EHR-Embedded Decision Support to Prevent Stroke in Patients With AF

NCT04099485 | Completed DMC

• 1 other identifier: CV185-764
• Study Type: interventional
• Target: 608
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Significance - Atrial fibrillation (AF) is the most common significant cardiac rhythm disorder and is a powerful common risk factor for stroke. Randomized trials have demonstrated that anticoagulation can reduce the risk of stroke in patients with AF. Yet, there continues to be widespread underutilization of this therapy. To address this practice gap locally and improve stroke prevention for patients with AF in the UC Health system, the investigators have assembled an interprofessional team, the Cincinnati Atrial Fibrillation Initiative (CAFI). Objectives - The objective of this project, "EHR-Embedded Decision Support to Prevent Stroke in Patients with AF", is to improve thromboprophylaxis treatment decisions for patients with non-valvular AF and to increase awareness of the underutilization of appropriate thromboprophylaxis in the University of Cincinnati Health system, including vulnerable populations with health disparities. To achieve this objective, the investigators will implement and evaluate the effectiveness of an Atrial Fibrillation Decision Support Tool (AFDST), embedded within the UC Health electronic health record (EHR) that will: (a) identify at the point of care, patients who might benefit substantially from a change in their current thromboprophylaxis; (b) provide patient-tailored guidance to support decision-making; and (c) provide an opportunity to refer the patient to a pharmacist-staffed AF Thromboprophylaxis Shared Decision-Making consultation service. Overview of Study Design - The overarching goal is to improve the rate of "appropriate thromboprophylaxis" by eliminating system barriers through provision of appropriate decision support in the right place and at the right time, that improves provider and patient knowledge about AF-related stroke risks, bleeding risks, practice gaps in prevention, and how to think about balancing risks and benefits of anticoagulation therapy, and by improving patient engagement in decision-making. The investigators have designed interventions based on a conceptual model that attributes the gap between evidence and practice to the following issues: 1) provider knowledge, 2) patient understanding and engagement, 3) sociodemographic factors that create barriers to care and treatment, and 4) systems barriers such as time constraints for busy clinicians and inadequate electronic health record-integrated decision support. The investigators will achieve the overarching goal through two aims. The first aim will be addressed by a randomized controlled trial that examines two strategies - 1) AFDST without best practice advisory \[BPA\] (current state), or 2) AFDST with BPA and semi-automated order set to refer patients to an AF Thromboprophylaxis Shared Decision-Making Service. The investigators will use the RE-AIM framework for the evaluation of implementation studies to assess outcomes of effectiveness, reach, and adoption. The second aim is to evaluate the impact of shared decision-making tools and services. The investigators believe that a shared decision-making specialty service that utilizes an EHR-embedded Atrial Fibrillation Shared Decision Making Tool (AFSDM) tool will improve a number of metrics for quality care. These include, among others, decrease decisional conflict, improve patient satisfaction with decision-making, improve patient knowledge, and improve adherence with final shared treatment decisions. Methods - The first aim will be accomplished through a clinical study in which AF patients in the UC Health primary care network will be randomized into one of two study arms. Briefly, these arms are: 1) Atrial Fibrillation Decision-Support Tool (AFDST); 2) AFDST with addition of best practice advisory (BPA) and option to refer to shared decision-making consultation services. Patients will enter the study as their clinicians receive BPAs, or in the case of the first study arm, when BPAs would have been generated as clinicians open medical records of patients for whom current thromboprophylaxis is not optimal. The second aim will be accomplished through a pre/post study design evaluating the impact of shared decision-making tools and services. Patients will be consented and enrolled following their referral to the pharmacist-staffed AF shared decision-making service. Patients consenting to participation in this aspect of the study, will have a shared decision-making visit with one of the anticoagulation pharmacists. Information to be collected will include a number of validated measures of decision quality, patient engagement and confidence, and connection with the clinical team gathered prior to and at the conclusion of the shared decision-making visit.

Conditions

Atrial Fibrillation

Keywords

anticoagulation; decision sciences; clinical informatics; implementation research

Outcome Measures

Primary Outcomes (1)

• "Appropriate Thromboprophylaxis"

  The primary outcome of interest for aim 1 is effectiveness, measured as the percent of patients with "appropriate thromboprophylaxis" based on the AFDST recommendation. If oral anticoagulant therapy is recommended, current treatment with any oral anticoagulant agent will be considered concordant with recommendations. We will assess post-intervention treatment at the completion of the study (up to 18 months) to determine the proportion of patients in each study arm receiving "appropriate thromboprophylaxis."

  by study completion, up to 18 months

Secondary Outcomes (4)

• Number of patients for whom BPA is generated divided by number of BPAs acknowledged by physician activation of AFDST.

  18 months

• Number of clinicians receiving a BPA divided by number who acknowledge the BPA by activating AFDST.

  18 months

• Strokes

  18 months

• Major bleeds

  18 months

Study Arms (2)

Current State

NO INTERVENTION

Clinicians of patients randomized to this arm will have access to the Atrial Fibrillation Decision-Support Tool (AFDST) embedded in our EHR (as they do now), but will not receive BPAs alerting them to patients who might benefit significantly from a change in anticoagulation treatment.

AFDST with BPA

EXPERIMENTAL

Clinicians of patients randomized to this arm will receive BPAs when they are in the medical record of an AF patient who might gain significantly from a change in anticoagulation treatment. In addition, clinicians will have the ability to refer patients to a pharmacist-staffed AF Thromboprophylaxis Shared Decision-Making Service based in our Anticoagulation Clinic.

Other: Electronic Health Record Best Practice Advisory

Interventions

Electronic Health Record Best Practice Advisory OTHER

The AFDST is a decision support tool that is embedded in our electronic health record system. Currently, this is a passive tool that requires the clinician to launch the tool if an analysis is desired. The experimental arm of this study will add a best practice advisory (BPA) that will trigger when a clinician is in the medical record of an AF patient who might gain substantial benefit (survival and quality of life) if treatment were changed from the current anticoagulation plan, which might be no anticoagulant therapy.

AFDST with BPA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of non-valvular atrial fibrillation or atrial flutter (I48.x)

You may not qualify if:

• Diagnosis of valvular heart disease (mitral valve disease (I05.x), aortic valve disease (I06.x), mitral and aortic valve disease (I08.x)), presence of prosthetic heart valve (Z95.2), or presence of xenogenic heart valve (Z95.3), or presence of other heart valve replacement (Z95.4).

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati Health System

Cincinnati, Ohio, 45257, United States

Location

Related Publications (5)

• Eckman MH, Costea A, Attari M, Munjal J, Wise RE, Knochelmann C, Flaherty ML, Baker P, Ireton R, Harnett BM, Leonard AC, Steen D, Rose A, Kues J. Shared decision-making tool for thromboprophylaxis in atrial fibrillation - A feasibility study. Am Heart J. 2018 May;199:13-21. doi: 10.1016/j.ahj.2018.01.003. Epub 2018 Jan 12.

  PMID: 29754650 BACKGROUND

• Eckman MH, Costea A, Attari M, Munjal J, Wise RE, Knochelmann C, Flaherty ML, Baker P, Ireton R, Harnett BM, Leonard AC, Steen D, Rose A, Kues J. Atrial fibrillation decision support tool: Population perspective. Am Heart J. 2017 Dec;194:49-60. doi: 10.1016/j.ahj.2017.08.016. Epub 2017 Aug 23.

  PMID: 29223435 BACKGROUND

• Eckman MH, Lip GY, Wise RE, Speer B, Sullivan M, Walker N, Kissela B, Flaherty ML, Kleindorfer D, Baker P, Ireton R, Hoskins D, Harnett BM, Aguilar C, Leonard AC, Arduser L, Steen D, Costea A, Kues J. Impact of an Atrial Fibrillation Decision Support Tool on thromboprophylaxis for atrial fibrillation. Am Heart J. 2016 Jun;176:17-27. doi: 10.1016/j.ahj.2016.02.009. Epub 2016 Feb 19.

  PMID: 27264216 BACKGROUND

• Shah SJ, Eckman MH, Aspberg S, Go AS, Singer DE. Effect of Variation in Published Stroke Rates on the Net Clinical Benefit of Anticoagulation for Atrial Fibrillation. Ann Intern Med. 2018 Oct 16;169(8):517-527. doi: 10.7326/M17-2762. Epub 2018 Sep 25.

  PMID: 30264130 BACKGROUND

• Eckman MH, Wise R, Knochelmann C, Mardis R, Wright S, Gummadi A, Dixon E, Becker R, Schauer DP, Flaherty ML, Costea A, Kleindorfer D, Ireton R, Baker P, Harnett BM, Adejare A, Leonard AC, Sucharew H, Costanzo A, Arduser L, Kues J. Electronic health record-embedded decision support to reduce stroke risk in patients with atrial fibrillation - Study protocol. Am Heart J. 2022 May;247:42-54. doi: 10.1016/j.ahj.2022.01.012. Epub 2022 Jan 23.

  PMID: 35081360 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Model Details: For the first aim AF patients in our UC Health primary care network will be randomized into one of two study arms: 1) Atrial Fibrillation Decision-Support Tool (AFDST); 2) AFDST with addition of best practice advisory (BPA) and option to refer to shared decision-making consultation services. Patients will enter the study as their clinicians receive BPAs, or in the case of the first study arm, when BPAs would have been generated as clinicians open medical records of patients for whom current thromboprophylaxis is not optimal. The second aim is a pre/post study evaluating the impact of shared decision-making tools and services. Patients consenting to participation in this aspect of the study, will have a shared decision-making visit with one of our anticoagulation pharmacists.

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: November 18, 2020
• Primary Completion: November 30, 2022
• Study Completion: February 28, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)