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Collaborative care intervention for risky opioid use among primary care patients: The STOP randomized clinical trial
McNeely, Jennifer; Subramaniam, Geetha A; Stone, Rebecca; Mazel, Shayna; Appleton, Noa; Rostam-Abadi, Yasna; Bunting, Amanda M; Shi, Yidan; Lovejoy, Travis I; Gelberg, Lillian; Beers, Donna; Kline, Margaret; Zhang, Song; Kim, Tobie; Case, Ashley; McCormack, Jennifer; Incze, Michael A; Liebschutz, Jane M; ,
BACKGROUND AND AIMS/OBJECTIVE:Individuals who engage in illicit or nonmedical opioid use may have elevated risk of health and social consequences, including progression to opioid use disorder (OUD). Preventive interventions to reduce this risk are lacking. This trial tested the impact of a primary care-integrated collaborative care approach for reducing risky opioid use, defined as nonmedical use of prescription opioids or any use of illicit opioids. DESIGN/METHODS:Cluster-randomized controlled trial randomized primary care providers (PCPs) and their patients into the Subthreshold Opioid Use Disorder Prevention (STOP) intervention or enhanced usual care (EUC). SETTING/METHODS:Primary care clinics at 5 U.S. sites. PARTICIPANTS/METHODS:PCPs and their patients were recruited January 2021-May 2023. A total of 119 PCP clusters (STOP = 48, EUC = 51) and 202 patients (STOP = 88, EUC = 114) enrolled. Eligible patients were adults (≥18 years) having current risky opioid use, without moderate-severe OUD. Patient participants were majority female (63.4%), white (70.8%) and non-Hispanic (96.5%), with a mean age of 55.7 [standard deviation (SD) = 12.7] years. At baseline, 63.4% of participants had moderate-severe pain (Brief Pain Inventory) and below average physical (79.2%) and mental (62.4%) health (SF-12). INTERVENTIONS/METHODS:The STOP collaborative care intervention consisted of brief advice from the PCP about reducing risky opioid use, meetings with a clinic-embedded nurse care manager over 12 months and remote health coaching (2-6 sessions). Both groups received primary care treatment as usual and overdose risk reduction materials. MEASUREMENTS/METHODS:The primary outcome was total days of risky opioid use, recorded from 6 monthly electronic surveys. A key secondary outcome was moderate-severe OUD at 6 and 12 months. FINDINGS/RESULTS:A total of 77 (87.5%) STOP and 107 (93.9%) EUC participants completed the 6-month assessment period. The primary outcome analysis used the Intention-to-Treat sample with multiple imputations of missing data. Mean days of risky opioid use at 180 days were lower in STOP than EUC [12.2 (SD = 27.73) vs. 15.5 (SD = 32.64)]; the difference between groups adjusted for baseline risky opioid use was not statistically significant (rate ratio 0.95, 95% confidence interval = 0.52-1.74). One STOP participant (1.1%) and 13 EUC participants (11.4%) developed moderate-severe OUD at 6 months, and 3 (3.4%) STOP and 6 (5.3%) EUC participants had moderate-severe OUD at 12 months (P < 0.001). CONCLUSIONS:This cluster-randomized controlled trial did not find evidence that the STOP intervention for reducing risky opioid use produced greater reductions over 6 months compared with enhanced usual care, though fewer intervention participants progressed to moderate-severe opioid use disorder. Patients had a high burden of pain and comorbidities that may present challenges to reducing opioid use.
PMID: 42331724
ISSN: 1360-0443
CID: 6055422
Racial disparities in drug toxicology testing among pregnant women & infants: a meta-analysis and systematic review
Choi, Sugy; Knopf, Elizabeth; Shim, Kwanbo; Sanico, Megan; Hade, Erinn M; Terplan, Mishka; Schiff, Davida; Habersham, Leah; Berry, Carolyn A; Neighbors, Charles J; McNeely, Jennifer
INTRODUCTION/UNASSIGNED:We synthesized evidence on racial disparities in perinatal toxicology testing among Black and White women and their infants in the United States, including testing practices and downstream consequences such as child welfare involvement. METHODS/UNASSIGNED:We systematically searched PubMed and PsycINFO for peer-reviewed studies published before January 2023 that examined perinatal toxicology testing and reported racial outcomes. Eligible studies assessed testing practices or related consequences. A random-effects meta-analysis estimated pooled rate ratios (RRs) and 95% confidence intervals (CIs) for disparities in testing. Thematic synthesis summarized qualitative findings on downstream outcomes. Sixteen studies (1993-2023) met inclusion criteria; six contributed to the meta-analysis, encompassing over 50 000 pregnant women and/or their infants. RESULTS/UNASSIGNED:Black women and their infants were significantly more likely to be tested than their White counterparts (RR = 2.58; 95% CI: 2.03-3.29). While recent studies suggest disparities in referral to child welfare services after positive tests may be narrowing, earlier research indicates disproportionate reporting and child removal among Black and Hispanic families. CONCLUSION/UNASSIGNED:Racial inequities in perinatal and infant toxicology testing persist, with implications for maternal and child health. Future research should investigate multilevel drivers of these disparities and inform equitable policy and practice.
PMCID:13071810
PMID: 41982634
ISSN: 2976-5390
CID: 6027782
Implementing substance use services into acute care settings for pregnant and birthing people: A systematic scoping review of implementation and quality improvement strategies
King, Carla; Fawole, Adetayo; Laynor, Gregory; McNeely, Jennifer; Terplan, Mishka; Lee, Matthew; Choi, Sugy
Pregnant and birthing people with untreated substance use disorders (SUDs) face multiple risks of mortality and morbidity. Acute care settings (i.e., hospital inpatient, labor/delivery and emergency departments) are one opportunity to provide substance use services, but have had limited implementation. This scoping review synthesized studies that used an implementation science or quality improvement (QI) strategy to implement substance use services into acute care settings for pregnant or birthing people. Our aim was to 1) characterize the implemented strategies; 2) assess the inclusion of racial equity in study design and implementation; 3) summarize measures and outcomes used to evaluate implementation; and 4) identify reported barriers and facilitators to implementation. We searched MEDLINE (PubMed), CINAHL Complete (EBSCO), Scopus (Elsevier), and APA PsycINFO (Ovid) for published studies using keywords and structured vocabulary, and supplemented database searches with a grey literature search of conference proceedings. Two authors independently screened then extracted studies that met eligibility criteria. After removing 661 duplicates, we screened 1101 studies by title and abstract and excluded 1037. Thirty-six were excluded after full text review yielding 28 studies for extraction. Studies were observational (n = 20, 71%), QI (n = 7, 25%), and experimental (n = 1, 4%). Twenty (71%) focused on SUDs broadly; 8 (29%) targeted OUD. Five strategy types were identified: 1) education and learning collaboratives (n = 11, 39%); 2) clinical workflows and pathways (n = 7, 25%); 3) brief interventions (n = 2, 7%); 4) peer support (n = 4, 14%); and 5) structural changes (n = 4, 14%). Five studies (18%) considered racial and ethnic equity in design or implementation. Overall, studies highlight promising strategies to implement substance use services for pregnant and birthing people in acute care settings. However, many strategies were not rigorously evaluated and few considered racial and ethnic equity in design or implementation. Future research should focus on more rigorous evaluations of implementation strategies, measure downstream outcomes such as adoption and sustained use of substance use services, and apply a racial equity lens more explicitly.
PMCID:12987426
PMID: 41824393
ISSN: 1932-6203
CID: 6016082
Refining a Novel Measure of Polysubstance Use: Applying the Cognitive Interview Method with People Who Use Drugs
Bunting, Amanda M; Griffin, Brittany; Rubens, Adam; Lima, Daniel; Lam, Victoria; Bender, Matheus; Fawole, Adetayo; McNeely, Jennifer; Cleland, Charles M
BACKGROUND:Cognitive interviewing is a methodological technique to elicit feedback on item comprehension and response categories by the target population. This method can be particularly relevant when working with vulnerable populations, such as people who use drugs, and for complex behaviors, including the use of multiple drugs (i.e., polysubstance use). While cognitive interviewing is recognized as an important technique, few case studies of the method have been published. OBJECTIVE:The current manuscript details the cognitive interview method employed as part of the development of a novel polysubstance assessment tool. RESULTS:Participants (n=28) with recent polysubstance use provided qualitative feedback using an iterative study design. Results detail the decision-making process of the study team to improve comprehension of complex behaviors, specifically simultaneous and same-day polysubstance use. Notably, the administration modality changed from self to interviewer-administered to facilitate participant understanding. CONCLUSIONS:Findings highlight the utility of the cognitive interview method in improving assessments of substance use.
PMID: 41718537
ISSN: 1532-2491
CID: 6005292
The Polysubstance Assessment Tool: Reliability, acceptability and feasibility of a novel measure of polysubstance use
Bunting, Amanda M; Cleland, Charles M; Barratt, S Michaela; Griffin, Brittany; Williams, Jaimee; Oser, Carrie B; Lee, Joshua D; McNeely, Jennifer
BACKGROUND AND AIMS/OBJECTIVE:There are currently no brief quantitative assessments that capture the drug patterns of people who engage in use of more than one drug on the same day or simultaneously. The current study examined the retest reliability, acceptability and feasibility of a new quantitative assessment to measure polysubstance use. DESIGN/METHODS:A tool for assessing simultaneous and same-day polysubstance behaviors, the polysubstance assessment tool (PAT) was developed in interviewer-administered and electronic self-administered formats. Participants were allocated 1:1 to receive either version of the PAT and returned one to three days later to repeat the assessment. SETTING/METHODS:New York City, New York, USA. PARTICIPANTS/METHODS:Adults (18 + years, n = 115) who reported use of more than one drug per day in the last 30 days. MEASUREMENTS/METHODS:Test-retest reliability estimates for dichotomous items were assessed using Cohen's kappa, Gwet's Agreement Coefficient 1 (AC1) and percent agreement. Continuous items were assessed with two-way mixed effects intraclass correlations. Bivariate analyses examined acceptability using nine Likert-type survey questions. Feasibility was examined via time to completion. FINDINGS/RESULTS:Overall reliability was moderate to excellent [Gwet's AC1 range 0.70-0.96; intraclass correlation (ICC) range 0.62-0.88]. Reliability was higher for simultaneous polysubstance use (Gwet's AC1 = 0.90) as compared with same-day (Gwet's AC1 = 0.70). Acceptability was high, with no statistically significant difference between the self- and interviewer-administered versions of the tool. Median time to completion was 7 minutes, and was statistically significantly lower for the self-administered tool (median = 5 minutes) compared with the interviewer-administered version (median = 8 minutes) (P < 0.001). CONCLUSIONS:A new polysubstance assessment tool appears to have good reliability and can be considered by researchers seeking a quantitative measure of polysubstance use behaviors given its simplicity, high acceptability and quick completion time.
PMID: 41677773
ISSN: 1360-0443
CID: 6002392
Peer Navigator Intervention and Opioid-Related Adverse Events for Emergency Department Patients: A Randomized Clinical Trial
Doran, Kelly M; Welch, Alice E; Kepler, Kelsey L; Jeffers, Angela; Chambless, Dominique; Cowan, Ethan; Wittman, Ian; Regina, Angela; Siu, Katherine; Bailey, Veronika S; Rostam-Abadi, Yasna; Kennedy, Joseph; Kunins, Hillary V; Gwadz, Marya; Shelley, Donna; Cleland, Charles M; McNeely, Jennifer
IMPORTANCE/UNASSIGNED:Emergency departments (EDs) serve patients at high risk for overdose. There is increasing interest in peer-delivered ED interventions for substance use but little rigorous research on their effectiveness. OBJECTIVE/UNASSIGNED:To examine the effectiveness of an initiative (Relay) operated by the New York City Health Department that dispatches trained peer wellness advocates (WAs) to support ED patients after a nonfatal opioid overdose. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This randomized clinical trial compared Relay and site-directed care (SDC) at 4 EDs in New York, New York. Adult patients presenting after opioid-involved overdose were enrolled from October 6, 2020, to June 30, 2022, with 12 months of outcome follow-up. Statistical analysis was performed from November 4, 2024, to May 6, 2025. INTERVENTION/UNASSIGNED:ED workers (generally physicians) called the Relay hotline for patients presenting after a suspected opioid-involved overdose. WAs met patients in the ED to provide peer support and brief overdose risk reduction education. WAs attempted to contact patients for 90 days to provide ongoing support, education, and referrals using a harm reduction framework. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Opioid-related adverse events (any opioid-involved overdose [fatal or nonfatal] or any other substance use-related ED visit) in the 12 months after enrollment were identified using health care administrative data plus self-report. RESULTS/UNASSIGNED:Among a total of 253 participants randomized, 127 were randomized to the Relay arm and 126 to the SDC arm. A total of 247 participants, 125 in the Relay arm and 122 in the SDC arm (190 [76.9%] men; 80 [32.4%] Black, 126 [51.0%] Hispanic or Latinx, 76 [30.8%] White, and 91 other race [36.8%]), were included in the intention-to-treat analyses. No statistically significant differences between arms were observed for the primary outcome (mean [SD] opioid-related adverse events, 3.29 [4.52] in the Relay arm and 4.10 [9.36] in the SDC arm; rate ratio, 1.02; 95% CI, 0.72-1.45; P = .90). By 12 months after enrollment, 24 participants (9.7%) had died (17 [70.8%] due to overdose). Relay participants reported high satisfaction with the ED intervention. CONCLUSIONS AND RELEVANCE/UNASSIGNED:This randomized clinical trial examining the impact of an ED peer navigator intervention on subsequent opioid-related adverse events did not find significant outcome differences for Relay vs SDC participants. These findings highlight the importance of intervening to save lives in this high-risk population and suggest potential refinements to future ED peer intervention research. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT04317053.
PMID: 41649817
ISSN: 2574-3805
CID: 6000622
A multi-level explanatory-sequential mixed-methods study of perinatal toxicology practices in New York State: Protocol
Choi, Sugy; Knopf, Elizabeth; Kim, Erin; Neighbors, Charles J; Berry, Carolyn A; Hade, Erinn; Trinh-Shevrin, Chau; Terplan, Mishka; Seligman, Neil S; Garry, David J; McNeely, Jennifer
OBJECTIVE:Maternal morbidity and mortality (MMM) rates from drug overdoses have increased, especially among pregnant and postpartum women aged 35-44. However, there is limited understanding of how current toxicology testing practices are implemented in hospital settings and how well they support, or undermine, linkage to care. The goal of the study is to understand variations in toxicology testing use among pregnant and postpartum women, explore hospital- and individual-level differences, and assess outcomes. METHODS:Using the Socio-cultural Framework for the Study of Health Service Disparities (SCF-HSD) we will perform a mixed-methods study to understand testing policies and practices in NY State. Aim 1 will employ multilevel statistical models using New York State Medicaid claims data (2021-2024) to identify predictors of perinatal toxicology testing and characterize hospital-level variation across hospitals. Aim 2 will involve one-on-one interviews with hospital administrators and clinical staff to document and analyze testing policies and practices, capturing diverse perspectives on testing rationales, attitudes, and adherence. Aim 3 will integrate quantitative and qualitative evidence through a mixed-methods design, incorporating perspectives of individuals with lived experience, via focus group sessions to inform and refine hospital policy recommendations. DISCUSSION/CONCLUSIONS:Our findings will inform how to improve disparities in toxicology testing for pregnant and postpartum women. Addressing these challenges requires shifting emphasis toward standardized, evidence-based toxicology testing protocols, strengthening pathways to supportive services, and advancing policy reforms that reduce stigma and inequities in care.
PMCID:12755800
PMID: 41474779
ISSN: 1932-6203
CID: 5987042
"They Never, Never, Never Give Up on Me": Perspectives on an Addiction Consult Service From Hospitalized People Who Use Opioids at 6 New York City Public Hospitals
Textor, Lauren; King, Carla; Rostam-Abadi, Yasna; Fernando, Jasmine; Appleton, Noa; Bunting, Amanda M; Fawole, Adetayo; Barron, Charles; Schatz, Daniel; McNeely, Jennifer
BACKGROUND:Lifesaving medications for opioid use disorder (MOUD) exist; however, most people with opioid use disorder (OUD) do not receive treatment. Hospitalization is one important opportunity to engage people with OUD and offer treatment, including MOUD. Between 2018 and 2020, 6 public hospitals in New York City launched the "Consult for Addiction Treatment and Care in Hospitals" (CATCH) program to provide interprofessional addiction consult services to hospitalized patients. METHODS:This qualitative study aims to add perspectives from 30 racially and ethnically diverse people with opioid-related diagnoses who were hospitalized at a CATCH hospital between October 2019 and April 2021. We used purposive sampling to recruit demographically diverse individuals who accepted or declined aspects of CATCH services. Interviews were audio-recorded, transcribed, and coded for emergent themes using grounded theory techniques. The framework of structural vulnerability was utilized to highlight how social context impacts patients' experiences of healthcare, and in turn affects their addiction trajectories. RESULTS:Participants overwhelmingly accepted MOUD to manage withdrawal symptoms during hospitalization, and many planned to continue MOUD after discharge. Participants appreciated the interprofessional support of CATCH teams which included medical providers, social workers, addiction counselors, and peers. While participants felt that CATCH made holistic addiction treatment including MOUD more accessible, structural issues created barriers to continuing treatment long term. Some participants still felt stigmatized or "punished" for their drug use by non-CATCH providers. CONCLUSION/CONCLUSIONS:CATCH met an urgent need for nonjudgmental care and medical management of opioid withdrawal. Additional interventions that address broader needs, including housing and social supports, as well as trust-building healthcare encounters for patients who have been historically marginalized, are needed to meet the public health goal of preventing overdose and reducing drug-related morbidity for this population.
PMID: 41327789
ISSN: 2976-7350
CID: 5974812
Implementation outcomes included in NIDA Clinical Trials Network (CTN) studies: A systematic review of studies conducted over 20 years
Gonzalez, Sophia T; Horigian, Viviana E; Cheng, Hannah; Hagedorn, Hildi J; Shmueli-Blumberg, Dikla; Campbell, Cynthia I; Lin, Chunqing; Rogers, Erin; Baloh, Jure; Hilton, Rachel; Vena, Ashley; McNeely, Jennifer; Glass, Joseph E
BACKGROUND:The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) has supported clinical trials of substance use disorder (SUD) interventions for 25 years. This review describes the use of implementation outcomes across CTN trials, characterizes outcomes included, and identifies gaps and potential opportunities to strengthen implementation research within the CTN and the field of SUD treatment. METHODS:This systematic review included active or completed studies listed on the CTN Dissemination Library webpage as of August 18, 2021, and approved by the CTN for development by January 1, 2022. Study summaries and protocols were reviewed if they: 1) measured at least one implementation outcome and 2) examined a practice change, intervention, or process. Extracted data elements included trial design characteristics, implementation frameworks, and outcome assessment domains informed by the RE-AIM and Proctor Implementation Outcomes Frameworks. RESULTS:114 protocols were considered, 42 full-text protocols were screened, and 25 were included for data extraction. Start dates of trials spanned a 20-year period (2004-2024) with latter studies including more implementation outcomes. Fidelity (n = 29) and reach/penetration (n = 26) were the most included implementation outcomes. Equity was not identified in any protocols. Methods of defining, capturing, and evaluating outcomes data varied across trials and outcomes. CONCLUSION/CONCLUSIONS:The inclusion of implementation outcomes increased over time, perhaps reflecting a growing emphasis on implementation research. Incorporating measures of equity could advance knowledge about differential receipt or effectiveness of SUD interventions. Future research should seek to improve the consistency and comprehensiveness in descriptions of implementation science elements.
PMID: 41135832
ISSN: 2949-8759
CID: 5957432
Clinical Impact of an Expanded MOUD Access Initiative for Patients Hospitalized With Infections From Intravenous Opioid Use
Keegan, Jack; Peppard, William; Bauer, Rebecca; Alvarez, Mary Beth; Stoner, Kimberly; McNeely, Jennifer
BACKGROUND/UNASSIGNED:Despite their efficacy, medications for opioid use disorder (MOUD) remain underutilized in patients with infections from intravenous opioid use (I-IOU). This study evaluates the impact of an Expanded MOUD Access Initiative (EMAI) on MOUD uptake and other clinical outcomes in patients hospitalized for I-IOU at an institution without addiction medicine consultation. METHODS/UNASSIGNED:We performed a retrospective pre-post study of hospital admissions for I-IOU before (January 2019-June 2021) and after (January 2022-December 2023) EMAI introduction. Data was collected via chart review. The EMAI eliminated restrictions on methadone use and established a new order set for buprenorphine inductions. The primary outcome was MOUD receipt; secondary outcomes included patient directed discharge (PDD) and 30-day re-hospitalization. RESULTS/UNASSIGNED:There were 129 hospitalizations prior to the intervention (control) and 98 after (EMAI). MOUD receipt was significantly higher in the EMAI group (75.5% vs 31.0%; OR, 6.86 [95% CI, 3.84-12.61]). In patients not receiving MOUD prior to admission (n = 176), new inductions occurred more frequently in the EMAI group (68.0% vs 11.9%; OR, 15.76 [95% CI, 7.50-35.78]). PDD was lower in the EMAI group (23.5% vs 48.8%; OR, 0.32 [95% CI, 0.10-0.57]), as was 30-day re-hospitalization (12.2% vs 22.5%; OR, 0.48 [95% CI, 0.22-0.98]). In a multivariable logistic regression model, the EMAI was the only variable to show a statistically significant association with MOUD receipt (aOR, 6.89 [95% CI, 3.75-13.11]). CONCLUSIONS/UNASSIGNED:The EMAI was associated with increased MOUD uptake, reduced PDD, and fewer 30-day re-hospitalizations despite the lack of addiction medicine consultation.
PMCID:12481112
PMID: 41036175
ISSN: 2667-0364
CID: 5953372