Feedback Intervention and Treatment Times in ST- Elevation Myocardial Infarction (FITT-STEMI)
Recruitment status was Recruiting
The purpose of this study is to examine if formalized data assessment and systematic feedback improves treatment times (i.e. contact-to-balloon time and door-to-balloon time) in patients with myocardial infarction with ST-segment elevation (STEMI).
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Feedback Intervention and Treatment Times in ST- Elevation Myocardial Infarction (FITT-STEMI): A Multicenter Trial Analyzing the Effects of Systematic Data Feedback on Treatment Quality and Survival Rates.|
- Contact to Balloon Time [ Time Frame: five consecutive three month periods (quarters) ] [ Designated as safety issue: No ]
- mortality (in-hospital-mortality; 30-day-mortality; 1-year-mortality) [ Time Frame: five consecutive three month periods (quarters) ] [ Designated as safety issue: No ]
- Door to Balloon time [ Time Frame: five consecutive three-month periods (quarters) ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Experimental: Data Feedback||
Behavioral: Data analysis and Feedback
Data analysis feedback: quarterly meetings with all stakeholders to present data and discuss potential areas of improvement.
For many patients with myocardial infarction with ST-segment elevation (STEMI), the time from presentation to percutaneous coronary intervention (PCI) exceeds established goals. Formalized data feedback is one strategy proposed to reduce treatment time in STEMI-patients. The aim of this multicenter study is to evaluate whether systematic data analysis and feedback leads to shorter contact-to-balloon and door-to-balloon times and reduces mortality in different regional care networks serving patients with STEMI. The multicenter trial includes hospitals with primary percutaneous coronary intervention (PCI) capacity. Existing protocols encourage prompt transfer of patients with STEMI to the PCI center and emphasize minimizing time to treatment. In each participating center, all patients presenting with STEMI are enrolled. The study is conducted prospectively during five consecutive 3-month periods (quarters). Data collection is web-based and identical for the five quarters. For each center, time points from initial contact with the medical system to revascularization are assessed, analyzed and presented in an interactive session to hospital and emergency services staff. This formalized data feedback is performed at the end of each quarter.
Patients presenting during the first three-month period are included as the reference group. Data from patients with STEMI presenting during the next four quarters are presented in the same manner. Comparisons between the reference group and the next quarters will be made with the Gehan and Pearson χ2 tests.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794001
|Contact: Karl H. Scholz, MD.||+email@example.com|
|Contact: Dorothe Ahlersmann, MD.||+firstname.lastname@example.org|
|Hildesheim, Niedersachsen, Germany, 31134|
|Contact: Karl H Scholz, MD. +49-5121-90-5035 email@example.com|
|Contact: Dorothe Ahlersmann, MD. +49-5121-90-1036 firstname.lastname@example.org|
|Principal Investigator: Karl H. Scholz, MD.|
|Study Director:||Karl H. Scholz, MD.||St.Bernward Hospital|