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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04726371
• Other study ID #: 2020P003803, 2020P003957
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2021
• Est. completion date: October 2022

Study information

• Verified date: January 2021
• Source: Massachusetts General Hospital
• Contact: Stephen J Bartels, MD, MS
• Phone: 617-726-5213
• Email: SJBARTELS[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Persons with Serious Mental Illness (SMI) and Intellectual Disabilities and Developmental Disabilities (ID/DD) are disproportionately vulnerable to COVID-19 for three reasons: (1) Medical vulnerability. Smoking, chronic obstructive pulmonary disease, cardiovascular disease, and diabetes all increase COVID-19 mortality and are about 2-3 times more prevalent among persons with SMI. People with ID/DD suffer higher rates of COVID-19 risk factors, including pre-existing chronic conditions, heart defects, obesity, chronic respiratory problems or lung disease, lower immune function, cancer, and diabetes. (2) Residential vulnerability. The congregate care settings in which many people with SMI and ID/DD live carry many of the same higher risks of COVID-19 transmission currently affecting assisted-living settings and nursing homes across the nation. (3) Health behavior vulnerability. Some people with SMI and ID/DD have cognitive, behavioral, and physical challenges that heighten COVID-19 risk by hampering personal protective practices (PPP) (i.e., hand hygiene, physical distancing, use of face masks). Moreover, the staff who work in congregate care settings are often subject to high rates of exposure, have low socioeconomic status, use public transportation, and lack personal protective equipment. This collection of factors contributes to an extraordinarily high risk of COVID-19 morbidity, and mortality. Despite payment reforms and mandated best practices for COVID-19 for congregate care by the MA Department of Public Health, rates of coronavirus illness for residents with SMI and ID/DD are 8 times higher (12%), and for staff 2 times higher (3.0%), compared to the general population in the surrounding "hot spot" communities (1.5%) selected for this study. This tragic health disparity confirms that key decision-makers lack the knowledge of how to optimally tailor best practices for this highly vulnerable population and the staff who provide their care to effectively reduce their high risk of COVID-19 and COVID-19 related mortality.

The investigators' overall goal is to reduce COVID-19 and other infectious-disease incidence, hospitalizations, and mortality among staff and adults with Serious Mental Illness (SMI) and Intellectual and Developmental Disabilities (ID/DD) in congregate-living settings in Massachusetts. The investigators address 2 comparative-effectiveness questions:

With the goal of prioritizing and resourcing actionable best practices: What is the comparative effectiveness of different types and intensities of five basic preventive interventions-screening, isolation, contact tracing, personal protective practices (PPP) (i.e., hand hygiene, physical distancing, use of face masks), and vaccination-in reducing rates of COVID-19, hospitalizations, and mortality in staff and adult residents with SMI and ID/DD in congregate care settings? Effectiveness Hypothesis: Of the 5 preventive interventions, tailored screening, effective use of isolation, and increased vaccination acceptance will be associated with the greatest reduction of staff and resident COVID-19 rates and related hospitalizations.

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 ID/DD: (1) Tailored Best Practices (TBP) specifically adapted for staff and residents with SMI and ID/DD in congregate living settings or (2) Generic Best-Practices (GBP) consisting of state and federal standard guidelines for all congregate care settings? Implementation Hypothesis: TBP will be associated with greater implementation fidelity and lower staff and resident rates of COVID-19 and hospitalization than GBP.

To test these hypotheses, the investigators will pursue three Aims:

Aim 1: The investigators will synthesize existing data collected by the six provider organizations on (1) rates of COVID-19, hospitalization, and mortality and (2) use of screening, isolation, contact tracing, PPP, and vaccination in 400 group homes for SMI and ID/DD. The investigators will also collect qualitative data through surveys and virtual focus groups on the experience of staff and residents, and on barriers and facilitators to implementing recommended practices.

Aim 2: The investigators will determine the comparative effectiveness of different COVID-19 preventive practices (screening, isolation, contact tracing, use of PPP, vaccination) by populating a validated simulation model and engage decision makers and stakeholders in selecting priorities for best practices. The investigators will apply the Clinical and Economic Analysis of COVID-19 Interventions (CEACOV), a COVID-19 simulation model that has already been developed and validated, to simulate the 2,050 residents and 3,300 staff of the 400 group homes for persons with SMI and ID/DD in the study. The investigators will compare the effectiveness of different types, intensities, and combinations of the five identified interventions: screening, isolation, contact tracing, PPP, and vaccination.

On completion of the simulation modeling at month 3, the investigators will convene a COVID-19 Quality Improvement Collaborative (CQIC) Virtual Summit including consumers, providers, advocates, and key decision makers, during which the investigators will summarize the results of the comparative effectiveness simulation model and present alternative scenarios demonstrating the impact of increasing or decreasing amounts or combinations of various practices. The CQIC Virtual Summit and 1-2 additional brief virtual meetings will result in recommendations for a final prioritized set of actionable and feasible Tailored Best Practices (TBP) for implementation. The CQIC will review and adapt relevant COVID-19 training materials and finalize a TBP implementation package.

Aim 3: The investigators will employ a cluster randomized trial design with 200 group homes randomized to implementation of "Tailored Best Practices" (TBP) compared to 200 group homes randomized to "Generic Best Practices" (GBP). The investigators will engage in a three-month observational pre-randomization period to assess the baseline use of preventive practices and rates of COVID in each group home to better isolate the effect of the introduction of the TBP intervention. The investigators have also incorporated a 3-month implementation phase in order to accommodate implementing the TBP intervention with fidelity across 200 group homes during the same time period. The best practice implementation fidelity and COVID-19 incidence are co-primary outcomes with group home as the unit of analysis. Within each site, the investigators will engage in repeated measurement of these outcomes across 6 time points (Baseline, 3, 6, 9, 12, and 15 months) so that time effects (observed and latent) can be modeled precisely in the presence of any fluctuations in incidence over time.

By month 16 of the project, the investigators will know the effectiveness of the Tailored Best Practices (TBP) implementation for a diverse array of state-supported group homes for SMI and ID/DD with broad generalizability to similar settings across the nation that will be broadly distributed through dissemination materials at the end of the project.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5350
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. All congregate care homes in Massachusetts operated by the following public-sector community-based human service organizations: Vinfen, Bay Cove, Advocates, North Suffolk, Open Sky, and Riverside

2. The group home must serve adults with SMI (Serious Mental Illness, i.e., DSM-V Diagnosis of Axis-I Mental Illness with persistent functional impairment) or adults with ID/DD (Intellectual and Developmental Disabilities)

3. All residents and staff of the home must be age 18 or older

Exclusion Criteria:

1. All congregate care homes in Massachusetts not operated by any of the public-sector community-based human service organizations mentioned above

Related Conditions & MeSH terms

• Axis I Diagnosis
• Coronavirus
• Coronavirus Infections
• Covid19
• Developmental Disabilities
• Developmental Disability
• Intellectual Disability
• Mental Disorders
• Mental Illness

