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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099485
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Mark Eckman, M.D., University of Cincinnati

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Electronic Health Record Best Practice Advisory Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: EHR-Embedded Decision Support to Prevent Stroke in Patients With AF
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Current State
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.
Experimental: AFDST with BPA
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
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.




Primary Outcome Measures :
  1. "Appropriate Thromboprophylaxis" [ Time Frame: by study completion, up to 18 months ]
    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."


Secondary Outcome Measures :
  1. Number of patients for whom BPA is generated divided by number of BPAs acknowledged by physician activation of AFDST. [ Time Frame: 18 months ]
    Reach is defined as the total number of patients for whom the BPA was acknowledged by activating the AFDST, divided by the total numbers of patients for whom advisories were generated.

  2. Number of clinicians receiving a BPA divided by number who acknowledge the BPA by activating AFDST. [ Time Frame: 18 months ]
    Adoption is defined as the total number of clinicians who acknowledge any advisory, divided by the total number of clinicians who receive advisories. We will measure reach, adoption, and effectiveness following both implementation of BPAs and implementation of semi-automated referral orders for shared decision-making consultation. We also will collect overall usage data to see how often the AFDST is invoked both prior to and following study initiation.

  3. Strokes [ Time Frame: 18 months ]
    Strokes resulting in hospitalization at the University of Cincinnati Medical Center.

  4. Major bleeds [ Time Frame: 18 months ]
    Major bleeds resulting in hospitalization at the University of Cincinnati Medical Center.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099485


Contacts
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Contact: Ruth Wise, MSN 513-5587581 ruth.wise@uc.edu
Contact: Mark Eckman 5135587464 mark.eckman@uc.edu

Sponsors and Collaborators
University of Cincinnati
Publications:
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Responsible Party: Mark Eckman, M.D., Professor of Clinical Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT04099485    
Other Study ID Numbers: CV185-764
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mark Eckman, M.D., University of Cincinnati:
anticoagulation
decision sciences
clinical informatics
implementation research
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes