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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):

January 24, 2009
January 27, 2009
March 20, 2012
October 2008
May 2010   (Final data collection date for primary outcome measure)
Decisional conflict [ Time Frame: Immediately following and 1-month post-intervention ]
Same as current
Complete list of historical versions of study NCT00829478 on ClinicalTrials.gov Archive Site
  • Knowledge regarding atrial fibrillation [ Time Frame: Immediately following study intervention and 1 month post-intervention ]
  • Anxiety [ Time Frame: Immediately following intervention and 1 month post-intervention ]
  • Changes in treatment plan for atrial fibrillation [ Time Frame: Within 30 days post-intervention ]
  • Quality of clinician-patient communication [ Time Frame: Clinician visit immediately post-intervention ]
Same as current
Not Provided
Not Provided
 
Improving the Quality of Care for Atrial Fibrillation by Promoting Patient-Centered Decision Making
Improving Quality of Care for Atrial Fibrillation by Promoting Patient-Centered Decision Making
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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Atrial Fibrillation
  • Behavioral: Decision Aid for Atrial Fibrillation
    Single contact educational session
  • Other: Usual Care
    Usual Care
  • Placebo Comparator: 1
    Usual Care
    Intervention: Other: Usual Care
  • Experimental: 2
    Intervention
    Intervention: Behavioral: Decision Aid for Atrial Fibrillation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
June 2010
May 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
45 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00829478
Fried0011
Yes
Not Provided
Not Provided
VA Connecticut Healthcare System
VA Connecticut Healthcare System
  • Donaghue Medical Research Foundation
  • Yale University
Principal Investigator: Terri R Fried, M.D. VA Connecticut HS
VA Connecticut Healthcare System
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP