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The HEALing Communites Study: A special issue of Drug and Alcohol Dependence

Published in December 2020 this special issue of Drug and Alcohol Dependence features a collection of papers introducing the design and implementation of HEALing Communities Study.

Introduction to the special issue on the HEALing Communities Study

Nabila El-Bassel, Rebecca D. Jackson, Jeffery Samet, and Sharon L. Walsh

Drug and Alcohol Dependence

Published December 2020 (Open Access) https://doi.org/10.1016/j.drugalcdep.2020.108327

Abstract

The severity of the overdose epidemic underscores the urgent need for innovative and high impact interventions that promote the rapid penetration and scale up of evidence-based practices (EBPs) in communities profoundly affected by fatal opioid overdose. This special issue shares scientific advancements in implementation research design and evaluation of a novel data-driven community-based intervention. The HEALing (Helping End Addiction Long-Term) Communities Study (HCS) is a four-year study that is designed to examine the effectiveness of the Communities That HEAL (CTH) intervention. The CTH intervention supports the dissemination of EBPs in 67 communities across four high-burdened states—Kentucky, Massachusetts, New York, and Ohio. The diversity in these communities in terms of rural-urban status, race-ethnicity and other social determinants of health facilitates generalizability of results to other communities across the US.

The nine papers in this special issue describe critical elements that constitute the HCS framework and design. This includes the implementation of EBPs that have a substantial impact on fatal and non-fatal opioid overdose, the Opioid-overdose Reduction Continuum of Care Approach, communication campaigns to increase awareness and demand for EBPs and reduce stigma against people with OUD and MOUD interventions, and the process of community engagement. This includes how to form community coalitions and gain their commitment, and steps taken to mobilize coalitions to pursue EBP implementation and ensure EBPs are adapted for community needs.

The collective papers in this issue demonstrate that the design of any complex study must adapt to unanticipated temporal events, including the rapidly emerging COVID-19 crisis. Readers will learn about the scientific process of the design and implementation of a community-engaged intervention, its methodologies, guiding conceptual models, and research implementation strategies that can be applied to address other health issues.

Addressing opioid overdose deaths: The vision for the HEALing communities study

Redonna K. Chandler, Jennifer VIllani, Thomas Clarke, Elinore F. McCance-Katz, and Nora D. Volkow

Drug and Alcohol Dependence

Published December 2020 (Open Access) https://doi.org/10.1016/j.drugalcdep.2020.108329

Abstract

The United States is facing two devastating public health crises– the opioid epidemic and the COVID-19 pandemic. Within this context, one of the most ambitious implementation studies in addiction research is moving forward. Launched in May 2019, the HEALing Communities Study (HCS) was developed by the National Institutes of Health (NIH) and the Substance Abuse and Mental Health Services Administration (SAMHSA) as part of the Helping to End Addiction Long-termSM Initiative (National Institutes of Health, 2020). The goal for this research was to reduce opioid overdose deaths by 40 % in three years by enhancing and integrating the delivery of multiple evidence-based practices (EBPs) with proven effectiveness in reducing opioid overdose deaths across health care, justice, and community settings. This paper describes the initial vision, goals, and objectives of this initiative; the impact of COVID-19; and the potential for knowledge to be generated from HCS at the intersection of an unrelenting epidemic of opioid misuse and overdoses and the ravishing COVID-19 pandemic.

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

The HEALing Communities Study Consortium

University of Kentucky Contributing Authors: Sharon L. Walsh, Heather M. Bush, Joshua L. Bush, Laura C. Fanucchi, Donald W. Helme, Hannah K. Knudsen, Nicky Lewis, Michelle R. Lofwall, Katherine R. Marks, Jennifer Miles, Carrie B. Oser, Patricia R. Freeman, Svetla Slavova, Drew Speer, Michele Staton, Danelle J. Stevens-Watkins, Hilary L. Surratt, Jeffery C. Talbert, Katherine L. Thompson, Philip M. Westgate, April M. Young

Drug and Alcohol Dependence

Published December 2020 (Open Access) https://doi.org/10.1016/j.drugalcdep.2020.108335

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.

Community engagement to implement evidence-based practices in the HEALing communities study

Linda Sprague Martinez, Bruce D. Rapkin, April Young, Bridget Freisthler, LaShawn Glasgow, Tim Hunt, Pamela J. Salsberry, Emmanuel A. Oga, Amanda Fallin-Bennett, Tracy J. Plouck, Mari-Lynn Drainoni, Patricia R. Freeman, Hilary Surratt, Jennifer Gulley, Greer A. Hamilton, Paul Bowman, Carter A. Roeber, Nabila El-Bassel, and Tracy Battaglia

Drug and Alcohol Dependence

Published December 2020 (Open Access) https://doi.org/10.1016/j.drugalcdep.2020.108326

 

Background

The implementation of evidence-based practices to reduce opioid overdose deaths within communities remains suboptimal. Community engagement can improve the uptake and sustainability of evidence-based practices. The HEALing Communities Study (HCS) aims to reduce opioid overdose deaths through the Communities That HEAL (CTH) intervention, a community-engaged, data-driven planning process that will be implemented in 67 communities across four states.

Methods

An iterative process was used in the development of the community engagement component of the CTH. The resulting community engagement process uses phased planning steeped in the principles of community based participatory research. Phases include: 0) Preparation, 1) Getting Started, 2) Getting Organized, 3) Community Profiles and Data Dashboards, 4) Community Action Planning, 5) Implementation and Monitoring, and 6) Sustainability Planning.

The Opioid-overdose Reduction Continuum of Care Approach (ORCCA): Evidence-based practices in the HEALing Communities Study

Theresa Winhusen, Alexander Walley, Laura C. Fanucchi, Tim Hunt, Mike Lyons, Michelle Lofwall, Jennifer L. Brown, Patricia R. Freeman, Edward Nunes, Donna Beets, Richard Saitz, Leyla Stambaugh, Emmanuel A. Oga, Nicole Herron, Trevor Baker, Christopher D. Cook, Monica F. Roberts, Daniel P. Alford, Joanna L. Starrels, and Redonna K. Chandler

Drug and Alcohol Dependence

Published December 2020 (Open Access) https://doi.org/10.1016/j.drugalcdep.2020.108325

Background

The number of opioid-involved overdose deaths in the United States remains a national crisis. The HEALing Communities Study (HCS) will test whether Communities That HEAL (CTH), a community-engaged intervention, can decrease opioid-involved deaths in intervention communities (n = 33), relative to wait-list communities (n = 34), from four states. The CTH intervention seeks to facilitate widespread implementation of three evidence-based practices (EBPs) with the potential to reduce opioid-involved overdose fatalities: overdose education and naloxone distribution (OEND), effective delivery of medication for opioid use disorder (MOUD), and safer opioid analgesic prescribing. A key challenge was delineating an EBP implementation approach useful for all HCS communities.

Methods

A workgroup composed of EBP experts from HCS research sites used literature reviews and expert consensus to: 1) compile strategies and associated resources for implementing EBPs primarily targeting individuals 18 and older; and 2) determine allowable community flexibility in EBP implementation. The workgroup developed the Opioid-overdose Reduction Continuum of Care Approach (ORCCA) to organize EBP strategies and resources to facilitate EBP implementation.

Health communication campaigns to drive demand for evidence-based practices and reduce stigma in the HEALing communities study

R. Craig Lefebvre, Redonna K. Chandler, Donald W. Helme, Robin Kerner, Sarah Mann, Michael D. Stein, Jennifer Reynolds, Michael D. Slater, Amrachi R. Anakaraonye, Dacia Beard, Olivia Burrus, Jenna Frkovich, Haley Hedrick, Nicky Lewis, and Emma Rodgers

Drug and Alcohol Dependence

Published December 2020 (Open Access) https://doi.org/10.1016/j.drugalcdep.2020.108338

Background

The HEALing Communities Study (HCS) is testing whether the Communities that Heal (CTH) intervention can decrease opioid overdose deaths through the implementation of evidence-based practices (EBPs) in highly impacted communities. One of the CTH intervention components is a series of communications campaigns to promote the implementation of EBPs, increase demand for naloxone and medications for opioid use disorder (MOUD), and decrease stigma toward people with opioid use disorder and the use of EBPs, especially MOUD. This paper describes the approach to developing and executing these campaigns.

Model and approach for assessing implementation context and fidelity in the HEALing Communities Study

Hannah K. Knudsen, Mari-Lynn Drainoni, Louisa Gilbert, Timothy R. Huerta, Carrie B. Oser, Alison M. Aldrich, Aimee N.C. Campbell, Erika L. Crable, Bryan R. Garner, LaShawn M. Glasgow, Dawn Goddard-Eckrich, Katherine R. Marks, Ann Scheck McAlearney, Emmanuel A. Oga, Airel L. Scalise, and Daniel M. Walker

Drug and Alcohol Dependence

Published December 2020 (Open Access) https://doi.org/10.1016/j.drugalcdep.2020.108330

Background

In response to the U.S. opioid epidemic, the HEALing (Helping to End Addiction Long-termSM) Communities Study (HCS) is a multisite, wait-listed, community-level cluster-randomized trial that aims to test the novel Communities That HEAL (CTH) intervention, in 67 communities. CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths. We present the rationale for and adaptation of the RE-AIM/PRISM framework and methodological approach used to capture the CTH implementation context and to evaluate implementation fidelity.

Community dashboards to support data-informed decision-making in the HEALing communities study

Elwin Wu, Jennifer Villani, Alissa Davis, Naleef Fareed, Daniel R. Harris, Timothy R. Huerta, Marc R. LaRochelle, Cortney C. Miller, and Emmanuel A. Oga

Drug and Alcohol Dependence

Published December 2020 (Open Access) https://doi.org/10.1016/j.drugalcdep.2020.108331

Background

With opioid misuse, opioid use disorder (OUD), and opioid overdose deaths persisting at epidemic levels in the U.S., the largest implementation study in addiction research—the HEALing Communities Study (HCS)—is evaluating the impact of the Communities That Heal (CTH) intervention on reducing opioid overdose deaths in 67 disproportionately affected communities from four states (i.e., “sites”). Community-tailored dashboards are central to the CTH intervention’s mandate to implement a community-engaged and data-driven process. These dashboards support a participating community’s decision-making for selection and monitoring of evidence-based practices to reduce opioid overdose deaths.

Operationalizing and selecting outcome measures for the HEALing Communities Study

Svetla Slavova, Marc R. LaRochelle, Elisabeth D. Root, Daniel J. Feaster, Jennifer Villani, Charles E. Knott, Jeffery Talbert, Aimee Mack, Dushka Crane, Dana Bernson, Austin Booth, and Sharon L. Walsh

Drug and Alcohol Dependence

Published December 2020 (Open Access) https://doi.org/10.1016/j.drugalcdep.2020.108328

Background

The Helping to End Addiction Long-termSM (HEALing) Communities Study (HCS) is a multisite, parallel-group, cluster randomized wait-list controlled trial evaluating the impact of the Communities That HEAL intervention to reduce opioid overdose deaths and associated adverse outcomes. This paper presents the approach used to define and align administrative data across the four research sites to measure key study outcomes.

Health economic design for cost, cost-effectiveness and simulation analyses in the HEALing Communities Study

Arnie P. Aldridge, Carolina Barbosa, Joshua A. Barocas, Joshua L. Bush, Jagpreet Chhatwal, Kristin J. Harlow, Ayaz Hyder, Benjamin P. Linas, Kathryn E. McCollister, Jake R. Morgan, Sean M. Murphy, Caroline Savitzky, Bruce R. Schackman, Eric E. Seiber, Laura E. Starbird, Jennifer Villani, and Gary A. Zarkin

Drug and Alcohol Dependence

Published December 2020 (Open Access) https://doi.org/10.1016/j.drugalcdep.2020.108336

Background

The HEALing Communities Study (HCS) is designed to implement and evaluate the Communities That HEAL (CTH) intervention, a conceptually driven framework to assist communities in selecting and adopting evidence-based practices to reduce opioid overdose deaths. The goal of the HCS is to produce generalizable information for policy makers and community stakeholders seeking to implement CTH or a similar community intervention. To support this objective, one aim of the HCS is a health economics study (HES), the results of which will inform decisions around fiscal feasibility and sustainability relevant to other community settings.

Modifications to the HEALing Communities Study in response to Covid-19 related disruptions

Scott T. Walters, Redonna K. Chandler, Thomas Clarke, Nabila El-Bassel, Lashawn M. Glasgow, Rebecca D. Jackson, Emmanuel A. Oga, Jeffrey H. Samet, Sharon L. Walsh, and Gary A. Zarkin

Drug Alcohol Dependence

Published May 2021 (Open Access) https://doi.org/10.1016/j.drugalcdep.2021.108669

HCS Publications using Kentucky-specific data

HCS publications developed using Kentucky-specific data.

The development of a recovery coaching training curriculum to facilitate linkage to and increase retention on medications for opioid use disorder

Trevor Moffitt, Amanda Fallin-Bennet, Laura Fanucchi, Sharon L. Walsh, Christopher Cook, Devin Oller, Anna Ross, Molly Gallivan, John Lauckner, Jeremy Byard, Phoebe Wheeler-Crum, and Michelle R. Lofwall

Frontiers in Public Health

Published February 2024 (Open Access) https://doi.org/10.3389/fpubh.2024.1334850

Introduction: Medication treatment for opioid use disorder (MOUD) decreases opioid overdose risk and is the standard of care for persons with opioid use disorder (OUD). Recovery coach (RC)-led programs and associated training curriculums to improve outcomes around MOUD are limited. We describe our comprehensive training curriculum including instruction and pedagogy for novel RC-led MOUD linkage and retention programs and report on its feasibility.

Equity of overdose education and naloxone distribution provided in the Kentucky HEALing Communities Study

Douglas R. Oyler, Hannah K. Knudsen, Carrie B. Oser, Sharon L. Walsh, Monica Roberts, Shawn R. Nigam, Philip M. Westgate, and Patricia R. Freeman

Drug & Alcohol Dependence Reports 

Published March 2024 (Open Access) https://doi.org/10.1016/j.dadr.2023.100207 

Background

Opioid overdoses differentially affect demographic groups. Strategies to reduce overdose deaths, specifically overdose education and naloxone distribution (OEND), are not consistently delivered equitably.

Results

A total of 26,273 demographic records were analyzed from 137 partner agencies. Most agencies were in behavioral health (85.6 %) or criminal justice sectors (10.4 %). About half of OEND recipients were male (50.6 %), which was significantly lower than the 70.3 % of overdose decedents who were male, (p<0.001). OEND recipients tended to be younger than overdose decedents, but there were not significant differences in race/ethnicity between OEND recipients and overdose decedents. Over 40 % of OEND recipients had overdosed, and 68.9 % had witnessed a prior overdose. There were notable differences across facility types, as males and Black individuals accounted for fewer OEND recipients in addiction treatment facilities compared to jails.

Examination of naloxone dosing patterns for opioid overdose by emergency medical services in Kentucky during increased fentanyl use from 2018 to 2021

Peter Rock, Svetla Slavova, Philip M. Westgate, Aisaku Nakamura, and Sharon L. Walsh

Drug and Alcohol Dependence

Published February 2024 (Open Access) https://doi.org/10.1016/j.drugalcdep.2023.111062

Background

Fatal overdoses involving fentanyl/fentanyl analogs (F/FA) have increased in the US, raising questions about naloxone doses for F/FA overdose reversal. Emergency medical services (EMS) data provide an opportunity to examine naloxone administration changes as fentanyl increases in the illicit opioid supply.

Scaling up overdose education and naloxone distribution in Kentucky: adoption and reach achieved through a "hub with many spokes" model

Hannah K. Knudsen, Patricia R. Freeman, Douglas R. Oyler, Carrie B. Oser, and Sharon L. Walsh

Addiction Science & Clinical Practice

Published November 2023 (Open Access) https://doi.org/10.1186/s13722-023-00426-6 

Background

Scaling up overdose education and naloxone distribution (OEND), an evidence-based practice for reducing opioid overdose mortality, in communities remains a challenge. Novel models and intentional implementation strategies are needed. Drawing upon the EPIS model’s phases of Exploration, Preparation, Implementation, and Sustainment (Aarons et al. in Adm Policy Ment Health 38:4–23, 2011), this paper describes the development of the University of Kentucky’s unique centralized “Naloxone Hub with Many Spokes” approach to implementing OEND as part of the HEALing Communities Study (HCS-KY).

