NCT07248488

Brief Summary

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.

Trial Health

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Trial Health Score

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

Enrollment
1,792

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Sep 2026

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

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

September 7, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2028

8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2028

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

November 18, 2025

Last Update Submit

November 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effectiveness of a standardized protocol for managing childhood fever, combining systematic recommendations and text messages sent to parents with advices on seeking unscheduled care: visits to the emergency room and/or medical consultations

    21 days after the initial emergency call to the SAMU Centre 15

Study Arms (2)

Combined intervention

EXPERIMENTAL

Standardized recommendations during emergency calls and sending of advisory text messages

Other: Standardized recommendations during emergency calls and sending advisory text message

Traditional regulation

NO INTERVENTION

Interventions

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.

Combined intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH Annecy Genevois

Annecy, Auvergne-Rhône-Alpes, 74370, France

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Virginie SAVRY, MD

    Centre Hospitalier Annecy Genevois

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start (Estimated)

September 7, 2026

Primary Completion (Estimated)

March 20, 2028

Study Completion (Estimated)

March 28, 2028

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations