Best Practices to Prevent COVID-19 Illness in Staff and People With Serious Mental Illness and Developmental Disabilities in Congregate Living Settings
Phase: NA
Conditions: Intellectual Disability, Developmental Disability, Axis I Diagnosis, Mental Illness, Covid19, Coronavirus
Sponsor: Massachusetts General Hospital

 
 
  
 
Best Practices to Prevent COVID-19 Illness 
in Staff and People with Serious Mental 
Illness and Developmental Disabilities in 
Congregate Living Settings 
NCT04726371 
 
 
Full Study Protocol 
Version date: April 5, 2022 
 
 

 
 
Partners Human Subjects Research Application Form 
 
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
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Answer all questions accurately and completely in order to provide the PHRC with the relevant 
information to assess the risk-benefit ratio for the study.  Do not leave sections blank. 
 
PRINCIPAL/OVERALL INVESTIGATOR
 
Stephen J. Bartels, MD, MS  
 
PROTOCOL TITLE 
 
Best Practices to Prevent COVID-19 Illness in Staff and People with Serious 
Mental Illness and Intellectual/Developmental Disabilities in Congregate 
Living Settings 
 
FUNDING
 
PCORI 
 
VERSION DATE
 
04/05/22 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested.
 
This is a COVID-19 related protocol. 
 
Our 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 
disabilities/developmental disabilities (ID/DD) in congregate living settings.  
 
Aim: To compare the effectiveness of “Tailored Best Practices” (TBP) specifically adapted for 
staff and residents with SMI and ID/DD in congregate living settings and “Generic Best 
Practices” (GBP) consisting of state and federal standard guidelines for all congregate living 
settings. The purpose of this comparison is to determine if the additional effort entailed in 
implementing TBP and the associated training and coaching result in better outcomes and 
warrant system-wide dissemination. 
 
Hypothesis: TBP will be associated with greater implementation fidelity to COVID-19 
prevention best practices and lower staff and resident rates of COVID-19 and hospitalization 
than GBP. 
 
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 

 
 
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Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
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Persons with SMI and 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 we 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. We do not know (1) optimal practical screening practices for people with SMI and 
ID/DD, (2) how to feasibly and effectively provide isolation in the close shared quarters of group 
homes, (3) how to conduct reliable contract tracing for staff and residents, or (4) how to 
support pragmatic and effective personal protective practices. The proposed study will produce 
actionable results addressing these knowledge gaps that can be immediately implemented 
within the first few months of the project. 
  
RESEARCH DESIGN AND METHODS 
Briefly describe study design and anticipated enrollment, i.e., number of subjects to be enrolled 
by researchers study-wide and by Partners researchers.  Provide a brief summary of the 
eligibility criteria (for example, age range, gender, medical condition).  Include any local site 
restrictions, for example, “Enrollment at Partners will be limited to adults although the sponsor’s 
protocol is open to both children and adults.”
 
Our study will include a target of 400 state-funded congregate care homes for adults with SMI 
(DSM-V Diagnosis of Axis-I Mental Illness with persistent functional impairment) and for adults 
with ID/DD (Intellectual and Developmental Disabilities) (age 18+), operated by public-sector 
community-based human service organizations (Vinfen, Bay Cove, Advocates, North Suffolk, 
Open Sky, and Riverside). We anticipate recruiting up to 450 group homes in order to achieve 
our final sample of 400 group homes that will be appropriately balanced when randomized by 
stratification with respect to 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 

 
 
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non-Hispanic Caucasian versus other). We anticipate that there will be approximately 1400 
residents with SMI and approximately 800 residents with ID/DD in the participating group 
homes. In addition, we anticipate that there will be approximately 3300 group home staff: 
approximately 1650 working in group homes for adults with SMI and approximately 1650 
working in group homes for adults with ID/DD. No human subjects will be enrolled by Partners 
researchers or at Partners sites.  
 
We will employ a cluster-randomized trial design with 200 group homes randomized to the 
implementation of TBP compared to 200 group homes randomized to GBP. 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. There are four main components to Tailored Best Practices: 
Measurement, Feedback, and House Plans; Motivational Interviewing; Interactive Education; 
and Trusted Messengers. Detailed descriptions of each component, along with supplemental 
materials, have been included in this submission in the attached TBP Manual [file name: 
"02_TBP Manual_2021NOV29_clean"]. In brief: 
 
Measurement, Feedback, and House Plans: 
 
Following each completion of the Fidelity survey (described below) by program directors (i.e., 
group home leaders) at baseline, 3-, 6-, 9, and 12-months post-randomization, the group 
home’s program director will receive a statistical dashboard that shows the group home’s 
fidelity performance in relation to other group homes. Visual, group home-level, easy-to-view 
displays will be provided, comparing current measures to prior measures and to the average 
performance and range of performance of other group homes in this study. The benchmarks 
also provide the opportunity for group home managers to discuss potential ways to improve 
and to potentially consult with “high performing” sites on strategies and lessons learned. 
 
After receiving the statistical dashboard, each group home will receive assistance in creating 
and executing a group home-specific House Plan for fidelity performance improvement. We will 
work with the program directors to review areas that need improvement, discuss barriers that 
are preventing each program from increasing their success, set reasonable goals, and identify 
target completion dates. If deemed feasible and appropriate, group homes may receive 
Motivational Benefits (i.e., celebrations, accommodations, or rewards) as part of the House 
Plan. The framing of the House Plan is consistent with mirroring and complementing the global 
goal of resuming highly valued activities and relationships. All group homes will receive the 
Measurement, Feedback, and House Plans component of TBP once every three months for the 
duration of the study following the completion of each program director survey. 
 
Motivational Interviewing: 
 

 
 
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We have adapted the principles of motivational interviewing to focus on COVID-19 prevention 
practices by engaging individuals in discussing personal goals, wellness behavior practices, 
COVID-19 prevention, pros and cons of different approaches, and aligning future prevention 
practice goals with overall personal and group home goals. This component will be delivered 
primarily in small groups with separate sessions for residents and staff. We will also create an 
electronic version of Motivational Interviewing with a prerecorded video that program directors 
may use in their group homes. All residents with SMI and staff will be encouraged to participate 
in an initial motivational interviewing session within the first eight months of the intervention 
and a booster session in the latter seven months of the intervention. 
 
Interactive Education: 
 
The Interactive Education component of TBP will be available to residents and staff in multiple 
forms to accommodate the needs and wants of each group home. Interactive Education 
involves sharing an educational material (e.g., a video, handout, or demonstration) and 
discussion of that material. Interactive Education will be delivered either by 1) program 
directors on their own time or 2) a COVID-19 Physician Expert from the research team during a 
Zoom session. Interactive Education will utilize Educational Toolkits – collections of publicly 
available materials (e.g., flyers, videos, social stories) from reputable sources, such as the CDC 
and the WHO, curated by a COVID-19 Physician Expert in collaboration and with input from 
stakeholders. The Educational Toolkits contain materials that are tailored to our target 
populations, including people with SMI and ID/DD, non-English language speakers, and people 
identifying with racial and ethnic minorities. All residents and staff will receive some form of 
Interactive Education within the first eight months of the intervention and a second dose in the 
latter seven months of the intervention. 
 
Trusted Messengers: 
 
As with Interactive Education, the Trusted Messenger component of TBP may be delivered in 
multiple forms to tailor it to each group home’s unique needs. Data from research and input 
from stakeholders supports the potential value of trusted messengers as a source for 
information and stories of personal experiences that can be highly persuasive in supporting 
personal health behavior change. Video testimonials of peers provide an accessible and scalable 
format for participants to hear from peers, so we have created five Peer Testimonial Videos 
featuring frontline staff, certified peer specialists, residents, and legal guardians telling their 
personal stories with COVID-19 and emphasizing why they chose to receive a COVID-19 vaccine. 
Residents and staff may view these videos during Motivational Interviewing. For residents with 
legal guardians, we will email a video or mail a link to the video to the legal guardians, as 
guardians play a crucial role in the decision for a resident to get vaccinated. Separate from the 
videos, we will encourage participants to serve as trusted messengers for their peers by sharing 
their personal experiences during Motivational Interviewing sessions and other study activities. 
All residents and staff will receive some form of Trusted Messenger within the first eight 
months of the intervention and a second dose in the latter seven months of the intervention. 
 

 
 
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TBP was determined as described in IRB protocols 2020P003803, 2020P003957, and 
2020P000967. In brief, TBP was determined through a process that combined: (1) knowledge 
learned from the community providers on the prior course of COVID-19 in the group homes; (2) 
qualitative data from key informant interviews of residents and staff on the barriers and 
facilitators to using recommended best practices; (3) a validated simulation model to determine 
the comparative effectiveness of different COVID-19 preventive practices (screening, isolation, 
contact tracing, use of PPP, vaccination) using the previously collected data; followed by (4) 
engaging decision-makers and stakeholders in selecting specific priorities for “tailored best 
practices”. The cluster randomized trial will compare the effectiveness of “Tailored Best 
Practices” (TBP) specifically adapted for staff and residents with SMI and ID/DD in congregate 
living settings to “Generic Best Practices” (GBP) consisting of state and federal standard 
guidelines for all congregate living settings. The purpose of this comparison is to determine if 
the additional effort entailed in implementing TBP and the associated training and coaching 
result in better outcomes and warrant system-wide dissemination. 
 
We will engage in several activities to help inform program directors in participating group 
homes about the study. We will 1) draft an email for the CEOs of the six provider organizations 
to send to program directors, including a short video explaining the Fidelity survey; 2) distribute 
flyers to program directors explaining the study; and 3) use a brief slide deck to explain the 
study to program directors. All materials used for these outreach activities have been included 
in this submission as attachments [file names: "00_Project Flyer SMI_2021SEP22", “01_Project 
Flyer IDDD_2021SEP22”, "00_TBP Orientation Slides_2021SEP20", "00_TBP CEO 
Letter_2021SEP22", and "00_PD video_2021SEP20"]. 
 
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 to implement TBP specific to the setting, staff, and residents. Implementation fidelity 
will be measured including the proportion of staff and residents participating in recommended 
screening, isolating, contact tracing, PPP protocols, and vaccination interventions, along with 
the outcomes of new COVID-19 incidence as 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. 
 
At each data collection point, we will evaluate implementation and effectiveness outcomes by 
secondary analysis of routine data collected by our community partners (e.g., dates of COVID-
19 infection, hospitalization, mortality) as well as data from surveys completed by program 
directors (i.e., those who oversee individual group homes) assessing each group home’s fidelity 
and adoption of their assigned set of best practices (TBP or GBP). These fidelity outcomes will 
be assessed at baseline, 3, 6, 9, 12, and 15 months.  
 
We will also send the same fidelity survey to a second staff member at an equivalent level of 
the program director within the same group home (e.g., group home nurses). The purpose of 
this second fidelity survey will be to measure the intra-rater reliability of fidelity measures 

 
 
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within the same group home. If we have ≥ 80% concordance between two raters in the first 
10% of group homes surveyed, we will stop the second survey collection. If the concordance is 
< 80%, we will continue to measure intra-rater reliability, using the same process above, until 
concordance is ≥ 80% or until all group homes are surveyed again, whichever comes first. Re-
training of TBP may occur between time points if concordance is < 80% and areas for 
improvement are identified by our research team.  
 
The fidelity survey data will be collected using REDCap. Individual survey links will be e-mailed 
to the group home managers by the provider organizations who will also provide the group 
home study IDs. Survey responses will be directly submitted back to the MGH research team. 
The provider organizations will not have access to the individual responses. No PHI data will be 
collected as part of the survey. No individual-level group home data will be shared with the 
individual’s employer (provider organization), although overall summary statistics across group 
homes may be shared for quality improvement. 
 
In addition to the data collected at the six time points described above, we will analyze the 
responses of residents, staff, and (where applicable) legal guardians of residents to a short 
Needs Assessment questionnaire at two time points: baseline and 12 months. The needs 
assessment questions have been developed collaboratively with stakeholders and have direct 
value to provider organizations by helping to organize and standardize questions that they 
would otherwise need or want to ask in order to manage COVID at the individual level for 
quality improvement and COVID care planning. The needs assessment will be completed by 
staff, residents, and legal guardians with support as needed by members of the research staff, 
community-based research implementation team, or community-based project managers. The 
Needs Assessment questionnaire data will be collected using REDCap or on paper. Individual 
survey links will be e-mailed, or paper surveys will be delivered to the staff, residents, and legal 
guardians by the provider organizations who will also provide the individual study IDs.  Survey 
responses will be directly submitted back to the research team. The provider organizations will 
not have access to the individual responses. No PHI data will be collected. No individual-level 
data will be shared with the provider organizations, although overall summary statistics across 
group homes may be shared for quality improvement. These data will inform ways to improve 
the TBP intervention package and will provide an evaluation as to how TBP is impacting the 
experiences of individuals. 
 
Consistent with good practice in clinical trials, we will conduct a nine-month interim analysis of 
outcomes by an independent Data and Safety Monitoring Board (DSMB). In the event that 
there is a clinically and statistically significant difference favoring TBP with respect to COVID-19 
incidence and related hospitalizations and/or mortality, the DSMB will have the authority to 
then terminate the randomized trial, and the comparison group will also receive TBP. We would 
then continue to collect scheduled follow-up data at the predetermined points in time and 
conduct appropriate subsequent pre-post analyses. Finally, in the event that the final analysis 
(at the end of the active trial) shows that TBP is superior to GBP, we are committed to providing 
training and implementation support of TBP to the control group homes over the last few 
months of the study. Of note, the cluster randomized trial design was discussed in detail with 

 
 
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the CEOs of our partnering community organizations and, given the safeguards described above 
(continued incorporation by GBP of state-of-the-art recommended best practices; an interim 
analysis and DSMB; and commitment to provide training and accommodation support to all 
group homes if shown to be effective), the CEOs were enthusiastically in support of this final 
study design. 
 
 
 
Briefly describe study procedures.  Include any local site restrictions, for example, “Subjects 
enrolled at Partners will not participate in the pharmacokinetic portion of the study.”  Describe 
study endpoints.
 
The study does not involve recruitment of human subjects at Partners. The sources of material 
for the study include (1) COVID-monitoring data already routinely collected by the participating 
provider organizations, (2) a Fidelity, Adoption, and Adaptation survey that program directors 
will complete through REDCap, and (3) a Needs Assessment questionnaire that will be 
completed by residents, staff, and legal guardians through REDCap or on paper with support (as 
needed) by the community-based implementation team, community-based project managers, 
and research staff. 
 
For (1) COVID-monitoring data already routinely collected by the participating provider 
organizations: At baseline, 3, 6, 9, 12, and 15 months post-baseline, we will request a limited 
data set, as defined in Section 164.514 (e) of the Privacy Rule, whereby our community partners 
will send us routinely collected data that includes dates of COVID-19 events for individual staff 
and residents (i.e., dates of positive test results, hospitalizations, deaths, and vaccinations). We 
will also receive the unique, encrypted identifiers of the group home(s) that residents lived in 
and staff worked in during each 3-month data collection period. For staff who were not initially 

 
 
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included in the secondary data we received from provider organizations as part of IRB protocol 
2020P003803, we will also obtain information on demographic characteristics (e.g., age, 
gender, race/ethnicity, ZIP code). For residents who were not initially included in the secondary 
data we received from provider organizations as part of IRB protocol 2020P003803, we will 
obtain similar information on demographic characteristics, and health status (e.g., diagnoses, 
use of assistive equipment). The data elements we will receive will be associated with only a 
unique, encrypted identifier (detailed below) that will not be linkable with any personal 
identifiable information by the investigative/research team.  
 
For (2) the Fidelity, Adoption, and Adaptation survey, the data elements will consist of 
information at the group home level. At the six time points mentioned above, we will ask all 
program directors to complete the Fidelity, Adoption, and Adaptation survey on behalf of the 
group home at which they work. The fidelity section will consist of questions that evaluate how 
well the group home has adhered to the assigned best practices for five intervention areas: 
screening, isolation, contact tracing, personal protective practices (PPP), and vaccination. For 
example, the fidelity section will ask program directors to report the proportion of residents 
and staff observed to have received the recommended type and frequency of screening.  
 
The adoption section will include 12 questions on the acceptability, appropriateness, and 
feasibility of the assigned best practices. For example, we will ask program directors to score on 
a scale of 1 to 5 how suitable the assigned best practices seem for the group home. The 
adaptation section will include 9 questions where program directors can describe any 
adaptations they have made to the assigned best practices. 
 
We will also send the same fidelity survey to a second staff member at an equivalent level of 
the program director within the same group home (e.g., group home nurses). The purpose of 
this second fidelity survey will be to measure the intra-rater reliability of fidelity measures 
within the same group home. If we have ≥ 80% concordance between two raters in the first 
10% of group homes surveyed, we will stop the second survey collection. If the concordance is 
< 80%, we will continue to measure intra-rater reliability, using the same process above, until 
concordance is ≥ 80% or until all group homes are surveyed again, whichever comes first. Re-
training of TBP may occur between time points if concordance is < 80% and areas for 
improvement are identified by our research team. Prior to February 2022, participants will 
receive a $5 gift card for their participation, and beginning in February 2022, participants will 
receive a $10 gift card for their participation. For the 12-month and 15-month follow-up Fidelity 
surveys (beginning in May 2022), we will implement a raffle process wherein all respondents 
will be entered into the raffle to win one of three $50 gift cards in addition to the $10 they will 
receive for completing the survey. Community research staff at Vinfen and community-based 
project managers will distribute all cards to protect identities from the MGH research team. As 
described above, for (2) these data elements will be linked to the group home, which will be 
identified with only a unique, encrypted identifier (detailed below).  
 
For (3) the Needs Assessment Questionnaire, the data elements collected will be at the 
individual resident and staff levels. All residents, staff, and legal guardians who consent will 

 
 
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complete the Needs Assessment questionnaire over a 2-4 week period at the two time points 
mentioned above. Where applicable, verbal, written, or electronic consent will be first obtained 
from legal guardians of residents before obtaining residents’ assent and administering the 
questionnaire to the residents. The content of the questionnaire has been agreed on between 
MGH researchers and stakeholders. This set of questions is brief (~20 questions) and covers 
three subject areas: (1) knowledge and reported use of COVID-19 protective practices; (2) 
vaccine acceptance and (for refusers) reasons for hesitancy/refusal; and (3) mental health, 
physical health, social support, and vocational secondary impacts of COVID-19. For example, 
respondents may be asked to select from a list the reasons they declined vaccination. We have 
worked with stakeholders to adapt the questionnaire so that it is accessible for the ID/DD 
residents. The ID/DD resident version has now been submitted as an amendment to this 
protocol. The legal guardian version is abbreviated, containing only questions relating to 
vaccines. De-identified data from this needs assessment will help to inform refinement of the 
Tailored Best Practices intervention and will also be provided to the provider organizations to 
support setting program priorities and planning.  
 
The Needs Assessment questionnaire data will be collected using REDCap or on paper (to 
accommodate participants’ needs). For those completing the questionnaire on-line, individual 
survey links will be e-mailed to the staff, residents, and legal guardians by the provider 
organizations who will also provide the individual study IDs. Survey responses will be directly 
submitted back to the MGH research team. For those completing the questionnaire on paper, 
provider organizations will distribute paper copies of the survey and provide the individual 
study IDs. Deidentified survey responses will be handed or mailed directly to the community 
research staff at Vinfen for the purposes of providing remuneration. The community research 
staff at Vinfen will not see any responses, and after remuneration has been provided, they will 
hand-deliver the deidentified paper surveys to the MGH research team.  
 
The provider organizations will not have access to the individual responses. No PHI data will be 
collected. No individual-level data will be shared with the provider organizations, although 
overall summary statistics across group homes may be shared for quality improvement. Our 
community partners will assist in the scheduling of online secure Zoom sessions to provide 
support for questionnaire administration as needed, and they will handle all identifying 
information for participants. Partners researchers who provide assistance in administering the 
Needs Assessment questionnaires will do so virtually and will only know the first name of 
participants. There will be no audio or video recording involved in the questionnaire 
administration. Participants will receive a $10 gift card for their participation; community 
research staff at Vinfen and community-based project managers will distribute the cards to 
protect identities from the MGH research team. If needed, we will provide tablets to our 
community partners pre-programmed with the questionnaire. 
 
For (3) the Needs Assessment Questionnaire, all residents and staff will be identified with only a 
unique, encrypted identifier (detailed below) that will not be linkable with any personal 
identifiable information by the investigative/research team. Where applicable, all legal 
guardians will be identified using the unique, encrypted identifier of their ward. 

 
 
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Consistent with hybrid effectiveness-implementation trials, there are co-primary outcomes: a 
primary effectiveness outcome and a primary implementation outcome. 
 
The primary effectiveness outcome is new COVID-19 group home incidence (new laboratory-
confirmed COVID-19 cases among residents and staff). Secondary effectiveness outcomes are 
rates of hospitalization and mortality.  
 
The primary implementation outcome is Best Practices Fidelity measured by the COVID-19 Best 
Practices Fidelity Measure developed for this project and refined with input from stakeholders 
(uploaded as an attachment to this IRB submission) 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. 
Secondary implementation outcomes (informed by the RE-AIM implementation framework) 
include the following: staff and resident Best Practices Adoption (Acceptability, 
Appropriateness, and Feasibility Measures); Reach (% of homes using TBPs with 80% fidelity); 
and Maintenance (% of homes maintaining 80% fidelity over the 15-month study period). 
 
For studies involving treatment or diagnosis, provide information about standard of care at 
Partners (e.g., BWH, MGH) and indicate how the study procedures differ from standard care.  
Provide information on available alternative treatments, procedures, or methods of diagnosis.
 
N/A. This study does not involve treatment or diagnosis.  
 
Describe how risks to subjects are minimized, for example, by using procedures which are 
consistent with sound research design and which do not unnecessarily expose subjects to risk or 
by using procedures already being performed on the subject for diagnostic or treatment purposes.
 
This proposal involves a cluster-randomized trial design where Tailored Best Practices (TBP) and 
Generic Best Practices (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 primary risk is the potential loss of confidentiality. However, we will implement several 
existing security structures described below to minimize this risk and will only present 
aggregated data.  
 
All COVID-monitoring data, Fidelity, Adoption, and Adaptation survey data, and Needs 
Assessment questionnaire data received from provider organizations during this study will 
exclude personal identifiable information (PII) and we will limit protected health information 
(PHI) to the minimum necessary to attain the project goals to assess the implementation and 

 
 
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effectiveness of TBP compared to GBP in five prevention pillars (i.e., screening, isolation, 
contact tracing, use of PPP, and vaccination).  
 
To protect against loss of confidentiality, in all datasets, sites and subjects will be assigned an 
encrypted study identifier that is distinct from other identifying information. Through identifier 
and PHI multilayered blinding, data transferred to MGH will thus be deidentified. Each of the 6 
provider organizations will be assigned a letter or number series that cannot be used to easily 
identify them. Vinfen, as a primary collaborating provider organization, will hold the 
organizational key used to identify each organization. Each provider organization will keep their 
own key for identifying homes, staff, and residents. For purposes of presentation and 
publication, data will be presented in aggregate form with no cells with fewer than 10 subjects. 
All data will be transmitted from the provider organizations to Massachusetts General Hospital 
using a secure e-mail portal and then stored behind the Massachusetts General Hospital 
firewall in a password-protected folder on a shared research drive. Data will not be stored on 
removable devices (e.g., laptops, external drives), and no persons outside of the study team will 
have access. In addition to security measures (e.g., password protection of files, encoded 
identifiers, network firewalls, and locked, magnetic card secured work premises), investigators 
and staff are required to be CITI certified in Human Subjects Research and sign a confidentiality 
agreement. Data will be transferred to MGH via secure file transfer or through REDCap.  
 
Individuals will receive standard of care for general best practices for COVID-19 prevention in 
the GBP arm and no less than that strategy in the TBP arm. We will convene an independent 
group of experts in a Data Safety Monitoring Board (DSMB) to meet at 9 months into the trial to 
review the interim analysis of outcomes and at 15 months into the trial. The DSMB will monitor 
the recruitment status, adverse events, and follow-up rates and advise the study and make 
recommendations on continuation, modification, or termination of the trial (e.g., early stopping 
rules). In the event that the interim 9-month follow-up analysis reveals a highly clinically and 
statistically significant difference in COVID incidence and related adverse outcomes between 
TBP and GBP, the DSMB will determine if the trial should be halted and if all sites should receive 
TBP. In the event of this determination, we will continue to collect scheduled follow-up data at 
the predetermined points in time and conduct appropriate subsequent pre-post analyses.  
 
Any risks from administering the Needs Assessment questionnaire are minimized by engaging 
residents in settings that are familiar to them. Administration will be conducted by trained 
clinicians and researchers. 
 
Describe explicitly the methods for ensuring the safety of subjects.  Provide objective criteria for 
removing a subject from the study, for example, objective criteria for worsening disease/lack of 
improvement and/or unacceptable adverse events.  The inclusion of objective drop criteria is 
especially important in studies designed with placebo control groups.
 
We request a waiver of written consent from residents and staff for COVID-monitoring data 
because we will receive only limited data sets with no transfer of individually identifiable data 
from participating provider organizations to MGH investigators. This data will be sent to 

 
 
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Partners researchers through the Partners Secure File Transfer Service (PSFTS). We will 
implement a process (detailed below) to ensure proper handling and transfer of protected 
health information (PHI) in the limited data sets from the provider organizations to Partners 
researchers. 
 
Partners researchers will not have any contact with program directors, and there is no PHI data 
collected as part of the survey, so completion of the Fidelity, Adoption, and Adaptation survey 
by program directors will imply consent. The fidelity survey data will be collected using REDCap. 
Individual survey links will be e-mailed to the group home managers by the provider 
organizations who will also provide the group home study IDs. Survey responses will be directly 
submitted back to the MGH research team. The provider organizations will not have access to 
the individual responses. No PHI data will be collected as part of the fidelity survey. The 
introduction to the survey will inform program directors that no individual-level group home 
data will be shared with the individual’s employer (provider organization), although overall 
summary statistics across group homes may be shared for quality improvement.  
 
The major risk to participants who complete the Needs Assessment questionnaire will be 
discomfort with the questions. Study recruitment materials and the preamble to the 
questionnaire inform participants that they can refuse to answer any questions and can 
terminate the questionnaire at any time. For residents who have legal guardians, a legal 
guardian will provide verbal, written, or electronic consent to participate, and verbal assent will 
be gathered from the resident by group home staff before administering the questionnaire. The 
decision to complete the Needs Assessment questionnaire by Frontline Staff will imply consent. 
The decision to complete the Needs Assessment questionnaire by legal guardians will imply 
consent. 
 
All potential participants will be informed that neither their names nor the name of their group 
home or agency will be included in any published reports and that their identities will remain 
confidential with agency and state leadership.  
 
Agency directors will provide written consent for their sites to be included in the study. 
 
To protect against loss of confidentiality, in all datasets, sites and subjects will be assigned an 
encrypted study identifier that is distinct from other identifying information. Through identifier 
and PHI multilayered blinding, data transferred to MGH will thus be deidentified. Each of the 6 
provider organizations will be assigned a letter or number series that cannot be used to easily 
identify them. Vinfen, as a primary collaborating provider organization, will hold the 
organizational key used to identify each organization. Each provider organization will keep their 
own key for identifying homes, staff, and residents. For purposes of presentation and 
publication, data will be presented in aggregate form with no cells with fewer than 10 subjects. 
All data will be transmitted from the provider organizations to Massachusetts General Hospital 
using a secure e-mail portal and then stored behind the Massachusetts General Hospital 
firewall in a password-protected folder on a shared research drive. Data will not be stored on 
removable devices (e.g., laptops, external drives), and no persons outside of the study team will 

 
 
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have access. In addition to security measures (e.g., password protection of files, encoded 
identifiers, network firewalls, and locked, magnetic card secured work premises), investigators 
and staff are required to be CITI certified in Human Subjects Research and sign a confidentiality 
agreement. Data will be transferred to MGH via secure file transfer or through REDCap. 
Specifically regarding the Needs Assessment questionnaires, facilities will manage recruitment 
and MGH researchers will not know the full names of participants. 
 
FORESEEABLE RISKS AND DISCOMFORTS 
Provide a brief description of any foreseeable risks and discomforts to subjects.  Include those 
related to drugs/devices/procedures being studied and/or administered/performed solely for 
research purposes.  In addition, include psychosocial risks, and risks related to privacy and 
confidentiality.  When applicable, describe risks to a developing fetus or nursing infant.
 
The primary risk to subjects is the potential loss of confidentiality, which we believe is minimal 
given the security measures we have in place for data transmission. 
 
EXPECTED BENEFITS 
Describe both the expected benefits to individual subjects participating in the research and the 
importance of the knowledge that may reasonably be expected to result from the study.  Provide 
a brief, realistic summary of potential benefits to subjects, for example, “It is hoped that the 
treatment will result in a partial reduction in tumor size in at least 25% of the enrolled subjects.”  
Indicate how the results of the study will benefit future patients with the disease/condition being 
studied and/or society, e.g., through increased knowledge of human physiology or behavior, 
improved safety, or technological advances.
 
The intent is that subjects in group homes randomized to receive the Tailored Best Practices 
intervention package (TBP) will experience reduced rates of COVID-19 incidence, 
hospitalization, and mortality. Subjects in group homes randomized to receive Generic Best 
Practices (GBP) will not receive any personal health benefits as a result of participation.  
 
This study will advance knowledge on the comparative effectiveness of different strategies and 
implementation approaches for preventing COVID-19, morbidity, and mortality in high-risk 
congregate living environments for staff and people with SMI and IDD/DD. Additionally, this 
study will help determine if the additional effort entailed in implementing TBP and the 
associated training and coaching result in better outcomes and warrant system-wide 
dissemination. This study could also contribute to knowledge on COVID-19 prevention for 
future infectious disease outbreaks in these settings. 
 
EQUITABLE SELECTION OF SUBJECTS 
The risks and benefits of the research must be fairly distributed among the populations that stand 
to benefit from it.  No group of persons, for example, men, women, pregnant women, children, 
and minorities, should be categorically excluded from the research without a good scientific or 
ethical reason to do so.  Please provide the basis for concluding that the study population is 
representative of the population that stands to potentially benefit from this research.

 
 
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It is expected that the recruited sample will resemble the racial/ethnic composition of the 
general population of congregate living facilities in MA. Children will be excluded. No groups of 
persons will be categorically excluded from the study. 
 
When people who do not speak English are excluded from participation in the research, provide 
the scientific rationale for doing so.  Individuals who do not speak English should not be denied 
participation in research simply because it is inconvenient to translate the consent form in 
different languages and to have an interpreter present.
 
N/A. People who do not speak English are not categorically excluded from the study. Upon IRB 
approval, we will obtain certified translations of all study materials into Spanish and Haitian 
Creole. We will then submit the translated materials and the documents with the certification 
of translation to the IRB as an amendment. 
 
For guidance, refer to the following Partners policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English
          http://healthcare.partners.org/phsirb/nonengco.htm
 
 
RECRUITMENT PROCEDURES 
Explain in detail the specific methodology that will be used to recruit subjects.  Specifically 
address how, when, where and by whom subjects will be identified and approached about 
participation.  Include any specific recruitment methods used to enhance recruitment of women 
and minorities.
 
Participants for the Needs Assessment questionnaires will include frontline staff, 
residents with SMI and ID/DD at congregate living settings, and (where applicable) legal 
guardians of residents. The Chief Executive Officers (CEOs) of the 6 community provider 
organizations have expressed their willingness to participate in this study and each provided a 
letter of support for the proposal.  
 
Before completing each questionnaire, all staff, residents, and legal guardians will receive a 
recruitment letter and fact sheet explaining the study and containing all information necessary 
to consent to participate. For individuals whose participation requires consent from a legal 
guardian (consistent with provider organization policies and compliant with EOHHS 
requirements), the Vinfen implementation team will partner with the provider organizations to 
send a recruitment letter and fact sheet to the legal guardian and obtain consent via e-mail or 
postal mail. The community research staff at Vinfen and community-based project managers 
may also call legal guardians to obtain verbal consent for the resident’s participation. All phone 
calls will follow an IRB-approved script. A final assent will be gathered from the participant by 
group home staff at the start of the questionnaire. 
  

 
 
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Provide details of remuneration, when applicable.  Even when subjects may derive medical 
benefit from participation, it is often the case that extra hospital visits, meals at the hospital, 
parking fees or other inconveniences will result in additional out-of-pocket expenses related to 
study participation.  Investigators may wish to consider providing reimbursement for such 
expenses when funding is available
 
Participants in the Needs Assessment questionnaire will receive remuneration in the amount of 
$10 after each completion of the questionnaire. If a participant completes both questionnaires, 
this will amount to a total of $20.  
 
Prior to February 2022, participants completing the fidelity survey will receive remuneration in 
the amount of $5 after each completion of the survey. The baseline, 3-month, and 6-month-
follow-up time points occur prior to February 2022. Beginning in February 2022, participants 
completing the fidelity survey will receive remuneration in the amount of $10 after each 
completion of the survey. The 9-month, 12-month, and 15-month-follow-up time points occur 
after January 2022. If a participant completes all six surveys, this will amount to a total of $45, 
as participants receive $5 each for the first 3 surveys and $10 each for the last 3 surveys. For 
the 12-month and 15-month follow-up Fidelity surveys (beginning May 2022), we will 
implement a raffle process wherein all respondents will be entered into the raffle to win one of 
three $50 gift cards in addition to the $10 they will automatically receive for completing the 
survey. The first pull for a $50 gift card will occur 2.5 weeks into the survey period, including all 
respondents who have completed the survey up to that point. The second pull for a $50 gift 
card will occur 5 weeks into the survey period, again including all respondents who have 
completed the survey up to that point. The third and final pull for a $50 gift card will occur after 
the survey period has concluded, including all respondents who completed the survey. This 
design allows respondents who complete the survey within the first 2.5 weeks to have three 
opportunities to win a $50 gift card; those who complete the survey after the first 2.5 weeks 
but within the first 5 weeks will have two opportunities to win a $50 gift card; and those who 
complete the survey after 5 weeks will have one opportunity to win a $50 gift card. This raffle 
process will be run by community research staff at Vinfen, as they will be responsible for 
remuneration, as described below. 
 
For all surveys and questionnaires completed in REDCap: The last page of the survey in 
REDCap will give participants the opportunity to specify how they would like to receive their gift 
card: via e-mail or (for residents and staff only) in-person. The participant must then provide 
contact information (their e-mail address or the physical address of their group home) to 
receive remuneration. The survey responses will automatically go to MGH, and the contact 
information will automatically go to community research staff at Vinfen. This way, no 
researchers will be able to link the responses to the contact information. If a participant 
chooses to receive the gift card via e-mail, community research staff at Vinfen and community-
based project managers will send an electronic gift card to the provided e-mail address. If a 
participant chooses to receive the gift card in-person (only available for residents and staff), the 
community research staff at Vinfen and community-based project managers will deliver a 

 
 
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physical gift card to the participant at their group home. If the participant is not present at the 
time of delivery, the gift card will be delivered in a sealed envelope to the participant’s mailbox. 
 
For all resident and staff questionnaires completed on paper: We will provide each group 
home with a log to track who has completed the questionnaire on paper. This log will have a 
space for participants to specify how they would like to receive their gift card: via e-mail or in-
person. The participant must also provide their contact information (their e-mail address or the 
physical address of their group home) to receive remuneration. If members of the study team 
are unable to hand-deliver the paper surveys to the group home, group home staff (who will 
have been trained to respect residents’ autonomy and confidentiality regarding the 
questionnaire, as described below) will work with residents to assemble a package and send the 
package to community research staff at Vinfen via postal mail. The package will contain: 1) all 
completed, de-identified paper questionnaires and 2) a sealed envelope containing the log 
sheet. Community research staff at Vinfen will keep the sealed envelope containing the log 
sheet and give the de-identified questionnaires to MGH researchers. This way, no researchers 
will be able to link the responses to the contact information. If a participant chooses to receive 
the gift card via e-mail, community research staff at Vinfen and community-based project 
managers will send an electronic gift card to the provided e-mail address. If a participant 
chooses to receive the gift card in-person, the community research staff at Vinfen and 
community-based project managers will deliver a physical gift card to the participant at their 
group home. If the participant is not present at the time of delivery, the gift card will be 
delivered in a sealed envelope to the participant’s mailbox. 
 
For all legal guardian questionnaires complete on paper: We will provide each legal guardian 
with a form where they can provide their e-mail address to receive remuneration. Legal 
guardians will assemble a package and send the package to community research staff at Vinfen 
via postal mail. The package will contain: 1) the de-identified paper questionnaire and 2) a 
sealed envelope containing the remuneration form (and the consent form for their ward’s 
participation in the Needs Assessment). Community research staff at Vinfen will keep the 
sealed envelope containing the remuneration form and the consent form and give the de-
identified questionnaires to MGH researchers. This way, no researchers will be able to link the 
responses to the contact information. Community research staff at Vinfen and community-
based project managers will send an electronic gift card to the provided e-mail address. 
 
For guidance, refer to the following Partners policies: 
          Recruitment of Research Subjects 
          http://healthcare.partners.org/phsirb/recruit.htm
 
          Guidelines for Advertisements for Recruiting Subjects
          http://healthcare.partners.org/phsirb/advert.htm
 
          Remuneration for Research Subjects
          http://healthcare.partners.org/phsirb/remun.htm
 

 
 
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CONSENT PROCEDURES 
Explain in detail how, when, where, and by whom consent is obtained, and the timing of consent 
(i.e., how long subjects will be given to consider participation).  For most studies involving more 
than minimal risk and all studies involving investigational drugs/devices, a licensed physician 
investigator must obtain informed consent.  When subjects are to be enrolled from among the 
investigators’ own patients, describe how the potential for coercion will be avoided.
 
This study is a cluster-randomized trial design where TBP and GBP will be delivered within each 
agency as part of routine training activities.  
 
Agency directors will provide written consent for their sites to be included in the study. 
 
We request a waiver of written consent from residents and staff for COVID-monitoring data 
because we will receive only limited data sets with no transfer of individually identifiable data 
from participating provider organizations to MGH investigators.  
 
Partners researchers will not have any contact with program directors, and there is no PHI data 
collected as part of the survey, so the decision to complete the Fidelity, Adoption, and 
Adaptation survey by program directors will imply consent. 
 
For the Needs Assessment questionnaires, each time the questionnaires are administered, all 
staff, residents, and legal guardians will receive a recruitment letter and fact sheet explaining 
the study and containing all information necessary to consent to participate. 
 
Frontline Staff Consent: Partners researchers will not have any contact with Staff participants, 
and there is no PHI data collected as part of the questionnaire, so the decision to complete the 
Needs Assessment questionnaire by Frontline Staff will imply consent. 
 
Resident Consent or Consent from Legal Guardian for Resident: MGH researchers, community 
research staff at Vinfen, and community-based project managers will train group home staff to 
administer the survey to residents in a way that respects residents’ autonomy and privacy. This 
training will specifically emphasize that: 1) a resident’s decision to participate or not is 
completely voluntary and staff may not pressure residents in any way and 2) if a resident 
chooses to participate, the resident should feel free to respond to questions however they 
want and not feel pressure from staff to respond in a specific way. For residents whose 
participation requires consent from a legal guardian (consistent with provider organization 
policies and compliant with EOHHS requirements), the Vinfen implementation team will partner 
with the provider organizations to send a recruitment letter and fact sheet to the legal guardian 
and obtain electronic or written consent (yes/no) via e-mail or postal mail. If the legal guardian 
is contacted by e-mail, an on-line form will be included in a secure REDCap link where the legal 
guardian can provide electronic consent for their ward’s participation. The completed 
electronic consent form will go directly to community research staff at Vinfen. If the legal 
guardian is contacted by postal mail, a paper form will be included where the legal guardian can 

 
 
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provide written consent for their ward’s participation. The completed consent form will be sent 
by the legal guardian to community research staff at Vinfen via postal mail. The community 
research staff at Vinfen and community-based project managers may also call legal guardians to 
obtain verbal consent for the resident’s participation. All phone calls will follow an IRB-
approved script. Community research staff at Vinfen and community-based project managers 
will be responsible for documenting and tracking consent from guardians. For residents who 
remain eligible (i.e., excluding residents whose legal guardians did not explicitly provide 
consent), a group home staff member will go through the fact sheet with the resident and 
answer any questions. The staff member will ask the resident if they would like to complete the 
questionnaire, emphasizing that their participation is completely voluntary. If the resident 
provides verbal consent (or assent, if there is a legal guardian) to participate, the staff member 
will provide the resident with a link to the on-line questionnaire or a paper copy of the 
questionnaire. Residents who are non-verbal will provide consent (or assent if there is a legal 
guardian) using their preferred communication strategy (i.e., Yes/No from Augmentative 
Communication Device or Communication Board). This consent (or assent if there is a legal 
guardian) via device will serve as the individual’s “verbal consent”. Group home staff may assist 
in setting residents up at a computer in a private location in the house. Group home staff will 
be available to the resident for technical and logistical assistance while they complete the 
questionnaire, but they will not pressure or influence the resident’s questionnaire responses in 
any way. The resident may ask group home staff to assist in setting up a Zoom call with 
community research staff at Vinfen, community-based project managers, or MGH researchers. 
If a member of the community research staff at Vinfen is present at the group home for study 
activities, they may assist the resident in person upon request. In the event that a group home 
resident has significant cognitive disabilities and judged by the group home director to be 
unable to complete the questionnaire questions (even when assisted), it will be up to the 
discretion of the group home director to determine if the individual is not able to participate. 
The provider organization will also document reasons for non-participation, when applicable.  
 
We will take a number of precautions to prevent residents with legal guardians from mistakenly 
completing the survey without guardian consent. We will complete all guardian outreach prior 
to distributing surveys to residents. After guardian outreach has been completed, each group 
home will receive a packet that contains: an instruction sheet, a recruitment letter, a fact sheet, 
surveys, and a log sheet. The log sheet will be preprinted to only include the names of residents 
who have the necessary consent to complete the survey with a checkbox next to each name to 
indicate if they completed the survey or not. There will be no spaces on the log sheet to add 
additional names. This will inform group home staff who can complete the survey and 
discourage them from adding additional names. The list of names on the log sheet will be 
verified by two members of the community research staff at Vinfen prior to survey distribution 
to ensure that only those with the appropriate consent are on the sheet. Each survey will have 
a cover sheet on which the respondent’s name will be preprinted. In the unlikely event that a 
resident completes the survey without the necessary consent, this will allow us to isolate the 
survey and retain those completed with the necessary consent. This should also make it 
extremely clear to group home staff which residents should receive a survey. When possible, 
community-based project managers and Implementation Coaches will hand deliver these 

 
 
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packets to the group homes and be present while residents complete the survey, ensuring that 
only those with the necessary consent receive a survey. They will then collect all surveys and 
the log sheet in exchange for gift cards (receipts will be signed for gift cards) and deliver them 
to community research staff Vinfen. If a project manager or Implementation Coach is unable to 
hand-deliver a packet, they will mail the packet to the group home. Shortly after delivery, the 
project manager and Implementation Coaches will call the group home’s program director to 
confirm they have received the package, understand the instructions, and know which 
residents may take the survey. Group home staff will be instructed to use the log sheet to verify 
which residents are eligible to complete the survey prior to distributing surveys. Group home 
staff who are less familiar with the residents (e.g., temp staff) will also be instructed to verify 
the resident’s name with the resident prior to giving them the labeled survey. Group home staff 
will check off the boxes on the log sheet next to the names of the residents who completed the 
survey. The group home staff will mail the completed surveys and the log sheet directly to the 
community research staff at Vinfen. Upon receiving the packets, community research staff at 
Vinfen will look at the cover sheet attached to each survey and verify that the resident had the 
necessary consent. They will then remove the cover sheet from the survey and hand-deliver the 
now-deidentified survey to MGH. In the unlikely event that a resident completes the survey 
without the necessary consent, Vinfen will discard the isolated survey. 
 
Legal Guardian Consent: At the same time that legal guardians are asked to consent to allow 
their ward to participate in the Needs Assessment, we will also ask the legal guardians to 
complete a shortened version of the Needs Assessment that focusses exclusively on vaccines. 
Partners researchers will not have any contact with legal guardian participants, and there is no 
individually identifiable data collected as part of the questionnaire, so the decision to complete 
the shortened Needs Assessment questionnaire on vaccines by legal guardians will imply 
consent. 
 
The fact sheet will be provided each time the individual is invited to complete the questionnaire 
and includes the statement that participants can withdraw at any time during the study. During 
informed consent administration, we shall inform participants that they can refuse to answer 
any questions and can terminate the questionnaire at any time. All potential participants will be 
informed that their names and the name of their group home or agency will not be collected 
and will not be included in any published reports and that their identities will remain 
confidential with agency and state leadership. Failure to participate in the questionnaire will 
not affect the services the potential subject receives from DMH and/or DDS or their provider 
organization now or in the future. Failure to participate in the questionnaire also will not affect 
any benefits the potential subject receives now or has a right to receive. 
 
 
NOTE: When subjects are unable to give consent due to age (minors) or impaired decision-
making capacity, complete the forms for Research Involving Children as Subjects of Research 
and/or Research Involving Individuals with Impaired Decision-making Capacity, available on 
the New Submissions page on the PHRC website: 
http://healthcare.partners.org/phsirb/newapp.htm#Newapp

 
 
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For guidance, refer to the following Partners policy: 
          Informed Consent of Research Subjects
          http://healthcare.partners.org/phsirb/infcons.htm
 
 
DATA AND SAFETY MONITORING 
Describe the plan for monitoring the data to ensure the safety of subjects.  The plan should 
include a brief description of (1) the safety and/or efficacy data that will be reviewed; (2) the 
planned frequency of review; and (3) who will be responsible for this review and for determining 
whether the research should be altered or stopped.  Include a brief description of any stopping 
rules for the study, when appropriate.  Depending upon the risk, size and complexity of the 
study, the investigator, an expert group, an independent Data and Safety Monitoring Board 
(DSMB) or others might be assigned primary responsibility for this monitoring activity.        
 
NOTE: Regardless of data and safety monitoring plans by the sponsor or others, the principal 
investigator is ultimately responsible for protecting the rights, safety, and welfare of subjects 
under his/her care.
 
All data will be stored on secure servers at each provider organization and Massachusetts 
General Hospital and will not leave the performance sites; data will not be stored on removable 
devices (e.g., laptops, external drives), and no persons outside of the study team will have 
access. In addition to security measures (e.g., password protection of files, encoded identifiers, 
network firewalls, and locked, magnetic card secured work premises), investigators and staff 
are required to be CITI certified in Human Subjects Research and sign a confidentiality 
agreement.  
 
We will convene an independent group of experts in a Data Safety Monitoring Board (DSMB) to 
meet quarterly for the duration of the trial. The DSMB will monitor the recruitment status, 
adverse events, and follow-up rates and advise the study and make recommendations on 
continuation, modification, or termination of the trial (e.g., early stopping rules). As required by 
PCORI, we will provide preliminary findings within the first year of the study. In the event that 
the interim 9-month follow-up analysis reveals a highly clinically and statistically significant 
difference in COVID incidence and related adverse outcomes between TBP and GBP, the DSMB 
will determine if the trial should be halted and if all sites should receive TBP. In the event of this 
determination, we will continue to collect scheduled follow-up data at the predetermined 
points in time and conduct appropriate subsequent pre-post analyses.  
 
Describe the plan to be followed by the Principal Investigator/study staff for review of adverse 
events experienced by subjects under his/her care, and when applicable, for review of sponsor 
safety reports and DSMB reports.  Describe the plan for reporting adverse events to the sponsor 
and the Partners’ IRB and, when applicable, for submitting sponsor safety reports and DSMB 
reports to the Partners’ IRBs.  When the investigator is also the sponsor of the IND/IDE, include 
the plan for reporting of adverse events to the FDA and, when applicable, to investigators at 
other sites.   
 

 
 
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NOTE: In addition to the adverse event reporting requirements of the sponsor, the principal 
investigator must follow the Partners Human Research Committee guidelines for Adverse Event 
Reporting
 
The PI and co-PI are responsible for routine monitoring of the progress of the research to 
assure that all project members are familiar and comply with human subjects protection. The PI 
and co-PI will assure that all research team members comply with federal regulations with 
respect to the protection of human subjects. A member of the study team will be responsible 
for tracking and reporting unanticipated events. We will convene an independent group of 
experts (DSMB) to meet quarterly for the duration of the trial. The DSMB will monitor the 
recruitment status, adverse events, and follow-up rates and advise the study and make 
recommendations on continuation, modification, or termination of the trial (e.g., early stopping 
rules). 
 
MONITORING AND QUALITY ASSURANCE 
Describe the plan to be followed by the principal investigator/study staff to monitor and assure 
the validity and integrity of the data and adherence to the IRB-approved protocol.  Specify who 
will be responsible for monitoring, and the planned frequency of monitoring.  For example, 
specify who will review the accuracy and completeness of case report form entries, source 
documents, and informed consent.   
 
NOTE: Regardless of monitoring plans by the sponsor or others, the principal investigator is 
ultimately responsible for ensuring that the study is conducted at his/her investigative site in 
accordance with the IRB-approved protocol, and applicable regulations and requirements of the 
IRB.
 
The PI and co-PI are responsible for routine monitoring of the progress of the research to 
assure that all project members are familiar and comply with human subjects protection. The PI 
and co-PI will assure that all research team members comply with federal regulations with 
respect to the protection of human subjects. A member of the study team will be responsible 
for tracking and reporting unanticipated events. 
 
For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance
          http://healthcare.partners.org/phsirb/datasafe.htm
 
          Adverse Event Reporting Guidelines
          http://healthcare.partners.org/phsirb/adverse_events.htm
 
 
PRIVACY AND CONFIDENTIALITY 
Describe methods used to protect the privacy of subjects and maintain confidentiality of data 
collected.  This typically includes such practices as substituting codes for names and/or medical 
record numbers; removing face sheets or other identifiers from completed 
surveys/questionnaires; proper disposal of printed computer data; limited access to study data; 

 
 
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use of password-protected computer databases; training for research staff on the importance of 
confidentiality of data, and storing research records in a secure location.   
 
NOTE: Additional measures, such as obtaining a Certificate of Confidentiality, should be 
considered and are strongly encouraged when the research involves the collection of sensitive 
data, such as sexual, criminal or illegal behaviors.
 
To protect against loss of confidentiality, in all datasets, group homes (i.e., sites) and 
participants will be assigned an encrypted study identifier that is distinct from other identifying 
information. Through identifier and PHI multilayered blinding, data transferred to MGH will 
thus be deidentified. Each of the 6 provider organizations will be assigned a letter or number 
series that cannot be used to easily identify them. Vinfen, as the primary collaborating provider 
organization, will hold the organizational key used to identify each organization. Each provider 
organization will keep their own key for identifying homes, staff, and residents. The keys will 
not be shared with MGH investigators and will be destroyed at the earliest opportunity. For 
purposes of presentation and publication, data will be presented in aggregate form with no 
cells with fewer than 10 subjects. All data will be transmitted from the provided organizations 
to Massachusetts General Hospital using a secure e-mail portal and then stored behind the 
Massachusetts General Hospital firewall in a password-protected folder on a shared research 
drive. Data will not be stored on removable devices (e.g., laptops, external drives), and no 
persons outside of the study team will have access. In addition to security measures (e.g., 
password protection of files, encoded identifiers, network firewalls, and locked, magnetic card 
secured work premises), investigators and staff are required to be CITI certified in Human 
Subjects Research and sign a confidentiality agreement. Data will be transferred to MGH via 
secure file transfer or through REDCap.  
 
For COVID-monitoring data, we will enter into data use agreements with each of our 
community partners prior to receiving the limited data sets, as required by section 164.514(e) 
of the Privacy Rule. The data manager and program coordinator at MGH will then organize a 
security awareness training with the program managers at the provider organizations to ensure 
proper handling and transfer of protected health information (PHI) from the provider 
organizations to Partners researchers. The training will cover the importance of sharing PHI-
data exclusively through the Partners Secure File Transfer Service (PSFTS); directions on how to 
share files through PSFTS; a description of what qualifies as PHI and which PHI is permitted to 
be shared with Partners researchers for this project; and instructions on how to assess files for 
breaches in PHI protocol prior to transferring to MGH. After completing this training, the 
following steps will be taken:  
1. Prior to sharing files with Partners researchers, provider program managers will conduct 
a detailed assessment of the files to ensure compliance with PHI restrictions. 
2. Provider program managers will first send the files (which should already be compliant 
with PHI restrictions) to our community research partners at Vinfen, who will perform 
an additional assessment to ensure compliance with PHI restrictions. Vinfen and the 
other provider organizations already have Business Associate Agreements (BAAs) in 
place to allow this data transfer.    

 
 
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3. Data files will then be transferred from Vinfen to Partners researchers through the 
Partners Secure File Transfer Service (PSFTS).   
4. On receipt of new Data Files, the study Data Manager at MGH will confirm compliance 
with PHI restrictions by reviewing the files for PHI on an encrypted computer. No data 
will be shared to others on the research team until this data review process has been 
conducted.  Once full compliance has been confirmed, the files will be uploaded to a 
secure Dropbox folder for data analysis by IRB approved investigators and staff.  
5. In the event that the Data Manager review determines that restricted PHI has been 
erroneously sent by the provider organizations to Partners researchers, the data 
manager will immediately delete the sensitive information and notify the provider 
organization and IRB. The data manager will then contact the provider program 
manager to establish a corrective plan for data review to ensure that the future data 
transfer process has fully removed restricted PHI before transfer. 
 
Regarding the Needs Assessment questionnaires, informant identities will be known only by 
community partners who will recruit participants within their own organizations. Identifying 
information will be maintained for 7 years after the completion of the data collection (as 
required by PCORI) and then destroyed. All notes and records will be kept on Partners 
encrypted devices to assure the privacy and security of the data. 
 
SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
Specimens or data collected by Partners investigators will be sent to research collaborators 
outside Partners, indicate to whom specimens/data will be sent, what information will be sent, 
and whether the specimens/data will contain identifiers that could be used by the outside 
collaborators to link the specimens/data to individual subjects
 
Mass General Brigham (MGB) researchers will be sharing all data collected as part of this study 
(i.e., secondary data from provider organizations, Fidelity survey data, and Needs Assessment 
survey data) with the Inter-University Consortium for Political and Social Research (ICPSR) at 
the University of Michigan, as required by the Patient-Centered Outcomes Research Institute 
(PCORI), who funds this study. PCORI requires that MGB researchers systematically create and 
preserve the confidential data that was generated from the project in a repository to facilitate 
data sharing. The project data is being sent to ICPSR on a non-exclusive basis for the purpose of 
allowing its Archive to examine and process the materials according to standard Archive 
practices and making the project data available to researchers at other institutions. 
 
All data shared from this study will exclude personal identifiable information (PII) and we will 
limit protected health information (PHI) to the minimum necessary to attain the project goals. 
All group homes, staff, and clients will be identified with only a unique, encrypted identifier 
(detailed above) that will not be linkable with any personal identifiable information by the 
outside collaborators. The only PHI collected is zip code of staff residence and group home. This 
data will be thoroughly cleaned prior to being stored in the repository. 
 

 
 
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 MGB researchers will enter into a Restricted-Use Data Contributor agreement [file name: 
“PCORI Data Contributor Agreement_Skotko_11_1_21 (1)”] with the Regents of the University 
of Michigan on behalf of ICPSR prior to sharing any data. 
 
 
Specifically address whether specimens/data will be stored at collaborating sites outside Partners 
for future use not described in the protocol.  Include whether subjects can withdraw their 
specimens/data, and how they would do so.  When appropriate, submit documentation of IRB 
approval from the recipient institution.
 
As mentioned above,  all data collected as part of this study (i.e., secondary data from provider 
organizations, Fidelity survey data, and Needs Assessment survey data) will be stored in a data 
repository at ICPSR at the University of Michigan, as required by PCORI, who funds this study. 
All data in the repository will be de-identified in accordance with the HIPAA Privacy Rule (45 
C.F.R. § 164.514(b)), so there will be no identifiable information stored in the repository, and 
subjects will not be able to withdraw their de-identified data. 
 
RECEIVING SPECIMENS/DATA FROM RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
When specimens or data collected by research collaborators outside Partners will be sent to 
Partners investigators, indicate from where the specimens/data will be obtained and whether the 
specimens/data will contain identifiers that could be used by Partners investigators to link the 
specimens/data to individual subjects.  When appropriate, submit documentation of IRB 
approval and a copy of the IRB-approved consent form from the institution where the 
specimens/data were collected.
 
Data collected by research collaborators outside Partners sent to Partners investigators involves 
collection of baseline and follow-up data on COVID screening/testing, infection, 
hospitalizations, and deaths; fidelity and adoption of recommended best practices; and COVID 
care quality. All of the data will be collected by participating provider organizations from a 
community sample of 400 group homes within the 6 community provider organizations. No 
residents or staff will be individually identified in these data. In all datasets, sites and subjects 
will be assigned an encrypted study identifier that is distinct from other identifying information.  
 
For all Needs assessment questionnaire participants, the use of identifiers will only be used by 
community partner organizations recruiting within their organization.  
 
Data used for analysis will be identified with a study number only. Data transfer will be secured 
using the SEND SECURE protocol used by Partners Healthcare to transfer encrypted data files 
among collaborators only on an as-needed basis. We restrict access control by limiting user 
accounts to only those connected with our research. We are also vigilant in maintaining 
operating systems and programs by keeping current with security patches and closing off 
unneeded or insecure ports and services. Workstations and servers on the Partners Healthcare 
network are behind a firewall maintained by the Partners Network Security Team. Machines 

 
 
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can only be accessed from behind the firewall or through the Partners VPN service using either 
a pre-assigned digital certificate or an RSASecurID.