NCT00979264

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Mar 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

June 26, 2012

Status Verified

June 1, 2012

Enrollment Period

1.6 years

First QC Date

September 15, 2009

Last Update Submit

June 22, 2012

Conditions

Heart Failure

Keywords

Quality Improvement

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (3)

  • Improvement in Defect Free (all or none) score based on the combined Get With the Guidelines Heart Failure Achievement and Quality Measures

    1 year

  • Improvement in scores of each individual Get With the Guidelines Heart Failure Achievement and Quality Measure

    1 year

  • Improvement in length of stay and in-patient mortality.

    1 year

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

ACTIVE COMPARATOR

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

Behavioral: Intensive quality improvement tools

Interventions

Intensive quality improvement toolsBEHAVIORAL

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.

Intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Clinical Research Institute

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

  • 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.

    PMID: 26175533DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Eric D Peterson, MD, MPH

    Duke Clinical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 15, 2009

First Posted

September 17, 2009

Study Start

March 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

June 26, 2012

Record last verified: 2012-06

Locations

US(1)