Intellectual DisabilityNCT04726371
Best Practices to Prevent COVID-19 Illness in Staff and People With Serious Mental Illness and Developmental Disabilities in Congregate Living Settings
A study testing Generic Best Practices and Tailored Best Practices in people with Intellectual Disability and Developmental Disability, run by Massachusetts General Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disability, Developmental Disability, Axis I Diagnosis
- What is being tested?
- Generic Best Practices and Tailored Best Practices
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. All congregate care homes in Massachusetts not operated by any of the public-sector community-based human service organizations mentioned above
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the detailed 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.
- Conditions
- Intellectual Disability, Developmental Disability, Axis I Diagnosis, Mental Illness, Covid19, Coronavirus
- Being tested
- Generic Best Practices, Tailored Best Practices
- Keywords
- COVID-19, Coronavirus, Intellectual Disabilities, Developmental Disabilities, Serious Mental Illness, Congregate Living, Group Homes
- Medical subject headings
- Intellectual Disability, Developmental Disabilities, Mental Disorders, COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generic Best PracticesBehavioural
Also called GBP
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 PracticesBehavioural
Also called TBP
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Tailored Best Practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
New COVID-19 Group Home Incidence
New laboratory-confirmed COVID-19 cases among residents and staff. Measured as new cases per 100 person-months.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Assessed from April 1 to the date of vaccination (up to June 30, 2022), up to 15 months for each participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Nov 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Advocates, Bay Cove Human Services, North Suffolk Mental Health Association, Open Sky Community Services, Riverside Community Care, Inc., Dartmouth College, Vinfen
- Responsible party
- Principal investigator, Stephen Bartels, Massachusetts General Hospital
- Investigators
- Stephen J Bartels, MD, MS, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726371
- Sponsor's protocol ID
- 2020P003803, 2020P003957
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2021
- Last updated
- 12 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38926810Becker 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.
PubMed 38915130Constantin 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.
PubMed 38597249Fung 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.
PubMed 37938475Levison 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.
PubMed 36539061
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Practices to Prevent COVID-19 Illness in Staff and People With Serious Mental Illness and Developmental Disabilities in Congregate Living Settings
- ClinicalTrials.gov ID
- NCT04726371
- Acronym / sponsor ID
- 2020P003803, 2020P003957
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Advocates, Bay Cove Human Services, North Suffolk Mental Health Association, Open Sky Community Services, Riverside Community Care, Inc., Dartmouth College, Vinfen
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Posted 12 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Generic Best Practices (GBP) | Active comparator | Behavioral: Generic Best PracticesThe ~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. |
| Tailored Best Practices (TBP) | Experimental | Behavioral: Tailored Best PracticesThe ~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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 1. All congregate care homes in Massachusetts not operated by any of the public-sector community-based human service organizations mentioned above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Generic Best PracticesAlso: GBPGBP 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. | Behavioural | Generic Best Practices (GBP) |
| Tailored Best PracticesAlso: TBPTBP 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. | Behavioural | Tailored Best Practices (TBP) |
Primary outcome
New COVID-19 Group Home Incidence
Time frame: The outcome was measured at baseline, 3-, 6-, 9-, 12-, and 15-months post-baseline.
New laboratory-confirmed COVID-19 cases among residents and staff. Measured as new cases per 100 person-months.
Best Practices Fidelity
Time frame: The outcome will be measured at baseline, 3-, 6-, 9-, 12-, and 15-months post-baseline.
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).
Full COVID-19 Vaccination Status Among Residents
Time frame: Assessed from April 1 to the date of vaccination (up to June 30, 2022), up to 15 months for each participant.
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.
Full COVID-19 Vaccination Status Among Staff
Time frame: Assessed from April 1 to the date of vaccination (up to June 30, 2022), up to 15 months for each participant.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38926810Bartels 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.
- Derived from this study: PubMed 38915130Becker 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.
- Derived from this study: PubMed 38597249Constantin 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.
- Derived from this study: PubMed 37938475Fung 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.
- Derived from this study: PubMed 36539061Levison 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J Bartels, MD, MS principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Generic Best Practices and Tailored Best Practices in people with Intellectual Disability and Developmental Disability, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New COVID-19 Group Home Incidence (time frame: The outcome was measured at baseline, 3-, 6-, 9-, 12-, and 15-months post-baseline.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04726371, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.