MedTrace Logo

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

NCT03640715 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2018-08-21

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • EMILIE GARRIDO PRADALIE · APHM

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2019-11-30
Completion
2020-05-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03640715 on ClinicalTrials.gov