Feedback Intervention and Treatment Times in ST- Elevation Myocardial Infarction

NCT ID: NCT00794001

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2026-12-31

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.

Part III (Advance Phase): The purpose is to develop, introduce and evaluate prospectively an automated, highly standardized feedback tool informing participating centers on key performance characteristics (procedural and clinical outcomes).

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.

The multi-phase FITT-STEMI project is structured as follows:

Part I (Pilot Phase)

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.

Part II (Implementation Phase)

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. Estimated Enrollment: 50,000 participants (Phases I and II).

Part III (Advance Phase)

This phase of the multi-phase FITT-STEMI aims to develop, introduce and evaluate prospectively an automated, highly standardized feedback tool informing participating centers on key performance characteristics (procedural and clinical outcomes). A stepped wedge design with baseline phase will be used. The participating (newly recruited or already established) centres will be randomly allocated to switching over from the implemented feedback form to the new automated, highly standardized feedback tool; the switch-over process is staggered over time. Estimated Enrollment: 60,000 participants (Phases I - III).

Conditions

Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Data Feedback

The intervention is systematic feedback on performance (using predefined quality indicators) to cardiology, ED, and EMS-stakeholders and staff.

Group Type: EXPERIMENTAL

Data analysis and Feedback

Intervention Type: BEHAVIORAL

Data analysis feedback: quarterly meetings with all stakeholders to present data and discuss potential areas of improvement.

Interventions

Data analysis and Feedback

Data analysis feedback: quarterly meetings with all stakeholders to present data and discuss potential areas of improvement.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ALKK: Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausaerzte

UNKNOWN

Sponsor Role: collaborator

The German Heart Foundation

OTHER

Sponsor Role: collaborator

Aerztekammer Niedersachsen

UNKNOWN

Sponsor Role: collaborator

Karl Heinrich Scholz

OTHER

Sponsor Role: lead

Responsible Party

Karl Heinrich Scholz

Professor Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Karl H. Scholz, MD.

Role: STUDY_DIRECTOR

St.Bernward Hospital

Locations

St.Bernward Hospital

Hildesheim, Lower Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Karl H. Scholz, MD.

Role: CONTACT

k.scholz@fitt-stemi.de

+49-5121-90-1036

Thomas Meyer, MD. PHD.

Role: CONTACT

Thomas.meyer@med.uni-goettingen.de

+49-551-39-64940

Facility Contacts

Karl H Scholz, MD.

Role: primary

k.scholz@fitt-stemi.de

+49-5121-90-1036

Thomas Meyer, MD., PHD

Role: backup

Thomas.meyer@med.uni-goettingen.de

+49-551-39-64940

References

Ting HH, Krumholz HM, Bradley EH, Cone DC, Curtis JP, Drew BJ, Field JM, French WJ, Gibler WB, Goff DC, Jacobs AK, Nallamothu BK, O'Connor RE, Schuur JD; American Heart Association Interdisciplinary Council on Quality of Care and Outcomes Research, Emergency Cardiovascular Care Committee; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Clinical Cardiology. Implementation and integration of prehospital ECGs into systems of care for acute coronary syndrome: a scientific statement from the American Heart Association Interdisciplinary Council on Quality of Care and Outcomes Research, Emergency Cardiovascular Care Committee, Council on Cardiovascular Nursing, and Council on Clinical Cardiology. Circulation. 2008 Sep 2;118(10):1066-79. doi: 10.1161/CIRCULATIONAHA.108.190402. Epub 2008 Aug 13. No abstract available.

Reference Type: BACKGROUND

PMID: 18703464 (View on PubMed)

Scholz KH, Hilgers R, Ahlersmann D, Duwald H, Nitsche R, von Knobelsdorff G, Volger B, Moller K, Keating FK. Contact-to-balloon time and door-to-balloon time after initiation of a formalized data feedback in patients with acute ST-elevation myocardial infarction. Am J Cardiol. 2008 Jan 1;101(1):46-52. doi: 10.1016/j.amjcard.2007.07.078. Epub 2007 Nov 19.

Reference Type: RESULT

PMID: 18157964 (View on PubMed)

Scholz KH, von Knobelsdorff G, Ahlersmann D, Keating FK, Jung J, Werner GS, Nitsche R, Duwald H, Hilgers R. [Optimizing systems of care for patients with acute myocardial infarction. STEMI networks, telemetry ECG, and standardized quality improvement with systematic data feedback]. Herz. 2008 Mar;33(2):102-9. doi: 10.1007/s00059-008-3120-6. German.

