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
Cite this record
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.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.559 | 0.525 | 0.592 | wilson | |
| Risk in group 2 | 0.563 | 0.529 | 0.596 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00411 | -0.0516 | 0.0434 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.993 | 0.912 | 1.08 | log | |
| Odds ratio, group 1 over group 2 | 0.983 | 0.811 | 1.19 | log | |
| Number needed to treat, for one fewer participant with the outcome on Generic Best Practices (GBP) than on Tailored Best Practices (TBP) | 243 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Generic 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. | 467 | 836 | OG000 |
| Group 2 | Tailored 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. | 471 | 837 | OG001 |
Source ClinicalTrials.gov
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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04726371?tab=results
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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