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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00829478

Acronym

AFIB

Enrollment

135

Registered

2009-01-27

Start date

2008-10-31

Completion date

2010-06-30

Last updated

2012-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Cerebrovascular accident, Anticoagulation, Decision-making

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.

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.

Interventions

BEHAVIORALDecision Aid for Atrial Fibrillation

Single contact educational session

OTHERUsual Care

Usual Care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Decisional conflict	Immediately following and 1-month post-intervention

Secondary

Measure	Time frame
Knowledge regarding atrial fibrillation	Immediately following study intervention and 1 month post-intervention
Anxiety	Immediately following intervention and 1 month post-intervention
Changes in treatment plan for atrial fibrillation	Within 30 days post-intervention
Quality of clinician-patient communication	Clinician visit immediately post-intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026