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (9)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Advocates, Bay Cove Human Services, Dartmouth College, North Suffolk Mental Health Association, Open Sky Community Services, Patient-Centered Outcomes Research Institute, Riverside Community Care, Inc., Vinfen Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New COVID-19 Group Home Incidence at Baseline	New laboratory-confirmed COVID-19 cases among residents and staff	The outcome will be measured at baseline (prior to intervention implementation).
Primary	New COVID-19 Group Home Incidence at 3 Months	New laboratory-confirmed COVID-19 cases among residents and staff	The outcome will be measured 3 months after intervention implementation.
Primary	New COVID-19 Group Home Incidence at 6 Months	New laboratory-confirmed COVID-19 cases among residents and staff	The outcome will be measured 6 months after intervention implementation.
Primary	New COVID-19 Group Home Incidence at 9 Months	New laboratory-confirmed COVID-19 cases among residents and staff	The outcome will be measured 9 months after intervention implementation.
Primary	New COVID-19 Group Home Incidence at 12 Months	New laboratory-confirmed COVID-19 cases among residents and staff	The outcome will be measured 12 months after intervention implementation.
Primary	New COVID-19 Group Home Incidence at 15 Months	New laboratory-confirmed COVID-19 cases among residents and staff	The outcome will be measured 15 months after intervention implementation.
Primary	Best Practices Fidelity at Baseline	Best Practices Fidelity is measured by the COVID-19 Best Practices Fidelity Measure developed for this project and refined with input from stakeholders consisting of fidelity to COVID best practices (e.g. number of staff and residents participating in recommended screening, isolating, contact tracing, PPP protocols, and vaccination interventions by staff and residents of the group homes). Of note, measuring implementation fidelity as the primary outcome provides a test of the effectiveness of TBP vs. GBP independent of the incidence of new cases over the 15-month project if rates of new COVID-19 happen to sharply decline due to temporal trends or a vaccine.	The outcome will be measured at baseline (prior to intervention implementation).
Primary	Best Practices Fidelity at 3 Months	Best Practices Fidelity is measured by the COVID-19 Best Practices Fidelity Measure developed for this project and refined with input from stakeholders consisting of fidelity to COVID best practices (e.g. number of staff and residents participating in recommended screening, isolating, contact tracing, PPP protocols, and vaccination interventions by staff and residents of the group homes). Of note, measuring implementation fidelity as the primary outcome provides a test of the effectiveness of TBP vs. GBP independent of the incidence of new cases over the 15-month project if rates of new COVID-19 happen to sharply decline due to temporal trends or a vaccine.	The outcome will be measured 3 months after intervention implementation.
Primary	Best Practices Fidelity at 6 Months	Best Practices Fidelity is measured by the COVID-19 Best Practices Fidelity Measure developed for this project and refined with input from stakeholders consisting of fidelity to COVID best practices (e.g. number of staff and residents participating in recommended screening, isolating, contact tracing, PPP protocols, and vaccination interventions by staff and residents of the group homes). Of note, measuring implementation fidelity as the primary outcome provides a test of the effectiveness of TBP vs. GBP independent of the incidence of new cases over the 15-month project if rates of new COVID-19 happen to sharply decline due to temporal trends or a vaccine.	The outcome will be measured 6 months after intervention implementation.
Primary	Best Practices Fidelity at 9 Months	Best Practices Fidelity is measured by the COVID-19 Best Practices Fidelity Measure developed for this project and refined with input from stakeholders consisting of fidelity to COVID best practices (e.g. number of staff and residents participating in recommended screening, isolating, contact tracing, PPP protocols, and vaccination interventions by staff and residents of the group homes). Of note, measuring implementation fidelity as the primary outcome provides a test of the effectiveness of TBP vs. GBP independent of the incidence of new cases over the 15-month project if rates of new COVID-19 happen to sharply decline due to temporal trends or a vaccine.	The outcome will be measured 9 months after intervention implementation.
Primary	Best Practices Fidelity at 12 Months	Best Practices Fidelity is measured by the COVID-19 Best Practices Fidelity Measure developed for this project and refined with input from stakeholders consisting of fidelity to COVID best practices (e.g. number of staff and residents participating in recommended screening, isolating, contact tracing, PPP protocols, and vaccination interventions by staff and residents of the group homes). Of note, measuring implementation fidelity as the primary outcome provides a test of the effectiveness of TBP vs. GBP independent of the incidence of new cases over the 15-month project if rates of new COVID-19 happen to sharply decline due to temporal trends or a vaccine.	The outcome will be measured 12 months after intervention implementation.
Primary	Best Practices Fidelity at 15 Months	Best Practices Fidelity is measured by the COVID-19 Best Practices Fidelity Measure developed for this project and refined with input from stakeholders consisting of fidelity to COVID best practices (e.g. number of staff and residents participating in recommended screening, isolating, contact tracing, PPP protocols, and vaccination interventions by staff and residents of the group homes). Of note, measuring implementation fidelity as the primary outcome provides a test of the effectiveness of TBP vs. GBP independent of the incidence of new cases over the 15-month project if rates of new COVID-19 happen to sharply decline due to temporal trends or a vaccine.	The outcome will be measured 15 months after intervention implementation.