Improving the Quality of Care for Atrial Fibrillation by... | NCT00829478

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

NCT00829478

Sponsor

VA Connecticut Healthcare System

Status

Completed

Last Update Posted

Mar 20, 2012Estimated

Enrollment

135Actual

Phase

Phase 1

Conditions

Atrial Fibrillation

Interventions

Decision Aid for Atrial Fibrillation
Usual Care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

May 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jan 24, 2009

First Submission Date that Met QC Criteria

Jan 26, 2009

First Posted Date

Jan 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2012

Last Update Posted Date

Mar 20, 2012Estimated

Name	Class
Donaghue Medical Research Foundation	OTHER
Yale University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

135Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	Usual Care	Other: Usual Care
2	Experimental	Intervention	Behavioral: Decision Aid for Atrial Fibrillation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Decision Aid for Atrial Fibrillation	Behavioral	Single contact educational session	2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Knowledge regarding atrial fibrillation		Immediately following study intervention and 1 month post-intervention
Anxiety		Immediately following intervention and 1 month post-intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Terri R Fried, M.D.	VA Connecticut HS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Connecticut Healthcare System - West Haven Campus		West Haven	Connecticut	06516	United States

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D020521	Stroke

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003661	Decision Support Techniques

Ancestor Terms

ID	Term
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided