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

April 1, 2020 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gemma Berga Congost, RN, MSc, PhD student
  • Phone Number: 7926 932919000
  • Email: gberga@santpau.cat

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • FGS Hospital de la Santa Creu i Sant Pau
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

  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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Door-to-balloon time (D2B)
Time Frame: 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
up to 30 days; From the arrival at the emergency room to the balloon time up to discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ER arrival-ECG time
Time Frame: 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.
up to 30 days; from the arrival at the emergency department to the ECG realization up to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

March 24, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-IAM-2015-84

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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