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

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ClinicalTrials.gov Identifier: NCT01002456
Recruitment Status : Completed
First Posted : October 27, 2009
Results First Posted : October 15, 2014
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Level 1: (provide site-specifi information) Other: Level 2 (Provide site- and patient-specific information) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison
Study Start Date : October 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Level 1: site-specific information
provide site-specific information on nonadherence
 Other: Level 1: (provide site-specifi information)
provide site-specific information on non-adherence to guideline
Level 2: site-, patient-specific info
provide site- and patient-specific information on nonadherence
 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


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Adherence to Guideline Prescription [ Time Frame: 6 months ]
    full adherence to guideline medication and dose


Secondary Outcome Measures :
  1. Progress Toward Adherence to Guideline Prescription [ Time Frame: 6 months ]
    either change to a guideline agent or dose increase of a guideline agent


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • VA sites
  • Males and females

Exclusion Criteria:

none

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002456


Locations
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United States, Illinois
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-5000
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Principal Investigator: Madeline McCarren, PhD MPH Edward Hines Jr. VA Hospital, Hines, IL
More Information
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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01002456    
Other Study ID Numbers: RRP 09-136
VMS #120 ( Other Identifier: PBM VAMedSAFE )
First Posted: October 27, 2009    Key Record Dates
Results First Posted: October 15, 2014
Last Update Posted: April 28, 2015
Last Verified: September 2014
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Adrenergic beta-Antagonists
Guideline Adherence
Drug Prescriptions
target dose
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases