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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04925401
Other study ID # APHP210578
Secondary ID 2021-A00643-38
Status Completed
Phase N/A
First received
Last updated
Start date November 2, 2021
Est. completion date October 21, 2022

Study information

Verified date November 2022
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date October 21, 2022
Est. primary completion date October 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France APHP Assistance Publique des Hôpitaux de Paris Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (14)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Schmitt BD. Fever phobia: misconceptions of parents about fevers. Am J Dis Child. 1980 Feb;134(2):176-81. — View 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. — View Citation

Walsh A, Edwards H. Management of childhood fever by parents: literature review. J Adv Nurs. 2006 Apr;54(2):217-27. Review. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 day
Secondary 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 1 day
Secondary 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. 1 day
Secondary 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. 1 day
Secondary 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. 1 day
Secondary 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. 1 day
Secondary 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. 1 day
Secondary 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. 1 day
Secondary 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. 1 day
Secondary 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. 1 day
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