Evaluation of Knowledge About Fever After Consultation in the Pediatric Emergency Department (FEARVER)
Primary Purpose
Febrile Illness, Fever, Stress
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
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.
Sponsored by
About this trial
This is an interventional prevention trial for Febrile Illness focused on measuring Febrile episode, pediatric, pediatric emergency department, therapeutic education
Eligibility Criteria
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
Sites / Locations
- APHP Assistance Publique des Hôpitaux de Paris
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Information brochure Arm
Habitual care
Arm Description
The experimental group will receive an information brochure on fever in children and how to deal with a febrile episode and usual medical management.
The control group will receive the usual medical management
Outcomes
Primary Outcome Measures
Number of participants with correct answer to question about management of a paediatric febrile episode.
Number of correct answers to question n°7 (what to do during a febrile episode) of the questionnaire
Secondary Outcome Measures
Number of participants with correct answer to question n°1 about knowledge about paediatric febrile episode
Answer to question n°1, 2, 3, 4, 5, 6, 8, 9 & 10. Number of participants with correct answers, between the two arms
Number of participants with correct answer to question n°2 about knowledge's about paediatric febrile episode
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.
Number of participants with correct answer to question n°3 about knowledge's about paediatric febrile episode
Answer to question n° 3. Number of participants with correct answers, between the two arms.
Number of participants with correct answer to question n°4 about knowledge's about paediatric febrile episode
Answer to question n° 4. Number of participants with correct answers, between the two arms.
Number of participants with correct answer to question n°5 about knowledge's about paediatric febrile episode
Answer to question n° 5. Number of participants with correct answers, between the two arms.
Number of participants with correct answer to question n°6 about knowledge's about paediatric febrile episode
Answer to question n° 6. Number of participants with correct answers, between the two arms.
Number of participants with correct answer to question n°8 about knowledge's about paediatric febrile episode
Answer to question n° 8. Number of participants with correct answers, between the two arms.
Number of participants with correct answer to question n°9 about knowledge's about paediatric febrile episode
Answer to question n° 9. Number of participants with correct answers, between the two arms.
Number of participants with correct answer to question n°10 about knowledge's about paediatric febrile episode
Answer to question n° 10. Number of participants with correct answers, between the two arms.
Full Information
NCT ID
NCT04925401
First Posted
May 27, 2021
Last Updated
November 4, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04925401
Brief Title
Evaluation of Knowledge About Fever After Consultation in the Pediatric Emergency Department
Acronym
FEARVER
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
October 21, 2022 (Actual)
Study Completion Date
October 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Febrile Illness, Fever, Stress
Keywords
Febrile episode, pediatric, pediatric emergency department, therapeutic education
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Information brochure Arm
Arm Type
Experimental
Arm Description
The experimental group will receive an information brochure on fever in children and how to deal with a febrile episode and usual medical management.
Arm Title
Habitual care
Arm Type
No Intervention
Arm Description
The control group will receive the usual medical management
Intervention Type
Behavioral
Intervention Name(s)
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.
Intervention Description
An information brochure on fever in children and how to deal with a paediatric febrile episode and usual medical management.
Primary Outcome Measure Information:
Title
Number of participants with correct answer to question about management of a paediatric febrile episode.
Description
Number of correct answers to question n°7 (what to do during a febrile episode) of the questionnaire
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Number of participants with correct answer to question n°1 about knowledge about paediatric febrile episode
Description
Answer to question n°1, 2, 3, 4, 5, 6, 8, 9 & 10. Number of participants with correct answers, between the two arms
Time Frame
1 day
Title
Number of participants with correct answer to question n°2 about knowledge's about paediatric febrile episode
Description
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.
Time Frame
1 day
Title
Number of participants with correct answer to question n°3 about knowledge's about paediatric febrile episode
Description
Answer to question n° 3. Number of participants with correct answers, between the two arms.
Time Frame
1 day
Title
Number of participants with correct answer to question n°4 about knowledge's about paediatric febrile episode
Description
Answer to question n° 4. Number of participants with correct answers, between the two arms.
Time Frame
1 day
Title
Number of participants with correct answer to question n°5 about knowledge's about paediatric febrile episode
Description
Answer to question n° 5. Number of participants with correct answers, between the two arms.
Time Frame
1 day
Title
Number of participants with correct answer to question n°6 about knowledge's about paediatric febrile episode
Description
Answer to question n° 6. Number of participants with correct answers, between the two arms.
Time Frame
1 day
Title
Number of participants with correct answer to question n°8 about knowledge's about paediatric febrile episode
Description
Answer to question n° 8. Number of participants with correct answers, between the two arms.
Time Frame
1 day
Title
Number of participants with correct answer to question n°9 about knowledge's about paediatric febrile episode
Description
Answer to question n° 9. Number of participants with correct answers, between the two arms.
Time Frame
1 day
Title
Number of participants with correct answer to question n°10 about knowledge's about paediatric febrile episode
Description
Answer to question n° 10. Number of participants with correct answers, between the two arms.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène CHAPPUY, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
APHP Assistance Publique des Hôpitaux de Paris
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
7352443
Citation
Schmitt BD. Fever phobia: misconceptions of parents about fevers. Am J Dis Child. 1980 Feb;134(2):176-81.
Results Reference
background
PubMed Identifier
10698135
Citation
Poirier MP, Davis PH, Gonzalez-del Rey JA, Monroe KW. Pediatric emergency department nurses' perspectives on fever in children. Pediatr Emerg Care. 2000 Feb;16(1):9-12. doi: 10.1097/00006565-200002000-00003.
Results Reference
background
PubMed Identifier
28233682
Citation
Burokiene S, Kairiene I, Stricka M, Labanauskas L, Cerkauskiene R, Raistenskis J, Burokaite E, Usonis V. Unscheduled return visits to a pediatric emergency department. Medicina (Kaunas). 2017;53(1):66-71. doi: 10.1016/j.medici.2017.01.003. Epub 2017 Jan 31.
Results Reference
background
PubMed Identifier
29874409
Citation
Bereznicki BJ, Tucker MG, Beggs SA, Zosky GR, Bereznicki LR. Emergency department presentations of febrile children to an Australian public hospital. J Paediatr Child Health. 2018 Dec;54(12):1308-1313. doi: 10.1111/jpc.14071. Epub 2018 Jun 6.
Results Reference
background
PubMed Identifier
22966028
Citation
Enarson MC, Ali S, Vandermeer B, Wright RB, Klassen TP, Spiers JA. Beliefs and expectations of Canadian parents who bring febrile children for medical care. Pediatrics. 2012 Oct;130(4):e905-12. doi: 10.1542/peds.2011-2140. Epub 2012 Sep 10.
Results Reference
background
PubMed Identifier
16679875
Citation
Betz MG, Grunfeld AF. 'Fever phobia' in the emergency department: a survey of children's caregivers. Eur J Emerg Med. 2006 Jun;13(3):129-33. doi: 10.1097/01.mej.0000194401.15335.c7.
Results Reference
background
PubMed Identifier
24942934
Citation
Morrison AK, Chanmugathas R, Schapira MM, Gorelick MH, Hoffmann RG, Brousseau DC. Caregiver low health literacy and nonurgent use of the pediatric emergency department for febrile illness. Acad Pediatr. 2014 Sep-Oct;14(5):505-9. doi: 10.1016/j.acap.2014.05.001. Epub 2014 Jun 16.
Results Reference
background
PubMed Identifier
16553708
Citation
Walsh A, Edwards H. Management of childhood fever by parents: literature review. J Adv Nurs. 2006 Apr;54(2):217-27. doi: 10.1111/j.1365-2648.2006.03802.x.
Results Reference
background
PubMed Identifier
18727765
Citation
Walsh A, Edwards H, Fraser J. Parents' childhood fever management: community survey and instrument development. J Adv Nurs. 2008 Aug;63(4):376-88. doi: 10.1111/j.1365-2648.2008.04721.x.
Results Reference
background
PubMed Identifier
27432451
Citation
Peetoom KK, Smits JJ, Ploum LJ, Verbakel JY, Dinant GJ, Cals JW. Does well-child care education improve consultations and medication management for childhood fever and common infections? A systematic review. Arch Dis Child. 2017 Mar;102(3):261-267. doi: 10.1136/archdischild-2016-311042. Epub 2016 Jul 18.
Results Reference
background
PubMed Identifier
17727587
Citation
Considine J, Brennan D. Effect of an evidence-based education programme on ED discharge advice for febrile children. J Clin Nurs. 2007 Sep;16(9):1687-94. doi: 10.1111/j.1365-2702.2006.01716.x.
Results Reference
background
PubMed Identifier
25066313
Citation
Monsma J, Richerson J, Sloand E. Empowering parents for evidence-based fever management: An integrative review. J Am Assoc Nurse Pract. 2015 Apr;27(4):222-9. doi: 10.1002/2327-6924.12152. Epub 2014 Jul 25.
Results Reference
background
PubMed Identifier
12847427
Citation
Broome ME, Dokken DL, Broome CD, Woodring B, Stegelman MF. A study of parent/grandparent education for managing a febrile illness using the CALM approach. J Pediatr Health Care. 2003 Jul-Aug;17(4):176-83. doi: 10.1067/mph.2003.4.
Results Reference
background
PubMed Identifier
19755888
Citation
Baker MD, Monroe KW, King WD, Sorrentino A, Glaeser PW. Effectiveness of fever education in a pediatric emergency department. Pediatr Emerg Care. 2009 Sep;25(9):565-8. doi: 10.1097/PEC.0b013e3181b4f64e.
Results Reference
background
Learn more about this trial
Evaluation of Knowledge About Fever After Consultation in the Pediatric Emergency Department
We'll reach out to this number within 24 hrs