Heart FailureCERTs-HFNCT00979264
Centers for Education on Research and Therapeutics - Heart Failure: Targeted Intervention Study
A study testing Intensive quality improvement tools in people with Heart Failure, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Intensive quality improvement tools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All sites participating in Get With the Guidelines Heart Failure.
Who cannot join
- Sites in Get With the Guidelines Heart Failure which opt out of participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research Institute
Durham, North Carolina, 27705
About this study
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.
- Conditions
- Heart Failure
- Being tested
- Intensive quality improvement tools
- Keywords
- Quality Improvement
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive quality improvement toolsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intensive quality improvement tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 year
Improvement in scores of each individual Get With the Guidelines Heart Failure Achievement and Quality Measure
Measured: 1 year
Improvement in length of stay and in-patient mortality.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Eric D Peterson, MD, MPH, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979264
- Sponsor's protocol ID
- Pro00004022
- Other IDs
- 1U18HS016964
- Acronym
- CERTs-HF
- Status last verified
- Jun 2012
- First submitted
- 15 Sep 2009
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26175533
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centers for Education on Research and Therapeutics - Heart Failure: Targeted Intervention Study
- ClinicalTrials.gov ID
- NCT00979264
- Acronym / sponsor ID
- CERTs-HF / Pro00004022
- Conditions
- Heart Failure
- Keywords
- Quality Improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard quality improvement approaches available through participation in Get With the Guidelines - Heart Failure. |
| Intervention | Active comparator | Behavioral: Intensive quality improvement toolsEnhanced and/or intensive quality improvement approaches, coupled with standard approaches available through participation in Get With the Guidelines - Heart Failure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All sites participating in Get With the Guidelines Heart Failure.
Key exclusion criteria (1 listed)
- Sites in Get With the Guidelines Heart Failure which opt out of participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive quality improvement toolsPersonalized 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. | Behavioural | Intervention |
Primary outcome
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
3 secondary outcomes
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
Improvement in scores of each individual Get With the Guidelines Heart Failure Achievement and Quality Measure
Time frame: 1 year
Improvement in length of stay and in-patient mortality.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
- Derived from this study: PubMed 26175533DeVore 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric D Peterson, MD, MPH principal investigator
Duke Clinical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive quality improvement tools in people with Heart Failure, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00979264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012.