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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04333381
Other study ID # IIBSP-IAM-2015-84
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date December 31, 2022

Study information

Verified date April 2020
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact Gemma Berga Congost, RN, MSc, PhD student
Phone 932919000
Email gberga@santpau.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 450
Est. completion date December 31, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


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
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

Locations

Country Name City State
Spain FGS Hospital de la Santa Creu i Sant Pau Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Door-to-balloon time (D2B) 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 ER arrival-ECG time 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
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