Drug disposal deserts: An assessment of receptacle availability in Kentucky community pharmacies

Dustin K. Miracle, Noah Smith, Svetla Slavova, Laura K. Stinson, Monica F. Roberts, Peter Rock, Sharon L. Walsh, and Patricia R. Freeman

The Journal of Rural Health

Published July 2023  https://doi.org/10.1111/jrh.12786

Purpose

The purpose of this study was to describe the county-level availability of drug disposal receptacles in Kentucky community pharmacies and show the relationship between installed receptacles and opioid analgesic (OA)/controlled substance dispensing rates, stratifying where possible by urban-rural classification.

The prevalence of opioid use disorder in Kentucky's counties: A two-year multi-sample capture-recapture analysis

Katherine Thompson, Joshua A. Barocas, Chris Delcher, Jungjun Bae, Lindsey Hammerslag, Jianing Wang, Redonna Chandler, Jennifer Villani, Sharon Walsh, and Jeffery Talbert

Drug and Alcohol Dependence

Published January 2023 (Open Access) https://doi.org/10.1016/j.drugalcdep.2022.109710

Background

Kentucky has one of the highest opioid overdose mortality rates in the United States. Accurate estimates of people with opioid use disorder (OUD) are critical to plan for the scope of interventions required to reduce overdose and opioid misuse. Commonly used household surveys are known to underestimate OUD at the state-level and do not provide county-level estimates.

Changing Trends in Drug Overdose Mortality in Kentucky: An Examination of Race and Ethnicity, Age, and Contributing Drugs, 2016-2020

Svetla Slavova, Patricia R. Freeman, Peter Rock, Candace Brancato, Sarah Hargrove, Madison Liford, Dana Quisenberry, and Sharon L. Walsh

Public Health Reports

Published February 2022 (Open Access) https://doi.org/10.1177/00333549221074390

Objectives:

Increased drug overdose mortality among non-Hispanic Black people in the United States in the past 5 years highlights the need for better tailored programs and services. We evaluated (1) changes in drug overdose mortality for various racial and ethnic groups and (2) drug involvement to inform drug overdose prevention efforts in Kentucky.

Trends in Drug Overdose Mortality Rates in Kentucky, 2019-2020

Svetla Slavova, Dana Quesinberry, Sarah Hargrove, Peter Rock, Candace Brancato, Patricia R. Freeman, and Sharon L. Walsh

JAMA Network Open

Published July 2021 (Open Access) https://doi.org/10.1001/jamanetworkopen.2021.16391

Introduction

In April 2020, early signals from emergency medical services data raised concerns for increasing numbers of drug overdoses during the emerging COVID-19 pandemic in Kentucky.1 Subsequently, provisional national data for the 12-month period ending May 2020 showed accelerated drug overdose deaths, resulting in a Health Alert Network Advisory calling for expanded prevention efforts.2 This cross-sectional study evaluates the changes in drug overdose mortality rates for Kentucky residents between 2019 and 2020.

HCS Publications featuring University of Kentucky Authors

HCS Publications featuring authors from the University of Kentucky and faculty and staff from HCS sites in Massachusetts, New York, and Ohio.

Community-level determinants of stakeholder perceptions of community stigma toward people with opioid use disorders, harm reduction services and treatment in the HEALing Communities Study

Alissa Davis, Kristi Lynn Stringer, Mari-Lynn Drainoni, Carrie B. Oser, Hannah K. Knudsen, Alison Aldrich, Hilary L. Surratt, Daniel M. Walker, Louisa Gilbert, Dget L. Downey, Sam D. Gardner, Sylvia Tan, Lisa M. Lines, Nathan Vandergrift, Nicole Mack, JaNae Holloway, Karsten Lunze, Amy Scheck McAlearney, Timothy R. Huerta, Dawn A. Goddard-Eckrich, and Nabila El-Bassel

International Journal of Drug Policy

Published December 2023 https://doi.org/10.1016/j.drugpo.2023.104241

Background

Community stigma toward people with opioid use disorder (OUD) can impede access to harm reduction services and treatment with medications for opioid use disorder (MOUD). Such community OUD stigma is partially rooted in community-level social and economic conditions, yet there remains a paucity of large-scale quantitative data examining community-level factors associated with OUD stigma. We examined whether rurality, social inequity, and racialized segregation across communities from four states in the HEALing Communities Study (HCS) were associated with 1) greater perceived community stigma toward people treated for OUD, 2) greater perceived intervention stigma toward MOUD, and 3) greater perceived intervention stigma toward naloxone by community stakeholders in the HCS.

Telemedicine Buprenorphine Initiation and Retention in Opioid Use Disorder Treatment for Medicaid Enrolees

Lindsey R. Hammerslag, Aimee Mack, Redonna K. Chandler, Laura C. Fanucchi, Daniel J. Feaster, Marc R. LaRochelle, Michelle R. Lofwall, Michael Nau, Jennifer Villani, Sharon L. Walsh, Philip M. Westgate, Svetla Slavova, and Jeffery C. Talbert

JAMA Network Open

Published October 2023 (Open Access) https://doi.org/10.1001/jamanetworkopen.2023.36914 

Importance

Early COVID-19 mitigation strategies placed an additional burden on individuals seeking care for opioid use disorder (OUD). Telemedicine provided a way to initiate and maintain transmucosal buprenorphine treatment of OUD.

Objective

To examine associations between transmucosal buprenorphine OUD treatment modality (telemedicine vs traditional) during the COVID-19 public health emergency and the health outcomes of treatment retention and opioid-related nonfatal overdose.

Development and validation of a community-level social determinants of health index for drug overdose deaths in the HEALing Communities Study

Nina Cesare, Lisa M. Lines, Redonna Chandler, Erin B. Gibson, Rachel Vickers-Smith, Rebecca Jackson, Angela R. Bazzi, Dawn Goddard-Eckrish, Nasim Sabounchi, Deena J. Chisholm, Nathan Vandergrift, and Emmanuel Oga

Journal of Substance Use & Addiction Treatment

Published October 2023 https://doi.org/10.1016/j.josat.2023.209186

Introduction

Social determinants of health (SDoH), such as socioeconomic status, education level, and food insecurity, are believed to influence the opioid crisis. While global SDoH indices such as the CDC's Social Vulnerability Index (SVI) and Area Deprivation Index (ADI) combine the explanatory power of multiple social factors for understanding health outcomes, they may be less applicable to the specific challenges of opioid misuse and associated outcomes. This study develops a novel index tailored to opioid misuse outcomes, tests the efficacy of this index in predicting drug overdose deaths across contexts, and compares the explanatory power of this index to other SDoH indices.

 

Contributions of a central registry to monitor methadone -treatment through the HEALing Communities Study

Katherine R. Marks, Jeffery Talbert, Lindsey R. Hammerslag, Michelle R. Lofwall, Laura C. Fanucchi, Holly Broce, and Sharon L. Walsh

Journal of Opioid Management

Published October 2023 https://doi.org/10.5055/jom.2023.0801

Objective: 

To describe the process of establishing a Methadone Central Registry (MCR) as part of the HEALing (Helping to End Addiction Long-termSM) Communities Study (HCS) and to support recommendations with evidence of its functionality relative to Medicaid claims data for monitoring utilization of methadone, an evidence-based treatment for opioid use disorder.

Lessons Learned from Developing Tailored Community Communication Campaigns in the HEALing Communities Study

Michael D. Stein, Carol Krause, Emma Rodgers, Anita Silwal, Donald Helme, Michael Slater, Dacia Beard, Nicky Lewis, Jamie Luster, Kara Stephens, and Craig Lefebvre

Journal of Health Communication

Published October 2023  https://doi.org/10.1080/10810730.2023.2262948

Abstract

This paper outlines lessons learned from tailoring communication campaigns to increase demand for, and reduce stigma toward, evidence-based practices to reduce opioid overdose deaths in 66 communities participating in the HEALing (Helping to End Addiction Long-termSM) Communities Study (HCS). We present nine lessons gathered about how to engage local communities in both virtual and in-person opioid messaging and distribution between February 2019 and June 2022. The research team created four communication campaigns and did extensive, tailored marketing and promotion to assist communities in implementing evidence-based clinical activities to reduce opioid overdose mortality. Various strategies and venues were used to amplify HCS messages, using free and paid outlets for message distribution, focusing primarily on social media due to the COVID-19 pandemic. Increasing the availability of medications for opioid use disorder and naloxone, as HCS attempted, is not enough; getting people to accept and use them depends on communication efforts. This paper focuses on the process of preparing communities for communication campaign activities, which we hope can help guide other communities preparing for opioid or substance-related campaigns in the future.

Spatial access to buprenorphine-waivered prescribers in the HEALing communities study: Enhanced 2-step floating catchment area analyses in Massachusetts, Ohio, and Kentucky

Shikhar Shrestha, Megan R. Lindstrom, Daniel Harris, Peter Rock, Sumeeta Srinivasan, Jennifer C. Pustz, Ric Bayly, and Thomas J. Stopka

Journal of Substance Use and Addiction Treatment

Published July 2023 (Open Access) https://doi.org/10.1016/j.josat.2023.209077

Introduction

The opioid overdose epidemic continues to impact a large swath of the population in the US. Medications for opioid use disorders (MOUD) are an effective resource to combat the epidemic; however, there is limited research on MOUD treatment access that accounts for both supply of and demand for services. We aimed to examine access to buprenorphine prescribers in the HEALing Communities Study (HCS) Wave 2 communities in Massachusetts, Ohio, and Kentucky during 2021, and the association between buprenorphine access and opioid-related incidents, specifically fatal overdoses and opioid-related responses by emergency medical services (EMS).

State alignment with federal regulations in 2022 to relax buprenorphine 30-patient waiver requirements

Anita Silwal, Jeffery Talbert, Robert M. Bohler, Jordan Kelsch, Christopher Cook, Derek Blevins, Molly Gallivan, Timothy Hunt, Sarah M. Hatcher, Cindy Parks Thomas, Soncere Williams, Laura Fanucchi, Michelle R. Lofwall 

Drug and Alcohol Dependence Reports

Published June 2023 (Open Access) https://doi.org/10.1016/j.dadr.2023.100164

Background

In 2021, the Department of Health and Human Services released guidelines allowing waiver-eligible providers seeking to treat up to 30 patients to be exempt from waiver training (WT) and the counseling and other ancillary services (CAS) attestation. This study evaluates if states and the District of Columbia had more restrictive policies preventing adoption of the 2021 federal guidelines.

Community selected strategies to reduce opioid-related overdose deaths in the HEALing (Helping to End Addiction Long-term SM) communities study

Redonna Chandler, Edward V. Nunes, Sylvia Tan, Patricia R. Freeman, Alexander Y. Walley, Michelle Lofwall, Emmanuel Oga, LaShawn Glasgow, Jennifer L. Brown, Laura Fanucchi, Donna Beers, Timothy Hunt, Rachel Bowers-Sword, Carter Roeber, Trevor Baker, and T. John Winhusen

Drug and Alcohol Dependence

Published April 2023 (Open Access) https://doi.org/10.1016/j.drugalcdep.2023.109804

Abstract

The Helping End Addictions Long Term (HEALing) Communities Study (HCS) seeks to significantly reduce overdose deaths in 67 highly impacted communities in Kentucky (KY), Massachusetts (MA), New York (NY), and Ohio (OH) by implementing evidence-based practices (EBPs) to reduce overdose deaths. The Opioid-overdose Reduction Continuum of Care Approach (ORCCA) organizes EBP strategies under three menus: Overdose Education and Naloxone Distribution (OEND), Medication Treatment for Opioid Use Disorder (MOUD), and Safer Prescribing and Dispensing Practices (SPDP). The ORCCA sets requirements for strategy selection but allows flexibility to address community needs. This paper describes and compiles strategy selection and examines two hypotheses: 1) OEND selections will differ significantly between communities with higher versus lower opioid-involved overdose deaths; 2) MOUD selections will differ significantly between urban versus rural settings.

The policy landscape for naloxone distribution in four states highly impacted by fatal opioid overdoses

Robert M. Bohler, Patricia R. Freeman, Jennifer Villani, Tim Hunt, Beth S. Linas, Alexander Y. Walley, Traci C. Green, Michelle R. Lofwall, Carly Bridden, Lisa A. Frazier, Laura C. Fanucchi, Jeffery C. Talbert, and Redonna K. Chandler

Drug and Alcohol Dependence Reports

Published March 2023 (Open Access) https://doi.org/10.1016/j.dadr.2022.100126

Background

Expanding access to naloxone is one of the most impactful interventions in decreasing opioid-related mortality. However, state distribution rates of naloxone are insufficient to meet community need. The current study sought to better understand this gap by focusing on state policies that may facilitate or impede naloxone distribution in four states highly impacted by fatal opioid overdoses – Kentucky, Massachusetts, New York, and Ohio.

Protocol for community-driven selection of strategies to implement evidence-based practices to reduce opioid overdoses in the HEALing Communities Study: a trial to evaluate a community-engaged intervention in Kentucky, Massachusetts, New York, and Ohio

April M. Young, Jennifer L. Brown, Timothy Hunt, Linda S. Sprague Martinez, Redonna Chandler, Emmanuel Oga, T. John Winhusen, Trevor Baker, Tracy Battaglia, Rachel Bowers-Sword, Amy Button, Amanda Fallin-Bennett, Laura Fanucchi, Patricia Freeman, LaShawn M. Glasgow, Jennifer Gulley, Charles Kendell, Michelle Lofwall, Michael S. Lyons, Maria Quinn, Brude David Rapking, Hilary L. Surratt, and Sharon L. Walsh

BMJ Open 

Published September 2022 (Open Access) https://doi.org/10.1136/bmjopen-2021-059238 

Introduction 

Opioid-involved overdose deaths continue to surge in many communities, despite numerous evidence-based practices (EBPs) that exist to prevent them. The HEALing Communities Study (HCS) was launched to develop and test an intervention (ie, Communities That HEAL (CTH)) that supports communities in expanding uptake of EBPs to reduce opioid-involved overdose deaths. This paper describes a protocol for a process foundational to the CTH intervention through which community coalitions select strategies to implement EBPs locally.

New HHS Guidance for Increasing Number of Buprenorphine Clinicians Who Can Treat OUD

Anita Silwal, Anna Maria South, Cindy P. Thomas, Jeffery Talbert, Laura C. Fanucchi, Michelle R. Lofwall, and Robert M. Bohler

The Hospitalist

Published June 2022  https://www.the-hospitalist.org/hospitalist/article/32316/clinical-guidelines/new-hhs-guidance-for-increasing-number-of-buprenorphine-providers-who-can-treat-oud/ 

The ongoing opioid epidemic 

The U.S. hit a grim milestone of more than 100,000 drug overdose deaths,1 most opioid-involved, in the 12 months ending April 2021. This alarming increase underscores the critical need to expand access to effective medications for opioid use disorder (OUD), including in the hospital setting, as noted by Linker and colleagues in The Hospitalist in December, 2021.2

New hope: federal policy change aims to remove barriers

In a further effort to expand the buprenorphine prescribing workforce, HHS issued a new policy guideline4 on April 28, 2021. It outlined a process where eligible providers with a valid DEA registration and state clinical license can receive the 30-patient-limit waivers without completing the prerequisite 8- or 24-hour waiver training for physicians and non-physicians, respectively, and attesting to the capacity to refer patients to counseling and other ancillary services. 

Performance of model-based vs. permutation tests in the HEALing Communities Study, a covariate constrained cluster randomized trial

Xiaoyu Tang, Timothy Heeren, Philip M. Westgate, Daniel J. Feaster, Soledad A. Fernandex, Nathan Vandergrift, and Debbie M. Cheng

BMC

Published September 2022 (Open Access) https://doi.org/10.1186/s13063-022-06708-9

Background

The HEALing (Helping to End Addiction Long-termSM) Communities Study (HCS) is a multi-site parallel group cluster randomized wait-list comparison trial designed to evaluate the effect of the Communities That Heal (CTH) intervention compared to usual care on opioid overdose deaths. Covariate-constrained randomization (CCR) was applied to balance the community-level baseline covariates in the HCS. The purpose of this paper is to evaluate the performance of model-based tests and permutation tests in the HCS setting. We conducted a simulation study to evaluate type I error rates and power for model-based and permutation tests for the multi-site HCS as well as for a subgroup analysis of a single state (Massachusetts). We also investigated whether the maximum degree of imbalance in the CCR design has an impact on the performance of the tests.

Exploring perspectives on changing opioid prescribing practices: A qualitative study of community stakeholders in the HEALing Communities Study

Daniel M. Walker, Janet E. Childrehose, Sadie Chen, Nicolette Coovert, Rebecca D. Jackson, Natasha Kurien, Ann Scheck McAlearney, Jaclyn Volney, Daniel P. Alford, Julie Bosak, Douglas R. Oyler, Laura K. Stinson, Melika Behrooz, Mia-Cara Christoper, and Mari-Lynn Drainoni

Drug and Alcohol Dependence

Published April 2022 (Open Access) https://doi.org/10.1016/j.drugalcdep.2022.109342

Background:

Community-based perspectives are needed to more broadly inform policy-makers, public health practitioners, prescribers, and pharmacists about community-led and broader efforts to reduce opioid overprescribing, and ultimately reduce prescription opioid use disorder, overdoses and fatalities. The aim of this study is to explore community-based perspectives on efforts to change opioid prescribing practices in their communities.

Broadband internet subscription rates and opioid prescribing via telemedicine during the COVID-19 pandemic

Douglas R. Oyler, Svetla Slavova, Patricia R. Freeman, Zhengyan Huang, Jeffery Talbert, Sharon L. Walsh, and Philip M. Westgate

Journal of Rural Health

Published February 2022 (Open Access) https://doi.org/10.1111/jrh.12653

Purpose:

In response to the COVID-19 pandemic, the US DEA allowed controlled substance prescriptions to be issued following a telemedicine encounter. This study evaluated changes in opioid prescribing in Kentucky counties with low and high rates of broadband subscription before, during, and after a series of statewide emergency declarations that may have affected health care access.

Placing Racial Equity at the Center of Substance Use Research: Lessons From the HEALing Communities Study

Avik Chatterjee, LaShawn Glasgow, Mackenzie Bullard, Mariah Sabir, Greer Hamilton, Deborah Chassler, Danelle J. Stevens-Watkins, Dawn Goddard-Eckrich, Emma Rodgers, Joan Chaya, Sandra Rodriguez, Damara N. Gutnick, Emmanuel A. Oga, Pamela Salsberry, Linda Sprague Martinez

American Journal of Public Health

Published February 2022 (Open Access) https://doi.org/10.2105/AJPH.2021.306572

Background

Structural racism, “the totality of ways in which societies foster racial discrimination through mutually reinforcing systems of housing, education, employment, earnings, benefits, credit, media, health care, and criminal justice,” is pervasive in the United States, impacting all systems including addiction treatment.1(p1453) This article describes efforts to center racial equity in the Helping to End Addiction Long-Term (HEALing) Communities Study (HCS), a multisite implementation research study sponsored by the National Institute on Drug Abuse and the Substance Abuse and Mental Health Services Administration to reduce opioid overdose deaths in highly affected communities.2 Guided by what Public Health Critical Race Praxis (a framework to help researchers understand and challenge the power hierarchies that buttress health inequities) terms “disciplinary self- critique,”3 we share lessons and opportunities that we hope will resonate with researchers and funders in the addiction field and help us all better center racial equity in our work.

Community coalition and key stakeholder perceptions of the community opioid epidemic prior to an intensive community-level intervention

Mari-Lynn Drainoni, Hannah K. Knudsen, Kathy Adams, Shaquita A. Andrews-Higgins, Sandi Back, Laura K. Barkowski, Evan J. Batty, Melika R. Behroox, Sydney Bell, Sadie Chen, Mia-Cara Christopher, Nicolette Coovert, Erika L. Crable, Anindita Dasgupta, Michael Goetz, Dawn Goddard-Eckrich, Jeanie L. Hartman, Holly Heffer, Pulwasha Iftikhar,Latasha Jones, Samantha Lang, Karsten Lunze, Anna Martin, Tara McCrimmon, Melissa K. Reedy-Johnson, Carter Roeber, Ariel L. Scalise, Cynthia J. Sieck, Daniel M. Walker, Galya Walt, Jennifer D. Wood, Priscilla Zito, and Ann Scheck McAlearney

Journal of Substance Use and Addiction Treatment

Published January 2022 https://doi.org/10.1016/j.jsat.2022.108731

Introduction:

Opioid overdoses are a major public health emergency in the United States. Despite effective treatments that can save lives, access to and utilization of such treatments are limited. Community context plays an important role in addressing treatment barriers and increasing access. The HEALing Communities Study (HCS) is a multisite community-level cluster-randomized trial that will study implementation and outcomes of a community coalition-based intervention (Communities that HEAL [CTH]) that implements evidence-based practices (EBPs) to reduce opioid overdose deaths in four states. To examine contextual factors critical to understanding implementation, we assessed the perspectives of community members about their communities, current substance use–related services, and other important issues that could impact intervention implementation.

Marginal modeling in community randomized trials with rare events: Utilization of the negative binomial regression model

Philip M. Westgate, Debbie M. Cheng, Daniel J. Feaster, Soledad Fernandez, Abigail B. Shoben, and Nathan Vandergrift

Clinical Trials 

Published January 2022 (Open Access) https://doi.org/10.1177/17407745211063479

Background/aims

This work is motivated by the HEALing Communities Study, which is a post-test only cluster randomized trial in which communities are randomized to two different trial arms. The primary interest is in reducing opioid overdose fatalities, which will be collected as a count outcome at the community level. Communities range in size from thousands to over one million residents, and fatalities are expected to be rare.

Traditional marginal modeling approaches in the cluster randomized trial literature include the use of generalized estimating equations with an exchangeable correlation structure when utilizing subject-level data, or analogously quasi-likelihood based on an over-dispersed binomial variance when utilizing community-level data. These approaches account for and estimate the intra-cluster correlation coefficient, which should be provided in the results from a cluster randomized trial. Alternatively, the coefficient of variation or R coefficient could be reported.

In this manuscript, we show that negative binomial regression can also be utilized when communities are large and events are rare. The objectives of this manuscript are: 1) to show that the negative binomial regression approach targets the same marginal regression parameter(s) as an over-dispersed binomial model, and to explain why the estimates may differ; 2) to derive formulas relating the negative binomial overdispersion parameter k with the intra-cluster correlation coefficient, coefficient of variation and R coefficient; and 3) analyze pre-intervention data from the HEALing Communities Study to demonstrate and contrast models as well as to show how to report the intra-cluster correlation coefficient, coefficient of variation and R coefficient when utilizing negative binomial regression.

The impact of the national stay-at-home order on emergency department visits for suspected opioid overdose during the first wave of the COVID-19 pandemic

Elisabeth D. Root, Svetla Slavova, Marc LaRochelle, Daniel J. Feaster, Jennifer Villani, Jolene Defiore-Hymer, Nabila El-Bassel, Rosa Ergas, Kitty Gelberg, Rebecca Jackson, Kara Manchester, Megha Parikh, Peter Rock, and Sharon L. Walsh

Drug and Alcohol Dependence

Published November 2021 (Open Access) https://doi.org/10.1016/j.drugalcdep.2021.108977

Background

Although national syndromic surveillance data reported declines in emergency department (ED) visits after the declaration of the national stay-at-home order for COVID-19, little is known whether these declines were observed for suspected opioid overdose.

Methods

This interrupted time series study used syndromic surveillance data from four states participating in the HEALing Communities Study: Kentucky, Massachusetts, New York, and Ohio. All ED encounters for suspected opioid overdose (n = 48,301) occurring during the first 31 weeks of 2020 were included. We examined the impact of the national public health emergency for COVID-19 (declared on March 14, 2020) on trends in ED encounters for suspected opioid overdose.

Disparities in opioid overdose death trends by race/ethnicity, 2018-2019, From the HEALing Communities Study

Marc R. Larochelle, Svetla Slavova, Elisabeth D. Root, Daniel J. Feaster, Patrick J. Ward, Sabrina C. Selk, Charles Knott, Jennifer Villani, and Jeffrey H. Samet

American Journal of Public Health

Published October 2021 https://doi.org/10.2105/AJPH.2021.306431

Abstract

Objectives. To examine trends in opioid overdose deaths by race/ethnicity from 2018 to 2019 across 67 HEALing Communities Study (HCS) communities in Kentucky, New York, Massachusetts, and Ohio.

Methods. We used state death certificate records to calculate opioid overdose death rates per 100 000 adult residents of the 67 HCS communities for 2018 and 2019. We used Poisson regression to calculate the ratio of 2019 to 2018 rates. We compared changes by race/ethnicity by calculating a ratio of rate ratios (RRR) for each racial/ethnic group compared with non-Hispanic White individuals.

Extracting Semantics from Census-based Reference Data

Daniel R. Harris and Nima Seyedtalebi

2021 IEEE 15th International Conference on Semantic Computing (ICSC)

Published January 2021  https://doi.org/10.1109/icsc50631.2021.00022

Abstract

We present preliminary findings in extracting semantics from reference data generated by the United States Census Bureau. US Census reference data is based upon surveys designed to collect demographics and other socioeconomic factors by geographical regions. These data sets contain thousands of variables; this complexity makes the reference data difficult to learn, query, and integrate into analyses. Researchers often avoid working directly with US Census reference data and instead work with census-derived extracts capturing a much smaller subset of records. We propose to use natural language processing to extract the semantics of census-based reference data and to map census variables to known ontologies. This semantic processing reduces the large volume of variables into more manageable sets of conceptual variables that can be organized by meaning and semantic type.

HCS Publications from Across the Consortium

The HEALing Communities Study is a multiyear study under a cooperative agreement supported by the National Institute on Drug Abuse, part of the National Institutes of Health (NIH).  Research grant awards were issued to the:

  • University of Kentucky in Lexington
  • Boston Medical Center in Boston
  • Columbia University in New York City
  • Ohio State University in Columbus. 

The four sites collaborated throughout the study, producing both state-specific and Consortium-wide resources, publications, and analyses.  This webpage focuses on the contributions of the HCS-Kentucky team; to access all publications, including those from the other sites, please follow the link on the right.