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

March 16, 2012 updated by: VA Connecticut Healthcare System

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

135

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System - West Haven Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Behavioral: Decision Aid for Atrial Fibrillation
Single contact educational session
Placebo Comparator: 1
Usual Care
Other: 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

This is where you will find people and organizations involved with this study.

Sponsor

VA Connecticut Healthcare System

Collaborators

Yale University
Donaghue Medical Research Foundation

Investigators

  • Principal Investigator: Terri R Fried, M.D., VA Connecticut HS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

January 24, 2009

First Submitted That Met QC Criteria

January 26, 2009

First Posted (Estimate)

January 27, 2009

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 16, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

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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