The HEALing (Helping to End Addiction Long-term SM) Communities Study: Protocol for a cluster randomized trial at the community level to reduce opioid overdose deaths through implementation of an integrated set of evidence-based practices

HEALing Communities Study Consortium

doi:10.1016/j.drugalcdep.2020.108335

The HEALing (Helping to End Addiction Long-term ^SM) Communities Study: Protocol for a cluster randomized trial at the community level to reduce opioid overdose deaths through implementation of an integrated set of evidence-based practices

Drug Alcohol Depend. 2020 Dec 1:217:108335. doi: 10.1016/j.drugalcdep.2020.108335. Epub 2020 Oct 17.

Author

HEALing Communities Study Consortium

Collaborators

HEALing Communities Study Consortium:
Sharon L Walsh¹, Nabila El-Bassel², Rebecca D Jackson³, Jeffrey H Samet⁴, Maneesha Aggarwal², Arnie P Aldridge⁵, Trevor Baker⁶, Carolina Barbosa⁵, Joshua A Barocas⁴, Tracy A Battaglia⁴, Donna Beers⁶, Dana Bernson⁷, Rachel Bowers-Sword⁶, Carly Bridden⁶, Jennifer L Brown⁸, Heather M Bush⁹, Joshua L Bush⁹, Amy Button¹⁰, Aimee N C Campbell², Magdalena Cerda¹¹, Debbie M Cheng¹², Jag Chhatwal¹³, Thomas Clarke¹⁴, Kevin P Conway⁵, Erika L Crable¹², Andrea Czajkowski¹⁵, James L David², Mari-Lynn Drainoni¹², Laura C Fanucchi⁹, Daniel J Feaster¹⁶, Soledad Fernandez³, Darcy Freedman¹⁷, Bridget Freisthler³, Louisa Gilbert², LaShawn M Glasgow⁵, Dawn Goddard-Eckrich², Damara Gutnick¹⁰, Kristin Harlow³, Donald W Helme⁹, Terry Huang¹⁸, Timothy R Huerta³, Timothy Hunt², Ayaz Hyder³, Robin Kerner², Katherine Keyes², Charles E Knott⁵, Hannah K Knudsen⁹, Michael Konstan¹⁷, Marc R Larochelle⁴, R Craig Lefebvre⁵, Frances Levin², Nicky Lewis⁹, Benjamin P Linas⁶, Michelle R Lofwall⁹, David Lounsbury¹⁰, Michael S Lyons⁸, Sarah Mann³, Katherine R Marks⁹, Ann McAlearney³, Kathryn E McCollister¹⁶, Tara McCrimmon², Jennifer Miles⁹, Cortney C Miller¹², Denis Nash¹⁸, Edward Nunes², Emmanuel A Oga⁵, Carrie B Oser⁹, Tracy Plouck¹⁹, Bruce Rapkin¹⁰, Patricia R Freeman⁹, Sandra Rodriguez², Elisabeth Root³, Lisa Rosen-Metsch², Nasim Sabounchi¹⁸, Richard Saitz¹², Pamela Salsberry³, Caroline Savitsky⁶, Bruce R Schackman²⁰, Eric E Seiber³, Michael D Slater³, Svetla Slavova⁹, Drew Speer⁹, Linda Sprague Martinez¹², Leyla F Stambaugh⁵, Michele Staton⁹, Michael D Stein¹², Danelle J Stevens-Watkins⁹, Hilary L Surratt⁹, Jeffery C Talbert⁹, Katherine L Thompson⁹, Kim Toussant³, Nathan A Vandergrift⁵, Jennifer Villani¹⁵, Daniel M Walker³, Alexander Y Walley⁶, Scott T Walters²¹, Philip M Westgate⁹, Theresa Winhusen⁸, Elwin Wu², April M Young⁹, Greg Young³, Gary A Zarkin⁵, Redonna K Chandler¹⁵

Affiliations

¹ University of Kentucky, Lexington, KY, USA. Electronic address: sharon.walsh@uky.edu.
² Columbia University, New York, NY, USA.
³ The Ohio State University, Columbus, OH, USA.
⁴ Boston University, Boston, MA, USA; Boston Medical Center Boston, MA, USA.
⁵ RTI International, Research Triangle Park, NC, USA.
⁶ Boston Medical Center Boston, MA, USA.
⁷ Massachusettes Department of Public Health, Boston, MA, USA.
⁸ University of Cincinnati, Cincinnati, OH, USA.
⁹ University of Kentucky, Lexington, KY, USA.
¹⁰ Montefiore, New Rochelle, NY, USA.
¹¹ New York University, New York, NY, USA.
¹² Boston University, Boston, MA, USA.
¹³ Massachusetts General Hospital, Boston, MA, USA.
¹⁴ Substance Abuse and Mental Health Services Association, Rockville, MD, USA.
¹⁵ National Institute on Drug Abuse, Bethesda, MD, USA.
¹⁶ Miami University, Miami, Florida, USA.
¹⁷ Case Western University, Cleveland, OH, USA.
¹⁸ CUNY, New York, NY, USA.
¹⁹ Ohio University, Athens, OH, USA.
²⁰ Cornell University, New York, NY, USA.
²¹ University of North Texas Health Science Center, Fort Worth, TX, USA.

Abstract

Background: Opioid overdose deaths remain high in the U.S. Despite having effective interventions to prevent overdose deaths, there are numerous barriers that impede their adoption. The primary aim of the HEALing Communities Study (HCS) is to determine the impact of an intervention consisting of community-engaged, data-driven selection, and implementation of an integrated set of evidence-based practices (EBPs) on reducing opioid overdose deaths.

Methods: The HCS is a four year multi-site, parallel-group, cluster randomized wait-list controlled trial. Communities (n = 67) in Kentucky, Massachusetts, New York and Ohio are randomized to active intervention (Wave 1), which starts the intervention in Year 1 or the wait-list control (Wave 2), which starts the intervention in Year 3. The HCS will test a conceptually driven framework to assist communities in selecting and adopting EBPs with three components: 1) a community engagement strategy with local coalitions to guide and implement the intervention; 2) a compendium of EBPs coupled with technical assistance; and 3) a series of communication campaigns to increase awareness and demand for EBPs and reduce stigma. An implementation science framework guides the intervention and allows for examination of the multilevel contexts that promote or impede adoption and expansion of EBPs. The primary outcome, number of opioid overdose deaths, will be compared between Wave 1 and Wave 2 communities during Year 2 of the intervention for Wave 1. Numerous secondary outcomes will be examined.

Discussion: The HCS is the largest community-based implementation study in the field of addiction with an ambitious goal of significantly reducing fatal opioid overdoses.

Keywords: Community engagement; HEALing Communities Study; Helping to End Addiction Long-term; Medications for opioid use disorder (MOUD); Naloxone; Opioid prescribing; Opioid use disorder (OUD); Overdose.

Publication types

Research Support, N.I.H., Extramural

MeSH terms

Behavior, Addictive
Clinical Trial Protocols as Topic*
Drug Overdose / prevention & control
Evidence-Based Practice / methods*
Humans
Massachusetts
New York
Ohio
Opiate Overdose / mortality
Opiate Overdose / prevention & control*
Opioid-Related Disorders / drug therapy
Randomized Controlled Trials as Topic

Abstract

Publication types

MeSH terms

Grants and funding