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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Level 2 (Provide site- and patient-specific information)

• Registration Number: NCT01002456
• Lead Sponsor: US Department of Veterans Affairs

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-23
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Primary Completion: 2011-06
• Study Completion: 2012-10
• Status Verified: 2014-09
• Results First Submitted: 2014-09-26
• Results First Submitted QC: 2014-10-08
• Results First Posted: 2014-10-15
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• VA sites
• Males and females

Exclusion Criteria

none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Level 2: site-, patient-specific info	Level 2 (Provide site- and patient-specific information)	provide site- and patient-specific information on nonadherence

Primary Outcome Measures

Name	Time	Method
Rate of Adherence to Guideline Prescription	6 months	full adherence to guideline medication and dose

Secondary Outcome Measures

Name	Time	Method
Progress Toward Adherence to Guideline Prescription	6 months	either change to a guideline agent or dose increase of a guideline agent

Trial Locations

Locations (1)

Edward Hines Jr. VA Hospital, Hines, IL; 🇺🇸 Hines, Illinois, United States