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Background Ensuring patients receive an effective dose of therapeutic exercises and activities is a significant challenge for inpatient rehabilitation. My Therapy is a self-management program which encourages independent practice of occupational therapy and physiotherapy exercises and activities, outside of supervised therapy sessions. Methods This implementation trial aims to determine both the clinical effectiveness of My Therapy on the outcomes of function and health-related quality of life, and cost-effectiveness per minimal clinically important difference (MCID) in functional independence achieved and per quality adjusted life year (QALY) gained, compared to usual care. Using a stepped-wedge cluster randomised design, My Therapy will be implemented across eight rehabilitation wards (inpatient and home-based) within two public and two private Australian health networks, over 54-weeks. We will include 2,160 patients aged 18 + years receiving rehabilitation for any diagnosis. Each ward will transition from the usual care condition (control group receiving usual care) to the experimental condition (intervention group receiving My Therapy in addition to usual care) sequentially at six-week intervals. The primary clinical outcome is achievement of a MCID in the Functional Independence Measure (FIM™) at discharge. Secondary outcomes include improvement in quality of life (EQ-5D-5L) at discharge, length of stay, 30-day re-admissions, discharge accommodation, follow-up rehabilitation services and adverse events (falls). The economic outcomes are the cost-effectiveness per MCID in functional independence (FIM™) achieved and per QALY gained, for My Therapy compared to usual care, from a health-care sector perspective. Cost of implementation will also be reported. Clinical outcomes will be analysed via mixed-effects linear or logistic regression models, and economic outcomes will be analysed via incremental cost-effectiveness ratios. Discussion The My Therapy implementation trial will determine the effect of adding self-management within inpatient rehabilitation care. The results may influence health service models of rehabilitation including recommendations for systemic change to the inpatient rehabilitation model of care to include self-management. Findings have the potential to improve patient function and quality of life, and the ability to participate in self-management. Potential health service benefits include reduced hospital length of stay, improved access to rehabilitation and reduced health service costs. Trial registration This study was prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12621000313831; registered 22/03/2021, http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380828&isReview=true).

BackgroundProcess evaluations have been recommended alongside clinical and economic evaluations to enable an in-depth understanding of factors impacting results. My Therapy is a self-management program designed to augment usual care inpatient rehabilitation through the provision of additional occupational therapy and physiotherapy exercises and activities, for the patient to complete outside of supervised therapy. The aims of the process evaluation are to assess the implementation process by investigating fidelity, quality of implementation, acceptability, adoption, appropriateness, feasibility and adaptation of the My Therapy intervention; and identify contextual factors associated with variations in outcomes, including the perspectives and experiences of patients and therapists.MethodsThe process evaluation will be conducted alongside the clinical and economic evaluation of My Therapy, within eight rehabilitation wards across two public and two private Australian health networks. All participants of the stepped wedge cluster randomised trial (2,160 rehabilitation patients) will be included in the process evaluation (e.g., ward audit); with a subset of 120 participants undergoing more intensive evaluation (e.g., surveys and activity logs). In addition, 24 staff (occupational therapists and physiotherapists) from participating wards will participate in the process evaluation. The mixed-methods study design will adopt a range of quantitative and qualitative research approaches. Data will be collected via a service profile survey and audits of clinical practice across the participating wards (considering areas such as staffing profiles and prescription of self-management programs). The intensive patient participant data collection will involve structured therapy participation and self-management program audits, Exercise Self Efficacy Scale, patient activity logs, patient surveys, and patient-worn activity monitors. Staff data collection will include surveys and focus groups.DiscussionThe process evaluation will provide context to the clinical and economic outcomes associated with the My Therapy clinical trial. It considers how clinical and economic outcomes were achieved, and how to sustain the outcomes within the participating health networks. It will also provide context to inform future scaling of My Therapy to other health networks, and influence future models of rehabilitation and related policy.Trial registrationThis study was prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12621000313831; registered 22/03/2021,http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380828&isReview=true).

Ensuring patients receive an effective dose of therapeutic exercises and activities is a significant challenge for inpatient rehabilitation. My Therapy is a self-management program which encourages independent practice of occupational therapy and physiotherapy exercises and activities, outside of supervised therapy sessions.This implementation trial aims to determine both the clinical effectiveness of My Therapy on the outcomes of function and health-related quality of life, and cost-effectiveness per minimal clinically important difference (MCID) in functional independence achieved and per quality adjusted life year (QALY) gained, compared to usual care. Using a stepped-wedge cluster randomised design, My Therapy will be implemented across eight rehabilitation wards (inpatient and home-based) within two public and two private Australian health networks, over 54-weeks. We will include 2,160 patients aged 18 + years receiving rehabilitation for any diagnosis. Each ward will transition from the usual care condition (control group receiving usual care) to the experimental condition (intervention group receiving My Therapy in addition to usual care) sequentially at six-week intervals. The primary clinical outcome is achievement of a MCID in the Functional Independence Measure (FIM™) at discharge. Secondary outcomes include improvement in quality of life (EQ-5D-5L) at discharge, length of stay, 30-day re-admissions, discharge accommodation, follow-up rehabilitation services and adverse events (falls). The economic outcomes are the cost-effectiveness per MCID in functional independence (FIM™) achieved and per QALY gained, for My Therapy compared to usual care, from a health-care sector perspective. Cost of implementation will also be reported. Clinical outcomes will be analysed via mixed-effects linear or logistic regression models, and economic outcomes will be analysed via incremental cost-effectiveness ratios.The My Therapy implementation trial will determine the effect of adding self-management within inpatient rehabilitation care. The results may influence health service models of rehabilitation including recommendations for systemic change to the inpatient rehabilitation model of care to include self-management. Findings have the potential to improve patient function and quality of life, and the ability to participate in self-management. Potential health service benefits include reduced hospital length of stay, improved access to rehabilitation and reduced health service costs.This study was prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12621000313831; registered 22/03/2021, http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380828isReview=true ).