Best Practices to Prevent COVID-19 Illness in Staff and People With Serious Mental Illness and Developmental Disabilities in Congregate Living Settings

Summary

Best Practices to Prevent COVID-19 Illness in Staff and People With Serious Mental Illness and Developmental Disabilities in Congregate Living Settings is a research study aimed at developing, implementing, and evaluating a package of interventions specifically designed to reduce COVID-19 and other infectious-disease incidence, hospitalizations, and mortality among staff and adults with Serious Mental Illness and Intellectual and Developmental Disabilities in congregate-living settings.

Conditions

• Intellectual Disability
• Developmental Disability
• Axis I Diagnosis
• Mental Illness
• Covid19
• Coronavirus

Interventions

BEHAVIORAL

Generic Best Practices

GBP consists of (1) Massachusetts Executive Office of Health and Human Services distribution of standard guidelines and policies for public health prevention and management of COVID and (2) standard virtual training of the staff of the group homes in these generic COVID-19 prevention practices including recommended use of hand washing, use of PPE, and symptom-triggered screening. Group homes randomized to this intervention will receive standard recommended and fully vetted best practices with respect to preventing and managing COVID-19 based on recommendations by the CDC and on consultation with leading national experts in infectious disease working with the Commonwealth of Massachusetts. The control condition does not represent inferior or substandard practice. As findings occur and as policy leads to adjustments in recommendations during the course of the study, the GBP condition will incorporate recommendations that are appropriate and up-to-date with CDC and state policy.

BEHAVIORAL

Tailored Best Practices

TBP consists of optimized, tailored, and highly specific COVID-19 best practices and training materials specific to the setting, staff, and residents with SMI and ID/DD in congregate living settings based on the comparative effectiveness of different types, intensities, and combinations of COVID-19 prevention practices (screening, isolation, contact tracing, use of PPP, vaccination) specifically modeled for residents and staff of congregate living settings for people with ID/DD and SMI derived by a simulation model. Results from this modeling process will be provided to stakeholders to support decision makers in prioritizing resources and practices with the greatest impact on reducing COVID-19 tailored for people with SMI and ID/DD in congregate living settings. This process to determine the content of TBP will occur as part of this study prior to randomization.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Advocates

  collaborator UNKNOWN

• Bay Cove Human Services

  collaborator OTHER

• North Suffolk Mental Health Association

  collaborator OTHER

• Open Sky Community Services

  collaborator UNKNOWN

• Riverside Community Care, Inc.

  collaborator UNKNOWN

• Dartmouth College

  collaborator OTHER

• Vinfen

  collaborator INDUSTRY

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Stephen J Bartels, MD, MS · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-11-01

Primary Completion

2022-11-30

Completion

2022-11-30

Countries

• United States

Study Locations