A novel rural hospital/clinic-system practice-based research network: the Rural Addiction Implementation Network (RAIN) initiative and its goals, implementation, and early results.

Background: Rural and frontier communities face high rates of opioid use disorders (OUDs). In 2021, the Rural Addiction Implementation Network (RAIN) sought to establish a rural hospital/clinic-system practice-based research network (RH-PBRN) to facilitate implementation of evidence-based addiction-related prevention, treatment, and recovery (PTR) services to reduce the morbidity of OUD and substance use disorder (SUD) in rural communities.Objective: To describe the goals and implementation of PTR activities of RAIN, a novel RH-PBRN.Methods: RAIN identified teams of external/internal facilitators at four rural hospitals/clinic-networks to achieve at least 15 PTR activities involving OUD and other SUDs. RAIN utilized an implementation-facilitation approach: facilitators assessed the implementation environment and promoted interventions to overcome barriers to PTR implementation. Other interventions included site visits, community of learning calls, and e-communication. RAIN assessed and recorded facilitators and barriers to implementation, milestone attainment, and outcomes of PTR activities. At 18 months, we queried facilitators about the fidelity and implementation of RAIN activities.Results: RAIN established an HP-PBRN in four sites (Idaho, Montana, Utah, and Wyoming). Within the HP-PBRN, 20 PTR activities were established (p = 7, T = 10, R = 3; range 3-7 per site). Barriers to implementation of PTR activities included competing clinical demands, especially due to COVID-19, lack of dedicated effort for staff at sites, and stigma of addiction and its treatment. Facilitators of implementation included the use of trained expert facilitators and communication between the sites.Conclusions: RAIN implemented 20 addiction-related PTR activities in four rural hospitals/clinic-networks. RAIN's intervention model could be replicated to address addiction-related harms in other rural communities.

Design and development of a machine-learning-driven opioid overdose risk prediction tool integrated in electronic health records in primary care settings.

BACKGROUND: Integrating advanced machine-learning (ML) algorithms into clinical practice is challenging and requires interdisciplinary collaboration to develop transparent, interpretable, and ethically sound clinical decision support (CDS) tools. We aimed to design a ML-driven CDS tool to predict opioid overdose risk and gather feedback for its integration into the University of Florida Health (UFHealth) electronic health record (EHR) system. METHODS: We used user-centered design methods to integrate the ML algorithm into the EHR system. The backend and UI design sub-teams collaborated closely, both informed by user feedback sessions. We conducted seven user feedback sessions with five UF Health primary care physicians (PCPs) to explore aspects of CDS tools, including workflow, risk display, and risk mitigation strategies. After customizing the tool based on PCPs' feedback, we held two rounds of one-on-one usability testing sessions with 8 additional PCPs to gather feedback on prototype alerts. These sessions informed iterative UI design and backend processes, including alert frequency and reappearance circumstances. RESULTS: The backend process development identified needs and requirements from our team, information technology, UFHealth, and PCPs. Thirteen PCPs (male = 62%, White = 85%) participated across 7 user feedback sessions and 8 usability testing sessions. During the user feedback sessions, PCPs (n = 5) identified flaws such as the term "high risk" of overdose potentially leading to unintended consequences (e.g., immediate addiction services referrals), offered suggestions, and expressed trust in the tool. In the first usability testing session, PCPs (n = 4) emphasized the need for natural risk presentation (e.g., 1 in 200) and suggested displaying the alert multiple times yearly for at-risk patients. Another 4 PCPs in the second usability testing session valued the UFHealth-specific alert for managing new or unfamiliar patients, expressed concerns about PCPs' workload when prescribing to high-risk patients, and recommended incorporating the details page into training sessions to enhance usability. CONCLUSIONS: The final backend process for our CDS alert aligns with PCP needs and UFHealth standards. Integrating feedback from PCPs in the early development phase of our ML-driven CDS tool helped identify barriers and facilitators in the CDS integration process. This collaborative approach yielded a refined prototype aimed at minimizing unintended consequences and enhancing usability.

The Association Between Chronic Pain, Substance use, and Primary Care Experience Among Veterans with Ongoing or Recent Homelessness.

BACKGROUND: Chronic pain and problematic substance use are prevalent among Veterans with homeless experience (VHE) and may contribute to a challenging primary care experience. OBJECTIVE: To examine the association of chronic pain and problematic substance use with unfavorable primary care experiences among VHE and to explore the association of pain treatment utilization and unfavorable care experiences in VHE with chronic pain. METHODS: We surveyed VHE (n = 3039) engaged in homeless-tailored primary care at 29 Veterans Affairs Medical Centers (VAMCs). We assessed unfavorable primary care experiences with four validated Primary Care Quality-Homeless (PCQ-H) scales: multivariable logistic regressions explored associations between unfavorable care experiences for VHE with chronic pain and problematic substance use, chronic pain alone, problematic substance use alone, or neither. We then examined the association between receipt of pain treatments and unfavorable experiences among VHE with chronic pain. Last, we identified PCQ-H items that had the greatest difference in unfavorable response rates between VHE with and without chronic pain. RESULTS: The prevalence of unfavorable primary care experience was higher on all four scales for patients reporting chronic pain (with or without problematic substance use) (all p < 0.001), but not for problematic substance use alone, compared to VHE with neither pain nor problematic substance use. In analyses limited to VHE with chronic pain, those on long-term opioids were less likely to report an unfavorable experience (OR = 0.49, 95%CI 0.34-0.69). Receipt of occupational therapy was associated with lower odds of reporting an unfavorable experience (OR = 0.83, 95%CI 0707-0.98). PCQ-H items related to trust, relationships, and provider communication had the greatest differences in dissatisfaction ratings (all p < 0.001). CONCLUSIONS: Chronic pain is associated with unfavorable primary care experiences among VHE, potentially contributing to poor care outcomes. Strategies are needed to enhance patient-provider trust and communication and increase VHE's access to effective pain treatments.

Prevention of postpartum methamphetamine use with micronized progesterone trial (PROMPT): A pilot randomized controlled trial protocol.

Background: While most pregnant individuals with methamphetamine use disorder (MUD) achieve abstinence, the postpartum period remains a vulnerable time for return to methamphetamine use (MU). Promising data from human and animal models, including three randomized controlled trials, suggest that micronized progesterone may prevent postpartum return to cocaine and nicotine use by reducing cravings. The primary objective of this study is to assess feasibility of enrollment and randomization of postpartum individuals with MUD to micronized progesterone to prevent return to MU. The secondary objectives are to evaluate safety, establish a preliminary estimate of efficacy, and characterize the association between allopregnanolone levels and methamphetamine cravings. Methods: This is a pilot double-blind placebo randomized controlled trial. We plan to enroll 40 postpartum individuals with MUD over 24-months. Individuals, stratified by opioid use disorder (OUD), are randomized 1:1-400 mg oral micronized progesterone daily or placebo and attend weekly study sessions for 12 weeks. Feasibility is measured by achieving 80 % of enrollment goal. Safety is evaluated by side effect frequency, mental health status changes, lactation and medical complications. Efficacy is assessed by comparing proportion of participants with return to MU and time to return to MU based on self-report or urine testing between treatment and control groups. Salivary allopregnanolone levels and methamphetamine cravings are compared between the groups. Conclusion: Study results will provide a first critical step towards potential intervention for prevention of return to MU among postpartum individuals. Completion of this trial will set the stage for a large-scale efficacy trial.

Association of Daily Doses of Buprenorphine With Urgent Health Care Utilization.

Importance: Higher buprenorphine doses may benefit the increasing number of individuals using fentanyl and other synthetic opioids, but there is little empirical evidence on the efficacy of such higher doses. Objective: To examine the association between higher buprenorphine doses (above 16 mg and 24 mg) and subsequent emergency department (ED) or inpatient service use among patients diagnosed with opioid use disorder. Design, Setting, and Participants: This cross-sectional study was a retrospective analysis of health data from Optum's deidentified Clinformatics Data Mart Database from 2016 to 2021 for commercially insured individuals aged 18 years or older diagnosed with opioid use disorder (OUD). Eligible participants initiated buprenorphine after at least 90 days of enrollment and were dispensed at least a 14-day supply of buprenorphine. Data were analyzed from September 2023 through February 2024. Exposures: Maximum buprenorphine dose received by a patient for 14 or more days: more than 24 mg, more than 16 mg to 24 mg, more than 8 mg to 16 mg, or 1 mg to 8 mg. Main Outcomes and Measures: Days from initiation of the maximum buprenorphine dose to an ED or inpatient visit for a behavioral health diagnosis, controlling for patient demographics, comorbid conditions, time to reaching maximum dose, buprenorphine discontinuation, and pre-buprenorphine health care utilization. Results: A total of 35 451 individuals with an OUD diagnosis who began buprenorphine treatment were identified (mean [SD] age, 46.2 [15.1] years; 20 983 male [59.2%]; 3326 Black [9.4%], 2411 Hispanic [6.8%], 26 712 White [75.3%]). The most common dose was more than 8 mg to 16 mg daily (14 802 patients [42.9%]), with 9669 patients (27.3%) in the 1 mg to 8 mg tier, 10 329 patients (29.1%) in the 8 mg to 16 mg tier, and 651 patients (1.8%) in the tier receiving more than 24 mg. Among all patients receiving buprenorphine, 12.5% experienced an ED or inpatient visit. Survival analysis shows patients receiving doses more than 24 mg and between 16 mg to 24 mg had longer times to ED or inpatient use than patients receiving from 8 mg to 16 mg (time ratio [TR], 1.11; 95% CI, 1.02 to 1.20) and more than 24 mg (TR, 1.37; 95% CI, 1.04 to 1.81). Findings for doses above 16 mg daily were consistent for observation windows as short as 365 days (more than 24 mg: TR, 1.48; 95% CI, 1.01-2.18; more than 16 mg to 24 mg: TR, 1.19; 95% CI, 1.06-1.32). Conclusions and Relevance: These findings contribute to the sparse empirical research regarding potential benefits of higher-dose buprenorphine treatment of individuals with OUD. Clinicians should be aware of the potential effects of higher buprenorphine doses on health care utilization while policymakers work to ensure equitable access to individuals who could potentially benefit from higher doses.

Associations Between Reductions in Depressive Symptoms and Reductions in Pain and Anxiety Symptoms and Substance Use: Emulation of a Randomized Trial.

Introduction: Depressive symptoms are linked with pain, anxiety, and substance use. Research estimating whether a reduction in depressive symptoms is linked to subsequent reductions in pain and anxiety symptoms and substance use is limited. Methods: Using data from the Veterans Aging Cohort Study, a multisite observational study of U.S. veterans, the authors used a target trial emulation framework to compare individuals with elevated depressive symptoms (Patient Health Questionnaire-9 score ≥ 10) who experienced reductions in depressive symptoms (Patient Health Questionnaire-9 score < 10) with those whose symptoms persisted (Patient Health Questionnaire-9 score ≥ 10) at the next follow-up visit (on average, 1 year later). Using inverse probability of treatment weighting, the authors estimated ORs and 95% CIs for associations between depressive symptom reduction status and improvement on the following: anxiety symptoms, pain symptoms, unhealthy alcohol use, and use of tobacco, cannabis, cocaine, and/or illicit opioids. Results: Reductions in depressive symptoms were associated with reductions in pain symptoms (OR=1.43, 95% CI=1.01, 2.02), anxiety symptoms (OR=2.50, 95% CI=1.63, 3.83), and illicit opioid use (OR=2.07, 95% CI=1.13, 3.81). Depressive symptom reductions were not associated with reductions in unhealthy alcohol use (OR=0.85, 95% CI=0.48, 1.52) or use of tobacco (OR=1.49, 95% CI=0.89, 2.48), cannabis (OR=1.07, 95% CI=0.63, 1.83), or cocaine (OR=1.28, 95% CI=0.73, 2.24). Conclusions: Reducing depressive symptoms may potentially reduce pain and anxiety symptoms and illicit opioid use. Future work should determine whether reductions achieved through antidepressant medications, behavioral therapy, or other means have comparable impact.

Developing Evidence to Support Policy: Protocol for the StrAtegic PoLicy EvIdence-Based Evaluation CeNTer (SALIENT).

BACKGROUND: All federal agencies are required to support appropriation requests with evidence and evaluation (US Public Law 115-435; the Evidence Act). The StrAtegic PoLicy EvIdence-Based Evaluation CeNTer (SALIENT) is 1 of 6 centers that help the Department of Veterans Affairs (VA) meet this requirement. OBJECTIVE: Working with the existing VA evaluation structure, SALIENT evaluations will contribute to (1) optimize policies and programs for veteran populations; (2) improve outcomes regarding health, equity, cost, and provider well-being; (3) advance the science of dissemination and knowledge translation; and (4) expand the implementation and dissemination science workforce. METHODS: We leverage the Lean Sprint methodology (iterative, incremental, rule-governed approach to clearly defined, and time-boxed work) and 3 cores to develop our evaluation plans collaboratively with operational partners and key stakeholders including veterans, policy experts, and clinicians. The Operations Core will work with evaluation teams to develop timelines, facilitate work, monitor progress, and guide quality improvement within SALIENT. The Methods Core will work with evaluation teams to identify the most appropriate qualitative, quantitative, and mixed methods approaches to address each evaluation, ensure that the analyses are conducted appropriately, and troubleshoot when problems with data acquisition and analysis arise. The Knowledge Translation (KT) Core will target key partners and decision makers using a needs-based market segmentation approach to ensure that needs are incorporated in the dissemination of knowledge. The KT Core will create communications briefs, playbooks, and other materials targeted at these market segments to facilitate implementation of evidence-based practices and maximize the impact of evaluation results. RESULTS: The SALIENT team has developed a center infrastructure to support high-priority evaluations, often to be responsive to shifting operational needs and priorities. Our team has engaged in our core missions and operations to rapidly evaluate a high-priority areas, develop a comprehensive Lean Sprint systems redesign approach to training, and accelerate rapid knowledge translation. CONCLUSIONS: With an array of interdisciplinary expertise, operational partnerships, and integrated resources, SALIENT has an established and evolving infrastructure to rapidly develop and implement high-impact evaluations. Projects are developed with sustained efficiency approaches that can pivot to new priorities as needed and effectively translate knowledge for key stakeholders and policy makers, while creating a learning health system infrastructure to foster the next generation of evaluation and implementation scientists. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/59830.

Expert Panel Consensus on the Effectiveness and Implementation of Models to Support Posthospitalization Care Transitions for People With Substance Use Disorders.

OBJECTIVES: Hospitals are increasingly offering treatment for substance use disorders (SUDs) during medical admissions. However, there is a lack of consensus on the best approach to facilitating a successful transition to long-term medical and SUD care after hospitalization. We aimed to establish a hierarchy of existing SUD care transition models in 2 categories-effectiveness and implementation-using an expert consensus approach. METHODS: We conducted a modified online Delphi study that convened 25 interdisciplinary clinicians with experience facilitating posthospitalization care transitions for patients with SUD. Panelists rated 10 prespecified posthospitalization care transition models according to 6 criteria concerning each model's anticipated effectiveness (eg, linkage to care, treatment retention) and implementation (eg, feasibility, acceptability). Ratings were made on a 9-point bidirectional scale. Group consensus was determined using the interpercentile range adjusted for symmetry. RESULTS: After 3 rounds of the Delphi process (96% retention across all 3 rounds), consensus was reached on all 60 rating criteria. Interdisciplinary addiction consult teams (ACTs) and in-reach from partnering outpatient clinics were rated highest for effectiveness. Interdisciplinary ACTs and bridge clinics were rated highest for implementation. Screening, brief intervention, and referral to treatment; protocol implementation; and postdischarge outreach received the lowest ratings overall. Feasibility of implementation was perceived as the largest challenge for all highly rated models. CONCLUSIONS: An expert consensus approach including diverse clinician stakeholders found that interdisciplinary ACT, in-reach from partnering outpatient clinics, and bridge clinics had the greatest potential to enhance posthospitalization care transitions for patients with SUD when considering both perceived effectiveness and implementation.

Organizational and patient factors associated with positive primary care experiences for veterans with current or recent homelessness.

OBJECTIVE: To identify organizational service features associated with positive patient ratings of primary care within primary care clinics tailored to accommodate persons with ongoing and recent experiences of homelessness (PEH). DATA SOURCES AND STUDY SETTING: PEH receiving primary care in 29 United States Veterans Health Administration homeless-tailored clinics were surveyed about their primary care experience using the validated Primary Care Quality-Homeless (PCQ-H) survey. Characteristics of the clinics were assessed through surveys of clinic staff using a new organizational survey developed through literature review, site visits, statistical analysis, and consensus deliberation. STUDY DESIGN: Cross-sectional examination of patients' ratings of care based on surveys of patients, and of clinic characteristics, analyzed with Classification and Regression Tree (CART) analysis, a form of machine learning. DATA COLLECTION METHODS: Patient surveys (n = 3394) were obtained from a random sample of enrolled patients by both mail and telephone by an external survey contractor. Staff (n = 52 from 29 clinics) were interviewed by telephone. PRINCIPAL FINDINGS: This analysis identified service features that impact patient experience favorably, including aspects of patient-centeredness, team identity, strong external leadership support, and service that reach beyond traditional primary care clinic confines. Results varied according to the patient experience scale analyzed. Individual characteristics of PEH, such as degree of social support, general health, and unsheltered status, were also correlated with how they rate care. CONCLUSIONS: Organizational characteristics correlate with ratings of primary care from patients with recent and ongoing homelessness. Primary care programs serving homeless individuals can assure better care based on who they hire, how they foster team identity, what services they provide, and the strength of leadership support to protect a homeless-focused mission.

Trauma Prevalence and Its Association With Health-Related Quality of Life in Pregnant Persons with Opioid Use Disorder.

OBJECTIVES: Trauma screening is recommended for pregnant persons with opioid use disorder (OUD), but there is limited literature on screening results from buprenorphine treatment. This study's objectives were to 1) describe the types, and severity, of traumatic events reported and 2) evaluate the associations between trauma and health-related quality of life (HRQoL). METHODS: Baseline data from an ongoing trial were analyzed. Participants were 155 pregnant persons with OUD receiving, or enrolling in, buprenorphine treatment at one of 13 sites. The experience, and relative severity, of 14 high magnitude stressors were assessed with the trauma history screen. The Patient-Reported Outcomes Measurement Information System-29+2 was used to assess 8 HRQoL domains. RESULTS: Traumatic stressors were reported by 91% of the sample (n = 155), with 54.8% reporting a lifetime persisting posttraumatic distress (PPD) event and 29.7% reporting a childhood PPD event. The most prevalent lifetime PPD event was sudden death of a close family/friend (25.8%); physical abuse was the most prevalent childhood PPD event (10.3%). Participants with lifetime PPD, relative to no PPD, reported significantly greater pain interference (P = 0.02). Participants with childhood PPD, relative to no PPD, had significantly worse HRQoL overall (P = 0.01), and worse pain intensity (P = 0.002), anxiety (P = 0.003), depression (P = 0.007), fatigue (P = 0.002), and pain interference (P < 0.001). CONCLUSIONS: A majority of pregnant persons enrolled/enrolling in buprenorphine treatment reported persisting posttraumatic distress with sudden death of close family/friend being the most prevalent originating event; clinicians should consider the impact that the opioid-overdose epidemic may be having in increasing trauma exposure in patients with OUD.

Medicare Payment for Opioid Treatment Programs.

Importance: Medicare began paying for medications for opioid use disorder (MOUD) at opioid treatment programs (OTPs) that dispense methadone and other MOUD in January 2020. There has been little research describing the response to this payment change and whether it resulted in more patients receiving MOUD or just a shift in who pays for this care. Objective: To describe how many and which Medicare beneficiaries receive care from OTPs and how this compares to those receiving MOUD in other settings. Design, Setting, and Participants: This cross-sectional study included all patients receiving MOUD care identified in 2019-2022 100% US Medicare Parts B and D claims. Patients receiving care in an OTP who were dually insured with Medicare and Medicaid in the 2019-2020 Transformed Medicaid Statistical Information System were also included. Exposure: Receiving MOUD care in an OTP. Main Outcomes and Measures: Comparisons of 2022 beneficiaries treated in OTPs vs other non-OTP settings in 2022. Results: The share of Medicare beneficiaries treated by OTPs rose steadily from 4 per 10 000 (14 160 beneficiaries) in January 2020 to 7 per 10 000 (25 596 beneficiaries) in August 2020, then plateaued through December 2022; of 38 870 patients (23% ≥66 years; 35% female) treated at an OTP in 2022, 96% received methadone. Patients in OTPs, compared to those receiving MOUD in other settings, were more likely be 65 years and younger (65% vs 62%; P < .001), less likely to be White (72% vs 82%; P < .001), and more likely to be an urban resident (86% vs 74%; P < .001). When Medicare OTP coverage began, there was no associated drop in the number of dually insured patients with Medicaid with an OTP claim. Of the 1854 OTPs, 1115 (60%) billed Medicare in 2022, with the share billing Medicare ranging from 13% to 100% across states. Conclusions and Relevance: This study showed that since the initiation of Medicare OTP coverage in 2020, there has been a rapid increase in the number of Medicare beneficiaries with claims for OTP services for MOUD, and most OTPs have begun billing Medicare. Patients in OTPs were more likely to be urban residents and members of racial or ethnic minority groups than the patients receiving other forms of MOUD.

Improving access to buprenorphine for rural veterans in a learning health care system.

OBJECTIVE: To describe a learning health care system research process designed to increase buprenorphine prescribing for the treatment of opioid use disorder (OUD) in rural primary care settings within U.S. Department of Veterans Affairs (VA) treatment facilities. DATA SOURCES AND STUDY SETTING: Using national administrative data from the VA Corporate Data Warehouse, we identified six rural VA health care systems that had improved their rate of buprenorphine prescribing within primary care from 2015 to 2020 (positive deviants). We conducted qualitative interviews with leaders, clinicians, and staff involved in buprenorphine prescribing within primary care from these sites to inform the design of an implementation strategy. STUDY DESIGN: Qualitative interviews to inform implementation strategy development. DATA COLLECTION/EXTRACTION METHODS: Interviews were audio-recorded, transcribed verbatim, and coded by a primary coder and secondary reviewer. Analysis utilized a mixed inductive/deductive approach. To develop an implementation strategy, we matched clinical needs identified within interviews with resources and strategies participants had utilized to address these needs in their own sites. PRINCIPAL FINDINGS: Interview participants (n = 30) identified key clinical needs and strategies for implementing buprenorphine in rural, primary care settings. Common suggestions included the need for clinical mentorship or a consult service, buprenorphine training, and educational resources. Building upon interview findings and in partnership with a clinical team, we developed an implementation strategy composed of an engaging case-based training, an audit and feedback process, and educational resources (e.g., Buprenorphine Frequently Asked Questions, Rural Care Model Infographic). CONCLUSIONS: We describe a learning health care system research process that leveraged national administrative data, health care provider interviews, and clinical partnership to develop an implementation strategy to encourage buprenorphine prescribing in rural primary care settings.

Integrating Buprenorphine for Opioid Use Disorder into Rural, Primary Care Settings.

BACKGROUND: Medications for opioid use disorder (MOUD) including buprenorphine are effective, but underutilized. Rural patients experience pronounced disparities in access. To reach rural patients, the US Department of Veterans Affairs (VA) has sought to expand buprenorphine prescribing beyond specialty settings and into primary care. OBJECTIVE: Although challenges remain, some rural VA health care systems have begun offering opioid use disorder (OUD) treatment with buprenorphine in primary care. We conducted interviews with clinicians, leaders, and staff within these systems to understand how this outcome had been achieved. DESIGN: Using administrative data from the VA Corporate Data Warehouse (CDW), we identified rural VA health care systems that had improved their rate of primary care-based buprenorphine prescribing over the period 2015-2020. We conducted qualitative interviews (n = 30) with staff involved in implementing or prescribing buprenorphine in these systems to understand the processes that had facilitated implementation. PARTICIPANTS: Clinicians, staff, and leaders embedded within rural VA health care systems located in the Northwest, West, Midwest (2), South, and Northeast. APPROACH: Qualitative interviews were analyzed using a mixed inductive/deductive approach. KEY RESULTS: Interviews revealed the processes through which buprenorphine was integrated into primary care, as well as processes insufficient to enact change. Implementation was often initially catalyzed through a targeted hire. Champions then engaged clinicians and leaders one-on-one to "pitch" the case, describe concordance between buprenorphine prescribing and existing goals, and delineate the supportive role that they could provide. Sites were prepared for implementation by developing new clinical teams and redesigning clinical processes. Each of these processes was made possible with the active, instrumental support of leadership. CONCLUSIONS: Results suggest that rural systems seeking to improve buprenorphine accessibility in primary care may need to alter primary care structures to accommodate buprenorphine prescribing, whether through new hires, team development, or clinical redesign.

PT-IN-MIND: study protocol for a multisite randomised feasibility trial investigating physical therapy with integrated mindfulness (PT-IN-MIND) for patients with chronic musculoskeletal pain and long-term opioid treatment who attend outpatient physical therapy.

INTRODUCTION: Many individuals receiving outpatient physical therapy have musculoskeletal pain and up to one-third use prescription opioids. The impact of physical therapist-led mindfulness-based interventions integrated with evidence-based physical therapy (I-EPT) to manage patients with chronic musculoskeletal pain and long-term opioid treatment has not been elucidated. This project evaluates the feasibility of conducting a cluster randomised trial to test the effectiveness of I-EPT. METHODS AND ANALYSIS: Study 1 aim: Refine and manualise the I-EPT treatment protocol. Our approach will use semistructured interviews of patients and physical therapists to refine an I-EPT training manual. Study 2 aim: Evaluate different intensities of physical therapist training programmes for the refined I-EPT treatment protocol. Physical therapists will be randomised 1:1:1 to high-intensity training (HighIT), low-IT (LowIT) training and no training arms. Following training, competency in the provision of I-EPT (LowIT and HighIT groups) will be assessed using standardised patient simulations. Study 3 aim: Evaluate the feasibility of the I-EPT intervention across domains of the Reach, Effectiveness, Adoption, Implementation, Maintenance implementation framework. The refined I-EPT treatment protocol will be tested in two different health systems with 90 patients managed by the randomised physical therapists. The coprimary endpoints for study 3 are the proportions of the Pain, Enjoyment of Life and General Activity Scale and the Timeline Followback for opioid use/dose collected at 12 weeks. ETHICS AND DISSEMINATION: Ethics approval for the study was obtained from the University of Utah, University of Florida and Florida State University Institutional Review Boards. Informed consent is required for participant enrolment in all phases of this project. On completion, study data will be made available in compliance with NIH data sharing policies. TRIAL REGISTRATION NUMBER: NCT05875207.

Average Daily Dose Trajectories for Episodes of Buprenorphine Treatment for Opioid Use Disorder.

BACKGROUND: High-dose (≥24 mg) buprenorphine daily doses (BDD) may be important in treating patients with opioid use disorder (OUD) to improve retention and prevent overdose, particularly in the context of increased illicit fentanyl use. This study sought to: (1) identify trajectories for average BDD among patients initiating buprenorphine treatment for OUD and (2) assess patient characteristics associated with these identified trajectories. METHODS: Buprenorphine treatment episodes among patients in the US Veterans Healthcare Administration (VHA) from federal fiscal years 2006 to 2020 were identified. Group-based trajectory modeling (GBTM) was used to identify BDD trajectories based on weekly averages of BDD over the 180 days after buprenorphine episode initiation. RESULTS: A total of 79 303 buprenorphine treatment episodes among 44 583 patients were included in the analytic sample. GBTM identified 9 latent trajectories for BDD: (1) moderate dose, early discontinuation (10.1%), (2) moderate dose, delayed discontinuation (4.5%), (3) moderate dose, moderate-paced discontinuation (5.2%), (4) low-moderate dose, delayed discontinuation (7.0%), and (5) low-moderate dose, early discontinuation (21.1%), (6) low dose retention (9.6%), (7) low-moderate dose retention (16.7%), (8) moderate dose retention (18.6%), and (9) high dose retention (7.4%). Patient BDD can broadly be characterized as low [2-4 mg/day], low-moderate (6-8 mg/day), moderate (12-18 mg/day), and high dose (≥ 24 mg/day). Patients with episodes in the high BDD trajectory have the lowest social risk (eg, lowest rate of past-year history of homelessness) and the lowest diagnosed rate of physical and mental health-related comorbidities compared to those following other trajectories. CONCLUSIONS: BDD ranges widely and patient characteristics are significantly different between those episodes following differing BDD trajectories. Future research on the association between BDD and subsequent patient outcomes (eg, overdose) needs to carefully consider these differences in baseline characteristics.

Are gaps in rates of retention on buprenorphine for treatment of opioid use disorder closing among veterans across different races and ethnicities? A retrospective cohort study.

INTRODUCTION: The U.S. Veterans Health Administration has undertaken several initiatives to improve veterans' access to and retention on buprenorphine because it prevents overdose and reduces drug-related morbidity. We aimed to determine whether improvements in retention duration over time was equitable across veterans of different races and ethnicities. METHODS: This retrospective cohort study was conducted among veterans who initiated buprenorphine from federal fiscal years (FY) 2006 to 2020 after diagnosis of opioid use disorder. Using an accelerated failure time model, we estimated the association between time to buprenorphine discontinuation and FY of initiation, race and ethnicity, and other control covariates. We followed veterans from buprenorphine initiation until they discontinued or had a censoring event. We then estimated the predicted median days retained on buprenorphine, the average marginal effect of initiating in a later FY, the same measure by race and ethnicity, the incremental effect of the various racial and ethnic identities in contrast to non-Hispanic White, and the total change in the size of the gap over the 15 years of the study between veterans with a minoritized racial or ethnic identity compared to non-Hispanic White veterans. RESULTS: Most of the 31,797 veterans in the sample were non-Hispanic White (74.5 %), from urban areas (83.5 %), male (92.0 %), and had significant comorbidities, most frequently anxiety disorders (51.0 %) and depression (63.0 %). Overall, 49.8 % of veterans were retained at least 180 days. The average marginal effect of FY was 7.0 days [95%CI:5.3, 8.8] but was significantly smaller among veterans identifying as Black or African American [3.2 days; 95%CI:2.4, 4.1] or Asian [3.6 days; 95%CI:1.6, 5.7] compared to veterans who identify as non-Hispanic White [7.9 days; 95%CI:5.9, 9.9]. Additional measures of change were significant for veterans identifying as Hispanic White or with two or more races. CONCLUSION: Although buprenorphine retention in OUD treatment improved for all veterans over the 15-year study period, veterans from most minoritized racial and ethnic groups fell further behind as gains in duration on therapy accrued primarily to non-Hispanic White veterans. Targeted interventions addressing specific challenges experienced by veterans with minoritized identities are needed to close gaps in retention on buprenorphine.

Commentary With Study Protocol: Implementation and Effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) as an Adjunct to Methadone Treatment for Opioid Use Disorder (IMPOWR-MORE).

Traditional methadone treatment (MT) for opioid use disorder (OUD) fails to systematically address the physical pain, emotion dysregulation, and reward processing deficits that co-occur with OUD, and novel interventions that address these issues are needed to improve MT outcomes. Mindfulness-Oriented Recovery Enhancement (MORE) remediates the hedonic dysregulation in brain reward systems that is associated with OUD. Our pilot and phase 2 randomized controlled trials of MORE were the first to demonstrate MORE's feasibility, acceptability, and efficacy as delivered in MT clinics; MORE significantly reduced drug use (eg, benzodiazepines, barbiturates, cocaine, marijuana, opioids, and other drugs), craving, depression, anxiety, and pain among people with OUD. However, uptake of novel, efficacious interventions like MORE may be slow in MT because time and resources are often limited. Therefore, to best address potential implementation issues and to optimize future MORE implementation and dissemination, in this study, we will utilize a Type 2, Hybrid Implementation-Effectiveness study design. We will not only evaluate MORE's effectiveness but also assess barriers and facilitators to integrating MORE into MT. MT clinicians will receive training in (1) a higher intensity MORE implementation strategy consisting of training in the full MORE treatment manual or (2) a minimal intensity implementation strategy consisting of a simple, scripted mindfulness practice (SMP) extracted from the MORE treatment manual with minimal training. We aim to: (1) using a Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, examine barriers and facilitators to implementation of MORE and SMP in MT, and evaluate strategies for optimizing training, fidelity, and engagement, (2) optimize existing MORE and SMP training and implementation toolkits, including adaptable resources that can accelerate the translation of evidence into practice, and (3) compared to usual MT, evaluate the relative effectiveness of MORE plus MT or SMP plus MT (N = 450).

Barriers to Buprenorphine Dispensing by Medicaid-Participating Community Retail Pharmacies.

Importance: Controlled substances have regulatory requirements under the US Federal Controlled Substance Act that must be met before pharmacies can stock and dispense them. However, emerging evidence suggests there are pharmacy-level barriers in access to buprenorphine for treatment for opioid use disorder even among pharmacies that dispense other opioids. Objective: To estimate the proportion of Medicaid-participating community retail pharmacies that dispense buprenorphine, out of Medicaid-participating community retail pharmacies that dispense other opioids and assess if the proportion dispensing buprenorphine varies by Medicaid patient volume or rural-urban location. Design, Setting, and Participants: This serial cross-sectional study included Medicaid pharmacy claims (2016-2019) data from 6 states (Kentucky, Maine, North Carolina, Pennsylvania, Virginia, West Virginia) participating in the Medicaid Outcomes Distributed Research Network (MODRN). Community retail pharmacies serving Medicaid-enrolled patients were included, mail-order pharmacies were excluded. Analyses were conducted from September 2022 to August 2023. Main Outcomes and Measures: The proportion of pharmacies dispensing buprenorphine approved for opioid use disorder among pharmacies dispensing an opioid analgesic or buprenorphine prescription to at least 1 Medicaid enrollee in each state. Pharmacies were categorized by median Medicaid patient volume (by state and year) and rurality (urban vs rural location according to zip code). Results: In 2016, 72.0% (95% CI, 70.9%-73.0%) of the 7038 pharmacies that dispensed opioids also dispensed buprenorphine to Medicaid enrollees, increasing to 80.4% (95% CI, 79.5%-81.3%) of 7437 pharmacies in 2019. States varied in the percent of pharmacies dispensing buprenorphine in Medicaid (range, 73.8%-96.4%), with significant differences between several states found in 2019 (χ2 P < .05), when states were most similar in the percent of pharmacies dispensing buprenorphine. A lower percent of pharmacies with Medicaid patient volume below the median dispensed buprenorphine (69.1% vs 91.7% in 2019), compared with pharmacies with above-median patient volume (χ2 P < .001). Conclusions and Relevance: In this serial cross-sectional study of Medicaid-participating pharmacies, buprenorphine was not accessible in up to 20% of community retail pharmacies, presenting pharmacy-level barriers to patients with Medicaid seeking buprenorphine treatment. That some pharmacies dispensed opioid analgesics but not buprenorphine suggests that factors other than compliance with the Controlled Substance Act influence pharmacy dispensing decisions.

"They Ask Questions, But They Don't Want the Answers"-Perceptions of Clinical Communication Among Veterans Discontinuing Buprenorphine for the Treatment of Opioid Use Disorder.

BACKGROUND: Many patients with opioid use disorder (OUD) discontinue treatment prematurely, increasing their risk of opioid-related overdose and death. While patient-centered care is considered the gold standard in treating chronic illness, it may be practiced less frequently in the context of OUD care. Patient-provider communication can influence patients' care experiences, potentially having an impact on treatment retention and care decision-making. METHODS: This study was conducted at the VA Portland Health Care System from March 2021 to April 2022. We conducted qualitive interviews with patients who had discontinued buprenorphine for the treatment of OUD within the past year. Coding and analysis were guided by inductive qualitative content analysis. Retrospective medical record review identified clinical and demographic characteristics of participants. RESULTS: Twenty patients completed an interview. Participant age ranged from 28 to 74 years (median 63 years). Ninety percent of participants were white and 90% male. Many participants expressed frustration and feelings of disempowerment in OUD care processes. Patients with a history of long-term prescribed opioid use frequently expressed stigmatizing views of OUD, and perceptions of disagreement with providers over diagnosis and care choices. Elderly patients and those with multiple comorbidities expressed confusion over significant aspects of their care, as well as difficulty navigating treatment logistics like appointment requirements and medication dose changes. Some patients reported later restarting buprenorphine in new settings, and described feeling respected and involved in care decisions as a facilitator for continuing treatment. CONCLUSIONS: Prioritizing patient-centered communication in OUD treatment could improve the patient experience and potentially support treatment retention. Subgroups of OUD patients, such as those with a history of long-term prescribed opioid use, elderly patients with multiple comorbidities, or those who express stigmatizing medication views, could particularly benefit from tailored communication strategies that address their individual concerns.

The Development of an Opioid Misuse Training Program for Physical Therapists: A Learning Community Approach.

INTRODUCTION: Musculoskeletal pain and opioid misuse frequently co-occur. REVIEW OF THE LITERATURE: The US Preventive Services Task Force calls for all health care providers to be trained to screen for misuse and/or opioid use disorder. The purpose of this study was to develop and implement an opioid misuse training program that could be used by physical therapists. SUBJECTS: Thirteen practicing physical therapists were invited to participate in a curriculum development project. METHODS: Using the Curriculum Framework, a collaborative learning approach was used to develop an opioid misuse training program and training manual for physical therapists. Four training sessions were provided virtually every 2 weeks. Topics included an introduction to the opioid crisis, screening, assessing, and communicating with patients and with the health care team about opioid misuse. Each didactic session was followed by a participant feedback session where participants provided recommendations on improving the training content and their impressions on the barriers and facilitators to incorporating the training into practice. A companion training manual was created and sent to participants for comment. Participants were asked over email to describe whether and how they incorporated training materials into clinical practice during the training curriculum. RESULTS: All participants attended sessions 1-3. Twelve (92.3%) attended the fourth session. Based on the participants' feedback, training sessions were edited, and a companion training manual was finalized and distributed to each participant. After the fourth session, 9 participants (69.2%) reported using what they learned in the training. During the participant feedback sessions, participants regarded the training as important. Some participants expressed barriers to discussing opioids with patients and concerns about whether the training was within physical therapists' scope of practice. DISCUSSION AND CONCLUSION: An iteratively developed training program for physical therapists to address opioid misuse was acceptable, feasible, and provided immediate practice change by most participants.