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OpenTrials
Completed

NCT Number: NCT00829478

Improving the 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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

VA Connecticut Healthcare System - West Haven Campus

West Haven, Connecticut, 06516, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision Aid for Atrial Fibrillation

Behavioral

Single contact educational session

Usual Care

Other

Usual Care

Primary outcomes

  1. Decisional conflict

    Time frame: Immediately following and 1-month post-intervention

Secondary outcomes

  1. Knowledge regarding atrial fibrillation

    Time frame: Immediately following study intervention and 1 month post-intervention

  2. Anxiety

    Time frame: Immediately following intervention and 1 month post-intervention

  3. Changes in treatment plan for atrial fibrillation

    Time frame: Within 30 days post-intervention

  4. Quality of clinician-patient communication

    Time frame: Clinician visit immediately post-intervention

Sponsors and collaborators

Lead sponsor

VA Connecticut Healthcare System

Fed

Collaborators

  • Donaghue Medical Research Foundation
  • Yale University

Registry information

Official study title

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

Acronym: AFIB

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 27, 2009
Registry last updated
Mar 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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