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

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ClinicalTrials.gov Identifier: NCT00829478
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : March 20, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Behavioral: Decision Aid for Atrial Fibrillation Other: Usual Care Phase 1

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Improving Quality of Care for Atrial Fibrillation by Promoting Patient-Centered Decision Making
Study Start Date : October 2008
Primary Completion Date : May 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1
Usual Care
Other: Usual Care
Usual Care
Experimental: 2
Intervention
Behavioral: Decision Aid for Atrial Fibrillation
Single contact educational session


Outcome Measures

Primary Outcome Measures :
  1. Decisional conflict [ Time Frame: Immediately following and 1-month post-intervention ]

Secondary Outcome Measures :
  1. Knowledge regarding atrial fibrillation [ Time Frame: Immediately following study intervention and 1 month post-intervention ]
  2. Anxiety [ Time Frame: Immediately following intervention and 1 month post-intervention ]
  3. Changes in treatment plan for atrial fibrillation [ Time Frame: Within 30 days post-intervention ]
  4. Quality of clinician-patient communication [ Time Frame: Clinician visit immediately post-intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829478


Locations
United States, Connecticut
VA Connecticut Healthcare System - West Haven Campus
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Connecticut Healthcare System
Donaghue Medical Research Foundation
Yale University
Investigators
Principal Investigator: Terri R Fried, M.D. VA Connecticut HS
More Information

Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT00829478     History of Changes
Other Study ID Numbers: Fried0011
First Posted: January 27, 2009    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: March 2012

Keywords provided by VA Connecticut Healthcare System:
Atrial fibrillation
Cerebrovascular accident
Anticoagulation
Decision-making

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes