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Trial Title:
Use of a Colorectal Cancer Screening Decision Support Tool in Primary Care
NCT ID:
NCT06625983
Condition:
Colorectal Cancer Control and Prevention
Colorectal Cancer Screening
Shared Decision Making
Decision Aid
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
colorectal cancer screening
shared decision making
electronic health record
randomized controlled trial
decision tool
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Practices will be randomized to receive the decision tool or not receive the decision
tool.
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
CRC decision tool
Description:
CRC decision tool included in the primary care bundle questionnaire
Arm group label:
CRC decision tool
Other name:
intervention
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).
Criteria for 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
Gender:
All
Minimum age:
45 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
October 1, 2024
Completion date:
August 1, 2026
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06625983
