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

NCT ID: NCT01002456

Last Updated: 2015-04-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Level 1: site-specific information

provide site-specific information on nonadherence

Group Type OTHER

Level 1: (provide site-specifi information)

Intervention Type OTHER

provide site-specific information on non-adherence to guideline

Level 2: site-, patient-specific info

provide site- and patient-specific information on nonadherence

Group Type OTHER

Level 2 (Provide site- and patient-specific information)

Intervention Type OTHER

provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions

Interventions

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Level 1: (provide site-specifi information)

provide site-specific information on non-adherence to guideline

Intervention Type OTHER

Level 2 (Provide site- and patient-specific information)

provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* VA sites
* Males and females

Exclusion Criteria

none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Madeline McCarren, PhD MPH

Role: PRINCIPAL_INVESTIGATOR

Edward Hines Jr. VA Hospital, Hines, IL

Locations

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Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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VMS #120

Identifier Type: OTHER

Identifier Source: secondary_id

RRP 09-136

Identifier Type: -

Identifier Source: org_study_id

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