Study of the Conditions of the Effects of Health Mediation on Underserved Population

Mediation Clinical Trial

— ECEMSo  

Official title:

Study of the Conditions of the Effects of Health Mediation on Underserved Populations' Healthcare Utilization

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06180746
• Other study ID #: CHUBX 2020/70
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: September 15, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Bordeaux
• Contact: Judith Martin-Fernandez, PhD
• Phone: +33557822871
• Email: judith.martin-fernandez[@]u-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1041
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Mediation

Intervention

Behavioral:
• Knowledge mobilization to facilitate the structuring of health mediation
The ECEMSo intervention involves knowledge mobilization to facilitate the structuring of health mediation throughout French territory, and the development of a co-designed effective action plan to facilitate cancer screening uptake by people living in informal housing. The action plan will, consider territorial specificities at the regional level. The ECEMSo project team will organize a seminar and three workshops. The aim of the seminar and workshops is to mobilize knowledge to facilitate i) the structuring of health mediation in the regions, and ii) the development of an action plan with health mediators and other stakeholders to foster organized cancer screenings uptake by underserved people. This action plan must match with the needs of people living in informal housing, and must be coordinated, suitable and feasible to implement, in terms of knowledge about people living in informal housing specificities and specific local collaborations

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of health mediation on healthcare utilization in people living in informal housing (PLIH) in France	The difference in healthcare utilization by PLIH between groups 2 and group 3	At six months follow-up
Primary	Impact of the intervention on people living in informal housing (PLIH) uptake of organized cancer screening	The difference in organized cancer screening uptake (breast cancer, colorectal cancer, cervical cancer) between PLIH in group 1 and PLIH in group 2	At six months follow-up
Primary	Health mediation conditions required to foster utilization of healthcare services among people living in informal housing (PLIH) in France	The difference in organized cancer screening uptake (at 2 years since diagnosis for breast cancer and colorectal cancer, at 3 years since diagnosis for cervical cancer) between PLIH in group 1 and people living in informal housing in group 3	At six months follow-up