Infant ConditionsENVUNCT03640715
Validation of a Screening Tool for Social and Health Vulnerability in Pediatric Clinical Practice
A study testing ENVU in people with Infant Conditions, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
In 2014, the french hospital emphasized the need for tools to screen for social fragility in order to make explicit the choices of orientation of patients. To date, caregivers do not have any tools or clinical benchmarks for individual assessment of pediatric social and health vulnerability. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Infant Conditions
- What is being tested?
- ENVU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2018to May 2020
- Phase
- Interventional
- 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 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- from 3 to 15 years old,
- And consultant in the SAUP and PASS services investigators,
- And outside periods of custody and affluence,
- And accompanied by at least one parent or guardian
- And accepting to participate.
Who cannot join
- Consultation in SAUP during the period of guard or affluence,
- Or Patient who has already consulted at PASS,
- Or child who has already participated in the study,
- Or in the absence of any parent (father or mother),
- Or current child protection measure - or evoked by doctors during the stay at SAUP,
- Or parents who do not speak French and can not translate at the moment of inclusion,
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- Or inclusion of another child of the siblings,
- Or refusal of the child or parents,
- Or impossibility to organize an interview with an expert caregiver during the stay at the SAUP without prolonging it.
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
REMI LAPORTE, MD, +33 491368813, RemiJulien.LAPORTE@ap-hm.fr
About this study
Official title: Validation of a Screening Tool for Social and Health Vulnerability in Pediatric Clinical Practice Tool Child Vulnerable -ENVU
In 2014, the french hospital emphasized the need for tools to screen for social fragility in order to make explicit the choices of orientation of patients. To date, caregivers do not have any tools or clinical benchmarks for individual assessment of pediatric social and health vulnerability.
The use of the Health Care Access Permanence Services (PASS) is intended to facilitate access to the health care system for people in precarious situations with care and social support within and outside the institutions. health.
Read more
The hypothesis tested is that the use of a formalized tool makes it possible to improve the detection of pediatric social vulnerability and to overcome reluctance to practice by a simple, rapid and justified approach with regard to ongoing care.
The primary objective is to validate a clinical tool for screening for pediatric social and health vulnerability - Tool: VUlnerable Child (ENVU) -; to allow for an appropriate orientation of the patient care pathway. The metrological validation of diagnostic performances (sensitivity, specificity, positive and negative likelihood ratios) will be studied in confrontation with the opinion of an expert caregiver in the care of vulnerable populations.
This multicenter cross-sectional validation study of the screening tool will be conducted in two SAUPs with a pediatric PASS.
1000 children will be included in the centers for a period of 1 year.
Following the introduction of the ENVU tool and after an expert interview, three groups of patients will be identified:
Group A: no vulnerability according to expert with no indication of any PASS marker care Group B: probable vulnerability according to the expert with indication of at least one PASS marker care Group C: high vulnerability according to the expert with indication of at least two care markers PASS Group B and C patients will be reviewed at 6 months for a second visit to the ENVU tool.
The main evaluation criterion will be the concordance between the indication of the use of the PASS by the "expert" PASS nurse (indicator of a significant social and health vulnerability) and the result of the ENVU tool.
Read the detailed description
In 2014, the french hospital emphasized the need for tools to screen for social fragility in order to make explicit the choices of orientation of patients. To date, caregivers do not have any tools or clinical benchmarks for individual assessment of pediatric social and health vulnerability.
The use of the Health Care Access Permanence Services (PASS) is intended to facilitate access to the health care system for people in precarious situations with care and social support within and outside the institutions. health.
The hypothesis tested is that the use of a formalized tool makes it possible to improve the detection of pediatric social vulnerability and to overcome reluctance to practice by a simple, rapid and justified approach with regard to ongoing care.
The primary objective is to validate a clinical tool for screening for pediatric social and health vulnerability - Tool: VUlnerable Child (ENVU) -; to allow for an appropriate orientation of the patient care pathway. The metrological validation of diagnostic performances (sensitivity, specificity, positive and negative likelihood ratios) will be studied in confrontation with the opinion of an expert caregiver in the care of vulnerable populations.
The secondary objectives will be to study the validity of the ENVU tool with regard to pathologies epidemiologically associated with social vulnerability: hypotrophy, prematurity, weight-loss disorders, school delay, asthma, skin infection, oral health, visual disturbances not treatment, delayed immunization, over-consumption of unscheduled care in SAUP, iron deficiency and lead poisoning (if research indicated by the reason for consultation). The illustration of the added value of the PASS care will be observed by a before-after study of the ENVU tool and the collected clinical data.
This multicenter cross-sectional validation study of the screening tool will be conducted in two SAUPs with a pediatric PASS.
1000 children will be included in the centers for a period of 1 year.
Following the introduction of the ENVU tool and after an expert interview, three groups of patients will be identified:
Group A: no vulnerability according to expert with no indication of any PASS marker care Group B: probable vulnerability according to the expert with indication of at least one PASS marker care Group C: high vulnerability according to the expert with indication of at least two care markers PASS Group B and C patients will be reviewed at 6 months for a second visit to the ENVU tool.
The main evaluation criterion will be the concordance between the indication of the use of the PASS by the "expert" PASS nurse (indicator of a significant social and health vulnerability) and the result of the ENVU tool.
- Conditions
- Infant Conditions
- Being tested
- ENVU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENVUOther
"ENfant VUlnerable": a clinical tool for screening for social and health vulnerability in pediatrics - tool: VUlnerable Child (ENVU) -; to allow for an appropriate orientation of the patient care pathway. The metrological validation of diagnostic performances (sensitivity, specificity, positive and negative likelihood ratios) will be studied in confrontation with the opinion of an expert caregiver in the care of vulnerable populations.
| Study group | Role | What they receive |
|---|---|---|
| group A | Other | Group A: no vulnerability according to expert with no indication of any PASS marker care Receives: Other: ENVU |
| group B | Other | Group B: probable vulnerability according to the expert with indication of at least one PASS marker care Receives: Other: ENVU |
| group c | Other | Group C: high vulnerability according to the expert with indication of at least two care markers PASS Receives: Other: ENVU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient for whom expertise is in good accordance with ENVU tool
The main evaluation criterion will be the concordance between the indication of the use of the PASS by the caretaker of the "expert" PASS (indicator of a significant social and health vulnerability) and the result of the ENVU tool.
Measured: 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study startOct 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant ConditionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640715
- Sponsor's protocol ID
- 2017-28
- Acronym
- ENVU
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Laporte R, Babe P, Jouve E, Daguzan A, Mazoue F, Minodier P, Noel G, Urbina D, Gentile S. Developing and Validating an Individual-Level Deprivation Index for Children's Health in France. Int J Environ Res Public Health. 2022 Dec 16;19(24):16949. doi: 10.3390/ijerph192416949.
PubMed 36554830
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Screening Tool for Social and Health Vulnerability in Pediatric Clinical Practice Tool Child Vulnerable -ENVU
- ClinicalTrials.gov ID
- NCT03640715
- Acronym / sponsor ID
- ENVU / 2017-28
- Conditions
- Infant Conditions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 21 Aug 2018 (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.
In 2014, the french hospital emphasized the need for tools to screen for social fragility in order to make explicit the choices of orientation of patients. To date, caregivers do not have any tools or clinical benchmarks for individual assessment of pediatric social and health vulnerability.
The use of the Health Care Access Permanence Services (PASS) is intended to facilitate access to the health care system for people in precarious situations with care and social support within and outside the institutions. health.
The hypothesis tested is that the use of a formalized tool makes it possible to improve the detection of pediatric social vulnerability and to overcome reluctance to practice by a simple, rapid and justified approach with regard to ongoing care.
The primary objective is to validate a clinical tool for screening for pediatric social and health vulnerability - Tool: VUlnerable Child (ENVU) -; to allow for an appropriate orientation of the patient care pathway. The metrological validation of diagnostic performances (sensitivity, specificity, positive and negative likelihood ratios) will be studied in confrontation with the opinion of an expert caregiver in the care of vulnerable populations.
This multicenter cross-sectional validation study of the screening tool will be conducted in two SAUPs with a pediatric PASS.
1000 children will be included in the centers for a period of 1 year.
Following the introduction of the ENVU tool and after an expert interview, three groups of patients will be identified:
Group A: no vulnerability according to expert with no indication of any PASS marker care Group B: probable vulnerability according to the expert with indication of at least one PASS marker care Group C: high vulnerability according to the expert with indication of at least two care markers PASS Group B and C patients will be reviewed at 6 months for a second visit to the ENVU tool.
The main evaluation criterion will be the concordance between the indication of the use of the PASS by the "expert" PASS nurse (indicator of a significant social and health vulnerability) and the result of the ENVU tool.
Detailed description
In 2014, the french hospital emphasized the need for tools to screen for social fragility in order to make explicit the choices of orientation of patients. To date, caregivers do not have any tools or clinical benchmarks for individual assessment of pediatric social and health vulnerability.
The use of the Health Care Access Permanence Services (PASS) is intended to facilitate access to the health care system for people in precarious situations with care and social support within and outside the institutions. health.
The hypothesis tested is that the use of a formalized tool makes it possible to improve the detection of pediatric social vulnerability and to overcome reluctance to practice by a simple, rapid and justified approach with regard to ongoing care.
The primary objective is to validate a clinical tool for screening for pediatric social and health vulnerability - Tool: VUlnerable Child (ENVU) -; to allow for an appropriate orientation of the patient care pathway. The metrological validation of diagnostic performances (sensitivity, specificity, positive and negative likelihood ratios) will be studied in confrontation with the opinion of an expert caregiver in the care of vulnerable populations.
The secondary objectives will be to study the validity of the ENVU tool with regard to pathologies epidemiologically associated with social vulnerability: hypotrophy, prematurity, weight-loss disorders, school delay, asthma, skin infection, oral health, visual disturbances not treatment, delayed immunization, over-consumption of unscheduled care in SAUP, iron deficiency and lead poisoning (if research indicated by the reason for consultation). The illustration of the added value of the PASS care will be observed by a before-after study of the ENVU tool and the collected clinical data.
This multicenter cross-sectional validation study of the screening tool will be conducted in two SAUPs with a pediatric PASS.
1000 children will be included in the centers for a period of 1 year.
Following the introduction of the ENVU tool and after an expert interview, three groups of patients will be identified:
Group A: no vulnerability according to expert with no indication of any PASS marker care Group B: probable vulnerability according to the expert with indication of at least one PASS marker care Group C: high vulnerability according to the expert with indication of at least two care markers PASS Group B and C patients will be reviewed at 6 months for a second visit to the ENVU tool.
The main evaluation criterion will be the concordance between the indication of the use of the PASS by the "expert" PASS nurse (indicator of a significant social and health vulnerability) and the result of the ENVU tool.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | Other | Other: ENVUGroup A: no vulnerability according to expert with no indication of any PASS marker care |
| group B | Other | Other: ENVUGroup B: probable vulnerability according to the expert with indication of at least one PASS marker care |
| group c | Other | Other: ENVUGroup C: high vulnerability according to the expert with indication of at least two care markers PASS |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- from 3 to 15 years old,
- And consultant in the SAUP and PASS services investigators,
- And outside periods of custody and affluence,
- And accompanied by at least one parent or guardian
- And accepting to participate.
Key exclusion criteria (9 listed)
- Consultation in SAUP during the period of guard or affluence,
- Or Patient who has already consulted at PASS,
- Or child who has already participated in the study,
- Or in the absence of any parent (father or mother),
- Or current child protection measure - or evoked by doctors during the stay at SAUP,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENVU"ENfant VUlnerable": a clinical tool for screening for social and health vulnerability in pediatrics - tool: VUlnerable Child (ENVU) -; to allow for an appropriate orientation of the patient care pathway. The metrological validation of diagnostic performances (sensitivity, specificity, positive and negative likelihood ratios) will be studied in confrontation with the opinion of an expert caregiver in the care of vulnerable populations. | Other | group A, group B, group c |
Primary outcome
Number of patient for whom expertise is in good accordance with ENVU tool
Time frame: 1 days
The main evaluation criterion will be the concordance between the indication of the use of the PASS by the caretaker of the "expert" PASS (indicator of a significant social and health vulnerability) and the result of the ENVU tool.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Derived from this study: PubMed 36554830Laporte R, Babe P, Jouve E, Daguzan A, Mazoue F, Minodier P, Noel G, Urbina D, Gentile S. Developing and Validating an Individual-Level Deprivation Index for Children's Health in France. Int J Environ Res Public Health. 2022 Dec 16;19(24):16949. doi: 10.3390/ijerph192416949.
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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.
EMILIE GARRIDO PRADALIE study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENVU in people with Infant Conditions, run by Assistance Publique Hopitaux De Marseille 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 21 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact remi laporte, MD (+33 491368813, RemiJulien.LAPORTE@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient for whom expertise is in good accordance with ENVU tool (time frame: 1 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03640715, which also lists 1 linked publication.
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 21 Aug 2018.