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

NCT04852146 | Unknown

• 1 other identifier: CHUBX 2019/64
• Study Type: observational
• Target: 820
• Locations: 1 country
• Sites: 7

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.

Conditions

Acute Coronary Syndrome

Keywords

electronic feedback; ST+ ACR; Cardiovascular registry

Outcome Measures

Primary Outcomes (1)

• Assessing effectiveness of an e-feedback deployment intervention.

  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.

  28 months after the baseline

Secondary Outcomes (4)

• Studying acceptability and effectiveness determinants of an e-feedback deployment intervention.

  28 months after the baseline

• Evaluate effectiveness of e-feedback deployment intervention

  28 months after the baseline

• Economic assessment

  28 months after the baseline

• Assessment of health care consumption

  28 months after the baseline

Study Arms (2)

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

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

Interventions

Electronic feedback PROCEDURE

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; Professional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- refusal to participate to REANIM or ACIRA registers.
• Professional 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Reanim: collaborator
• Acira: collaborator

Study Sites (7)

Centre Hospitalier Agen Nérac

Agen, 47923, France

Location

Centre Hospitalier de la Cote Basque

Bayonne, 64100, France

Location

Hôpital Pellegrin

Bordeaux, 33000, France

Location

Hôpital de Libourne

Libourne, 33500, France

Location

Centre Hospitalier de Mont de Marsan

Mont-de-Marsan, 40024, France

Location

Centre Hospitalier de Pau

Pau, 64000, France

Location

Centre Hospitalier Périgueux

Périgueux, 24000, France

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Florence SAILLOUR-GLENISSON, Dr

  UMES

  STUDY CHAIR

Central Study Contacts

Catherine PRADEAU, Dr

CONTACT

5 57 82 04 14; catherine.pradeau@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 21, 2021
• Study Start: September 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 21, 2021

Record last verified: 2021-04

Locations

FR (7)