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Electronic Feedback for Data Restitution and Valorization to the Emergency Teams in Aquitaine. (FERVEUR)

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ClinicalTrials.gov Identifier: NCT04852146
Recruitment Status : Not yet recruiting
First Posted : April 21, 2021
Last Update Posted : April 21, 2021
Sponsor:
Collaborators:
Reanim
Acira
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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Brief Summary:

ST+ Acute Coronary Syndrome (ACS) is a major cause of mortality, morbidity and healthcare costs in Europe and France. Emergency trans-luminal angioplasty (TLA), the gold standard treatment, is the major determinant of vital prognosis and functional recovery of patients with ST+ ACS.

However, data from surveys and French practice registers highlight frequent deviations from the recommendations at different stages of the procedure; in the pre-hospital phase these malfunctions result in longer delays. Improving the quality of care for patients with ST+ ACS, and in particular improving compliance with recommended delays in the acute phase, is a public health priority in France.

Feedback has been identified as one of the most effective interventions to improve practices and organisations in healthcare institutions. Feedbacks are defined as "any summary of a care performance over a given period of time that can be transmitted a posteriori to the health professional in any form, whether written, oral or by computer (in this case called e-feedbacks)". Feedbacks, by objectifying the level of individual and collective performance, encourage recipients to modify their practices and organisations to improve their performance. It also acts as a social pressure mechanism. While the minimum elements of feedback have been identified in the literature, there is a lack of information about the optimal operational modalities for their deployment, which limits the system's capacity to implement them. To overcome this lack of information, there is a consensus in the scientific community that research on feedback should focus not only on analysing its effectiveness, but above all on the determinants of its effectiveness. With regard to the quality of management of patients with ST+ ACS, only four trials were found in the literature that studied the effectiveness of feedbacks; none of them defined the optimal intervention for deploying feedbacks in the emergency department setting.

Practice registers, particularly in the cardiovascular field, have shown their effectiveness in improving practices, particularly through the implementation of feedback to practitioners, who produce data. In 2012, the ARS Aquitaine set up two regional cardiovascular registers constituting permanent, nominative, continuous and exhaustive records of the management of patients suffering from coronary pathologies: the Aquitaine Interventional Cardiology Register (ACIRA) and the Aquitaine Register of Initial Management of Myocardial Infarction (REANIM). The cross-referencing of the REANIM and ACIRA registers constitutes an exhaustive cohort of patients with ST+ ACS containing information on the management of the entire care pathway, from the onset of symptoms to the end of the hospitalization for the management of the acute episode. This cohort, which is unique in France in the field of coronary pathologies, makes it possible to produce unprecedented and highly accurate information, particularly concerning the time taken to provide care. Wishing to actively engage in a process of changing practices, the Aquitaine Cardiovascular Registries team has developed an e-feedback tool for emergency, EMS and cardiology teams. This tool alone cannot contribute to effectively improving patient care. It is necessary to build an intervention for the deployment of this tool that takes into account the scientific data and the organisational constraints of care. Secondly, the evaluation of the effectiveness and economic impact of this e-feedbacks tool deployment intervention will allow us to know its real added value on practices, organisations and health care expenditure.


Condition or disease Intervention/treatment
Acute Coronary Syndrome Procedure: Electronic feedback

Detailed Description:

The study has two phases:

  • A phase of construction of the intervention based on qualitative analyses of the focus groups near the professionals of the establishments of the 7 zones SAMU concerned and semi-directive interviews near the directions of the establishments of the 7 zones SAMU concerned;
  • A phase of evaluation of the impact of the intervention which is based on a mixed method mixing quantitative and qualitative analyses. The qualitative analyses are based on semi-directive interviews with the professionals concerned in the establishments of the 7 participating UAS zones. The study design of the quantitative part is a cluster randomised controlled trial in a transverse stepped wedge design. The clusters are represented by 7 UAS zones of the ex-Aquitaine region.
Study Design
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Study Type : Observational
Estimated Enrollment : 820 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electronic Feedback for the Restitution and Valorization of Data on the Management of Acute Coronary Syndrome With ST Segment Elevation in Aquitaine to Emergency Teams
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025
Groups and Cohorts
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Group/Cohort Intervention/treatment
Professional
The sample of professionals will be made up of doctors and nurses of the emergency structures (pre and intra-hospital), doctors and nurses of interventional cardiology and ambulance drivers practising in an establishment of the 7 participating SAMU zones
 Procedure: Electronic feedback
Feedbacks have been identified as one of the most effective interventions to improve practices and organisations in health care institutions. It is also a tool for facilitating and coordinating practice registers, improving the contribution of data producers and the quality of data.
Patient
The patient sample will consist of patients included in the REANIM registry during the study period (the entire period of the stepped wedge randomised controlled trial).
 Procedure: Electronic feedback
Feedbacks have been identified as one of the most effective interventions to improve practices and organisations in health care institutions. It is also a tool for facilitating and coordinating practice registers, improving the contribution of data producers and the quality of data.


Outcome Measures
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Primary Outcome Measures :
  1. Assessing effectiveness of an e-feedback deployment intervention. [ Time Frame: 28 months after the baseline ]
    To assess the effectiveness of an e-feedbacks deployment intervention on the proportion of patients with ST+ ACS managed within the recommended time from qualifying ECG to balloon inflation.


Secondary Outcome Measures :
  1. Studying acceptability and effectiveness determinants of an e-feedback deployment intervention. [ Time Frame: 28 months after the baseline ]
    Qualitative analysis of acceptability and effectiveness determinants of an e-feedback deployment intervention in emergency facilities: understanding the implementation contexts, usual professionals behaviours, difficulties encountered in practice, needs and expectations with regard to the intervention. Thanks to indicivuals interviews.

  2. Evaluate effectiveness of e-feedback deployment intervention [ Time Frame: 28 months after the baseline ]
    Evaluate effectiveness of e-feedback deployment intervention, thanks to the time between qualifying ECG and balloon inflation

  3. Economic assessment [ Time Frame: 28 months after the baseline ]
    Total cost (in €) of production (design, implementation) of the electronic feedback intervention, thanks to micro-costing

  4. Assessment of health care consumption [ Time Frame: 28 months after the baseline ]
    Difference in health care consumption between the period with and without the intervention and typology of health care consumption between the groups based on SNDS data.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient with ST+ ACS, who accept to participate to REANIM or ACIRA registers, and treated by one of the 7 participating emergency zones.

Professional who volunteered to participate in the interviews,from establishments in the 7 participating emergency zones taking care of patients with ST+ ACS in Ex-Aquitaine.

Criteria

Patient criteria:

Inclusion Criteria:

  • Patients over 18 years of age residing in metropolitan France;
  • Patients with ST+ ACS less than 24 hours old;
  • Patients treated by one of the 19 SMURs (primary and secondary) or one of the 32 emergency services in Aquitaine.

Exclusion Criteria:

- refusal to participate to REANIM or ACIRA registers.

Professional criteria:

Inclusion Criteria:

- Professionals who volunteered to participate in the interviews, from establishments in the 7 participating emergency zones taking care of patients with ST+ ACS in Ex-Aquitaine.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04852146


Contacts
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Contact: Catherine PRADEAU, Dr 5 57 82 04 14 ext +33 catherine.pradeau@chu-bordeaux.fr

Locations
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France
Centre Hospitalier Agen Nérac
Agen, France, 47923
Contact: Catherine PRADEAU, Dr    5 57 82 04 14 ext +33    catherine.pradeau@chu-bordeaux.fr   
Centre Hospitalier de la Cote Basque
Bayonne, France, 64100
Contact: Catherine PRADEAU, Dr    5 57 82 04 14 ext +33    catherine.pradeau@chu-bordeaux.fr   
Hôpital Pellegrin
Bordeaux, France, 33000
Contact: Catherine PRADEAU, Dr    5 57 82 04 14 ext +33    catherine.pradeau@chu-bordeaux.fr   
Hôpital de Libourne
Libourne, France, 33500
Contact: Catherine PRADEAU, Dr    5 57 82 04 14 ext +33    catherine.pradeau@chu-bordeaux.fr   
Centre Hospitalier de Mont de Marsan
Mont de Marsan, France, 40024
Contact: Catherine PRADEAU, Dr    5 57 82 04 14 ext +33    catherine.pradeau@chu-bordeaux.fr   
Centre Hospitalier de Pau
Pau, France, 64000
Contact: Catherine PRADEAU, Dr    5 57 82 04 14 ext +33    catherine.pradeau@chu-bordeaux.fr   
Centre Hospitalier Périgueux
Périgueux, France, 24000
Contact: Catherine PRADEAU, Dr    5 57 82 04 14 ext +33    catherine.pradeau@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
Reanim
Acira
Investigators
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Study Chair: Florence SAILLOUR-GLENISSON, Dr UMES
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04852146    
Other Study ID Numbers: CHUBX 2019/64
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
electronic feedback
ST+ ACR
Cardiovascular registry
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Emergencies
Disease
Pathologic Processes
 Disease Attributes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases