Comparative effectiveness of digital mental healthcare models for adults with epilepsy: A study protocol of a randomized controlled trial.

OBJECTIVE: Mental health complaints are prevalent among people with epilepsy, yet there are major barriers that prevent access to psychological care, including high out-of-pocket costs and a lack of accessible specialized services. The purpose of the current study is to examine the comparative efficacy, acceptability, cost-effectiveness, and long-term outcomes of a digital psychological intervention when delivered under two models of care (i.e., guided vs. unguided) in supporting the mental health and functioning of adults with epilepsy. METHOD: Approximately 375 participants across Australia will be enrolled. Eligible participants will have a confirmed diagnosis of epilepsy, experience difficulties with their emotional health, be at least 18 years of age, and live in Australia. Participants will be randomized (2:2:1) to receive the Wellbeing Neuro Course, a 10-week internet-delivered program, with (i.e., guided) or without guidance by a mental health clinician (i.e., unguided), or be allocated to a treatment-as-usual waiting-list control group. Participants will complete online questionnaires at pre-, post-treatment, and 3- and 12-month follow-up and consent to have their data linked to their medical records to capture healthcare system resource use and costs. ANALYSIS: Primary outcome measures will be symptoms of depression and anxiety. A cost-utility analysis will be undertaken using the Australian healthcare system perspective and according to current economic evaluation guidelines. Resource use and costs to the healthcare system during the study period will be captured via data linkage to relevant administrative datasets in Australia. SIGNIFICANCE: The results of this trial will provide important data concerning the relative outcomes of these different models of care and will inform the integration of digital psychological interventions translation into healthcare services. ETHICS AND DISSEMINATION: The Human Research Ethics Committee of Macquarie University approved the proposed study (Reference No: 520231325151475). The results will be disseminated through peer-reviewed publication(s). ANZCTR TRIAL REGISTRATION NUMBER: ACTRN12623001327673. PLAIN LANGUAGE SUMMARY: This study seeks to find out if a 10-week online psychological treatment can improve the mental health and well-being of Australian adults with epilepsy. Around 375 participants will be randomly assigned to different groups: one will receive treatment with guidance from mental health clinician (guided group), one without guidance (unguided group), and one starting later (waiting control group). All participants will fill out the same outcome measures online. The main goal of this research is to compare these groups and assess how well the treatment works in improving mental health outcomes.

Understanding implementation completion of tailored motivational interviewing in multidisciplinary adolescent HIV clinics.

Background: Understanding the barriers and facilitators of implementation completion is critical to determining why some implementation efforts fail and some succeed. Such studies provide the foundation for developing further strategies to support implementation completion when scaling up evidence-based practices (EBPs) such as Motivational Interviewing. Method: This mixed-methods study utilized the Exploration, Preparation, Implementation, and Sustainment framework in an iterative analytic design to compare adolescent HIV clinics that demonstrated either high or low implementation completion in the context of a hybrid Type III trial of tailored motivational interviewing. Ten clinics were assigned to one of three completion categories (high, medium, and low) based on percentage of staff who adhered to three components of implementation strategies. Comparative analysis of staff qualitative interviews compared and contrasted the three high-completion clinics with the three low-completion clinics. Results: Results suggested several factors that distinguished high-completion clinics compared to low-completion clinics including optimism, problem-solving barriers, leadership, and staff stress and turnover. Conclusions: Implementation strategies targeting these factors can be added to EBP implementation packages to improve implementation success. Plain Language Summary: While studies have begun to address adherence to intervention techniques, this is one of the first studies to address organizational adherence to implementation strategies. Youth HIV providers from different disciplines completed interviews about critical factors in both the inner and outer context that can support or hinder an organization's adherence to implementation strategies. Compared to less adherent clinics, more adherent clinics reported more optimism, problem-solving, and leadership strengths and less staff stress and turnover. Implementation strategies addressing these factors could be added to implementation packages to improve implementation success.

Relations between provider adherence to a tailored motivational intervention protocol and competence in motivational interviewing.

OBJECTIVES: To evaluate the association between provider adherence to Tailored Motivational Interviewing implementation strategy and motivational interviewing (MI) competence. METHODS: 156 youth-focused HIV providers enrolled in a parent implementation science trial completed: a) quarterly standardized patient assessments (SPI) during Baseline; b) a workshop, individual coaching sessions, and quarterly SPI plus feedback during Implementation; and c) quarterly SPI during Sustainment. Competence was measured using the MI-CRS and tracking data was used to assess adherence. We examined overall adherence as well as adherence to each implementation strategy in relation to MI competence. RESULTS: Overall adherence was not associated with overall MI competence. MI competence significantly increased from Baseline to Implementation and Baseline to Sustainment. Some individual implementation strategies were associated with change in competence and the probability of achieving Intermediate/Advanced competence. CONCLUSIONS: The results suggest that 100% percent adherence to all TMI implementation strategies may not be necessary. Completing some of the TMI implementation strategies yielded improvements in MI competence. The use of routine tracking data to measure adherence maybe more pragmatic than using observational coders and more objective than self-reports. PRACTICE IMPLICATIONS: In busy HIV clinics, MI training should focus on strategies most directly associated with increased provider competence.

Determining the role and responsibilities of the community epilepsy nurse in the management of epilepsy.

AIMS AND OBJECTIVES: The aim of this study is to enhance the understanding of the core elements and influencing factors on the community-based epilepsy nurse's role and responsibilities. BACKGROUND: Internationally, epilepsy nurse specialists play a key role in providing person-centred care and management of epilepsy but there is a gap in understanding of their role in the community. DESIGN: A national three-stage, mixed-method study was conducted. METHODS: One-on-one, in-depth semi-structured qualitative interviews were conducted online with 12 community-based epilepsy nurses (Stage 1); retrospective analysis of data collected from the National Epilepsy Line, a nurse-led community helpline (Stage 2); and focus group conducted with four epilepsy nurses, to delve further into emerging findings (Stage 3). A thematic analysis was conducted in Stages 1 and 3, and a descriptive statistical analysis of Stage 2 data. Consolidated Criteria for Reporting Qualitative studies checklist was followed for reporting. RESULTS: Three key themes emerged: (1) The epilepsy nurse career trajectory highlighted a lack of standardised qualifications, competencies, and career opportunities. (2) The key components of the epilepsy nurse role explored role diversity, responsibilities, and models of practice in the management of living with epilepsy, and experiences navigating complex fragmented systems and practices. (3) Shifting work practices detailed the adapting work practices, impacted by changing service demands, including COVID-19 pandemic experiences, role boundaries, funding, and resource availability. CONCLUSION: Community epilepsy nurses play a pivotal role in providing holistic, person-centred epilepsy management They contribute to identifying and addressing service gaps through innovating and implementing change in service design and delivery. RELEVANCE TO CLINICAL PRACTICE: Epilepsy nurses' person-centred approach to epilepsy management is influenced by the limited investment in epilepsy-specific integrated care initiatives, and their perceived value is impacted by the lack of national standardisation of their role and scope of practice. NO PATIENT OR PUBLIC CONTRIBUTION: Only epilepsy nurses' perspectives were sought.

Online randomised factorial trial of electronic Screening and Brief Intervention for alcohol use in pregnancy: a study protocol.

INTRODUCTION: Approximately 1 in 7 pregnant women in the USA report past-month alcohol use. Strong evidence connects prenatal alcohol exposure with a range of adverse perinatal outcomes, including the spectrum of conditions known as fetal alcohol spectrum disorders. Screening and Brief Intervention (SBI) has been recommended for pregnant women but has proven difficult to implement. This study will test the efficacy of single-session technology-delivered SBI (electronic SBI) for alcohol use in pregnancy, while simultaneously evaluating the possible additional benefit of tailored text messages and/or booster sessions in a 3×2 factorial trial. METHOD AND ANALYSIS: This full factorial trial will use online advertising and clinic-based flyers to recruit pregnant women meeting criteria for unhealthy alcohol use, and randomly assign them to one of six conditions crossing three levels of brief intervention (none, single 120-minute session and single session plus two 5-minute boosters) with two levels of tailored text messaging (none vs twice weekly messages). The primary analysis will test for dose-response effects of the brief intervention on alcohol abstinence, defined as no self-report of alcohol use in the 90 days prior to 34 weeks' gestation, and negative results for ethyl glucuronide analysis of fingernail samples. Secondary analyses will examine main and interaction effects of tailored text messaging as well as intervention effects on birth outcomes. ETHICS AND DISSEMINATION: Ethical approval was provided by the Michigan State University Biomedical and Health Institutional Review Board (STUDY00005298). Results will be presented at conferences and community forums, in addition to being published in a peer-reviewed journal. Intervention content demonstrating sufficient efficacy and safety will be made publicly available. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04332172).

Tailored Motivational Interviewing in Adolescent HIV Clinics: Primary Outcome Analysis of a Stepped Wedge Implementation Trial.

BACKGROUND: Youth continue to have the poorest outcomes along the HIV prevention and care continua. Motivational Interviewing (MI) may promote behavior change and reduce perceived stigma, but providers often demonstrate inadequate MI competence. This study tested Tailored Motivational Interviewing (TMI), a set of implementation strategies designed to improve MI competence in youth HIV providers. SETTING: Ten HIV clinics in the Adolescent Trials Network for HIV/AIDS Interventions. METHODS: In a stepped wedge design, 10 clinics (N = 151 providers) were randomized in 5 clusters every 3 months to receive TMI for a 12-month implementation period. Sites were rerandomized within each cluster to receive communities of practice guidance with or without internal facilitator support in the sustainment period. Standard patient assessments were coded every 3 months for 36 months. RESULTS: Nesting was addressed using mixed-effects regression models, with random effects for providers and sites. TMI resulted in significantly improved MI competence over baseline. Despite small reductions in competence in the sustainment window, competence was still significantly improved over baseline, with no difference between the 2 sustainment conditions. CONCLUSIONS: TMI may be an important tool to capacitate the HIV HealthForce to end the HIV epidemic in young people.

Tailored Motivational Interviewing (TMI): A Pilot Implementation-Effectiveness Trial to Promote MI Competence in Adolescent HIV Clinics.

This brief report describes results of piloted Tailored Motivational Interviewing (TMI). Tailoring focused on site-specific training needs, target patient behaviors, and implementation facilitators and barriers that staff anticipated. Participating staff (N = 31) at two adolescent HIV clinics completed a pre-training qualitative interview (N = 27), and MI competency assessments based on three pre- and six post-training standard patient role-plays (N = 27). Results included pre- to post-training MI competence improvement (t (153) = - 4.13, p ≤ 0.001) and change in competency category distribution (X2 = (2, N = 155) = 15.72, p ≤ 0.001), providing initial support for the implementation of TMI in adolescent HIV clinic settings.

Barriers and facilitators to implementing a motivational interviewing-based intervention: a multi-site study of organizations caring for youth living with HIV.

Understanding possible barriers and facilitators to effective implementation of evidence-based interventions to help high-risk youth prevent and manage HIV is crucial for their scale-up. This manuscript analyzes qualitative interview data collected during the early phase implementation of a motivational interviewing (MI) based intervention at 10 HIV care clinics in the United States providing services to youth. Using the Exploration-Preparation-Implementation-Sustainment (EPIS) framework to understand the implementation and the dynamic adaptation process (DAP) model to balance notions of intervention fidelity and flexibility, providers and stakeholders at each site (N = 97) were interviewed prior to implementation to gather their perspectives on organizational readiness for the intervention, as well as provider and client characteristics. The interviewers summarized their experience with rapid feedback forms (RFFs). Data extracted from the RFFs highlighted anticipated barriers to and facilitators of the proposed MI-based intervention, with the EPIS framework used to organize these findings. Study findings illustrate the inner and outer contextual factors that affect implementation and denote the points at which the MI-based intervention may be tailored to fit the unique context of a clinic while remaining faithful to the intervention's original design.

Development of the Motivational Interviewing Coach Rating Scale (MI-CRS) for health equity implementation contexts.

OBJECTIVE: The field of implementation science emphasizes efficient and effective fidelity measurement for research outcomes and feedback to support quality improvement. This paper reports on such a measure for motivational interviewing (MI), developed with rigorous methodology and with diverse samples. METHOD: Using item response theory (IRT) methods and Rasch modeling, we analyzed coded (a) recordings (n = 99) of intervention sessions in a clinical trial of African American adolescents with obesity; (b) standard patient interactions (n = 370) in an implementation science study with youth living with HIV; and (c) standard patient interactions (n = 172) in a diverse community sample. RESULTS: These methods yielded a reliable and valid 12-item scale on several indicators using Rausch modeling including single construct dimensionality, strong item-session maps, good rating scale functionality, and item fit after revisions. However, absolute agreement was modest. The 12 items yielded thresholds for 4 categories: beginner, novice, intermediate and advanced. CONCLUSIONS: The 12-item Motivational Interviewing Coach Rating Scale is the first efficient and effective fidelity measure appropriate with diverse ethnic groups, with interventions that are MI only or interventions that integrate MI with other interventions, and with adolescents and families as well as adults. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Determining the role and responsibilities of the Australian epilepsy nurse in the management of epilepsy: a study protocol.

INTRODUCTION: Epilepsy is a common neurological condition affecting between 3% and 3.5% of the Australian population at some point in their lifetime. The effective management of chronic and complex conditions such as epilepsy requires person-centred and coordinated care across sectors, from primary to tertiary healthcare. Internationally, epilepsy nurse specialists are frequently identified as playing a vital role in improving the integration of epilepsy care and enhancing patient self-management. This workforce has not been the focus of research in Australia to date. METHODS AND ANALYSIS: This multistage mixed-method study examines the role and responsibilities of epilepsy nurses, particularly in primary and community care settings, across Australia, including through the provision of a nurse helpline service. A nationwide sample of 30 epilepsy nurses will be purposively recruited via advertisements distributed by epilepsy organisations and through word-of-mouth snowball sampling. Two stages (1 and 3) consist of a demographic questionnaire and semistructured interviews (individual or group) with epilepsy nurse participants, with the thematic data analysis from this work informing the areas for focus in stage 3. Stage 2 comprises of a retrospective descriptive analysis of phone call data from Epilepsy Action Australia's National Epilepsy Line service to identify types of users, their needs and reasons for using the service, and to characterise the range of activities undertaken by the nurse call takers. ETHICS AND DISSEMINATION: Ethics approval for this study was granted by Macquarie University (HREC: 52020668117612). Findings of the study will be published through peer-reviewed journal articles and summary reports to key stakeholders, and disseminated through public forums and academic conference presentations. Study findings will also be communicated to people living with epilepsy and families.

Quality of life and its association with comorbidities and adverse events from antiepileptic medications: Online survey of patients with epilepsy in Australia.

OBJECTIVE: This study aimed to explore the quality of life (QoL) of adult patients with epilepsy (PwE) in Australia and its relationship with comorbidities and adverse events (AEs) from antiepileptic drugs (AEDs). METHODS: Cross-sectional surveys were completed by PwE, or carer proxies, recruited via the online pharmacy application MedAdvisor and Australian PwE Facebook groups from May to August 2018. Data were collected on demographics, epilepsy severity and management, AEs, comorbidities, and QoL (using the Patient-Weighted Quality of Life in Epilepsy Inventory [QOLIE-10-P] total score). Two linear regression models were constructed to explore associations between AEs or comorbidities and QOLIE-10-P score, with possible confounders determined using stepwise selection. RESULTS: Nine hundred and seventy-eight of 1267 responses were eligible (mean age of respondents: 44.5 years, 64% female, 52% employed). Recent AED use was reported by 97%; 47% were on AED monotherapy, 35% had ≤2 lifetime AEDs, and 55% were seizure-free for >1 year. After stepwise selection, control variables included in both models were time since diagnosis, employment status, seizure frequency, number of currently prescribed AEDs, and number of general practitioner (GP) visits per year. In the model for comorbidities, "psychiatric disorders" was associated with the largest QOLIE-10-P score decrease (-23.14, p < 0.001). In the model for AEs, which additionally controlled for depression and anxiety disorder, self-reported "memory problems" was associated with the largest decrease in QOLIE-10-P score (-14.27, p < 0.001). CONCLUSIONS: In this survey of Australian PwE, many of whom had relatively well-controlled epilepsy, psychiatric and self-reported memory problems were common and associated with the greatest detrimental impact on QoL. Further research is needed to better understand the underlying causes of impaired QoL and thereby improve its management.

Testing a Motivational Interviewing Implementation Intervention in Adolescent HIV Clinics: Protocol for a Type 3, Hybrid Implementation-Effectiveness Trial.

BACKGROUND: Motivational interviewing (MI) has been shown to effectively improve self-management for youth living with HIV (YLH) and has demonstrated success across the youth HIV care cascade-currently, the only behavioral intervention to do so. Substantial barriers prevent the effective implementation of MI in real-world settings. Thus, there is a critical need to understand how to implement evidence-based practices (EBPs), such as MI, and promote behavior change in youth HIV treatment settings as risk-taking behaviors peak during adolescence and young adulthood. OBJECTIVE: This study aims to describe the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) protocol of a tailored MI (TMI) implementation-effectiveness trial (ATN 146 TMI) to scale up an EBP in multidisciplinary adolescent HIV settings while balancing flexibility and fidelity. This protocol is part of the Scale It Up program described in this issue. METHODS: This study is a type 3, hybrid implementation-effectiveness trial that tests the effect of TMI on fidelity (MI competency and adherence to program requirements) while integrating findings from two other ATN protocols described in this issue-ATN 153 Exploration, Preparations, Implementation, Sustainment and ATN 154 Cascade Monitoring. ATN 153 guides the mixed methods investigation of barriers and facilitators of implementation, while ATN 154 provides effectiveness outcomes. The TMI study population consists of providers at 10 adolescent HIV care sites around the United States. These 10 clinics are randomly assigned to 5 blocks to receive the TMI implementation intervention (workshop and trigger-based coaching guided by local implementation teams) utilizing the dynamic wait-listed controlled design. After 12 months of implementation, a second randomization compares a combination of internal facilitator coaching with the encouragement of communities of practice (CoPs) to CoPs alone. Participants receive MI competency assessments on a quarterly basis during preimplementation, during the 12 months of implementation and during the sustainment period for a total of 36 months. We hypothesize that MI competency ratings will be higher among providers during the TMI implementation phase compared with the standard care phase, and successful implementation will be associated with improved cascade-related outcomes, namely undetectable viral load and a greater number of clinic visits among YLH. RESULTS: Participant recruitment began in August 2017 and is ongoing. As of mid-May 2018, TMI has 150 active participants. CONCLUSIONS: This protocol describes the underlying theoretical framework, study design, measures, and lessons learned for TMI, a type 3, hybrid implementation-effectiveness trial, which has the potential to scale up MI and improve patient outcomes in adolescent HIV settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT03681912; https://clinicaltrials.gov/ct2/show/NCT03681912 (Archived by WebCite at http://www.webcitation.org/754oT7Khx). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11200.

Adolescent HIV Healthcare Providers' Competencies in Motivational Interviewing Using a Standard Patient Model of Fidelity Monitoring.

The goal of this project is to describe adolescent HIV care providers' competence in Motivational Interviewing (MI) using a standard patient interaction model of fidelity assessment. Providers (N = 151) at 11 clinics completed monthly MI role plays. The MI Coach Rating Scale was utilized to assess MI skill. Despite mean differences in baseline MI ability by provider type (medical providers, psychologists/social workers, other), when examined together, only clinic had a significant main effect. Aspects of the clinic environment may have a greater impact on providers' baseline MI ability than their job type. Future research should continue to explore these clinic factors.

Frequency and predictors of psychological distress after a diagnosis of epilepsy: A community-based study.

OBJECTIVE: The objective of the study was to determine the frequency and predictors of psychological distress after a diagnosis of epilepsy. METHODS: The Sydney Epilepsy Incidence Study to Measure Illness Consequences (SEISMIC) was a prospective, multicenter, community-based study of people of all ages with newly diagnosed epilepsy in Sydney, Australia. Analyses involved multivariate logistic regression and multinomial logit regression to identify predictors of psychological distress, assessed using the Hospital Anxiety and Depression Scale (HADS) and the Strengths and Difficulties Questionnaire (SDQ), as part of structured interviews. RESULTS: Psychological distress occurred in 33% (95% confidence interval [CI] 26 to 40%) and 24% (95% CI 18 to 31%) of 180 adults at baseline and 12months, respectively, and 23% (95% CI 14 to 33%) of 77 children at both time points. Thirty adults and 7 children had distress at baseline who recovered at 12months, while 15 adults and 7 children had new onset of distress during this period. History of psychiatric or behavioral disorder (for adults, odds ratio [OR] 6.82, 95% CI 3.08 to 15.10; for children, OR 28.85, 95% CI 2.88 to 288.60) and higher psychosocial disability (adults, OR 1.17, 95% CI 1.07 to 1.27) or lower family functioning (children, OR 1.80, 95% CI 1.08 to 3.02) were associated with psychological distress (C statistics 0.80 and 0.78). CONCLUSIONS: Psychological distress is common and fluctuates in frequency after a diagnosis of epilepsy. Those with premorbid psychological, psychosocial, and family problems are at high risk of this adverse outcome.

An Australian nationwide survey on medicinal cannabis use for epilepsy: History of antiepileptic drug treatment predicts medicinal cannabis use.

Epilepsy Action Australia conducted an Australian nationwide online survey seeking opinions on and experiences with the use of cannabis-based products for the treatment of epilepsy. The survey was promoted via the Epilepsy Action Australia's main website, on their Facebook page, and by word of mouth. The survey consisted of 39 questions assessing demographics, clinical factors, including diagnosis and seizure types, and experiences with and opinions towards cannabis use in epilepsy. A total of 976 responses met the inclusion criteria. Results show that 15% of adults with epilepsy and 13% of parents/guardians of children with epilepsy were currently using, or had previously used, cannabis products to treat epilepsy. Of those with a history of cannabis product use, 90% of adults and 71% of parents reported success in reducing seizure frequency after commencing cannabis products. The main reasons for medicinal cannabis use were to manage treatment-resistant epilepsy and to obtain a more favorable side-effect profile compared to standard antiepileptic drugs. The number of past antiepileptic drugs tried was a significant predictor of medicinal cannabis use in both adults and children with epilepsy. Fifty-six percent of adults with epilepsy and 62% of parents/guardians of children with epilepsy expressed willingness to participate in clinical trials of cannabinoids. This survey provides insight into the use of cannabis products for epilepsy, in particular some of the likely factors influencing use, as well as novel insights into the experiences of and attitudes towards medicinal cannabis in people with epilepsy in the Australian community. This article is part of a Special Issue entitled "Cannabinoids and Epilepsy".

Glial cells in ALS: the missing link?

Amyotrophic lateral sclerosis (ALS) was initially known as Charcot's sclerosis, named after the French neurobiologist and physician Jean-Martin Charcot who first described this type of muscular atrophy in the early nineteenth century. In the United States, ALS became widely known as Lou Gehrig's disease after the famous baseball player who succumbed to the disease in the late 1930s. Currently, ALS is the most common motor neuron disease, with a worldwide incidence of 8 cases per 100,000 population per year. Familial forms constitute approximately 5% to 10% of all cases. Onset increases with age, with a peak in the seventh decade and a slight preponderance (relative risk, 1.3-1.5) among men compared with women. Rapid progression of motor neuron loss leads to death an average of 3 to 5 years after symptom onset. The cause of ALS remains unknown and there is still no curative therapy.