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

Infection Clinical Trial

— CHILI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594553
• Other study ID #: ZonMw GGG - 836021022
• Status: Completed
• Phase: N/A
• First received: October 26, 2015
• Last updated: September 15, 2016
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: ZonMw, Netherlands Organisation for Health Research and DevelopmentNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Description:

A GP-parent information exchange tool in the form of an interactive booklet has the potential to provide parents with information about symptoms and fever management and consistent information during GP consultations. Thereby enhancing their self-management and providing them with safety net advice when they return home.

It is hypothesized that the use of such an interactive booklet during consultations for febrile children at GP out-of-hours centres will result in a reduced number of antibiotic prescriptions, improved parental satisfaction and reduced intention to re-consult.

The development of the interactive booklet concerned a three-stage process and is based on extensive qualitative work among parents, GPs and other professionals involved in childhood fever management. The booklet incorporates already existing information about fever, alarm symptoms, advice on 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.

We will perform a cluster-randomised controlled trial at 20 GP out-of-hours centres in the Netherlands. GP out-of-hours centres will be stratified by size, to ensure equal distribution of size between the intervention and control group. The required number of clusters and participants was based on the following assumptions: (1) ICC of 0.01, (2) alpha of 0.05, power of 0.80, (3) proportion of antibiotic prescriptions in control group of 25% and a proportion of 19% in the intervention group (6% minimal clinical relevant difference) and (4) 10% loss to follow-up and 10% efficiency loss based on unequal cluster sizes. Based on a previous cohort study, we estimated to include 1000 children per cluster (GP out-of-hours centre) within six months, resulting in a need for 20 clusters and an effective sample size of 737 patients in the intervention and control group (1474 in total).

The booklet will be used during consultations with febrile children at the GP out-of-hours centres that are randomly allocated by computer to the intervention. The child's symptoms will determine which information and advice parents receive from the GP.

Statistical analysis will be performed based on intention to treat principle by performing multilevel logistic regression analysis using IBM SPSS version 21.0 and MLwiN software. We will determine independent factors associated with antibiotic prescriptions. The same will be done for secondary outcomes.

All data will be obtained, managed and monitored according to the guidelines of Good Clinical Practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1262
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 12 Years

Eligibility

Inclusion Criteria:

• Age between three months and twelve years

• GP decides this is a fever-related consultation

Exclusion Criteria:

• Age under 3 months or over 12 years

• GP decides this is NOT a fever-related consultation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Antibiotic Prescriptions
• Infection

Intervention

Behavioral:
• GP-parent information-exchange tool
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.

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

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. Review. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Intention to re-consult	Intention to re-consult for similar illnesses among parents, number of parents with the intention to re-consult	Asked within two weeks after initial consultation	No
Secondary	Parental satisfaction with care	VAS scale 1-10	Asked within two weeks after initial consultation	No
Secondary	Self-reported adverse events related to the fever episode like hospital admission		Asked within two weeks after initial consultation	No
Secondary	Antibiotic prescription rates at re-consultations	Prescription rates at re-consultations for the same illness episode (defined as a consultation for the same reason over the last two weeks)	Asked within two weeks after initial consultation	No
Secondary	Consultation rates	Consultation rates of fever related consultations of children below the age of 12 years between intervention and control groups, through 6 months of study completion.	During complete study period, during 6 months of study completion	No
Secondary	Referral to secondary care	Number of participants with Referral to secondary care during initial consultation	Baseline (during initial consultation)	No