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Comparison · NCT04726371-bbf244f5

Generic Best Practices (GBP) vs Tailored Best Practices (TBP): Full COVID-19 Vaccination Status Among Staff

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Generic Best Practices (GBP) vs Tailored Best Practices (TBP): Full COVID-19 Vaccination Status Among Staff. Trial comparisons, record NCT04726371-bbf244f5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04726371-bbf244f5

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.5590.5250.592wilson
Risk in group 20.5630.5290.596wilson
Risk difference, group 1 minus group 2-0.00411-0.05160.0434newcombe hybrid score
Risk ratio, group 1 over group 20.9930.9121.08log
Odds ratio, group 1 over group 20.9830.8111.19log
Number needed to treat, for one fewer participant with the outcome on Generic Best Practices (GBP) than on Tailored Best Practices (TBP)243from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Generic Best Practices (GBP)
The \~200 group homes randomized into this arm will receive the Generic Best Practices (GBP) intervention package as part of routine training activities. GBP consists of state and federal standard guidelines for COVID-19 mitigation for all congregate living settings.~Generic Best Practices: GBP consists of (1) Massachusetts Executive Office of Health and Human Services distribution of standard guidelines and policies for public health prevention and management of COVID and (2) standard virtual training of the staff of the group homes in these generic COVID-19 prevention practices including recommended use of hand washing, use of PPE, and symptom-triggered screening. Group homes randomized to this intervention will receive standard recommended and fully vetted best practices with respect to preventing and managing COVID-19 based on recommendations by the CDC and on consultation with leading national experts in infectious disease working with the Commonwealth of Massachusetts. The control condition does not represent inferior or substandard practice. As findings occur and as policy leads to adjustments in recommendations during the course of the study, the GBP condition will incorporate recommendations that are appropriate and up-to-date with CDC and state policy.
467836OG000
Group 2Tailored Best Practices (TBP)
The \~200 group homes randomized into this arm will receive the Tailored Best Practices (TBP) intervention package as part of routine training activities. TBP consists of COVID-19 mitigation measures specifically adapted for staff and residents with SMI and ID/DD in congregate living settings. Sites in this arm will receive coaching specific to the setting, staff, and residents.~Tailored Best Practices: TBP consists of optimized, tailored, and highly specific COVID-19 best practices and training materials specific to the setting, staff, and residents with SMI and ID/DD in congregate living settings based on the comparative effectiveness of different types, intensities, and combinations of COVID-19 prevention practices (screening, isolation, contact tracing, use of PPP, vaccination) specifically modeled for residents and staff of congregate living settings for people with ID/DD and SMI derived by a simulation model. Results from this modeling process will be provided to stakeholders to support decision makers in prioritizing resources and practices with the greatest impact on reducing COVID-19 tailored for people with SMI and ID/DD in congregate living settings. This process to determine the content of TBP will occur as part of this study prior to randomization.
471837OG001

Outcome

Type
PRIMARY
Title
Full COVID-19 Vaccination Status Among Staff
Description
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.
Time frame
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.

Source ClinicalTrials.gov

Trial

Title
Best Practices to Prevent COVID-19 Illness in Staff and People With Serious Mental Illness and Developmental Disabilities in Congregate Living Settings
NCT number
NCT04726371
Phases
NA
Conditions
Intellectual Disability, Developmental Disability, Axis I Diagnosis, Mental Illness, Covid19, Coronavirus
Interventions
Generic Best Practices, Tailored Best Practices
Lead sponsor
Massachusetts General Hospital
Results first posted
2025-02-12

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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