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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02885896
Other study ID # D50849
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date October 2021
Est. completion date October 2022

Study information

Verified date March 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2022
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group 3 Months to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hcl-Ghe-Epicime Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of unscheduled consultations 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. up to 7 days after inclusion