Evaluation of Knowledge About Fever After Consultation in the Pediatric Emergency Department (FEARVER)

November 4, 2022 updated by: Assistance Publique - Hôpitaux de Paris

Evaluation of Knowledge About Fever After Consultation in the Pediatric Emergency Department: Standard Consultation Versus Standard Consultation With Distribution of an Information Leaflet About Fever in Pre-consultation

The purpose of this study is to evaluate the effect of an information brochure on parent / legal guardians' knowledge of what to do about their child's febrile episode after a pediatric emergency department visit.

Single-center randomized controlled trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fever is a common symptom of viral or bacterial infection in pediatrics. Previous studies using both qualitative and quantitative methods have established that intervention with parents/legal guardians on fever management decreases their worry and anxiety related to their child's occurrence of a febrile episode, limits unwise use of antipyretic medication (Walsh, 2006; Walsh, 2008; Peetom, 2017), but also reduces the use of emergency room or telephone medical consultations (Peetom, 2017).

The majority of visits for febrile conditions in children over 3 months of age are avoidable and do not require emergency and/or hospital care. Mistaken beliefs and lack of knowledge about what to do in the event of a febrile episode lead parents to consult a hospital emergency room for their child, which can have an impact on emergency room overcrowding.

The proportion of emergency room visits for febrile conditions assessed by the Intake and Referral Nurse (IOR) as not requiring urgent care raises questions about parents'/legal guardians' knowledge of fever, its monitoring, and what to do during a febrile episode.

The aim of our study is to evaluate parents' knowledge of fever and the appropriate course of action during a febrile episode in a pediatric emergency department of a Parisian university hospital by comparing standard management practices with the knowledge provided by an information brochure.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • APHP Assistance Publique des Hôpitaux de Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be of legal age
  • Be the parent/legal guardian of a child aged between 3 months and 15 years,
  • A child with a fever > 38°celsus on arrival at the emergency room (measured by electronic thermometer rectally for children under 2 years of age or axillary/oral for children over 2 years of age),
  • Severity of care rating by the IOA grade 4 (non-emergency care)
  • Parent affiliated to a social security system or entitled to it
  • Parent under "AME" French social security system
  • Parent informed and having signed the consent

Exclusion Criteria

  • Parent/legal guardian who does not speak or read French,
  • Child with a pathology that does not allow for rectal temperature taking
  • Parent/legal guardian with a visual impairment that prevents reading the information note and/or the information brochure.
  • Parent / legal guardian under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Information brochure Arm
The experimental group will receive an information brochure on fever in children and how to deal with a febrile episode and usual medical management.
Behavioral: The Information brochure will be created on the basis of information given by the French pediatric network Courlygone and the French National Authority for Health.
An information brochure on fever in children and how to deal with a paediatric febrile episode and usual medical management.
No Intervention: Habitual care
The control group will receive the usual medical management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with correct answer to question about management of a paediatric febrile episode.
Time Frame: 1 day
Number of correct answers to question n°7 (what to do during a febrile episode) of the questionnaire
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with correct answer to question n°1 about knowledge about paediatric febrile episode
Time Frame: 1 day
Answer to question n°1, 2, 3, 4, 5, 6, 8, 9 & 10. Number of participants with correct answers, between the two arms
1 day
Number of participants with correct answer to question n°2 about knowledge's about paediatric febrile episode
Time Frame: 1 day
Answer to question n° 2. Number of participants with correct answers, between the two arms. Factors associated with a high number of correct responses: age of child, age of legal guardian, socio-professional category, child's place in sibling group, child's medical follow-up.
1 day
Number of participants with correct answer to question n°3 about knowledge's about paediatric febrile episode
Time Frame: 1 day
Answer to question n° 3. Number of participants with correct answers, between the two arms.
1 day
Number of participants with correct answer to question n°4 about knowledge's about paediatric febrile episode
Time Frame: 1 day
Answer to question n° 4. Number of participants with correct answers, between the two arms.
1 day
Number of participants with correct answer to question n°5 about knowledge's about paediatric febrile episode
Time Frame: 1 day
Answer to question n° 5. Number of participants with correct answers, between the two arms.
1 day
Number of participants with correct answer to question n°6 about knowledge's about paediatric febrile episode
Time Frame: 1 day
Answer to question n° 6. Number of participants with correct answers, between the two arms.
1 day
Number of participants with correct answer to question n°8 about knowledge's about paediatric febrile episode
Time Frame: 1 day
Answer to question n° 8. Number of participants with correct answers, between the two arms.
1 day
Number of participants with correct answer to question n°9 about knowledge's about paediatric febrile episode
Time Frame: 1 day
Answer to question n° 9. Number of participants with correct answers, between the two arms.
1 day
Number of participants with correct answer to question n°10 about knowledge's about paediatric febrile episode
Time Frame: 1 day
Answer to question n° 10. Number of participants with correct answers, between the two arms.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Hélène CHAPPUY, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2021

Primary Completion (Actual)

October 21, 2022

Study Completion (Actual)

October 21, 2022

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP210578
  • 2021-A00643-38 (Other Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress

Clinical Trials on The Information brochure will be created on the basis of information given by the French pediatric network Courlygone and the French National Authority for Health.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe