Early Diagnosis of Acute Myocardial Infarction: Impact of an Educational and Organizational Intervention

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)

Overall Status

Recruiting

CT.gov ID

NCT04333381

Collaborator

(none)

450

Enrollment

Location

Arms

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The hypothesis is that an educational program aimed at emergency nurses and the implementation of measures at the organizational level reduce the time between arrival at the emergency room and the opening of the artery or balloon by 40% in patients attending for acute myocardial infarction.

Condition or Disease	Intervention/Treatment	Phase
STEMI Myocardial Infarction Nurses Education Emergency Room	Other: Educational and organizational intervention Other: Common Practice	N/A

Detailed Description

The time between arrival in the emergency room (ER) and balloon time (D2B) in ST segment elevation myocardial infarction (STEMI) is one of the best indicators of quality care in patients with STEMI. Hospitals with more strategies to improve this quality of care have a shorter door-to-balloon time. The aim is to evaluate the effectiveness, in the time between the arrival in the ER and the balloon time, of an educational and organizational intervention for the early diagnosis of myocardial infarction for emergency nurses.

The aim of this study is to improve the time between arrival to ER and balloon time.

The study consists of two phases:

Phase I (PRE): in this phase, the aim is to describe the attendance times and to evaluate the causes of delay in attendance in STEMI patients. With the findings, a plan will be drawn up that includes the integration of an educational program for emergency nurses and organizational measures; oriented to improve the early diagnosis and delays in STEMI.

Phase II (POST): in this phase, the aim is to evaluate the effectiveness in improving delays in the care of patients with STEMI after the implementation of the educational and organizational intervention developed in phase 1. On the other hand, will evaluate the satisfaction of the emergency nurses with the training they received through educational and organizational intervention.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Quasi-experimental design study, pre-post intervention typeQuasi-experimental design study, pre-post intervention type

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Early Diagnosis of Acute Myocardial Infarction: Impact of an Educational and Organizational Intervention

Actual Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Common Practice Patients included in the phase I will receive common practice.	Other: Common Practice Common practice is based on care by emergency nurses who did not receive any systematized education of acute myocardial infarction led by interventional cardiology nurses. On the other hand, emergency management is based on Plan-Do-Study-Act methodology and in the historical sample some organizational improvement strategies did not exist or were beginning to be implemented
Experimental: Educational and organizational measures Patients included in the phase II will be attended by emergency nurses that received the educational and organizational intervention.	Other: Educational and organizational intervention Patients included after a systematic educational and organizational intervention for early diagnosis and care in myocardial infarction, aimed at emergency nurses of a tertiary Hospital capable in primary PCI. The educational intervention will consist: Systematized educational intervention on acute myocardial infarction for emergency triage nurses will consist of theoretical and practical training through case presentations and clinical simulation. The organizational intervention will consist: Development and dissemination of an early diagnostic tool for acute myocardial infarction: STEMI infographics. It will be provided to all emergency nurses and emergency triage boxes Update the STEMI hospital protocol and adapt it to the current clinical guidelines of the European Society of Cardiology (ESC) Review organizational strategies and definition of new improvement measures Audit the delays in STEMI Periodic multi-disciplinary update sessions

Arm

Intervention/Treatment

Active Comparator: Common Practice

Patients included in the phase I will receive common practice.

Other: Common Practice

Common practice is based on care by emergency nurses who did not receive any systematized education of acute myocardial infarction led by interventional cardiology nurses. On the other hand, emergency management is based on Plan-Do-Study-Act methodology and in the historical sample some organizational improvement strategies did not exist or were beginning to be implemented

Experimental: Educational and organizational measures

Patients included in the phase II will be attended by emergency nurses that received the educational and organizational intervention.

Other: Educational and organizational intervention

Patients included after a systematic educational and organizational intervention for early diagnosis and care in myocardial infarction, aimed at emergency nurses of a tertiary Hospital capable in primary PCI. The educational intervention will consist: Systematized educational intervention on acute myocardial infarction for emergency triage nurses will consist of theoretical and practical training through case presentations and clinical simulation. The organizational intervention will consist: Development and dissemination of an early diagnostic tool for acute myocardial infarction: STEMI infographics. It will be provided to all emergency nurses and emergency triage boxes Update the STEMI hospital protocol and adapt it to the current clinical guidelines of the European Society of Cardiology (ESC) Review organizational strategies and definition of new improvement measures Audit the delays in STEMI Periodic multi-disciplinary update sessions

Outcome Measures

Primary Outcome Measures

Door-to-balloon time (D2B) [up to 30 days; From the arrival at the emergency room to the balloon time up to discharge]
The time between arrival at the emergency room (ER) and balloon time (D2B) in STEMI

Secondary Outcome Measures

ER arrival-ECG time [up to 30 days; from the arrival at the emergency department to the ECG realization up to discharge]
The time between the arrival at the emergency department and the ECG.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients ≥18 years
Admitted to the emergency room of the same center

Exclusion Criteria:

Pregnant women
Patients who did not receive coronariography were excluded

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	FGS Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08041

Sponsors and Collaborators

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

ClinicalTrials.gov Identifier:

NCT04333381

Other Study ID Numbers:

IIBSP-IAM-2015-84

First Posted:

Apr 3, 2020

Last Update Posted:

Apr 3, 2020

Last Verified:

Apr 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myocardial Infarction

Infarction

Emergencies

Study Results

No Results Posted as of Apr 3, 2020