Trial Outcomes & Findings for Best Practices to Prevent COVID-19 Illness in Staff and People With Serious Mental Illness and Developmental Disabilities in Congregate Living Settings (NCT NCT04726371)
NCT ID: NCT04726371
Last Updated: 2025-02-12
Results Overview
New laboratory-confirmed COVID-19 cases among residents and staff. Measured as new cases per 100 person-months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
415 participants
Primary outcome timeframe
The outcome was measured at baseline, 3-, 6-, 9-, 12-, and 15-months post-baseline.
Results posted on
2025-02-12
Participant Flow
Unit of recruitment and analysis was Group Home (GH). Recruitment occurred between 11/2020-12/2020. CEOs of 6 provider organizations provided letters of commitment to participate in the trial and written consent for their sites to be included. All GHs were included other than those with residents \<=18 years of age and Acquired Brain Injury homes. No individual participants were recruited, provided informed consent, or were enrolled in the study.
No group homes enrolled in the study were excluded before assignment to groups.
Unit of analysis: Group home
Participant milestones
| Measure |
Generic Best Practices (GBP)
The 207 group homes randomized into this arm received the Generic Best Practices (GBP) intervention package as part of routine training activities. GBP consisted of state and federal standard guidelines for COVID-19 mitigation for all congregate living settings.
Generic Best Practices: GBP consisted 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 received 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 did not represent inferior or substandard practice. As findings occurred and as policy led to adjustments in recommendations during the course of the study, the GBP condition incorporated recommendations that were appropriate and up-to-date with CDC and state policy.
|
Tailored Best Practices (TBP)
The 208 group homes randomized into this arm received the Tailored Best Practices (TBP) intervention package as part of routine training activities. TBP consisted of COVID-19 mitigation measures specifically adapted for staff and residents with SMI and ID/DD in congregate living settings. Sites in this arm received coaching specific to the setting, staff, and residents.
Tailored Best Practices: TBP consisted 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 were four main components to Tailored Best Practices: Measurement, Feedback, and House Plans; Motivational Interviewing; Interactive Education; and Trusted Messengers.
|
|---|---|---|
|
Overall Study
STARTED
|
4836 207
|
4538 208
|
|
Overall Study
Residents (Vaccination Analysis)
|
492 207
|
407 208
|
|
Overall Study
Staff (Vaccination Analysis)
|
836 207
|
836 208
|
|
Overall Study
COMPLETED
|
3481 206
|
3262 208
|
|
Overall Study
NOT COMPLETED
|
1355 1
|
1276 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Best Practices to Prevent COVID-19 Illness in Staff and People With Serious Mental Illness and Developmental Disabilities in Congregate Living Settings
Baseline characteristics by cohort
| Measure |
Generic Best Practices (GBP)
n=207 Group homes
The 207 group homes randomized into this arm received the Generic Best Practices (GBP) intervention package as part of routine training activities. GBP consisted of state and federal standard guidelines for COVID-19 mitigation for all congregate living settings.
Generic Best Practices: GBP consisted 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 received 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 did not represent inferior or substandard practice. As findings occurred and as policy led to adjustments in recommendations during the course of the study, the GBP condition incorporated recommendations that were appropriate and up-to-date with CDC and state policy.
|
Tailored Best Practices (TBP)
n=208 Group homes
The 208 group homes randomized into this arm received the Tailored Best Practices (TBP) intervention package as part of routine training activities. TBP consisted of COVID-19 mitigation measures specifically adapted for staff and residents with SMI and ID/DD in congregate living settings. Sites in this arm received coaching specific to the setting, staff, and residents.
Tailored Best Practices: TBP consisted 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 were four main components to Tailored Best Practices: Measurement, Feedback, and House Plans; Motivational Interviewing; Interactive Education; and Trusted Messengers.
|
Total
n=415 Group homes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.54 years
STANDARD_DEVIATION 5.90 • n=207 Group homes
|
44.16 years
STANDARD_DEVIATION 5.84 • n=208 Group homes
|
44.36 years
STANDARD_DEVIATION 5.87 • n=415 Group homes
|
|
Sex/Gender, Customized
Female
|
48.74 percentage of participants
STANDARD_DEVIATION 23.48 • n=207 Group homes
|
49.53 percentage of participants
STANDARD_DEVIATION 23.86 • n=208 Group homes
|
49.13 percentage of participants
STANDARD_DEVIATION 23.65 • n=415 Group homes
|
|
Sex/Gender, Customized
Male
|
49.87 percentage of participants
STANDARD_DEVIATION 23.45 • n=207 Group homes
|
49.20 percentage of participants
STANDARD_DEVIATION 23.78 • n=208 Group homes
|
49.54 percentage of participants
STANDARD_DEVIATION 23.59 • n=415 Group homes
|
|
Sex/Gender, Customized
Other/missing
|
1.40 percentage of participants
STANDARD_DEVIATION 3.75 • n=207 Group homes
|
1.27 percentage of participants
STANDARD_DEVIATION 3.28 • n=208 Group homes
|
1.33 percentage of participants
STANDARD_DEVIATION 3.52 • n=415 Group homes
|
|
Race/Ethnicity, Customized
NH White
|
38.39 percentage of participants
STANDARD_DEVIATION 22.45 • n=207 Group homes
|
35.70 percentage of participants
STANDARD_DEVIATION 22.21 • n=208 Group homes
|
37.06 percentage of participants
STANDARD_DEVIATION 22.35 • n=415 Group homes
|
|
Race/Ethnicity, Customized
NH Black or African-American
|
48.01 percentage of participants
STANDARD_DEVIATION 22.72 • n=207 Group homes
|
51.08 percentage of participants
STANDARD_DEVIATION 22.94 • n=208 Group homes
|
49.53 percentage of participants
STANDARD_DEVIATION 22.86 • n=415 Group homes
|
|
Race/Ethnicity, Customized
Hispanic/Latinx
|
4.70 percentage of participants
STANDARD_DEVIATION 6.41 • n=207 Group homes
|
5.06 percentage of participants
STANDARD_DEVIATION 7.72 • n=208 Group homes
|
4.88 percentage of participants
STANDARD_DEVIATION 7.08 • n=415 Group homes
|
|
Race/Ethnicity, Customized
NH Other
|
4.16 percentage of participants
STANDARD_DEVIATION 6.90 • n=207 Group homes
|
4.37 percentage of participants
STANDARD_DEVIATION 7.27 • n=208 Group homes
|
4.26 percentage of participants
STANDARD_DEVIATION 7.08 • n=415 Group homes
|
|
Race/Ethnicity, Customized
Not answered/Missing
|
4.73 percentage of participants
STANDARD_DEVIATION 7.12 • n=207 Group homes
|
3.79 percentage of participants
STANDARD_DEVIATION 6.16 • n=208 Group homes
|
4.26 percentage of participants
STANDARD_DEVIATION 6.67 • n=415 Group homes
|
|
Division
ID/DD
|
103 Group homes
n=207 Group homes
|
103 Group homes
n=208 Group homes
|
206 Group homes
n=415 Group homes
|
|
Division
SMI
|
104 Group homes
n=207 Group homes
|
105 Group homes
n=208 Group homes
|
209 Group homes
n=415 Group homes
|
PRIMARY outcome
Timeframe: The outcome was measured at baseline, 3-, 6-, 9-, 12-, and 15-months post-baseline.Population: One group home in the GBP arm closed between the 6- and 9-month follow-up periods. The BL sample size here is different than the BL descriptive table. For the BL descriptive table, we assigned participants on an intent-to-treat basis in order to avoid overlap. However, for our analysis, participant allocation was based on the home that they lived or worked in during the study period. Since some staff worked in multiple homes across both arms, the samples are not mutually exclusive.
New laboratory-confirmed COVID-19 cases among residents and staff. Measured as new cases per 100 person-months.
Outcome measures
| Measure |
Generic Best Practices (GBP)
n=207 Group home
The 207 group homes randomized into this arm received the Generic Best Practices (GBP) intervention package as part of routine training activities. GBP consisted of state and federal standard guidelines for COVID-19 mitigation for all congregate living settings.
Generic Best Practices: GBP consisted 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 received 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 did not represent inferior or substandard practice. As findings occurred and as policy led to adjustments in recommendations during the course of the study, the GBP condition incorporated recommendations that were appropriate and up-to-date with CDC and state policy.
|
Tailored Best Practices (TBP)
n=208 Group home
The 208 group homes randomized into this arm received the Tailored Best Practices (TBP) intervention package as part of routine training activities. TBP consisted of COVID-19 mitigation measures specifically adapted for staff and residents with SMI and ID/DD in congregate living settings. Sites in this arm received coaching specific to the setting, staff, and residents.
Tailored Best Practices: TBP consisted 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 were four main components to Tailored Best Practices: Measurement, Feedback, and House Plans; Motivational Interviewing; Interactive Education; and Trusted Messengers.
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|---|---|---|
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New COVID-19 Group Home Incidence
3-month follow-up
|
0.16 New COVID-19 cases per 100 person-months
Interval 0.05 to 0.27
|
0.09 New COVID-19 cases per 100 person-months
Interval 0.01 to 0.17
|
|
New COVID-19 Group Home Incidence
6-month follow-up
|
0.69 New COVID-19 cases per 100 person-months
Interval 0.48 to 0.9
|
0.55 New COVID-19 cases per 100 person-months
Interval 0.4 to 0.7
|
|
New COVID-19 Group Home Incidence
Baseline
|
1.61 New COVID-19 cases per 100 person-months
Interval 1.38 to 1.84
|
1.40 New COVID-19 cases per 100 person-months
Interval 1.2 to 1.6
|
|
New COVID-19 Group Home Incidence
9-month follow-up
|
2.27 New COVID-19 cases per 100 person-months
Interval 2.04 to 2.5
|
2.35 New COVID-19 cases per 100 person-months
Interval 2.12 to 2.59
|
|
New COVID-19 Group Home Incidence
12-month follow-up
|
5.67 New COVID-19 cases per 100 person-months
Interval 5.38 to 5.95
|
5.75 New COVID-19 cases per 100 person-months
Interval 5.45 to 6.06
|
|
New COVID-19 Group Home Incidence
15-month follow-up
|
2.22 New COVID-19 cases per 100 person-months
Interval 1.99 to 2.45
|
2.35 New COVID-19 cases per 100 person-months
Interval 2.12 to 2.58
|
PRIMARY outcome
Timeframe: The outcome will be measured at baseline, 3-, 6-, 9-, 12-, and 15-months post-baseline.Population: Best Practices Fidelity was measured using a voluntary survey completed only by group home Program Directors who consented to participate at each time point. Participant counts are limited to individuals in homes whose Program Directors contributed survey responses during each time period. Participants were assigned to homes based on where they lived or worked during the study period. Since some staff worked in multiple homes across both arms, the samples are not mutually exclusive.
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).
Outcome measures
| Measure |
Generic Best Practices (GBP)
n=199 Group home
The 207 group homes randomized into this arm received the Generic Best Practices (GBP) intervention package as part of routine training activities. GBP consisted of state and federal standard guidelines for COVID-19 mitigation for all congregate living settings.
Generic Best Practices: GBP consisted 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 received 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 did not represent inferior or substandard practice. As findings occurred and as policy led to adjustments in recommendations during the course of the study, the GBP condition incorporated recommendations that were appropriate and up-to-date with CDC and state policy.
|
Tailored Best Practices (TBP)
n=207 Group home
The 208 group homes randomized into this arm received the Tailored Best Practices (TBP) intervention package as part of routine training activities. TBP consisted of COVID-19 mitigation measures specifically adapted for staff and residents with SMI and ID/DD in congregate living settings. Sites in this arm received coaching specific to the setting, staff, and residents.
Tailored Best Practices: TBP consisted 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 were four main components to Tailored Best Practices: Measurement, Feedback, and House Plans; Motivational Interviewing; Interactive Education; and Trusted Messengers.
|
|---|---|---|
|
Best Practices Fidelity
Baseline
|
82.01 score on a scale
Interval 81.46 to 82.57
|
80.27 score on a scale
Interval 79.75 to 80.79
|
|
Best Practices Fidelity
3-month follow-up
|
85.96 score on a scale
Interval 85.47 to 86.45
|
86.11 score on a scale
Interval 85.65 to 86.56
|
|
Best Practices Fidelity
6-month follow-up
|
84.98 score on a scale
Interval 84.42 to 85.54
|
86.14 score on a scale
Interval 85.68 to 86.6
|
|
Best Practices Fidelity
9-month follow-up
|
84.58 score on a scale
Interval 84.07 to 85.09
|
85.24 score on a scale
Interval 84.78 to 85.69
|
|
Best Practices Fidelity
12-month follow-up
|
84.50 score on a scale
Interval 83.94 to 85.06
|
84.69 score on a scale
Interval 84.17 to 85.22
|
|
Best Practices Fidelity
15-month follow-up
|
84.25 score on a scale
Interval 83.66 to 84.84
|
85.28 score on a scale
Interval 84.78 to 85.78
|
PRIMARY outcome
Timeframe: Assessed from April 1 to the date of vaccination (up to June 30, 2022), up to 15 months for each participant.Population: Residents with SMI or ID/DD who were not fully vaccinated by March 31, 2021.
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.
Outcome measures
| Measure |
Generic Best Practices (GBP)
n=492 Participants
The 207 group homes randomized into this arm received the Generic Best Practices (GBP) intervention package as part of routine training activities. GBP consisted of state and federal standard guidelines for COVID-19 mitigation for all congregate living settings.
Generic Best Practices: GBP consisted 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 received 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 did not represent inferior or substandard practice. As findings occurred and as policy led to adjustments in recommendations during the course of the study, the GBP condition incorporated recommendations that were appropriate and up-to-date with CDC and state policy.
|
Tailored Best Practices (TBP)
n=407 Participants
The 208 group homes randomized into this arm received the Tailored Best Practices (TBP) intervention package as part of routine training activities. TBP consisted of COVID-19 mitigation measures specifically adapted for staff and residents with SMI and ID/DD in congregate living settings. Sites in this arm received coaching specific to the setting, staff, and residents.
Tailored Best Practices: TBP consisted 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 were four main components to Tailored Best Practices: Measurement, Feedback, and House Plans; Motivational Interviewing; Interactive Education; and Trusted Messengers.
|
|---|---|---|
|
Full COVID-19 Vaccination Status Among Residents
|
73 Participants
|
77 Participants
|
PRIMARY outcome
Timeframe: Assessed from April 1 to the date of vaccination (up to June 30, 2022), up to 15 months for each participant.Population: Staff who were not fully vaccinated by March 31, 2021.
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.
Outcome measures
| Measure |
Generic Best Practices (GBP)
n=836 Participants
The 207 group homes randomized into this arm received the Generic Best Practices (GBP) intervention package as part of routine training activities. GBP consisted of state and federal standard guidelines for COVID-19 mitigation for all congregate living settings.
Generic Best Practices: GBP consisted 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 received 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 did not represent inferior or substandard practice. As findings occurred and as policy led to adjustments in recommendations during the course of the study, the GBP condition incorporated recommendations that were appropriate and up-to-date with CDC and state policy.
|
Tailored Best Practices (TBP)
n=837 Participants
The 208 group homes randomized into this arm received the Tailored Best Practices (TBP) intervention package as part of routine training activities. TBP consisted of COVID-19 mitigation measures specifically adapted for staff and residents with SMI and ID/DD in congregate living settings. Sites in this arm received coaching specific to the setting, staff, and residents.
Tailored Best Practices: TBP consisted 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 were four main components to Tailored Best Practices: Measurement, Feedback, and House Plans; Motivational Interviewing; Interactive Education; and Trusted Messengers.
|
|---|---|---|
|
Full COVID-19 Vaccination Status Among Staff
|
467 Participants
|
471 Participants
|
Adverse Events
Generic Best Practices (GBP)
Serious events: 16 serious events
Other events: 0 other events
Deaths: 1 deaths
Tailored Best Practices (TBP)
Serious events: 11 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Generic Best Practices (GBP)
n=2059 participants at risk
The 207 group homes randomized into this arm received the Generic Best Practices (GBP) intervention package as part of routine training activities. GBP consisted of state and federal standard guidelines for COVID-19 mitigation for all congregate living settings.
Generic Best Practices: GBP consisted 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 received 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 did not represent inferior or substandard practice. As findings occurred and as policy led to adjustments in recommendations during the course of the study, the GBP condition incorporated recommendations that were appropriate and up-to-date with CDC and state policy.
|
Tailored Best Practices (TBP)
n=1777 participants at risk
The 208 group homes randomized into this arm received the Tailored Best Practices (TBP) intervention package as part of routine training activities. TBP consisted of COVID-19 mitigation measures specifically adapted for staff and residents with SMI and ID/DD in congregate living settings. Sites in this arm received coaching specific to the setting, staff, and residents.
Tailored Best Practices: TBP consisted 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 were four main components to Tailored Best Practices: Measurement, Feedback, and House Plans; Motivational Interviewing; Interactive Education; and Trusted Messengers.
|
|---|---|---|
|
Infections and infestations
Inpatient hospitalization due to COVID-19 infection
|
0.78%
16/2059 • Adverse event data were collected from baseline through 15-month follow-up, totaling 1 year and 6 months.
The adverse event data collected for this study includes COVID-19-related events. All deaths and hospitalizations in the data were caused by COVID-19, meaning deaths and hospitalization unrelated to COVID-19 were not included. Furthermore, the adverse events data only include adverse events for group home residents and not for group home staff.
|
0.62%
11/1777 • Adverse event data were collected from baseline through 15-month follow-up, totaling 1 year and 6 months.
The adverse event data collected for this study includes COVID-19-related events. All deaths and hospitalizations in the data were caused by COVID-19, meaning deaths and hospitalization unrelated to COVID-19 were not included. Furthermore, the adverse events data only include adverse events for group home residents and not for group home staff.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Stephen Bartels
The Mongan Institute at Massachusetts General Hospital
Phone: 617-726-5213
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place