- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00829478
Improving the Quality of Care for Atrial Fibrillation by Promoting Patient-Centered Decision Making (AFIB)
Improving Quality of Care for Atrial Fibrillation by Promoting Patient-Centered Decision Making
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Connecticut
-
West Haven, Connecticut, United States, 06516
- VA Connecticut Healthcare System - West Haven Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2
Intervention
|
Single contact educational session
|
Placebo Comparator: 1
Usual Care
|
Usual Care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decisional conflict
Time Frame: Immediately following and 1-month post-intervention
|
Immediately following and 1-month post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Knowledge regarding atrial fibrillation
Time Frame: Immediately following study intervention and 1 month post-intervention
|
Immediately following study intervention and 1 month post-intervention
|
Anxiety
Time Frame: Immediately following intervention and 1 month post-intervention
|
Immediately following intervention and 1 month post-intervention
|
Changes in treatment plan for atrial fibrillation
Time Frame: Within 30 days post-intervention
|
Within 30 days post-intervention
|
Quality of clinician-patient communication
Time Frame: Clinician visit immediately post-intervention
|
Clinician visit immediately post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Terri R Fried, M.D., VA Connecticut HS
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fried0011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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