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The majority of adults suffering from alcohol use disorders (AUD) do not receive treatment. To address this gap in care, we must develop new models to increase identification, engagement and delivery of accessible and effective treatment. This paper describes the protocol for a randomized controlled trial (RCT) testing a novel telehealth treatment model for primary care patients with untreated AUD. We aim to recruit 300 adults across 2 healthcare systems for this two-arm RCT. Participants, initially identified for recruitment based on AUD-related indicators in their electronic health record (EHR), are RCT-eligible if they meet AUD criteria (mild, moderate, severe), report ≥ 3 drinking days/week in past 30 days, and have not received AUD psychotherapy in the past 90 days. Participants are randomized to an intervention or enhanced usual care control (EUC) condition, both individually-delivered. The intervention includes a telephone-delivered motivational interviewing (MI) engagement session and 8 sessions of MI-Cognitive Behavioral Therapy (MI-CBT). EUC involves AUD psychoeducation, advice to reduce drinking and seek treatment, and provision of community resources. Outcomes will be measured at 3-, 6-, and 12-months; primary outcomes include: AUD psychotherapy initiation and engagement (within the study and external community) and alcohol consumption (percent drinking days and heavy drinking days). This study addresses whether proactive patient identification and engagement and delivery of patient-centered telehealth psychotherapy to patients with untreated AUD is effective in increasing treatment use and improving alcohol outcomes. If effective, this could be a highly scalable model for reducing the public health impact of AUD. ClinicalTrials.gov # NCT05410561. University of Michigan HUM00204315. Ann Arbor VA IRB #1655886. [ABSTRACT FROM AUTHOR]

Purpose An ostomy adversely affects health-related quality of life (HRQOL) in a diverse population of cancer survivors and their caregivers. Hit-or-miss ostomy care, nurse counseling, and community referral have been the primary modes of self-management education and support in the peri-operative setting. Few evidence-based, systematic ostomy self-management programs are available to ensure optimal post-operative care. This paper describes the study design of a telehealth-based Ostomy Self-management Training (OSMT) program for cancer survivors and their caregivers. Methods The study is a three-year, randomized trial that tests the effectiveness of the OSMT program on survivor activation, self-efficacy, and HRQOL. The intervention integrates goal setting and problem-solving approaches to enhance survivor activation and self-efficacy to carry out ostomy care. The curriculum is delivered via four group sessions administered by trained ostomy certified nurses (WOCNs) and peer ostomates. An additional session is offered to caregivers to address their needs in relation to ostomy care. Telehealth approaches through videoconferencing are used to enhance program delivery to participants in three different geographic areas across two time zones. Participants join sessions via real-time videoconferencing from their homes. Conclusions The OSMT program has high potential to make a positive impact on the unique physical, psychological, social, and spiritual needs of cancer survivors living with a permanent ostomy. The study design, process, and telehealth approach contributes to the success of future dissemination efforts of the intervention into diverse clinical and community settings. [ABSTRACT FROM AUTHOR]

Managing chronic pain effectively is often challenging for health care providers and patients. Telehealth technologies can bridge geographic distance and improve patients' quality of care in communities where access to pain specialists has previously been unavailable. This paper describes the development and evaluation of a telehealth intervention (TelePain) designed to address the need for pain specialist consultation regarding pain and symptom management issues in non-academic medical centers. We describe the theoretical foundation and development of a multifaceted intervention using a cluster randomized clinical trial design. Health care providers and their patients with chronic pain are enrolled in the study. Patient participants receive the intervention (report of symptoms and receipt of a pain graph) weekly for 8 weeks and are contacted at 12 weeks for completion of post-intervention follow-up measures. Their providers attend TelePain sessions which involve a didactic presentation on an evidence-based topic related to pain management followed by patient case presentations and discussion by community clinicians. Symptom management recommendations for each patient case are made by a panel of pain specialists representing internal medicine, addiction medicine, rehabilitation medicine, anesthesiology, psychiatry, and nursing. The outcomes assessed in this randomized trial focus on pain intensity, pain's interference on function and sleep, and anxiety, depression, and cost-effectiveness. Some of the challenges and lessons that we have learned early in implementing the TelePain intervention are also reported. [ABSTRACT FROM AUTHOR]

Abstract: Home-based telemental health (TMH) treatments have the potential to address current and future health needs of military service members, veterans, and their families, especially for those who live in rural or underserved areas. The use of home-based TMH treatments to address the behavioral health care needs of U.S. military healthcare beneficiaries is not presently considered standard of care in the Military Health System. The feasibility, safety, and clinical efficacy of home-based TMH treatments must be established before broad dissemination of home-based treatment programs can be implemented. This paper describes the design, methodology, and protocol of a clinical trial that compares in-office to home-based Behavioral Activation for Depression (BATD) treatment delivered via web-based video technology for service members and veterans with depression. This grant funded three-year randomized clinical trial is being conducted at the National Center for Telehealth and Technology at Joint-base Lewis-McChord and at the Portland VA Medical Center. Best practice recommendations regarding the implementation of in-home telehealth in the military setting as well as the cultural and contextual factors of providing in-home care to active duty and veteran military populations are also discussed. [Copyright &y& Elsevier]

Abstract: Pain is the most common physical symptom in primary care, accounting for an enormous burden in terms of patient suffering, quality of life, work and social disability, and health care and societal costs. Although collaborative care interventions are well-established for conditions such as depression, fewer systems-based interventions have been tested for chronic pain. This paper describes the study design and baseline characteristics of the enrolled sample for the Stepped Care to Optimize Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial conducted in five primary care clinics. SCOPE has enrolled 250 primary care veterans with persistent (3months or longer) musculoskeletal pain of moderate severity and randomized them to either the stepped care intervention or usual care control group. Using a telemedicine collaborative care approach, the intervention couples automated symptom monitoring with a telephone-based, nurse care manager/physician pain specialist team to treat pain. The goal is to optimize analgesic management using a stepped care approach to drug selection, symptom monitoring, dose adjustment, and switching or adding medications. All subjects undergo comprehensive outcome assessments at baseline, 1, 3, 6 and 12months by interviewers blinded to treatment group. The primary outcome is pain severity/disability, and secondary outcomes include pain beliefs and behaviors, psychological functioning, health-related quality of life and treatment satisfaction. Innovations of SCOPE include optimized analgesic management (including a stepped care approach, opioid risk stratification, and criteria-based medication adjustment), automated monitoring, and centralized care management that can cover multiple primary care practices. [Copyright &y& Elsevier]

Abstract: Background: Patients requiring complex care are at high risk during the transition from one setting of care to another. Effective interventions to support care transitions have been designed but are very resource intensive. Telemonitoring has been considered as an approach to enhance care transition support, but many telemonitoring systems require special equipment or web-based interfaces to interact with patients and caregivers. Methods/design: In this paper we report our protocol for developing and testing E-Coach, an interactive voice response (IVR)-enhanced care transition intervention that monitors patients at home using their personal phone. The elements described include 1) development of an IVR monitoring system that will be based on Coleman''s four pillars of care transition support; 2) development of a web-based “dashboard” of IVR responses that alert care transition nurses (CTN) of patient/caregiver concerns after discharge and allow documentation by the CTN when patients/caregivers are called; 3) pilot testing of the IVR system by patients and providers with refinement of the system based on patient/provider input; and 4) a pragmatic protocol for formal testing through a randomized controlled trial (RCT) of the E-Coach intervention in congestive heart failure (CHF) and chronic obstructive pulmonary disease (COPD) patients admitted to a large tertiary hospital. Trial Registration: CT.gov#: NCT01135381. [Copyright &y& Elsevier]

Childhood obesity disproportionately affects rural communities where access to pediatric weight control services is limited. Telehealth may facilitate access to these services. This paper describes the rationale, curriculum, and methodology for conducting a randomized controlled pilot trial of a rural, family-based, telehealth intervention that aims to improve weight-related behaviors among children, compared to monthly newsletters. A mixed-methods randomized design will randomly assign 44 rural families with one or more children aged 5 to 11 years identified as overweight or obese to an intervention or newsletter control group. The intervention group will attend 'eatNplay' group videoconferencing telehealth sessions, conducted weekly by a registered nurse and a motivational interviewing expert, to discuss diet, exercise, sleep, and peer group influences. The control group will receive newsletters covering these topics. Outcome measures at baseline, 12, and 26 weeks will assess 1) participant engagement and satisfaction with 'eatNplay'; 2) child's BMI, dietary behavior, physical activity, and sleep behavior; and 3) parent/guardians' self-reported beliefs, behaviors, attitudes, perceived stress, and perceived quality of life. Analyses will employ 1) thematic analysis of semi-structured parent/guardian interviews after follow-up to help refine the intervention (e.g., curriculum), and 2) linear mixed models to compare outcomes between groups pre- and post-intervention and reduce bias from unobserved variables. Results of this pilot study could refine methodology for conducting telehealth studies, acceptability of healthcare provider-involved recruitment, interdisciplinary team approach, and addressing childhood obesity in rural communities through telehealth. • Family-based telehealth intervention. • Conducted through virtual communication during the COVID-19 pandemic. • Family involvement to sustain weight control in rural communities. • Using mixed-methods to develop rationale, curriculum, and methodology. [ABSTRACT FROM AUTHOR]

Young adults who are lesbian, gay, bisexual, trans, queer or questioning, intersex, asexual and other diverse genders and sexualities (LGBTQIA+) are more likely to experience mental health difficulties and are at significantly elevated risk of substance abuse, self-harm and suicide, relative to their heterosexual, endosex and cisgender peers. There is a need for effective mental health interventions for LGBTQIA+ young adults. Mindful Self-Compassion training is a promising approach; among LGBTQIA+ individuals, self-compassion accounts for more variation in mental health outcomes than bullying, victimization, and adverse childhood experiences combined. Furthermore, LGBTQIA+ individuals with high self-compassion report more positive identity and happiness, less self-stigma, and lower suicidality than those with low self-compassion. This paper outlines the rationale and protocol for a single-blind CONSORT-compliant randomised controlled trial, comparing group Mindful Self-Compassion to a delayed-treatment waitlist control group, for improving mental health, decreasing self-criticism and increasing self-compassion in LGBTQIA+ young adults (age 18–25 years). Mindful Self-Compassion training is an 8-week group program that focuses on cultivating self-compassion and mindfulness. While typically delivered as a face-to-face program, the proposed trial will investigate efficacy of the program when provided via videoconferencing. Videoconference Mindful Self-Compassion training has the potential to improve the mental health of Australian LGBTQIA+ young adults and provide a possible cost-effective, scalable intervention for this population. The proposed trial will be the first to determine its efficacy for LGBTQIA+ young adults and will provide the first data on the delivery of the program via videoconferencing. [ABSTRACT FROM AUTHOR]

Managing complex psychiatric disorders like PTSD and bipolar disorder is challenging in Federally Qualified Health Centers (FQHCs) delivering care to U.S residents living in underserved rural areas. This protocol paper describes SPIRIT, a pragmatic comparative effectiveness trial designed to compare two approaches to managing PTSD and bipolar disorder in FQHCs. Treatment comparators are: 1) Telepsychiatry Collaborative Care, which integrates consulting telepsychiatrists into primary care teams, and 2) Telepsychiatry Enhanced Referral, where telepsychiatrists and telepsychologists treat patients directly. Because Telepsychiatry Enhanced Referral is an adaptive intervention, a Sequential, Multiple Assignment, Randomized Trial design is used. Twenty-four FQHC clinics without on-site psychiatrists or psychologists are participating in the trial. The sample is patients screening positive for PTSD and/or bipolar disorder who are not already engaged in pharmacotherapy with a mental health specialist. Intervention fidelity is measured but not controlled. Patient treatment engagement is measured but not required, and intent-to-treat analysis will be used. Survey questions measure treatment engagement and effectiveness. The Short-Form 12 Mental Health Component Summary (SF-12 MCS) is the primary outcome. A third (34%) of those enrolled (n = 1004) are racial/ethnic minorities, 81% are not fully employed, 68% are Medicaid enrollees, 7% are uninsured, and 62% live in poverty. Mental health related quality of life (SF-12 MCS) is 2.5 standard deviations below the national mean. We hypothesize that patients randomized to Telepsychiatry Collaborative Care will have better outcomes than those randomized to Telepsychiatry Enhanced Referral because a higher proportion will engage in evidence-based treatment. [ABSTRACT FROM AUTHOR]

As more individuals from diverse backgrounds are diagnosed with Type 1 Diabetes (T1D), the need to address resulting disparities in diabetes outcomes among these populations also escalates. Although young adulthood proves challenging for all patients with diabetes, young adults (YA) from racial/ethnic minorities and low socioeconomic backgrounds face even greater T1D management obstacles. The poorer outcomes in these populations drive an urgent need for alternative care models to improve YA's engagement in their T1D clinical care and address barriers to improved health outcomes. Previous telemedicine initiatives for T1D have yielded positive diabetes care results, especially in YA, offering one promising way to reach this high-risk population. To serve these patients better, an established and successful home telehealth group appointment model, "CoYoT1 Clinic" (Co lorado Yo ung Adults with T1 D), was adapted to provide care to YA with T1D at a large urban children's hospital in Southern California. At this location, ~70% of patients have public/no insurance, and 85% are racial/ethnic minorities. In this paper, we report the process of adapting the CoYoT1 Clinic model and designing a randomized controlled trial (RCT) to evaluate its efficacy. The adapted model uses meticulous study-design methods that incorporate patient advisors, quantitative and qualitative data collection, collaboration with local stakeholders, intervention development, and patient randomization into a factorial design analyzing telemedicine versus in-person and patient-centered versus standard care. The new model addresses the needs of high-risk YA in Southern California, with the goal of increasing access to care, improving follow-up frequency, and strengthening patient and provider satisfaction. The study is registered with ClinicalTrials.gov (Clinical Trials Number: NCT03793673). [ABSTRACT FROM AUTHOR]