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

Study Overview
=================
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.

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

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Level 1: (provide site-specifi information)
* Other: Level 2 (Provide site- and patient-specific information)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: VA sites Males and females Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Level 1: site-specific information<br>provide site-specific information on nonadherence | Other: Level 1: (provide site-specifi information)<br>* provide site-specific information on non-adherence to guideline<br>|
| Other: Level 2: site-, patient-specific info<br>provide site- and patient-specific information on nonadherence | Other: Level 2 (Provide site- and patient-specific information)<br>* provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Adherence to Guideline Prescription | full adherence to guideline medication and dose | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress Toward Adherence to Guideline Prescription | either change to a guideline agent or dose increase of a guideline agent | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adrenergic beta-Antagonists, Guideline Adherence, Drug Prescriptions, target dose