Effects of live-online, group mindfulness training on opioid use and anxiety during buprenorphine treatment: A comparative effectiveness RCT.

BACKGROUND: Office-based opioid treatment with buprenorphine has emerged as a popular evidence-based treatment for opioid use disorder. Unfortunately, psychosocial stress, anxiety, pain, and co-morbid substance use increase patients' risk for relapse. We designed this study to compare the effects of complementing buprenorphine treatment with 24 weeks of a live-online Mindful Recovery Opioid Care Continuum (M-ROCC) group to a time and attention-matched, live-online Recovery Support Group (RSG) active control condition. METHODS: We plan to enroll a maximum of N = 280 and randomize at least N = 192 patients prescribed buprenorphine through referrals from office-based and telemedicine buprenorphine treatment providers and social media advertisements. Participants will be randomly assigned to M-ROCC or RSG and will be blinded to their treatment condition. The primary outcome for this study will be biochemically confirmed periods of abstinence from illicit opioids, as measured by self-reported use and randomly collected, video-observed oral fluid toxicology testing during the final 12 weeks of study participation. Secondary outcomes include changes in Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and pain interference scores between baseline and week 24. RESULTS: The trial was funded by the National Institutes of Health, HEAL Initiative through NCCIH (R33AT010125). Data collection is projected to end by September 2023, and we expect publication of results in 2024. CONCLUSION: If the M-ROCC intervention is found to be effective in this format, it will demonstrate that live-online mindfulness groups can improve outcomes and address common co-morbidities like anxiety and pain during buprenorphine treatment.

An Evaluation of STFM's National Addiction Curriculum.

BACKGROUND AND OBJECTIVES: Family physicians are well positioned to treat patients with substance use disorders (SUDs), expand access to care, destigmatize addiction, and provide a biopsychosocial treatment approach. There is a great need to train residents and faculty to competency in SUD treatment. Through the Society of Teachers of Family Medicine (STFM) Addiction Collaborative, we created and evaluated the first national family medicine (FM) addiction curriculum using evidence-based content and teaching principles. METHODS: After launching the curriculum with 25 FM residency programs, we collected formative feedback through monthly faculty development sessions and summative feedback through 8 focus groups with 33 faculty members and 21 residents. We used qualitative thematic analysis to assess the value of the curriculum. RESULTS: The curriculum enriched resident and faculty knowledge across all SUD topics. It changed their attitudes in viewing addiction as a chronic disease within the scope of FM practice, increased confidence, and decreased stigma. It nurtured behavior change, enhancing communication and assessment skills and encouraging collaboration across disciplines. Participants valued the flipped-classroom approach, videos, cases, role plays, ready-made teacher's guides, and one-page summaries. Having protected time to complete the modules and temporally coupling the modules with the live, faculty-led sessions enhanced learning. CONCLUSION: The curriculum provides a comprehensive, ready-made, evidenced-based platform for training residents and faculty in SUDs. It can be implemented by faculty with all levels of prior expertise, cotaught by physicians and behavioral health providers, tailored to each program's didactic schedule, and modified based on the local culture and resource availability.

Multidisciplinary Approach for Managing Complex Pain and Addiction in Primary Care: A Qualitative Study.

PURPOSE: Primary care providers (PCPs) may feel ill-equipped to effectively and safely manage patients with chronic pain, an addiction, or both. This study evaluated a multidisciplinary approach of supporting PCPs in their management of this psychosocially complex patient population, to inform subsequent strategies clinics can use to support PCPs. METHODS: Four years ago, at our academic community health safety-net system, we created a multidisciplinary consultation service to support PCPs in caring for complex patients with pain and addiction. We collected and thematically analyzed 66 referral questions to understand PCPs' initially expressed needs, interviewed 14 referring PCPs to understand their actual needs that became apparent during the consultation, and identified discrepancies between these sets of needs. RESULTS: Many of the PCPs' expressed needs aligned with their actual needs, including needing expertise in the areas of addiction, safe prescribing of opioids, nonopioid treatment options, and communication strategies for difficult conversations, a comprehensive review of the case, and a biopsychosocial approach to management. But several PCP needs emerged after the initial consultation that they did not initially anticipate, including confirming their medical decision-making process, emotional validation, feeling more control, having an outside entity take the burden off the PCP for management decisions, boundary setting, and reframing the visit to focus on the patient's function, values, and goals. CONCLUSIONS: A multidisciplinary consultation service can act as a mechanism to meet the needs of PCPs caring for psychosocially complex patients with pain and addiction, including unanticipated needs. Future research should explore the most effective ways to meet PCP needs across populations and health systems.

Linking MATTERS: Barriers and Facilitators to Implementing Emergency Department-Initiated Buprenorphine-Naloxone in Patients with Opioid Use Disorder and Linkage to Long-Term Care.

BACKGROUND: In March 2019, our health system launched a project called Linking MATTERS (Medication for Addiction Treatment linkage Through Emergency depaRtmentS) to initiate evidence-based treatment for opioid use disorder (OUD) with buprenorphine-naloxone (B/N) in our emergency departments and connect patients to our primary care sites to continue their addiction care. Methods: Six months after project implementation, we conducted in-depth interviews with frontline providers (n = 14), including emergency physicians and hospitalists, recovery coaches, ED and outpatient nurses, and case managers. We used qualitative thematic analysis to identify barriers and facilitators to implementation and suggestions for improving the project. Results: We identified five salient themes: (1) provider trainings: mandated, rather than optional trainings, facilitated provider uptake; (2) provider attitudes: there was a growing recognition of addiction as a chronic, medical disease and the value of B/N in supporting patients' recovery, driven by a desire to make a difference in patients' lives; (3) patient engagement: frontline providers with lived experience of addiction who had designated time (such as recovery coaches) were optimally positioned to engage patients; (4) the linking mechanism: personal connections between ED and outpatient providers, rather than follow-up telephone calls, facilitated linkage; and (5) suggestions for improving the program, including: a physical space/bridge clinic to provide patient linkage, expansion of the recovery coach program, and standardized, evidence-based interdisciplinary trainings for all frontline providers. Conclusion: The insights provided will support further program modifications. Healthcare systems should explore whether the components we identified warrant attention locally based on their unique infrastructure and culture.

A Change Management Case Study for Safe Opioid Prescribing and Opioid Use Disorder Treatment.

BACKGROUND: Given that prescribing practices have contributed to the current opioid epidemic and that primary care clinicians are the largest prescribers of opioids, family physicians must consider the twin goals of safely prescribing opioids for patients with chronic pain while effectively identifying and treating those who have developed opioid use disorder (OUD). However, family physicians may feel constrained by a culture and systems in their offices that do not support achieving these twin goals. METHODS: In a family medicine clinic within a larger academic institution that cares for an underserved, multicultural patient population in the greater Boston area, we provide a case study that illustrates the twin goals of safe opioid prescribing and treating OUD. We used 2 models of change management-Lewin's Three-Step Change Theory and the McKinsey 7S Model of Change-as a framework to describe our 5-year process of using cultural and structural elements to support these efforts. RESULTS: Deliberate use of change management theory to support both safe opioid prescribing and treating patients with OUD over the past 5 years resulted in changes to the practices, people, skills, and infrastructure within our clinic. These changes have demonstrated a sense of stability and sustainability and hence now represent our clinic's current culture. CONCLUSION: The Lewin and 7S models of change can be helpful guides to creating and maintaining a foundation of office-wide culture and structural support to meet the twin goals of safe opioid prescribing and treating patients with OUD.

Implementing group visits for opioid use disorder: A case series.

Background: Group-based models of Office-Based Opioid Treatment with buprenorphine-naloxone (B/N) are increasingly being implemented in clinical practice to increase access to care and provide additional therapeutic benefits. While previous studies reported these Group-Based Opioid Treatment (GBOT) models are feasible for providers and acceptable to patients, there has been no literature to help providers with the more practical aspects of how to create and maintain GBOT in different outpatient settings. Case series: We present 4 cases of GBOT implementation across a large academic health care system, highlighting various potential approaches for providers who seek to implement GBOT and demonstrate "success" based on feasibility and sustainability of these models. For each case, we describe the pros and cons and detail the personnel and resources involved, patient mix and group format, workflow logistics, monitoring and management, and sustainability components. Discussion: The implementation details illustrate that there is no one-size-fits-all approach, although feasibility is commonly supported by a team-based, patient-centered medical home. This approach includes the capacity for referral to higher levels of mental health and addiction support services and is bolstered by ongoing provider communication and shared resources across the health system. Future research identifying the core and malleable components to implementation, their evidence base, and how they might be influenced by site-specific resources, culture, and other contextual factors can help providers better understand how to implement a GBOT model in their unique clinical environment.

Building a Group-Based Opioid Treatment (GBOT) blueprint: a qualitative study delineating GBOT implementation.

BACKGROUND: Group-Based Opioid Treatment (GBOT) has recently emerged as a mechanism for treating patients with opioid use disorder (OUD) in the outpatient setting. However, the more practical "how to" components of successfully delivering GBOT has received little attention in the medical literature, potentially limiting its widespread implementation and utilization. Building on a previous case series, this paper delineates the key components to implementing GBOT by asking: (a) What are the core components to GBOT implementation, and how are they defined? (b) What are the malleable components to GBOT implementation, and what conceptual framework should providers use in determining how to apply these components for effective delivery in their unique clinical environment? METHODS: To create a blueprint delineating GBOT implementation, we integrated findings from a previously conducted and separately published systematic review of existing GBOT studies, conducted additional literature review, reviewed best practice recommendations and policies related to GBOT and organizational frameworks for implementing health systems change. We triangulated this data with a qualitative thematic analysis from 5 individual interviews and 2 focus groups representing leaders from 5 different GBOT programs across our institution to identify the key components to GBOT implementation, distinguish "core" and "malleable" components, and provide a conceptual framework for considering various options for implementing the malleable components. RESULTS: We identified 6 core components to GBOT implementation that optimize clinical outcomes, comply with mandatory policies and regulations, ensure patient and staff safety, and promote sustainability in delivery. These included consistent group expectations, team-based approach to care, safe and confidential space, billing compliance, regular monitoring, and regular patient participation. We identified 14 malleable components and developed a novel conceptual framework that providers can apply when deciding how to employ each malleable component that considers empirical, theoretical and practical dimensions. CONCLUSION: While further research on the effectiveness of GBOT and its individual implementation components is needed, the blueprint outlined here provides an initial framework to help office-based opioid treatment sites implement a successful GBOT approach and hence potentially serve as future study sites to establish efficacy of the model. This blueprint can also be used to continuously monitor how components of GBOT influence treatment outcomes, providing an empirical framework for the ongoing process of refining implementation strategies.

Teaching evidence-based medicine application: transformative concepts of information mastery that foster evidence-informed decision-making.

Information mastery is an approach to applying the methods of evidence-based medicine to everyday practice. The aim of this research is to describe concepts identified by clinicians attending a 3-day course on applied evidence-based medicine that led to 'transformative learning', in which they experienced a deep, structural shift in the basic premises of thought, feelings and actions in their approach to making medical decisions. We used a qualitative approach to capture the lived experience of 12 current and 9 prior attendees of the 'information mastery' course through individual interviews, focus groups and observation. Data were thematically analysed and themes were reported. We found that current and previous attendees who seemed to undergo transformative learning identified eight concepts that constitute an information mastery approach to medical decision-making, which we grouped into two general themes. Some participants attending this course underwent transformative learning, resulting in an alternative decision-making process no longer relying on the anecdotes or guidance of others (what 'ought to work') and instead on incorporating patient-oriented outcomes based on the best evidence (what 'does work').

Making the Most of Continuing Medical Education: Evidence of Transformative Learning During a Course in Evidence-Based Medicine and Decision Making.

