Drug use practices and wound care experiences in the age of xylazine adulteration.

INTRODUCTION: Exposure to xylazine has been associated with wounds distinct from typical injection-related skin and soft tissue infections. We sought to understand drug use and wound care practices, and treatment experiences of people who use drugs (PWUD) in a high-prevalence area of xylazine adulteration. METHODS: In August 2023, we surveyed adult PWUD reporting at least one past-year drug use-related wound across three Massachusetts syringe service programs. Using a representative illustration, participants indicated if they had experienced a xylazine wound in the past 90 days. We compared demographic, drug use factors, wound care, and medical treatment experiences among those with and without xylazine wounds. We also conducted additional content analysis of open-ended responses. RESULTS: Of the 171 respondents, 87 % (n=148) had a xylazine wound in the past 90 days. There were no statistically significant demographic differences between those with and without xylazine wounds. Among those primarily injecting (n=155), subcutaneous injection was nearly ten times more likely among people with xylazine wounds. For those with xylazine wounds (n=148), many engaged in heterogeneous wound self-treatment practices, and when seeking medical care, 74 % experienced healthcare stigma and 58 % had inadequate pain and withdrawal management. CONCLUSION: People with self-identified xylazine wounds were more likely to engage in subcutaneous injection and faced several barriers seeking medical wound treatment. Programs serving people exposed to xylazine should work to support safer injection practices, including alternatives to injecting and improving access to high-quality, effective wound care. Further study is warranted to understand the causes, promoters, and prevention of xylazine-related wounds.

Treatment Approaches for Opioid Use Disorder Offered in US Substance Use Treatment Facilities.

This study compares medication and psychosocial treatments for opioid use disorder, as well as treatments offered at opioid and nonopioid treatment program facilities for commonly co-occurring substance use disorders and mental disorders.

Efficacy of a Pain Self-Management Intervention Tailored to People With HIV: A Randomized Clinical Trial.

Importance: Chronic pain is a common condition for which efficacious interventions tailored to highly affected populations are urgently needed. People with HIV have a high prevalence of chronic pain and share phenotypic similarities with other highly affected populations. Objective: To evaluate the efficacy of a behavioral pain self-management intervention called Skills to Manage Pain (STOMP) compared to enhanced usual care (EUC). Design, Setting, and Participants: This randomized clinical trial included adults with HIV who experienced at least moderate chronic pain for 3 months or more. The study was set at the University of Alabama at Birmingham and the University of North Carolina-Chapel Hill large medical centers from August 2019 to September 2022. Intervention: STOMP combined 1-on-1 skill-building sessions delivered by staff interventionists with group sessions co-led by peer interventionists. The EUC control group received the STOMP manual without any 1-on-1 or group instructional sessions. Main Outcomes and Measures: The primary outcome was pain severity and the impact of pain on function, measured by the Brief Pain Inventory (BPI) summary score. The primary a priori hypothesis was that STOMP would be associated with a decreased BPI in people with HIV compared to EUC. Results: Among 407 individuals screened, 278 were randomized to STOMP intervention (n = 139) or EUC control group (n = 139). Among the 278 people with HIV who were randomized, the mean (SD) age was 53.5 (10.0) years; 126 (45.0%) identified as female, 146 (53.0%) identified as male, 6 (2.0%) identified as transgender female. Of the 6 possible 1-on-1 sessions, participants attended a mean (SD) of 2.9 (2.5) sessions. Of the 6 possible group sessions, participants attended a mean (SD) of 2.4 (2.1) sessions. Immediately after the intervention compared to EUC, STOMP was associated with a statistically significant mean difference for the primary outcome, BPI total score: -1.25 points (95% CI, -1.71 to -0.78 points; P < .001). Three months after the intervention, the mean difference in BPI total score remained statistically significant, favoring the STOMP intervention -0.62 points (95% CI, -1.09 to -0.14 points; P = .01). Conclusion and Relevance: The findings of this randomized clinical trial support the efficaciousness of STOMP as an intervention for chronic pain in people with HIV. Future research will include implementation studies and work to understand the optimal delivery of the intervention. Trial Registration: ClinicalTrials.gov Identifier: NCT03692611.

Study Protocol for Pain Self-Management and Patient-Oriented Buprenorphine Dosing for Pain and Retention in Office-Based Opioid Treatment: A Hybrid Type 1, 2 × 2 Factorial Randomized Controlled Trial.

Chronic pain is a significant factor for patients with opioid use disorder (OUD) contributing to suboptimal retention in buprenorphine treatment, which is a crucial predictor of long-term health outcomes. This study aims to address the critical need for effective interventions targeting chronic pain management within office-based opioid treatment (OBOT) programs. We are conducting a multisite, hybrid type 1, 2 × 2 factorial randomized clinical trial to determine the effectiveness of 2 novel interventions, pain self-management (PSM) and patient-oriented buprenorphine dosing (POD), to decrease pain interference and improve retention in buprenorphine treatment. PSM, a manualized and customizable approach delivered through individual and peer-led group sessions, aims to decrease pain-related symptoms and quality of life. POD involves split dosing of buprenorphine to extend the duration of analgesia to better match its duration of efficacy at managing OUD symptoms, leading to improved retention in buprenorphine treatment. Eligible participants will be randomized into 1 of 4 groups: (1) PSM + POD, (2) PSM + Standard Buprenorphine Dosing, (3) Usual Care + POD, or (4) Usual Care + Standard Buprenorphine Dosing. Usual Care refers to usual care for chronic pain and Standard Buprenorphine Dosing refers to the participant's current dosing regimen. Secondary objectives encompass overall pain reduction, decreased opioid use, improved pain symptom management, and exploration of implementation strategies. The supplemental approved protocol provides comprehensive insights into the procedures and variables being investigated. As part of the HEAL Initiative®-funded Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR) network, this study aims to fill gaps in behavioral and medication treatments for individuals with co-occurring chronic pain and OUDs, improving pain management and retention in care. Successful outcomes from this trial may inform future larger trials, offering essential evidence for implementation considerations and reimbursement decisions.

"To prescribe or not to prescribe, that is the question": Perspectives on opioid prescribing for chronic, cancer-related pain from clinicians who treat pain in survivorship.

BACKGROUND: Opioid pain management in cancer survivorship is a complex and understudied topic. METHODS: The authors conducted in-depth, qualitative interviews to understand clinician approaches to opioid pain management in chronic cancer pain and to generate ideas for improvement. They used a rigorous, inductive, qualitative, descriptive approach to examine clinician (n = 20) perspectives about opioid pain management in survivorship, including oncologists (n = 5), palliative care clinicians (n = 8), primary care clinicians (n = 5), and pain management specialists (n = 2). RESULTS: The findings indicated that no consistent medical home exists for chronic pain management in cancer survivors and that there are fundamental differences in how each subspecialty approaches chronic pain management in survivorship (e.g., "Do we think of this as noncancer pain or cancer pain?… This is in this limbo zone-this gray zone-because it's cancer-related pain, right?"). Simultaneously, clinicians are influenced by their peers' perceptions of their opioid prescribing decisions, sparking intraprofessional tension when disagreement occurs. In these instances, clinicians described overthinking and doubting their clinical decision-making as well as a sense of judgment, pressure, and/or shame. Finally, clinicians acknowledged a fear of consequences for opioid prescribing decisions. Specifically, participants cited conflict with patients, sometimes escalating to aggression and threats of violence, as well as potential disciplinary actions and/or legal consequences. CONCLUSIONS: Participants suggested that opportunities to improve chronic cancer pain care include developing clear, systematic guidance for chronic cancer pain management, facilitating clinician communication and consultation, creating tailored survivorship care plans in partnership with patients, and developing accessible, evidence-based, complementary pain treatments.

Optimizing evidence-based practice implementation: a case study on simulated patient protocols in long-term opioid therapy.

BACKGROUND: Substantial work has been done to update or create evidence-based practices (EBPs) in the changing health care landscape. However, the success of these EBPs is limited by low levels of clinician implementation. OBJECTIVE: The goal of this study is to describe the use of standardized/simulated patient/person (SP) methodology as a framework to develop implementation bundles to increase the effectiveness, sustainability, and reproducibility of EBPs across health care clinicians. DESIGN: We observed 12 clinicians' first-time experiences with six unique decision-making algorithms, developed previously using rigorous Delphi methods, for use with patients exhibiting concerning behaviors associated with long-term opioid therapy (LTOT) for chronic pain. Clinicians were paired with two SPs trained to portray individuals with one of the concerning behaviors addressed by the algorithms in a telehealth environment. The SP evaluations were followed by individual interviews, guided by the Consolidated Framework for Implementation Research (CFIR), with each of the clinician participants. PARTICIPANTS: Twelve primary care clinicians and 24 SPs in Western Pennsylvania. MAIN MEASUREMENT: The primary outcome was identifying likely facilitators for the successful implementation of the EBP using the SP methodology. Our secondary outcome was to assess the feasibility of using SPs to illuminate likely implementation barriers and facilitators. RESULTS: The SP portrayal illuminated factors that were pertinent to address in the implementation bundle. SPs were realistic in their portrayal of patients with concerning behaviors associated with LTOT for chronic pain, but clinicians also noted that their patients in practice may have been more aggressive about their treatment plan. CONCLUSIONS: SP simulation provides unique opportunities for obtaining crucial feedback to identify best practices in the adoption of new EBPs for high-risk patients. SETTING: Zoom simulated patient evaluations.

Target trial emulation for comparative effectiveness research with observational data: Promise and challenges for studying medications for opioid use disorder.

Medications for opioid use disorder (MOUD) increase retention in care and decrease mortality during active treatment; however, information about the comparative effectiveness of different forms of MOUD is sparse. Observational comparative effectiveness studies are subject to many types of bias; a robust framework to minimize bias would improve the quality of comparative effectiveness evidence. This paper discusses the use of target trial emulation as a framework to conduct comparative effectiveness studies of MOUD with administrative data. Using examples from our planned research project comparing buprenorphine-naloxone and extended-release naltrexone with respect to the rates of MOUD discontinuation, we provide a primer on the challenges and approaches to employing target trial emulation in the study of MOUD.

Buprenorphine dispensing before and after the April 2021 X-Waiver exemptions: An interrupted time series analysis.

BACKGROUND: Until the end of 2022, a special registration, known as the X-waiver, was required to prescribe buprenorphine in the US. Before its removal, US federal regulations trialed an X-waiver exemption, initiated on April 28, 2021, which permitted buprenorphine prescribing for up to 30 patients without additional training. We aimed to understand if these regulatory changes impacted buprenorphine dispensing. METHODS: We conducted an interrupted time series analysis to understand changes in buprenorphine dispensing during the 26 weeks after the X-waiver exemption compared to the expected baseline trend established in the 26 weeks before using the IQVIA Longitudinal Prescription claims database. The primary outcome was number of new buprenorphine prescribers nationwide (defined as no prior buprenorphine prescription dispensed in the last 26 weeks). Segmented regression estimated relative changes in buprenorphine dispensing at 1, 13, and 26 weeks post-X-waiver change. RESULTS: A total of 15,517,525 prescriptions filled for 1,328,172 patients (43.4 % female) ordered by 62,312 providers were included for analysis. At 26 weeks post-X-waiver change, there was no change in the number of new prescribers compared to the expected baseline trend (-2.7 % [95 % CI:-8.3,2.9]). The number of new (15.2 % [4.6,25.8]) and existing (1.7 % [0.9,2.4]) patients and patients per prescriber (4.3 % [3,5.6]) increased. Buprenorphine prescriptions reimbursed by Medicaid increased (7.5 % [6.6,8.4]) while commercial fills decreased (-3.4 % [-5.3,-1.5]). CONCLUSIONS: The number of new prescribers did not increase six months post-X-waiver exemption while new patients continued to enter treatment at higher-than-expected rates. These findings suggest that additional interventions beyond the recent X-waiver removal may be needed to increase access to buprenorphine.

Benefits, Harms, and Stakeholder Perspectives Regarding Opioid Therapy for Pain in Individuals With Metastatic Cancer: Protocol for a Descriptive Cohort Study.

BACKGROUND: Opioids are a key component of pain management among patients with metastatic cancer pain. However, the evidence base available to guide opioid-related decision-making in individuals with advanced cancer is limited. Patients with advanced cancer or cancer that is unlikely to be cured frequently experience pain. Opioids are a key component of pain management among patients with metastatic cancer pain. Many individuals with advanced cancer are now living long enough to experience opioid-related harm. Emerging evidence from chronic noncancer pain literature suggests that longer-term opioid therapy may have limited benefits for pain and function, and opioid-related harms are also a major concern. However, whether these benefits and harms of opioids apply to patients with cancer-related pain is unknown. OBJECTIVE: This manuscript outlines the protocol for the "Opioid Therapy for Pain in Individuals With Metastatic Cancer: The Benefits, Harms, and Stakeholder Perspectives (BEST) Study." The study aims to better understand opioid decision-making in patients with advanced cancer, along with opioid benefits and harms, through prospective examination of patients' pain experiences and opioid side effects and understanding the decision-making by patients, care partners, and clinicians. METHODS: This is a multicenter, prospective cohort study that aims to enroll 630 patients with advanced cancer, 20 care partners, and 20 clinicians (670 total participants). Patient participants must have an advanced solid cancer diagnosis, defined by the American Cancer Society as cancer that is unlikely to be cured. We will recruit patient participants within 12 weeks after diagnosis so that we can understand opioid benefits, harms, and perspectives on opioid decision-making throughout the course of their advanced cancer (up to 2 years). We will also specifically elicit information regarding long-term opioid use (ie, opioids for ≥90 consecutive days) and exclude patients on long-term opioid therapy before an advanced cancer diagnosis. Lived-experience perspectives related to opioid use in those with advanced cancer will be captured by qualitative interviews with a subset of patients, clinicians, and care partners. Our data collection will be grounded in a behavioral decision research approach that will allow us to develop future interventions to inform opioid-related decision-making for patients with metastatic cancer. RESULTS: Data collection began in October 2022 and is anticipated to end by November 2024. CONCLUSIONS: Upon successful execution of our study protocol, we anticipate the development of a comprehensive evidence base on opioid therapy in individuals with advanced cancer guided by the behavioral decision research framework. The information gained from this study will be used to guide interventions to facilitate opioid decisions among patients, clinicians, and care partners. Given the limited evidence base about opioid therapy in people with cancer, we envision this study will have significant real-world implications for cancer-related pain management and opioid-related clinical decision-making. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54953.

Implementing harm reduction kits in an office-based addiction treatment program.

BACKGROUND: The rising rates of drug use-related complications call for a paradigm shift in the care for people who use drugs. While addiction treatment and harm reduction have historically been siloed in the US, co-location of these services in office-based addiction treatment (OBAT) settings offers a more realistic and patient-centered approach. We describe a quality improvement program on integrating harm reduction kits into an urban OBAT clinic. METHODS: After engaging appropriate stakeholders and delivering clinician and staff trainings on safer use best practices, we developed a clinical workflow for universal offering and distribution of pre-packaged kits coupled with patient-facing educational handouts. We assessed: (1) kit uptake with kit number and types distributed; and (2) implementation outcomes of feasibility, acceptability, appropriateness, and patient perceptions. RESULTS: One-month post-implementation, 28% (40/141) of completed in-person visits had at least one kit request, and a total of 121 kits were distributed. Staff and clinicians found the program to be highly feasible, acceptable, and appropriate, and patient perceptions were positive. CONCLUSIONS: Incorporating kits in OBAT settings is an important step toward increasing patient access and utilization of life-saving services. Our program uncovered a significant unmet need among our patients, suggesting that kit integration within addiction treatment can improve the standard of care for people who use drugs.

Influence of patient trust in provider and health literacy on receipt of guideline-concordant chronic opioid therapy in HIV care settings.

OBJECTIVE: Persons with HIV (PWH) frequently receive opioids for pain. Health literacy and trust in provider may impact patient-provider communication, and thus receipt of guideline-concordant opioid monitoring. We analyzed baseline data of HIV-positive patients on chronic opioid therapy (COT) in a trial to improve guideline-concordant COT in HIV clinics. DESIGN: Retrospective cohort study. SETTING: Two hospital-based safetynet HIV clinics in Boston and Atlanta. PATIENTS AND PARTICIPANTS: A cohort of patients who were ≥18 years, HIV-positive, had received ≥ 3 opioid prescriptions from a study site ≥21 days apart within a 6-month period during the prior year and had ≥1 visit at the HIV clinic in the prior 18 months. MAIN OUTCOME MEASURES: Adjusted logistic regression models examined whether health literacy and trust in provider (scale scored 11-55, higher indicates more trust) were associated with: (1) ≥ 2 urine drug tests (UDTs) and (2) presence of an opioid treatment agreement. RESULTS: Among 166 PWH, mean trust in provider was 47.4 (SD 6.6); 117 (70 percent) had adequate health literacy. Fifty patients (30 percent) had ≥ 2 UDTs and 20 (12 percent) had a treatment agreement. The adjusted odds ratio (aOR) for a one-point increase in trust in provider was 0.97 for having ≥ 2 UDTs (95 percent CI 0.92-1.02) and 1.03 for opioid treatment agreement (95 percent CI 0.95-1.12). The aOR for adequate health literacy was 0.89 for having ≥ 2 UDTs (95 percent CI 0.42-1.88) and 1.66 for an opioid treatment agreement (95 percent CI 0.52-5.31). CONCLUSIONS: Health literacy and trust in provider were not associated with chronic opioid therapy quality outcomes.

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.

Stakeholder-Driven Intervention Development for Dialysis Trials Using a Design Sprint Methodology.

Rationale & Objective: Stigma contributes to ineffective treatment for pain among individuals with kidney failure on dialysis, particularly with buprenorphine pain treatment. To address stigma, we adapted a Design Sprint, an industry-developed structured exercise where an interdisciplinary group works over 5 days to clarify the problem, identify and choose a solution, and build and test a prototype. Study Design: Adapted Design Sprint which clarified the problem to be solved, proposed solutions, and created a blueprint for the selected solution. Settings & Participants: Five individuals with pain and kidney disease receiving dialysis, 5 physicians (nephrology, palliative care, and addiction medicine) and 4 large dialysis organization leaders recruited for specific expertise or experience. Conducted through online platform (Zoom) and virtual white board (Miro board). Analytical Approach: Descriptions of the Design Sprint adaptations and processes. Results: To facilitate patient comfort, a patient-only phase included four 90-minute sessions over 2-weeks, during which patient participants used a mapping process to define the critical problem and sketch out solutions. In a physician-only phase, consisting of two 120-minute sessions, participants accomplished the same tasks. During a combined phase of two 120-minute sessions, patients, physicians, and large dialysis organization representatives vetted and developed solutions from earlier phases, leading to an intervention blueprint. Videoconferencing technology allowed for geographically diverse representation and facilitated participation from patients experiencing medical illness. The electronic whiteboard permitted interactive written contributions and voting on priorities instead of only verbal discussion, which may privilege physician participants. A skilled qualitative researcher facilitated the sessions. Limitations: Challenges included the time commitment of the sessions, absences owing to illness or emergencies, and technical difficulties. Conclusions: An adapted Design Sprint is a novel method of efficiently and rapidly incorporating multiple stakeholders to develop solutions for clinical challenges in kidney disease. Plain Language Summary: Stigma contributes to ineffective treatment for pain among individuals with kidney failure on dialysis, particularly when using buprenorphine, an opioid pain medicine with a lower risk of sedation used to treat addiction. To develop a stigma intervention, we adapted a Design Sprint, an industry-developed structured exercise where an interdisciplinary group works over 5 days to clarify the problem, identify and choose a solution, and build and test a prototype. We conducted 3 sprints with (1) patients alone, (2) physicians alone, and (3) combined patients, physicians, and dialysis organization representatives. This paper describes the adaptations and products of sprints as a method for gathering diverse stakeholder voices to create an intervention blueprint efficiently and rapidly.

A Simulated Patient Protocol for Implementing Evidence-Based Practices in Health Care Delivery.

Background: Substantial work has been done to update or create evidence-based practices (EBPs) in the changing health care landscape. However, the success of these EBPs is limited by low levels of clinician implementation. The goal of this study is to describe the use of simulated patient (SP) methodology as a framework to develop implementation bundles to increase the effectiveness, sustainability, and reproducibility of EBPs across health care clinicians. The primary outcome was identifying likely facilitators for the successful implementation of EBP. Our secondary outcome was the assess the feasibility of using SPs to illuminate likely implementation barriers and facilitators. Methods: We observed 12 primary care clinicians' first-time experiences with six unique decision-making algorithms for use with patients exhibiting concerning behaviors associated with long-term opioid therapy (LTOT) for chronic pain over Zoom. Each clinician was paired with two simulated patients trained to portray individuals with one of the concerning behaviors addressed by the algorithms. The Standardized Patient-evaluations were followed by CFIR guided one-on-one interviews with the clinicians. Results: The SP portrayal illuminated factors that were pertinent to address in the implementation bundle. SPs were realistic in their portrayal of patients with concerning behaviors associated with LTOT for chronic pain, but clinicians also noted that their patients in practice may have been more aggressive about their treatment plan. Conclusions: SP simulation provides unique opportunities for obtaining crucial feedback to identify best practices in the adoption of new EBPs for high-risk patients.

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial.

OBJECTIVES: Patients with opioid use disorder (OUD) are increasingly being hospitalized for acute medical illnesses. Despite initiation of medications for OUD (MOUDs), many discontinue treatment after discharge. To evaluate whether a psychosocial intervention can improve MOUD retention after hospitalization, we conducted a pilot randomized controlled trial of a peer recovery coach intervention. METHODS: An existing peer recovery coach intervention was adapted for this trial. Hospitalized adults with OUD receiving MOUD treatment were randomized to receive either a recovery coach intervention or treatment-as-usual. For those in the intervention arm, the coach guided the participant to complete a relapse prevention plan, maintained contact throughout the 6-month follow-up period, encouraged MOUD continuation, and helped to identify community resources. Those receiving treatment-as-usual were discharged with a referral to outpatient treatment. Primary outcome was retention in MOUD treatment at 6 months. Secondary outcomes were the proportion of participants readmitted to the hospital and the number of days until treatment discontinuation and to hospital readmission. RESULTS: Twenty-five individuals who provided consent and randomized to the recovery coach intervention (n = 13) or treatment-as-usual (n = 12) were included in the analysis. No significant differences were found in the proportion of participants retained in MOUD treatment at 6 months (38.5% vs 41.7%, P = 0.87), proportion of participants readmitted at 6 months (46.2% vs 41.2%, P = 0.82), or the time to treatment discontinuation (log-rank P = 0.92) or readmission (log-rank P = 0.85). CONCLUSIONS: This pilot trial failed to demonstrate that a recovery coach intervention improved MOUD treatment retention compared with treatment-as-usual among hospitalized individuals with OUD.

Nurse Care Management for Opioid Use Disorder Treatment: The PROUD Cluster Randomized Clinical Trial.

Importance: Few primary care (PC) practices treat patients with medications for opioid use disorder (OUD) despite availability of effective treatments. Objective: To assess whether implementation of the Massachusetts model of nurse care management for OUD in PC increases OUD treatment with buprenorphine or extended-release injectable naltrexone and secondarily decreases acute care utilization. Design, Setting, and Participants: The Primary Care Opioid Use Disorders Treatment (PROUD) trial was a mixed-methods, implementation-effectiveness cluster randomized clinical trial conducted in 6 diverse health systems across 5 US states (New York, Florida, Michigan, Texas, and Washington). Two PC clinics in each system were randomized to intervention or usual care (UC) stratified by system (5 systems were notified on February 28, 2018, and 1 system with delayed data use agreement on August 31, 2018). Data were obtained from electronic health records and insurance claims. An implementation monitoring team collected qualitative data. Primary care patients were included if they were 16 to 90 years old and visited a participating clinic from up to 3 years before a system's randomization date through 2 years after. Intervention: The PROUD intervention included 3 components: (1) salary for a full-time OUD nurse care manager; (2) training and technical assistance for nurse care managers; and (3) 3 or more PC clinicians agreeing to prescribe buprenorphine. Main Outcomes and Measures: The primary outcome was a clinic-level measure of patient-years of OUD treatment (buprenorphine or extended-release injectable naltrexone) per 10 000 PC patients during the 2 years postrandomization (follow-up). The secondary outcome, among patients with OUD prerandomization, was a patient-level measure of the number of days of acute care utilization during follow-up. Results: During the baseline period, a total of 130 623 patients were seen in intervention clinics (mean [SD] age, 48.6 [17.7] years; 59.7% female), and 159 459 patients were seen in UC clinics (mean [SD] age, 47.2 [17.5] years; 63.0% female). Intervention clinics provided 8.2 (95% CI, 5.4-∞) more patient-years of OUD treatment per 10 000 PC patients compared with UC clinics (P = .002). Most of the benefit accrued in 2 health systems and in patients new to clinics (5.8 [95% CI, 1.3-∞] more patient-years) or newly treated for OUD postrandomization (8.3 [95% CI, 4.3-∞] more patient-years). Qualitative data indicated that keys to successful implementation included broad commitment to treat OUD in PC from system leaders and PC teams, full financial coverage for OUD treatment, and straightforward pathways for patients to access nurse care managers. Acute care utilization did not differ between intervention and UC clinics (relative rate, 1.16; 95% CI, 0.47-2.92; P = .70). Conclusions and Relevance: The PROUD cluster randomized clinical trial intervention meaningfully increased PC OUD treatment, albeit unevenly across health systems; however, it did not decrease acute care utilization among patients with OUD. Trial Registration: ClinicalTrials.gov Identifier: NCT03407638.

Expert consensus-based guidance on approaches to opioid management in individuals with advanced cancer-related pain and nonmedical stimulant use.

BACKGROUND: Clinicians treating cancer-related pain with opioids regularly encounter nonmedical stimulant use (i.e., methamphetamine, cocaine), yet there is little evidence-based management guidance. The aim of the study is to identify expert consensus on opioid management strategies for an individual with advanced cancer and cancer-related pain with nonmedical stimulant use according to prognosis. METHODS: The authors conducted two modified Delphi panels with palliative care and addiction experts. In Panel A, the patient's prognosis was weeks to months and in Panel B the prognosis was months to years. Experts reviewed, rated, and commented on the case using a 9-point Likert scale from 1 (very inappropriate) to 9 (very appropriate) and explained their responses. The authors applied the three-step analytical approach outlined in the RAND/UCLA to determine consensus and level of clinical appropriateness of management strategies. To better conceptualize the quantitative results, they thematically analyzed and coded participant comments. RESULTS: Consensus was achieved for all management strategies. The 120 Experts were mostly women (47 [62%]), White (94 [78%]), and physicians (115 [96%]). For a patient with cancer-related and nonmedical stimulant use, regardless of prognosis, it was deemed appropriate to continue opioids, increase monitoring, and avoid opioid tapering. Buprenorphine/naloxone transition was inappropriate for a patient with a short prognosis and of uncertain appropriateness for a patient with a longer prognosis. CONCLUSION: Study findings provide urgently needed consensus-based guidance for clinicians managing cancer-related pain in the context of stimulant use and highlight a critical need to develop management strategies to address stimulant use disorder in people with cancer. PLAIN LANGUAGE SUMMARY: Among palliative care and addiction experts, regardless of prognosis, it was deemed appropriate to continue opioids, increase monitoring, and avoid opioid tapering in the context of cancer-related pain and nonmedical stimulant use. Buprenorphine/naloxone transition as a harm reduction measure was inappropriate for a patient with a short prognosis and of uncertain appropriateness for a patient with a longer prognosis.

Dispensary Staff Perceptions About the Benefits, Risks, and Safety of Cannabis for Medical Purposes.

BACKGROUND: Therapeutic use of cannabis is common in the United States (up to 18.7% of Americans aged ≥12), and dispensaries in the US are proliferating rapidly. However, the efficacy profile of medical cannabis is unclear, and customers often rely on dispensary staff for purchasing decisions. The objective was to describe cannabis dispensary staff perceptions of medical cannabis benefits and risks, as well as its safety in high-risk populations. METHODS: Online Survey study conducted using Qualtrics from February 13, 2020 to October 2, 2020 with a national sample of dispensary staff who reportedinteracting with customers in a cannabis dispensary selling tetrahydrocannabinol-containing products. Participants were queried about benefits ("helpfulness") and risks ("worry") about cannabis for a variety of medical conditions, and safety in older adults and pregnant women on a five-point Likert scale. These results were then collapsed into three categories including "neutral" (3/5). "I don't know" (uncertainty) was a response option for helpfulness and safety. RESULTS: Participants (n = 434) were from 29 states and included patient-facing dispensary staff (40%); managers (32%); pharmacists (13%); and physicians, nurse practitioners, or physician assistants (5%). Over 80% of participants perceived cannabis as helpful for post-traumatic stress disorder (88.7%), epilepsy (85.3%) and cancer (83.4%). Generally, participants were not concerned about potential cannabis risks, including increased use of illicit drugs (76.3%), decreases in intelligence (74.4%), disrupted sleep (71.7%), and new/worsening health problems from medical cannabis use (70.7%). Cannabis was considered safe in older adults by 81.3% of participants, though there was much less consensus on safety in pregnancy. CONCLUSIONS: Cannabis dispensary staff generally view medical cannabis as beneficial and low-risk. However, improvements in dispensary staff training, an increased role for certifying clinicians, and interventions to reduce dispensary staff concerns (e.g., cost, judgment) may improve evidence-based staff recommendations to patients seeking medical cannabis.