A patient-centered nurse-supported primary care-based collaborative care program to treat opioid use disorder and depression: Design and protocol for the MI-CARE randomized controlled trial.

BACKGROUND: Opioid use disorder (OUD) contributes to rising morbidity and mortality. Life-saving OUD treatments can be provided in primary care but most patients with OUD don't receive treatment. Comorbid depression and other conditions complicate OUD management, especially in primary care. The MI-CARE trial is a pragmatic randomized encouragement (Zelen) trial testing whether offering collaborative care (CC) to patients with OUD and clinically-significant depressive symptoms increases OUD medication treatment with buprenorphine and improves depression outcomes compared to usual care. METHODS: Adult primary care patients with OUD and depressive symptoms (n ≥ 800) from two statewide health systems: Kaiser Permanente Washington and Indiana University Health are identified with computer algorithms from electronic Health record (EHR) data and automatically enrolled. A random sub-sample (50%) of eligible patients is offered the MI-CARE intervention: a 12-month nurse-driven CC intervention that includes motivational interviewing and behavioral activation. The remaining 50% of the study cohort comprise the usual care comparison group and is never contacted. The primary outcome is days of buprenorphine treatment provided during the intervention period. The powered secondary outcome is change in Patient Health Questionnaire (PHQ)-9 depression scores. Both outcomes are obtained from secondary electronic healthcare sources and compared in "intent-to-treat" analyses. CONCLUSION: MI-CARE addresses the need for rigorous encouragement trials to evaluate benefits of offering CC to generalizable samples of patients with OUD and mental health conditions identified from EHRs, as they would be in practice, and comparing outcomes to usual primary care. We describe the design and implementation of the trial, currently underway. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05122676. Clinical trial registration date: November 17, 2021.

Decision-making among adolescents prescribed antipsychotic medications: Interviews to gain perspectives of youth without psychosis or mania.

OBJECTIVES: This study aimed to understand the experiences of youth who had been prescribed antipsychotics but did not have psychosis, mania, autism spectrum disorder, or developmental disability. METHODS: Twenty-three qualitative telephone interviews were conducted with youth aged 11-18 who had been prescribed an antipsychotic medication but did not have a diagnosis of psychotic disorder, bipolar disorder, autism spectrum disorder, or developmental disability. Participants were recruited from four U.S. healthcare systems participating in the pragmatic trial Safer Use of Antipsychotics in Youth (SUAY). Interviews were recorded, transcribed and analyzed using template analysis techniques. RESULTS: Prior to initiating an antipsychotic medication, most participants experienced behavioral health crises; many felt that they had no options other than to start the medication. Other core themes included: (1) antipsychotics had both positive psychosocial outcomes, such as improvement of family life, and adverse effects, such as drowsiness or weight gain, (2) antipsychotics were only one part of a broader treatment plan, (3) efforts were made to maximize benefits and minimize side effects through careful titration, (4) feedback from friends and family was important in the decision to continue. CONCLUSIONS: The findings provide valuable insights into how to engage youth in conversations around the use of antipsychotics.

Development of a Symptom-Focused Model to Guide the Prescribing of Antipsychotics in Children and Adolescents: Results of the First Phase of the Safer Use of Antipsychotics in Youth (SUAY) Clinical Trial.

