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, Bruce David Rapkin, Hilary L Surratt, Sharon L Walsh, 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, Bruce David Rapkin, Hilary L Surratt, Sharon L Walsh

Abstract

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.

Methods and analysis: The CTH is being implemented in 67 communities (randomised to receive the intervention) in four states in partnership with coalitions (one per community). Coalitions must select at least five strategies, including one to implement each of the following EBPs: (a) overdose education and naloxone distribution; expanded (b) access to medications for opioid use disorder (MOUD), (c) linkage to MOUD, (d) retention in MOUD and (e) safer opioid prescribing/dispensing. Facilitated by decision aid tools, the community action planning process includes (1) data-driven goal setting, (2) discussion and prioritisation of EBP strategies, (3) selection of EBP strategies and (4) identification of next steps. Following review of epidemiologic data and information on existing local services, coalitions set goals and discuss, score and/or rank EBP strategies based on feasibility, appropriateness within the community context and potential impact on reducing opioid-involved overdose deaths with a focus on three key sectors (healthcare, behavioural health and criminal justice) and high-risk/vulnerable populations. Coalitions then select EBP strategies through consensus or majority vote and, subsequently, suggest or choose agencies with which to partner for implementation.

Ethics and dissemination: The HCS protocol was approved by a central Institutional Review Board (Advarra). Results of the action planning process will be disseminated in academic conferences and peer-reviewed journals, online and print media, and in meetings with community stakeholders.

Trial registration number: NCT04111939.

Keywords: PUBLIC HEALTH; STATISTICS & RESEARCH METHODS; Substance misuse.

Conflict of interest statement

Competing interests: Competing interest disclosures include the following: LSM is a consultant for the Boston Public Health Commission, Action for Boston Area development and the Young Foundation, SLW has served as a scientific advisor to Opiant Pharmaceuticals, Titan Pharmaceuticals, Astra Zeneca, Cerevel, Arbor Pharmaceuticals, Brainsway, Summit Biosciences, Trevi and Camurus. JLB ad ML receive investigator-initiated support paid to the institution from Gilead Sciences, Inc. MRL has consulted for Titan Pharmaceuticals and Camurus. AF-B is the Program Director of Voices of Hope, a University of Kentucky HCS partner organisation. PF, HLS, AMY, EO, LMG, RC, JG, CK and LF have no competing interests.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Guidelines for HEALing Communities Study Community Action Planning Process to reduce opioid overdose deaths through overdose education and naloxone distribution, expansion of medications for opioid use disorder and safer opioid prescribing and dispensin. MOUD, medications for opioid use disorder; OEND, overdose education and naloxone distribution; ORCCA, Opioid-Overdose Reduction Continuum of Care Approach.
Figure 2
Figure 2
Core components of the HEALing Communities Study Community Action Planning Process to reduce opioid overdose deaths through overdose education and naloxone distribution, medications for opioid use disorder and safer opioid prescribing and dispensing. EBP, evidence-based practice; MOUD, medications for opioid use disorder; OEND, overdose education and naloxone distribution; ORCCA, Opioid-Overdose Reduction Continuum of Care Approach.

References

    1. Krausz RM, Westenberg JN, Ziafat K. The opioid overdose crisis as a global health challenge. Curr Opin Psychiatry 2021;34:405–12. 10.1097/YCO.0000000000000712
    1. World Health Organization . Opioid overdose 2021. Available: [Accessed 04 Aug 2021].
    1. National Institute on Drug Abuse . Overdose death rates Bethesda, MD2021. Available: [Accessed 29 Jan 2021].
    1. Ahmad FB RL, Sutton P, Rossen LM, Lipphardt A, Ahmad FB, et al., eds. Provisional drug overdose death counts: national center for health statistics. National Center for Health Statistics, 2021.
    1. Strang J, Volkow ND, Degenhardt L, et al. . Opioid use disorder. Nat Rev Dis Primers 2020;6:3. 10.1038/s41572-019-0137-5
    1. Bohnert ASB, Guy GP, Losby JL. Opioid prescribing in the United States before and after the centers for disease control and prevention's 2016 opioid guideline. Ann Intern Med 2018;169:367–75. 10.7326/M18-1243
    1. Walley AY, Xuan Z, Hackman HH, et al. . Opioid overdose rates and implementation of overdose education and nasal naloxone distribution in Massachusetts: interrupted time series analysis. BMJ 2013;346:f174. 10.1136/bmj.f174
    1. Larochelle MR, Bernson D, Land T, et al. . Medication for opioid use disorder after nonfatal opioid overdose and association with mortality: a cohort study. Ann Intern Med 2018;169:137–45. 10.7326/M17-3107
    1. Wu E, Villani J, Davis A, et al. . Community dashboards to support data-informed decision-making in the healing communities study. Drug Alcohol Depend 2020;217:108331–31. 10.1016/j.drugalcdep.2020.108331
    1. Welty L, Harrison A, Abram K. Key substance use and mental health indicators in the United States: results from the 2016 national survey on drug use and health (HHS publication No. SMA 17-5044, NSDUH series H-52). Rockville, MD: center for behavioral health statistics and quality. Substance Abuse and Mental Health Services Administration Retrieved College of Health Sciences; 2019: 128.
    1. Williams AR, Nunes EV, Bisaga A, et al. . Developing an opioid use disorder treatment cascade: a review of quality measures. J Subst Abuse Treat 2018;91:57–68. 10.1016/j.jsat.2018.06.001
    1. Freeman PR, Hankosky ER, Lofwall MR, et al. . The changing landscape of naloxone availability in the United States, 2011-2017. Drug Alcohol Depend 2018;191:361–4. 10.1016/j.drugalcdep.2018.07.017
    1. Guy GP, Zhang K, Bohm MK, et al. . Vital signs: changes in opioid prescribing in the United States, 2006-2015. MMWR Morb Mortal Wkly Rep 2017;66:697. 10.15585/mmwr.mm6626a4
    1. Guy GP, Zhang K, Halpin J, et al. . An examination of concurrent opioid and benzodiazepine prescribing in 9 states, 2015. Am J Prev Med 2019;57:629–36. 10.1016/j.amepre.2019.06.007
    1. Guy GP, Zhang K, Schieber LZ, et al. . County-Level opioid prescribing in the United States, 2015 and 2017. JAMA Intern Med 2019;179:574–6. 10.1001/jamainternmed.2018.6989
    1. Walsh SL, El-Bassel N, Jackson RD, et al. . The HEALing (Helping to End Addiction Long-termSM) 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;217:108335. 10.1016/j.drugalcdep.2020.108335
    1. Sprague Martinez L, Rapkin BD, Young A, et al. . Community engagement to implement evidence-based practices in the healing communities study. Drug Alcohol Depend 2020;217:108326. 10.1016/j.drugalcdep.2020.108326
    1. Winhusen T, Walley A, Fanucchi LC, et al. . The opioid-overdose reduction continuum of care approach (ORCCA): evidence-based practices in the healing communities study. Drug Alcohol Depend 2020;217:108325. 10.1016/j.drugalcdep.2020.108325
    1. Lefebvre RC, Chandler RK, Helme DW, et al. . Health communication campaigns to drive demand for evidence-based practices and reduce stigma in the healing communities study. Drug Alcohol Depend 2020;217:108338. 10.1016/j.drugalcdep.2020.108338
    1. Rosenthal BB, Greenawalt J, Ivery JM. Coalitions: Essential tools for organizing. In: Staples L, ed. Roots to power: a manual for Grassroots organizing: a manual for Grassroots organizing. 297. London: Praeger, 2016.
    1. Oesterle S, Kuklinski MR, Hawkins JD, et al. . Long-Term effects of the communities that care trial on substance use, antisocial behavior, and violence through age 21 years. Am J Public Health 2018;108:659–65. 10.2105/AJPH.2018.304320
    1. Shapiro VB, Hawkins JD, Oesterle S. Building local infrastructure for community adoption of science-based prevention: the role of coalition functioning. Prev Sci 2015;16:1136–46. 10.1007/s11121-015-0562-y
    1. Arthur MW, Hawkins JD, Brown EC, et al. . Implementation of the communities that care prevention system by coalitions in the community youth development study. J Community Psychol 2010;38:245–58. 10.1002/jcop.20362
    1. Butterfoss FD. Coalitions and partnerships in community health: John Wiley & Sons; 2007.
    1. Wandersman A, Goodman RM, Butterfoss FD. Understanding coalitions and how they operate. In: Minkler M, ed. Community organizing community building for health. 2nd. New Brunswick: NJ Rutgers University Press, 1997: 261–77.
    1. Powell BJ, McMillen JC, Proctor EK, et al. . A compilation of strategies for implementing clinical innovations in health and mental health. Med Care Res Rev 2012;69:123–57. 10.1177/1077558711430690
    1. Rugs D, Hills HA, Moore KA, et al. . A community planning process for the implementation of evidence-based practice. Eval Program Plann 2011;34:29–36. 10.1016/j.evalprogplan.2010.06.002
    1. Pellecchia M, Mandell DS, Nuske HJ, et al. . Community-academic partnerships in implementation research. J Community Psychol 2018;46:941–52. 10.1002/jcop.21981
    1. Centers for Disease Control and Prevention . Principles of community engagement. Second, 2011.
    1. World Health Organization . WHO community engagement framework for quality, people-centred and resilient health services; 2017.
    1. World Health Organization . Community engagement: a health promotion guide for universal health coverage in the hands of the people. Geneva, 2020.
    1. C. D. I. Study Group, CDI Study Group . Community-directed interventions for priority health problems in Africa: results of a multicountry study. Bull World Health Organ 2010;88:509–18. 10.2471/BLT.09.069203
    1. World Health Organization & United Nations Children’s Fund (UNICEF) . Conducting community engagement for COVID-19 vaccines: interim guidance; 2021. [Accessed 31 Jan 2021].
    1. US Department of Health and Human Services . Biden-Harris administration bolsters monkeypox response; HHS Secretary Becerra Declares public health emergency. Washington, D.C; 2022.
    1. Slavova S, LaRochelle MR, Root ED, et al. . Operationalizing and selecting outcome measures for the healing communities study. Drug Alcohol Depend 2020;217:108328. 10.1016/j.drugalcdep.2020.108328
    1. Westgate PM, Cheng DM, Feaster DJ, et al. . Marginal modeling in community randomized trials with rare events: utilization of the negative binomial regression model. Clin Trials 2022;19:162-171. 10.1177/17407745211063479
    1. Winhusen T, Theobald J, Lewis D, et al. . Development and initial testing of a tailored telephone intervention delivered by peers to prevent recurring opioid-overdoses (TTIP-PRO). Health Educ Res 2016;31:146–60. 10.1093/her/cyw010
    1. Caudarella A, Dong H, Milloy MJ, et al. . Non-Fatal overdose as a risk factor for subsequent fatal overdose among people who inject drugs. Drug Alcohol Depend 2016;162:51–5. 10.1016/j.drugalcdep.2016.02.024
    1. Darke S, Mills KL, Ross J, et al. . Rates and correlates of mortality amongst heroin users: findings from the Australian treatment outcome study (ATOS), 2001-2009. Drug Alcohol Depend 2011;115:190–5. 10.1016/j.drugalcdep.2010.10.021
    1. Larochelle MR, Bernstein R, Bernson D, et al. . Touchpoints - Opportunities to predict and prevent opioid overdose: A cohort study. Drug Alcohol Depend 2019;204:107537–37. 10.1016/j.drugalcdep.2019.06.039
    1. Strang J, McCambridge J, Best D, et al. . Loss of tolerance and overdose mortality after inpatient opiate detoxification: follow up study. BMJ 2003;326:959–60. 10.1136/bmj.326.7396.959
    1. Binswanger IA, Stern MF, Deyo RA, et al. . Release from prison--a high risk of death for former inmates. N Engl J Med 2007;356:157–65. 10.1056/NEJMsa064115
    1. Merrall ELC, Kariminia A, Binswanger IA, et al. . Meta-Analysis of drug-related deaths soon after release from prison. Addiction 2010;105:1545–54. 10.1111/j.1360-0443.2010.02990.x
    1. Walley AY, Lodi S, Li Y, et al. . Association between mortality rates and medication and residential treatment after in-patient medically managed opioid withdrawal: a cohort analysis. Addiction 2020;115:1496–508. 10.1111/add.14964
    1. Sun EC, Dixit A, Humphreys K, et al. . Association between concurrent use of prescription opioids and benzodiazepines and overdose: retrospective analysis. BMJ 2017;356:j760. 10.1136/bmj.j760
    1. Brugal MT, Barrio G, De LFL, et al. . Factors associated with non-fatal heroin overdose: assessing the effect of frequency and route of heroin administration. Addiction 2002;97:319–27. 10.1046/j.1360-0443.2002.00058.x
    1. Cho J, Spence MM, Niu F, et al. . Risk of overdose with exposure to prescription opioids, benzodiazepines, and non-benzodiazepine Sedative-Hypnotics in adults: a retrospective cohort study. J Gen Intern Med 2020;35:696–703. 10.1007/s11606-019-05545-y
    1. Gladden RM, O'Donnell J, Mattson CL, et al. . Changes in opioid-involved overdose deaths by opioid type and presence of benzodiazepines, cocaine, and methamphetamine-25 states, july-december 2017 to january-june 2018. MMWR Morb Mortal Wkly Rep 2019;68:737–44. 10.15585/mmwr.mm6834a2
    1. Park TW, Larochelle MR, Saitz R, et al. . Associations between prescribed benzodiazepines, overdose death and buprenorphine discontinuation among people receiving buprenorphine. Addiction 2020;115:924–32. 10.1111/add.14886
    1. O'Driscoll PT, McGough J, Hagan H, et al. . Predictors of accidental fatal drug overdose among a cohort of injection drug users. Am J Public Health 2001;91:984–7. 10.2105/ajph.91.6.984
    1. Pabayo R, Alcantara C, Kawachi I, et al. . The role of depression and social support in non-fatal drug overdose among a cohort of injection drug users in a Canadian setting. Drug Alcohol Depend 2013;132:603–9. 10.1016/j.drugalcdep.2013.04.007
    1. Wines JD, Saitz R, Horton NJ, et al. . Overdose after detoxification: a prospective study. Drug Alcohol Depend 2007;89:161–9. 10.1016/j.drugalcdep.2006.12.019
    1. Tobin KE, Latkin CA. The relationship between depressive symptoms and nonfatal overdose among a sample of drug users in Baltimore, Maryland. J Urban Health 2003;80:220–9. 10.1093/jurban/jtg025
    1. Bosilkovska M, Walder B, Besson M, et al. . Analgesics in patients with hepatic impairment: pharmacology and clinical implications. Drugs 2012;72:1645–69. 10.2165/11635500-000000000-00000
    1. Green TC, McGowan SK, Yokell MA, et al. . Hiv infection and risk of overdose: a systematic review and meta-analysis. AIDS 2012;26:403–17. 10.1097/QAD.0b013e32834f19b6
    1. Jolley CJ, Bell J, Rafferty GF, et al. . Understanding heroin overdose: a study of the acute respiratory depressant effects of injected pharmaceutical heroin. PLoS One 2015;10:e0140995–e95. 10.1371/journal.pone.0140995
    1. Vu Q, Beselman A, Monolakis J, et al. . Risk factors for opioid overdose among hospitalized patients. J Clin Pharm Ther 2018;43:784–9. 10.1111/jcpt.12701
    1. Bazazi AR, Zelenev A, Fu JJ, et al. . High prevalence of non-fatal overdose among people who inject drugs in Malaysia: correlates of overdose and implications for overdose prevention from a cross-sectional study. Int J Drug Policy 2015;26:675–81. 10.1016/j.drugpo.2014.11.010
    1. Slavova S, Quesinberry D, Hargrove S, et al. . Trends in drug overdose mortality rates in Kentucky, 2019-2020. JAMA Netw Open 2021;4:e2116391–e91. 10.1001/jamanetworkopen.2021.16391
    1. Slavova S, Rock P, Bush HM, et al. . Signal of increased opioid overdose during COVID-19 from emergency medical services data. Drug Alcohol Depend 2020;214:108176–76. 10.1016/j.drugalcdep.2020.108176
    1. Stephenson J. Drug overdose deaths head toward record number in 2020, CDC Warns. JAMA Health Forum 2020;1:e201318–e18. 10.1001/jamahealthforum.2020.1318
    1. Wakeman SE, Green TC, Rich J. An overdose surge will compound the COVID-19 pandemic if urgent action is not taken. Nat Med 2020;26:819–20. 10.1038/s41591-020-0898-0
    1. Holland KM, Jones C, Vivolo-Kantor AM, et al. . Trends in US emergency department visits for mental health, overdose, and violence outcomes before and during the COVID-19 pandemic. JAMA Psychiatry 2021;78:372–9. 10.1001/jamapsychiatry.2020.4402
    1. Friedman J, Beletsky L, Schriger DL. Overdose-related cardiac arrests observed by emergency medical services during the US COVID-19 epidemic. JAMA Psychiatry 2021;78:562–4. 10.1001/jamapsychiatry.2020.4218
    1. Centers for Disease Control and Prevention . Overdose Deaths Accelerating During COVID-19, 2020. Available:
    1. Centers for Disease Control and Prevention . Increase in fatal drug overdoses across the United States driven by synthetic opioids before and during the COVID-19. Pandemic: CDC Health Alert Network, 2020.
    1. Aldridge AP, Barbosa C, Barocas JA, et al. . Health economic design for cost, cost-effectiveness and simulation analyses in the healing communities study. Drug Alcohol Depend 2020;217:108336. 10.1016/j.drugalcdep.2020.108336
    1. Knudsen HK, Drainoni M-L, Gilbert L, et al. . Model and approach for assessing implementation context and fidelity in the healing communities study. Drug Alcohol Depend 2020;217:108330. 10.1016/j.drugalcdep.2020.108330
    1. Taljaard M, Weijer C, Grimshaw JM, et al. . The Ottawa statement on the ethical design and conduct of cluster randomised trials: Precis for researchers and research ethics committees. BMJ 2013;346:f2838. 10.1136/bmj.f2838

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