INTRODUCTION: Continuing medical information courses have been criticized for not promoting behavior change among their participants. For behavior change to occur, participants often need to consciously reject previous ideas and transform their way of thinking. Transformational learning is a process that cultivates deep emotional responses and can lead to cognitive and behavioral change in learners, potentially facilitating rich learning experiences and expediting knowledge translation. We explored participants' experiences at a 2-day conference designed to support transformative learning as they encounter new concepts within Information Mastery, which challenge their previous frameworks around the topic of medical decision making. Using the lens of transformative learning theory, we asked: how does Information Mastery qualitatively promote perspective transformation and hence behavior change? METHODS: We used a hermeneutic phenomenologic approach to capture the lived experience of 12 current and nine previous attendees of the "Information Mastery" course through individual interviews, focus groups, and observation. Data were thematically analyzed. RESULTS: Both prevoius and current conference attendees described how the delivery of new concepts about medical decision making evoked strong emotional responses, facilitated personal transformation, and propelled expedited behavior change around epistemological, moral, and information management themes, resulting in a newfound sense of self-efficacy, confidence, and ownership in their ability to make medical decisions. DISCUSSION: When the topic area holds the potential to foster a qualitative reframing of learners' guiding paradigms and worldviews, attention should be paid to supporting learners' personalized meaning-making process through transformative learning opportunities to promote translation into practice.

Implementation of a multidisciplinary, team-based model to treat chronic hepatitis C in the primary care setting: Lessons learned.

Hepatitis C virus (HCV) is the most common blood-borne virus in the U.S., and its incidence continues to rise. With approval of direct-acting antiviral medications, treatment for Chronic Hepatitis C (CHC) has become highly efficacious with a minimal side effect profile. Primary care physicians are well-positioned to address this increased demand, yet most do not feel comfortable treating CHC. In this case report, we describe implementation of a multidisciplinary team-based approach for treating CHC at multiple primary care sites across a large safety net health system. We focus on the evolving nature of implementation of our model through iterative Plan-Do-Study-Act (PDSA) cycles, highlighting the importance of developing an interdependent, multidisciplinary team, providing training, and ongoing support of Primary Care Hepatitis C Specialists, responding to the evolving nature of CHC treatment and policies, and ensuring high quality treatment. This process allowed us to continually grow and adapt our approach to make it feasible and successful. We share our "lessons" learned for others looking to bring CHC treatment, and potentially other specialty-based treatment, into the primary care setting.

Group-based treatment of opioid use disorder with buprenorphine: A systematic review.

BACKGROUND: Opioid use disorder (OUD) has become a public health crisis in the U.S., and there is a need to develop effective clinical treatment strategies. Coupling buprenorphine/naloxone (B/N) maintenance with counseling is encouraged as a best practice, yet the efficacy research on individual counseling in B/N-based Office-Based Opioid Treatment (OBOT) has been equivocal to date. In contrast, models for integrating B/N prescribing through group-based counseling could potentially have a differential impact, yet no systematic reviews have focused on examining the extent of the literature on group-based models of B/N delivery. METHODS: We conducted a systematic literature review to identify existing studies characterizing the different formats of Group-Based Opioid Treatment (GBOT), which we defined as the coupling of B/N prescribing with required office-based group counseling. Using this definition of GBOT, B/N prescribing could occur either concurrently during a medical visit with group counseling (i.e., Shared Medical Appointment) or asynchronously (i.e., Group Psychotherapy). We assessed for all available scientific literature reporting on the feasibility, acceptability and/or efficacy of these different forms of GBOT. The systematic review protocol used PRISMA standards. RESULTS: We included 10 peer-reviewed, full-text articles and 5 conference abstracts of office-based opioid use disorder treatment that reported data on the feasibility, acceptability, and efficacy of Group-Based Opioid Treatment with B/N. Of the ten full-text articles we included 4 studies describing a shared medical appointment (SMA) model and 6 studies describing a group psychotherapy model. Of these studies, all were low in quality due to study design and only three were randomized controlled trials. No studies were appropriately designed to rigorously compare the efficacy of a GBOT approach (i.e., B/N prescribing with required group-based counseling) versus B/N prescribing with required individual counseling; nor were they designed for rigorous comparison with medication management alone. Nevertheless, most studies reported on the feasibility and acceptability of various models representative of a GBOT approach. CONCLUSION: The small number of studies and study design limited the conclusions that could be drawn about the feasibility, acceptability, and efficacy of group-based B/N treatment. More research is needed to determine whether benefits exist of GBOT with B/N.

Why use group visits for opioid use disorder treatment in primary care? A patient-centered qualitative study.

