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.
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.
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 group | Role | What they receive |
|---|---|---|
| phone call to emergency department | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted7 Dec 2020
- Study startJul 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Why it stopped: obsolete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Compliance After Telephone Triage Advice During and After Confinement During the COVID-19 Epidemic in France
- ClinicalTrials.gov ID
- NCT04656444
- Acronym / sponsor ID
- COVIDTEL / 20-HPNCL-03
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: obsolete study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| phone call to emergency department | – | – |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Calls received during the weekends or holidays. Calls received outside working hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
parental anxiety
Time frame: at 24 hours post inclusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.