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; David Krane; Karen Donelan; Kelly Aschbrenner; Hao D Trieu; Cindy Chau; Anna Wilson; Nicolas M Oreskovic; Kelly Irwin; Lisa I Iezzoni; Haiyi Xie; Ronita Samuels; Paula Silverman; Joey Batson; Ahmed Fathi; Stefanie Gamse; Sibyl Holland; Jessica Wolfe; Kim Shellenberger; Elizabeth Cella; Bruce Bird; Brian G Skotko; Stephen Bartels

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

Contemp Clin Trials. 2023 Feb:125:107053. doi: 10.1016/j.cct.2022.107053. Epub 2022 Dec 17.

Authors

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.

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.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Adult
COVID-19 Vaccines
COVID-19* / prevention & control
Child
Developmental Disabilities
Group Homes
Humans
Randomized Controlled Trials as Topic
SARS-CoV-2

Substances

COVID-19 Vaccines

Associated data

ClinicalTrials.gov/NCT04726371