Improving the Quality of Care for Atrial Fibrillation by Promoting Patient-Centered Decision Making

Overview

The primary aim of this proposal is to determine the effectiveness of a decision support tool on improving the process of shared decision-making for treatment on nonvalvular atrial fibrillation (NVAF) compared to receipt of usual care.

Full Title of Study: “Improving Quality of Care for Atrial Fibrillation by Promoting Patient-Centered Decision Making”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 2010

Detailed Description

Decision-making regarding appropriate therapy for non-valvular atrial fibrillation (NVAF) is a complex process. Different options carry with them different profiles of risks and benefits, and choosing the "right" therapy depends upon the patient's understanding of these risks and benefits and a consideration of the risks and benefits according to the patient's values and preferences. Studies have shown that patients' preferred therapy frequently disagrees with what is recommended by disease management guidelines. The purpose of this study is to examine an intervention to improve the quality of decision-making for NVAF compared to usual care. The intervention has several components, including: a) educating the patient about why values and preferences are important to the decision-making process, b) providing an individualized assessment of the risks and benefits of each of the treatment options, c) exploring patients' values and preferences as they relate to the risks and benefits of each of the treatment options, d) preparing the patient to discuss his/her preferences with the physician.

Interventions

  • Behavioral: Decision Aid for Atrial Fibrillation
    • Single contact educational session
  • Other: Usual Care
    • Usual Care

Arms, Groups and Cohorts

  • Placebo Comparator: 1
    • Usual Care
  • Experimental: 2
    • Intervention

Clinical Trial Outcome Measures

Primary Measures

  • Decisional conflict
    • Time Frame: Immediately following and 1-month post-intervention

Secondary Measures

  • Knowledge regarding atrial fibrillation
    • Time Frame: Immediately following study intervention and 1 month post-intervention
  • Anxiety
    • Time Frame: Immediately following intervention and 1 month post-intervention
  • Changes in treatment plan for atrial fibrillation
    • Time Frame: Within 30 days post-intervention
  • Quality of clinician-patient communication
    • Time Frame: Clinician visit immediately post-intervention

Participating in This Clinical Trial

Inclusion Criteria

  • 45 years or older – Be scheduled to see primary Doctor at VA – Diagnosis of atrial fibrillation – English speaking Exclusion Criteria:

  • Have valvular disease as the cause of Afib – Be on warfarin for a condition other than NVAF – Have a contraindication to warfin – Have a contraindication to ASA – Life expectancy of less than 12 months – Cognitive impairment – Receiving anti-platelet agent other than aspirin – Receiving care in a supervised resident clinic or from an attending physician who refuses participation in the study – Bleed with identified source in the last 12 months – Bleed with an unidentified source – History of intracerebral hemorrhage – Severe hearing impairment – Severe visual impairment

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • VA Connecticut Healthcare System
  • Collaborator
    • Donaghue Medical Research Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Terri R Fried, M.D., Principal Investigator, VA Connecticut HS

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