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

Colorectal Cancer Screening Decision Support Tool in the Primary Care Bundle Questionnaire

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.

Study Overview

• Status: Completed
• Conditions: Decision Aid; Colorectal Cancer Screening; Shared Decision Making; Colorectal Cancer Control and Prevention
• Intervention / Treatment: Other: CRC decision tool

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 Type: Interventional
• Enrollment (Actual): 9205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Mass General Brigham

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CRC decision tool; intervention arm	Other: CRC decision tool; CRC decision tool included in the primary care bundle questionnaire; Other Names: intervention
No Intervention: control; control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRC screening completion	Assessment of electronic health record data to determine completion of CRC screening by any modality	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Study Director: Karen Sepucha, PhD, MGH; Principal Investigator: Karen Blumenthal, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Actual): January 1, 2026
• Study Completion (Actual): January 1, 2026

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; shared decision making; colorectal cancer screening; electronic health record; decision tool
• 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; Investigative Techniques; Methods
• Other Study ID Numbers: 2024P000687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: deidentified data will be made available upon request
• IPD Sharing Time Frame: The IPD will be available once the study is completed and after approval by the IRB.
• IPD Sharing Access Criteria: Requests will be reviewed by the PI and the IRB.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No