Strengths, challenges, and strategies for implementing pragmatic multicenter randomized controlled trials (RCTs): example of the Personalized Citizen Assistance for Social Participation (APIC) trial.

BACKGROUND: Randomized controlled trials (RCTs) are rigorous scientific research designs for evaluating intervention effectiveness. However, implementing RCTs in a real-world context is challenging. To develop strategies to improve its application, it is essential to understand the strengths and challenges of this design. This study thus aimed to explore the strengths, challenges, and strategies for improving the implementation of a pragmatic multicenter, prospective, two-arm RCT evaluating the effects of the Personalized Citizen Assistance for Social Participation (Accompagnement-citoyen Personnalisé d'Intégration Communautaire: APIC; weekly 3-h personalized stimulation sessions given by a trained volunteer over a 12-month period) on older adults' health, social participation, and life satisfaction. METHODS: A multiple case study was conducted with 14 participants, comprising one research assistant, seven coordinators, and six managers of six community organizations serving older adults, who implemented the APIC in the context of a RCT. Between 2017 and 2023, qualitative data were extracted from 24 group meetings, seven semi-directed interviews, emails exchanged with the research team, and one follow-up document. RESULTS: Aged between 30 and 60 (median ± SIQR: 44.0 ± 6.3), most participants were women from organizations already offering social participation interventions for older adults and working with the public sector. Reported strengths of this RCT were its relevance in assessing an innovative intervention to support healthy aging, and the sharing of common goals, expertise, and strategies with community organizations. Challenges included difficulties recruiting older adults, resistance to potential control group assignments, design complexity, and efforts to mobilize and engage volunteers. The COVID-19 pandemic lockdown and health measures exacerbated challenges related to recruiting older adults and mobilizing volunteers and complicated delivery of the intervention. The strategies that mostly overcame difficulties in recruiting older adults were reducing sample size, simplifying recruitment procedures, emphasizing the health follow-up, extending partnerships, and recognizing and supporting volunteers better. Because of the lockdown and physical distancing measures, the intervention was also adapted for remote delivery, including via telephone or videoconferencing. CONCLUSION: Knowledge of the strengths and challenges of pragmatic RCTs can contribute to the development of strategies to facilitate implementation studies and better evaluate health and social participation interventions delivered under real-life conditions. TRIAL REGISTRATION: NCT03161860; Pre-results. Registered on May 22, 2017.

Measuring the Optimal Time Interval Between Arrival and First Mental Health Evaluation's for Refugees in Québec: A Scoping Review.

To map the state of the existing literature to identify the optimal time frame between the arrival of refugees in a host country and psychosocial assessments. We conducted scoping review using the method of Arksey and O'Malley (2005). A systematic search of 5 databases including PubMed, Psycinfo (OVID), PsycINFO BD APA, Scopus and Web of Sciences) and grey literature identified 2698 references. Thirteen studies published between 2010 and 2021 were considered eligible. A data extraction grid was designed and tested by the research team. It is not so ease to identify the most appropriate time interval to assess the mental health of newly settled refugees. All the studies selected agree on the need to carry out an initial assessment when refugees arrive in their host country. Several authors agree on the need to carry out screening at least twice during the resettlement period. However, what is less clear is the best time to perform the second screening. This scoping review mainly helped in highlighting the lack of probing data on the mental health indicators focused on during the assessment and on the optimal timeline for the assessment of refugees. Further research is needed to determine whether developmental and psychological screening is beneficial, the right time to perform the screening, and the most appropriate collection instruments and interventions.