Realist evaluation of the impact of health mediation on underserved populations’ healthcare utilization and cancer screening uptake: the ECEMSo case study protocol

Realist evaluation of the impact of health mediation on underserved populations’ healthcare utilization and cancer screening uptake: the ECEMSo case study protocol | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Realist evaluation of the impact of health mediation on underserved populations’ healthcare utilization and cancer screening uptake: the ECEMSo case study protocol Elodie Richard, Garance Perret, Leila Ramiz, Frédérique Quirino Chaves, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3937146/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: 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 (PLIH) in France. This paper describes the study protocol. Methods: 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, PLIH 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 PLIH. 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. The calculated required number of participants includes 960 health mediation beneficiaries, 54 health mediators, 27 health and social workers, and many other stakeholders, identified through snowball sampling. Discussion : In terms of evidence-based intervention research, this study will provide a comprehensive picture of the conditions under which health mediation has a positive effect on underserved populations’ healthcare utilization. Trial registration numbers : NCT06180746 12/12/2023 Healthcare utilization cancer screening health mediation complex intervention realist evaluation study protocol underserved populations Figures Figure 1 Figure 2 Contributions to the literature The ECEMSo study represents one of the first experimental studies on health mediation impact. In terms of evidence-based intervention research, this study will provide a comprehensive picture of the conditions under which health mediation has a positive effect on underserved populations’ healthcare utilization. The realist approach will allow to understand what components are necessary to create a beneficial effect of health mediation, as well as this effect’s transferability to other contexts. 1. Context The French National Authority for Health (HAS) defines health mediation as a temporary process of ‘going towards’ populations, health workers, social workers and institutions, as well as ‘working with’ people in a logic of empowerment ( 1 ). Health mediators’ work involves information-, education-, and communication-based activities (i.e., activities in individual or collective settings with adapted tools), as well as health system navigation activities (e.g., booking appointments, physically accompanying a patient to a health center). It also involves activities to mobilize, engage and bring together professionals and the targeted populations (e.g., co-construction of tools to facilitate stakeholder communication, co-construction of training on underserved populations’ needs, using a participatory approach during research study design, implementation and evaluation), and activities which bring together professionals and other stakeholders (e.g., training for professionals on the specific needs of underserved populations, advocacy with the competent health authorities) ( 2 ). Health mediation is implemented at the individual, organizational and/or community-based level ( 2 ). Health mediators have different training backgrounds (e.g., health or social sector training). Some have no qualification in the field but have legitimacy thanks to their extensive personal knowledge of the population they are working with ( 2 ). Health mediation is a promising intervention 1 but is also a complex subject to study, as it combines a diverse set of activities that require constant adaptations in a socially changing setting. Health mediation may foster healthcare utilization, in particular by underserved populations, and lead to tailored care strategies ( 4 – 6 ). However, no study has yet demonstrated its effectiveness in an experimental context ( 2 ). Underserved people are socially disadvantaged and comprise many heterogeneous populations. They have higher morbidity and mortality rates than the general population ( 7 , 9 ). They are underserved by the healthcare system because of their social and administrative position, and/or discrimination ( 7 – 9 ). Furthermore, health messages are not adapted to their living conditions. Accordingly, they are less receptive to them ( 10 – 13 ). These various factors combine to negatively impact their healthcare utilization ( 2 ). Studies conducted in the US ( 14 , 15 ) have shown that in addition to barriers to healthcare utilization, and especially to cancer screening uptake, women in precarious situations and homeless women have a higher risk of not receiving follow-up care after an abnormal smear or an abnormal mammogram ( 16 ). Another US study showed that 13% of invasive cervical cancers were due to no or poor follow-up after an abnormal Pap smear test result ( 17 ). Previous studies conducted in France among underserved women living in precarity, highlighted less frequent cancer screening than among women in the general population (i.e., having better living conditions) ( 18 , 19 ). These results raise questions about the efficacy of current French cancer prevention strategies for the most disadvantaged populations, especially since they are anchored in behavioral- and screening-based interventions ( 20 ). Some authors in the field of interventional health research working on the complexity of interventions, highlighted the need for a solid conceptual framework - upstream of any evaluation - that takes into account all the specificities of both the intervention and the context ( 21 ). As mentioned above, health mediation practices are multiform – as they constantly adapt to the context – and multilevel ( 2 ). They constitute an interventional system, that is to say “a set of interrelated human and non-human contextual agents within spatial and temporal boundaries generating mechanistic configurations – mechanisms – which are prerequisites for change in health” ( 22 ). Using the realist approach ( 21 ), we previously proposed mapping a solid analysis framework for the theoretical conditions needed to influence both health mediation (in terms of feasibility and success) and its effect on healthcare utilization, by identifying the context-mechanism-outcome configurations (CMOs) of heath mediation 2 (2). The ECEMSO-case study is based on this framework. The ECEMSo-case study aims to identify the impact of health mediation on healthcare utilization, in particular organized cancer screening uptake among underserved populations living in informal housing (PLIH) in France. Each of the study’s three objectives answers a specific research question, as presented in Table 1 . Table 1 ECEMSo objectives and related research questions. ECEMSo-case study, France, 2023. Research question Description of objective Study objective 1 What is the difference between health mediation (group 2*) and other health-system navigation interventions (group 3**) in terms of the impact on healthcare utilization among PLIH in France? Identify the impact of health mediation on healthcare utilization in PLIH in France Study objective 2 What is the difference between health mediation with the ECEMSo intervention (group 1***) and without it (group 2*) in terms of the impact on on PLIH uptake of organized cancer screening? Identify the impact of the ECEMSo intervention**** on PLIH uptake of organized cancer screening (breast cancer, colorectal cancer, cervical cancer) Study objective 3 What is the difference between health mediation with the ECEMSo intervention (group 1***) and other health-system navigation interventions (group 3**) in terms of the impact on PLIH uptake of organized cancer screening? Identify health mediation conditions required to foster utilization of healthcare services – specifically cancer screening uptake – among PLIH in France *group 2 : routine health mediation implemented by health mediators but no ECEMSo intervention **group 3 : other (i.e., different from ECEMSo intervention) health system navigation interventions implemented by social workers and health workers ***group 1 : routine health mediation implemented by health mediators and ECEMSo intervention implemented **** the ECEMSo intervention is a knowledge mobilization plan to facilitate i) the structuring of health mediation throughout French territory, and ii) the development of an effective action plan to facilitate cancer screening uptake by PLIH PLIH: people living in informal housing 2. Methods and analysis 2.1. Realist approach Realist evaluations are theory-based ( 23 ). They seek to understand the interactions between the external context components in which an intervention is implemented (i.e., the components that influence both intervention activities and mechanisms), the intervention components (i.e., activities), and the mechanisms (i.e., agent reaction that produces a change) ( 24 ). More specifically, they aim to understand what components are necessary to create a beneficial effect of an intervention, as well as this effect’s transferability to other contexts. In Pawson and Tilley’s realist approach to evaluating an intervention ( 25 ), the effectiveness of an intervention depends on the underlying mechanisms at play within a given context. Accordingly, this evaluation involves identifying CMOs ( 26 ) with the aim of evaluating how and under what circumstances an intervention can function effectively. The realist approach is linked to the black box paradigm ( 27 ) and differs from the experimental paradigm, which evaluates an intervention’s effectiveness without investigating the mechanisms at work or the influence of the context ( 28 ). Realist evaluations use the notion of generative causality, and are based on three assumptions ( 25 ): i) an intervention does not work in itself and is not what produces an effect, ii) every intervention triggers a mechanism or a set of mechanisms that enables a reaction to be produced, and iii) every intervention is situated in a specific context. The question is not “Does this intervention work?” but “How, for whom, and in what circumstances does this intervention work?” ( 24 ). 2.2. Applying the realist approach to our study The description of the realist approach above highlights why it is a suitable choice for the ECEMSo-case study. More specifically, we will use a realist evaluation to assess not only the effectiveness of the ECEMSo intervention and health mediation, but also the interactions between health mediation and its contexts. The ECEMSo study will validate CMOs previously identified in our analysis framework of health mediation (see above). In other words, we created hypotheses for how this intervention (i.e., health mediation) can function effectively. We will use a case study methodological approach ( 29 ), whereby each health mediator employed by a care structure participating in the study will constitute a case, as each mediator will have his/her own work context. Health mediation will be studied to identify the mechanisms at play in the given context (i.e., for each structure/case) along with differences in outcomes (i.e., healthcare utilization) depending on the care elements provided (i.e., health mediation with ECEMSo intervention, only health mediation, only other health system navigation interventions (see groups above)). CMOs will be validated through analysis of each case. A cross-case analysis will highlight recurrent CMOs, thereby identifying key features for possible replication of health mediation in another context. 2.3. Study population Participants will be recruited in various structures in several French regions to create three different participant profiles as follows: i ) people living in informal housing; ii ) professionals facilitating underserved populations’ healthcare utilization and cancer screening uptake; i ) other stakeholders. i) People living in informal housing For this study, we chose to select PLIH. Informal housing is defined as housing that “deviates, often temporarily, from a set of land, architectural, urban planning, landscape and social standards. Most of the time, it is spontaneous, which does not mean that there is no organization” ( 30 ). In the present study, informal housing corresponds to living on the streets, in a shanty house, a squat or caravan. We chose this subset of underserved populations because we hypothesize that they face greater structural barriers (e.g., material, socioeconomic, administrative, geographic, and social capital-based) to their use of healthcare, and greater difficulties overcoming these barriers because of social exclusion. ii) Professionals facilitating underserved populations’ healthcare utilization and cancer screening uptake The second participant profile comprises workers facilitating underserved populations’ healthcare utilization, and specifically cancer screening uptake. These workers include health mediators, health workers (e.g., nurses, general practitioners) and social workers (e.g., social assistants, specialist educators, economic and family counsellors). During the study, health mediators will implement health mediation in Groups 1 and 2 (see Study Design section below) as part of ‘routine care’ for PLIH (i.e., assisting in access to rights, healthcare, prevention interventions, and in health promotion) in collaboration with other stakeholders (see participant profile iii below). Health workers and social workers will continue to provide routine help to PLIH to navigate to healthcare system in group 3. iii) Other involved stakeholders The third participant profile comprises stakeholders at the territorial (i.e., town, metropolis, or county) level. These include all workers, front-line local actors and decision makers involved in the issues and needs of underserved populations, some of whom having decision-making power, and with whom the professionals in profile ii collaborate. They include, among others, civil servants working in decentralized services, health insurance agents, and health professional unions. 2.4. Participant inclusion and exclusion criteria The study inclusion criteria for PLIH (i.e., profile i ) are: (a) living on the streets, in a shanty house, squat, or caravan, (b) living in an area covered by one of care structures participating in the ECEMSo-case study, (c) over 18 years old, (d) able to understand the detailed information provided about the ECEMSo case study. With respect to profile ii , the inclusion criteria are (a) must be a health mediator, a health worker or a social worker belonging to one of the study’s participating care structures, and (b) must provide support to PLIH. Finally, the only inclusion criterion for the other stakeholder group (i.e., profile iii ) is being an actor concerned or involved with the issues and needs of PLIH. Exclusion criteria for profile i are: (a) suffering from cognitive and/or psychiatric disorders, and (b) being under guardianship or curatorship. There is no exclusion criterion for professionals in profiles ii or iii . 2.5. Participating structures and participant recruitment The recruitment of participating structures employing health mediators, social workers and health workers started in February 2023, and is still ongoing. Structures from a total of six different regions throughout France will be involved: Normandy and Pays de la Loire (northwest), Ile-de-France and Centre-Val de Loire (central), Nouvelle-Aquitaine (southwest), and Auvergne-Rhône-Alpes (southeast). The study regions were selected in such a way as to ensure a diverse mix in terms of geographical locations (i.e., rural, urban, and semi-urban area), health mediator experience (i.e., novice or expert), initial training (i.e., training in the fields of health or social care, or training in another field but were biological or ethnic peers of the persons supported), the type of structure (i.e., providing either social or healthcare services or both), and the relevant regional health agency’s level of political commitment to integrate health mediation into the region’s care offer at the territorial level. For the latter, we created three classifications of commitment as follows: acquired (i.e., health mediation politically and financially supported since the start of the French Program for Access to Prevention and Care for the most Disadvantaged Populations (PRAPS) in 2018); incipient (i.e., health mediation politically and financially supported during PRAPS but not since the beginning of the program); complicated (i.e., health mediation politically and financially supported but its implementation remains sub-optimal (e.g., competition between structures, health mediation issues, and ethics not respected)). All the professionals in the solicited structures who meet profile ii inclusion criteria and who agree to participate will be recruited. Once included, during a visit prior to study initiation, we will ask them to introduce the ECEMSo project team to the PLIH whom they provide support to, in order to facilitate participant recruitment. All persons from the three profiles who meet the eligibility criteria and who agree to participate will be included for quantitative data collection. For qualitative data collection for profile i only, three PLIH receiving support from each mediator and/or health worker and/or social worker will be selected randomly among those who provide quantitative data. Financial compensation (approximately 14 euros) will be offered to each participating PLIH. Other stakeholders (i.e., profile iii above) will be identified using snowball sampling through the help of participating health mediators, health workers and social workers. 3. Study design ECEMSo is a French, six-month, longitudinal, multi-center (i.e., multi-care structure), multi-case (i.e., health mediators), mixed-method study using an explanatory sequential design. The study sample will be divided into three mixed participant profile groups. Group 1 will comprise health mediators, the PLIH they support, and other involved stakeholders. As well as health mediation, the ECEMSo intervention will be implemented in this group. This will be organized and supported by the ECEMSo research team. The intervention is described in detail in section 3.1. Group 2 will comprise health mediators and other involved stakeholders. In this group, health mediation will be organized for the PLIH who the mediators support. The ECEMSo intervention will not be implemented. Group 3 will comprise health workers, social workers and other involved stakeholders. Neither health mediation not the ECEMSo intervention will be implemented. Instead, other healthcare navigation interventions will be implemented by participating health workers and social workers and by the other involved stakeholders. 3.1. ECEMSo intervention In the conceptual framework for analyzing health mediation which we previously designed (see above), one of the CMO needed to foster healthcare utilization was collective self-efficacy 3 within a community of practice 4 . Through this collective self-efficacy, professionals within the community of practice can overcome obstacles which hamper them from adapting their work system and the support activities which they implement for underserved people. Consequently, this facilitates the latter’s utilization of healthcare. This collective self-efficacy is generated by the territorial structuring of health mediation, which in turn is the result of integrated collaboration between all the stakeholders involved (i.e., health mediators, health workers, social workers, and other stakeholders) to respond to the needs and problems of underserved populations. Integrated collaboration aims to co-construct new, more systemic interventions (e.g., multisector government policies). It requires the integration of objectives, processes, resources, and activities, as well as a high degree of collaboration and interdependence between stakeholders ( 31 ). 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 PLIH. A range of persons will be invited to participate as follows: (i) all the health mediators taking part in the ECEMSo case study and the coordinators in the structures where they work, (ii) cancer screening and vulnerability task managers at the regional health agency and the health promotion task manager at the county-level for the relevant regional health agency, (iii) the contact person for organized cancer screening, the vulnerability task manager, and the partnership task manager working for the French social security system at the regional level, (iv) the specialist doctor at the relevant regional cancer screening center, and finally, (v) representatives of health professionals and local healthcare associations likely to perform CANCER screening (e.g., Médecins du Monde, la Croix-Rouge, Les Restos du Coeur. The action plan will, consider territorial specificities at the regional level. In other words, six specific action plans will be drawn up, one for each participating region. At least one health mediation structure per region will participate. In terms of the territorial structuring element of the intervention, the ECEMSo project team will organize a seminar and three workshops, two in the first study trimester and one in the second trimester. This intervention, together with health mediation, will be implemented in Group 1 (Fig. 2 ). The aim of the seminar and workshops is to mobilize knowledge to facilitate i) the structuring of health mediation in the six 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 PLIH, and must be coordinated, suitable and feasible to implement, in terms of knowledge about PLIH specificities and specific local collaborations. The operational objectives of the seminar and workshops are presented in Table 2. Seminar To present the health mediation conceptual framework previously developed by our team*. To identify each participant’s role, goals, and abilities in terms of PLIH needs and problems Workshop 1 To develop a shared understanding of the problems and needs PLIH face in terms of organized cancer screening uptake. To identify common objectives to respond to these problems and needs within the scope of each professional’s abilities (i.e., to define a sufficient area of ​​convergence). Workshop 2 To design an action plan to foster organized cancer screening uptake by PLIH which is coordinated and co-constructed by all the stakeholders involved in the needs and problems of PLIH at the territorial level. Workshop 3 To monitor the implementation of the action plan, and make necessary modifications and adjustments to it. * Ref 2 Table 2. Objectives of the knowledge mobilization seminar and workshops, ECEMSo case study, France, 2023. 3.2. Outcomes Table 3 presents the study outcomes. Table 3 Outcomes according to each of ECEMSo’s three study objectives, ECEMSo case study, France, 2023. Research question Objective Outcome Study Objective 1 What is the difference between health mediation (group 2*) and other health-system navigation interventions (group 3**) in terms of the impact on healthcare utilization among PLIH in France? Identify the impact of health mediation on healthcare utilization in PLIH in France Difference in healthcare utilization by PLIH between groups 2 and group 3, at six months follow-up Study Objective 2 What is the difference between health mediation with the ECEMSo intervention (group 1***) and without it (group 2*) in terms of the impact on on PLIH uptake of organized cancer screening? Identify the impact of the ECEMSo intervention**** on PLIH uptake of organized cancer screening (breast cancer, colorectal cancer, cervical cancer) 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 of follow-up Study Objective 3 What is the difference between health mediation with the ECEMSo intervention (group 1***) and other health-system navigation interventions (group 3**) in terms of the impact on PLIH uptake of organized cancer screening? Identify health mediation conditions required to foster utilization of healthcare services – specifically cancer screening uptake – among PLIH in France 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 PLIH in group 3, at six months of follow-up *group 2 : routine health mediation implemented by health mediators but no ECEMSo intervention **group 3 : other (i.e., different from ECEMSo intervention) health system navigation interventions implemented by social workers and health workers ***group 1 : routine health mediation implemented by health mediators and ECEMSo intervention implemented **** the ECEMSo intervention is a knowledge mobilization plan to facilitate i) the structuring of health mediation throughout French territory, and ii) the development of an effective action plan to facilitate cancer screening uptake by PLIH PLIH: people living in informal housing 3.3. Data collection and tools Quantitative data tools (e.g., questionnaires, etc.) will first be used to identify CMOs (see above). Complementing these data, qualitative tools (i.e., focus groups, etc.) will collect data to identify more precisely the interactions between the context and the mechanisms that foster healthcare utilization (specifically cancer screening uptake) by the participating PLIH, and to better understand the context in which health mediators and the other stakeholders involved operate. Where possible, for the study questionnaires, we will choose the most comprehensible (i.e., for underserved populations) standardized scales possible, with as small a number of items as possible. The data to be collected are described in Supplementary Material 1. a) Data collection (general) Participant inclusion and data collection will be conducted by trained interviewers previously recruited within the ECEMSo project team. The interviewers, with the help of health mediators, health workers and social workers in the participating care structures, will first carry out a visit prior to the inclusion period, in order to introduce the study and its organization to PLIH (i.e., potential participants) receiving health mediation support. A second similar visit will take place for other stakeholders who the mediators, health workers and social workers work with. Quantitative and qualitative data will be collected on a declarative basis. During baseline inclusion and follow-up, participants will be interviewed using several data collection tools: questionnaires, interviews, observations, focus groups and tracking tables of professionals’ work activities. The choice of the data collection tools was based on the CMOs that emerged in our health mediation analysis framework 5 (see above) ( 2 ). The tools have already been designed and pre-tested among their respective profile participants (see profiles i , ii , and iii above). Figure 1 explains the organization of data collection for the ECEMSo case study. b) Quantitative data collection tools A quantitative questionnaire will be administered by the interviewers to participating PLIH face to face at baseline (or T0) in October 2023. A description of how this questionnaire was developed can be found in section 3.4. A simplified version of the questionnaire will then be administered by telephone every two months until six months of follow-up (i.e., T1, T2, T3) (Fig. 1 ). The interviewers will also administer a quantitative questionnaire to participating health mediators, health workers, and social workers face to face at baseline (T0). Furthermore, they will track these professionals’ activities in a tracking table over the follow-up. For the other stakeholders, quantitative data will be collected using a face-to-face questionnaire administered by the interviewers, both at baseline (T0) and the end of the follow-up (T3). c) Qualitative data collection tools The trained interviewers will conduct face-to-face semi-structured interviews with participating PLIH at the end of the follow-up (T3) using an interview guide. Focus groups combining health mediators, health workers, social workers, and the other participating stakeholders will be organized at the end of the study (T3). Observations of health mediators’, health workers’ and social workers’ activities in the participating care structures will take place at baseline (T0) and between T2 and T3. 3.4. Health mediation stakeholder involvement in developing the data collection tools As mentioned above, the recruitment of participating structures is still ongoing. Between February 2023 and August 2023, health mediators working in structures already recruited came together in meetings to share their opinions about questionnaires that could be used for the participating PLIH and for ‘other stakeholder’ participants (i.e., profiles i and iii ). Specifically, they were asked – based on their experience – to validate, modify, or reject questions included in the draft questionnaires that had been created by the project team. In another set of meetings, directors of the recruited care structures, health mediators, health workers and social workers not included in the study were asked to do the same for the health mediator-specific questionnaire. Thanks to these meetings, modifications were made to the questionnaires to take into account PLIH specificities in terms of their mobility and their accessibility to the healthcare system. 3.5. Sample size calculation We hypothesize that healthcare utilization (specifically, organized cancer screening uptake) will be 10% higher in group 2 compared to group 3. We based the sample size calculation using a superiority test, with the hypothesis that receiving support from a health mediator would increase healthcare utilization. We expect the prevalence of healthcare utilization in group 3 to be 80%, and 90% in group 2. Accordingly, for 80% power, and an alpha risk of 5%, the required number of PLIH for the study is 834 ( 32 – 34 ). Applying an inflation factor ( 35 ) of 1.77 to take into account clusters, and assuming that 15% of people may be lost to follow-up, the final minimum number of PLIH who must be recruited is 960 (i.e., 320 persons in group 1, group 2, and group 3). Moreover, approximately 80 professionals (i.e., 54 health mediators and 27 health workers/social workers) must also be included in each group. We made no required sample size calculation for other stakeholders, as snowball sampling will be performed for them. 4. Data analysis 4.1. Quantitative and qualitative analyses This mixed-methods study involves an explanatory sequential design ( 36 ). The first phase consists in collecting and analyzing quantitative data (see above), followed by the collection and the analysis of qualitative data (see above). This second step will help to explain, confirm, and complement the quantitative results (Fig. 2 ). Data analysis will include an analysis of each case (i.e., each participating care structure), an analysis of each group (i.e., group 1, group 2, group 3) and a cross-case/group analysis, which will allow us to compare and observe potential effects in specific contexts. By validating initial middle-range theories 6 (i.e., CMOs, see above), the data analysis will help us to answer the question: “In what contextual conditions and through which mechanisms does health mediation produce outcomes?”. This validation will combine data from quantitative and qualitative analyses to provide new insights into the effect of health mediation on fostering healthcare utilization, especially cancer screening uptake. The quantitative analysis will be performed using R and SAS software, while the qualitative analysis will be conducted using NVivo software. We shall perform a descriptive analysis. Specifically, participants’ characteristics will be described in means and standard deviation, or in counts and proportions, depending on the type of variable. Results will be weighted taking into account the probability of inclusion in the study. In terms of the ECEMSo case study’s three primary objectives (see above), the following analyses will be conducted: Objective 1 analysis : We will perform Chi2 tests to compare healthcare utilization in PLIH in group 2 with PLIH in group 3, at six months follow-up. Objective 2 analysis : Based on a theory-driven approach, we will perform a multilevel mixed logistic regression stratified by group (i.e., groups 2 and 3). Two levels will be considered. The first will combine all variables related to health mediators, while they will combine all variables related to PLIH. The dependent variable is cancer screening uptake by PLIH (O). The independent variables will be all the context elements (C) and mechanisms (M), which could foster healthcare utilization by PLIH. All the qualitative data (i.e., data collected from the face-to-face semi-structured interviews, the observations and the focus groups) will be analyzed using content analysis, which involves “a set of techniques for systematically and objectively analyzing and describing the content of communication. The aim [of content analysis] is to obtain indicators allowing inferences to be made about the messages and how they are produced and received (inferred variables)” ( 37 ). Content analysis encodes, classifies, and ranks communications to examine patterns, trends, and distinguishing features; in our case, this translates as the presence and the potential recurrence of CMOs within each case and across all cases. A coding grid, based on the final version of our analysis framework of health mediation ( 2 ) 7 , will help us to analyze data from i) the semi-structured interviews conducted among participating PLIH, ii) our observations of health mediators, health workers and social workers, as well as iii) the focus groups with health mediators and other stakeholders. The data from each quantitative and qualitative tool will be presented in a table summarizing the data obtained, in order to identify the recurrence of CMOs in each case (i.e., each health mediator). Objective 3 analysis : We will perform trend tests to identify the effect of the ECEMSo intervention on cancer screening uptake by comparing PLIH in groups 1 and 2, at six months follow-up. 5. Ethics and dissemination 5.1 Ethical approval and consent to participate The study protocol was approved by the French data protection authority in November 2023. All participants who meet the eligibility criteria will be invited to participate. Prior to the beginning of the study, all eligible persons will receive an information letter about the ECEMSo case study describing its aims, detailing how data will be collected, and indicating participating PLIHs’ rights interms of data access, opposition and rectification. For participants who do not understand French or who have reading difficulties in French, the information letter will be translated by interviewers who speak the participants’ spoken language. 5.2. Results dissemination The results will be disseminated through various academic and non-academic platforms. Specifically, they will be disseminated in international peer-reviewed journals and presented at international and national conferences. A public report will describe all the steps of the study, the results and recommendations. A possible presentation of the final study results to all the participants and funders is also envisaged. 6. Conclusion The ECEMSo case study aims to provide a better understanding of the causes of underutilization of healthcare - and specifically of organized cancer screening - by PLIH, and more generally underserved populations. It also aims to measure the impact of health mediation on healthcare utilization for these populations in France. In terms of evidence-based intervention research, this study will provide a comprehensive picture of the conditions under which health mediation has a positive effect on underserved populations’ healthcare utilization. Highlighting the effect of mediation and studying the conditions needed for this effect in different contexts will lead us to develop recommendations for the structuring of health mediation at a national level in France. We shall compile these recommendations in a guide. The latter could be used to support the transferability and future scaling-up of health mediation in other contexts. Moreover, in terms of care pathways, this guide could be used to foster primary and secondary healthcare and organized cancer screening uptake. Health mediation may strengthen relationships between health mediators, health workers, social workers and other stakeholders at the territorial level. It may also help to create a support network focusing on the needs and problems of underserved people. In other words, health mediation could develop the inter-sectoral and territorial anchoring necessary for promoting healthcare in these populations inside a community of practice. Declarations Ethics approval and consent to participate All methods will be carried out in accordance with relevant guidelines and regulations. Informed consent was obtained from all subjects and/or their legal guardian(s). ECEMSo protocol was approved by a named institutional and/or licensing committee. The study protocol was approved by the French National Commission for Commission nationale de l'informatique et des libertés (CNIL - agreement decision DR-2013- 147 – November 2023) and the ethical committee : Comité Éthique et Scientifique pour les Recherches, les Études et les Évaluations dans le domaine de la Santé (CESREES) (Approval number : 11900952 Bis). Consent for publication Not applicable Availability of data and materials Not applicable (this manuscript does not report data generation or analysis) Competing interests The authors declare no competing interests. Funding This study protocol has been peer reviewed by the French National Cancer Institute (INCA) (Award decision: 2021/008). This work was supported by the French National Cancer Institute (INCA) (Grant: 2021/008), the National Federation of Associations in Solidarity with Gypsies and Travellers (Fnasat-GV) and the Santé publique France Institute. Authors’ contributions SV, LC, ER conceived the first version of the ECEMSo study. JMF conceived the design of the finalized study. ER developed the health mediation conceptual framework under supervision by SV and LC. ER, GP, FQC, JMF and SV created the data collection tools. ER and GP developed the data analysis framework. ER and GP drafted the first version of the manuscript. GP and LR calculated the required sample size and the ethics protocol. JMF and SV supervised the development of the study protocol. All authors reviewed the manuscript and approved the final version for publication. Acknowledgements The authors would like to thank Lucie de Lubersac, Murièle Conort, Mélina Calla, Florence, Frédérique Quirino Chaves, Romain Lafilé, Emmanuel Marie, Sébastien Boivin, Claudia Marchetti and Cécile Coutant, Margot Oberlis, and the health mediators working with Croix-Rouge Guyane for co-designing the ECEMSo case study. Our thanks also to Jude Sweeney (Milan, Italy) for the English editing and revision of the manuscript. References HAS. La médiation en santé pour les personnes éloignées des systèmes de prévention et de soins. 2017;70. Richard E, Vandentorren S, Cambon L. Conditions for the success and the feasibility of health mediation for healthcare use by underserved populations: a scoping review. BMJ Open 1 sept. 2022;12(9):e062051. Lacouture A. publique (EHESP) E des hautes études en santé. Etat de l’art des dispositifs mis en oeuvre à l’étranger pour favoriser auprès des décideurs le recours aux données sur des interventions probantes ou prometteuses dans le champ de la prévention ou de la promotion de la santé. EHESP juin 2016;58. Blanc G, Pelosse L. La médiation santé: Un outil pour l’accès à la santé ? FRAES. 2010;22. Haut conseil de la santé publique. Inégalités sociales de santé: sortir de la fatalité. HCSP déc 2009;101. Guillaume-Hofnung M. La Médiation. Que sais je ? 2020;128. Bounaud V, Texier N. Facteurs de non-recours aux soins des personnes en situation de précarité. ORS. 2017;37. Legros M. Pour un accès plus égal et facilité à la santé et aux soins. Conférence Natl Contre Pauvr Pour L’inclusion Soc. 2012;54. Rockliffe L, Chorley AJ, Marlow LAV, Forster AS. It’s hard to reach the hard-to-reach: the challenges of recruiting people who do not access preventative healthcare services into interview studies. Int J Qual Stud Health Well-Being. 2018;13(1):8. Vandentorren S, Vuillermoz C. Unmet healthcare needs in homeless women with children in the Greater Paris area in France. PLoS ONE. 2017;8. de Vries SG, Cremers AL, Heuvelings CC, Greve PF, Visser BJ, Bélard S, et al. Barriers and facilitators to the uptake of tuberculosis diagnostic and treatment services by hard-to-reach populations in countries of low and medium tuberculosis incidence: a systematic review of qualitative literature. Lancet Infect Dis mai. 2017;17(5):e128–43. Heuvelings CC, Greve PF, de Vries SG, Visser B, Bélard S, Janssen S, et al. Effectiveness of service models and organisational structures supporting tuberculosis identification and management in hard-to-reach populations in countries of low and medium tuberculosis incidence: a systematic review. BMJ Open 8 sept. 2018;8(9):e019642. Gelberg L, Andersen RM, Leake BD. The Behavioral Model for Vulnerable Populations: application to medical care use and outcomes for homeless people. Health Serv Res. 2000;34(6):1273–302. Sweet S. Barriers and Facilitators to Adherence to Follow-up for Abnormal Cervical Cytology: A Review of the Evidence with Implications for Clinical Practice. juin 2012 [cité 9 sept 2020]; Disponible sur: https://kb.osu.edu/handle/1811/51950 . Engelstad LP, Stewart S, Otero-Sabogal R, Leung MS, Davis PI, Pasick RJ. The effectiveness of a community outreach intervention to improve follow-up among underserved women at highest risk for cervical cancer. Prev Med 1 sept. 2005;41(3):741–8. Quinlivan JA, Petersen RW, Davy M, Evans SF. Abnormal pap smears in teenage mothers and the association with domestic violence, homelessness, and Chlamydia. J Low Genit Tract Dis avr. 2004;8(2):112–7. Leyden WA, Manos MM, Geiger AM, Weinmann S, Mouchawar J, Bischoff K, et al. Cervical Cancer in Women With Comprehensive Health Care Access: Attributable Factors in the Screening Process. JNCI J Natl Cancer Inst 4 mai. 2005;97(9):675–83. Rousseau A, Bohet P, Merlière J, Treppoz H, Heules-Bernin B, Ancelle-Park R. Evaluation du dépistage organisé et du dépistage individuel du cancer du col de l’utérus: utilité des données de l’Assurance maladie. :4. Dalmon C, Guillot E, Rodrigues A, Alves K, Madelenat P, Mahieu-Caputo D, et al. Cancer du col et précarité, accès aux soins diagnostic et traitement. Bull Cancer (Paris) 1 oct. 2009;96(10):961–9. De Jesus M, Rodrigue-Moulinié CM, Rahmani S, Balamou C. Addressing Cancer Screening Inequities by Promoting Cancer Prevention Knowledge, Awareness, Self-Efficacy, and Screening Uptake Among Low-Income and Illiterate Immigrant Women in France. Int J Public Health. 2021;66:1604055. Thabane L, Cambon L, Potvin L, Pommier J, Kivits J, Minary L et al. Population health intervention research: what is the place for pilot studies? Trials. 30 mai. 2019;20:8. Cambon L, Terral P, Alla F. From intervention to interventional system: towards greater theorization in population health intervention research. BMC Public Health déc. 2019;19(1):339. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: The new Medical Research Council guidance. Int J Nurs Stud 1 mai. 2013;50(5):587–92. Pawson R, Tilley N. Realistic evaluation. sage; 1997. Pawson R. Evidence-based policy: a realist perspective. sage; 2006. Pawson R, Greenhalgh T, Harvey G, Walshe K. Realist review–a new method of systematic review designed for complex policy interventions. J Health Serv Res Policy juill. 2005;10(Suppl 1):21–34. Astbury B, Leeuw FL. Unpacking Black Boxes: Mechanisms and Theory Building in Evaluation. Am J Eval 1 sept. 2010;31(3):363–81. Campbell DT, Stanley JC. Experimental and quasi-experimental designs for research. Belomt, CA: Wadsworth; 2011. p. 84. Yin RK. Case Study Research: Design and Methods. Sage Publ. 1994;200. Imbert C, Chapon J, Mialocq M. L’habitat informel dans l’ouest de l’Ariège: marginalité ou alternative à la norme ? — Géoconfluences [Internet]. [cité 23 sept 2022]. Disponible sur: http://geoconfluences.ens-lyon.fr/informations-scientifiques/dossiers-regionaux/france-espaces-ruraux-periurbains/articles-scientifiques/habitat-informel-ariege-marge-innovante . Bilodeau A, Parent A, anne, Potvin L. Les collaborations intersectorielles et l’action en partenariat, comment ça marche? Chaire Rech Can Approch Communaut Inégalités Santé. 2019;43. PREVAC: étude de couverture vaccinale. et accès à la vaccination contre la COVID-19 des populations précaires [Internet]. [cité 20 mai 2022]. Disponible sur: https://www.santepubliquefrance.fr/les-actualites/2022/prevac-etude-de-couverture-vaccinale-et-acces-a-la-vaccination-contre-la-covid-19-des-populations-precaires . Fédération. Nationale des Associations Solidaires d’Action avec les Tsiganes et les gens du voyage (FNASAT). La santé des Gens du voyage. 2019. DRESS. Le recours aux soins des sans-domicile: neuf sur dix ont consulté un médecin en 2012. Etudes Résultats. 2015;(933):6. Giraudeau B. L’essai clinique randomisé par grappes. MS Médecine Sci. 2004;20(3):363–6. Cresswell J, Plano C, Vicki L. Designing and Conducting Mixed Methods Research (3rd ed.). Sage Publ. 2017;300. Bardin L. L’ analyse de contenu. 2nd edition. Paris: PUF; 2013. [Internet]. 2018 [cité 9 sept 2018]. Disponible sur: https://www.puf.com/content/L_analyse_de_contenu . Footnotes A promising intervention is “an intervention whose efficacy has not been evaluated by research, but for which a solid normative evaluation induces a presumption of relevant results” ( 3 ). Richard E., Ramiz L., Martin Fernandez J., Cambon L-Vandentorren S, Health mediation mechanisms influencing healthcare utilization by underserved populations: a theory-driven qualitative study. Frontiers in Public Health, 2023, 14. (Submitted) Richard E., Ramiz L., Oltean M., Troussier V., Ulracher C., Speed O., Conort M., Coutant C., Quirino Chaves F., Martin Fernandez J., Vandentorren S-Cambon L, A priori Context-Mechanism-Outcome configurations explaining the effect of health mediation on the fostering of healthcare utilization: a Realist Qualitative Study. Implementation science, 2023, 20. (Submitted) Collective self-efficacy is understood here as the perception of the collective ability to overcome obstacles in order to adapt the system to welcome and support underserved populations. Richard E., Ramiz L., Oltean M., Troussier V., Ulracher C., Speed O., Conort M., Coutant C., Quirino Chaves F., Martin Fernandez J., Vandentorren S-Cambon L, A priori Context-Mechanism-Outcome configurations explaining the effect of health mediation on the fostering of healthcare utilization: a Realist Qualitative Study. Implementation science, 2023, 20. (Submitted) Richard E., Ramiz L., Martin Fernandez J., Cambon L-Vandentorren S, Health mediation mechanisms influencing healthcare utilization by underserved populations: a theory-driven qualitative study. Frontiers in Public Health, 2023, 14. (Submitted) Richard E., Ramiz L., Oltean M., Troussier V., Ulracher C., Speed O., Conort M., Coutant C., Quirino Chaves F., Martin Fernandez J., Vandentorren S-Cambon L, A priori Context-Mechanism-Outcome configurations explaining the effect of health mediation on the fostering of healthcare utilization: a Realist Qualitative Study. Implementation science, 2023, 20. (Submitted) Richard E., Ramiz L., Oltean M., Troussier V., Ulracher C., Speed O., Conort M., Coutant C., Quirino Chaves F., Martin Fernandez J., Vandentorren S-Cambon L, A priori Context-Mechanism-Outcome configurations explaining the effect of health mediation on the fostering of healthcare utilization: a Realist Qualitative Study. Implementation science, 2023, 20. (Submitted) Richard E., Ramiz L., Martin Fernandez J., Cambon L-Vandentorren S, Health mediation mechanisms influencing healthcare utilization by underserved populations: a theory-driven qualitative study. Frontiers in Public Health, 2023, 14. (Submitted) Richard E., Ramiz L., Oltean M., Troussier V., Ulracher C., Speed O., Conort M., Coutant C., Quirino Chaves F., Martin Fernandez J., Vandentorren S-Cambon L, A priori Context-Mechanism-Outcome configurations explaining the effect of health mediation on the fostering of healthcare utilization: a Realist Qualitative Study. Implementation science, 2023, 20. (Submitted) Additional Declarations No competing interests reported. Supplementary Files SM1.docxarticleprotocole.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3937146","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":272495213,"identity":"8be95d77-745e-4248-88c2-d45552d3803d","order_by":0,"name":"Elodie Richard","email":"data:image/png;base64,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","orcid":"","institution":"Fnasat","correspondingAuthor":true,"prefix":"","firstName":"Elodie","middleName":"","lastName":"Richard","suffix":""},{"id":272495214,"identity":"182e922b-b4bc-4957-b828-bf8ec02d95d2","order_by":1,"name":"Garance Perret","email":"","orcid":"","institution":"Centre Hospitalier Universitaire de Bordeaux","correspondingAuthor":false,"prefix":"","firstName":"Garance","middleName":"","lastName":"Perret","suffix":""},{"id":272495215,"identity":"5b1bfe31-a651-41d1-85b4-111463132d16","order_by":2,"name":"Leila Ramiz","email":"","orcid":"","institution":"Centre Hospitalier Universitaire de Bordeaux","correspondingAuthor":false,"prefix":"","firstName":"Leila","middleName":"","lastName":"Ramiz","suffix":""},{"id":272495216,"identity":"75de2345-74e7-478c-85fd-dddc20ef4c72","order_by":3,"name":"Frédérique Quirino Chaves","email":"","orcid":"","institution":"Fnasat","correspondingAuthor":false,"prefix":"","firstName":"Frédérique","middleName":"Quirino","lastName":"Chaves","suffix":""},{"id":272495217,"identity":"e1f27348-8ee9-486d-94ed-f802d16d5954","order_by":4,"name":"linda Cambon","email":"","orcid":"","institution":"University of Bordeaux","correspondingAuthor":false,"prefix":"","firstName":"linda","middleName":"","lastName":"Cambon","suffix":""},{"id":272495218,"identity":"296ec610-227b-4f0e-b4ed-08bd9c9e9363","order_by":5,"name":"Stéphanie Vandentorren","email":"","orcid":"","institution":"Santé Publique France","correspondingAuthor":false,"prefix":"","firstName":"Stéphanie","middleName":"","lastName":"Vandentorren","suffix":""},{"id":272495219,"identity":"42bf4e63-3f3a-48de-a7ed-67ca3f90df6e","order_by":6,"name":"Judith Martin Fernandez","email":"","orcid":"","institution":"University of Bordeaux","correspondingAuthor":false,"prefix":"","firstName":"Judith","middleName":"Martin","lastName":"Fernandez","suffix":""}],"badges":[],"createdAt":"2024-02-07 14:35:33","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3937146/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3937146/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":51135429,"identity":"f0e27a8b-5ee9-4ce5-9ae3-b47928d75a02","added_by":"auto","created_at":"2024-02-14 18:29:34","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":114069,"visible":true,"origin":"","legend":"\u003cp\u003eData collection organization of the ECEMSo case study, with study populations. ECEMSo-case study, France, 2023.\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-3937146/v1/e2734c07a737786af151029e.png"},{"id":51135427,"identity":"1a34a5c4-496a-4dd3-9eb1-229bd59c8ab3","added_by":"auto","created_at":"2024-02-14 18:29:33","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":26370,"visible":true,"origin":"","legend":"\u003cp\u003eECEMSo mixed-methods study using an explanatory sequential design. ECEMSo-case study, France, 2023.\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-3937146/v1/3c29c267a6d87baf94cd0fa8.png"},{"id":64209038,"identity":"fc756e35-ed13-448d-b5de-9d554c641bfa","added_by":"auto","created_at":"2024-09-10 06:41:12","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":719603,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3937146/v1/cdf7f0a0-e6bc-4e88-bf63-de0fa8a9b189.pdf"},{"id":51135428,"identity":"d1d0142b-345c-4699-ad52-12c0f01faaec","added_by":"auto","created_at":"2024-02-14 18:29:34","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":70644,"visible":true,"origin":"","legend":"","description":"","filename":"SM1.docxarticleprotocole.docx","url":"https://assets-eu.researchsquare.com/files/rs-3937146/v1/85fc3d9620422834649d7a20.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Realist evaluation of the impact of health mediation on underserved populations’ healthcare utilization and cancer screening uptake: the ECEMSo case study protocol","fulltext":[{"header":"Contributions to the literature","content":"\u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eThe ECEMSo study represents one of the first experimental studies on health mediation impact.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eIn terms of evidence-based intervention research, this study will provide a comprehensive picture of the conditions under which health mediation has a positive effect on underserved populations\u0026rsquo; healthcare utilization.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eThe realist approach will allow to understand what components are necessary to create a beneficial effect of health mediation, as well as this effect\u0026rsquo;s transferability to other contexts.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e"},{"header":"1. Context","content":"\u003cp\u003eThe French National Authority for Health (HAS) defines health mediation as a temporary process of \u0026lsquo;going towards\u0026rsquo; populations, health workers, social workers and institutions, as well as \u0026lsquo;working with\u0026rsquo; people in a logic of empowerment (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Health mediators\u0026rsquo; work involves information-, education-, and communication-based activities (i.e., activities in individual or collective settings with adapted tools), as well as health system navigation activities (e.g., booking appointments, physically accompanying a patient to a health center). It also involves activities to mobilize, engage and bring together professionals and the targeted populations (e.g., co-construction of tools to facilitate stakeholder communication, co-construction of training on underserved populations\u0026rsquo; needs, using a participatory approach during research study design, implementation and evaluation), and activities which bring together professionals and other stakeholders (e.g., training for professionals on the specific needs of underserved populations, advocacy with the competent health authorities) (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eHealth mediation is implemented at the individual, organizational and/or community-based level (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). Health mediators have different training backgrounds (e.g., health or social sector training). Some have no qualification in the field but have legitimacy thanks to their extensive personal knowledge of the population they are working with (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). Health mediation is a promising intervention\u003csup\u003e1\u003c/sup\u003e but is also a complex subject to study, as it combines a diverse set of activities that require constant adaptations in a socially changing setting.\u003c/p\u003e \u003cp\u003eHealth mediation may foster healthcare utilization, in particular by underserved populations, and lead to tailored care strategies (\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). However, no study has yet demonstrated its effectiveness in an experimental context (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eUnderserved people are socially disadvantaged and comprise many heterogeneous populations. They have higher morbidity and mortality rates than the general population (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). They are underserved by the healthcare system because of their social and administrative position, and/or discrimination (\u003cspan additionalcitationids=\"CR8\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). Furthermore, health messages are not adapted to their living conditions. Accordingly, they are less receptive to them (\u003cspan additionalcitationids=\"CR11 CR12\" citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). These various factors combine to negatively impact their healthcare utilization (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eStudies conducted in the US (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e) have shown that in addition to barriers to healthcare utilization, and especially to cancer screening uptake, women in precarious situations and homeless women have a higher risk of not receiving follow-up care after an abnormal smear or an abnormal mammogram (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). Another US study showed that 13% of invasive cervical cancers were due to no or poor follow-up after an abnormal Pap smear test result (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). Previous studies conducted in France among underserved women living in precarity, highlighted less frequent cancer screening than among women in the general population (i.e., having better living conditions) (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). These results raise questions about the efficacy of current French cancer prevention strategies for the most disadvantaged populations, especially since they are anchored in behavioral- and screening-based interventions (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eSome authors in the field of interventional health research working on the complexity of interventions, highlighted the need for a solid conceptual framework - upstream of any evaluation - that takes into account all the specificities of both the intervention and the context (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). As mentioned above, health mediation practices are multiform \u0026ndash; as they constantly adapt to the context \u0026ndash; and multilevel (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). They constitute an interventional system, that is to say \u0026ldquo;a set of interrelated human and non-human contextual agents within spatial and temporal boundaries generating mechanistic configurations \u0026ndash; mechanisms \u0026ndash; which are prerequisites for change in health\u0026rdquo; (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). Using the realist approach (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e), we previously proposed mapping a solid analysis framework for the theoretical conditions needed to influence both health mediation (in terms of feasibility and success) and its effect on healthcare utilization, by identifying the context-mechanism-outcome configurations (CMOs) of heath mediation\u003csup\u003e2\u003c/sup\u003e (2). The ECEMSO-case study is based on this framework.\u003c/p\u003e \u003cp\u003eThe ECEMSo-case study aims to identify the impact of health mediation on healthcare utilization, in particular organized cancer screening uptake among underserved populations living in informal housing (PLIH) in France. Each of the study\u0026rsquo;s three objectives answers a specific research question, as presented in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eECEMSo objectives and related research questions. ECEMSo-case study, France, 2023.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eResearch question\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eDescription of objective\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStudy objective 1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWhat is the difference between health mediation (group 2*) and other health-system navigation interventions (group 3**) in terms of the impact on healthcare utilization among PLIH in France?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIdentify the impact of health mediation on healthcare utilization in PLIH in France\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStudy objective 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWhat is the difference between health mediation with the ECEMSo intervention (group 1***) and without it (group 2*) in terms of the impact on on PLIH uptake of organized cancer screening?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIdentify the impact of the ECEMSo intervention**** on PLIH uptake of organized cancer screening (breast cancer, colorectal cancer, cervical cancer)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStudy objective 3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWhat is the difference between health mediation with the ECEMSo intervention (group 1***) and other health-system navigation interventions (group 3**) in terms of the impact on PLIH uptake of organized cancer screening?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIdentify health mediation conditions required to foster utilization of healthcare services \u0026ndash; specifically cancer screening uptake \u0026ndash; among PLIH in France\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003e*group 2 : routine health mediation implemented by health mediators but no ECEMSo intervention\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003e**group 3 : other (i.e., different from ECEMSo intervention) health system navigation interventions implemented by social workers and health workers\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003e***group 1 : routine health mediation implemented by health mediators and ECEMSo intervention implemented\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003e**** the ECEMSo intervention is a knowledge mobilization plan to facilitate i) the structuring of health mediation throughout French territory, and ii) the development of an effective action plan to facilitate cancer screening uptake by PLIH\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003ePLIH: people living in informal housing\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e"},{"header":"2. Methods and analysis","content":" \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003cp\u003e2.1. Realist approach\u003c/p\u003e \u003cp\u003eRealist evaluations are theory-based (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). They seek to understand the interactions between the external context components in which an intervention is implemented (i.e., the components that influence both intervention activities and mechanisms), the intervention components (i.e., activities), and the mechanisms (i.e., agent reaction that produces a change) (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). More specifically, they aim to understand what components are necessary to create a beneficial effect of an intervention, as well as this effect\u0026rsquo;s transferability to other contexts. In Pawson and Tilley\u0026rsquo;s realist approach to evaluating an intervention (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e), the effectiveness of an intervention depends on the underlying mechanisms at play within a given context. Accordingly, this evaluation involves identifying CMOs (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e) with the aim of evaluating how and under what circumstances an intervention can function effectively. The realist approach is linked to the black box paradigm (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e) and differs from the experimental paradigm, which evaluates an intervention\u0026rsquo;s effectiveness without investigating the mechanisms at work or the influence of the context (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e). Realist evaluations use the notion of generative causality, and are based on three assumptions (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e): i) an intervention does not work in itself and is not what produces an effect, ii) every intervention triggers a mechanism or a set of mechanisms that enables a reaction to be produced, and iii) every intervention is situated in a specific context. The question is not \u0026ldquo;Does this intervention work?\u0026rdquo; but \u0026ldquo;How, for whom, and in what circumstances does this intervention work?\u0026rdquo; (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e2.2. Applying the realist approach to our study\u003c/p\u003e \u003cp\u003eThe description of the realist approach above highlights why it is a suitable choice for the ECEMSo-case study. More specifically, we will use a realist evaluation to assess not only the effectiveness of the ECEMSo intervention and health mediation, but also the interactions between health mediation and its contexts.\u003c/p\u003e \u003cp\u003eThe ECEMSo study will validate CMOs previously identified in our analysis framework of health mediation (see above). In other words, we created hypotheses for how this intervention (i.e., health mediation) can function effectively.\u003c/p\u003e \u003cp\u003eWe will use a case study methodological approach (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e), whereby each health mediator employed by a care structure participating in the study will constitute a case, as each mediator will have his/her own work context. Health mediation will be studied to identify the mechanisms at play in the given context (i.e., for each structure/case) along with differences in outcomes (i.e., healthcare utilization) depending on the care elements provided (i.e., health mediation with ECEMSo intervention, only health mediation, only other health system navigation interventions (see groups above)). CMOs will be validated through analysis of each case. A cross-case analysis will highlight recurrent CMOs, thereby identifying key features for possible replication of health mediation in another context.\u003c/p\u003e \u003cp\u003e2.3. Study population\u003c/p\u003e \u003cp\u003eParticipants will be recruited in various structures in several French regions to create three different participant profiles as follows: \u003cem\u003ei\u003c/em\u003e) people living in informal housing; \u003cem\u003eii\u003c/em\u003e) professionals facilitating underserved populations\u0026rsquo; healthcare utilization and cancer screening uptake; \u003cem\u003ei\u003c/em\u003e) other stakeholders.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003ei) People living in informal housing\u003c/h3\u003e\n\u003cp\u003eFor this study, we chose to select PLIH. Informal housing is defined as housing that \u0026ldquo;deviates, often temporarily, from a set of land, architectural, urban planning, landscape and social standards. Most of the time, it is spontaneous, which does not mean that there is no organization\u0026rdquo; (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e). In the present study, informal housing corresponds to living on the streets, in a shanty house, a squat or caravan.\u003c/p\u003e \u003cp\u003eWe chose this subset of underserved populations because we hypothesize that they face greater structural barriers (e.g., material, socioeconomic, administrative, geographic, and social capital-based) to their use of healthcare, and greater difficulties overcoming these barriers because of social exclusion.\u003c/p\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eii) Professionals facilitating underserved populations\u0026rsquo; healthcare utilization and cancer screening uptake\u003c/h2\u003e \u003cp\u003eThe second participant profile comprises workers facilitating underserved populations\u0026rsquo; healthcare utilization, and specifically cancer screening uptake. These workers include health mediators, health workers (e.g., nurses, general practitioners) and social workers (e.g., social assistants, specialist educators, economic and family counsellors). During the study, health mediators will implement health mediation in Groups 1 and 2 (see \u003cspan refid=\"Sec7\" class=\"InternalRef\"\u003eStudy Design\u003c/span\u003e section below) as part of \u0026lsquo;routine care\u0026rsquo; for PLIH (i.e., assisting in access to rights, healthcare, prevention interventions, and in health promotion) in collaboration with other stakeholders (see participant profile \u003cem\u003eiii\u003c/em\u003e below). Health workers and social workers will continue to provide routine help to PLIH to navigate to healthcare system in group 3.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eiii) Other involved stakeholders\u003c/h2\u003e \u003cp\u003eThe third participant profile comprises stakeholders at the territorial (i.e., town, metropolis, or county) level. These include all workers, front-line local actors and decision makers involved in the issues and needs of underserved populations, some of whom having decision-making power, and with whom the professionals in profile \u003cem\u003eii\u003c/em\u003e collaborate. They include, among others, civil servants working in decentralized services, health insurance agents, and health professional unions.\u003c/p\u003e \u003cp\u003e2.4. Participant inclusion and exclusion criteria\u003c/p\u003e \u003cp\u003eThe study inclusion criteria for PLIH (i.e., profile \u003cem\u003ei\u003c/em\u003e) are: (a) living on the streets, in a shanty house, squat, or caravan, (b) living in an area covered by one of care structures participating in the ECEMSo-case study, (c) over 18 years old, (d) able to understand the detailed information provided about the ECEMSo case study. With respect to profile \u003cem\u003eii\u003c/em\u003e, the inclusion criteria are (a) must be a health mediator, a health worker or a social worker belonging to one of the study\u0026rsquo;s participating care structures, and (b) must provide support to PLIH. Finally, the only inclusion criterion for the other stakeholder group (i.e., profile \u003cem\u003eiii\u003c/em\u003e) is being an actor concerned or involved with the issues and needs of PLIH.\u003c/p\u003e \u003cp\u003eExclusion criteria for profile \u003cem\u003ei\u003c/em\u003e are: (a) suffering from cognitive and/or psychiatric disorders, and (b) being under guardianship or curatorship. There is no exclusion criterion for professionals in profiles \u003cem\u003eii\u003c/em\u003e or \u003cem\u003eiii\u003c/em\u003e.\u003c/p\u003e \u003cp\u003e2.5. Participating structures and participant recruitment\u003c/p\u003e \u003cp\u003eThe recruitment of participating structures employing health mediators, social workers and health workers started in February 2023, and is still ongoing. Structures from a total of six different regions throughout France will be involved: Normandy and Pays de la Loire (northwest), Ile-de-France and Centre-Val de Loire (central), Nouvelle-Aquitaine (southwest), and Auvergne-Rh\u0026ocirc;ne-Alpes (southeast). The study regions were selected in such a way as to ensure a diverse mix in terms of geographical locations (i.e., rural, urban, and semi-urban area), health mediator experience (i.e., novice or expert), initial training (i.e., training in the fields of health or social care, or training in another field but were biological or ethnic peers of the persons supported), the type of structure (i.e., providing either social or healthcare services or both), and the relevant regional health agency\u0026rsquo;s level of political commitment to integrate health mediation into the region\u0026rsquo;s care offer at the territorial level. For the latter, we created three classifications of commitment as follows: \u003cem\u003eacquired\u003c/em\u003e (i.e., health mediation politically and financially supported since the start of the French Program for Access to Prevention and Care for the most Disadvantaged Populations (PRAPS) in 2018); \u003cem\u003eincipient\u003c/em\u003e (i.e., health mediation politically and financially supported during PRAPS but not since the beginning of the program); \u003cem\u003ecomplicated\u003c/em\u003e (i.e., health mediation politically and financially supported but its implementation remains sub-optimal (e.g., competition between structures, health mediation issues, and ethics not respected)).\u003c/p\u003e \u003cp\u003eAll the professionals in the solicited structures who meet profile \u003cem\u003eii\u003c/em\u003e inclusion criteria and who agree to participate will be recruited. Once included, during a visit prior to study initiation, we will ask them to introduce the ECEMSo project team to the PLIH whom they provide support to, in order to facilitate participant recruitment.\u003c/p\u003e \u003cp\u003eAll persons from the three profiles who meet the eligibility criteria and who agree to participate will be included for quantitative data collection. For qualitative data collection for profile \u003cem\u003ei\u003c/em\u003e only, three PLIH receiving support from each mediator and/or health worker and/or social worker will be selected randomly among those who provide quantitative data. Financial compensation (approximately 14 euros) will be offered to each participating PLIH. Other stakeholders (i.e., profile \u003cem\u003eiii\u003c/em\u003e above) will be identified using snowball sampling through the help of participating health mediators, health workers and social workers.\u003c/p\u003e \u003c/div\u003e"},{"header":"3. Study design","content":"\u003cp\u003eECEMSo is a French, six-month, longitudinal, multi-center (i.e., multi-care structure), multi-case (i.e., health mediators), mixed-method study using an explanatory sequential design. The study sample will be divided into three mixed participant profile groups.\u003c/p\u003e \u003cp\u003e \u003cb\u003eGroup 1\u003c/b\u003e will comprise health mediators, the PLIH they support, and other involved stakeholders. As well as health mediation, the ECEMSo intervention will be implemented in this group. This will be organized and supported by the ECEMSo research team. The intervention is described in detail in section 3.1.\u003c/p\u003e \u003cp\u003e \u003cb\u003eGroup 2\u003c/b\u003e will comprise health mediators and other involved stakeholders. In this group, health mediation will be organized for the PLIH who the mediators support. The ECEMSo intervention will not be implemented.\u003c/p\u003e \u003cp\u003e \u003cb\u003eGroup 3\u003c/b\u003e will comprise health workers, social workers and other involved stakeholders. Neither health mediation not the ECEMSo intervention will be implemented. Instead, other healthcare navigation interventions will be implemented by participating health workers and social workers and by the other involved stakeholders.\u003c/p\u003e \u003cp\u003e3.1. ECEMSo intervention\u003c/p\u003e \u003cp\u003eIn the conceptual framework for analyzing health mediation which we previously designed (see above), one of the CMO needed to foster healthcare utilization was collective self-efficacy\u003csup\u003e3\u003c/sup\u003e within a community of practice\u003csup\u003e4\u003c/sup\u003e. Through this collective self-efficacy, professionals within the community of practice can overcome obstacles which hamper them from adapting their work system and the support activities which they implement for underserved people. Consequently, this facilitates the latter\u0026rsquo;s utilization of healthcare. This collective self-efficacy is generated by the territorial structuring of health mediation, which in turn is the result of integrated collaboration between all the stakeholders involved (i.e., health mediators, health workers, social workers, and other stakeholders) to respond to the needs and problems of underserved populations. Integrated collaboration aims to co-construct new, more systemic interventions (e.g., multisector government policies). It requires the integration of objectives, processes, resources, and activities, as well as a high degree of collaboration and interdependence between stakeholders (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe 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 PLIH. A range of persons will be invited to participate as follows: (i) all the health mediators taking part in the ECEMSo case study and the coordinators in the structures where they work, (ii) cancer screening and vulnerability task managers at the regional health agency and the health promotion task manager at the county-level for the relevant regional health agency, (iii) the contact person for organized cancer screening, the vulnerability task manager, and the partnership task manager working for the French social security system at the regional level, (iv) the specialist doctor at the relevant regional cancer screening center, and finally, (v) representatives of health professionals and local healthcare associations likely to perform CANCER screening (e.g., \u003cem\u003eM\u0026eacute;decins du Monde, la Croix-Rouge, Les Restos du Coeur.\u003c/em\u003e The action plan will, consider territorial specificities at the regional level. In other words, six specific action plans will be drawn up, one for each participating region. At least one health mediation structure per region will participate.\u003c/p\u003e \u003cp\u003eIn terms of the territorial structuring element of the intervention, the ECEMSo project team will organize a seminar and three workshops, two in the first study trimester and one in the second trimester. This intervention, together with health mediation, will be implemented in Group 1 (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The aim of the seminar and workshops is to mobilize knowledge to facilitate i) the structuring of health mediation in the six 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 PLIH, and must be coordinated, suitable and feasible to implement, in terms of knowledge about PLIH specificities and specific local collaborations.\u003c/p\u003e \u003cp\u003eThe operational objectives of the seminar and workshops are presented in Table\u0026nbsp;2.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"No\" id=\"Taba\" border=\"1\"\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSeminar\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTo present the health mediation conceptual framework previously developed by our team*.\u003c/p\u003e \u003cp\u003eTo identify each participant\u0026rsquo;s role, goals, and abilities in terms of PLIH needs and problems\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWorkshop 1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTo develop a shared understanding of the problems and needs PLIH face in terms of organized cancer screening uptake.\u003c/p\u003e \u003cp\u003eTo identify common objectives to respond to these problems and needs within the scope of each professional\u0026rsquo;s abilities (i.e., to define a sufficient area of ​​convergence).\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWorkshop 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTo design an action plan to foster organized cancer screening uptake by PLIH which is coordinated and co-constructed by all the stakeholders involved in the needs and problems of PLIH at the territorial level.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWorkshop 3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTo monitor the implementation of the action plan, and make necessary modifications and adjustments to it.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"2\"\u003e* Ref 2\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eTable\u0026nbsp;2. Objectives of the knowledge mobilization seminar and workshops, ECEMSo case study, France, 2023.\u003c/p\u003e \u003cp\u003e3.2. Outcomes\u003c/p\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e3\u003c/span\u003e presents the study outcomes.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eOutcomes according to each of ECEMSo\u0026rsquo;s three study objectives, ECEMSo case study, France, 2023.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eResearch question\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eObjective\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eOutcome\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStudy Objective 1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWhat is the difference between health mediation (group 2*) and other health-system navigation interventions (group 3**) in terms of the impact on healthcare utilization among PLIH in France?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIdentify the impact of health mediation on healthcare utilization in PLIH in France\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDifference in healthcare utilization\u003c/p\u003e \u003cp\u003eby PLIH between groups 2 and group 3, at six months follow-up\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStudy Objective 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWhat is the difference between health mediation with the ECEMSo intervention (group 1***) and without it (group 2*) in terms of the impact on on PLIH uptake of organized cancer screening?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIdentify the impact of the ECEMSo intervention**** on PLIH uptake of organized cancer screening (breast cancer, colorectal cancer, cervical cancer)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDifference in organized cancer screening uptake (breast cancer, colorectal cancer, cervical cancer) between PLIH in group 1 and PLIH in group 2, at six months of follow-up\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStudy Objective 3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWhat is the difference between health mediation with the ECEMSo intervention (group 1***) and other health-system navigation interventions (group 3**) in terms of the impact on PLIH uptake of organized cancer screening?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIdentify health mediation conditions required to foster utilization of healthcare services \u0026ndash; specifically cancer screening uptake \u0026ndash; among PLIH in France\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDifference 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 PLIH in group 3, at six months of follow-up\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003e*group 2 : routine health mediation implemented by health mediators but no ECEMSo intervention\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003e**group 3 : other (i.e., different from ECEMSo intervention) health system navigation interventions implemented by social workers and health workers\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003e***group 1 : routine health mediation implemented by health mediators and ECEMSo intervention implemented\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003e**** the ECEMSo intervention is a knowledge mobilization plan to facilitate i) the structuring of health mediation throughout French territory, and ii) the development of an effective action plan to facilitate cancer screening uptake by PLIH\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003ePLIH: people living in informal housing\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e3.3. Data collection and tools\u003c/p\u003e \u003cp\u003eQuantitative data tools (e.g., questionnaires, etc.) will first be used to identify CMOs (see above). Complementing these data, qualitative tools (i.e., focus groups, etc.) will collect data to identify more precisely the interactions between the context and the mechanisms that foster healthcare utilization (specifically cancer screening uptake) by the participating PLIH, and to better understand the context in which health mediators and the other stakeholders involved operate. Where possible, for the study questionnaires, we will choose the most comprehensible (i.e., for underserved populations) standardized scales possible, with as small a number of items as possible. The data to be collected are described in Supplementary Material 1.\u003c/p\u003e\n\u003ch3\u003ea) Data collection (general)\u003c/h3\u003e\n\u003cp\u003eParticipant inclusion and data collection will be conducted by trained interviewers previously recruited within the ECEMSo project team. The interviewers, with the help of health mediators, health workers and social workers in the participating care structures, will first carry out a visit prior to the inclusion period, in order to introduce the study and its organization to PLIH (i.e., potential participants) receiving health mediation support. A second similar visit will take place for other stakeholders who the mediators, health workers and social workers work with. Quantitative and qualitative data will be collected on a declarative basis. During baseline inclusion and follow-up, participants will be interviewed using several data collection tools: questionnaires, interviews, observations, focus groups and tracking tables of professionals\u0026rsquo; work activities. The choice of the data collection tools was based on the CMOs that emerged in our health mediation analysis framework\u003csup\u003e5\u003c/sup\u003e (see above) (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). The tools have already been designed and pre-tested among their respective profile participants (see profiles \u003cem\u003ei\u003c/em\u003e, \u003cem\u003eii\u003c/em\u003e, and \u003cem\u003eiii\u003c/em\u003e above). Figure\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e explains the organization of data collection for the ECEMSo case study.\u003c/p\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eb) Quantitative data collection tools\u003c/h2\u003e \u003cp\u003eA quantitative questionnaire will be administered by the interviewers to participating PLIH face to face at baseline (or T0) in October 2023. A description of how this questionnaire was developed can be found in section 3.4. A simplified version of the questionnaire will then be administered by telephone every two months until six months of follow-up (i.e., T1, T2, T3) (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe interviewers will also administer a quantitative questionnaire to participating health mediators, health workers, and social workers face to face at baseline (T0). Furthermore, they will track these professionals\u0026rsquo; activities in a tracking table over the follow-up. For the other stakeholders, quantitative data will be collected using a face-to-face questionnaire administered by the interviewers, both at baseline (T0) and the end of the follow-up (T3).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003ec) Qualitative data collection tools\u003c/h2\u003e \u003cp\u003eThe trained interviewers will conduct face-to-face semi-structured interviews with participating PLIH at the end of the follow-up (T3) using an interview guide.\u003c/p\u003e \u003cp\u003eFocus groups combining health mediators, health workers, social workers, and the other participating stakeholders will be organized at the end of the study (T3).\u003c/p\u003e \u003cp\u003eObservations of health mediators\u0026rsquo;, health workers\u0026rsquo; and social workers\u0026rsquo; activities in the participating care structures will take place at baseline (T0) and between T2 and T3.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e3.4. Health mediation stakeholder involvement in developing the data collection tools\u003c/p\u003e \u003cp\u003eAs mentioned above, the recruitment of participating structures is still ongoing. Between February 2023 and August 2023, health mediators working in structures already recruited came together in meetings to share their opinions about questionnaires that could be used for the participating PLIH and for \u0026lsquo;other stakeholder\u0026rsquo; participants (i.e., profiles \u003cem\u003ei\u003c/em\u003e and \u003cem\u003eiii\u003c/em\u003e). Specifically, they were asked \u0026ndash; based on their experience \u0026ndash; to validate, modify, or reject questions included in the draft questionnaires that had been created by the project team.\u003c/p\u003e \u003cp\u003eIn another set of meetings, directors of the recruited care structures, health mediators, health workers and social workers \u003cem\u003enot\u003c/em\u003e included in the study were asked to do the same for the health mediator-specific questionnaire.\u003c/p\u003e \u003cp\u003eThanks to these meetings, modifications were made to the questionnaires to take into account PLIH specificities in terms of their mobility and their accessibility to the healthcare system.\u003c/p\u003e \u003cp\u003e3.5. Sample size calculation\u003c/p\u003e \u003cp\u003eWe hypothesize that healthcare utilization (specifically, organized cancer screening uptake) will be 10% higher in group 2 compared to group 3. We based the sample size calculation using a superiority test, with the hypothesis that receiving support from a health mediator would increase healthcare utilization. We expect the prevalence of healthcare utilization in group 3 to be 80%, and 90% in group 2. Accordingly, for 80% power, and an alpha risk of 5%, the required number of PLIH for the study is 834 (\u003cspan additionalcitationids=\"CR33\" citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e). Applying an inflation factor (\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e) of 1.77 to take into account clusters, and assuming that 15% of people may be lost to follow-up, the final minimum number of PLIH who must be recruited is 960 (i.e., 320 persons in group 1, group 2, and group 3). Moreover, approximately 80 professionals (i.e., 54 health mediators and 27 health workers/social workers) must also be included in each group. We made no required sample size calculation for other stakeholders, as snowball sampling will be performed for them.\u003c/p\u003e \u003c/div\u003e"},{"header":"4. Data analysis","content":" \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003cp\u003e4.1. Quantitative and qualitative analyses\u003c/p\u003e \u003cp\u003eThis mixed-methods study involves an explanatory sequential design (\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e). The first phase consists in collecting and analyzing quantitative data (see above), followed by the collection and the analysis of qualitative data (see above). This second step will help to explain, confirm, and complement the quantitative results (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eData analysis will include an analysis of each case (i.e., each participating care structure), an analysis of each group (i.e., group 1, group 2, group 3) and a cross-case/group analysis, which will allow us to compare and observe potential effects in specific contexts. By validating initial middle-range theories\u003csup\u003e6\u003c/sup\u003e (i.e., CMOs, see above), the data analysis will help us to answer the question: \u0026ldquo;In what contextual conditions and through which mechanisms does health mediation produce outcomes?\u0026rdquo;. This validation will combine data from quantitative and qualitative analyses to provide new insights into the effect of health mediation on fostering healthcare utilization, especially cancer screening uptake. The quantitative analysis will be performed using R and SAS software, while the qualitative analysis will be conducted using NVivo software.\u003c/p\u003e \u003cp\u003eWe shall perform a descriptive analysis. Specifically, participants\u0026rsquo; characteristics will be described in means and standard deviation, or in counts and proportions, depending on the type of variable. Results will be weighted taking into account the probability of inclusion in the study.\u003c/p\u003e \u003cp\u003eIn terms of the ECEMSo case study\u0026rsquo;s three primary objectives (see above), the following analyses will be conducted:\u003c/p\u003e \u003cp\u003e \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eObjective 1 analysis\u003c/span\u003e: We will perform Chi2 tests to compare healthcare utilization in PLIH in group 2 with PLIH in group 3, at six months follow-up.\u003c/p\u003e \u003cp\u003e \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eObjective 2 analysis\u003c/span\u003e: Based on a theory-driven approach, we will perform a multilevel mixed logistic regression stratified by group (i.e., groups 2 and 3). Two levels will be considered. The first will combine all variables related to health mediators, while they will combine all variables related to PLIH. The dependent variable is cancer screening uptake by PLIH (O). The independent variables will be all the context elements (C) and mechanisms (M), which could foster healthcare utilization by PLIH.\u003c/p\u003e \u003cp\u003eAll the qualitative data (i.e., data collected from the face-to-face semi-structured interviews, the observations and the focus groups) will be analyzed using content analysis, which involves \u0026ldquo;a set of techniques for systematically and objectively analyzing and describing the content of communication. The aim [of content analysis] is to obtain indicators allowing inferences to be made about the messages and how they are produced and received (inferred variables)\u0026rdquo; (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e). Content analysis encodes, classifies, and ranks communications to examine patterns, trends, and distinguishing features; in our case, this translates as the presence and the potential recurrence of CMOs within each case and across all cases. A coding grid, based on the final version of our analysis framework of health mediation (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003csup\u003e7\u003c/sup\u003e, will help us to analyze data from i) the semi-structured interviews conducted among participating PLIH, ii) our observations of health mediators, health workers and social workers, as well as iii) the focus groups with health mediators and other stakeholders.\u003c/p\u003e \u003cp\u003eThe data from each quantitative and qualitative tool will be presented in a table summarizing the data obtained, in order to identify the recurrence of CMOs in each case (i.e., each health mediator).\u003c/p\u003e \u003cp\u003e \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eObjective 3 analysis\u003c/span\u003e: We will perform trend tests to identify the effect of the ECEMSo intervention on cancer screening uptake by comparing PLIH in groups 1 and 2, at six months follow-up.\u003c/p\u003e \u003c/div\u003e "},{"header":"5. Ethics and dissemination","content":"\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003cp\u003e \u003cstrong\u003e5.1 Ethical approval and consent to participate\u003c/strong\u003e \u003cp\u003eThe study protocol was approved by the French data protection authority in November 2023. All participants who meet the eligibility criteria will be invited to participate. Prior to the beginning of the study, all eligible persons will receive an information letter about the ECEMSo case study describing its aims, detailing how data will be collected, and indicating participating PLIHs\u0026rsquo; rights interms of data access, opposition and rectification. For participants who do not understand French or who have reading difficulties in French, the information letter will be translated by interviewers who speak the participants\u0026rsquo; spoken language.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e5.2. Results dissemination\u003c/p\u003e \u003cp\u003eThe results will be disseminated through various academic and non-academic platforms. Specifically, they will be disseminated in international peer-reviewed journals and presented at international and national conferences. A public report will describe all the steps of the study, the results and recommendations. A possible presentation of the final study results to all the participants and funders is also envisaged.\u003c/p\u003e \u003c/div\u003e"},{"header":"6. Conclusion","content":"\u003cp\u003eThe ECEMSo case study aims to provide a better understanding of the causes of underutilization of healthcare - and specifically of organized cancer screening - by PLIH, and more generally underserved populations. It also aims to measure the impact of health mediation on healthcare utilization for these populations in France.\u003c/p\u003e \u003cp\u003eIn terms of evidence-based intervention research, this study will provide a comprehensive picture of the conditions under which health mediation has a positive effect on underserved populations\u0026rsquo; healthcare utilization. Highlighting the effect of mediation and studying the conditions needed for this effect in different contexts will lead us to develop recommendations for the structuring of health mediation at a national level in France. We shall compile these recommendations in a guide. The latter could be used to support the transferability and future scaling-up of health mediation in other contexts. Moreover, in terms of care pathways, this guide could be used to foster primary and secondary healthcare and organized cancer screening uptake. Health mediation may strengthen relationships between health mediators, health workers, social workers and other stakeholders at the territorial level. It may also help to create a support network focusing on the needs and problems of underserved people. In other words, health mediation could develop the inter-sectoral and territorial anchoring necessary for promoting healthcare in these populations inside a community of practice.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll methods will be carried out in accordance with relevant guidelines and regulations. Informed consent was obtained from all subjects and/or their legal guardian(s). ECEMSo protocol was approved by a named institutional and/or licensing committee.\u0026nbsp;The study protocol was approved by the French National Commission for Commission nationale de l\u0026apos;informatique et des libert\u0026eacute;s (CNIL - agreement decision DR-2013- 147 \u0026ndash; November 2023) and the ethical committee\u0026nbsp;: Comit\u0026eacute; \u0026Eacute;thique et Scientifique pour les Recherches, les \u0026Eacute;tudes et les \u0026Eacute;valuations dans le domaine de la Sant\u0026eacute; (CESREES) (Approval number\u0026nbsp;: 11900952 Bis).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable (this manuscript does not report data generation or analysis)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study protocol has been peer reviewed by the French National Cancer Institute (INCA) (Award decision: 2021/008). This work was supported by the French National Cancer Institute (INCA) (Grant: 2021/008), the National Federation of Associations in Solidarity with Gypsies and Travellers (Fnasat-GV) and the Sant\u0026eacute; publique France Institute.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSV, LC, ER conceived the first version of the ECEMSo study. JMF conceived the design of the finalized study. ER developed the health mediation conceptual framework under supervision by SV and LC. ER, GP, FQC, JMF and SV created the data collection tools. ER and GP developed the data analysis framework. ER and GP drafted the first version of the manuscript. GP and LR calculated the required sample size and the ethics protocol. JMF and SV supervised the development of the study protocol. All authors reviewed the manuscript and approved the final version for publication.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors would like to thank Lucie de Lubersac, Muri\u0026egrave;le Conort, M\u0026eacute;lina Calla, Florence, Fr\u0026eacute;d\u0026eacute;rique Quirino Chaves, Romain Lafil\u0026eacute;, Emmanuel Marie, S\u0026eacute;bastien Boivin, Claudia Marchetti and C\u0026eacute;cile Coutant, Margot Oberlis, and the health mediators working with Croix-Rouge Guyane \u0026nbsp;for co-designing the ECEMSo case study. Our thanks also to Jude Sweeney (Milan, Italy) for the English editing and revision of the manuscript.\u003cbr\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eHAS. 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Etudes R\u0026eacute;sultats. 2015;(933):6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGiraudeau B. L\u0026rsquo;essai clinique randomis\u0026eacute; par grappes. MS M\u0026eacute;decine Sci. 2004;20(3):363\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCresswell J, Plano C, Vicki L. Designing and Conducting Mixed Methods Research (3rd ed.). Sage Publ. 2017;300.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBardin L. L\u0026rsquo; analyse de contenu. 2nd edition. Paris: PUF; 2013. [Internet]. 2018 [cit\u0026eacute; 9 sept 2018]. Disponible sur: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.puf.com/content/L_analyse_de_contenu\u003c/span\u003e\u003cspan address=\"https://www.puf.com/content/L_analyse_de_contenu\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Footnotes","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003e A promising intervention is \u0026ldquo;an intervention whose efficacy has not been evaluated by research, but for which a solid normative evaluation induces a presumption of relevant results\u0026rdquo; (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003e Richard E., Ramiz L., Martin Fernandez J., Cambon L-Vandentorren S, Health mediation mechanisms influencing healthcare utilization by underserved populations: a theory-driven qualitative study. Frontiers in Public Health, 2023, 14. (Submitted)\u003c/span\u003e\u003cdiv id=\"Par28\" class=\"Para\"\u003eRichard E., Ramiz L., Oltean M., Troussier V., Ulracher C., Speed O., Conort M., Coutant C., Quirino Chaves F., Martin Fernandez J., Vandentorren S-Cambon L, A priori Context-Mechanism-Outcome configurations explaining the effect of health mediation on the fostering of healthcare utilization: a Realist Qualitative Study. Implementation science, 2023, 20. (Submitted)\u003c/div\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003e Collective self-efficacy is understood here as the perception of the collective ability to overcome obstacles in order to adapt the system to welcome and support underserved populations.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003e Richard E., Ramiz L., Oltean M., Troussier V., Ulracher C., Speed O., Conort M., Coutant C., Quirino Chaves F., Martin Fernandez J., Vandentorren S-Cambon L, A priori Context-Mechanism-Outcome configurations explaining the effect of health mediation on the fostering of healthcare utilization: a Realist Qualitative Study. Implementation science, 2023, 20. (Submitted)\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003e Richard E., Ramiz L., Martin Fernandez J., Cambon L-Vandentorren S, Health mediation mechanisms influencing healthcare utilization by underserved populations: a theory-driven qualitative study. Frontiers in Public Health, 2023, 14. (Submitted)\u003c/span\u003e\u003cdiv id=\"Par69\" class=\"Para\"\u003eRichard E., Ramiz L., Oltean M., Troussier V., Ulracher C., Speed O., Conort M., Coutant C., Quirino Chaves F., Martin Fernandez J., Vandentorren S-Cambon L, A priori Context-Mechanism-Outcome configurations explaining the effect of health mediation on the fostering of healthcare utilization: a Realist Qualitative Study. Implementation science, 2023, 20. (Submitted)\u003c/div\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003e Richard E., Ramiz L., Oltean M., Troussier V., Ulracher C., Speed O., Conort M., Coutant C., Quirino Chaves F., Martin Fernandez J., Vandentorren S-Cambon L, A priori Context-Mechanism-Outcome configurations explaining the effect of health mediation on the fostering of healthcare utilization: a Realist Qualitative Study. Implementation science, 2023, 20. (Submitted)\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003e Richard E., Ramiz L., Martin Fernandez J., Cambon L-Vandentorren S, Health mediation mechanisms influencing healthcare utilization by underserved populations: a theory-driven qualitative study. Frontiers in Public Health, 2023, 14. (Submitted)\u003c/span\u003e\u003cdiv id=\"Par93\" class=\"Para\"\u003eRichard E., Ramiz L., Oltean M., Troussier V., Ulracher C., Speed O., Conort M., Coutant C., Quirino Chaves F., Martin Fernandez J., Vandentorren S-Cambon L, A priori Context-Mechanism-Outcome configurations explaining the effect of health mediation on the fostering of healthcare utilization: a Realist Qualitative Study. Implementation science, 2023, 20. (Submitted)\u003c/div\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Healthcare utilization, cancer screening, health mediation, complex intervention, realist evaluation, study protocol, underserved populations","lastPublishedDoi":"10.21203/rs.3.rs-3937146/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3937146/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cem\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e\u003c/em\u003e 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 (PLIH) in France. This paper describes the study protocol.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e\u003c/em\u003e 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, PLIH 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 PLIH. 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.\u003c/p\u003e\n\u003cp\u003eQuantitative 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. The calculated required number of participants includes 960 health mediation beneficiaries, 54 health mediators, 27 health and social workers, and many other stakeholders, identified through snowball sampling.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e\u003c/em\u003e: In terms of evidence-based intervention research, this study will provide a comprehensive picture of the conditions under which health mediation has a positive effect on underserved populations’ healthcare utilization.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration numbers\u003c/strong\u003e: \u0026nbsp;NCT06180746 12/12/2023\u003c/p\u003e","manuscriptTitle":"Realist evaluation of the impact of health mediation on underserved populations’ healthcare utilization and cancer screening uptake: the ECEMSo case study protocol","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-02-14 18:29:28","doi":"10.21203/rs.3.rs-3937146/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"37ab4a53-a4fd-4701-99d5-70f04ecd007f","owner":[],"postedDate":"February 14th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-09-10T06:33:04+00:00","versionOfRecord":[],"versionCreatedAt":"2024-02-14 18:29:28","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3937146","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3937146","identity":"rs-3937146","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}