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

NCT ID: NCT04333381

Last Updated: 2020-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

STEMI Myocardial Infarction Nurses Education Emergency Room

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Quasi-experimental design study, pre-post intervention type
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Common Practice

Patients included in the phase I will receive common practice.

Group Type ACTIVE_COMPARATOR

Common Practice

Intervention Type OTHER

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

Educational and organizational measures

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

Group Type EXPERIMENTAL

Educational and organizational intervention

Intervention Type OTHER

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.

1. 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.
2. 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

1. 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.
2. 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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

FGS Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gemma Berga Congost, RN, MSc, PhD student

Role: CONTACT

932919000 ext. 7926

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gemma Berga Congost

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Berga Congost G, Martinez Momblan MA, Valverde Bernal J, Marquez Lopez A, Ruiz Gabalda J, Garcia-Picart J, Puig Campmany M, Brugaletta S. Association of sex and age and delay predictors on the time of primary angioplasty activation for myocardial infarction patients in an emergency department. Heart Lung. 2023 Mar-Apr;58:6-12. doi: 10.1016/j.hrtlng.2022.10.014. Epub 2022 Nov 3.

Reference Type DERIVED
PMID: 36335910 (View on PubMed)

Berga Congost G, Brugaletta S, Valverde Bernal J, Marquez Lopez A, Ruiz Gabalda J, Garcia-Picart J, Puig Campmany M, Martinez Momblan MA. The importance of organizational variables in treatment time for patients with ST-elevation acute myocardial infarction improve delays in STEMI. Australas Emerg Care. 2021 Jun;24(2):141-146. doi: 10.1016/j.auec.2020.10.001. Epub 2020 Nov 14.

Reference Type DERIVED
PMID: 33199195 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IIBSP-IAM-2015-84

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sonothrombolysis in Patients With STEMI
NCT03092089 COMPLETED PHASE2
Resistance STEMI Study
NCT03439150 TERMINATED NA