Clinical trial NCT06921954: Study Effects of the PRECAPP System on Precarious and Vulnerable Pregnant Women
Official title: Study Effects of the PRECAPP System on Precarious and Vulnerable Pregnant Women
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pregnant Women
Vulnerable Patients
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Age ≥ 18 years
* Follow-up in 2023 at Gonesse Hospital
* Patient having started her PRECAPP follow-up in 2023, between the 2nd and 5th month of pregnancy and having been accompanied throughout her PRECAPP journey (before, during and after childbirth): Classic" PRECAPP pathway
* Patient with integration (in 2023) of the PRECAPP program late in pregnancy (up to 1 month before delivery): PRECAPP "late" pathway
* Vulnerable and precarious patient not followed by PRECAPP but who should have been (maternity course completed in 2023): PRECAPP "non-integration" pathway

Brief summary: The themes of city-hospital coordination, patient pathways and the decompartmentalization of the city-hospital-medical-social and social sectors are becoming a major preoccupation for the healthcare sector, and a key factor in its dynamic transformation. A number of initiatives taken in this direction, either by the regulatory authorities (development of tools to promote coordination between healthcare professionals), by hospital establishments or by city professionals (notably CPTS), attest to a growing interest in the subject.

The École des Mines de Paris, whose highly collaborative research methods (research-intervention) are anchored in concrete support for transformation projects, and the University of Lille (LUMEN) are thus increasingly called upon to support players in these areas.

In this context, collaborative work with a Quebec research team (Ecole Nationale d'Administration Publique and Université de Sherbrooke) was launched in 2023 to compare forms of healthcare pathway management between two different healthcare systems, and their effects on vulnerable people (elderly, disabled, migrants, homeless, etc.). In France, the quantitative component is based on the use of PMSI databases, and aims to analyze the characteristics of "abnormally long" patient stays, in order to identify variables (relating either to patients or to care) likely to explain longer lengths of stay. The qualitative component is based on interviews with professionals and the reconstruction of patient pathways marked by breaks in care. The aim is to understand the very notion of breakdowns, the mechanisms by which they occur and the strategies put in place to avoid or deal with them.

Collaboration with the PRECAPP research team

As part of the qualitative component of the research program, the French team met several times between February and summer 2024 with members of the PRECAPP program. The PRECAPP system's function (to support vulnerable pregnant women in the perinatal period) and its mission (to identify the risks of disruption to care as early as possible in pregnancy, and to coordinate care during pregnancy and in the postnatal period) are at the heart of the Franco-Quebec research.

An initial working meeting between the PRECAPP team and the researchers provided an opportunity to describe the system and to demonstrate that its operation and the specific support it provides make it possible to anticipate certain difficulties in the care of women (before, during and after birth) and to help avoid disruptions in care.

The PRECAPP system is therefore fully in line with a comprehensive approach to the perinatal care of precarious and vulnerable women. This care concerns intra-hospital care, but it also contributes to the decompartmentalization of city-hospital care.

It is with the aim of highlighting the contributions of the PRECAPP system to the quality of care provided, the limits to its action, and to assess the way in which it helps to avoid breakdowns, that a collaboration between researchers and practitioners has been set up and will enable this study to be carried out.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Follow-up in 2023 at Gonesse Hospital
* Patient having started her PRECAPP follow-up in 2023, between the 2nd and 5th month of pregnancy and having been accompanied throughout her PRECAPP journey (before, during and after childbirth): Classic" PRECAPP pathway
* Patient with integration (in 2023) of the PRECAPP program late in pregnancy (up to 1 month before delivery): PRECAPP "late" pathway
* Vulnerable and precarious patient not followed by PRECAPP but who should have been (maternity course completed in 2023): PRECAPP "non-integration" pathway

Exclusion Criteria:

* Patient without vulnerability/poverty
* Patient not followed at the CHG in 2023

Primary outcomes:
measure: demographics
timeFrame: enrollment
measure: clinics
timeFrame: enrollment
Secondary outcomes:
measure: follow up
timeFrame: enrollment
Other outcomes:
Locations:
Study officials:
References: