Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods.

BACKGROUND: Preventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not meet criteria for treatment with opioid agonists or antagonists (subthreshold OUD) is poorly understood. The Subthreshold Opioid Use Disorder Prevention (STOP) Trial is designed to study the efficacy of a collaborative care intervention to reduce risky opioid use and to prevent progression to moderate or severe OUD in adult primary care patients with subthreshold OUD. METHODS: The STOP trial is a cluster randomized controlled trial, randomized at the PCP level, conducted in 5 distinct geographic sites. STOP tests the efficacy of the STOP intervention in comparison to enhanced usual care (EUC) in adult primary care patients with risky opioid use that does not meet criteria for moderate-severe OUD. The STOP intervention consists of (1) a practice-embedded nurse care manager (NCM) who provides patient participant education and supports primary care providers (PCPs) in engaging and monitoring patient-participants; (2) brief advice, delivered to patient participants by their PCP and/or prerecorded video message, about health risks of opioid misuse; and (3) up to 6 sessions of telephone health coaching to motivate and support behavior change. EUC consists of primary care treatment as usual, plus printed overdose prevention educational materials and an educational video on cancer screening. The primary outcome measure is self-reported number of days of risky (illicit or nonmedical) opioid use over 180 days, assessed monthly via text message using items from the Addiction Severity Index and the Current Opioid Misuse Measure. Secondary outcomes assess other substance use, mental health, quality of life, and healthcare utilization as well as PCP prescribing and monitoring behaviors. A mixed effects negative binomial model with a log link will be fit to estimate the difference in means between treatment and control groups using an intent-to-treat population. DISCUSSION: Given a growing interest in interventions for the management of patients with risky opioid use, and the need for primary care-based interventions, this study potentially offers a blueprint for a feasible and effective approach to improving outcomes in this population. TRIAL REGISTRATION: Clinicaltrials.gov, identifier NCT04218201, January 6, 2020.

Mobile service delivery in response to the opioid epidemic in Philadelphia.

BACKGROUND: The harms of opioid use disorder (OUD) and HIV infection disproportionately impact marginalized populations, especially people experiencing homelessness and people who inject drugs (PWID). Mobile OUD service delivery models are emerging to increase access and reduce barriers to OUD care. While there is growing interest in these models, there is limited research about the services they provide, how they operate, and what barriers they face. We characterize the capacity, barriers, and sustainment of mobile OUD care services in a large city with a high incidence of OUD and HIV. METHODS: From May to August 2022, we conducted semi-structured interviews with leadership from all seven mobile OUD care units (MOCU) providing a medication for OUD or other substance use disorder services in Philadelphia. We surveyed leaders about their unit's services, staffing, operating location, funding sources, and linkages to care. Leaders were asked to describe their clinical approach, treatment process, and the barriers and facilitators to their operations. Interview recordings were coded using rapid qualitative analysis. RESULTS: MOCUs are run by small, multidisciplinary teams, typically composed of a clinician, one or two case managers, and a peer recovery specialist or outreach worker. MOCUs provide a range of services, including medications for OUD, wound care, medical services, case management, and screening for infectious diseases. No units provide methadone, but all units provide naloxone, six write prescriptions for buprenorphine, and one unit dispenses buprenorphine. The most frequently reported barriers include practical challenges of working on a MOCU (e.g. lack of space, safety), lack of community support, and patients with substantial medical and psychosocial needs. Interviewees reported concerns about funding and specifically as it relates to providing their staff with adequate pay. The most frequently reported facilitators include positive relationships with the community, collaboration with other entities (e.g. local nonprofits, the police department, universities), and having non-clinical staff (e.g. outreach workers, peer recovery specialists) on the unit. CONCLUSIONS: MOCUs provide life-saving services and engage marginalized individuals with OUD. These findings highlight the challenges and complexities of caring for PWID and demonstrate a need to strengthen collaborations between MOCU providers and the treatment system. Policymakers should consider programmatic funding for permanent mobile OUD care services.

Improving the Delivery of Chronic Opioid Therapy Among People Living With Human Immunodeficiency Virus: A Cluster Randomized Clinical Trial.

BACKGROUND: Chronic pain is prevalent among people living with human immunodeficiency virus (PLWH); managing pain with chronic opioid therapy (COT) is common. Human immunodeficiency virus (HIV) providers often diverge from prescribing guidelines. METHODS: This 2-arm, unblinded, cluster-randomized clinical trial assessed whether the Targeting Effective Analgesia in Clinics for HIV (TEACH) intervention improves guideline-concordant care compared to usual care for PLWH on COT. The trial was implemented from 2015 to 2018 with 12-month follow-up at safety-net hospital-based HIV clinics in Boston and Atlanta. We enrolled 41 providers and their 187 patients on COT. Prescribers were randomized 1:1 to either a 12-month intervention consisting of a nurse care manager with an interactive electronic registry, opioid education, academic detailing, and access to addiction specialists or a control condition consisting of usual care. Two primary outcomes were assessed through electronic medical records: ≥2 urine drug tests and any early COT refills by 12 months. Other outcomes included possible adverse consequences. RESULTS: At 12 months, the TEACH intervention arm had higher odds of ≥2 urine drug tests than the usual care arm (71% vs 20%; adjusted odds ratio [AOR], 13.38 [95% confidence interval {CI}, 5.85-30.60]; P < .0001). We did not detect a statistically significant difference in early refills (22% vs 30%; AOR, 0.55 [95% CI, .26-1.15]; P = .11), pain severity (6.30 vs 5.76; adjusted mean difference, 0.10 [95% CI, -1.56 to 1.75]; P = .91), or HIV viral load suppression (86.9% vs 82.1%; AOR, 1.21 [95% CI, .47-3.09]; P = .69). CONCLUSIONS: TEACH is a promising intervention to improve adherence to COT guidelines without evident adverse consequences.

Study protocol for the targeting effective analgesia in clinics for HIV (TEACH) study - a cluster randomized controlled trial and parallel cohort to increase guideline concordant care for long-term opioid therapy among people living with HIV.

Background: People living with HIV (PLWH) frequently experience chronic pain and receive long-term opioid therapy (LTOT). Adherence to opioid prescribing guidelines among their providers is suboptimal. Objective: This paper describes the protocol of a cluster randomized trial, targeting effective analgesia in clinics for HIV (TEACH), which tested a collaborative care intervention to increase guideline-concordant care for LTOT among PLWH. Methods: HIV physicians and advanced practice providers (n = 41) were recruited from September 2015 to December 2016 from two HIV clinics in Boston and Atlanta. Patients receiving LTOT from participating providers were enrolled through a waiver of informed consent (n = 187). After baseline assessment, providers were randomized to the control group or the year-long TEACH intervention involving: (1) a nurse care manager and electronic registry to assist with patient management; (2) opioid education and academic detailing; and (3) facilitated access to addiction specialists. Randomization was stratified by site and LTOT patient volume. Primary outcomes (≥2 urine drug tests, early refills, provider satisfaction) were collected at 12 months. In parallel, PLWH receiving LTOT (n = 170) were recruited into a longitudinal cohort at both clinics and underwent baseline and 12-month assessments. Secondary outcomes were obtained through patient self-report among participants enrolled in both the cohort and the RCT (n = 117). Conclusions: TEACH will report the effects of an intervention on opioid prescribing for chronic pain on both provider and patient-level outcomes. The results may inform delivery of care for PLWH on LTOT for chronic pain at a time when opioid practices are being questioned in the US.

Chronic Opioid Therapy in People Living With Human Immunodeficiency Virus: Patients' Perspectives on Risks, Monitoring, and Guidelines.

Background: Chronic opioid therapy (COT) is common in people living with human immunodeficiency virus (PLHIV), but is not well studied. We assessed opioid risk behaviors, perceptions of risk, opioid monitoring, and associated Current Opioid Misuse Measure (COMM) scores of PLHIV on COT. Methods: COT was defined as ≥3 opioid prescriptions ≥21 days apart in the past 6 months. Demographics, substance use, COMM score, and perceptions of and satisfaction with COT monitoring were assessed among PLHIV on COT from 2 HIV clinics. Results: Among participants (N = 165) on COT, 66% were male and 72% were black, with a median age of 55 (standard deviation, 8) years. Alcohol and drug use disorders were present in 17% and 19%, respectively. In 43%, the COMM score, a measure of potential opioid misuse, was high. Thirty percent had an opioid treatment agreement, 66% a urine drug test (UDT), and 12% a pill count. Ninety percent acknowledged opioids' addictive potential. Median (interquartile range) satisfaction levels (1-10 [10 = highest]) were 10 (7-10) for opioid treatment agreements, 9.5 (6-10) for pill counts, and 10 (8-10) for UDT. No association was found between higher COMM score and receipt of or satisfaction with COT monitoring. Conclusions: Among PLHIV on COT, opioid misuse and awareness of the addictive potential of COT are common, yet COT monitoring practices were not guideline concordant. Patients who received monitoring practices reported high satisfaction. Patient attitudes suggest high acceptance of guideline concordant care for PLHIV on COT when it occurs.