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. Author manuscript; available in PMC: 2025 Oct 18.
Published in final edited form as: Drug Alcohol Depend. 2025 Jul 9;274:112785. doi: 10.1016/j.drugalcdep.2025.112785

Effects of the Communities That HEAL Intervention on Initiation, Retention, and Linkage to Medications for Opioid Use Disorder (MOUD): A Cluster Randomized Wait-List Controlled Trial

Jennifer L Brown 1,*, Marc R Larochelle 2,*, Laura C Fanucchi 3, Deirdre C Calvert 4, Aimee N C Campbell 5, Redonna K Chandler 6, Daniel J Feaster 7, LaShawn M Glasgow 8, Erin B Gibson 9, JaNae Holloway 8, Michelle R Lofwall 10, Aimee Mack 11, Nicole Mack 8, Edward V Nunes 5, Jeffery C Talbert 3,12, Sylvia Tan 8, Nathan Vandergrift 8, Jennifer Villani 6, Kat Asman 8, Hermik Babakhanlou-Chase 4, Sarah M Bagley 13, Tracy A Battaglia 13, Derek Blevins 5, Carly Bridden 14, Debbie M Cheng 15, Mia Christopher 8, Lindsay W Cogan 16, Chinazo O Cunningham 17, Barry Eggleston 8, Naleef Fareed 18, Soledad Fernandez 18, Darcy A Freedman 19, Caroline E Freiermuth 20, Bridget Freisthler 21, Louisa Gilbert 22, Lindsey Hammerslag 12, Daniel Harris 23, Timothy Hunt 22, Shazia Hussain 17, Phuong Huynh 18, Rebecca D Jackson 18, Emily B Kauffman 18, Charles Knott 8, Hannah K Knudsen 10, R Craig Lefebvre 8, Frances R Levin 5, Rick Massatti 24, Ann Scheck McAlearney 18, Jake R Morgan 25, Rosie Munoz Lopez 13, David W Lounsbury 26, Lisa Newman 8, Katrina Nickels 27, Emmanuel A Oga 8, Devin A Oller 27, Theodore V Parran 28, Maria Quinn 29, Kelly S Ramsey 30, Bruce D Rapkin 26, Pamela Salsberry 31, Michael Stein 25, Jessica L Taylor 2, Julie Teater 18, Scott T Walters 32, Gary A Zarkin 8, Nabila El-Bassel 22,+, T John Winhusen 33,+, Jeffrey H Samet 2,34,+, Sharon L Walsh 10,+
PMCID: PMC12302724  NIHMSID: NIHMS2098541  PMID: 40684522

Abstract

Medications for opioid use disorder (MOUD) can reduce opioid use and overdose deaths. This study examined whether the Communities That HEAL (CTH) intervention increased MOUD initiation, retention, and linkage. The HEALing Communities Study was a multi-site, 2-arm, parallel, community-level, cluster-randomized, unblinded, wait-list controlled trial conducted in 67 communities (n=34 intervention, n=33 control). Using Prescription Drug Monitoring Programs and Medicaid claims data, we compared mean community-level rates of MOUD outcomes during the 1-year comparison period (July 2021-June 2022) for: (a) MOUD receipt at least once; (b) continuous MOUD receipt for 180 days; and (c) MOUD linkage within 31 days following an opioid-related emergency department or hospital encounter. For intervention and control communities, adjusted rates of receiving MOUD at least once were 578 (95% CI: 562, 594) and 596 (95% CI: 572, 621) per 1,000 Medicaid enrollees, respectively [adjusted Relative Rate (aRR)=0.97 (95% CI: 0.93, 1.01)]. Adjusted rates of receiving MOUD for 180 consecutive days (retention) were 614 (95% CI: 595, 634) and 620 (95% CI: 603, 638) per 1,000 Medicaid enrollees receiving MOUD at least once for intervention and control communities, respectively [aRR=0.99 (95% CI: 0.95, 1.04)]. The adjusted rate of linkage was 280 (95% CI: 254, 310) and 252 (95% CI: 226, 281) per 1,000 encounters for intervention and control communities, respectively [aRR=1.11 (95% CI: 0.96, 1.28). Compared to control communities, communities that received the CTH intervention did not demonstrate higher rates of MOUD use, retention, or linkage. Additional efforts are needed to improve uptake and sustained use of MOUD.

Trial Registration:

ClinicalTrials.gov Identifier: NCT04111939

Keywords: Opioid use disorder, HEALing Communities Study, Medications for opioid use disorder, Communities That HEAL intervention

1. Background

Opioid-related morbidity and mortality continue at crisis levels in the United States (U.S.). The prevalence of opioid use disorder (OUD) in the U.S. in 2019 was estimated between 2.0–2.8% (Keyes et al., 2022), with >500,000 opioid overdose deaths between 1999 and 2020 (CDC, 2021), and an estimated 82,136 deaths in 2022 (Ahmad et al., 2023; CDC, 2022). Opioids, particularly fentanyl, remain the primary driver of U.S. overdose deaths, and racial disparities are widening (Larochelle et al., 2021; Mattson et al., 2021).

Buprenorphine and methadone are FDA-approved medications for OUD (MOUD; Krupitsky et al., 2011; Lee et al., 2018; Mattick et al., 2009, 2014) that decrease opioid-related overdose deaths (Larochelle et al., 2019; Pearce et al., 2020; Sordo et al., 2017). Access to and receipt of MOUD, however, remain limited in the U.S. (Bresett & Kruse-Diehr, 2023; Saloner & Karthikeyan, 2015; Williams et al., 2019). In a Massachusetts cohort of >17,000 opioid overdose survivors, fewer than 3 in 10 received MOUD in the year post-overdose (Larochelle et al., 2018). The proportion of individuals with OUD who are linked to MOUD is similarly low, ranging from 13–28% (Mauro et al., 2022). Retention in treatment with MOUD is critical; discontinuation of MOUD is associated with increases in opioid overdose deaths (Sordo et al., 2017). Unfortunately, MOUD retention in the U.S. is low. In clinical trial settings and highly resourced office-based addiction treatment clinics, 6-month buprenorphine retention approaches 50–60%, but in more typical U.S. community-based treatment settings estimates range from 22–30% (Hser et al., 2014; LaBelle et al., 2016; Lee et al., 2018; Weinstein et al., 2017). Furthermore, MOUD access is inequitable – non-Hispanic White persons have greater access to MOUD than minoritized groups (Gaeta Gazzola et al., 2023; Hall et al., 2020).

The HEALing Communities Study (HCS; The HEALing Communities Study, 2020) was a trial evaluating the effectiveness of the Communities That HEAL (CTH) intervention to reduce opioid overdose deaths in Kentucky (KY), Massachusetts (MA), New York (NY), and Ohio (OH) utilizing a community-engaged, data-driven approach to select and implement evidence-based practices (EBPs) to reduce opioid overdose deaths, including strategies to improve access to MOUD (Winhusen et al., 2020). As detailed elsewhere, communities randomized to the CTH intervention did not have significantly lower opioid overdose deaths compared to control communities [adjusted rate ratio of 0.91 (95% confidence interval, 0.76 to 1.09; p=0.30)] (The HEALing Communities Study Consortium, 2024). The aim of the current analysis was to examine whether communities randomized to the CTH intervention had higher MOUD initiation, retention, or linkage to MOUD, relative to wait-list control communities.

2. Methods

2.1. Study Design and Setting.

HCS is a parallel-group, cluster randomized, unblinded, wait-list controlled trial of 67 communities – KY (n=16), MA (n=16), NY (n=16), and OH (n=19) – with at least 30% of communities being rural. Communities are the unit of analysis and consist of counties (n=48) or cities/towns (n=19; 16 in MA and 3 in NY). Communities highly impacted by opioid-related overdose fatalities (≥25 opioid-related fatalities per 100,000 people, based on 2016 data were recruited in 2018 (The HEALing Communities Study, 2020).

2.2. Study Procedures and Intervention.

We have previously published overviews of the conceptualization of HCS (Chandler et al., 2020; El-Bassel et al., 2020), the study protocol (The HEALing Communities Study, 2020), the CTH intervention (Sprague Martinez et al., 2020), and the implementation science framework employed in HCS (Knudsen et al., 2020). Briefly, community coalitions utilized a data-informed needs assessment to select strategies to implement from the Opioid-overdose Reduction Continuum of Care Approach (Winhusen et al., 2020), a compendium of EBPs to reduce opioid overdose mortality. The process by which communities selected EBPs is detailed in Young and colleagues (2022); additional detail regarding the MOUD EBPs selected by CTH communities is provided in Chandler et al. (2023). Communities received funds to support EBP implementation and were required to implement at least one strategy to: (a) expand MOUD treatment availability; (b) expand linkage to MOUD services; and (c) support MOUD treatment engagement and retention. MOUD EBP strategies focused specifically on buprenorphine and methadone. Buprenorphine included both sublingual and injectable formulations. While communities were required to implement three MOUD EBP strategies focused on buprenorphine and methadone, some communities also chose EBPs that included naltrexone.

2.3. Randomization.

Study arm allocation was executed using a covariate-constrained randomization procedure performed within each state. Constraint variables included urban/rural classification, baseline opioid overdose death rate, and community population. Thirty-four (34) communities were allocated to the CTH intervention, and 33 communities were allocated to the wait-list control arm. The CONSORT diagram is shown in Figure 1.

Figure 1.

Figure 1.

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CONSORT Flow Diagram: HEALing Communities in KY, MA, NY, and OH.

2.4. IRB & DSMB.

The protocol (Pro00038088) was approved by Advarra Inc., the HCS single Institutional Review Board (sIRB), and was granted a Waiver of Consent and a Full Waiver of HIPAA Authorization for secondary data analysis (3/6/2023, MOD00521925). The Data Safety Monitoring Board (DSMB), chartered by NIDA, was an independent group charged with monitoring the safety of participating communities.

2.5. Data Sources and Identification of MOUD.

We obtained data on MOUD from two sources: each state’s Prescription Drug Monitoring Program (PDMP), which contained data on all buprenorphine dispensing from pharmacies regardless of payer, and Medicaid claims, which contained data on buprenorphine, naltrexone, and methadone for OUD. Buprenorphine from PDMPs was identified using national drug codes (NDC) for transmucosal buprenorphine, buprenorphine/naloxone, and injectable buprenorphine formulations FDA-approved for OUD. Buprenorphine from Medicaid was identified using pharmacy claims via NDC codes and medical claims for in-office injectable buprenorphine administration. Methadone for OUD administered via an Opioid Treatment Program was identified via Medicaid claims. Naltrexone included both oral and injectable naltrexone formulations identified in pharmacy claims using NDC codes and in Medicaid claims using in-office injectable naltrexone administration procedure codes. See Supplemental Table 1 for additional information regarding the data sources, outcomes, and reference populations.

2.6. Timing of Outcome Assessments.

Communities randomized to the CTH intervention implemented the CTH for 30 months (January 2020-June 2022), during which time the wait-list control communities did not receive the intervention. Further, the EBP implementation timeframe was September 2020-June 2022. The baseline period was from January 2019-December 2019, and the comparison period was from July 2021-June 2022; thus, outcomes were assessed during EBP implementation.

2.7. Outcomes (Receipt of MOUD).

We identified the number of residents aged 18 years or older from each HCS community who received buprenorphine at least once, as recorded in the PDMP during the comparison period. Similarly, using Medicaid data, we calculated the number of enrollees aged 18–64 years who received a) buprenorphine, b) methadone, c) naltrexone, or d) any of the three MOUD at least once during the comparison period. Medicaid measures were limited to individuals with an OUD-related diagnosis, defined as International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis of opioid dependence or abuse in the 12 months preceding or during the comparison period.

2.8. Outcomes (Receipt of MOUD for at Least 180 Days).

For each MOUD retention measure, the numerator was the proportion of individuals receiving MOUD continuously for at least 180 days during or ending in the comparison period. The denominator for the PDMP buprenorphine retention measure was the buprenorphine use outcome for the 12-month period starting 6 months earlier to allow time to observe 180 days of continuous use. The denominator for the Medicaid measures was the number of individuals receiving MOUD at least once starting from 180 days before to 180 days after the start of the comparison period (Supplemental Figure 1). Continuous receipt was defined as no gap in medication coverage greater than 7 days, consistent with established quality measures (Supplemental Table 1; Center for Medicare & Medicaid Services, 2019).

2.9. Outcomes (Linkage to MOUD).

Using Medicaid data, we identified linkage to MOUD within 31 days after emergency department (ED) or hospital encounters defined as those with ICD-10-CM diagnosis codes for overdose or opioid-related complications (e.g., injection-related infections like abscess, cellulitis, septic arthritis, or endocarditis). Linkage to MOUD was defined as having at least one Medicaid claim for methadone, buprenorphine, or naltrexone in the 31 days following a qualifying ED visit (inclusive of the date of the event) or hospital encounter (inclusive of the date of hospital admission; Supplemental Table 1).

2.10. Statistical Methods.

Descriptive statistics were calculated for baseline community characteristics including age group, sex, race/ethnicity, urban/rural status, and opioid overdose death rate. Using an Intention-to-Treat (ITT) approach, each outcome was fit with a negative binomial regression model utilizing small sample adjusted empirical standard errors. Each model included intervention status as the independent variable of interest with additional fixed-effects of state, community urban/rural status, baseline opioid overdose death rate, and baseline rate of the outcome (or natural log of the rate, depending on the outcome). The natural log of the reference population during the comparison period was used as the model offset (Supplemental Table 1). Per outcome, the adjusted rate (and 95% CI) within each arm was reported as well as the adjusted relative rate (and 95% CI) comparing intervention and control communities. Subgroup analyses exploring the moderation of the intervention status by state, urban/rural status, age, and sex were performed for all outcomes; the moderation of intervention status by race/ethnicity was tested for Medicaid outcomes only. False discovery rate (FDR) adjustments to the corresponding moderation test p-values were applied using the Benjamini-Hochberg method (Benjamini & Hochberg, 1995). Estimates (and 95% CIs) and/or p-values for tests of levels within subgroups were only reported if the FDR-adjusted p-value from the test of interaction was significant (p<0.05). Missing data arising from suppression were imputed using multiple imputation. All analyses were conducted using SAS Version 9.4, and graphics were created using R version 4.3.1. The per protocol (PP) population was used in a priori specified sensitivity analyses.

3. Results

3.1. Community Characteristics

Baseline characteristics of communities randomized to the intervention (n=4,439,170 adult residents in 34 communities) and the wait-list control (n=3,772,336 adult residents in 33 communities) are summarized in Table 1. Distributions of age, sex, race/ethnicity, and urban/rural classification were comparable between the two arms. The combined population of adults were 73% non-Hispanic White, 52% female, and 57% were urban residents. The mean baseline rate of opioid overdose deaths was similar between intervention and control communities at 38.2 (SD=22.8) and 37.1 (SD=20.3) per 100,000 adult residents, respectively. One community randomized to the intervention arm withdrew before receiving the intervention (Figure 1).

Table 1.

Baseline Demographic Characteristics of Communities Participating in the HEALing Communities Study, by Intervention Arm (N=67)

Intervention Arm
Characteristic, statistic Intervention Control Overall
Number of Randomized Communities 34 33 67
Research Site, n(%)
 Kentucky 8 (23.5%) 8 (24.2%) 16 (23.9%)
 Massachusetts 8 (23.5%) 8 (24.2%) 16 (23.9%)
 New York 8 (23.5%) 8 (24.2%) 16 (23.9%)
 Ohio 10 (29.4%) 9 (27.3%) 19 (28.4%)
Urban/Rural Classification, n(%)
 Urban 19 (55.9%) 19 (57.6%) 38 (56.7%)
 Rural 15 (44.1%) 14 (42.4%) 29 (43.3%)
Population Aged 18+ 1 4,439,170 3,772,336 8,211,506
Age 1 , n(%)
 18–34 Years 1,334,880 (30.1%) 1,178,210 (31.2%) 2,513,090 (30.6%)
 35–54 Years 1,353,341 (30.5%) 1,180,392 (31.3%) 2,533,733 (30.9%)
 55+ Years 1,750,949 (39.4%) 1,413,734 (37.5%) 3,164,683 (38.5%)
Race/Ethnicity 1 , n(%)
 Non-Hispanic White 3,229,233 (72.7%) 2,750,369 (72.9%) 5,979,602 (72.8%)
 Non-Hispanic Black 728,037 (16.4%) 545,357 (14.5%) 1,273,394 (15.5%)
 Non-Hispanic Other 200,571 (4.5%) 153,956 (4.1%) 354,527 (4.3%)
 Hispanic 281,329 (6.3%) 322,654 (8.6%) 603,983 (7.4%)
Sex 1 , n(%)
 Male 2,133,827 (48.1%) 1,825,776 (48.4%) 3,959,603 (48.2%)
 Female 2,305,343 (51.9%) 1,946,560 (51.6%) 4,251,903 (51.8%)
Rate of Opioid Overdose Deaths 2
 Mean (SD) 38.2 (22.8) 37.1 (20.3) 37.7 (21.4)
 Median (Q1, Q3) 35.2 (21.6, 49.3) 32.7 (23.6, 48.6) 34.6 (22.9, 49.1)
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%: Percentages may not add up to 100 due to rounding

1

For communities that represent counties (n=48 of 67), population estimates are from 2020 Bridged-Race Population Estimates retrieved via https://www.cdc.gov/nchs/nvss/bridged_race.htm.

For communities that represent units smaller than counties (n=19 of 67), population estimates are from 2017–2021 American Community Survey 5-Year Estimates retrieved via https://data.census.gov/cedsci.

2

Rate per 100,000 community residents aged 18+ calculated as the number of events measured from January 2019 - December 2019 divided by the observed community population of individuals aged 18+ from the 2020 Bridged-Race Population Estimates or the 2017–2021 American Community Survey 5-Year Estimates multiplied by 100,000.

3.2. Receipt of MOUD

Across data sources and MOUD types, the mean baseline rate of individuals receiving MOUD was similar between intervention and control communities (Figure 2). During the comparison period, the mean unadjusted rates of MOUD receipt were also similar for intervention and control communities (Figure 2). After adjustment, we identified no differences between intervention and control communities across types of MOUD and data sources (Figure 3; Supplemental Tables 2, 3). For receipt of buprenorphine in the PDMP, the adjusted rates were 13.1 (95% CI: 12.6, 13.5) and 13.1 (95% CI: 12.7, 13.5) per 1,000 adults for the intervention and control communities, respectively. For receipt of any MOUD in Medicaid, the adjusted rates were 578 (95% CI: 562, 594) and 596 (95% CI: 572, 621) per 1,000 individuals with a diagnosis of opioid abuse or dependence in the intervention and control communities, respectively. The adjusted relative rates (aRR) for intervention versus control communities was 1.00 (95% CI: 0.95, 1.04) for receipt of buprenorphine in the PDMP and 0.97 (95% CI: 0.93, 1.01) for receipt of any MOUD in Medicaid.

Figure 2.

Figure 2.

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Box and whisker plots for unadjusted community-level rates of receipt of MOUD at least once and for at least 180 days for intervention and control communities during baseline (January 2019 – December 2019) and evaluation (July 2021 – June 2022) periods by data source and MOUD subtype.

Footnotes

Individuals Receiving MOUD at Least Once:

a: Unadjusted community rate presented as per 1,000 individuals aged 18+ from the 2020 Bridged-Race Population Estimates or the 2017–2021 American Community Survey 5-Year Estimates.

b-e: Unadjusted community rate presented as per 1,000 Medicaid recipients aged 18–64 with an OUD diagnosis in the 365 days preceding or during the measurement period.

Individuals Receiving MOUD for ≥ 180 Days:

a: Unadjusted community rate presented as per 1,000 individuals aged 18+ receiving buprenorphine products that are FDA approved for treatment of OUD during a one year period lagged 6 months from the measurement period.

b-e: Unadjusted community rate presented as per 1,000 Medicaid recipients aged 18–64 with an OUD diagnosis up to 365 days preceding or during the measurement period, with an eligible treatment span of MOUD at any point from 180 days prior to the measurement year to 180 days after the start of the measurement year.

See Supplementary Table 1 for details on outcome and reference populations.

Figure 3.

Figure 3.

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Adjusted Relative Rate Ratio comparing Intervention to Control communities for a) MOUD receipt and MOUD receipt for at least 180 days, and b) linkage to MOUD during comparison period (July 2021 – June 2022).

3.3. Retention on MOUD for at least 180 days

The mean baseline rates of receiving MOUD for at least 180 days (i.e., retention) were similar for intervention and control communities across types of MOUD and data sources (Figure 2). Among individuals with Medicaid in intervention communities at baseline, the mean (SD) unadjusted rates of retention on buprenorphine, methadone, and naltrexone (oral or injectable) for at least 180 days were 604 (91.0), 645 (166), and 116 (64) per 1,000 individuals that received MOUD at least once.

During the comparison period, the mean unadjusted rates of MOUD retention for at least 180 days were also similar for intervention and control communities (Figure 2). After adjustment, we identified no differences between intervention and control communities across types of MOUD and data sources (Figure 3; Supplemental Tables 2, 3). For receipt of buprenorphine for at least 180 days in the PDMP, the adjusted rates were 623 (95% CI: 609, 638) and 633 (95% CI: 615, 652) per 1,000 receiving buprenorphine at least once for the intervention and control communities, respectively. For receipt of any MOUD for at least 180 days in Medicaid, the adjusted rates were 614 (95% CI: 595, 634) and 620 (95% CI: 603, 638) per 1,000 individuals receiving MOUD at least once for the intervention and control communities, respectively. The aRR for intervention versus control communities was 0.98 (95% CI: 0.95, 1.02) for receipt of buprenorphine for at least 180 days in the PDMP and 0.99 (95% CI: 0.95, 1.04) for receipt of any MOUD for at least 180 days in Medicaid.

3.4. Linkage to MOUD after ED or Hospital Encounter

The mean unadjusted rates from Medicaid data for linkage to MOUD within 31 days of ED or hospital for nonfatal opioid overdose, and for linkage to MOUD within 31 days of an opioid-related ED encounter, were similar for intervention and control communities in the baseline and comparison periods (Supplemental Figure 2). During the comparison period, the adjusted rates of MOUD receipt within 31 days of an ED or hospital encounter for nonfatal opioid overdose were 280 (95% CI: 254, 310) and 252 (95% CI: 226, 281) per 1,000 encounters for intervention and control communities respectively; the aRR was 1.11 (95% CI: 0.96, 1.28; Figure 3; Supplemental Table 4).

3.5. Evidence-Based Practice Implementation

The 33 communities randomized to and participating in the CTH intervention selected a mean of 7.8 MOUD strategies each (Table 2). Of the 256 total MOUD strategies selected across all communities, 36% were implemented (defined as serving at least 1 individual) before the start of the comparison period (July 1, 2021), and 84% were implemented by January 1, 2022, six months later.

Table 2.

Number of MOUD Strategies Which Progressed to Active Implementation Before July 2021 and January 2022 from the Opioid-overdose Reduction Continuum of Care Approach Tracker for Intervention Communities Participating in the HEALing Communities Study (N=33*)a

Strategy Total Number of Strategies Implemented Strategies Implemented Before July 1, 2021 Strategies Implemented Before January 1, 2022
N N(%) N(%)
Menu 2: MOUD 256 92 (35.9%) 216 (84.4%)
MOUD Treatment in Primary Care, General Medical and Behavior Health Settings, Specialty Addiction/Substance Abuse Disorder Treatment Settings, and Recovery Programs 47 17 (36.2%) 44 (93.6%)
MOUD Treatment in Criminal Justice Settings 6 3 (50.0%) 4 (66.7%)
Access to MOUD Through Telemedicine 7 1 (14.3%) 5 (71.4%)
Interim Buprenorphine or Methadone or Medication Units 0 0 (0%) 0 (0%)
Linkage Programs: Hospital and First Responder Venuesb 13 4 (30.8%) 12 (92.3%)
Linkage Programs: Other Venues 62 17 (27.4%) 49 (79.0%)
Bridging MOUD Medications as Linkage Adjunct: Hospital and First Responder Venuesb 16 13 (81.3%) 16 (100.0%)
Bridging MOUD Medications as Linkage Adjunct: Other Venues 3 2 (66.7%) 3 (100.0%)
Enhancement of Clinical Delivery Approaches That Support Engagement and Retention 45 15 (33.3%) 36 (80.0%)
Use of Virtual Retention Approaches 3 0 (0%) 3 (100.0%)
Use of Retention Care Coordinators 11 5 (45.5%) 11 (100.0%)
Mental Health and Polysubstance Use Integration into MOUD Treatment 4 2 (50.0%) 3 (75.0%)
Reducing Barriers to Housing, Transportation, Childcare, and Accessing Other Community Benefits for People with OUD 39 13 (33.3%) 30 (76.9%)
Other 0 0 (0%) 0 (0%)
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*

n=1 community randomized to the CTH intervention withdrew prior to strategy selection

a

Results based on data pulled March 27, 2023; update to OH community Guernsey on September 18, 2023.

b

Subsetted to only strategies occurring in the following venues: Healthcare – Inpatient Services, Healthcare – Emergency Department, Healthcare – Other, First Responder Stations Summary of unique strategy-sector-venue triad combinations that were actively implemented (defined as serving at least 1 individual). The most recent entry for each triad is chosen. Duplicate triad entries are rolled to the triad level.

3.6. Per protocol and subgroup analyses

Per protocol analyses produced similar results. There were no significant subgroup interactions between receipt of the intervention across MOUD outcomes by subgroups of state, urban/rural classification, age, race/ethnicity, and sex.

4. Discussion

In this community-level cluster randomized trial, communities that received the CTH intervention did not have higher rates of individuals who received MOUD at least once, were retained on MOUD for at least 180 days, or were linked to MOUD following an ED or hospital encounter for an overdose or an injection-related complication during the 1-year comparison period. The lack of effect was consistent across MOUD subtypes and data sources. There was no difference between intervention and control communities on MOUD outcomes by state, urban/rural status, age, race/ethnicity, or sex.

Several possible reasons may explain why the CTH intervention did not result in increased MOUD use. Expanding MOUD is challenging, and the time to implement the EBPs in this study may have been insufficient to see results. Barriers to MOUD implementation include deeply ingrained stigma towards both people who use substances and MOUD (Davis et al., 2023; Levin & Nunes, 2022; McNeely et al., 2022). Thus, people with OUD may encounter challenges seeking MOUD. Moreover, providers may be hesitant or opposed to providing MOUD, be unaware of MOUD efficacy, or fear they lack the expertise or resources needed to manage MOUD (Davis et al., 2023; Levin & Nunes, 2022; McNeely et al., 2022). Additional MOUD implementation barriers include regulatory restrictions, and the time, effort, and financial resources needed to implement new MOUD services (Nunes et al., 2021). Importantly, structural barriers disproportionately impact people with OUD, such as poverty, housing instability, lack of transportation, and co-occurring mental health conditions, complicating engagement and retention in MOUD (Gaeta Gazzola et al., 2023; Hall et al., 2020; Marcovitz et al., 2016). Coalitions within each community chose strategies to address local barriers to MOUD EBP implementation utilizing a community-driven process as part of the CTH intervention (Young et al., 2022). However, the HCS timeline and reach of selected EBPs may have been insufficient to realize the full impact of these efforts during the evaluation period. Future work should examine CTH sustainability and long-term impact on MOUD implementation. Further, research examining both the internal and external contextual factors influencing MOUD EBP implementation and reach (as informed by the study’s implementation science framework; Knudsen et al., 2020), may help to elucidate specific factors that affected MOUD implementation. Increased funding for community-level initiatives and MOUD providers while addressing regulatory barriers might also hasten progress.

On average, communities randomized to the CTH intervention selected eight MOUD strategies. However, only a minority (36%) of these strategies were implemented – defined as having served at least one patient – by the start of the one-year comparison period, July 1, 2021. This proportion increased to 84% by January 1, 2022, halfway through the comparison period. However, this increase may not fully capture the time needed after the start of implementation to expand reach by raising awareness about the availability of MOUD EBPs, developing necessary infrastructure for a given EBP, and engaging patients in the EBP. Increasing MOUD at the community level may require a longer-term intervention and evaluation period to observe a measurable change. Thus, future large-scale community trials may necessitate extended study timelines to detect the potential impact of MOUD EBP implementation at the community level; an extended study period would allow additional time for MOUD EBP implementation activities and opportunities to expand the reach of implemented EBPs. This incomplete deployment of interventions may reflect the multiple barriers to the implementation of MOUD, and/or may be a problem of scale, in that the number of organizational sites implementing the strategies may have been insufficient to observe community-level impacts, particularly in larger communities. Additionally, the variability in strategies selected, some of which were expected to have a more potent impact on MOUD initiation or retention than others, may have impacted results. Furthermore, fentanyl and other high-potency synthetic opioids overtook the illicit drug supply and may have unmeasured impacts on MOUD use, linkage, and retention (Walters et al., 2021). Additional implementation research using qualitative data may identify other factors impacting MOUD implementation among HCS communities.

The COVID-19 pandemic had a substantial impact on healthcare operations during this time, diverting available resources and workforce assignments, limiting access to care, and affecting how people used opioids (e.g., using alone increases the potential for fatal overdose). During the COVID-19 pandemic, buprenorphine initiations decreased nationally, and receipt of methadone was particularly affected (Stein et al., 2023). COVID-19 policy responses loosened restrictions on telemedicine and removed annual demonstration of Medicaid eligibility, which represented major changes for the delivery of MOUD (Tilhou et al., 2022). Indeed, observational data from Medicaid indicates telemedicine increased MOUD retention, while the annual number of patients losing Medicaid coverage decreased (Hammerslag et al., 2023; Nelson et al., 2023). These major policy shifts during the COVID-19 pandemic impacting both control and intervention communities may have outweighed the impact of the CTH intervention. Further, the COVID-19 pandemic may have impacted the MOUD strategies selected by communities and their effectiveness.

This study had several limitations. First, HCS was a community-randomized trial, and over the same timeframe, there were secular local, state, and national efforts (including enacted policy changes) to address the crisis of opioid-related harms, including expanded use of MOUD, independent of HCS activities (The White House, 2022). Wait-list control communities likely received funding to implement initiatives to combat the opioid crisis as well, which would make the impact of the CTH intervention harder to detect. Additionally, policies implemented across states or nationally may have enhanced wait-list control communities’ implementation of MOUD expansion efforts (e.g., increased accessibility of telemedicine services; Tilhou et al., 2022). Second, services offered by EBP strategies were delivered in intervention communities but were not necessarily restricted to residents of those communities, and as a result, residents from nearby wait-list control communities also may have accessed those same MOUD resources. Finally, administrative data used to measure study outcomes have inherent limitations: they may be subject to misclassification; missingness of demographic data; and Medicaid data will miss treatment paid for by Medicare, private insurance, grants, or self-pay.

Conclusions

We did not identify a change in the number of individuals receiving MOUD at least once, retained for at least 180 days, or linked to MOUD following OUD-related encounters, among communities that received the CTH intervention compared to control communities during the 1-year comparison period. Expanding MOUD can decrease opioid use and overdose fatalities but faces multiple logistical and stigma-related barriers. Further efforts and strategies are needed to maximize the proportion of individuals with OUD treated with these efficacious medications.

Supplementary Material

1

Highlights.

  • Medications for opioid use disorder (MOUD) can reduce opioid use and overdoses.

  • This study examined if the Communities That HEAL (CTH) intervention impacted MOUD.

  • No differences were observed in rates of MOUD initiation, retention, or linkage.

  • Additional efforts are needed to improve uptake and sustained use of MOUD.

Funding Disclosure and Acknowledgements:

This research was supported by the National Institutes of Health and the Substance Abuse and Mental Health Services Administration through the NIH HEAL (Helping to End Addiction Long-term®) Initiative under award numbers UM1DA049394, UM1DA049406, UM1DA049412, UM1DA049415, UM1DA049417 (ClinicalTrials.gov Identifier: NCT04111939). Drs. Chandler and Villani were substantially involved in UM1DA049394, UM1DA049406, UM1DA049412, UM1DA049415, UM1DA049417, consistent with their roles as Scientific Officers. This study protocol (Pro00038088) was approved by Advarra Inc., the HEALing Communities Study single Institutional Review Board. We acknowledge the Kentucky Cabinet for Health and Family Services, Office of Inspector General, Division of Audits and Investigations and the Kentucky Cabinet for Health and Family Services, Office of Data Analytics for providing data referenced in this manuscript. We acknowledge the Massachusetts Department of Public Health for sharing the data used for this project and for providing technical support for the analysis. We acknowledge the New York State Department of Health for providing data referenced in this manuscript. We acknowledge the Ohio Board of Pharmacy and Ohio Department of Medicaid for providing data referenced in this manuscript. We wish to acknowledge the participation of the HEALing Communities Study communities, community coalitions, community partner service organizations and agencies, and Community Advisory Boards and state government officials who partnered with us on this study. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, the Substance Abuse and Mental Health Services Administration, or the NIH HEAL Initiative®.

Conflicts of Interest:

Dr. Michelle Lofwall reported serving as a research consultant to Berkshire Biomedical, Braeburn, Titan, and Journey Colab. Dr. Sharon Walsh reported serving as a scientific consultant to Titan, Opiant, Braeburn, Astra Zeneca, and Cerevel. Dr. Levin reported receiving grant support from US World Meds and research support from Aelis Pharmaceuticals. Dr. Frances Levin also reported receiving medication from Indivior for research and royalties from APA publishing. Dr. Levin reported serving on the National Advisory Council on Alcohol Abuse and Alcoholism. In addition, Dr. Levin reported serving as a nonpaid member of a Scientific Advisory Board for Alkermes, Atai Life Science, Boehringer Ingelheim, Indivior, Novartis, Teva, and US WorldMeds and is a consultant to Major League Baseball.

Footnotes

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