BACKGROUND: Primary care providers are well positioned to respond to the opioid crisis by providing buprenorphine/naloxone (B/N) through shared medical appointments (SMAs). Although quantitative research has been previously conducted on SMAs with B/N, the authors conducted a qualitative assessment from the patients' point of view, considering whether and how group visits provide value for patients. METHODS: Twenty-five participants with opioid use disorder (OUD) who were enrolled in a weekly B/N group visit at a family medicine clinic participated in either of two 1-hour-long focus groups, which were conducted as actual group visits. Participants were prompted with the question "How has this group changed you as a person?" Data were audio-recorded and professionally transcribed and analyzed using a qualitative thematic approach, identifying common communication behaviors and resulting attitudes about the value of the group visit model. RESULTS: Participants demonstrated several communication behaviors that support group members in their recovery, including offering direct emotional support to others struggling with difficult experiences, making an intentional effort to probe about others' lives, venting about heavy situations, joking to lighten the mood, and expressing feelings of gratitude to the entire group. These communication behaviors appear to act as mechanisms to foster a sense of accountability, a shared identity, and a supportive community. Other demonstrated group behaviors may detract from the value of the group experience, including side conversations, tangential comments, and individual participants disproportionately dominating group time. CONCLUSION: The group visit format for delivering B/N promotes group-specific communication behaviors that may add unique value in supporting patients in their recovery. Future research should elucidate whether these benefits can be isolated from those achieved solely through medication treatment with B/N and if similar benefits could be achieved in non-primary care sites.

How good is the evidence to support primary care practice?

Our goal was to determine the extent to which recommendations for primary care practice are informed by high-quality research-based evidence, and the extent to which they are based on evidence of improved health outcomes (patient-oriented evidence). As a substrate for study, we used Essential Evidence, an online, evidence-based, medical reference for generalists. Each of the 721 chapters makes overall recommendations for practice that are graded A, B or C using the Strength of Recommendations Taxonomy (SORT). SORT A represents consistent and good quality patient-oriented evidence; SORT B is inconsistent or limited quality patient-oriented evidence and SORT C is expert opinion, usual practice or recommendations relying on surrogate or intermediate outcomes. Pairs of researchers abstracted the evidence ratings for each chapter in tandem, with discrepancies resolved by the lead author. Of 3251 overall recommendations, 18% were graded 'A', 34% were 'B' and 49% were 'C'. Clinical categories with the most 'A' recommendations were pregnancy and childbirth, cardiovascular, and psychiatric; those with the least were haematological, musculoskeletal and rheumatological, and poisoning and toxicity. 'A' level recommendations were most common for therapy and least common for diagnosis. Only 51% of recommendations are based on studies reporting patient-oriented outcomes, such as morbidity, mortality, quality of life or symptom reduction. In conclusion, approximately half of the recommendations for primary care practice are based on patient-oriented evidence, but only 18% are based on patient-oriented evidence from consistent, high-quality studies.

Identification of functional domains in sarcoglycans essential for their interaction and plasma membrane targeting.

Mutations in sarcoglycans have been reported to cause autosomal-recessive limb-girdle muscular dystrophies. In skeletal and cardiac muscle, sarcoglycans are assembled into a complex on the sarcolemma from four subunits (alpha, beta, gamma, delta). In this report, we present a detailed structural analysis of sarcoglycans using deletion study, limited proteolysis and co-immunoprecipitation. Our results indicate that the extracellular regions of sarcoglycans consist of distinctive functional domains connected by proteinase K-sensitive sites. The N-terminal half domains are required for sarcoglycan interaction. The C-terminal half domains of beta-, gamma- and delta-sarcoglycan consist of a cysteine-rich motif and a previously unrecognized conserved sequence, both of which are essential for plasma membrane localization. Using a heterologous expression system, we demonstrate that missense sarcoglycan mutations affect sarcoglycan complex assembly and/or localization to the cell surface. Our data suggest that the formation of a stable complex is necessary but not sufficient for plasma membrane targeting. Finally, we provide evidence that the beta/delta-sarcoglycan core can associate with the C-terminus of dystrophin. Our results therefore generate important information on the structure of the sarcoglycan complex and the molecular mechanisms underlying the effects of various sarcoglycan mutations in muscular dystrophies.