People with serious mental illness (SMI) and intellectual or developmental disabilities (IDD) are at a disproportionately high risk for COVID-19 and poor COVID-19 outcomes due to high rates of health-related risk factors and living in congregate care settings. Rates of COVID-19 for residents with SMI and IDD in this project are 8 times higher—12 percent—and for staff, 2 times higher—3 percent—compared to the general population in the surrounding “hot spot” communities (1.5 percent) selected for this study.
We lack knowledge on how to best adapt, prioritize, deliver, and implement effective COVID-19 prevention strategies for this highly vulnerable population and the staff who provide their care.
- With the goal of prioritizing and resourcing actionable best practices, what is the comparative effectiveness of different types and intensities of four basic preventive interventions—screening, isolation, contact tracing, personal protective practices—in reducing rates of COVID-19 and related hospitalization and mortality in staff and adult residents with SMI and IDD in congregate care settings?
- With the goal of effectively implementing best practices, what is the most effective implementation strategy to reduce rates of COVID-19 in congregate care settings for persons with SMI and IDD: (1) Tailored Best Practices (TBP) specifically adapted for staff and residents with SMI and IDD in congregate living settings, or (2) Generic Best Practices (GBP) consisting of standard guidelines for all congregate care settings?
We will employ a Hybrid Type-II Effectiveness-Implementation study design and will address the following study aims:
- Aim 1: Synthesize Baseline Data: (a) Synthesize existing data on (1) rates of COVID-19 and related hospitalization and mortality; (2) use of screening, isolation, contact tracing, and personal protective practices in 400 group homes for SMI and IDD; and (3) barriers and facilitators to implementing recommended practices.
- Aim 2: Evaluate Effectiveness: Determine the comparative effectiveness of different COVID-19 preventive practices—screening, isolation, contact tracing, use of PPE—for residents and staff of group homes for SMI and IDD using a validated COVID-19 simulation model with data from Aim 1.
- Aim 3: Evaluate Implementation: Determine comparative effectiveness of implementing Tailored Best Practices (TBP) determined in Aim 2 compared to Generic Best Practices (GBP) for 400 congregate care homes for SMI and for IDD using a cluster-randomized design.
Main Components of the Intervention
- Aim 2: Comparative Effectiveness of Screening, Isolation, Contact Tracing, and Use of PPP
Comparators: (1) screening; (2) isolation; (3) contact tracing; and (4) personal protective practices.
- Aim 3: Comparative Effectiveness of Tailored Best Practices (TBP) Compared to Generic Best Practices (GBP)
Comparators: (1) Tailored Best Practices (TBP): COVID-19 prevention practices specifically tailored for staff and residents of congregate care settings for people with SMI and IDD determined in Aim 2, and (2) Generic Best Practices (GBP): Standard COVID-19 prevention and management practices required by the Massachusetts Department of Public Health based on CDC recommendations for congregate care.
Study Population and Setting
- Inclusion Criteria: State-funded congregate care settings for adults with SMI and for adults, ages 18 and older, with IDD
- Study Sample: 400 group homes with the highest rates of COVID-19 operated by six human services organizations in Massachusetts (with 3,300 staff and 2,050 residents
Primary and Secondary Outcomes
Consistent with a Hybrid Type-II Effectiveness-Implementation design there are two sets of outcomes:
Aim 2: Evaluation of the Effectiveness of Different COVID-19 Preventive Practices:
- Primary Outcome: Predicted rates of COVID-19 for residents and staff (separately).
- Secondary Outcomes: Predicted rates of COVID-19 and related hospitalization and mortality.
Aim 3: Evaluation of the Effectiveness of Different Implementation Strategies:
- Primary Implementation Outcome: TBP Fidelity (COVID-19 Best Practices Fidelity Measure).
- Secondary Implementation Outcome: Adoption (Acceptability, Appropriateness, and Feasibility Measures) Reach (Percentage of homes using TBPs with 80% fidelity); and Maintenance (% homes maintaining 80% fidelity over the 15-month study period.
- Co-Primary Effectiveness Outcome: COVID-19 incidence (Percentage of new laboratory-confirmed COVID-19 cases among residents and staff (separately).
- Secondary Outcomes: Rates of COVID-19 and related hospitalization, and mortality.
- Evaluation of the Comparative Effectiveness of Different COVID-19 Best Practices (Aim 2): Results at month 3.
- Evaluation of the Effectiveness of Different Implementation Strategies (Aim 3): Last follow-up at 15 months.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.