STEMINCT04333381
Early Diagnosis of Acute Myocardial Infarction: Impact of an Educational and Organizational Intervention
A study testing Educational and organizational intervention and Common Practice in people with STEMI and Myocardial Infarction, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI, Myocardial Infarction, Nurses
- What is being tested?
- Educational and organizational intervention and Common Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years
- Admitted to the emergency room of the same center
Who cannot join
- Pregnant women
- Patients who did not receive coronariography were excluded
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
FGS Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Gemma Berga Congost, gberga@santpau.cat
About this study
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.
Read the 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.
- Conditions
- STEMI, Myocardial Infarction, Nurses, Education, Emergency Room
- Being tested
- Educational and organizational intervention, Common Practice
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational and organizational interventionOther
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 PracticeOther
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
| Study group | Role | What they receive |
|---|---|---|
| Common Practice | Active comparator | Patients included in the phase I will receive common practice. Receives: Other: Common Practice |
| Educational and organizational measures | Experimental | Patients included in the phase II will be attended by emergency nurses that received the educational and organizational intervention. Receives: Other: Educational and organizational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Door-to-balloon time (D2B)
The time between arrival at the emergency room (ER) and balloon time (D2B) in STEMI
Measured: up to 30 days; From the arrival at the emergency room to the balloon time up to discharge
Secondary outcomes (1)
ER arrival-ECG time
The time between the arrival at the emergency department and the ECG.
Measured: up to 30 days; from the arrival at the emergency department to the ECG realization up to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Jul 2019
- Primary completion1 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental design study, pre-post intervention type
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333381
- Sponsor's protocol ID
- IIBSP-IAM-2015-84
- Status last verified
- Apr 2020
- First submitted
- 24 Mar 2020
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36335910Berga 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.
PubMed 33199195
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Acute Myocardial Infarction: Impact of an Educational and Organizational Intervention
- ClinicalTrials.gov ID
- NCT04333381
- Acronym / sponsor ID
- IIBSP-IAM-2015-84
- Conditions
- STEMI, Myocardial Infarction, Nurses, Education, Emergency Room
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental design study, pre-post intervention type
| Arm | Type | Receives |
|---|---|---|
| Common Practice | Active comparator | Other: Common PracticePatients included in the phase I will receive common practice. |
| Educational and organizational measures | Experimental | Other: Educational and organizational interventionPatients included in the phase II will be attended by emergency nurses that received the educational and organizational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥18 years
- Admitted to the emergency room of the same center
Key exclusion criteria (2 listed)
- Pregnant women
- Patients who did not receive coronariography were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational and organizational interventionPatients 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 | Other | Educational and organizational measures |
| Common PracticeCommon 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 | Other | Common Practice |
Primary outcome
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
1 secondary outcome
ER arrival-ECG time
Time frame: up to 30 days; from the arrival at the emergency department to the ECG realization up to discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Derived from this study: PubMed 36335910Berga 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.
- Derived from this study: PubMed 33199195Berga 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational and organizational intervention and Common Practice in people with STEMI and Myocardial Infarction, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gemma Berga Congost, RN, MSc, PhD student (932919000 ext. 7926, gberga@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04333381, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.