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

NCT ID: NCT06625983

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-16
• Study Completion Date: 2026-08-01

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).

Conditions

Colorectal Cancer Control and Prevention; Colorectal Cancer Screening; Shared Decision Making; Decision Aid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

CRC decision tool

intervention arm

Group Type: EXPERIMENTAL

CRC decision tool

Intervention Type: OTHER

CRC decision tool included in the primary care bundle questionnaire

control

control arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CRC decision tool

CRC decision tool included in the primary care bundle questionnaire

Intervention Type: OTHER

Other Intervention Names

intervention

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Karen J. Blumenthal, MD, MPH

Internist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Blumenthal, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Karen Sepucha, PhD

Role: STUDY_DIRECTOR

MGH

Locations

Mass General Brigham

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Suzanne Suzanne Brodney

Role: CONTACT

sbrodney@mgh.harvard.edu

6176434266

Facility Contacts

Suzanne Brodney

Role: primary

sbrodney@mgh.harvard.edu

6176434266

Other Identifiers

2024P000687

Identifier Type: -

Identifier Source: org_study_id