Surgeons' views of peer comparison and guideline-based feedback on postsurgery opioid prescriptions: a qualitative investigation.

BACKGROUND: Excess opioid prescribing after surgery can lead to prolonged opioid use and diversion. We interviewed surgeons who were part of a three-group cluster-randomised controlled trial aimed at reducing prescribed opioid quantities after surgery via two versions of a monthly emailed behavioural 'nudge' (messages encouraging but not mandating compliance with social norms and clinical guidelines around prescribing) at the end of the implementation year in order to understand surgeons' reasoning for changing or continuing their prescribing behaviour as a result of the intervention and the context for their rationale. METHODS: The study took place at a large healthcare system in northern California with surgeons from three surgical specialties-orthopaedics, obstetrics/gynaecology and general surgery. Following the intervention period, we conducted semistructured interviews with 36 surgeons who had participated in the trial, ensuring representation across trial arm, specialty and changes in prescribing quantities over the year. Interviews focused on reactions to the nudges, impacts of the nudges on prescribing behaviours and other factors impacting prescribing. Three study team members coded and analysed the transcribed interviews. RESULTS: Nudges were equally effective in reducing postsurgical opioid prescribing across surgical specialties and between intervention arms. Surgeons were generally receptive to the nudge intervention, noting that it reduced the size of their discharge opioid prescriptions by improving their awareness and intentionality around prescribing. Most were unaware that clinical guidelines around opioid prescribing existed. Some had reservations regarding the accuracy and context of information provided in the nudges, the prescription quantities encouraged by the nudges and feelings of being watched or admonished. A few described discussing the nudges with colleagues. Respondents emphasised that the prescribing behaviours are informed by individual clinical experience and patient-related and procedure-related factors. CONCLUSIONS: Surgeons were open to learning about their prescribing behaviour through comparisons to guidelines or peer behaviour and incorporating this feedback as one of several factors that guide discharge opioid prescribing. Increasing awareness of clinical guidelines around opioid prescribing is important for curbing postsurgical opioid overprescribing. TRIAL REGISTRATION NUMBER: NCT05070338.

Peer Comparison or Guideline-Based Feedback and Postsurgery Opioid Prescriptions: A Randomized Clinical Trial.

Importance: Excess opioid prescribing after surgery can result in prolonged use and diversion. Email feedback based on social norms may reduce the number of pills prescribed. Objective: To assess the effectiveness of 2 social norm-based interventions on reducing guideline-discordant opioid prescribing after surgery. Design, Setting, and Participants: This cluster randomized clinical trial conducted at a large health care delivery system in northern California between October 2021 and October 2022 included general, obstetric/gynecologic, and orthopedic surgeons with patients aged 18 years or older discharged to home with an oral opioid prescription. Interventions: In 19 hospitals, 3 surgical specialties (general, orthopedic, and obstetric/gynecologic) were randomly assigned to a control group or 1 of 2 interventions. The guidelines intervention provided email feedback to surgeons on opioid prescribing relative to institutionally endorsed guidelines; the peer comparison intervention provided email feedback on opioid prescribing relative to that of peer surgeons. Emails were sent to surgeons with at least 2 guideline-discordant prescriptions in the previous month. The control group had no intervention. Main Outcome and Measures: The probability that a discharged patient was prescribed a quantity of opioids above the guideline for the respective procedure during the 12 intervention months. Results: There were 38 235 patients discharged from 640 surgeons during the 12-month intervention period. Control-group surgeons prescribed above guidelines 36.8% of the time during the intervention period compared with 27.5% and 25.4% among surgeons in the peer comparison and guidelines arms, respectively. In adjusted models, the peer comparison intervention reduced guideline-discordant prescribing by 5.8 percentage points (95% CI, -10.5 to -1.1; P = .03) and the guidelines intervention reduced it by 4.7 percentage points (95% CI, -9.4 to -0.1; P = .05). Effects were driven by surgeons who performed more surgeries and had more guideline-discordant prescribing at baseline. There was no significant difference between interventions. Conclusions and Relevance: In this cluster randomized clinical trial, email feedback based on either guidelines or peer comparison reduced opioid prescribing after surgery. Guideline-based feedback was as effective as peer comparison-based feedback. These interventions are simple, low-cost, and scalable, and may reduce downstream opioid misuse. Trial Registration: ClinicalTrials.gov NCT05070338.

It takes a village: A pilot study of a group telehealth intervention for support persons affected by opioid use disorder.

INTRODUCTION: Opioid use disorder (OUD) has devastating effects on individuals, families, and communities. The Community Reinforcement and Family Training (CRAFT) is a Support Person (SP)-focused intervention that aims to increase SPs' communication strategies, positive reinforcement/rewards, and social support. This pilot study, called eINSPIRE (INtegrating Support Persons Into REcovery), adapted CRAFT for delivery via group telehealth. The aims were to evaluate the feasibility, acceptability, and preliminary effectiveness of this intervention on patient buprenorphine retention and SP mental health. METHODS: The study recruited patients receiving buprenorphine treatment in a primary care setting across five community health centers with their SP (N = 100 dyads). SP participants were randomly assigned to receive usual care (UC) or the eINSPIRE intervention. We interviewed Patients and SPs at baseline and three months later. The study collected patient buprenorphine retention data from the electronic medical record three months post-baseline. RESULTS: About 88 % (656/742) of potentially eligible patients were able to nominate a SP and 69 % (100/145) of nominated SPs were eligible and consented to the study. eINSPIRE groups had low reach (25 % of SPs attended), but high exposure (M = 7 of 10 sessions attended) and acceptability (classes helped them with their patient's OUD). The proportion of eINSPIRE patients (68 %) and UC patients (53 %) retained on buprenorphine at follow-up were similar (p = 0.203). SPs in both conditions reported similar reductions in their depression, anxiety, and impairment symptoms. CONCLUSIONS: Preliminary data suggest that eINSPIRE groups may not be feasible in primary care without further adaptations for this population. A future study with a larger sample size is needed to elucidate the observed distribution differences in buprenorphine retention. Future research should also explore methods to reduce barriers to SP session attendance to improve the reach of this evidence-based intervention.

Findings from an Organizational Context Survey to Inform the Implementation of a Collaborative Care Study for Co-occurring Disorders.

Primary care is an opportune setting to deliver treatments for co-occurring substance use and mental health disorders; however, treatment delivery can be challenging due multi-level implementation barriers. Documenting organizational context can provide insight into implementation barriers and the adaptation of new processes into usual care workflows. This study surveyed primary care and behavioral health staff from 13 clinics implementing a collaborative care intervention for opioid use disorders co-occurring with PTSD and/or depression as part of a multisite randomized controlled trial. A total of 323 completed an online survey for a 60% response rate. The Consolidated Framework for Implementation Research guided this assessment of multi-level factors that influence implementation. Most areas for improvement focused on inner setting (organizational level) constructs whereas individual-level constructs tended to be strengths. This work addresses a research gap regarding how organizational analyses can be used prior to implementation and provides practical implications for researchers and clinic leaders.

Design of CLARO+ (Collaboration Leading to Addiction Treatment and Recovery from Other Stresses, Plus): A randomized trial of collaborative care to decrease overdose and suicide risk among patients with co-occurring disorders.

BACKGROUND: The United States is mired in two intertwined epidemics of death from suicide and overdose. Opioid use disorder (OUD) and mental illness contribute to both, and individuals with co-occurring disorders (CODs) are a complex population at high risk. Although universal prevention makes sense from a public health perspective, medical and behavioral health providers often lack the time to proactively address these issues with all patients. In this study, we build upon a parent study called Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO), a model of collaborative care in which care coordinators deliver preventative measures to high-risk patients and coordinate care with the patients' care team, with the goal of increasing MOUD retention and decreasing risk of suicide and overdose. METHODS: CLARO+ adds intervention components on overdose prevention, recognition, and response training; lethal means safety counseling; and an effort to mail compassionate messages called Caring Contacts. Both CLARO and CLARO+ have been implemented at 17 clinics in New Mexico and California, and this study seeks to determine the difference in effectiveness between the two versions of the intervention. This paper describes the design protocol for CLARO+. CONCLUSION: CLARO+ is an innovative approach that aims to supplement existing collaborative care with additional suicide and overdose prevention strategies. CLINICALTRIALS: gov: NCT04559893.

Disparities in postoperative opioid prescribing by race and ethnicity: an electronic health records-based observational study from Northern California, 2015-2020.

OBJECTIVES: To examine racial and ethnic disparities in postoperative opioid prescribing. DATA SOURCES: Electronic health records (EHR) data across 24 hospitals from a healthcare delivery system in Northern California from January 1, 2015 to February 2, 2020 (study period). STUDY DESIGN: Cross-sectional, secondary data analyses were conducted to examine differences by race and ethnicity in opioid prescribing, measured as morphine milligram equivalents (MME), among patients who underwent select, but commonly performed, surgical procedures. Linear regression models included adjustment for factors that would likely influence prescribing decisions and race and ethnicity-specific propensity weights. Opioid prescribing, overall and by race and ethnicity, was also compared to postoperative opioid guidelines. DATA EXTRACTION: Data were extracted from the EHR on adult patients undergoing a procedure during the study period, discharged to home with an opioid prescription. PRINCIPAL FINDINGS: Among 61,564 patients, on adjusted regression analysis, non-Hispanic Black (NHB) patients received prescriptions with higher mean MME than non-Hispanic white (NHW) patients (+ 6.4% [95% confidence interval: 4.4%, 8.3%]), whereas Hispanic and non-Hispanic Asian patients received lower mean MME (-4.2% [-5.1%, -3.2%] and - 3.6% [-4.8%, -2.3%], respectively). Nevertheless, 72.8% of all patients received prescriptions above guidelines, ranging from 71.0 to 80.3% by race and ethnicity. Disparities in prescribing were eliminated among Hispanic and NHB patients versus NHW patients when prescriptions were written within guideline recommendations. CONCLUSIONS: Racial and ethnic disparities in opioid prescribing exist in the postoperative setting, yet all groups received prescriptions above guideline recommendations. Policies encouraging guideline-based prescribing may reduce disparities and overall excess prescribing.

Pilot randomized controlled trial of a hospital-based substance use treatment and recovery team (START) to improve initiation of medication for alcohol or opioid use disorder and linkage to follow-up care.

OBJECTIVES: We conducted a pilot randomized controlled trial (RCT) to explore whether a hospital inpatient addiction consult team (Substance Use Treatment and Recovery Team [START]) based on collaborative care was feasible, acceptable to patients, and whether it could improve uptake of medication in the hospital and linkage to care after discharge, as well as reduce substance use and hospital readmission. The START consisted of an addiction medicine specialist and care manager who implemented a motivational and discharge planning intervention. METHODS: We randomized inpatients age ≥ 18 with a probable alcohol or opioid use disorder to receive START or usual care. We assessed feasibility and acceptability of START and the RCT, and we conducted an intent-to-treat analysis on data from the electronic medical record and patient interviews at baseline and 1-month postdischarge. The study compared RCT outcomes (medication for alcohol or opioid use disorder, linkage to follow-up care after discharge, substance use, hospital readmission) between arms by fitting logistic and linear regression models. FINDINGS: Of 38 START patients, 97 % met with the addiction medicine specialist and care manager; 89 % received ≥8 of 10 intervention components. All patients receiving START found it to be somewhat or very acceptable. START patients had higher odds of initiating medication during the inpatient stay (OR 6.26, 95 % CI = 2.38-16.48, p < .001) and being linked to follow-up care (OR 5.76, 95 % CI = 1.86-17.86, p < .01) compared to usual care patients (N = 50). The study found no significant differences between groups in drinking or opioid use; patients in both groups reported using fewer substances at the 1-month follow-up. CONCLUSIONS: Pilot data suggest START and RCT implementation are feasible and acceptable and that START may facilitate medication initiation and linkage to follow-up for inpatients with an alcohol or opioid use disorder. A larger trial should assess effectiveness, covariates, and moderators of intervention effects.

Screening for opioid use disorder and co-occurring depression and post-traumatic stress disorder in primary care in New Mexico.

BACKGROUND: Identifying patients in primary care services with opioid use disorder and co-occurring mental health disorders is critical to providing treatment. Objectives of this study were to (1) assess the feasibility of recruiting people to screen in-person for opioid use disorder and co-occurring mental health disorders (depression and/or post-traumatic stress disorder) in primary care clinic waiting rooms in preparation for a randomized controlled trial, and (2) compare results of detecting these disorders by universal in-person screening compared to electronic health record (EHR) diagnoses. METHODS: This cross-sectional feasibility and pilot study recruited participants from four primary care clinics, two rural and two urban, from three health care organizations in New Mexico. Inclusion criteria were adults (≥ 18 years), attending one of the four clinics as a patient, and who spoke English or Spanish. Exclusion criteria were people attending the clinic for a non-primary care visit (e.g., dental, prescription pick up, social support). The main outcomes and measures were (1) recruitment feasibility which was assessed by frequencies and proportions of people approached and consented for in-person screening, and (2) relative differences of detecting opioid use disorder and co-occurring mental health disorders in waiting rooms relative to aggregate EHR data from each clinic, measured by prevalence and prevalence ratios. RESULTS: Over two-weeks, 1478 potential participants were approached and 1145 were consented and screened (77.5% of patients approached). Probable opioid use disorder and co-occurring mental health disorders were identified in 2.4% of those screened compared to 0.8% in EHR. Similarly, universal screening relative to EHR identified higher proportions of probable opioid use disorder (4.5% vs. 3.4%), depression (17.5% vs. 12.7%) and post-traumatic stress disorder (19.0% vs. 3.6%). CONCLUSIONS: Universal screening for opioid use disorder, depression, and post-traumatic stress disorder was feasible, and identified three times as many patients with these co-occurring disorders compared to EHR. Higher proportions of each condition were also identified, especially post-traumatic stress disorder. Results support that there are likely gaps in identification of these disorders in primary care services and demonstrate the need to better address the persistent public health problem of these co-occurring disorders.

Perspectives Regarding Medications for Opioid Use Disorder Among Individuals with Mental Illness.

Most people with co-occurring opioid use disorder (OUD) and mental illness do not receive effective medications for treating OUD. To investigate perspectives of adults in a publicly-funded mental health system regarding medications for OUD (MOUD), we conducted semi-structured telephone interviews with 13 adults with OUD (current or previous diagnosis) receiving mental health treatment. Themes that emerged included: perceiving or using MOUDs as a substitute for opioids or a temporary solution to prevent withdrawal symptoms; negative perceptions about methadone/methadone clinics; and viewing MOUD use as "cheating". Readiness to quit was important for patients to consider MOUDs. All participants were receptive to discussing MOUDs with their mental health providers and welcomed the convenience of receiving care for their mental health and OUD at the same location. In conclusion, clients at publicly-funded mental health clinics support MOUD treatment, signaling a need to expand access and build awareness of MOUDs in these settings.

Evaluating the effectiveness of email-based nudges to reduce postoperative opioid prescribing: study protocol of a randomised controlled trial.

INTRODUCTION: Surgical patients are commonly prescribed more opioids at discharge than needed to manage their postoperative pain. These excess opioids increase the risks of new persistent opioid use, opioid-induced ventilatory impairment and opioid diversion. This study tests the effectiveness of two behavioural nudges, one based on peer behaviour and one based on best practice guidelines, in reducing excessive postoperative opioid prescriptions. METHODS AND ANALYSIS: The study will be conducted at 19 hospitals within a large healthcare delivery system in northern California, USA. Three surgical specialties (general surgery, orthopaedic surgery and obstetric/gynaecological surgery) at each hospital will be randomised either to a control group or to one of two active intervention arms. One intervention is grounded in the theory of injunctive norms, and provides feedback to surgeons on their postoperative opioid prescribing relative to prescribing guidelines endorsed by their institution. The other intervention draws from the theory of descriptive norms, and provides feedback similar to the first intervention but using peers' behaviour rather than guidelines as the benchmark for the surgeon's prescribing behaviour. The interventions will be delivered by a monthly email. Both interventions will be active for twelve months. The effects of each intervention relative to the control group and to each other will be tested using a four-level hierarchical model adjusted for multiple hypothesis testing. ETHICS AND DISSEMINATION: Using behavioural nudges rather than rigid policy changes allows us to target excessive prescribing without preventing clinicians from using their clinical judgement to address patient pain. All study activities have been approved by the RAND Human Subjects Protection Committee (ID 2018-0988). Findings will be disseminated through conference presentations, peer-reviewed publications and social media accounts. TRIAL REGISTRATION NUMBER: NCT05070338.

The Substance Use Treatment and Recovery Team (START) study: protocol for a multi-site randomized controlled trial evaluating an intervention to improve initiation of medication and linkage to post-discharge care for hospitalized patients with opioid use disorder.

