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

NCT06625983 | Recruiting

• 1 other identifier: 2024P000687
• Study Type: interventional
• Target: 80,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

colorectal cancer screening; shared decision making; electronic health record; randomized controlled trial; decision tool

Outcome Measures

Primary Outcomes (1)

• CRC screening completion

  Assessment of electronic health record data to determine completion of CRC screening by any modality

  12 months

Secondary Outcomes (2)

• Provider Experience

  During the 6 month intervention phase

• Shared Decision Making Process Measure

  During the 6 month intervention phase

Study Arms (2)

CRC decision tool

EXPERIMENTAL

intervention arm

Other: CRC decision tool

control

NO INTERVENTION

control arm

Interventions

CRC decision tool OTHER

CRC decision tool included in the primary care bundle questionnaire

Also known as: intervention

CRC decision tool

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• high risk of CRC

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Karen Blumenthal, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Karen Sepucha, PhD

  MGH

  STUDY DIRECTOR

Central Study Contacts

Suzanne Suzanne Brodney

CONTACT

6176434266; sbrodney@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internist

Model Details: Practices will be randomized to receive the decision tool or not receive the decision tool.

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 3, 2024
• Study Start: October 16, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The IPD will be available once the study is completed and after approval by the IRB.
• Access Criteria: Requests will be reviewed by the PI and the IRB.

Locations

US (1)