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

NCT04726371 | Completed Results DMC

• 1 other identifier: 2020P003803, 2020P003957
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

COVID-19; Coronavirus; Intellectual Disabilities; Developmental Disabilities; Serious Mental Illness; Congregate Living; Group Homes

Outcome Measures

Primary Outcomes (4)

• New COVID-19 Group Home Incidence

  New laboratory-confirmed COVID-19 cases among residents and staff. Measured as new cases per 100 person-months.

  The outcome was measured at baseline, 3-, 6-, 9-, 12-, and 15-months post-baseline.

• Best Practices Fidelity

  Best Practices Fidelity is measured by the COVID-19 Best Practices Fidelity Measure developed for this project and refined with input from stakeholders on relevant COVID-19-prevention policies (e.g. number of staff and residents participating in recommended screening, masking, hand washing, and vaccination in the group homes). The Fidelity scale was developed by operationally defining 2-4 items to assess each measure, with items scored on a 5- to 6-point continuum with a rating of 5 or 6 indicating full adherence to the fidelity standard and 1 indicating complete lack of adherence. A home's overall, continuous fidelity score was calculated by averaging measure-specific scores by time period. Each active measure was given equal weight. The percentage scores for each of these measures were then averaged together. The overall fidelity score ranged from a low of 20% (1 out of 5 on each item) to a high of 100% (5 out of 5 on each item).

  The outcome will be measured at baseline, 3-, 6-, 9-, 12-, and 15-months post-baseline.

• Full COVID-19 Vaccination Status Among Residents

  This outcome measure reflects the number of group home (GH) residents who were not fully vaccinated at the beginning of the study (by March 31, 2021) but became fully vaccinated during the study period. Individual-level dates of COVID-19 vaccinations were obtained from records maintained by GH organizations. A person was considered to be fully vaccinated when they received the full dosage of initial immunization(s) as recommended by the CDC during the study, either two initial doses of the Pfizer or Moderna vaccine or one dose of the Johnson \& Johnson vaccine. Baseline vaccination rates were established from January 1, 2021, to March 31, 2021.

  Assessed from April 1 to the date of vaccination (up to June 30, 2022), up to 15 months for each participant.

• Full COVID-19 Vaccination Status Among Staff

  This outcome measure reflects the number of group home (GH) staff who were not fully vaccinated at the beginning of the study (by March 31, 2021) but became fully vaccinated during the study period. Individual-level dates of COVID-19 vaccinations were obtained from records maintained by GH organizations. A person was considered to be fully vaccinated when they received the full dosage of initial immunization(s) as recommended by the CDC during the study, either two initial doses of the Pfizer or Moderna vaccine or one dose of the Johnson \& Johnson vaccine. Baseline vaccination rates were established from January 1, 2021, to March 31, 2021.

  Assessed from April 1 to the date of vaccination (up to June 30, 2022), up to 15 months for each participant.

Study Arms (2)

Generic Best Practices (GBP)

ACTIVE COMPARATOR

The \~200 group homes randomized into this arm will receive the Generic Best Practices (GBP) intervention package as part of routine training activities. GBP consists of state and federal standard guidelines for COVID-19 mitigation for all congregate living settings.

Behavioral: Generic Best Practices

Tailored Best Practices (TBP)

EXPERIMENTAL

The \~200 group homes randomized into this arm will receive the Tailored Best Practices (TBP) intervention package as part of routine training activities. TBP consists of COVID-19 mitigation measures specifically adapted for staff and residents with SMI and ID/DD in congregate living settings. Sites in this arm will receive coaching specific to the setting, staff, and residents.

Behavioral: Tailored Best Practices

Interventions

Generic Best Practices BEHAVIORAL

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.

Also known as: GBP

Generic Best Practices (GBP)

Tailored Best Practices BEHAVIORAL

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.

Also known as: TBP

Tailored Best Practices (TBP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• All residents and staff of the home must be age 18 or older

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Advocates: collaborator
• Bay Cove Human Services: collaborator
• North Suffolk Mental Health Association: collaborator
• Open Sky Community Services: collaborator
• Riverside Community Care, Inc.: collaborator
• Dartmouth College: collaborator
• Vinfen: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (5)

• Bartels S, Levison JH, Trieu HD, Wilson A, Krane D, Cheng D, Xie H, Donelan K, Bird B, Shellenberger K, Cella E, Oreskovic NM, Irwin K, Aschbrenner K, Fathi A, Gamse S, Holland S, Wolfe J, Chau C, Adejinmi A, Langlois J, Reichman JL, Iezzoni LI, Skotko BG. Tailored vs. General COVID-19 prevention for adults with mental disabilities residing in group homes: a randomized controlled effectiveness-implementation trial. BMC Public Health. 2024 Jun 26;24(1):1705. doi: 10.1186/s12889-024-18835-w.

  PMID: 38926810 DERIVED

• Becker JE, Shebl FM, Losina E, Wilson A, Levison JH, Donelan K, Fung V, Trieu H, Panella C, Qian Y, Kazemian P, Bird B, Skotko BG, Bartels S, Freedberg KA. Using simulation modeling to inform intervention and implementation selection in a rapid stakeholder-engaged hybrid effectiveness-implementation randomized trial. Implement Sci Commun. 2024 Jun 24;5(1):70. doi: 10.1186/s43058-024-00593-w.

  PMID: 38915130 DERIVED

• Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.

  PMID: 38597249 DERIVED

• Fung V, Levison JH, Wilson A, Cheng D, Chau C, Krane D, Trieu HD, Irwin K, Cella E, Bird B, Shellenberger K, Silverman P, Batson J, Fathi A, Gamse S, Wolfe J, Holland S, Donelan K, Samuels R, Becker JE, Freedberg KA, Reichman JL, Keller T, Tsai AC, Hsu J, Skotko BG, Bartels S. COVID-19-Related Outcomes Among Group Home Residents with Serious Mental Illness in Massachusetts in the First Year of the Pandemic. Adm Policy Ment Health. 2024 Jan;51(1):60-68. doi: 10.1007/s10488-023-01311-9. Epub 2023 Nov 8.

  PMID: 37938475 DERIVED

• Levison JH, Krane D, Donelan K, Aschbrenner K, Trieu HD, Chau C, Wilson A, Oreskovic NM, Irwin K, Iezzoni LI, Xie H, Samuels R, Silverman P, Batson J, Fathi A, Gamse S, Holland S, Wolfe J, Shellenberger K, Cella E, Bird B, Skotko BG, Bartels S. Best practices to reduce COVID-19 in group homes for individuals with serious mental illness and intellectual and developmental disabilities: Protocol for a hybrid type 1 effectiveness-implementation cluster randomized trial. Contemp Clin Trials. 2023 Feb;125:107053. doi: 10.1016/j.cct.2022.107053. Epub 2022 Dec 17.

  PMID: 36539061 DERIVED

MeSH Terms

Conditions

Intellectual Disability; Developmental Disabilities; Mental Disorders; COVID-19; Coronavirus Infections

Interventions

tributyl phosphate

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Stephen Bartels
• Organization: The Mongan Institute at Massachusetts General Hospital

sjbartels@mgh.harvard.edu

617-726-5213

Study Officials

• Stephen J Bartels, MD, MS

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, The Mongan Institute; James J. and Jean H. Mongan Chair of Health Policy and Community Health; Professor of Medicine

Model Details: The investigators will employ a cluster-randomized trial design with \~200 group homes randomized to the implementation of "Tailored Best Practices" (TBP) compared to \~200 group homes randomized to "Generic Best Practices" (GBP). Randomization will occur at the level of the group home stratified by group home type (SMI versus ID/DD), incident COVID-19 infection in the staff and residents (high incidence versus low incidence), and race/ethnicity (proportion non-Hispanic Caucasian versus other). TBP and GBP will be delivered within each agency as part of routine training activities. TBP sites will receive coaching specific to the setting, staff, and residents. The best practice implementation fidelity (i.e. staff and residents participating in recommended screening, isolating, contact tracing, PPP protocols, and vaccine acceptance), and COVID-19 incidence are co-primary outcomes with group home as the unit of analysis. The outcomes will be assessed at baseline, 3, 6, 9, 12, and 15 months.

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 27, 2021
• Study Start: November 1, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: February 12, 2025
• Results First Posted: February 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)