Early Diagnosis of Acute Myocardial Infarction: Impact of an Educational and Organizational Intervention
Primary Purpose
STEMI, Myocardial Infarction, Nurses
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Educational and organizational intervention
Common Practice
Sponsored by
About this trial
This is an interventional other trial for STEMI
Eligibility Criteria
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
Sites / Locations
- FGS Hospital de la Santa Creu i Sant PauRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Common Practice
Educational and organizational measures
Arm Description
Patients included in the phase I will receive common practice.
Patients included in the phase II will be attended by emergency nurses that received the educational and organizational intervention.
Outcomes
Primary Outcome Measures
Door-to-balloon time (D2B)
The time between arrival at the emergency room (ER) and balloon time (D2B) in STEMI
Secondary Outcome Measures
ER arrival-ECG time
The time between the arrival at the emergency department and the ECG.
Full Information
NCT ID
NCT04333381
First Posted
March 24, 2020
Last Updated
April 1, 2020
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT04333381
Brief Title
Early Diagnosis of Acute Myocardial Infarction: Impact of an Educational and Organizational Intervention
Official Title
Early Diagnosis of Acute Myocardial Infarction: Impact of an Educational and Organizational Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI, Myocardial Infarction, Nurses, Education, Emergency Room
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Quasi-experimental design study, pre-post intervention type
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Common Practice
Arm Type
Active Comparator
Arm Description
Patients included in the phase I will receive common practice.
Arm Title
Educational and organizational measures
Arm Type
Experimental
Arm Description
Patients included in the phase II will be attended by emergency nurses that received the educational and organizational intervention.
Intervention Type
Other
Intervention Name(s)
Educational and organizational intervention
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Common Practice
Intervention Description
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
Primary Outcome Measure Information:
Title
Door-to-balloon time (D2B)
Description
The time between arrival at the emergency room (ER) and balloon time (D2B) in STEMI
Time Frame
up to 30 days; From the arrival at the emergency room to the balloon time up to discharge
Secondary Outcome Measure Information:
Title
ER arrival-ECG time
Description
The time between the arrival at the emergency department and the ECG.
Time Frame
up to 30 days; from the arrival at the emergency department to the ECG realization up to discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gemma Berga Congost, RN, MSc, PhD student
Phone
932919000
Ext
7926
Email
gberga@santpau.cat
Facility Information:
Facility Name
FGS Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gemma Berga Congost
Email
gberga@santpau.cat
12. IPD Sharing Statement
Citations:
PubMed Identifier
33199195
Citation
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.
Results Reference
derived
Learn more about this trial
Early Diagnosis of Acute Myocardial Infarction: Impact of an Educational and Organizational Intervention
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