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

VA Connecticut Healthcare System

Status and phase: Completed; Phase 1

Conditions: Atrial Fibrillation

Treatments: Other: Usual Care; Behavioral: Decision Aid for Atrial Fibrillation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00829478

Fried0011

Details and patient eligibility

About

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 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.

Enrollment: 135 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

135 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Usual Care

Treatment:

Other: Usual Care

2

Experimental group

Description:

Intervention

Treatment:

Behavioral: Decision Aid for Atrial Fibrillation