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

NCT00829478 | Completed Phase 1 DMC

• 1 other identifier: Fried0011
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Cerebrovascular accident; Anticoagulation; Decision-making

Outcome Measures

Primary Outcomes (1)

• Decisional conflict

  Immediately following and 1-month post-intervention

Secondary Outcomes (4)

• 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

Study Arms (2)

1

PLACEBO COMPARATOR

Usual Care

Other: Usual Care

2

EXPERIMENTAL

Intervention

Behavioral: Decision Aid for Atrial Fibrillation

Interventions

Decision Aid for Atrial Fibrillation BEHAVIORAL

Single contact educational session

2

Usual Care OTHER

Usual Care

1

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Be scheduled to see primary Doctor at VA
• Diagnosis of atrial fibrillation
• English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Connecticut Healthcare System: lead
• Donaghue Medical Research Foundation: collaborator
• Yale University: collaborator

Study Sites (1)

VA Connecticut Healthcare System - West Haven Campus

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Terri R Fried, M.D.

  VA Connecticut HS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2009
• First Posted: January 27, 2009
• Study Start: October 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 20, 2012

Record last verified: 2012-03

Locations

US (1)