Reference Type: RESULT

PMID: 18344028 (View on PubMed)

Scholz KH, Maier SK, Jung J, Fleischmann C, Werner GS, Olbrich HG, Ahlersmann D, Keating FK, Jacobshagen C, Moehlis H, Hilgers R, Maier LS. Reduction in treatment times through formalized data feedback: results from a prospective multicenter study of ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2012 Aug;5(8):848-57. doi: 10.1016/j.jcin.2012.04.012.

Reference Type: RESULT

PMID: 22917457 (View on PubMed)

Maier LS, Maier SK, Scholz KH. Letter by Maier et al regarding article, "Emergency department bypass for ST-segment-elevation myocardial infarction patients identified with a prehospital electrocardiogram: a report from the American Heart Association Mission: Lifeline Program". Circulation. 2014 Mar 4;129(9):e371. doi: 10.1161/CIRCULATIONAHA.113.005631. No abstract available.

Reference Type: RESULT

PMID: 24589702 (View on PubMed)

Scholz KH, Maier SKG, Maier LS, Lengenfelder B, Jacobshagen C, Jung J, Fleischmann C, Werner GS, Olbrich HG, Ott R, Mudra H, Seidl K, Schulze PC, Weiss C, Haimerl J, Friede T, Meyer T. Impact of treatment delay on mortality in ST-segment elevation myocardial infarction (STEMI) patients presenting with and without haemodynamic instability: results from the German prospective, multicentre FITT-STEMI trial. Eur Heart J. 2018 Apr 1;39(13):1065-1074. doi: 10.1093/eurheartj/ehy004.

Reference Type: RESULT

PMID: 29452351 (View on PubMed)

Scholz KH, Friede T, Meyer T, Jacobshagen C, Lengenfelder B, Jung J, Fleischmann C, Moehlis H, Olbrich HG, Ott R, Elsasser A, Schroder S, Thilo C, Raut W, Franke A, Maier LS, Maier SK. Prognostic significance of emergency department bypass in stable and unstable patients with ST-segment elevation myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2020 Mar;9(1_suppl):34-44. doi: 10.1177/2048872618813907. Epub 2018 Nov 27.

Reference Type: RESULT

PMID: 30477317 (View on PubMed)

Scholz KH, Lengenfelder B, Jacobshagen C, Fleischmann C, Moehlis H, Olbrich HG, Jung J, Maier LS, Maier SK, Bestehorn K, Friede T, Meyer T. Long-term effects of a standardized feedback-driven quality improvement program for timely reperfusion therapy in regional STEMI care networks. Eur Heart J Acute Cardiovasc Care. 2021 May 25;10(4):397-405. doi: 10.1177/2048872620907323. Epub 2020 Jul 29.

Reference Type: RESULT

PMID: 32723177 (View on PubMed)

Scholz KH, Lengenfelder B, Thilo C, Jeron A, Stefanow S, Janssens U, Bauersachs J, Schulze PC, Winter KD, Schroder J, Vom Dahl J, von Beckerath N, Seidl K, Friede T, Meyer T. Impact of COVID-19 outbreak on regional STEMI care in Germany. Clin Res Cardiol. 2020 Dec;109(12):1511-1521. doi: 10.1007/s00392-020-01703-z. Epub 2020 Jul 16.

Reference Type: RESULT

PMID: 32676681 (View on PubMed)

Scholz M, Meyer T, Maier LS, Scholz KH. Infarct-Related Artery as a Donor of Collaterals in ST-Segment-Elevation Myocardial Infarction With Concomitant Chronic Total Occlusion: Challenge of the Double-Jeopardy Thesis. J Am Heart Assoc. 2023 Apr 4;12(7):e028115. doi: 10.1161/JAHA.122.028115. Epub 2023 Mar 21.

Reference Type: RESULT

PMID: 36942757 (View on PubMed)

Scholz P, Friede T, Scholz KH, Grabmaier U, Meyer T, Seidler T. Pre-hospital heparin is not associated with infarct vessel patency and mortality in ST-segment elevation myocardial infarction patients with out-of-hospital cardiac arrest. Clin Res Cardiol. 2024 Aug 1. doi: 10.1007/s00392-024-02499-y. Online ahead of print.

Reference Type: DERIVED

PMID: 39088062 (View on PubMed)

Scholz KH, Meyer T, Lengenfelder B, Vahlhaus C, Tongers J, Schnupp S, Burckhard R, von Beckerath N, Grusnick HM, Jeron A, Winter KD, Maier SKG, Danner M, Vom Dahl J, Neef S, Stefanow S, Friede T. Patient delay and benefit of timely reperfusion in ST-segment elevation myocardial infarction. Open Heart. 2021 May;8(1):e001650. doi: 10.1136/openhrt-2021-001650.

Reference Type: DERIVED

PMID: 33958491 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/18157964?ordinalpos=3&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

Related Info

Other Identifiers

GOE-01-10-07

Identifier Type: -

Identifier Source: org_study_id