Rationale and design of the ULYSS trial: A randomized multicenter evaluation of the efficacy of early Impella CP implantation in acute coronary syndrome complicated by cardiogenic shock.

CONTEXT: Despite 20 years of improvement in acute coronary syndromes care, patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) remains a major clinical challenge with a stable incidence and mortality. While intra-aortic balloon pump (IABP) did not meet its expectations, percutaneous mechanical circulatory supports (pMCS) with higher hemodynamic support, large availability and quick implementation may improve AMICS prognosis by enabling early hemodynamic stabilization and unloading. Both interventional and observational studies suggested a clinical benefit in selected patients of the IMPELLAⓇ CP device within in a well-defined therapeutic strategy. While promising, these preliminary results are challenged by others suggesting a higher rate of complications and possible poorer outcome. Given these conflicting data and its high cost, a randomized clinical trial is warranted to delineate the benefits and risks of this new therapeutic strategy. DESIGN: The ULYSS trial is a prospective randomized open label, 2 parallel multicenter clinical trial that plans to enroll patients with AMICS for whom an emergent percutaneous coronary intervention (PCI) is intended. Patients will be randomized to an experimental therapeutic strategy with pre-PCI implantation of an IMPELLAⓇ CP device on top of standard medical therapy or to a control group undergoing PCI and standard medical therapy. The primary objective of this study is to compare the efficacy of this experimental strategy by a composite end point of death, need to escalate to ECMO, long-term left ventricular assist device or heart transplantation at 1 month. Among secondary objectives 1-year efficacy, safety and cost effectiveness will be assessed. CLINICAL TRIAL REGISTRATION: NCT05366452.

Weaning of maintenance immunosuppressive therapy in lupus nephritis (WIN-Lupus): results of a multicentre randomised controlled trial.

OBJECTIVES: Lupus nephritis (LN) is a frequent complication of systemic lupus erythematosus (SLE). Severe (proliferative) forms of LN are treated with induction immunosuppressive therapy (IST), followed by maintenance IST, to target remission and avoid relapses. The optimal duration of maintenance IST is unknown. The WIN-Lupus trial tested whether IST discontinuation after 2‒3 years was non-inferior to IST continuation for two more years in proliferative LN. METHODS: WIN-Lupus was an investigator-initiated multicentre randomised controlled trial. Patients receiving maintenance IST with azathioprine or mycophenolate mofetil for 2-3 years, and hydroxychloroquine, were randomised (1:1) into two groups: (1) IST continuation and (2) IST discontinuation. The primary endpoint was the relapse rate of proliferative LN at 24 months. Main secondary endpoints were the rate of severe SLE flares, survival without renal relapse or severe flare, adverse events. RESULTS: Between 2011 and 2016, 96 patients (out of 200 planned) were randomised in WIN-Lupus: IST continuation group (n=48), IST discontinuation group (n=48). Relapse of proliferative LN occurred in 5/40 (12.5%) patients with IST continuation and in 12/44 (27.3%) patients with IST discontinuation (difference 14.8% (95% CI -1.9 to 31.5)). Non-inferiority was not demonstrated for relapse rate; time to relapse did not differ between the groups. Severe SLE flares (renal or extrarenal) were less frequent in patients with IST continuation (5/40 vs 14/44 patients; p=0.035). Adverse events did not differ between the groups. CONCLUSIONS: Non-inferiority of maintenance IST discontinuation after 2‒3 years was not demonstrated for renal relapse. IST discontinuation was associated with a higher risk of severe SLE flares. TRIAL REGISTRATION NUMBER: NCT01284725.

Un modèle innovant d'intervention, de dépistage et de prise en charge mobile de la COVID-19 chez les personnes sans-abri à Marseille.

INTRODUCTION: Homeless people are particularly at risk of becoming infected with COVID-19 because their precarious living conditions make prevention measure difficult. OBJECTIVE: We describe an innovative approach with the aim of implementing testing and monitoring adapted to the needs of the homeless people of Marseille (inhabitants of slums, squats or those living on the street). RESULTS: The intervention included 1) the coordination of 18 support organizations for homeless people, 2) the training and the provision of rapid serological and antigenic tests, 3) a mobile outreach team with community mediators in order to provide tests, including COVID-19 PCR on point of care, prevention and monitoring of positive cases. Acceptability of the intervention by participants, field organization was good. The lack of adapted places of accommodation was an important restricting factor for optimal care and support. CONCLUSION: The emergence of COVID-19 has highlighted discontinuities in health care among homeless people. Specific mobile outreach teams could limit the impact on this high-risk population.

Mortality in homeless people enrolled in the French housing first randomized controlled trial: a secondary outcome analysis of predictors and causes of death.

BACKGROUND: Homeless people face large excess mortality in comparison with the general population, but little is known about the effect of housing interventions like Housing First (HF) on their mortality. AIMS OF THE STUDY: 1) to explore 2-years mortality among homeless people with severe mental illness (SMI) included in French HF randomized controlled trial (RCT). 2) To examine causes of death among homeless participants. METHODS: For 703 participants of HF RCT: 353 in experimental group (HF) and 350 in control group (Treatment As Usual - TAU), any proof of life or death and causes of death were collected with a thorough retrospective investigation among relatives, institutions and administrative databases. Data collection took place from March to June 2017. RESULTS: 4.8% (n = 34) of the study participants died over the study period. Mean age of death was 40.9 (+/- 11.4) years. The overall 2-years mortality rate was 0.065 in the HF group (n = 23) versus 0.034 in the TAU group (n = 11). Mortality was associated with medications for opioid use disorder in multivariate Cox analysis (HR: 2.37, 95%CI 1.15-5.04, p = 0.025). Those in HF group seem to be more at risk of death compared to TAU group, mainly during the first 6 months of being housed, although the difference did not reach significance (HR: 0.49, 95%CI 0.24-1.01, p = 0.054). Violent deaths occurred in 52.2% of HF group's deaths versus 18.2% of TAU group's deaths, this excess being explained by 34.8% (n = 8) deaths by overdoses in HF group versus none in TAU group. LIMITATIONS: 1) 8.7% (n = 2) people in HF group died before HF intervention but were analyzed in intention-to-treat. 2) No proof of life or death has been found for only 0.6% in HF group (n = 2) but for 9.5% people in TAU group (n = 33) that could be anonymous deaths. 3) Undetermined causes represented 8.7% of deaths in HF group versus 36.4% in TAU group. 4) The small number of events (deaths) in the study population is a limitation for statistical analysis. CONCLUSIONS: Due to important limitations, we cannot conclude on HF effect on mortality, but our results nevertheless confirm that the vulnerability of long-term homeless people with SMI persists after accessing independent housing. Earlier intervention in the pathways of homelessness should be considered, alongside active specific support for addictions. TRIAL REGISTRATION: Ethics Committee Sud Mediterrannée V n° 11.050: trial number 2011-A00668-33: 28/07/2011. Clinicaltrials ID NCT01570712 : 4/4/2012.

Factors Associated with Providers' Work Engagement and Burnout in Homeless Services: A Cross-national Study.

The complexity of homeless service users' characteristics and the contextual challenges faced by services can make the experience of working with people in homelessness stressful and can put providers' well-being at risk. In the current study, we investigated the association between service characteristics (i.e., the availability of training and supervision and the capability-fostering approach) and social service providers' work engagement and burnout. The study involved 497 social service providers working in homeless services in eight different European countries (62% women; mean age = 40.73, SD = 10.45) and was part of the Horizon 2020 European study "Homelessness as Unfairness (HOME_EU)." Using hierarchical linear modeling (HLM), findings showed that the availability of training and supervision were positively associated with providers' work engagement and negatively associated with burnout. However, results varied based on the perceived usefulness of the training and supervision provided within the service and the specific outcome considered. The most consistent finding was the association between the degree to which a service promotes users' capabilities and all the aspects of providers' well-being analyzed. Results are discussed in relation to their implications for how configuration of homeless services can promote social service providers' well-being and high-quality care.

Homeless Adults' Recovery Experiences in Housing First and Traditional Services Programs in Seven European Countries.

Across Europe, as governments turn to housing-led strategies in attempts to reverse rising rates of homelessness, increasing numbers of Housing First (HF) programs are being implemented. As HF programs become more widespread, it is important to understand how service users experience them compared to the more prevalent traditional treatment-first approach to addressing long-term homelessness. Although there is a large body of research on service users' experiences of Housing First compared to treatment-first in North American contexts, comparatively less is known about how these two categories of homeless services are experienced in the European context. In a correlational and cross-sectional study, part of a larger examination of homelessness in Europe, participants (n = 520) engaged with either HF (n = 245) or traditional services (TS; n = 275) programs in seven countries completed measures of their experiences of services (consumer choice, housing quality, and service satisfaction) and recovery (time in independent housing, psychiatric symptoms, and community integration). Across the seven countries, participants engaged with HF programs reported experiencing more consumer choice, better perceived housing quality, and more satisfaction with services than participants engaged in TS programs. Participants in HF programs also reported a greater proportion of time in independent accommodation, fewer psychiatric symptoms, and more community integration. Varying patterns of association between experiences of services and recovery outcomes were observed. Findings indicate HF consistently predicts greater recovery than TS across diverse sociopolitical and economic contexts. Implications of findings for configurations of homeless services and homeless services policy are discussed.

Psychiatric advance directives for people living with schizophrenia, bipolar I disorders, or schizoaffective disorders: Study protocol for a randomized controlled trial - DAiP study.

BACKGROUND: Compulsory admission to psychiatric hospital is rising despite serious ethical concerns. Among measures to reduce compulsory admissions, Psychiatric Advance Directives (PAD) are the most promising, with intensive PAD (i.e. facilitated and shared) being the most effective. The aim of the study is to experiment Psychiatric Advance Directives in France. METHODS: A multicentre randomized controlled trial and qualitative approach conducted from January 2019 to January 2021 with intent-to-treat analysis. SETTING: Seven hospitals in three French cities: Lyon, Marseille, and Paris. Research assistants meet each participant at baseline, 6 months and 12 months after inclusion for face-to-face interviews. PARTICIPANTS: 400 persons with a DSM-5 diagnosis of bipolar I disorder (BP1), schizophrenia (SCZ), or schizoaffective disorders (SCZaff), compulsorily admitted to hospital within the last 12 months, with capacity to consent (MacCAT-CR), over 18 years old, and able to understand French. INTERVENTIONS: The experimental group (PAD) (expected n = 200) is invited to fill in a document describing their crisis plan and their wishes in case of loss of mental capacity. Participants meet a facilitator, who is a peer support worker specially trained to help them. They are invited to nominate a healthcare agent, and to share the document with them, as well as with their psychiatrist. The Usual Care (UC) group (expected n = 200) receives routine care. MAIN OUTCOMES AND MEASURES: The primary outcome is the rate of compulsory admissions to hospital during the 12-month follow-up. Secondary outcomes include quality of life (S-QoL18), satisfaction (CSQ8), therapeutic alliance (4-PAS), mental health symptoms (MCSI), awareness of disorders (SUMD), severity of disease (ICG), empowerment (ES), recovery (RAS), and overall costs. DISCUSSION: Implication of peer support workers in PAD, potential barriers of supported-decision making, methodological issues of evaluating complex interventions, evidence-based policy making, and the importance of qualitative evaluation in the context of constraint are discussed. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03630822. Registered 14th August 2018.

Is diverting loop ileostomy necessary for completion proctectomy with ileal pouch-anal anastomosis? A multicenter randomized trial of the GETAID Chirurgie group (IDEAL trial): rationale and design (NCT03872271).

BACKGROUND: There is no quality evidence of the benefit of defunctioning ileostomy (DI) in ileal pouch-anal anastomoses (IPAAs) performed for inflammatory bowel disease (IBD), but most surgical teams currently resort to DI. In the case of a staged procedure with subtotal colectomy first, completion proctectomy with IPAA is performed for healthy patients, namely, after nutritional support, inflammation reduction and immunosuppressive agent weaning. Therefore, the aim of this trial is to assess the need for systematic DI after completion proctectomy and IPAA for IBD. METHODS/DESIGN: This is a multicenter randomized open trial comparing completion proctectomy and IPAA without (experimental) or with (control) DI in patients presenting with ulcerative colitis or indeterminate colitis. Crohn's disease patients will not be included. The design is a superiority trial. The main objective is to compare the 6-month global postoperative morbidity, encompassing both surgical and medical complications, between the two groups. The morbidity of DI closure will be included, as appropriate. The sample size calculation is based on the hypothesis that the overall 6-month morbidity rate is 30% in the case of no stoma creation (i.e., experimental group) vs. 55% otherwise (control group). With the alpha risk and power are fixed to 0.05 and 0.80, respectively, and considering a dropout rate of 10%, the objective is set to 194 patients. The secondary objectives are to compare both strategies in terms of morbi-mortality at 6 months and functional results as well as quality of life at 12 months, namely, the 6-month major morbidity and unplanned reoperation rates, 6-month anastomotic leakage rate, 6-month mortality, length of hospital stay, 6-month unplanned readmission rate, quality of life assessed 3 and 12 months from continuity restoration (i.e., either IPAA or stoma closure), functional results assessed 3 and 12 months from continuity restoration, 12-month pouch results, 12-month cost-utility analysis, and 12-month global morbidity. DISCUSSION: The IDEAL trial is a nationwide multicenter study that will help choose the optimal strategy between DI and no ileostomy in completion proctectomy with IPAA for IBD. TRIAL REGISTRATION: ClinicalTrial.gov: NCT03872271, date of registration March 13th, 2019.

Cost-effectiveness of KRAS, EGFR and ALK testing for decision making in advanced nonsmall cell lung carcinoma: the French IFCT-PREDICT.amm study.

ALK rearrangement and EGFR/KRAS mutations constitute the primary biomarkers tested to provide targeted or nontargeted therapies in advanced nonsmall cell lung cancer (NSCLC) patients. Our objective was to assess the cost-effectiveness of biomarker testing for NSCLC.Between 2013 and 2014, 843 treatment-naive patients were prospectively recruited at 19 French hospitals into a longitudinal observational cohort study. Two testing strategies were compared, i.e. with "at least one biomarker status known" and "at least KRAS status known", in addition to "no biomarker testing" as the reference strategy. The Kaplan-Meier approach was employed to assess restricted mean survival time. Direct medical costs incurred by hospitals were estimated with regard to treatment, inpatient care and biomarker testing.Compared with "no biomarker testing", the "at least one biomarker status known" strategy yielded an incremental cost-effectiveness ratio of EUR13 230 per life-year saved, which decreased to EUR7444 per life-year saved with the "at least KRAS status known" testing strategy. In sensitivity analyses, biomarker testing strategies were less costly and more effective in 41% of iterations.In summary, molecular testing prior to treatment initiation proves to be cost-effective in advanced NSCLC management and may assist decision makers in defining conditions for further implementation of these innovations in general practice.

Comparison of different feeding regimes after pancreatoduodenectomy - a retrospective cohort analysis.

BACKGROUND: Delayed gastric emptying (DGE) is the most frequent pancreatic specific complication (PSC) after pancreaticoduodenectomy (PD). Several gastric decompression systems exist to manage DGE. Patients with a pancreatic tumor require prolonged nutrition; however, controversies exist concerning nutrition protocol after PD. The aim of the study was to assess the safety and efficacy of nasogastric (NG), gastrostomy (GT), and gastrojejunostomy (GJ) tubes with different feeding systems on postoperative courses. METHODS: Between January 2013 and March 2016, 86 patients underwent PD with pancreaticogastrostomy. Patients were divided into three groups: GJ group with enteral nutrition (EN, n = 12, 14%), NG (n = 31, 36%) and GT groups (n = 43, 50%), both with total parenteral nutrition (TPN). RESULTS: Patients in the GJ (n = 9, 75%) and GT (n = 18, 42%) groups had an American Society of Anesthesiologists (ASA) score of 3 more often than those in the NG group (n = 5, 16%, p ≤ 0.01). Multivariate analysis identified the GT tube with TPN as an independent risk factor of severe morbidity (p = 0.02) and DGE (p < 0.01). An ASA score of 3, jaundice, common pancreatic duct size ≤3 mm and soft pancreatic gland texture (p < 0.05) were found as independent risk factors of PSCs. Use of a GJ tube with EN, GT tube with TPN, jaundice, and PSCs were identified as independent risk factors for greater postoperative length of hospital stay (p < 0.01). Mean global hospitalization cost did not differ between groups. CONCLUSION: GT tube insertion with TPN was associated with increased severe postoperative morbidity and DGE and should not be recommended. EN through a GJ tube after PD is feasible but does not have clear advantages on postoperative courses compared to an NG tube.

Enhanced recovery after surgery (ERAS) for deep infiltrating endometriosis surgery: Experience of a French center.

OBJECTIVE: The objective of the study was to evaluate the implementation of an ERAS programme for deep pelvic endometriosis (DPE) surgery in terms of length of stay (LOS), postoperative complications (POC) and rehospitalisation rate. METHODS: This was a comparative retrospective monocentric study in the Gynaecologic Department of the La Conception Hospital in Marseille, France. We compared a 'conventional' group, with classic perioperative management corresponding to patients undergoing DPE surgery between April 8, 2014 and January 23, 2018, and an 'ERAS' group after setting up the ERAS protocol from February 6, 2018 to March 6, 2020. RESULTS: A total of 101 patients with DPE surgery were included, with 39 in the conventional group and 53 in the ERAS group. The LOS decreased by 1.91 days (p < 0.001). During the 45 postoperative days, no difference was found in rehospitalised rate (p = 1). The POC rate was 15/39 (38.5 %) in the conventional group and 12/53 (22.6 %) in the ERAS group (p = 0.1). CONCLUSION: The implementation of an ERAS programme for DPE surgery is an effective strategy because it can reduce the LOS without increasing the POC rate.

Morbidity and mortality in a prospective cohort of people who were homeless during the COVID-19 pandemic.

Introduction: Certain living conditions, such as homelessness, increase health risks in epidemic situations. We conducted a prospective observational cohort study to investigate the impact of the COVID-19 pandemic on morbidity and mortality in adult people who were homeless. Methods: The study population comprised around 40% of the entire population experiencing homelessness in Marseille. They were enrolled at 48 different locations during the first pandemic wave (June to August 2020) and were followed up 3 and 6 months later. Rapid serological screening for SARS-CoV-2 was performed by community outreach teams at each follow-up, who also conducted interviews. Death registers and hospital administrative databases were consulted. Results: A total of 1,332 participants [mean age 40.1 years [SD 14.2], women 339 (29.9%)] were enrolled in the cohort. Of these, 192 (14.4%) participants were found positive for COVID-19 and were propensity score matched (1:3) and compared with 553 non-COVID-19 cases. Living in emergency shelters was associated with COVID-19 infection. While 56.3% of the COVID-19-infected cohort reported no symptoms, 25.0% were hospitalized due to the severity of the disease. Presence of three or more pre-existing comorbidities was associated with all-cause hospitalization. Among COVID-19 cases, only older age was associated with COVID-19 hospitalization. Three deaths occurred in the cohort, two of which were among the COVID-19 cases. Conclusion: The study provides new evidence that the population experiencing homelessness faces higher risks of infection and hospitalization due to COVID-19 than the general population. Despite the efforts of public authorities, the health inequities experienced by people who are homeless remained major. More intensive and appropriate integrated care and earlier re-housing are needed.

Cumulative incidence of SARS-CoV-2 infection within the homeless population: insights from a city-wide longitudinal study.

OBJECTIVES: The aim of this study was to determine the risk factors associated with SARS-CoV-2 infection in a cohort of homeless people using survival analysis. Seroprevalence in the homeless community was also compared with that of the general population. DESIGN: Cohort study. SETTING: Data were collected across two testing sessions, 3 months apart, during which each participant was tested for anti-SARS-CoV-2 antibodies and completed a face-to-face survey. PARTICIPANTS: All homeless adults sleeping rough, in slums or squats, in emergency shelters or transitional accommodation in Marseille were eligible. PRIMARY OUTCOME MEASURES: Occurrence of a seroconversion event defined as a biologically confirmed SARS-CoV-2 infection. Local data from a national seroprevalence survey were used for comparison between homeless people and the general population. RESULTS: A total of 1249 people were included. SARS-CoV-2 seroprevalence increased from 6.0% (4.7-7.3) during the first session to 18.9% (16.0-21.7) during the second one, compared with 3.0% (1.9-4.2) and 6.5% (4.5-8.7) in the general population. Factors significantly associated with an increased risk of COVID-19 infection were: having stayed in emergency shelters (1.93 (1.18-3.15)), being an isolated parent (1.64 (1.07-2.52)) and having contact with more than 5-15 people per day (1.84 (1.27-2.67)). By contrast, smoking (0.46 (0.32-0.65)), having financial resources (0.70 (0.51-0.97)) and psychiatric or addictive comorbidities (0.52 (0.32-0.85)) were associated with a lower risk. CONCLUSION: We confirm that homeless people have higher infection rates than the general population, with increased risk in emergency shelters. There is growing evidence that, in addition to usual preventive measures, public policies should pay attention to adapt the type of accommodation and overall approach of precariousness. TRIAL REGISTRATION NUMBER: NCT04408131.

Effectiveness and Costs of Molecular Screening and Treatment for Bacterial Vaginosis to Prevent Preterm Birth: The AuTop Randomized Clinical Trial.

Importance: Bacterial vaginosis (BV) is a well-known risk factor for preterm birth. Molecular diagnosis of BV is now available. Its impact in the screening and treatment of BV during pregnancy on preterm births has not been evaluated to date. Objective: To evaluate the clinical and economic effects of point-of-care quantitative real-time polymerase chain reaction screen and treat for BV in low-risk pregnant women on preterm birth. Design, Setting, and Participants: The AuTop trial was a prospective, multicenter, parallel, individually randomized, open-label, superiority trial conducted in 19 French perinatal centers between March 9, 2015, and December 18, 2017. Low-risk pregnant women before 20 weeks' gestation without previous preterm births or late miscarriages were enrolled. Data were analyzed from October 2021 to November 2022. Interventions: Participants were randomized 1:1 to BV screen and treat using self-collected vaginal swabs (n = 3333) or usual care (n = 3338). BV was defined as Atopobium vaginae (Fannyhessea vaginae) load of 108 copies/mL or greater and/or Gardnerella vaginalis load of 109 copies/mL or greater, using point-of-care quantitative real-time polymerase chain reaction assays. The control group received usual care with no screening of BV. Main Outcomes and Measures: Overall rate of preterm birth before 37 weeks' gestation and total costs were calculated in both groups. Secondary outcomes were related to treatment success as well as maternal and neonate health. Post hoc subgroup analyses were conducted. Results: Among 6671 randomized women (mean [SD] age, 30.6 [5.0] years; mean [SD] gestational age, 15.5 [2.8] weeks), the intention-to-treat analysis of the primary clinical and economic outcomes showed no evidence of a reduction in the rate of preterm birth and total costs with the screen and treat strategy compared with usual care. The rate of preterm birth was 3.8% (127 of 3333) in the screen and treat group and 4.6% (153 of 3338) in the control group (risk ratio [RR], 0.83; 95% CI, 0.66-1.05; P = .12). On average, the cost of the intervention was €203.6 (US $218.0) per participant, and the total average cost was €3344.3 (US $3580.5) in the screen and treat group vs €3272.9 (US $3504.1) in the control group, with no significant differences being observed. In the subgroup of nulliparous women (n = 3438), screen and treat was significantly more effective than usual care (RR, 0.62; 95% CI, 0.45-0.84; P for interaction = .003), whereas no statistical difference was found in multiparous (RR, 1.30; 95% CI, 0.90-1.87). Conclusion and Relevance: In this clinical trial of pregnant women at low risk of preterm birth, molecular screening and treatment for BV based on A vaginae (F vaginae) and/or G vaginalis quantification did not significantly reduce preterm birth rates. Post hoc analysis suggests a benefit of screen and treat in low-risk nulliparous women, warranting further evaluation in this group. Trial Registration: ClinicalTrials.gov Identifier: NCT02288832.

Effect of Psychiatric Advance Directives Facilitated by Peer Workers on Compulsory Admission Among People With Mental Illness: A Randomized Clinical Trial.

Importance: Reducing the use of coercion in mental health care is crucial from a human rights and public health perspective. Psychiatric advance directives (PADs) are promising tools that may reduce compulsory admissions. Assessments of PADs have included facilitation by health care agents but not facilitation by peer workers. Objective: To determine the efficacy of PADs facilitated by peer workers (PW-PAD) in people with mental disorders. Design, Setting, and Participants: A multicenter randomized clinical trial was conducted in 7 French mental health facilities. Adults with a DSM-5 diagnosis of schizophrenia, bipolar I disorder, or schizoaffective disorder who had a compulsory admission in the past 12 months and the capacity to consent were enrolled between January 2019 and June 2020 and followed up for 12 months. Interventions: The PW-PAD group was invited to fill out a PAD form and meet a peer worker who was trained to assist in completing and sharing the form with relatives and psychiatrists. Main Outcomes and Measures: The primary outcome was the rate of compulsory admission at 12 months after randomization. The overall psychiatric admission rate, therapeutic alliance, quality of life, mental health symptoms, empowerment, and recovery outcomes were also investigated. Results: Among 394 allocated participants (median age, 39 years; 39.3% female; 45% with schizophrenia, 36% bipolar I disorder, and 19% schizoaffective disorder), 196 were assigned to the PW-PAD group and 198 to the control group. In the PW-PAD group, 27.0% had compulsory admissions compared with 39.9% in the control group (risk difference, -0.13; 95% CI, -0.22 to -0.04; P = .007). No significant differences were found in the rate of overall admissions, therapeutic alliance score, and quality of life. Participants in the PW-PAD group exhibited fewer symptoms (effect size, -0.20; 95% CI, -0.40 to 0.00), greater empowerment (effect size, 0.30; 95% CI, 0.10 to 0.50), and a higher recovery score (effect size, 0.44; 95% CI, 0.24 to 0.65), compared with those in the control group. Conclusions and Relevance: Peer worker-facilitated PADs are effective in decreasing compulsory hospital admissions and increasing some mental health outcomes (self-perceived symptoms, empowerment, and recovery). Involving peer workers in the completion of PADs supports the current shift of mental health care from substitute decision-making to supported decision-making. Trial Registration: ClinicalTrials.gov Identifier: NCT03630822.

Residential Mobility of a Cohort of Homeless People in Times of Crisis: COVID-19 Pandemic in a European Metropolis.

Most vulnerable individuals are particularly affected by the COVID-19 pandemic. This study takes place in a large city in France. The aim of this study is to describe the mobility of the homeless population at the beginning of the health crisis and to analyze its impact in terms of COVID-19 prevalence. From June to August 2020 and September to December 2020, 1272 homeless people were invited to be tested for SARS-CoV-2 antibodies and virus and complete questionnaires. Our data show that homeless populations are sociologically different depending on where they live. We show that people that were living on the street were most likely to be relocated to emergency shelters than other inhabitants. Some neighborhoods are points of attraction for homeless people in the city while others emptied during the health crisis, which had consequences for virus circulation. People with a greater number of different dwellings reported became more infected. This first study of the mobility and epidemiology of homeless people in the time of the pandemic provides unique information about mobility mapping, sociological factors of this mobility, mobility at different scales, and epidemiological consequences. We suggest that homeless policies need to be radically transformed since the actual model exposes people to infection in emergency.

"Locked down outside": Perception of hazard and health resources in COVID-19 epidemic context among homeless people.

While social inequality is widely recognised as being a risk factor for COVID-19 infection or serious forms of the disease, many questions still remain concerning the perception of hazard and protective measures by the most vulnerable populations. This mixed-methods study aimed (1) to describe the self-perceived health and protective measures linked to COVID-19 of homeless people in one of the largest and poorest cities in France, and (2) to assess which skills and resources they used to address the COVID-19 pandemic. The quantitative survey addressed these questions among a sample of 995 homeless people living either on the streets, in homeless shelters or in squats/slums, whereas the qualitative survey was constructed from 14 homeless interviewees. Both data collections were carried out between June and July 2020. Results showed that COVID-19 infection was clearly perceived by homeless people as a risk, but the experience of being homeless placed this risk among several others. Different practices of protection were observed according to the type of living place. Lockdown of the general population severely impacted the survival systems of the populations furthest from housing, with alarming rates of people without access to water or food. 77% of homeless participants reported that they encountered significant financial difficulties. All interviewees were particularly attentive to their health, with awareness and even a familiarity with the risks of infectious diseases long before the pandemic. Using a capability framework, our study showed a predominant lack of external health-related resources for homeless people, while internal health-related resources were more developed than expected. None of the places and lifestyles studied was favourable to health: collective shelters due to a greater restriction of people's choices, slums and street life due to a greater lack of basic resources.

Acceptability of a Novel Telemedication Review for Older Adults in Nursing Homes in France: A Qualitative Study.

PURPOSE: In France, polypharmacy among older people living in nursing homes (NH) is a major public health concern. In this context, the randomized controlled trial TEM-EHPAD was recently launched in various NH in southern France to evaluate the impact of implementing a novel telemedication review (TMR) on hospital admission rates of NH residents at high risk of iatrogenic disease. A qualitative study was integrated into the main trial study to assess general practitioners' (GP) and other NH healthcare professionals' (HP) acceptability of the proposed TMR before its implementation. MATERIAL AND METHODS: A qualitative study using face-to-face semi-structured interviews was conducted with 16 HP before the beginning of the intervention. A manual thematic analysis was performed on the transcribed interviews. RESULTS: Four main themes emerged from the thematic analysis: HP perceptions of the TMR, difficulties related to medication management for NH residents, HP perceptions of the roles of different professionals, and facilitators of good practices. Most participants were favorable to the TMR, but some GP expressed fears about loss of control over their prescription writing. CONCLUSION: This study fulfilled its objective to assess pre-intervention acceptability by GP and other HP. Results provided important information about how to adapt the TMR intervention to make it more acceptable to HP who will be involved in TEM-EHPAD. One of the main recommendations is the importance of providing participating GP with the opportunity to take part in the process of reviewing prescriptions.

SARS-CoV-2 rapid serological tests for field-based healthcare workers in homeless communities: A mixed-methods exploratory analysis.

OBJECTIVES: The high risk of SARS-CoV-2 transmission in homeless communities requires adapted prevention strategies for field-based healthcare workers (HCWs). Rapid serological tests (RSTs) could be an invaluable tool for HCWs to control COVID-19 transmission. This study assesses the benefits of RSTs for HCWs in Marseille, France. STUDY DESIGN: Mixed-methods exploratory analysis. METHODS: A mixed-methods approach was used, combining quantitative and qualitative data, to prospectively analyse acceptability of RSTs, prevalence of SARS-CoV-2 antibodies and prevention behaviours in 106 HCWs from 18 non-governmental organisations (NGOs) and health or social institutions in Marseille from June 1 to July 31, 2020. For the qualitative dimension, semi-structured individual interviews were conducted with 21 HCWs from 7 of 18 NGOs and institutions. RESULTS: Most of the 106 HCWs in the quantitative study reported better prevention measures at work than in their homes. Despite this, the majority reported that they felt unsafe at work in terms of COVID-19 infection risk. SARS-CoV-2 antibody seroprevalence among the study population was 6.1%. Only four HCWs refused to have an RST.The 21 qualitative interviews highlighted that HCWs were not afraid of RSTs or of any possible stigma associated with a positive serological status, although they were sometimes suspicious about RST validity. Downplaying their risk of infection was a coping strategy to keep both a sense of control and remain motivated at work. CONCLUSIONS: RSTs should be adopted as an additional tool in the strategy to protect both HCWs and healthcare service users. Additional follow-up of these observational findings is needed, especially with the increasing prevalence of vaccination in HCWs.