Clinical trial NCT06625983: Use of a Colorectal Cancer Screening Decision Support Tool in Primary Care
Official title: Colorectal Cancer Screening Decision Support Tool in the Primary Care Bundle Questionnaire
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 80000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Practices will be randomized to receive the decision tool or not receive the decision tool.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: CRC screening completion
timeFrame: 12 months
Secondary outcomes:
measure: Provider Experience
timeFrame: During the 6 month intervention phase
measure: Shared Decision Making Process Measure
timeFrame: During the 6 month intervention phase
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mass General Brigham
state: Massachusetts
Study officials:
affiliation: Mass General Brigham
name: Karen Blumenthal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MGH
name: Karen Sepucha, PhD
role: STUDY_DIRECTOR
References: