Preventing Overdose Using Information and Data from the Environment (PROVIDENT): protocol for a randomized, population-based, community intervention trial

Brandon D L Marshall, Nicole Alexander-Scott, Jesse L Yedinak, Benjamin D Hallowell, William C Goedel, Bennett Allen, Robert C Schell, Yu Li, Maxwell S Krieger, Claire Pratty, Jennifer Ahern, Daniel B Neill, Magdalena Cerdá, Brandon D L Marshall, Nicole Alexander-Scott, Jesse L Yedinak, Benjamin D Hallowell, William C Goedel, Bennett Allen, Robert C Schell, Yu Li, Maxwell S Krieger, Claire Pratty, Jennifer Ahern, Daniel B Neill, Magdalena Cerdá

Abstract

Background and aims: In light of the accelerating drug overdose epidemic in North America, new strategies are needed to identify communities most at risk to prioritize geographically the existing public health resources (e.g. street outreach, naloxone distribution efforts). We aimed to develop PROVIDENT (Preventing Overdose using Information and Data from the Environment), a machine learning-based forecasting tool to predict future overdose deaths at the census block group (i.e. neighbourhood) level.

Design: Randomized, population-based, community intervention trial.

Setting: Rhode Island, USA.

Participants: All people who reside in Rhode Island during the study period may contribute data to either the model or the trial outcomes.

Intervention: Each of the state's 39 municipalities will be randomized to the intervention (PROVIDENT) or comparator condition. An interactive, web-based tool will be developed to visualize the PROVIDENT model predictions. Municipalities assigned to the treatment arm will receive neighbourhood risk predictions from the PROVIDENT model, and state agencies and community-based organizations will direct resources to neighbourhoods identified as high risk. Municipalities assigned to the control arm will continue to receive surveillance information and overdose prevention resources, but they will not receive neighbourhood risk predictions.

Measurements: The primary outcome is the municipal-level rate of fatal and non-fatal drug overdoses. Fatal overdoses will be defined as unintentional drug-related death; non-fatal overdoses will be defined as an emergency department visit for a suspected overdose reported through the state's syndromic surveillance system. Intervention efficacy will be assessed using Poisson or negative binomial regression to estimate incidence rate ratios comparing fatal and non-fatal overdose rates in treatment vs. control municipalities.

Comments: The findings will inform the utility of predictive modelling as a tool to improve public health decision-making and inform resource allocation to communities that should be prioritized for prevention, treatment, recovery and overdose rescue services.

Trial registration: ClinicalTrials.gov NCT05096429.

Keywords: Machine learning; RCT; United States; overdose; overdose mortality; overdose risk; predictive analytics; predictive modelling; protocol.

Conflict of interest statement

DECLARATION OF INTERESTS

All authors have no conflicts of interest in undertaking this research.

© 2021 Society for the Study of Addiction.

Figures

FIGURE 1
FIGURE 1
Geographical distribution of unintentional drug-related overdose deaths in Rhode Island by location of injury, aggregated to the census block group, July 2016–June 2019
FIGURE 2
FIGURE 2
PROVIDENT community intervention trial logic model

References

    1. Donroe JH, Socias ME, Marshall BDL. The deepening opioid crisis in North America: historical context and current solutions. Curr Addict Rep. 2018;5:(4):454–463. 10.1007/s40429-018-0228-5
    1. Jalal H, Buchanich JM, Roberts MS, Balmert LC, Zhang K, Burke DS. Changing dynamics of the drug overdose epidemic in the United States from 1979 through 2016. Sci. 2018;361:(6408):eaau1184. 10.1126/science.aau1184
    1. Hedegaard H, Miniño AM, Warner M. Drug overdose deaths in the United States, 1999–2019 [internet]. Vol. NCHS Data Brief Hyattsville, MD: National Center for Health Statistics; 2020. Dec [cited 2020 Dec 31]. Report no.: no. 394. Available at:
    1. National Center for Health Statistics. Vital Statistics Rapid Release– Provisional Drug Overdose Data [internet]. 2018. [cited 2020 Oct 3]. Available at:
    1. Chang J, Agliata J, Guarinieri M. COVID-19—enacting a ‘new normal’ for people who use drugs. Int J Drug Policy. 2020;83:102832.
    1. Grebely J, Cerdá M, Rhodes T. COVID-19 and the health of people who use drugs: what is and what could be? Int J Drug Policy. 2020; 83:102958.
    1. Linas BP, Savinkina A, Barbosa C, Mueller PP, Cerdá M, Keyes K, et al. A clash of epidemics: impact of the COVID-19 pandemic response on opioid overdose. J Subst Abuse Treat. 2021;120: 108158.
    1. Li ZR, Xie E, Crawford FW, Warren JL, McConnell K, Copple JT, Johnson T, Gonsalves GS. Suspected heroin-related overdoses incidents in Cincinnati, Ohio: A spatiotemporal analysis. PLOS Med. 2019;16(11):e1002956. 10.1371/journal.pmed.1002956
    1. US Department of Health and Human Services. Trump Administration awards grants to states to combat opioid crisis [internet]. US Department of Health and Human Services; 2017. [cited 2017 Sep 21]. Available at:
    1. Prevention for States. Drug Overdose. CDC Injury Center; [internet]. 2017. [cited 2017 Sep 17]. Available at:
    1. Davis CS, Johnston JE, Pierce MW. Overdose epidemic, prescription monitoring programs, and public health: a review of state laws. Am J Public Health. 2015;105:e9–e11.
    1. HEALing Communities Study Consortium. 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;17: 108335.
    1. Saloner B, McGinty EE, Beletsky L, Bluthenthal R, Beyrer C, Botticelli M, et al. A public health strategy for the opioid crisis. Public Health Rep. 2018;133:24S–34S.
    1. Green TC, Rich JD, Marshall BDL, Bratberg J, McCance-Katz E. Rhode Island’s strategic plan on addiction and overdose: four strategies to alter the course of an epidemic [internet]. Providence, RI: Rhode Island Governor’s Overdose Prevention and Intervention Task Force; 2016. [cited 2017 Oct 1]. Available at:
    1. Hawk KF, Vaca FE, D’Onofrio G. Reducing fatal opioid overdose: prevention, treatment and harm reduction strategies. Yale J Biol Med. 2015;88:235–45.
    1. Guy GP Jr, Haegerich TM, Evans ME, Losby JL, Young R, Jones CM. Vital signs: pharmacy-based naloxone dispensing–United States, 2012–2018. Morb Mortal Wkly Rep. 2019;68:679–86.
    1. Walley AY, Xuan Z, Hackman HH, Quinn E, Doe-Simkins M, Sorensen-Alawad A, et al. Opioid overdose rates and implementation of overdose education and nasal naloxone distribution in Massachu-setts: interrupted time series analysis. BMJ. 2013;346:f174.
    1. Rowe C, Santos G-M, Vittinghoff E, Wheeler E, Davidson P, Coffin PO. Neighborhood-level and spatial characteristics associated with lay naloxone reversal events and opioid overdose deaths. J Urban Health. 2016;93:117–30.
    1. Abbas B, Marotta PL, Goddard-Eckrich D, Huang D, Schnaidt J, El-Bassel N, et al. Socio-ecological and pharmacy-level factors associated with naloxone stocking at standing-order naloxone pharmacies in New York City. Drug Alcohol Depend. 2021;218:108388.
    1. Gaur DS, Jacka BP, Green TC, Samuels EA, Hadland SE, Krieger MS, et al. US drug overdose mortality: 2009–2018 increases affect young people who use drugs. Int J Drug Policy. 2020;85:102906.
    1. Shover CL, Falasinnu TO, Dwyer CL, Santos NB, Cunningham NJ, Freedman RB, et al. Steep increases in fentanyl-related mortality west of the Mississippi River: recent evidence from county and state surveillance. Drug Alcohol Depend. 2020;216:108314.
    1. Davis CS, Green TC, Zaller ND. Addressing the overdose epidemic requires timely access to data to guide interventions. Drug Alcohol Rev. 2016;35:383–6.
    1. Slavova S, Delcher C, Buchanich JM, Bunn TL, Goldberger BA, Costich JF. Methodological complexities in quantifying rates of fatal opioid-related overdose. Curr Epidemiol Rep. 2019;6:263–74.
    1. Ward PJ, Rock PJ, Slavova S, Young AM, Bunn TL, Kavuluru R. Enhancing timeliness of drug overdose mortality surveillance: a machine learning approach. PLOS ONE. 2019;14:e0223318.
    1. Ising A, Proescholdbell S, Harmon KJ, Sachdeva N, Marshall SW, Waller AE. Use of syndromic surveillance data to monitor poisonings and drug overdoses in state and local public health agencies. Inj Prev. 2016;1:i43–9.
    1. Marshall BDL, Yedinak JL, Goyer J, Green TC, Koziol JA, Alexander-Scott N. Development of a statewide, publicly accessible drug overdose surveillance and information system. Am J Public Health. 2017; 107:1760–3.
    1. Hedegaard H, Miniño AM, Warner M. Drug overdose deaths in the United States, 1999–2018. NCHS Data Brief. 2020;1:1–8.
    1. Yedinak JL, Li Y, Krieger MS, Howe K, Ndoye CD, Lee H, et al. Machine learning takes a village: assessing neighbourhood-level vulnerability for an overdose and infectious disease outbreak. Int J Drug Policy. 2021;31:103395.
    1. Substance Abuse and Mental Health Services Administration (SAMSHA). The NSDUH Report: State Estimates of Nonmedical Use of Prescription Pain Relievers. Rockville, MD: SAMSHA; 2013.
    1. Powell D, Pacula RL. The Evolving Consequences of OxyContin Reformulation on Drug Overdoses [internet]. National Bureau of Economic Research; 2020 Working Paper Series. 2020. [cited 2020 Dec 31]. Available at:
    1. State of Rhode Island. Overdose Death Data [internet]. 2021. PreventOverdoseRI; [cited 2021 Jan 4]. Available at:
    1. US Census Bureau. Geographic Terms and Concepts—Block Groups [internet]. 2010 2012. [cited 2017 Sep 22]. Available at:
    1. Williams CT, Latkin CA. Neighborhood socioeconomic status, personal network attributes, and use of heroin and cocaine. Am J Prev Med. 2007;32:S203–10.
    1. Gordon-Larsen P Inequality in the built environment underlies key health disparities in physical activity and obesity. Pediatrics. 2006; 117:417–24.
    1. Sallis JF, Saelens BE, Frank LD, Conway TL, Slymen DJ, Cain KL, et al. Neighborhood built environment and income: examining multiple health outcomes. Soc Sci Med. 2009;68:1285–93.
    1. Jiang Y, McDonald JV, Goldschmidt A, Koziol J, McCormick M, Viner-Brown S, et al. State unintentional drug overdose reporting surveillance: opioid overdose deaths and characteristics in Rhode Island. R I Med J. 2018;101:25–30.
    1. Polley E, LeDell E, Kennedy C, Lendle S, van der Laan M. Package ‘SuperLearner’ [internet]. CRAN. 2018. [cited 2017 Jul 18].Available at:
    1. State of Rhode Island. Executive Order 15–14 [internet]. 2015. [cited 2021 Feb 26]. Available at:
    1. Raimondo GM. Rhode Island Overdose Prevention and Intervention Task Force Action Plan [internet]. State of Rhode Island and Providence Plantations; 2016. [cited 2017 Oct 1]. Available at:
    1. Rhode Island Department of Administration. Rhode Island Land Use Trends and Analysis (Including Land use Surveys for the Period 1970–1995) [internet]. Vol. Technical Paper number 147. Providence, RI; 2000. Available at:
    1. Mercado MC, Sumner SA, Spelke MB, Bohm MK, Sugerman DE, Stanley C. Increase in drug overdose deaths involving fentanyl– Rhode Island, January 2012–March 2014. Pain Med. 201;19: 511–23.
    1. McCormick M, Koziol J, Sanchez K. Development and use of a new opioid overdose surveillance system, 2016. R I Med J. 2017;100: 37–9.
    1. Lasher L, Rhodes J, Viner-Brown S. Identification and description of non-fatal opioid overdoses using Rhode Island EMS data, 2016– 2018. R I Med J. 2019;102:41–5.
    1. Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Admin Pol Ment Health. 2011;38:65–76.
    1. Atienza AA, King AC. Community-based health intervention trials: an overview of methodological issues. Epidemiol Rev. 2002;24:72–9.
    1. Murray DM, Varnell SP, Blitstein JL. Design and analysis of group-randomized trials: a review of recent methodological developments. Am J Public Health. 2004;94:423–32.
    1. O’Donnell J, Gladden RM, Mattson CL, Hunter CT, Davis NL. Vital signs: characteristics of drug overdose deaths involving opioids and stimulants–24 states and the District of Columbia, January–June 2019. Morb Mortal Wkly Rep. 2020;69:1189–97.
    1. Goodman SN, Goel S, Cullen MR. Machine learning, health disparities, and causal reasoning. Ann Intern Med. 2018;169:883–4.
    1. Rajkomar A, Hardt M, Howell MD, Corrado G, Chin MH. Ensuring fairness in machine learning to advance health equity. Ann Intern Med. 2018;169:866–72.
    1. National Center for Injury Prevention and Control. Prescription Drug Overdose Data and Statistics: Guide to ICD-9-CM and ICD-10 Codes Related to Poisoning and Pain [internet]. Centers for Disease Control and Prevention; 2013. Report no.: version 1.3. Available at:

Source: PubMed

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