Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT05236556
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-18
First Post:
2022-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF IV
Sponsor:
University of Massachusetts, Worcester
Organization:
Study Overview
Official Title:
Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF IV
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUPPORT-AF IV
Brief Summary:
Six million Americans live with atrial fibrillation (AF), a heart rhythm abnormality that is a major risk factor for stroke and only half of those AF patients receive oral anticoagulation (AC). Within the context of an ongoing collaboration between two large learning health systems, the investigators propose to study the impact of a shared clinical decision support tool embedded within the electronic health record designed to enhance guideline-based AC prescription. The hypothesis the investigators are testing is that the number of AC starts in patients seen by intervention providers will be higher than in patients seen by control providers. Additionally, the investigators are testing the hypothesis that the risk of not persisting on AC will be higher in the patients of control providers compared with patients of intervention providers.
Detailed Description:
The proposed project will examine the impact of a novel anticoagulant (AC) clinical decision support tool within the electronic health record (EHR) on AC prescribing behaviors among healthcare providers from two distinct health systems who receive it. Using a mixed-methods approach, the investigators will also examine how healthcare providers interact with the decision support tool to further refine the tool and measure its impact on anticoagulation prescribing behaviors. The investigators will also examine clinician engagement through provider interviews and detailed study of behaviors using electronic health record access logs. Finally, the investigators will refine the alert, develop a comprehensive dissemination plan, and create an implementation toolkit to widen the use of the alert at other learning health systems nationally.
After identifying a list of all cardiology providers and primary care providers (PCPs), the investigators will send an email to all providers notifying them of our research study and request for participation. The investigators will send this email through our data collection platform- Redcap-with a link to one item survey allowing providers to opt out. This follows the prior SUPPORT-AF II protocol which the investigators' Institutional Review Board (IRB) approved. Based on discussions with the IRB, the investigators do not anticipate requiring informed consent from providers or patients for executing this aim of the proposal. After removing providers who opted out, the investigators will randomize the remaining providers to either intervention or control in a 1:1 ratio, using randomly permuted blocks; randomization will be stratified jointly by provider type (cardiologist / PCP) and study site (University of Massachusetts/University of Florida). The allocation of the provider conducting the first visit for a patient will dictate the allocation for the patient.
After identifying a list of all cardiology providers and primary care providers (PCPs), the investigators will send an email to all providers notifying them of our research study and request for participation. The investigators will send this email through our data collection platform- Redcap-with a link to one item survey allowing providers to opt out. This follows the prior SUPPORT-AF II protocol which the investigators' Institutional Review Board (IRB) approved. Based on discussions with the IRB, the investigators do not anticipate requiring informed consent from providers or patients for executing this aim of the proposal. After removing providers who opted out, the investigators will randomize the remaining providers to either intervention or control in a 1:1 ratio, using randomly permuted blocks; randomization will be stratified jointly by provider type (cardiologist / PCP) and study site (University of Massachusetts/University of Florida). The allocation of the provider conducting the first visit for a patient will dictate the allocation for the patient.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: