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

Sponsors and Collaborators:	VA Connecticut Healthcare System The Donaghue Foundation Yale University
Information provided by:	VA Connecticut Healthcare System
ClinicalTrials.gov Identifier:	NCT00829478

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation	Behavioral: Decision Aid for Atrial Fibrillation Other: Usual Care	Phase I

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Improving Quality of Care for Atrial Fibrillation by Promoting Patient-Centered Decision Making

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by VA Connecticut Healthcare System:

Primary Outcome Measures:

Decisional conflict [ Time Frame: Immediately following and 1-month post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Knowledge regarding atrial fibrillation [ Time Frame: Immediately following study intervention and 1 month post-intervention ] [ Designated as safety issue: No ]
Anxiety [ Time Frame: Immediately following intervention and 1 month post-intervention ] [ Designated as safety issue: No ]
Changes in treatment plan for atrial fibrillation [ Time Frame: Within 30 days post-intervention ] [ Designated as safety issue: No ]
Quality of clinician-patient communication [ Time Frame: Clinician visit immediately post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	October 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Usual Care	Other: Usual Care Usual Care
2: Experimental Intervention	Behavioral: Decision Aid for Atrial Fibrillation Single contact educational session

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

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829478

Contacts

Contact: Lynne P Iannone, MS

203 932-5711 ext 2403

lynne.iannone@yale.edu

Locations

United States, Connecticut
VA Connecticut Healthcare System - West Haven Campus	Recruiting
West Haven, Connecticut, United States, 06516
Principal Investigator: Terri R. Fried, M.D.
Principal Investigator: Liana Fraenkel, M.D.

Sponsors and Collaborators

VA Connecticut Healthcare System

The Donaghue Foundation

Yale University

More Information

No publications provided

Responsible Party:	VA Connecticut Healthcare System, Yale University ( Terri Fried )
Study ID Numbers:	Fried0011
Study First Received:	January 24, 2009
Last Updated:	January 26, 2009
ClinicalTrials.gov Identifier:	NCT00829478 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Federal Government

Keywords provided by VA Connecticut Healthcare System:

Atrial fibrillation
Cerebrovascular accident
Anticoagulation
Decision-making

Study placed in the following topic categories:

Heart Diseases
Cerebral Infarction
Stroke
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on September 10, 2009