Effect of an Intervention Combining the Use of Standardized Information and Sending an SMS Advice Message to Parents Calling the SAMU Center 15 for Uncomplicated Fever in Children

NCT ID: NCT07248488

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1792 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-09-07

Study Completion Date

2028-03-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

During the winter of 2022/23, a standardized protocol for managing fever in children aged 3 months to 10 years was implemented at Annecy Genevois Hospital for a period of one month. This protocol included advice given by the regulator and sending a text message to parents after the call. A total of 182 calls were handled in one month: 95 during a 15-day period before the intervention was rolled out and 87 during a 15-day period during the intervention (43 with unread text messages and 44 with read text messages). All parents who read the text message understood it. The rate of compliance with advice was improved by the intervention when the text message was read (p \< 0.01), in terms of increased paracetamol intake, avoidance of cold baths, undressing the child, and administering fluids. When the text message was read, the rate of calls to the 15 emergency center fell from 13% before the intervention to 2% when the text message was read (p = 0.04). A downward trend in emergency room visits was also observed, from 13% before the intervention to 5% when the text message was read and 19% when the text message was not read (p = 0.13). These encouraging data suggest that a randomized study would demonstrate the value of this approach in routine practice.

Even if the effect of such protocols is moderate, the target audience is such that their impact on the use of unscheduled care and on the healthcare system could be significant, at a low implementation cost.

The use of a standardized protocol involving the sending of text messages in cases of uncomplicated fever in children makes it possible to:

* standardize the advice given by call center doctors,
* ensure the traceability of advice,
* help parents monitor their children.

The objective of this study is to determine, in a randomized trial, whether the combined use of standardized advice for children with fever and text messages sent to parents by the emergency medical service (EMS) can:

i) reduce the use of unscheduled medical care; ii) improve compliance with advice; iii) reduce the rate of callbacks to the emergency medical service; iv) improve parent satisfaction.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emergency Call Fever; Pediatric Fever Management; Parental Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled cluster trial, open-label, in the AuRA region, evaluating the superiority of using a standardized protocol for regulating fever in children, combining systematic recommendations and sending an SMS with advice to parents, compared to current practice (no standardized protocol, no text message advice) on the rate of unscheduled healthcare visits 7 days after the initial call to the 15 emergency center.

In both arms of the study, unscheduled healthcare visits within 7 days of the initial call will be assessed by responses to the follow-up text message on day 7 and a phone call from a Center 15 doctor between days 14 and 21, if the child has been hospitalized.

All patients included in the study will be followed up for a minimum of 7 days and a maximum of 21 days after the initial call to the 15 Center.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Combined intervention

Standardized recommendations during emergency calls and sending of advisory text messages

Group Type EXPERIMENTAL

Standardized recommendations during emergency calls and sending advisory text message

Intervention Type OTHER

When the emergency service is called, the coordinating physician provides standardized recommendations based on the treatment guidelines issued by the French Pediatric Society. After the emergency call, the parent who made the call receives a text message summarizing all the advice given by the doctor.

Traditional regulation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standardized recommendations during emergency calls and sending advisory text message

When the emergency service is called, the coordinating physician provides standardized recommendations based on the treatment guidelines issued by the French Pediatric Society. After the emergency call, the parent who made the call receives a text message summarizing all the advice given by the doctor.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Call for a child aged between 3 months and 10 years,
* Presenting with fever alone (SFMU/GPIP definition),
* Developing for less than 72 hours,
* Without clinical signs,
* And without signs of seriousness requiring emergency medical attention (as determined by SAMU Centre 15):

* Fever ≥41°C,
* Impaired consciousness,
* Convulsions,
* Dyspnea,
* Skin rash,
* Dehydration.


* Caller with parental authority over the child concerned by the call,
* Affiliated to a social security scheme or beneficiary of a similar scheme.

Exclusion Criteria

* Children who have already been the subject of a call to the SAMU Centre 15 emergency medical service in the last 15 days,
* Children with a history of urinary tract infection,
* Children referred by the dispatcher during the phone call to a healthcare facility for clinical evaluation (SMUR, private ambulance, fire department, parents referred to the emergency room or primary care physician).


* Calls made from a landline or foreign number, making it impossible to send text messages,
* Calls made by someone who cannot read or understand French.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Annecy Genevois

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Virginie SAVRY, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Annecy Genevois

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CH Annecy Genevois

Annecy, Auvergne-Rhône-Alpes, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marion BEUCHER

Role: CONTACT

+33450637032 ext. +33

Marion GHIDI

Role: CONTACT

+33450637031 ext. +33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hugo SCHMIT, MD

Role: primary

+33450637032 ext. +33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24-07

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Well-Child Visit Trial
NCT05086237 COMPLETED NA