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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06625983
Enrollment
9205
Registered
2024-10-03
Start date
2024-10-16
Completion date
2026-01-01
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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).

Interventions

OTHERCRC decision tool

CRC decision tool included in the primary care bundle questionnaire

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
CRC screening completion6 monthsAssessment of electronic health record data to determine completion of CRC screening by any modality

Secondary

MeasureTime frameDescription
Provider ExperienceDuring the 6 month intervention phaseProvider-reported question: Did you feel the CRC screening tool informed or affected your conversations in any way?
Shared Decision Making Process MeasureDuring the 6 month intervention phasePatient-reported survey question about involvement in the decision making process.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKaren Blumenthal, MD

Massachusetts General Hospital

STUDY_DIRECTORKaren Sepucha, PhD

MGH

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026