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

Atrial Fibrillation Clinical Trial

— AFIB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829478
• Other study ID #: Fried0011
• Status: Completed
• Phase: Phase 1
• First received: January 24, 2009
• Last updated: March 16, 2012
• Start date: October 2008
• Est. completion date: June 2010

Study information

• Verified date: March 2012
• Source: VA Connecticut Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Behavioral:
• Decision Aid for Atrial Fibrillation
Single contact educational session

Other:
• Usual Care
Usual Care

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System - West Haven Campus	West Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System	Donaghue Medical Research Foundation, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional conflict		Immediately following and 1-month post-intervention	No
Secondary	Knowledge regarding atrial fibrillation		Immediately following study intervention and 1 month post-intervention	No
Secondary	Anxiety		Immediately following intervention and 1 month post-intervention	No
Secondary	Changes in treatment plan for atrial fibrillation		Within 30 days post-intervention	No
Secondary	Quality of clinician-patient communication		Clinician visit immediately post-intervention	No