surveyed to understand their involvement in the decision making process and 300 providers will be surveyed to understand how the decision tool impacted the conversation with the patient. The IRB to conduct surveys of patients and providers was approved by the Mass General Brigham IRB (Protocol # 2024P002568).

Study Timeline

• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-03
• Study Start: 2024-10-16
• Status Verified: 2024-11
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-04-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80000

Inclusion Criteria

Adults aged 45-75 overdue for CRC screening at average risk of CRC have an annual visit scheduled with participating practices

Exclusion Criteria

• high risk of CRC

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRC decision tool	CRC decision tool	intervention arm

Primary Outcome Measures

Name	Time	Method
CRC screening completion	12 months	Assessment of electronic health record data to determine completion of CRC screening by any modality

Secondary Outcome Measures

Name	Time	Method
Provider Experience	During the 6 month intervention phase	Provider-reported question: Did you feel the CRC screening tool informed or affected your conversations in any way?
Shared Decision Making Process Measure	During the 6 month intervention phase	Patient-reported survey question about involvement in the decision making process.

Trial Locations

Locations (1)

Mass General Brigham; 🇺🇸 Boston, Massachusetts, United States