Emergency Service, HospitalSAS-LHNCT07207499
Evaluation of the Access to Healthcare Service
An observational study of Emergency Service, Hospital, run by University Hospital, Rouen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergency Service, Hospital
- What is being tested?
- intervention group Access to Care Service "SAS"
- How many people
- 9,280 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2025to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Show all 10Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Access to Healthcare Service Established in the Le Havre Area
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).
Read the 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"
- Conditions
- Emergency Service, Hospital
- Being tested
- control group ("standard" regulation device), intervention group Access to Care Service "SAS"
- Keywords
- Access to Care Service (SAS), telephone patient regulation service
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control group ("standard" regulation device)Other
Evaluate the time spent in the emergency room of patients referred to the emergency room by the "standard" regulation system
intervention group Access to Care Service "SAS"Other
Evaluate the time spent in the emergency room of patients referred to the emergency room by the Emergency Care Access Service (SAS)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 7
Secondary outcomes (5)
Description of the guidance given by the regulating physician in each of the devices (secondary judgment criterion no. 1)
The patient's orientation following the call (medical advice) will be recorded and evaluated.
Measured: Day 7
Description of the guidance given by the regulating physician in each of the devices (secondary judgment criterion no. 1)
The patient's orientation following the call (appointment with a healthcare professional) will be recorded and evaluated.
Measured: Day 7
Assessment of the patient's compliance rate with the guidance given by the regulating physician (secondary judgment criterion no. 2)
The patient's compliance with the guidance given by the private regulating physician will be recorded and evaluated.
Measured: Day 7
Assessment of the patient's compliance rate with the guidance given by the regulating physician (secondary judgment criterion no. 2)
The patient's compliance with the guidance given by the hospital regulating physician will be recorded and evaluated.
Measured: Day 7
Evaluation of the medical-economic impact of "SAS" regulation versus "standard" regulation (Qualitative component)
Analysis of the budgetary impact, i.e. the difference in costs between the two systems, taking into account the direction indicated and the general degree of compliance with the directions from the point of view of health insurance over 5 years.
Measured: Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Dec 2025 (estimated)
- Primary completion2 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Service, HospitalStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 9,280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207499
- Sponsor's protocol ID
- 2023/0350/HP
- Other IDs
- 2023-A02103-42
- Acronym
- SAS-LH
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Access to Healthcare Service Established in the Le Havre Area
- ClinicalTrials.gov ID
- NCT07207499
- Acronym / sponsor ID
- SAS-LH / 2023/0350/HP
- Conditions
- Emergency Service, Hospital
- Keywords
- Access to Care Service (SAS), telephone patient regulation service
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 9,280 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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"
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- For the primary analysis and secondary outcome measure 1:
- For the secondary analysis on patient compliance with the referral given by the regulating physician (secondary objective 2):
- For the qualitative component:
Key exclusion criteria (8 listed)
- For the primary analysis and secondary objective 1:
- For the secondary analysis on patient compliance with the referral given by the regulating physician (secondary objective 2) and for the qualitative component:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | – |
Primary outcome
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
Assessment of referral to an emergency department by the regulating physician who treated the patient (with or without urgent medical transport) by telephone call.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Service, Hospital, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elsa EF FAGOT-GRIFFIN, Doctor (02 35 14 84 46 ext. +33, elsa.griffin@univ-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.