OBJECTIVE: To develop a new approach to prescribing guidelines as part of a pragmatic trial, Safer Use of Antipsychotics in Youth (SUAY; ClinicalTrials.gov Identifier: NCT03448575), which supports prescribers in delivering high-quality mental health care to youths. METHOD: A nominal group technique was used to identify first- to nth-line treatments for target symptoms and potential diagnoses. The panel included US pediatricians, child and adolescent psychiatrists, and psychopharmacology experts. Meeting materials included information about Medicaid review programs, systematic reviews, prescribing guidelines, and a description of the pragmatic trial. Afterward, a series of 4 webinar discussions were held to achieve consensus on recommendations. RESULTS: The panel unanimously agreed that the guideline should focus on target symptoms rather than diagnoses. Guidance included recommendations for first- to nth-line treatment of target mental health symptoms, environmental factors to be addressed, possible underlying diagnoses that should first be considered and ruled out, and general considerations for pharmacological and therapeutic treatments. CONCLUSION: Prescribing guidelines are often ignored because they do not incorporate the real-world availability of first-line psychosocial treatments, comorbid conditions, and clinical complexity. Our approach addresses some of these concerns. If the approach proves successful in our ongoing pragmatic trial, Safer Use of Antipsychotics in Youth (SUAY), it may serve as a model to state Medicaid programs and health systems to support clinicians in delivering high-quality mental health care to youths. CLINICAL TRIAL REGISTRATION INFORMATION: Safer Use of Antipsychotics in Youth; http://clinicaltrials.gov/; NCT03448575.

Developing home-based telemental health services for youth: Practices from the SUAY Study.

INTRODUCTION: There are no published procedural or safety guidelines for home-based telemental health (TMH) therapy with youth, despite the unique challenges and risks of providing services to this population outside of a traditional clinic setting. We developed clinical, logistical, and safety procedures for home-based TMH with youth in the context of a large clinical trial. METHODS: A Targeted Approach to Safer Use of Antipsychotics in Youth (SUAY) study identifies youth ages 3-17 who are prescribed second-generation antipsychotic medication for non-psychotic disorders within large healthcare systems. Prescribing physicians receive psychopharmacology consultation. Patients receive a "navigator" to coordinate treatments and access to TMH if they do not have a local therapist. We optimized access by allowing TMH sessions to take place in the family's home, while providing guidelines for privacy, safety, and in-session crises. RESULTS: Clinical issues included providing flexibility in the treatment modality and engaging families. Logistical issues included remote consenting for treatment and troubleshooting technological problems. Safety issues included crisis and safety planning with the youth and family before and during treatment. DISCUSSION: The provision of home-based TMH therapy for youth requires adaptations to existing TMH procedural and safety guidelines to optimize clinical care, technology coordination, and safety.Trial registration number and trial register: Clinicaltrials.gov: NCT03448575.

Safer use of antipsychotics in youth (SUAY) pragmatic trial protocol.

BACKGROUND: Programs such as the Pediatric Access Line in Washington state have shown decreases in antipsychotic medication use by youth with non-psychotic disorders. Program outcomes have been studied with observational designs. This manuscript describes the protocol for Targeted and Safer Use of Antipsychotics in Youth (SUAY), a randomized controlled trial of psychiatrist review of prescriptions and facilitated access to psychosocial care. The aim of the intervention is to reduce the number of person-days of antipsychotic use among participants. METHODS: Recruitment occurs at 4 health systems. Targeted enrollment is 800 youth aged 3-17 years. Clinicians are block randomized to intervention versus usual care prior to the study. Youth are nested within the arm of the prescribing clinician. Clinicians in the intervention group receive an EHR-based best practice alert with options to expedite access to psychosocial care and all medication orders are reviewed by a child and adolescent psychiatrist with feedback provided to the prescriber. The primary outcome is person-days of antipsychotic medication use in the 6 months following the initial order. All randomized individuals contribute data regardless of their level of participation (including declining all services). DISCUSSION: The trial has been approved by the institutional review boards at each of the 4 sites. The intervention has 4 novel design features including automated recruitment using a best practice alert, psychiatrist medication order review and consultation, telephone navigation to psychosocial care, and telemental health visits. Recruitment began in March of 2018 and will be completed in June 2020. Follow-up will be completed December 31, 2020. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03448575.

Sustaining Research Networks: the Twenty-Year Experience of the HMO Research Network.

