CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 415 enrolled
Drug / intervention
Generic Best Practices +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04726371
NCT04726371N/ACompleted

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

Massachusetts General Hospital·interventional·Posted Jan 27, 2021·Updated Feb 12, 2025

In Brief

A clinical study evaluating Generic Best Practices and Tailored Best Practices for Intellectual Disability and 5 related conditions. Completed, enrolled 415 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJan 27, 2021
Enrollment StartNov 1, 2020
Primary CompletionNov 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.4 years ago

Interventions

Generic Best Practicesbehavioral

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.

Tailored Best Practicesbehavioral

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.