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Centers for Education on Research and Therapeutics - Heart Failure: Targeted Intervention Study (CERTs-HF)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive quality improvement tools
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring Quality Improvement

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All sites participating in Get With the Guidelines Heart Failure.

Exclusion Criteria:

  • Sites in Get With the Guidelines Heart Failure which opt out of participation.

Sites / Locations

  • Duke Clinical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Intervention

Arm Description

Standard quality improvement approaches available through participation in Get With the Guidelines - Heart Failure.

Enhanced and/or intensive quality improvement approaches, coupled with standard approaches available through participation in Get With the Guidelines - Heart Failure.

Outcomes

Primary Outcome Measures

Improvement in the overall opportunity-based composite of measures eligible for intervention (absolute score difference compared to the control arm) based on the existing Get With the Guidelines Heart Failure Achievement Measures and Quality Measures.

Secondary Outcome Measures

Improvement in Defect Free (all or none) score based on the combined Get With the Guidelines Heart Failure Achievement and Quality Measures
Improvement in scores of each individual Get With the Guidelines Heart Failure Achievement and Quality Measure
Improvement in length of stay and in-patient mortality.

Full Information

First Posted
September 15, 2009
Last Updated
June 22, 2012
Sponsor
Duke University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT00979264
Brief Title
Centers for Education on Research and Therapeutics - Heart Failure: Targeted Intervention Study
Acronym
CERTs-HF
Official Title
Centers for Education on Research and Therapeutics - Heart Failure: Targeted Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate whether a quarterly feedback, education and performance improvement site-based intervention has a greater impact on quality performance and adherence to evidenced-based guidelines than existing on-demand feedback. This study will use a randomized design to compare changes in quality performance and adherence to selected measures among hospitals using existing on-demand reports and general quality improvement (QI) efforts versus those receiving intensive, targeted QI feedback via reports, teleconferences, webinars, and specialized tool kits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Quality Improvement

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard quality improvement approaches available through participation in Get With the Guidelines - Heart Failure.
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Enhanced and/or intensive quality improvement approaches, coupled with standard approaches available through participation in Get With the Guidelines - Heart Failure.
Intervention Type
Behavioral
Intervention Name(s)
Intensive quality improvement tools
Intervention Description
Personalized performance improvement interventions, including premier site data reports, personalized feedback/teleconferences, comprehensive toolkits, and focused webinars; in addition to other general QI tools typically available through participation in Get With the Guidelines Heart Failure.
Primary Outcome Measure Information:
Title
Improvement in the overall opportunity-based composite of measures eligible for intervention (absolute score difference compared to the control arm) based on the existing Get With the Guidelines Heart Failure Achievement Measures and Quality Measures.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Improvement in Defect Free (all or none) score based on the combined Get With the Guidelines Heart Failure Achievement and Quality Measures
Time Frame
1 year
Title
Improvement in scores of each individual Get With the Guidelines Heart Failure Achievement and Quality Measure
Time Frame
1 year
Title
Improvement in length of stay and in-patient mortality.
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All sites participating in Get With the Guidelines Heart Failure. Exclusion Criteria: Sites in Get With the Guidelines Heart Failure which opt out of participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric D Peterson, MD, MPH
Organizational Affiliation
Duke Clinical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Clinical Research Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26175533
Citation
DeVore AD, Cox M, Heidenreich PA, Fonarow GC, Yancy CW, Eapen ZJ, Peterson ED, Hernandez AF. Cluster-Randomized Trial of Personalized Site Performance Feedback in Get With The Guidelines-Heart Failure. Circ Cardiovasc Qual Outcomes. 2015 Jul;8(4):421-7. doi: 10.1161/CIRCOUTCOMES.114.001333. Epub 2015 Jul 14.
Results Reference
derived

Learn more about this trial

Centers for Education on Research and Therapeutics - Heart Failure: Targeted Intervention Study

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