NCT01002456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2 years until next milestone

Results Posted

Study results publicly available

October 15, 2014

Completed
Last Updated

April 28, 2015

Status Verified

September 1, 2014

Enrollment Period

1.7 years

First QC Date

October 23, 2009

Results QC Date

September 26, 2014

Last Update Submit

April 6, 2015

Conditions

Keywords

Adrenergic beta-AntagonistsGuideline AdherenceDrug Prescriptionstarget dose

Outcome Measures

Primary Outcomes (1)

  • Rate of Adherence to Guideline Prescription

    full adherence to guideline medication and dose

    6 months

Secondary Outcomes (1)

  • Progress Toward Adherence to Guideline Prescription

    6 months

Study Arms (2)

Level 1: site-specific information

OTHER

provide site-specific information on nonadherence

Other: Level 1: (provide site-specifi information)

Level 2: site-, patient-specific info

OTHER

provide site- and patient-specific information on nonadherence

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

Interventions

provide site-specific information on non-adherence to guideline

Level 1: site-specific information

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

Level 2: site-, patient-specific info

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • VA sites
  • Males and females

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Madeline McCarren
Organization
Dept. of Veterans Affairs

Study Officials

  • Madeline McCarren, PhD MPH

    Edward Hines Jr. VA Hospital, Hines, IL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2009

First Posted

October 27, 2009

Study Start

October 1, 2009

Primary Completion

June 1, 2011

Study Completion

October 1, 2012

Last Updated

April 28, 2015

Results First Posted

October 15, 2014

Record last verified: 2014-09

Locations