La Trobe
1178995_Brusco,NK_2021.pdf (1.09 MB)

Self-managed occupational therapy and physiotherapy for adults receiving inpatient rehabilitation (‘My Therapy’): protocol for a stepped-wedge cluster randomised trial

Download (1.09 MB)
journal contribution
posted on 08.09.2021, 06:28 by Natasha BruscoNatasha Brusco, CL Ekegren, Nicholas TaylorNicholas Taylor, KD Hill, AL Lee, Lisa SomervilleLisa Somerville, Natasha LanninNatasha Lannin, D Wade, R Abdelmotaleb, L Callaway, SL Whittaker, Meg MorrisMeg Morris
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).

Funding

Funding for this project is provided by a National Health and Medical Research Council (NHMRC) Partnership Grant (NHMRC Partnership Grant APP1191881). In addition, each of the four participating health service made a cash contribution. It is declared that the funding source will have no influence over the study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. The administering institution, and therefore the trial sponsor, is prior to Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, School of Primary and Allied Health Care, Monash University, 47-49 Moorooduc Hwy, Frankston VIC 3199, Australia. NAL was supported by a Future Leader Fellowship (102,055) from the National Heart Foundation of Australia.

History

Publication Date

01/12/2021

Journal

BMC Health Services Research

Volume

21

Article Number

811

Pagination

11p.

Publisher

BMC

ISSN

1472-6963

Rights Statement

This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.