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Not yet recruiting NCT07207499

Evaluation of the Access to Healthcare Service

Observational Emergency Service, Hospital

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: control group ("standard" regulation device), intervention group Access to Care Service "SAS".
Who it may be relevant to
Registry conditions: Emergency Service, Hospital. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of the Access to Healthcare Service Established in the Le Havre Area

Overview

The Healthcare Access Service (SAS) of the Emergency Department of the CHG du Havre is a telephone regulation (i.e., orientation) service for users of Le Havre. Access to this service, during a call, gives access to a Medical Regulation Assistant (ARM) (first contact) who determines, in less than 30 seconds, the degree of urgency applicable to the "caller" in order to direct the latter to the "primary care" channel or the "urgent medical assistance" channel. Thus, in the context of a non-life-threatening emergency, this service allows access during the day to a consultation with a healthcare professional. When their primary care physician is not available, the "caller" is directed by a Medical Regulation Assistant (ARM) to an Unscheduled Care Operator (OSNP) who can provide medical advice, offer a teleconsultation, or direct them, depending on the situation, to an unscheduled care consultation in an office, at home, or at a health center. This service therefore allows for patient referrals and gives patients direct access to healthcare professionals known as "performers" of primary care (doctor, midwife, dentist) within very short timeframes (most often during the day, and 48 hours at the latest). This medical regulation is made possible through the use of a shared calendar between independent healthcare professionals and the healthcare access service (SAS). In the event of a life-threatening emergency, the "caller" is directed by the Medical Regulation Assistant (ARM) to an emergency Medical Regulation Assistant (ARM) who assesses the actual degree of urgency, the medical needs and the possibility of triggering the SAMU intervention. Before its implementation, the patient journey was complicated by the lack of a link between regulation and so-called "field" medical professionals, now called "performers" of primary care. Indeed, the initial so-called "standard" regulation system did not have a "primary care" referral system (with very rapid appointments to primary care for semi-emergencies (unscheduled community care)), potentially saving recourse to emergency services or medical time in situations not requiring medical advice (request for contact details of on-call pharmacy).

Detailed description

The SAS represents an evolution of SAMU medical regulation, no longer based solely on emergency medical assistance (the standard regulation system), but also combining it with outpatient medical regulation.

It is therefore a multi-professional platform that saves medical time by delegating some of the tasks (pre-triage, administrative information gathering², scheduling unscheduled care appointments) to non-medical personnel specifically trained for the task (Unscheduled Care Operators (OSNP)). This study seeks to assess the benefits of this new system in a context of very high social expectations. A comparative assessment is necessary between the Emergency Department's Access to Care Service (SAS) and the former "standard" regulation system to understand the overall impact of the "SAS" on the Le Havre healthcare area.

This study has multiple perspectives:

* For users, the aim is to compare the care trajectory of regulated users (healthcare professional(s) seen, emergency room stay, hospitalization, etc.) by the "SAS" versus "standard" regulation and to understand the use of Unscheduled Care (SNP) provided in the Le Havre area; * To assess the medical-economic impact of the "SAS" versus "standard" regulation. * For healthcare professionals, it is a question of understanding and describing the interactions between the "effectors" of primary care (doctor, midwife, dentist) and the regulators involved (Unscheduled Care Operator (OSNP) (via the Medical Regulation Assistant (ARM))) in the "SAS"

Interventions

  • Other control group ("standard" regulation device)
    Evaluate the time spent in the emergency room of patients referred to the emergency room by the "standard" regulation system
  • Other intervention group Access to Care Service "SAS"
    Evaluate the time spent in the emergency room of patients referred to the emergency room by the Emergency Care Access Service (SAS)

Primary outcome measures

  • Evaluate the savings in emergency room use attributable to the regulation system integrating the SAS compared to the standard control device [Time frame: day 7]
Secondary outcome measures (5)
  • Description of the guidance given by the regulating physician in each of the devices (secondary judgment criterion no. 1) [Time frame: Day 7]
  • Description of the guidance given by the regulating physician in each of the devices (secondary judgment criterion no. 1) [Time frame: Day 7]
  • Assessment of the patient's compliance rate with the guidance given by the regulating physician (secondary judgment criterion no. 2) [Time frame: Day 7]
  • Assessment of the patient's compliance rate with the guidance given by the regulating physician (secondary judgment criterion no. 2) [Time frame: Day 7]
  • Evaluation of the medical-economic impact of "SAS" regulation versus "standard" regulation (Qualitative component) [Time frame: Year 5]

Eligibility criteria

Inclusion criteria

  • For the primary analysis and secondary outcome measure 1:
  • All calls to 116-117 or 15 in the Le Havre area over the 40 study periods,
  • Non-opposition. Patients with a life-threatening emergency will be included in the primary analysis, even though there will be no pseudo-randomization of the systems for them. They are therefore included in the study.
  • For the secondary analysis on patient compliance with the referral given by the regulating physician (secondary objective 2):
  • Non-opposition of patients who used the SNP call for the primary analysis,
  • Randomly selected by sampling calls to 116-117 or 15 made over the study periods defined by the protocol.
  • For the qualitative component:
  • Major,
  • No opposition from regulators and major effectors of the SAS
  • Or No opposition from adult health patients in the Le Havre area who have used the unscheduled care system (outpatient or inpatient).

Exclusion criteria

  • For the primary analysis and secondary objective 1:
  • Refusal to participate,
  • Non-French speaking.
  • For the secondary analysis on patient compliance with the referral given by the regulating physician (secondary objective 2) and for the qualitative component:
  • Minor caller
  • Refusal to participate (patient or caller or both),
  • Non-French speaking (caller)
  • Only for adult healthcare users in the Le Havre area included in the qualitative component: Not having the independent capacity to use the SNP. Non-use of the SAS will not be a criterion for exclusion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

France · 1 center
  • Le Havre Hospital Group, — Le Havre

Identifiers

NCT: NCT07207499 · 2023/0350/HP · 2023-A02103-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