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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
Sponsor:
Collaborators:
ALKK: Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausaerzte
The German Heart Foundation
Aerztekammer Niedersachsen
Information provided by (Responsible Party):
Karl Heinrich Scholz, St.Bernward Hospital

Tracking Information
First Submitted Date  ICMJE November 18, 2008
First Posted Date  ICMJE November 19, 2008
Last Update Posted Date December 12, 2016
Study Start Date  ICMJE October 2007
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
Contact to Balloon Time [ Time Frame: six consecutive three month periods (quarters) ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2008)
Contact to Balloon Time [ Time Frame: five consecutive three month periods (quarters) ]
Change History Complete list of historical versions of study NCT00794001 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
mortality (in-hospital-mortality; 30-day-mortality; 1-year-mortality) [ Time Frame: six consecutive three month periods (quarters) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2008)
  • mortality (in-hospital-mortality; 30-day-mortality; 1-year-mortality) [ Time Frame: five consecutive three month periods (quarters) ]
  • Door to Balloon time [ Time Frame: five consecutive three-month periods (quarters) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feedback Intervention and Treatment Times in ST- Elevation Myocardial Infarction
Official Title  ICMJE 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.
Brief Summary

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.

Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE Behavioral: Data analysis and Feedback
Data analysis feedback: quarterly meetings with all stakeholders to present data and discuss potential areas of improvement.
Study Arms  ICMJE Experimental: Data Feedback
The intervention is systematic feedback on performance (using predefined quality indicators) to cardiology, ED, and EMS-stakeholders and staff.
Intervention: Behavioral: Data analysis and Feedback
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 10, 2015)
50000
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2008)
5000
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • all patients who received a diagnosis of STEMI* and were transported to the cardiac catheterization laboratory of the primary PCI center with the intention to perform primary PCI.

    • STEMI definition:
  • elevation of the ST-segments of greater than or equal to 0.1 mV in at least two contiguous limb- or precordial leads
  • new or presumable new left bundle branch block in the presence of typical symptoms

Exclusion Criteria:

  • STEMI-patients with duration of infarct-related symptoms longer than 24 hours are excluded
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karl H. Scholz, MD. +49-5121-90-5035 prof.dr.k.scholz@bernward-khs.de
Contact: Dorothe Ahlersmann, MD. +49-5121-90-1036 doro.ahlersmann@web.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00794001
Other Study ID Numbers  ICMJE GOE-01-10-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Karl Heinrich Scholz, St.Bernward Hospital
Study Sponsor  ICMJE Karl Heinrich Scholz
Collaborators  ICMJE
  • ALKK: Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausaerzte
  • The German Heart Foundation
  • Aerztekammer Niedersachsen
Investigators  ICMJE
Study Director: Karl H. Scholz, MD. St.Bernward Hospital
PRS Account St.Bernward Hospital
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP