Optimizing Management and Medication of Febrile Children in Out-of-hours Primary Care: CHILI Cluster RCT

NCT02594553 | Completed

• 1 other identifier: ZonMw GGG - 836021022
• Study Type: interventional
• Target: 1,262
• Locations: 1 country
• Sites: 1

Brief Summary

The CHILI cluster randomised controlled trial (RCT) will investigate whether the use of an interactive information booklet during consultations for febrile children at General Practice (GP) out-of-hours centres can reduce the number of antibiotic prescriptions, improve parental satisfaction and reduce intention to reconsult for childhood fever episodes.

Conditions

Antibiotic Prescriptions; Infection

Keywords

Antibiotics; Children; General Practitioner; GP; After-hours care; Out-of-hours care; Booklet; Primary Health Care; Child

Outcome Measures

Primary Outcomes (1)

• Antibiotic Prescription

  Antibiotic prescriptions for febrile children in GP out-of-hours centres during the initial consultation (dichotomous scale; number of participants with an antibiotic prescription).

  Baseline (Initial consultation)

Secondary Outcomes (6)

• Intention to re-consult

  Asked within two weeks after initial consultation

• Parental satisfaction with care

  Asked within two weeks after initial consultation

• Self-reported adverse events related to the fever episode like hospital admission

  Asked within two weeks after initial consultation

• Antibiotic prescription rates at re-consultations

  Asked within two weeks after initial consultation

• Consultation rates

  During complete study period, during 6 months of study completion

Study Arms (2)

Intervention

EXPERIMENTAL

All GPs working at the participating GP out-of-hours centres that are in the intervention group will use the GP-parent information-exchange tool (interactive booklet).

Behavioral: GP-parent information-exchange tool

Control

NO INTERVENTION

All GPs working at the participating GP out-of-hours centres that are in the control group will provide care as usual.

Interventions

GP-parent information-exchange tool BEHAVIORAL

The booklet incorporates already existing information about fever, alarm symptoms, advices use of medication and specific infectious diseases that frequently occur in childhood in combination with fever such as upper respiratory tract infections, and otitis media. The difference with these existing sources of information is the fact that they until now, were not incorporated into one booklet which can be physically handed over to parents.

Also known as: Interactive booklet

Intervention

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between three months and twelve years
• GP decides this is a fever-related consultation

You may not qualify if:

• Age under 3 months or over 12 years
• GP decides this is NOT a fever-related consultation

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229 HA, Netherlands

Location

Related Publications (8)

• de Bont EG, Alink M, Falkenberg FC, Dinant GJ, Cals JW. Patient information leaflets to reduce antibiotic use and reconsultation rates in general practice: a systematic review. BMJ Open. 2015 Jun 3;5(6):e007612. doi: 10.1136/bmjopen-2015-007612.

  PMID: 26041493 BACKGROUND

• de Bont EG, Lepot JM, Hendrix DA, Loonen N, Guldemond-Hecker Y, Dinant GJ, Cals JW. Workload and management of childhood fever at general practice out-of-hours care: an observational cohort study. BMJ Open. 2015 May 19;5(5):e007365. doi: 10.1136/bmjopen-2014-007365.

  PMID: 25991452 BACKGROUND

• de Bont EG, Peetoom KK, Moser A, Francis NA, Dinant GJ, Cals JW. Childhood fever: a qualitative study on GPs' experiences during out-of-hours care. Fam Pract. 2015 Aug;32(4):449-55. doi: 10.1093/fampra/cmv029. Epub 2015 Apr 25.

  PMID: 25914101 BACKGROUND

• de Bont EG, Cals JW. [An individual 'traffic light system' for children with fever?]. Ned Tijdschr Geneeskd. 2014;158:A7649. Dutch.

  PMID: 24754933 BACKGROUND

• de Bont EG, van Loo IH, Dukers-Muijrers NH, Hoebe CJ, Bruggeman CA, Dinant GJ, Cals JW. Oral and topical antibiotic prescriptions for children in general practice. Arch Dis Child. 2013 Mar;98(3):228-31. doi: 10.1136/archdischild-2012-303134. Epub 2012 Dec 25.

  PMID: 23268371 BACKGROUND

• de Bont EG, Loonen N, Hendrix DA, Lepot JM, Dinant GJ, Cals JW. Childhood fever: a qualitative study on parents' expectations and experiences during general practice out-of-hours care consultations. BMC Fam Pract. 2015 Oct 7;16:131. doi: 10.1186/s12875-015-0348-0.

  PMID: 26446754 BACKGROUND

• de Bont EGPM, Dinant GJ, Elshout G, van Well G, Francis NA, Winkens B, Cals JWL. Booklet for Childhood Fever in Out-of-Hours Primary Care: A Cluster-Randomized Controlled Trial. Ann Fam Med. 2018 Jul;16(4):314-321. doi: 10.1370/afm.2265.

  PMID: 29987079 DERIVED

• de Bont EG, Dinant GJ, Elshout G, van Well G, Francis NA, Winkens B, Cals JW. An illness-focused interactive booklet to optimise management and medication for childhood fever and infections in out-of-hours primary care: study protocol for a cluster randomised trial. Trials. 2016 Nov 17;17(1):547. doi: 10.1186/s13063-016-1667-8.

  PMID: 27855719 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Eefje de Bont, MD, MSc

  Research Institute CAPHRI, Department of Family Medicine, Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: November 3, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 16, 2016

Record last verified: 2015-10

Locations

NL (1)