Use of a Colorectal Cancer Screening Decision Support Too... | NCT06625983

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

NCT06625983

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Apr 6, 2026Actual

Enrollment

9,205Actual

Phase

Not Applicable

Conditions

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

Interventions

CRC decision tool

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 16, 2024Actual

Primary Completion Date

Jan 1, 2026Actual

Completion Date

Jan 1, 2026Actual

First Submitted Date

Oct 2, 2024

First Submission Date that Met QC Criteria

Oct 2, 2024

First Posted Date

Oct 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2026

Last Update Posted Date

Apr 6, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Karen J. Blumenthal, MD, MPH, Internist, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9,205Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CRC decision tool	Experimental	intervention arm	Other: CRC decision tool
control	No Intervention	control arm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CRC decision tool	Other	CRC decision tool included in the primary care bundle questionnaire	CRC decision tool

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karen Blumenthal, MD	Massachusetts General Hospital	Principal Investigator
Karen Sepucha, PhD	MGH	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mass General Brigham		Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

deidentified data will be made available upon request

Types

Study Protocol
Statistical Analysis Plan (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.

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008722	Methods

Ancestor Terms

ID	Term
D008919	Investigative Techniques

Browse Leaves

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Browse Branches

Not provided