. 2023 Feb:125:107053.

doi: 10.1016/j.cct.2022.107053. Epub 2022 Dec 17.

Best practices to reduce COVID-19 in group homes for individuals with serious mental illness and intellectual and developmental disabilities: Protocol for a hybrid type 1 effectiveness-implementation cluster randomized trial

Julie H Levison¹, David Krane², Karen Donelan², Kelly Aschbrenner³, Hao D Trieu², Cindy Chau², Anna Wilson², Nicolas M Oreskovic⁴, Kelly Irwin⁵, Lisa I Iezzoni², Haiyi Xie⁶, Ronita Samuels², Paula Silverman⁷, Joey Batson⁷, Ahmed Fathi⁷, Stefanie Gamse⁷, Sibyl Holland⁷, Jessica Wolfe⁷, Kim Shellenberger⁷, Elizabeth Cella⁷, Bruce Bird⁷, Brian G Skotko⁸, Stephen Bartels⁹

Affiliations

¹ Harvard Medical School, Massachusetts General Hospital, Mongan Institute, 100 Cambridge St, Suite 1600, Boston, MA 02114, USA; Harvard Medical School, Massachusetts General Hospital, Department of Medicine, 55 Fruit St, Gray 7-730, Boston, MA 02114, USA. Electronic address: jlevison@partners.org.
² Harvard Medical School, Massachusetts General Hospital, Mongan Institute, 100 Cambridge St, Suite 1600, Boston, MA 02114, USA.
³ Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Medical Center, Department of Psychiatry, One Medical Center Drive, Lebanon, NH 03756, USA.
⁴ Harvard Medical School, Massachusetts General Hospital, Department of Medicine, 55 Fruit St, Gray 7-730, Boston, MA 02114, USA; Harvard Medical School, Massachusetts General Hospital, Department of Pediatrics, Division of Medical Genetics and Metabolism, Down Syndrome Program, 125 Nashua Street, Suite 821, Boston, MA 02114, USA.
⁵ Harvard Medical School, Massachusetts General Hospital, Department of Psychiatry, 55 Fruit Street, Boston, MA 02114, USA.
⁶ Geisel School of Medicine at Dartmouth, Department of Biomedical Data Science, Williamson Translational Research Building, Third Floor, HB 7261, 1 Medical Center Drive, Lebanon, NH 03756, USA.
⁷ Vinfen Corporation, 950 Cambridge Street, Cambridge, MA 02141, USA.
⁸ Harvard Medical School, Massachusetts General Hospital, Department of Pediatrics, Division of Medical Genetics and Metabolism, Down Syndrome Program, 125 Nashua Street, Suite 821, Boston, MA 02114, USA; Harvard Medical School, Massachusetts General Hospital, Department of Pediatrics, 55 Fruit Street, Boston, MA 02214, USA.
⁹ Harvard Medical School, Massachusetts General Hospital, Mongan Institute, 100 Cambridge St, Suite 1600, Boston, MA 02114, USA; Harvard Medical School, Massachusetts General Hospital, Department of Medicine, 55 Fruit St, Gray 7-730, Boston, MA 02114, USA.

PMID: 36539061
PMCID: PMC9758744
DOI: 10.1016/j.cct.2022.107053

Best practices to reduce COVID-19 in group homes for individuals with serious mental illness and intellectual and developmental disabilities: Protocol for a hybrid type 1 effectiveness-implementation cluster randomized trial

Julie H Levison et al. Contemp Clin Trials. 2023 Feb.

. 2023 Feb:125:107053.

doi: 10.1016/j.cct.2022.107053. Epub 2022 Dec 17.

Authors

Affiliations

¹ Harvard Medical School, Massachusetts General Hospital, Mongan Institute, 100 Cambridge St, Suite 1600, Boston, MA 02114, USA; Harvard Medical School, Massachusetts General Hospital, Department of Medicine, 55 Fruit St, Gray 7-730, Boston, MA 02114, USA. Electronic address: jlevison@partners.org.
² Harvard Medical School, Massachusetts General Hospital, Mongan Institute, 100 Cambridge St, Suite 1600, Boston, MA 02114, USA.
³ Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Medical Center, Department of Psychiatry, One Medical Center Drive, Lebanon, NH 03756, USA.
⁴ Harvard Medical School, Massachusetts General Hospital, Department of Medicine, 55 Fruit St, Gray 7-730, Boston, MA 02114, USA; Harvard Medical School, Massachusetts General Hospital, Department of Pediatrics, Division of Medical Genetics and Metabolism, Down Syndrome Program, 125 Nashua Street, Suite 821, Boston, MA 02114, USA.
⁵ Harvard Medical School, Massachusetts General Hospital, Department of Psychiatry, 55 Fruit Street, Boston, MA 02114, USA.
⁶ Geisel School of Medicine at Dartmouth, Department of Biomedical Data Science, Williamson Translational Research Building, Third Floor, HB 7261, 1 Medical Center Drive, Lebanon, NH 03756, USA.
⁷ Vinfen Corporation, 950 Cambridge Street, Cambridge, MA 02141, USA.
⁸ Harvard Medical School, Massachusetts General Hospital, Department of Pediatrics, Division of Medical Genetics and Metabolism, Down Syndrome Program, 125 Nashua Street, Suite 821, Boston, MA 02114, USA; Harvard Medical School, Massachusetts General Hospital, Department of Pediatrics, 55 Fruit Street, Boston, MA 02214, USA.
⁹ Harvard Medical School, Massachusetts General Hospital, Mongan Institute, 100 Cambridge St, Suite 1600, Boston, MA 02114, USA; Harvard Medical School, Massachusetts General Hospital, Department of Medicine, 55 Fruit St, Gray 7-730, Boston, MA 02114, USA.

PMID: 36539061
PMCID: PMC9758744
DOI: 10.1016/j.cct.2022.107053

Abstract

Background: People with serious mental illness (SMI) and intellectual disabilities and/or developmental disabilities (ID/DD) living in group homes (GHs) and residential staff are at higher risk for COVID-19 infection, hospitalization, and death compared with the general population.

Methods: We describe a hybrid type 1 effectiveness-implementation cluster randomized trial to assess evidence-based infection prevention practices to prevent COVID-19 for residents with SMI or ID/DD and the staff in GHs. The trial will use a cluster randomized design in 400 state-funded GHs in Massachusetts for adults with SMI or ID/DD to compare effectiveness and implementation of "Tailored Best Practices" (TBP) consisting of evidence-based COVID-19 infection prevention practices adapted for residents with SMI and ID/DD and GH staff; to "General Best Practices" (GBP), consisting of required standard of care reflecting state and federal standard general guidelines for COVID-19 prevention in GHs. External (i.e., community-based research staff) and internal (i.e., GH staff leadership) personnel will facilitate implementation of TBP. The primary effectiveness outcome is incident SARS-CoV-2 infection and secondary effectiveness outcomes include COVID-19-related hospitalizations and mortality in GHs. The primary implementation outcomes are fidelity to TBP and rates of COVID-19 vaccination. Secondary implementation outcomes are adoption, adaptation, reach, and maintenance. Outcomes will be assessed at baseline, 3-, 6-, 9-, 12-, and 15-months post-randomization.

Conclusions: This study will advance knowledge on comparative effectiveness and implementation of two different strategies to prevent COVID-19-related infection, morbidity, and mortality and promote fidelity and adoption of these interventions in high-risk GHs for residents with SMI or ID/DD and staff.

Clinical trial registration number: NCT04726371.

Keywords: COVID-19; Coronavirus; Developmental disabilities; Group homes; Intellectual disabilities; Serious mental illness.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Skotko occasionally consults on the topic of Down syndrome through Gerson Lehrman Group. He receives remuneration from Down syndrome non-profit organizations for speaking engagements and associated travel expenses. Dr. Skotko receives annual royalties from Woodbine House, Inc., for the publication of his book, Fasten Your Seatbelt: A Crash Course on Down Syndrome for Brothers and Sisters. Within the past two years, he has received research funding from F. Hoffmann-La Roche, Inc., AC Immune, and LuMind Research Down Syndrome Foundation to conduct clinical trials for people with Down syndrome. Dr. Skotko is occasionally asked to serve as an expert witness for legal cases where Down syndrome is discussed. Dr. Skotko serves in a non-paid capacity on the Honorary Board of Directors for the Massachusetts Down Syndrome Congress and the Professional Advisory Committee for the National Center for Prenatal and Postnatal Down Syndrome Resources. Dr. Skotko has a sister with Down syndrome.

Figures

**Fig. 1**
Hybrid type 1 effectiveness-implementation cluster randomized trial design. Abbreviations: ID/DD: Intellectual and/or developmental disabilities; SMI: Serious mental illness.

**Fig. 2**
Logic Model for the Assessment of COVID-19 Effectiveness and Implementation Outcomes.

**Fig. 3**
COVID-19 Best Practices Fidelity Dashboard.

See this image and copyright information in PMC

References

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1. CDC Health Care for Individuals with Intellectual Disabilities, Cent. Dis. Control Prev. 2019. https://www.cdc.gov/grand-rounds/pp/2019/20191015-intellectual-disabilit... (accessed July 11, 2022)
1. FY 2017 RISP Infographics | How Many People with Intellectual or Developmental Disabilities Live in the United States? 2020. https://publications.ici.umn.edu/risp/2017/infographics/people-with-idd-... (accessed August 12, 2022)
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Best practices to reduce COVID-19 in group homes for individuals with serious mental illness and intellectual and developmental disabilities: Protocol for a hybrid type 1 effectiveness-implementation cluster randomized trial

Affiliations

Best practices to reduce COVID-19 in group homes for individuals with serious mental illness and intellectual and developmental disabilities: Protocol for a hybrid type 1 effectiveness-implementation cluster randomized trial

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Substances

Associated data

LinkOut - more resources

Full Text Sources

Medical

Research Materials

Miscellaneous