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

NCT ID: NCT00829478

Last Updated: 2012-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Usual Care

Group Type PLACEBO_COMPARATOR

Usual Care

Intervention Type OTHER

Usual Care

2

Intervention

Group Type EXPERIMENTAL

Decision Aid for Atrial Fibrillation

Intervention Type BEHAVIORAL

Single contact educational session

Interventions

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Decision Aid for Atrial Fibrillation

Single contact educational session

Intervention Type BEHAVIORAL

Usual Care

Usual Care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Donaghue Medical Research Foundation

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

VA Connecticut Healthcare System

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Terri R Fried, M.D.

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut HS

Locations

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VA Connecticut Healthcare System - West Haven Campus

West Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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Fried0011

Identifier Type: -

Identifier Source: org_study_id

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