Parental Compliance After Telephone Triage Advice During and After Confinement During the COVID-19 Epidemic in France (COVIDTEL)

July 13, 2021 updated by: Fondation Lenval

Novel Coronavirus disease 2019 (COVID-19) outbreak seriously challenges worldwide health care systems. The current climate of anxiety due to COVID-19 and home confinement limiting access to emergency departments (ED) have induced an increase of phone calls to the emergency call center "15" medical advices.

To determine if a pediatric telephone triage protocol may improve patient's pathways during COVID-19 outbreak, parental compliance is assessed after telephone advice, during and after home confinement (the end of home confinement in France was on May 11th 2020).

From 14th April 2020 to 7th June 2020, all calls received by the platform of telephone calls at Children's Lenval Hospital during open hours and open days are collected. For each call, symptoms are recorded by trained physicians and trained residents using a telephonic triage tool through a directed interview. A medical orientation is recommended to parents at the end of their call. Follow-up are conducted 2 to 4 days after with their consent by telephone interview in order to evaluate their compliance

Study Overview

Status

Withdrawn

Conditions

Detailed Description

Novel Coronavirus disease 2019 (COVID-19) outbreak seriously challenges worldwide health care systems. The current climate of anxiety due to COVID-19 and home confinement limiting access to emergency departments (ED) have induced an increase of phone calls to the emergency call center "15" for medical advices.

So far, Lenval Hospital pediatric ED didn't have a standardized telephonic triage protocol fitted to COVID-19 epidemic. Therefore, a telephonic triage tool is created as a decision support system in order to help physicians in regulating patient's pathways and in providing standardized medical advices.

To determine whether a pediatric telephone triage protocol may improve patient's orientation during COVID outbreak, parental compliance is assessed after telephone advice, during and after home confinement (the date of end of home confinement in France is 11th May 2020).

From 14th April 2020 to 7th June 2020, all calls received by the platform of telephone calls at Children's Lenval Hospital during open hours and open days are collected. For each call, symptoms are recorded by trained physicians and trained residents of the pediatric emergency department (PED) using a telephonic triage tool through a directed interview. A medical orientation is recommended to parents at the end of their call. Follow-up are conducted 2 to 4 days after with their consent by telephone interview in order to evaluate their compliance. Whatever the medical orientation given to parents, the investigators were able to visit PED in case of worsening of their child's condition or whenever they would feel the need a physical examination

Questioning parents about clinical condition of their child without a clinical look is challenging: on the one hand, clinical status of any sick child may change quickly; In the other hand, parents may not be reliable in evaluating their child's condition according to their level of concern. COVID-19 outbreak context may exacerbate parental anxiety and therefore induce inappropriate behavior.

Parents was considered as "non compliant" if they haven't followed the orientation initially given by the physician after telephone triage. They was considered as "compliant" (1) if they have respected the recommended orientation or (2) if they have had to bring their child at pediatric emergencies because of a worsening of his condition in the next 48 hours of the first call. In this specific case, to determine if the consultation at pediatric ED was necessary, the investigators recorded all resources utilization used and final orientation decided after visiting the ED. Thus, worsening of a child condition was defined as prescription of any diagnostic act and/or on-site therapeutic and/or hospitalization.

This study would allow to evaluate the applicability and the utility of a formalized telephone triage protocol fitted to COVID-19 epidemic, performed by trained medical staff in a Children's Hospital. Consequently, the investigators would be able to extend its use after the COVID outbreak period

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nice, France
        • Hôpitaux Pédiatrique de Nice CHU Lenval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients calling the emergency department during working hours and days: Monday to Friday from 8:30 a.m. to 6:30 p.m. and Saturday morning between 8:30 a.m. and 12:30 p.m.

Description

Inclusion Criteria:

Calls received by the platform of telephone calls at Children's Lenval Hospital on working days during working hours: Monday to Friday, 08h30-18h30, and Saturday 08h30-12h30

Exclusion Criteria:

Calls received during the weekends or holidays. Calls received outside working hours.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
phone call to emergency department

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
parental compliance
Time Frame: at 24 hours post inclusion
Compliance will be assessed by comparing the path defined by the doctor during the phone call and the orientation actually decided by the parents within 24 hours of the first phone call.
at 24 hours post inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
parental anxiety
Time Frame: at 24 hours post inclusion
The impact of advice given during a phone call on parental anxiety is assessed by comparing the level of anxiety between the first and second call (scale of 1, (not worried) to 5 (worried) )
at 24 hours post inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2021

Study Completion (ANTICIPATED)

October 1, 2021

Study Registration Dates

First Submitted

December 4, 2020

First Submitted That Met QC Criteria

December 4, 2020

First Posted (ACTUAL)

December 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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