Viewing Study NCT06625983



Ignite Creation Date: 2024-10-26 @ 3:41 PM
Last Modification Date: 2024-10-26 @ 3:41 PM
Study NCT ID: NCT06625983
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-10-02

Brief Title: Use of a Colorectal Cancer Screening Decision Support Tool in Primary Care
Sponsor: None
Organization: None

Study Overview

Official Title: Colorectal Cancer Screening Decision Support Tool in the Primary Care Bundle Questionnaire
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 eg 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 andor 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None