PURPOSE: As multi-institutional research networks assume a central role in clinical research, they must address the challenge of sustainability. Despite its importance, the concept of network sustainability has received little attention in the literature, and the sustainability strategies of durable scientific networks have not been described. INNOVATION: The Health Maintenance Organization Research Network (HMORN) is a consortium of 18 research departments in integrated health care delivery systems with over 15 million members in the United States and Israel. The HMORN has coordinated federally funded scientific networks and studies since 1994. This case study describes the HMORN approach to sustainability, proposes an operational definition of network sustainability, and identifies 10 essential elements that can enhance sustainability. CREDIBILITY: The sustainability framework proposed here is drawn from prior publications on organizational issues by HMORN investigators and from the experience of recent HMORN leaders and senior staff. CONCLUSION AND DISCUSSION: Network sustainability can be defined as (1) the development and enhancement of shared research assets to facilitate a sequence of research studies in a specific content area or multiple areas, and (2) a community of researchers and other stakeholders who reuse and develop those assets. Essential elements needed to develop the shared assets of a network include: network governance; trustworthy data and processes for sharing data; shared knowledge about research tools; administrative efficiency; physical infrastructure; and infrastructure funding. The community of researchers within a network is enhanced by: a clearly defined mission, vision and values; protection of human subjects; a culture of collaboration; and strong relationships with host organizations. While the importance of these elements varies based on the membership and goals of a network, this framework for sustainability can enhance strategic planning within the network and can guide relationships with external stakeholders.

Changes in health care costs before and after smoking cessation.

Previous research on health care costs among former smokers suggests that quitters incur greater health care costs for up to 4 years after cessation compared with continuing smokers. However, little is known about the relationship between health care costs and utilization in the periods before as well as after cessation. The present study used a retrospective cohort design with automated health plan and primary data to examine the health care costs and clinical experiences before and after smoking cessation among former smokers compared with a sample of continuing smokers. Subjects were a random sample of adults (aged 25 and older) whose smoking status was identified by a physician during a primary care visit to the Group Health Cooperative (GHC), a nonprofit, integrated health care delivery system in western Washington state. Total direct health care costs among former smokers began to rise in the quarter prior to cessation and were significantly greater (p < .001) than those of continuing smokers in the quarter immediately following cessation. This difference dissipated within one quarter following cessation. We replicated the postquit cost spike among former smokers found by other research and showed that this spike dissipated within the first year postquit. Smoking cessation did not result in sustained cost increases among former smokers.

Health care costs among smokers, former smokers, and never smokers in an HMO.

OBJECTIVE: We estimate long-term health care costs of former smokers compared with continuing and never smokers using a retrospective cohort study of HMO enrollees. Previous research on health care costs associated with former smokers has suggested that quitters may incur greater health care costs than continuing smokers, therefore, getting people to quit creates more expensive health care consumers. We studied the trend in cost for former smokers over seven years after they quit to assess how the cessation experience impacts total health care cost. DATA SOURCES/STUDY SETTING: Group Health Cooperative (GHC), a nonprofit mixed model health maintenance organization in western Washington state. STUDY DESIGN: Retrospective cohort study using automated and primary data collected through telephone interviews. PRINCIPAL FINDINGS: We find that former smokers' costs are significantly greater (p<.05) in the year immediately following cessation relative to continuing smokers, but former smokers' costs fall in year two. This decrease maintains throughout the six-year follow-up period. Although former smokers cost more than continuing smokers in the year after cessation, this increase appears to be transient. Long-term costs for former smokers are not statistically different from those of continuing smokers and cumulative health care expenses are lower by the seventh year postquit. Our evidence suggests that smoking cessation does not increase long-term heath care costs. CONCLUSIONS: Health care costs among former smokers increase relative to continuing smokers in the year after cessation but fall to a level that is statistically indistinguishable in the second year postquit. Any net increase in costs among former smokers relative to continuing smokers appears compensated for within two years post-quit and is maintained for at least six years after cessation.