Ignite Creation Date:
2024-05-06 @ 4:02 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04852146
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-04-21
First Post:
2021-04-15
Brief Title:
Electronic Feedback for Data Restitution and Valorization to the Emergency Teams in Aquitaine
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FERVEUR
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 systems 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
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 systems 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None