BACKGROUND: People with opioid use disorder experience high burden of disease from medical comorbidities and are increasingly hospitalized with medical complications. Medications for opioid use disorder are an effective, life-saving treatment, but patients with an opioid use disorder admitted to the hospital seldom initiate medication for their disorder while in the hospital, nor are they linked with outpatient treatment after discharge. The inpatient stay, when patients may be more receptive to improving their health and reducing substance use, offers an opportunity to discuss opioid use disorder and facilitate medication initiation and linkage to treatment after discharge. An addiction-focus consultative team that uses evidence-based tools and resources could address barriers, such as the need for the primary medical team to focus on the primary health problem and lack of time and expertise, that prevent primary medical teams from addressing substance use. METHODS: This study is a pragmatic randomized controlled trial that will evaluate whether a consultative team, called the Substance Use Treatment and Recovery Team (START), increases initiation of any US Food and Drug Administration approved medication for opioid use disorder (buprenorphine, methadone, naltrexone) during the hospital stay and increases linkage to treatment after discharge compared to patients receiving usual care. The study is being conducted at three geographically distinct academic hospitals. Patients are randomly assigned within each hospital to receive the START intervention or usual care. Primary study outcomes are initiation of medication for opioid use disorder in the hospital and linkage to medication or other opioid use disorder treatment after discharge. Outcomes are assessed through participant interviews at baseline and 1 month after discharge and data from hospital and outpatient medical records. DISCUSSION: The START intervention offers a compelling model to improve care for hospitalized patients with opioid use disorder. The study could also advance translational science by identifying an effective and generalizable approach to treating not only opioid use disorder, but also other substance use disorders and behavioral health conditions. TRIAL REGISTRATION: Clinicaltrials.gov: NCT05086796, Registered on 10/21/2021. https://www. CLINICALTRIALS: gov/ct2/results?recrs=ab&cond=&term=NCT05086796&cntry=&state=&city=&dist = .

Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO): process of adapting collaborative care for co-occurring opioid use and mental disorders.

BACKGROUND: Opioid use disorders (OUD), co-occurring with either depression and/or PTSD, are prevalent, burdensome, and often receive little or low-quality care. Collaborative care is a service delivery intervention that uses a team-based model to improve treatment access, quality, and outcomes in primary care patients, but has not been evaluated for co-occurring OUD and mental health disorders. To address this treatment and quality gap, we adapted collaborative care for co-occurring OUD and mental health disorders. METHODS: Our adapted model is called Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO). We used the five-step Map of Adaptation Process (McKleroy in AIDS Educ Prev 18:59-73, 2006) to develop the model. For each step, our stakeholder team of research and clinical experts, primary care partners, and patients provided input into adaptation processes (e.g., adaptation team meetings, clinic partner feedback, patient interviews and beta-testing). To document each adaptation and our decision-making process, we used the Framework for Reporting Adaptations and Modifications-Enhanced (Wiltsey Stirman in Implement Sci 14:1-10, 2019). RESULTS: We documented 12 planned fidelity-consistent adaptations to collaborative care, including a mix of content, context, and training/evaluation modifications intended to improve fit with the patient population (co-occurring disorders) or the New Mexico setting (low-resource clinics in health professional shortage areas). Examples of documented adaptations include use of community health workers as care coordinators; an expanded consultant team to support task-shifting to community health workers; modified training protocols for Problem-Solving Therapy and Written Exposure Therapy to incorporate examples of treating patients for depression or PTSD with co-occurring OUD; and having care coordinators screen for patients' social needs. CONCLUSIONS: We completed the first three steps of the Map of Adaptation Process, resulting in a variety of adaptations that we believe will make collaborative care more acceptable and feasible in treating co-occurring OUD and mental health disorders. Future steps include evaluating the effectiveness of CLARO and documenting reactive and/or planned adaptations to the model that occur during its implementation and delivery. Trial registration NCT04559893, NCT04634279. Registered 08 September 2020, https://clinicaltrials.gov/ct2/show/NCT04559893.

The opioid use disorder core outcomes set (OUD-COS) for treatment research: findings from a Delphi consensus study.

BACKGROUND AND AIM: There is no gold-standard and considerable heterogeneity in outcome measures used to evaluate treatments for opioid use disorder (OUD) along the opioid treatment cascade. The aim of this study was to develop the US National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder core outcomes set (OUD-COS). DESIGN: Four-round, e-Delphi expert panel consensus study and plenary research group discussion and targeted consultation. SETTING: United States. PARTICIPANTS: A panel of 25 members including clinical practitioners, clinical researchers and administrative staff from the CTN, the network's affiliated clinical and community sites and the NIDA Centre for the CTN. MEASUREMENTS: From a pool of 24 candidate items in four domains (biomedical/disease status; behaviors, symptoms and functioning; opioid treatment cascade; and morbidity and mortality), the panel completed an on-line questionnaire to rank items with defined specification on a 9-point scale for importance, with a standard 70% consensus criterion. FINDINGS: After the fourth round of the questionnaire and subsequent discussion, consensus was reached for five outcomes: two patient-reported (global impression of improvement and incident non-fatal overdose); one clinician-reported (illicit/non-medical drug toxicology); and two from administrative records (duration of treatment and fatal opioid poisoning). CONCLUSIONS: An e-Delphi consensus study has produced the US National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network opioid use disorder core outcomes set (version 1) for opioid use disorder treatment efficacy and effectiveness research.

Opioid Use Disorder Among Clients of Community Mental Health Clinics: Prevalence, Characteristics, and Treatment Willingness.

OBJECTIVE: The authors examined the prevalence of co-occurring opioid use disorder and willingness to engage in treatment among clients of eight Los Angeles County Department of Mental Health outpatient clinics. METHODS: Adults presenting for an appointment over a 2-week period were invited to complete a voluntary, anonymous health survey. Clients who indicated opioid use in the past year were offered a longer survey assessing probable opioid use disorder. Willingness to take medication and receive treatment also was assessed. RESULTS: In total, 3,090 clients completed screening. Among these, 8% had a probable prescription (Rx) opioid use disorder and 2% a probable heroin use disorder. Of the clients with probable Rx opioid use or heroin use disorder, 49% and 25% were female, respectively. Among those with probable Rx opioid use disorder, 43% were Black, 33% were Hispanic, and 12% were White, and among those with probable heroin use disorder, 24% were Black, 22% were Hispanic, and 39% were White. Seventy-eight percent of those with Rx opioid use disorder had never received any treatment, and 82% had never taken a medication for this disorder; 39% of those with heroin use disorder had never received any treatment, and 39% had never received a medication. The strongest predictor of willingness to take a medication was believing that it would help stop opioid use (buprenorphine, ß=13.54, p=0.003, and naltrexone long-acting injection, ß=15.83, p<0.001). CONCLUSIONS: These findings highlight the need to identify people with opioid use disorder and to educate clients in mental health settings about medications for these disorders.

Design of CLARO (Collaboration Leading to Addiction Treatment and Recovery from other Stresses): A randomized trial of collaborative care for opioid use disorder and co-occurring depression and/or posttraumatic stress disorder.

INTRODUCTION: Opioid use disorder (OUD) co-occurring with depression and/or posttraumatic stress disorder (PTSD) is common and, if untreated, may lead to devastating consequences. Despite the availability of evidence-based treatments for these disorders, receipt of treatment is low. Even when treatment is provided, quality is variable. Primary care is an important and underutilized setting for treating co-occurring disorders (COD) because OUD, depression and PTSD are frequently co-morbid with medical conditions and most people visit a primary care provider at least once a year. With rising rates of OUD and opioid-related fatalities, this is a critical treatment and quality gap in a vulnerable and stigmatized population. METHODS: CLARO (Collaboration Leading to Addiction Treatment and Recovery from Other Stresses) is a multi-site, randomized pragmatic trial of collaborative care (CC) for co-occurring disorders in 13 rural and urban primary care clinics in New Mexico to improve care for patients with OUD and co-occurring depression and/or PTSD. CC, a service delivery approach that uses multi-faceted interventions, has not been tested with COD. We will enroll and randomize 900 patients to either CC adapted for COD (CC-COD) or enhanced usual care (EUC) and will collect patient data at baseline, 3-, and 6-month follow-up. Our primary outcomes are medications for OUD (MOUD) access, MOUD continuity of care, depression symptoms, and PTSD symptoms. DISCUSSION: Although CC is effective for improving outcomes in primary care among patients with mental health conditions, it has not been tested for COD. This article describes the CLARO CC-COD intervention and clinical trial.

Core outcomes set for research on the treatment of opioid use disorder (COS-OUD): the National Institute on Drug Abuse Clinical Trials Network protocol for an e-Delphi consensus study.

BACKGROUND: A lack of consensus on the optimal outcome measures to assess the efficacy and effectiveness of interventions for the treatment of opioid use disorder (OUD) has hampered the pooling of research data for evidence synthesis and clinical guidelines. A core outcome set (COS) is a minimum set of outcome measures that are recommended for all studies of a particular condition. The National Drug Abuse Treatment Clinical Trials Network (CTN) Core Outcome Set for OUD (COS-OUD) is a development study to identify core constructs, meaningful outcomes, and their optimal measurement for all efficacy and effectiveness studies of OUD treatment and service delivery. METHODS/DESIGN: Overseen by an expert workgroup, a modified, stepwise, e-Delphi methodology will be used to gain consensus among a panel of clinical practitioners and researchers involved in the treatment of OUD, who are members of the CTN. Sequential rounds of anonymous, online questionnaires will be used to identify, rate the importance of, and refine a core outcome set. A consensus threshold will be achieved if at least 70% of the panel rate the measure as critical for inclusion in the COS-OUD. Where consensus is not reached or there are suggestions for new measures, these will be brought forward to a further round of review prior to a consensus meeting. Products from this study will be communicated via peer-reviewed scientific journals and conferences. DISCUSSION: This initiative will develop a COS for OUD intervention trials, treatment studies, and service delivery and will support the pooling of research and clinical practice data and efforts to develop measurement-based care within the OUD treatment cascade. TRIAL REGISTRATION: http://www.comet-initiative.org/Studies/Details/1579.

Organizational Capacity and Readiness to Provide Medication for Individuals with Co-Occurring Alcohol Use Disorders in Public Mental Health Settings.

Alcohol use disorders (AUD) in individuals with mental illness are largely untreated. The purpose of this study was to identify gaps in organizational capacity and readiness to provide medications for AUD in outpatient public mental health clinics. We selected a purposive sample of eight publicly funded outpatient mental health clinics operated by the Los Angeles County Department of Mental Health; clinics were chosen to maximize heterogeneity. Guided by theories of organizational capacity and readiness and research on the adoption of pharmacotherapy for AUD in primary and specialty care treatment settings, we conducted semi-structured interviews and focus groups with administrators, providers and staff, and a qualitative analysis of the results. Respondents described significant organizational capacity and behavioral readiness constraints to providing medication treatment for AUD. Both groups articulated a perception that mental health clinics were not designed to provide co-occurring AUD treatment because of large caseloads, staffing configurations, and time constraints that did not support the delivery of appropriate treatment, and a lack of protocols and workflow procedures. We documented organizational capacity and readiness constraints which impede the delivery of medication treatment for AUD in a large mental helth system. While some constraints have straightforward solutions, others require structural changes to the way care is delivered, and state-level funding and policy changes.

Assessment of Postoperative Opioid Prescriptions Before and After Implementation of a Mandatory Prescription Drug Monitoring Program.

Importance: Legislation mandating consultation with a prescription drug monitoring program (PDMP) was implemented in California on October 2, 2018. This mandate requires PDMP consultation before prescribing a controlled substance and integrates electronic health record (EHR)-based alerts; prescribers are exempt from the mandate if they prescribe no more than a 5-day postoperative opioid supply. Although previous studies have examined the consequences of mandated PDMP consultation, few have specifically analyzed changes in postoperative opioid prescribing after mandate implementation. Objective: To examine whether the implementation of mandatory PDMP consultation with concurrent EHR-based alerts was associated with changes in postoperative opioid quantities prescribed at discharge. Design Setting and Participants: This cross-sectional study performed an interrupted time series analysis of opioid prescribing patterns within a large health care system (Sutter Health) in northern California between January 1, 2015, and February 1, 2020. A total of 93 760 adult patients who received an opioid prescription at discharge after undergoing general, obstetric and gynecologic (obstetric/gynecologic), or orthopedic surgery were included. Exposures: Mandatory PDMP consultation before opioid prescribing, with concurrent integration of an EHR alert. Prescribers are exempt from this mandate if prescribing no more than a 5-day opioid supply postoperatively. Main Outcomes and Measures: The primary outcome was the total quantity of opioid medications (morphine milligram equivalents [MMEs] and number of opioid tablets) prescribed at discharge before and after implementation of the PDMP mandate, with separate analyses by surgical specialty (general, obstetric/gynecologic, and orthopedic) and most common surgical procedure within each specialty (laparoscopic cholecystectomy, cesarean delivery, and knee arthroscopy). The secondary outcome was the proportion of prescriptions with a duration of longer than 5 days. Results: Of 93 760 patients (mean [SD] age, 46.7 [17.6] years; 67.9% female) who received an opioid prescription at discharge, 65 911 received prescriptions before PDMP mandate implementation, and 27 849 received prescriptions after implementation. Most patients received general or obstetric/gynecologic surgery (48.6% and 30.1%, respectively), did not have diabetes (90.3%), and had never smoked (66.0%). Before the PDMP mandate was implemented, a decreasing pattern in opioid prescribing quantities was already occurring. During the quarter of implementation, total MMEs prescribed at discharge further decreased for all 3 surgical specialties (eg, medians for general surgery: ß = -10.00 [95% CI, -19.52 to -0.48]; obstetric/gynecologic surgery: ß = -18.65 [95% CI, -22.00 to -15.30]; and orthopedic surgery: ß = -30.59 [95% CI, -40.19 to -21.00]) after adjusting for the preimplementation prescribing pattern. The total number of tablets prescribed also decreased across specialties (eg, medians for general surgery: ß = -3.02 [95% CI, -3.47 to -2.57]; obstetric/gynecologic surgery: ß = -4.86 [95% CI, -5.38 to -4.34]; and orthopedic surgery: ß = -4.06 [95% CI, -5.07 to -3.04]) compared with the quarters before implementation. These reductions were not consistent across the most common surgical procedures. For cesarean delivery, the median number of tablets prescribed decreased during the quarter of implementation (ß = -10.00; 95% CI, -10.10 to -9.90), but median MMEs did not (ß = 0; 95% CI, -9.97 to 9.97), whereas decreases were observed in both median MMEs and number of tablets prescribed (MMEs: ß = -33.33 [95% CI, -38.48 to -28.19]; tablets: ß = -10.00 [95% CI, -11.17 to -8.82]) for laparoscopic cholecystectomy. For knee arthroscopy, no decreases were found in either median MMEs or number of tablets prescribed (MMEs: ß = 10.00 [95% CI, -22.33 to 42.33; tablets: ß = 0.83; 95% CI, -3.39 to 5.05). The proportion of prescriptions written for longer than 5 days also decreased significantly during the quarter of implementation across all 3 surgical specialties. Conclusions and Relevance: In this cross-sectional study, the implementation of mandatory PDMP consultation with a concurrent EHR-based alert was associated with an immediate decrease in opioid prescribing across the 3 surgical specialties. These findings might be explained by prescribers' attempts to meet the mandate exemption and bypass PDMP consultation rather than the PDMP consultation itself. Although policies coupled with EHR alerts may be associated with changes in postoperative opioid prescribing behavior, they need to be well designed to optimize evidence-based opioid prescribing.

Study design to evaluate a group-based therapy for support persons of adults on buprenorphine/naloxone.

BACKGROUND: Opioid use disorders (OUDs) have devastating effects on individuals, families, and communities. While medication treatments for OUD save lives and are increasingly utilized, rates of treatment dropout are very high. In addition, most existing medication treatments for OUD may often neglect the impact of untreated OUD on relationships and ignore the potential role support persons (SPs) could have on encouraging long-term recovery, which can also impact patient treatment retention. METHODS/DESIGN: The current study adapts Community Reinforcement and Family Training (CRAFT) for use with SPs (family member, spouse or friend) of patients using buprenorphine/naloxone (buprenorphine) in an outpatient community clinic setting. The study will evaluate whether the adapted intervention, also known as integrating support persons into recovery (INSPIRE), is effective in increasing patient retention on buprenorphine when compared to usual care. We will utilize a two-group randomized design where patients starting or restarting buprenorphine will be screened for support person status and recruited with their support person if eligible. Support persons will be randomly assigned to the INSPIRE intervention, which will consist of 10 rolling group sessions led by two facilitators. Patients and SPs will each be assessed at baseline, 3 months post-baseline, and 12 months post-baseline. Patient electronic medical record data will be collected at six and 12 months post-baseline. We will examine mechanisms of intervention effectiveness and also conduct pre/post-implementation surveys with clinic staff to assess issues that would affect sustainability. DISCUSSION: Incorporating the patient's support system may be an important way to improve treatment retention in medication treatments for OUD. If SPs can serve to support patient retention, this study would significantly advance work to help support the delivery of effective treatments that prevent the devastating consequences associated with OUD. Trial registration This study was registered with ClinicalTrials.gov, NCT04239235. Registered 27 January 2020, https://clinicaltrials.gov/ct2/show/NCT04239235 .