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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Behavioral: Decision Aid for Atrial Fibrillation
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Usual Care | Other: Usual Care<br>* Usual Care<br>|
| Experimental: 2<br>Intervention | Behavioral: Decision Aid for Atrial Fibrillation<br>* Single contact educational session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict |  | Immediately following and 1-month post-intervention | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Cerebrovascular accident, Anticoagulation, Decision-making