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Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Level 1: (provide site-specifi information)
Level 2 (Provide site- and patient-specific information)
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring Adrenergic beta-Antagonists, Guideline Adherence, Drug Prescriptions, target dose

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • VA sites
  • Males and females

Exclusion Criteria:

none

Sites / Locations

  • Edward Hines Jr. VA Hospital, Hines, IL

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Level 1: site-specific information

Level 2: site-, patient-specific info

Arm Description

provide site-specific information on nonadherence

provide site- and patient-specific information on nonadherence

Outcomes

Primary Outcome Measures

Rate of Adherence to Guideline Prescription
full adherence to guideline medication and dose

Secondary Outcome Measures

Progress Toward Adherence to Guideline Prescription
either change to a guideline agent or dose increase of a guideline agent

Full Information

First Posted
October 23, 2009
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT01002456
Brief Title
Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison
Official Title
Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall objective of the proposed pilot study is to begin evaluation of two methods for promoting adherence to guidelines for beta-blocker therapy in heart failure. The design includes site level baseline measurement, feedback, remeasurement after six months, and randomized (by site) comparison samples. The setting is VA sites, with intervention directed at the pharmacy.
Detailed Description
Current evidence-based guidelines in VA recommend one of three beta-blockers (carvedilol, metoprolol succinate, or bisoprolol) that have been shown to reduce mortality in heart failure patients with systolic dysfunction, with recommended target doses. However, Pharmacy Benefits Management (PBM) data indicate that prescribing for beta-blockers in heart failure patients that is not in accordance with guidelines is substantial, both in terms of the agent selected and the dose. Sites will be recruited and randomized to two different intensities of intervention to promote adherence to guidelines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Adrenergic beta-Antagonists, Guideline Adherence, Drug Prescriptions, target dose

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Level 1: site-specific information
Arm Type
Other
Arm Description
provide site-specific information on nonadherence
Arm Title
Level 2: site-, patient-specific info
Arm Type
Other
Arm Description
provide site- and patient-specific information on nonadherence
Intervention Type
Other
Intervention Name(s)
Level 1: (provide site-specifi information)
Intervention Description
provide site-specific information on non-adherence to guideline
Intervention Type
Other
Intervention Name(s)
Level 2 (Provide site- and patient-specific information)
Intervention Description
provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions
Primary Outcome Measure Information:
Title
Rate of Adherence to Guideline Prescription
Description
full adherence to guideline medication and dose
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Progress Toward Adherence to Guideline Prescription
Description
either change to a guideline agent or dose increase of a guideline agent
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: VA sites Males and females Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madeline McCarren, PhD MPH
Organizational Affiliation
Edward Hines Jr. VA Hospital, Hines, IL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward Hines Jr. VA Hospital, Hines, IL
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141-5000
Country
United States

12. IPD Sharing Statement

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Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison

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