PMID- 34384427 OWN - NLM STAT- MEDLINE DCOM- 20210816 LR - 20240403 IS - 1472-6963 (Electronic) IS - 1472-6963 (Linking) VI - 21 IP - 1 DP - 2021 Aug 13 TI - Self-managed occupational therapy and physiotherapy for adults receiving inpatient rehabilitation ('My Therapy'): protocol for a stepped-wedge cluster randomised trial. PG - 811 LID - 10.1186/s12913-021-06462-9 [doi] LID - 811 AB - 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 ). CI - (c) 2021. The Author(s). FAU - Brusco, Natasha K AU - Brusco NK AUID- ORCID: 0000-0002-8825-5109 AD - Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, School of Primary and Allied Health Care, Monash University, 47-49 Moorooduc Hwy, VIC, 3199, Frankston, Australia. natasha.brusco@monash.edu. AD - La Trobe University Centre for Sport and Exercise Medicine Research, Plenty Road & Kingsbury Drive, 3086, Bundoora, Australia. natasha.brusco@monash.edu. FAU - Ekegren, Christina L AU - Ekegren CL AUID- ORCID: 0000-0002-7656-6209 AD - Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, School of Primary and Allied Health Care, Monash University, 47-49 Moorooduc Hwy, VIC, 3199, Frankston, Australia. AD - Alfred Health, 55 Commercial Rd, 3004, Melbourne, Australia. FAU - Taylor, Nicholas F AU - Taylor NF AUID- ORCID: 0000-0001-9474-2504 AD - La Trobe University Centre for Sport and Exercise Medicine Research, Plenty Road & Kingsbury Drive, 3086, Bundoora, Australia. AD - Eastern Health, 5 Arnold St, 3128, Box Hill, Australia. FAU - Hill, Keith D AU - Hill KD AUID- ORCID: 0000-0002-2191-0308 AD - Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, School of Primary and Allied Health Care, Monash University, 47-49 Moorooduc Hwy, VIC, 3199, Frankston, Australia. FAU - Lee, Annemarie L AU - Lee AL AUID- ORCID: 0000-0002-8631-0135 AD - Cabrini Health, 154 Wattletree Rd, 3144, Malvern, Australia. AD - School of Physiotherapy, Monash University, 47-49 Moorooduc Hwy, VIC, 3199, Frankston, Australia. FAU - Somerville, Lisa AU - Somerville L AUID- ORCID: 0000-0001-7400-7342 AD - La Trobe University Centre for Sport and Exercise Medicine Research, Plenty Road & Kingsbury Drive, 3086, Bundoora, Australia. AD - Alfred Health, 55 Commercial Rd, 3004, Melbourne, Australia. FAU - Lannin, Natasha A AU - Lannin NA AUID- ORCID: 0000-0002-2066-8345 AD - La Trobe University Centre for Sport and Exercise Medicine Research, Plenty Road & Kingsbury Drive, 3086, Bundoora, Australia. AD - Alfred Health, 55 Commercial Rd, 3004, Melbourne, Australia. AD - Department of Neuroscience, Monash University, Central Clinical School, 99 Commercial Rd, 3004, Melbourne, Australia. FAU - Wade, Derick AU - Wade D AUID- ORCID: 0000-0002-1188-8442 AD - Physiotherapy and Rehabilitation, Faculty of Health and Life Sciences, Oxford Brookes University, Headington Campus, OX3 0BP, Oxford, United Kingdom. FAU - Abdelmotaleb, Rania AU - Abdelmotaleb R AD - Eastern Health, 5 Arnold St, 3128, Box Hill, Australia. FAU - Callaway, Libby AU - Callaway L AUID- ORCID: 0000-0002-3127-6312 AD - Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, School of Primary and Allied Health Care, Monash University, 47-49 Moorooduc Hwy, VIC, 3199, Frankston, Australia. AD - School of Occupational Therapy, Monash University, 47-49 Moorooduc Hwy, VIC, 3199, Frankston, Australia. FAU - Whittaker, Sara L AU - Whittaker SL AUID- ORCID: 0000-0001-7002-185X AD - Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, School of Primary and Allied Health Care, Monash University, 47-49 Moorooduc Hwy, VIC, 3199, Frankston, Australia. FAU - Morris, Meg E AU - Morris ME AUID- ORCID: 0000-0002-0114-4175 AD - La Trobe University Centre for Sport and Exercise Medicine Research, Plenty Road & Kingsbury Drive, 3086, Bundoora, Australia. AD - Healthscope ARCH, The Victorian Rehabilitation Centre, 499 Springvale Road, 3150, Glen Waverley, Australia. LA - eng GR - APP1191881/National Health and Medical Research Council/ PT - Clinical Trial Protocol PT - Journal Article DEP - 20210813 PL - England TA - BMC Health Serv Res JT - BMC health services research JID - 101088677 SB - IM EIN - BMC Health Serv Res. 2021 Sep 17;21(1):977. PMID: 34535151 MH - Adult MH - Australia MH - Cost-Benefit Analysis MH - Humans MH - Inpatients MH - *Occupational Therapy MH - Patient Discharge MH - Physical Therapy Modalities MH - Quality of Life MH - Randomized Controlled Trials as Topic PMC - PMC8361638 OTO - NOTNLM OT - Economic OT - Exercise OT - Implementation OT - Independence OT - Intensity OT - Occupational Therapy OT - Physical Therapy OT - Physiotherapy OT - Rehabilitation OT - Self-management COIS- The authors declare that they have no competing interests. Funding is NOT via a commercial organisation (therefore no funding conflict of interest). EDAT- 2021/08/14 06:00 MHDA- 2021/08/17 06:00 PMCR- 2021/08/13 CRDT- 2021/08/13 05:39 PHST- 2021/04/15 00:00 [received] PHST- 2021/04/30 00:00 [accepted] PHST- 2021/08/13 05:39 [entrez] PHST- 2021/08/14 06:00 [pubmed] PHST- 2021/08/17 06:00 [medline] PHST- 2021/08/13 00:00 [pmc-release] AID - 10.1186/s12913-021-06462-9 [pii] AID - 6462 [pii] AID - 10.1186/s12913-021-06462-9 [doi] PST - epublish SO - BMC Health Serv Res. 2021 Aug 13;21(1):811. doi: 10.1186/s12913-021-06462-9.