Clinical trial NCT06180746: Study of the Conditions of the Effects of Health Mediation on Underserved Population
Official title: Study of the Conditions of the Effects of Health Mediation on Underserved Populations' Healthcare Utilization
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mediation
Keywords: Healthcare utilization
Health mediation
Cancer screening
Complex intervention
realist evaluation
study protocol
underserved populations
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 1041
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design
Primary purpose: PREVENTION

Brief summary: The investigators are conducting a longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design. The ECEMSo study aims to identify the impact of health mediation on fostering healthcare utilization, in particular organized cancer screening uptake, by underserved populations living in informal housing in France.

Detailed description: Health mediation may foster underserved populations' healthcare utilization. No study to date has demonstrated its effectiveness in an experimental context. The ECEMSo case study aims to identify the impact of health mediation on fostering healthcare utilization - in particular organized cancer screening uptake - by underserved populations living in informal housing in France.

Grounded in a theory-based framework, the ECEMSo case study is a longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design. The study population comprises various participant profiles including health mediators, health workers, social workers, people living in informal housing whom these professionals support, and other stakeholders concerned with underserved populations' health issues. Participants will be recruited in several French regions and divided into three mixed participant profile groups. In group 1, health mediation and the ECEMSo intervention will be implemented. This intervention comprises knowledge mobilization to facilitate the structuring of health mediation throughout France, and the development of an action plan to facilitate cancer screening uptake by people living in informal housing. In group 2, only health mediation will be implemented (i.e., no ECEMSo intervention). In group 3, neither health mediation nor the ECEMSo intervention will be implemented, but health and social workers will implement other health system navigation interventions.

Quantitative and qualitative data will be collected by interviewers through face-to-face questionnaires, interviews, observations, focus groups, and tracking tables of health mediation activities over six months. Data collection will be based on the health mediation conceptual framework.

Eligibility criteria: People living in informal housing

Inclusion criteria:

* Living on the streets, in a shanty house, squat or caravan
* Living in an area covered by one of care structures participating in the ECEMSo study
* Being over 18 years old
* Being able to understand the detailed information provided about the ECEMso study

Exclusion criteria:

* Suffering from cognitive and/or psychiatric disorders
* Being under guardianship or curatorship

Health mediators, heal workers, socials workers

Inclusion criteria:

* Being a health mediator, a health worker or a social worker belonging to one of the study's participation care structures
* Providing support to people living in informal housing

Exclusion criteria: No

Stakeholder:

Inclusion criteria: Being an actor concerned or involved with the issues and needs of people living in informal housing

Exclusion criteria: No

Primary outcomes:
measure: Impact of health mediation on healthcare utilization in people living in informal housing (PLIH) in France
timeFrame: At six months follow-up
measure: Impact of the intervention on people living in informal housing (PLIH) uptake of organized cancer screening
timeFrame: At six months follow-up
measure: Health mediation conditions required to foster utilization of healthcare services among people living in informal housing (PLIH) in France
timeFrame: At six months follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Equipe Mérisp/PHARES, INSERM, BPH, U1219, University Hospital, Bordeaux
name: Judith Martin-Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References: