Clinical trial NCT00829478: Improving the Quality of Care for Atrial Fibrillation by Promoting Patient-Centered Decision Making
Official title: Improving Quality of Care for Atrial Fibrillation by Promoting Patient-Centered Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Cerebrovascular accident
Anticoagulation
Decision-making
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
Collaborators: name: Donaghue Medical Research Foundation
name: Yale University
First posted: 2009-01-27
Enrollment: 135
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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
* History of intracerebral hemorrhage
* Severe hearing impairment
* Severe visual impairment

Primary outcomes:
measure: Decisional conflict
timeFrame: Immediately following and 1-month post-intervention
Secondary outcomes:
measure: Knowledge regarding atrial fibrillation
timeFrame: Immediately following study intervention and 1 month post-intervention
measure: Anxiety
timeFrame: Immediately following intervention and 1 month post-intervention
measure: Changes in treatment plan for atrial fibrillation
timeFrame: Within 30 days post-intervention
measure: Quality of clinician-patient communication
timeFrame: Clinician visit immediately post-intervention
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System - West Haven Campus
state: Connecticut
Study officials:
affiliation: VA Connecticut HS
name: Terri R Fried, M.D.
role: PRINCIPAL_INVESTIGATOR
References: