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.

Barriers and facilitators to implementing priority setting and resource allocation tools in hospital decisions: A systematic review.

Health care budgets in high-income countries are having issues coping with unsustainable growth in demand, particularly in the hospital setting. Despite this, implementing tools systematising priority setting and resource allocation decisions has been challenging. This study answers two questions: (1) what are the barriers and facilitators to implementing priority setting tools in the hospital setting of high-income countries? and (2) what is their fidelity? A systematic review using the Cochrane methods was conducted including studies of hospital-related priority setting tools reporting barriers or facilitators for implementation, published after the year 2000. Barriers and facilitators were classified using the Consolidated Framework for Implementation Research (CFIR). Fidelity was assessed using priority setting tool's standards. Out of thirty studies, ten reported program budgeting and marginal analysis (PBMA), twelve multi-criteria decision analysis (MCDA), six health technology assessment (HTA) related frameworks, and two, an ad hoc tool. Barriers and facilitators were outlined across all CFIR domains. Implementation factors not frequently observed, such as 'evidence of previous successful tool application', 'knowledge and beliefs about the intervention' or 'external policy and incentives' were reported. Conversely, some constructs did not yield any barrier or facilitator including 'intervention source' or 'peer pressure'. PBMA studies satisfied the fidelity criteria between 86% and 100%, for MCDA it varied between 36% and 100%, and for HTA it was between 27% and 80%. However, fidelity was not related to implementation. This study is the first to use an implementation science approach. Results represent the starting point for organisations wishing to use priority setting tools in the hospital setting by providing an overview of barriers and facilitators. These factors can be used to assess readiness for implementation or to serve as the foundation for process evaluations. Through our findings, we aim to improve the uptake of priority setting tools and support their sustainable use.