Tailored vs. General COVID-19 prevention for adults with mental disabilities residing in group homes: a randomized controlled effectiveness-implementation trial.

BACKGROUND: People with serious mental illness (SMI) and people with intellectual disabilities/developmental disabilities (ID/DD) are at higher risk for COVID-19 and more severe outcomes. We compare a tailored versus general best practice COVID-19 prevention program in group homes (GHs) for people with SMI or ID/DD in Massachusetts (MA). METHODS: A hybrid effectiveness-implementation cluster randomized control trial compared a four-component implementation strategy (Tailored Best Practices: TBP) to dissemination of standard prevention guidelines (General Best-Practices: GBP) in GHs across six MA behavioral health agencies. GBP consisted of standard best practices for preventing COVID-19. TBP included GBP plus four components including: (1) trusted-messenger peer testimonials on benefits of vaccination; (2) motivational interviewing; (3) interactive education on preventive practices; and (4) fidelity feedback dashboards for GHs. Primary implementation outcomes were full COVID-19 vaccination rates (baseline: 1/1/2021-3/31/2021) and fidelity scores (baseline: 5/1/21-7/30/21), at 3-month intervals to 15-month follow-up until October 2022. The primary effectiveness outcome was COVID-19 infection (baseline: 1/1/2021-3/31/2021), measured every 3 months to 15-month follow-up. Cumulative incidence of vaccinations were estimated using Kaplan-Meier curves. Cox frailty models evaluate differences in vaccination uptake and secondary outcomes. Linear mixed models (LMMs) and Poisson generalized linear mixed models (GLMMs) were used to evaluate differences in fidelity scores and incidence of COVID-19 infections. RESULTS: GHs (n=415) were randomized to TBP (n=208) and GBP (n=207) including 3,836 residents (1,041 ID/DD; 2,795 SMI) and 5,538 staff. No differences were found in fidelity scores or COVID-19 incidence rates between TBP and GBP, however TBP had greater acceptability, appropriateness, and feasibility. No overall differences in vaccination rates were found between TBP and GBP. However, among unvaccinated group home residents with mental disabilities, non-White residents achieved full vaccination status at double the rate for TBP (28.6%) compared to GBP (14.4%) at 15 months. Additionally, the impact of TBP on vaccine uptake was over two-times greater for non-White residents compared to non-Hispanic White residents (ratio of HR for TBP between non-White and non-Hispanic White: 2.28, p = 0.03). CONCLUSION: Tailored COVID-19 prevention strategies are beneficial as a feasible and acceptable implementation strategy with the potential to reduce disparities in vaccine acceptance among the subgroup of non-White individuals with mental disabilities. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04726371, 27/01/2021. https://clinicaltrials.gov/study/NCT04726371 .

Designing a Participatory Total Worker Health® Organizational Intervention for Commercial Construction Subcontractors to Improve Worker Safety, Health, and Well-Being: The "ARM for Subs" Trial.

Background: Evidence supports organizational interventions as being effective for improving worker safety, health and well-being; however, there is a paucity of evidence-based interventions for subcontracting companies in commercial construction. Methods: A theory-driven approach supplemented by formative research through key stakeholder interviews and focus groups and an iterative vetting process with stakeholders, resulted in the development of an intervention for subcontractors in the commercial construction industry. We piloted the intervention in one subcontracting commercial construction company. We used these findings to adapt and finalize the intervention design to be tested in a future large-scale trial. Results: There were several key findings from the formative research, including challenges faced by companies and assets that should be considered in the intervention design. This resulted in a communication infrastructure company-based, continual improvement, participatory intervention design, consisting of a needs assessment and report, committee-led prioritization, action planning and implementation, and worker communication/feedback cycle. The pilot contributed to the final intervention design with modifications made with respect to timing, implementation support, capacity building, adaptability and sustainability. Conclusions: The use of a theory-driven participatory approach to developing an integrated organizational intervention for commercial construction subcontracting companies was important and necessary. It allowed us to consider the empirical evidence and relevant theories and tailor these to meet the needs of our target population. This study gives pragmatic insight into the early development of a complex intervention, with practical experience of how we adapted our intervention at each stage. This intervention will be tested in a future randomized trial.