IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE-HF)
This study has been completed.
Sponsor:
Medtronic Cardiac Rhythm Disease Management
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00303979
First received: March 15, 2006
Last updated: November 21, 2012
Last verified: November 2012
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| Tracking Information | |||||||||
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| First Received Date ICMJE | March 15, 2006 | ||||||||
| Last Updated Date | November 21, 2012 | ||||||||
| Start Date ICMJE | May 2005 | ||||||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To Observe Over the Aggregate IMPROVE-HF Practice Sites a Relative 20% or Greater Improvement in at Least 2 of the 7 Performance Measures at 24 Months Compared With Baseline. [ Time Frame: 24 Month ] [ Designated as safety issue: No ] The percent of patients that conformed to each performance measure will be calculated at baseline and 24 months. Based on the definition of each performance measure as defined in the performance measure constructs, each performance measure's baseline percentage and 24 month percentage will be calculated. The change in percentages from baseline is the baseline percentage subtracted from the 24 month percentage. Each performance measure will be evaluated separately to determine whether there is a relative 20% or greater improvement from baseline. The difference in percentages from baseline to 24 months and associated 95% confidence intervals on the differences will be presented. The percent improvement from baseline for each performance measure will be tested using a large sample test (z-test) on a proportion. |
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| Original Primary Outcome Measures ICMJE |
To evaluate the proportion of practices that demonstrate a relative 20% or greater improvement in 2 or more of the performance measures at 24 months compared with baseline | ||||||||
| Change History | Complete list of historical versions of study NCT00303979 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting | ||||||||
| Official Title ICMJE | Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting | ||||||||
| Brief Summary | The purpose of this study is to characterize current management of patients with either heart failure or prior myocardial infarction and left ventricular dysfunction and to assess the effect of education, specific clinical guidelines, reminder systems, comprehensive disease state management tools, benchmarked quality reports, and academic detailing on the use of evidence-based heart failure therapies in cardiology practices. This study is a quality improvement initiative that is being conducted through review of patient records. |
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| Detailed Description | IMPROVE HF, the largest US outpatient HF patient registry, has substantially contributed to our knowledge of how systolic HF and post MI left ventricular systolic dysfunction (LVSD) patients are treated in the outpatient setting. The findings of IMPROVE HF clearly support this guideline and may help to establish a model framework for future performance improvement programs for outpatient cardiology practices. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Heart failure patients in outpatient cardiology practices |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 34810 | ||||||||
| Completion Date | August 2009 | ||||||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00303979 | ||||||||
| Other Study ID Numbers ICMJE | 258 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Medtronic Cardiac Rhythm Disease Management | ||||||||
| Study Sponsor ICMJE | Medtronic Cardiac Rhythm Disease Management | ||||||||
| Collaborators ICMJE | Medtronic | ||||||||
| Investigators ICMJE |
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| Information Provided By | Medtronic Cardiac Rhythm Disease Management | ||||||||
| Verification Date | November 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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