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Covid19COVIDTELNCT04656444

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

An observational study of Covid19, run by Fondation Lenval at 1 site in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Covid19
How many people
0 participants
Where
1 siteFrance
Study dates
Jul 2021to Oct 2021
How long will I take part?
4 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hôpitaux Pédiatrique de Nice CHU Lenval

    Nice

Other trials in France

About this study

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

Read the 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

Conditions
Covid19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04656444
Study groupRoleWhat they receive
phone call to emergency departmentNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. parental compliance

    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.

    Measured: at 24 hours post inclusion

Secondary outcomes (1)
  1. parental anxiety

    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) )

    Measured: at 24 hours post inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2020
  2. Study startJul 2021 (estimated)
  3. Primary completionOct 2021 (estimated)
  4. Study completionOct 2021 (estimated)

Why it stopped: obsolete study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
Target duration
4 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT04656444
Sponsor's protocol ID
20-HPNCL-03
Acronym
COVIDTEL
Status last verified
Feb 2021
First submitted
4 Dec 2020
Last updated
19 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by Fondation Lenval at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

parental compliance (time frame: at 24 hours post inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.

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