Validation of a Screening Tool for Social and Health Vulnerability in Pediatric Clinical Practice

NCT03640715 | Unknown

• 1 other identifier: 2017-28
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infant Conditions

Outcome Measures

Primary Outcomes (1)

• 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.

  1 days

Study Arms (3)

group A

OTHER

Group A: no vulnerability according to expert with no indication of any PASS marker care

Other: ENVU

group B

OTHER

Group B: probable vulnerability according to the expert with indication of at least one PASS marker care

Other: ENVU

group c

OTHER

Group C: high vulnerability according to the expert with indication of at least two care markers PASS

Other: ENVU

Interventions

ENVU OTHER

"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.

group A; group B; group c

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

Location

Related Publications (1)

• 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.

  PMID: 36554830 DERIVED

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Central Study Contacts

remi laporte, MD

CONTACT

+33 491368813; RemiJulien.LAPORTE@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: October 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: May 1, 2020
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

FR (1)