A Phase 1 interventional study of Decision Aid for Atrial Fibrillation and Usual Care in Atrial Fibrillation, sponsored by VA Connecticut Healthcare System. Completed at 1 site in United States. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-20.
Sponsored by VA Connecticut Healthcare System · Phase 1 and Interventional
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.
3,869 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's enrollment of 135 is close to the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →VA Connecticut Healthcare System is the lead sponsor of 40 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Usual Care
Other: Usual Care
Intervention
Behavioral: Decision Aid for Atrial Fibrillation
Single contact educational session
Usual Care
Decisional conflict
Time frame: Immediately following and 1-month post-intervention
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
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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VA Connecticut Healthcare System