Feedback Intervention and Treatment Times in ST- Elevation Myocardial Infarction (FITT-STEMI)
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|ClinicalTrials.gov Identifier: NCT00794001|
Recruitment Status : Recruiting
First Posted : November 19, 2008
Last Update Posted : December 12, 2016
Part I (Pilot Phase): 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).
Part II (Implementation Phase): The Purpose is to prospectively investigate if survival can be improved by stringent use of this concept of formalized data analysis and systematic feedback of procedural and clinical data to all participating physicians and other members of the STEMI patients treating personnel.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Behavioral: Data analysis and Feedback||Not Applicable|
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.
Following the Pilot Phase started as feasibility study including a group of 6 different hospital systems of STEMI care, the multicenter FITT-STEMI-Implementation-Phase was started to investigate the effect of standardized documentation, analysis and systematic feedback-intervention on prognosis within a large group of different hospitals capable of primary PCI. This study is performed over 6 quarters including 3 feedback-sessions, and so far, 46 different PCI-hospitals capable of primary PCI participate at the FITT-STEMI-implementation-phase.
Following the initial study period with quarterly feedback-sessions, data collection is continued, and in all of these hospitals feedback-sessions with the EMS- and hospital-staff are held once a year (after quarters 8, 12, 16, and so on).
Participating hospitals So far, a total of 53 hospital-systems with primary PCI capacity and cooperating non-PCI-hospitals participate at the FITT-STEMI-program. At the PCI-Centers, 24 h PCI capability existing for at least one year prior to inclusion, at least two interventional cardiologists who could take call, and a volume of at least 250 PCI procedures as well as 50 PCI procedures in STEMI patients per year are required for participation at the project. All 6 key strategies of the ACC D2B-initiative (Bradley EH, NEJ 2006) were endorsed by the hospitals before participating in the project. All hospitals ensured prompt transfer of patients with STEMI to the PCI centers minimizing time to treatment.
The overall geographic catchment area currently serves a population of more than 10 million people in Germany with more than 5,500 STEMI patients per year, which is consistent with > 10 % of the German population and with > 10% of the patients treated with acute STEMI in German hospitals per year .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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.|
|Study Start Date :||October 2007|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Experimental: Data Feedback
The intervention is systematic feedback on performance (using predefined quality indicators) to cardiology, ED, and EMS-stakeholders and staff.
Behavioral: Data analysis and Feedback
Data analysis feedback: quarterly meetings with all stakeholders to present data and discuss potential areas of improvement.
- Contact to Balloon Time [ Time Frame: six consecutive three month periods (quarters) ]
- mortality (in-hospital-mortality; 30-day-mortality; 1-year-mortality) [ Time Frame: six consecutive three month periods (quarters) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00794001
|Contact: Karl H. Scholz, MD.||+firstname.lastname@example.org|
|Contact: Dorothe Ahlersmann, MD.||+email@example.com|
|Hildesheim, Niedersachsen, Germany, 31134|
|Contact: Karl H Scholz, MD. +49-5121-90-5035 firstname.lastname@example.org|
|Contact: Dorothe Ahlersmann, MD. +49-5121-90-1036 email@example.com|
|Principal Investigator: Karl H. Scholz, MD.|
|Study Director:||Karl H. Scholz, MD.||St.Bernward Hospital|