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

Phase 1

Completed

• Conditions: Atrial Fibrillation
• Interventions: Behavioral: Decision Aid for Atrial Fibrillation; Other: Usual Care

• Registration Number: NCT00829478
• Lead Sponsor: VA Connecticut Healthcare System

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-01-24
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-16
• Last Update Posted: 2012-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Decision Aid for Atrial Fibrillation	Intervention
1	Usual Care	Usual Care

Primary Outcome Measures

Name	Time	Method
Decisional conflict	Immediately following and 1-month post-intervention

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

VA Connecticut Healthcare System - West Haven Campus; 🇺🇸 West Haven, Connecticut, United States