Implementing digital interventions for co-occurring mental health and alcohol and other drug use problems in health and community settings: A study protocol for the eCliPSE cluster randomised controlled trial

Background Mental health and alcohol and other drug use problems consistently dominate the top causes of disease burden in Australians. eHealth stands to be a key tool in addressing these issues but is not routinely well-integrated into service provision models. This study will evaluate the uptake of the digital ecosystem and website, eCliPSE [electronic Clinical Pathways to Service Excellence], developed to improve the symptoms of mental health and alcohol and other drug use problems in people experiencing comorbidity. It will compare two different implementation strategies designed to engage consumers and health services with the eCliPSE website. Methods A cluster randomised controlled trial involving participants from 30 Australian mental health and alcohol and other drug use services will be conducted across 15 local health districts in NSW. Each district will be randomised to receive one of two interventions: (1) a Direct-to-Consumer [DtC] Marketing Strategy, or (2) the DtC strategy in addition to an Integrated Translation and Engagement Model [ITEM] of implementation developed by the research team. The effectiveness of each strategy in encouraging uptake of eCliPSE (number of registrations) will be evaluated and compared. Data will be collected using a combination of the eCliPSE website and social media analytics, quantitative surveys, ethnographic observation, document review and qualitative interviews. An economic evaluation will also estimate the cost-effectiveness of DtC + ITEM and budget impact of the strategies, if implemented across Australia. Discussion It is expected that the DtC marketing strategy will result in significant uptake of eCliPSE, that districts receiving DtC + ITEM will demonstrate significantly greater uptake of eCliPSE than those receiving DtC only, and that the combined strategy will be cost-effective compared to DtC alone. Findings from this study will inform future integration and upscaling of digital health tools into traditional service settings for mental health and alcohol and other drug use across Australia. Trial registration This trial is registered with the Australian New Zealand Clinical Trials Registry as: The eCliPSE Project: Implementing evidence-based eHealth interventions for comorbid mental health and alcohol and other drug use problems into health and community settings. The registration number is ACTRN12622000333718.