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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT04925401
Collaborator
(none)
220
1
2
12
18.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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.
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Prevention
Official Title:
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
Actual Study Start Date :
Nov 2, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of participants with correct answer to question about management of a paediatric febrile episode. [1 day]

    Number of correct answers to question n°7 (what to do during a febrile episode) of the questionnaire

Secondary Outcome Measures

  1. Number of participants with correct answer to question n°1 about knowledge about paediatric febrile episode [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

  2. Number of participants with correct answer to question n°2 about knowledge's about paediatric febrile episode [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.

  3. Number of participants with correct answer to question n°3 about knowledge's about paediatric febrile episode [1 day]

    Answer to question n° 3. Number of participants with correct answers, between the two arms.

  4. Number of participants with correct answer to question n°4 about knowledge's about paediatric febrile episode [1 day]

    Answer to question n° 4. Number of participants with correct answers, between the two arms.

  5. Number of participants with correct answer to question n°5 about knowledge's about paediatric febrile episode [1 day]

    Answer to question n° 5. Number of participants with correct answers, between the two arms.

  6. Number of participants with correct answer to question n°6 about knowledge's about paediatric febrile episode [1 day]

    Answer to question n° 6. Number of participants with correct answers, between the two arms.

  7. Number of participants with correct answer to question n°8 about knowledge's about paediatric febrile episode [1 day]

    Answer to question n° 8. Number of participants with correct answers, between the two arms.

  8. Number of participants with correct answer to question n°9 about knowledge's about paediatric febrile episode [1 day]

    Answer to question n° 9. Number of participants with correct answers, between the two arms.

  9. Number of participants with correct answer to question n°10 about knowledge's about paediatric febrile episode [1 day]

    Answer to question n° 10. Number of participants with correct answers, between the two arms.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 APHP Assistance Publique des Hôpitaux de Paris Paris France 75015

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT04925401
Other Study ID Numbers:
  • APHP210578
  • 2021-A00643-38
First Posted:
Jun 14, 2021
Last Update Posted:
Dec 8, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2021