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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 820

Contacts and Locations

• Study Contact: Name: Catherine PRADEAU, Dr; Phone Number: +33 5 57 82 04 14; Email: catherine.pradeau@chu-bordeaux.fr

Study Locations

• France
  • Agen, France, 47923
    • Centre Hospitalier Agen Nérac
    • Contact: Catherine PRADEAU, Dr; Phone Number: +33 5 57 82 04 14; Email: catherine.pradeau@chu-bordeaux.fr
  • Bayonne, France, 64100
    • Centre Hospitalier de la Cote Basque
    • Contact: Catherine PRADEAU, Dr; Phone Number: +33 5 57 82 04 14; Email: catherine.pradeau@chu-bordeaux.fr
  • Bordeaux, France, 33000
    • Hôpital Pellegrin
    • Contact: Catherine PRADEAU, Dr; Phone Number: +33 5 57 82 04 14; Email: catherine.pradeau@chu-bordeaux.fr
  • Libourne, France, 33500
    • Hôpital de Libourne
    • Contact: Catherine PRADEAU, Dr; Phone Number: +33 5 57 82 04 14; Email: catherine.pradeau@chu-bordeaux.fr
  • Mont de Marsan, France, 40024
    • Centre Hospitalier de Mont de Marsan
    • Contact: Catherine PRADEAU, Dr; Phone Number: +33 5 57 82 04 14; Email: catherine.pradeau@chu-bordeaux.fr
  • Pau, France, 64000
    • Centre Hospitalier de Pau
    • Contact: Catherine PRADEAU, Dr; Phone Number: +33 5 57 82 04 14; Email: catherine.pradeau@chu-bordeaux.fr
  • Périgueux, France, 24000
    • Centre Hospitalier Périgueux
    • Contact: Catherine PRADEAU, Dr; Phone Number: +33 5 57 82 04 14; Email: catherine.pradeau@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Studying acceptability and effectiveness determinants of an e-feedback deployment intervention.	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.	28 months after the baseline
Evaluate effectiveness of e-feedback deployment intervention	Evaluate effectiveness of e-feedback deployment intervention, thanks to the time between qualifying ECG and balloon inflation	28 months after the baseline
Economic assessment	Total cost (in €) of production (design, implementation) of the electronic feedback intervention, thanks to micro-costing	28 months after the baseline
Assessment of health care consumption	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.	28 months after the baseline

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Reanim; Acira
• Investigators: Study Chair: Florence SAILLOUR-GLENISSON, Dr, UMES

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 15, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 15, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: electronic feedback; ST+ ACR; Cardiovascular registry
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Disease; Syndrome; Emergencies; Acute Coronary Syndrome
• Other Study ID Numbers: CHUBX 2019/64

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No