NCT07207499

Brief Summary

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,280

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Dec 2025Jun 2027

First Submitted

Initial submission to the registry

September 26, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

September 26, 2025

Last Update Submit

September 26, 2025

Conditions

Keywords

Access to Care Service (SAS)telephone patient regulation service

Outcome Measures

Primary Outcomes (1)

  • Evaluate the savings in emergency room use attributable to the regulation system integrating the SAS compared to the standard control device

    Assessment of referral to an emergency department by the regulating physician who treated the patient (with or without urgent medical transport) by telephone call.

    day 7

Secondary Outcomes (5)

  • Description of the guidance given by the regulating physician in each of the devices (secondary judgment criterion no. 1)

    Day 7

  • Description of the guidance given by the regulating physician in each of the devices (secondary judgment criterion no. 1)

    Day 7

  • Assessment of the patient's compliance rate with the guidance given by the regulating physician (secondary judgment criterion no. 2)

    Day 7

  • Assessment of the patient's compliance rate with the guidance given by the regulating physician (secondary judgment criterion no. 2)

    Day 7

  • Evaluation of the medical-economic impact of "SAS" regulation versus "standard" regulation (Qualitative component)

    Year 5

Interventions

Evaluate the time spent in the emergency room of patients referred to the emergency room by the "standard" regulation system

Evaluate the time spent in the emergency room of patients referred to the emergency room by the Emergency Care Access Service (SAS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Users of the health system: The concept of users applies not only to the sick person and their loved ones but, more broadly, to any actual or potential user of the health system, in the health and medico-social fields, in establishments as well as in outpatient care or in home care

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Le Havre Hospital Group,

Le Havre, 76083, France

Location

MeSH Terms

Conditions

Emergencies

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Elsa EF FAGOT-GRIFFIN, Doctor

CONTACT

Benjamin BS SOUDAIS, Doctor

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 26, 2025

First Posted

October 6, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

January 2, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

The data provided will be the property of the sponsor and will be used solely for its own research activities.

Locations