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Clinical Trials/NCT00829478
NCT00829478
Completed
Phase 1

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

VA Connecticut Healthcare System1 site in 1 country135 target enrollmentOctober 2008

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
VA Connecticut Healthcare System
Enrollment
135
Locations
1
Primary Endpoint
Decisional conflict
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
June 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
VA Connecticut Healthcare System
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Decisional conflict

Time Frame: Immediately following and 1-month post-intervention

Secondary Outcomes

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

Study Sites (1)

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