Emergency Pediatric CarePLATEL-EVALNCT02885896
Assessing the Impact of a Call Center Providing Standardized Pediatric Advice (PLATEL-EVAL)
An observational study of Emergency Pediatric Care, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 3 months to 6 years
- Conditions the study is for
- Emergency Pediatric Care
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2021to Oct 2022
- 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 3 months to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children whom parents call the center 15 for pediatric advice
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Emergency Pediatric Care
- Keywords
- Call center, nurses, pediatrics, standardized messages, family counseling
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 |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 7 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: Principal investigator left the Hospices Civils de Lyon and has not been replaced
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Pediatric CareStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885896
- Sponsor's protocol ID
- D50849
- Acronym
- PLATEL-EVAL
- Status last verified
- Mar 2022
- First submitted
- 23 Aug 2016
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02885896
- Acronym / sponsor ID
- PLATEL-EVAL / D50849
- Conditions
- Emergency Pediatric Care
- Keywords
- Call center, nurses, pediatrics, standardized messages, family counseling
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Principal investigator left the Hospices Civils de Lyon and has not been replaced
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 1 Sep 2016 (estimated)
- 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children whom parents call the center 15 for pediatric advice
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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
Number of unscheduled consultations
Time frame: up to 7 days after inclusion
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.
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 31 Mar 2022.
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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 Emergency Pediatric Care, run by Hospices Civils de Lyon 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 6 inclusion and 4 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 31 Mar 2022. 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?
Number of unscheduled consultations (time frame: up to 7 days after 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 31 Mar 2022.