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Completed

NCT Number: NCT01002456

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • VA sites
  • Males and females

Exclusion criteria

none

Treatment and study plan

Level 1: (provide site-specifi information)

Other

provide site-specific information on non-adherence to guideline

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

Other

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

Primary outcomes

  1. Rate of Adherence to Guideline Prescription

    Time frame: 6 months

    full adherence to guideline medication and dose

Secondary outcomes

  1. Progress Toward Adherence to Guideline Prescription

    Time frame: 6 months

    either change to a guideline agent or dose increase of a guideline agent

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Oct 27, 2009
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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