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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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