- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02885896
Assessing the Impact of a Call Center Providing Standardized Pediatric Advice (PLATEL-EVAL) (PLATEL-EVAL)
Cluster-randomized Controlled Study Evaluating the Impact of a Call Center Providing Standardized Pediatric Advices Based on the Number of Unscheduled and Medically Unjustified Consultations
In order to show that tailored pediatric counselling by telephone can reduce the number of unscheduled and medically unjustified physicians visits in emergency structures, a randomized controlled study is conducted. It compares the proportion of cases which used the emergency services or unscheduled consultation according to whether they received (or not) nurses' telephone advices from the platform. Indeed, our hypothesis is that the presence of nurses responding at the Reception and Control Calls Center inside the Emergency Medical Services (in french : Service d'Aide Médicale d'Urgence SAMU) - whose role is to deliver appropriate advice to people calling for benign pathologies they see as urgent and to answer questions following specific recommendations - will reduce the number of unplanned and medically unjustified consultations in medical emergency structures.
This platform was set-up in order to show it may be a solution in response to the growing demand for pediatric care from the population, helping to reduce overcrowding in emergency care facilities. Indeed, promoting home care or only if necessary scheduled consultation reinforces the conduct to have when facing a pathology from their child. It will also help by reducing unjustified use of emergency structures, improving not only the users' reception conditions who actually require support in these structures with less waiting time, but also the working conditions for employees who perform there.
Study Overview
Status
Conditions
Study Type
Contacts and Locations
Study Locations
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Bron, France, 69500
- Hcl-Ghe-Epicime
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- The inclusion criteria are different depending on the subject concerned, for reasons related to risk factors of pediatric diseases. They are audited by the regulator doctor (who has a fact sheet) and are controlled by the nurse of the platform.
- For fever theme, a call is eligible if the child is older than 3 months and under 6 years old, and has had a fever for less than 48 hours.
- For the theme diarrhea, a call is eligible if the child in question is aged from 12 months to 3 years, and has had diarrhea. Fever and vomiting are not exclusion criteria.
- For the theme breathing difficulty, a call is eligible if the child in question is aged from 3 months to 3 years, has experienced discomfort breathing and has shown no fever. Stuffy nose, runny nose and cough are not exclusion criteria.
- For the theme fall with head shock, a call is eligible if the child concerned is a toddler and until the age of 12.
- For the theme crying infant, a call is eligible if the child in question is aged 0-4 months and has been crying. Fever is an exclusion criterion.
Exclusion Criteria:
- Refusal of participation or refusal to be reminded to 7 days,
- Children with impaired general condition and / or behavior change during the call,
- Situation requiring medical attention without delay,
- Lack of understanding of the caller
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Experimental period (active platform)
During the experimental period, the eligible calls will be transferred to the platform by SAMU regulator doctors, and callers will be subject to health advice by specially trained nurses.
The nurse conduct the call by holding the conversation guide, giving advice for a home care, answering questions from the circle (caller, family,..) and ensuring the proper understanding of these tips.
An information leaflet for the theme of the call will be sent in the days following the call to the caller of the experimental group having given their consent.
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Control period (inactive platform)
During the control periods, the call center will not be active, eligible calls can not receive advice from nurses, but will be subject to the usual care: the regulator doctor will treat the call as its current practice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of unscheduled consultations
Time Frame: up to 7 days after inclusion
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The main objective of the study is to compare the number of unscheduled consultations within 7 days following inclusion, i.e. the call at Centre15 (reception and regulation calls center) between the sample with access to telephone advice and the one who received the usual care (control group) .
Our assumption is that the number of appeals for emergency medical services will be lower in the group that received advice from the platform than in the control group.
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up to 7 days after inclusion
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D50849
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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