Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02594553
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : September 16, 2016
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Antibiotic Prescriptions Infection Behavioral: GP-parent information-exchange tool Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Management and Medication of Febrile Children in Out-of-hours Primary Care: the CHILI Cluster Randomised Trial
Study Start Date : November 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Fever

Arm Intervention/treatment
Experimental: Intervention
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
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.
Other Name: Interactive booklet

No Intervention: Control
All GPs working at the participating GP out-of-hours centres that are in the control group will provide care as usual.



Primary Outcome Measures :
  1. Antibiotic Prescription [ Time Frame: Baseline (Initial consultation) ]
    Antibiotic prescriptions for febrile children in GP out-of-hours centres during the initial consultation (dichotomous scale; number of participants with an antibiotic prescription).


Secondary Outcome Measures :
  1. Intention to re-consult [ Time Frame: Asked within two weeks after initial consultation ]
    Intention to re-consult for similar illnesses among parents, number of parents with the intention to re-consult

  2. Parental satisfaction with care [ Time Frame: Asked within two weeks after initial consultation ]
    VAS scale 1-10

  3. Self-reported adverse events related to the fever episode like hospital admission [ Time Frame: Asked within two weeks after initial consultation ]
  4. Antibiotic prescription rates at re-consultations [ Time Frame: Asked within two weeks after initial consultation ]
    Prescription rates at re-consultations for the same illness episode (defined as a consultation for the same reason over the last two weeks)

  5. Consultation rates [ Time Frame: During complete study period, during 6 months of study completion ]
    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.

  6. Referral to secondary care [ Time Frame: Baseline (during initial consultation) ]
    Number of participants with Referral to secondary care during initial consultation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594553


Locations
Layout table for location information
Netherlands
Maastricht University
Maastricht, Limburg, Netherlands, 6229 HA
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Eefje de Bont, MD, MSc Research Institute CAPHRI, Department of Family Medicine, Maastricht University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02594553    
Other Study ID Numbers: ZonMw GGG - 836021022
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: October 2015
Keywords provided by Maastricht University Medical Center:
Antibiotics
Children
General Practitioner
GP
After-hours care
Out-of-hours care
Booklet
Primary Health Care
Child
Additional relevant MeSH terms:
Layout table for MeSH terms
Fever
Body Temperature Changes
Signs and Symptoms