Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000313831
Ethics application status
Approved
Date submitted
22/01/2021
Date registered
22/03/2021
Date last updated
2/02/2023
Date data sharing statement initially provided
22/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
My Therapy: Effect of Self-Managed Occupational Therapy and Physiotherapy on Rehabilitation Outcomes
Scientific title
Effect of Self-Managed Occupational Therapy and Physiotherapy (My Therapy) on Rehabilitation Outcomes for Adults Receiving Inpatient Rehabilitation: A Stepped Wedge Cluster Randomised Trial
Secondary ID [1] 302644 0
NHMRC APP1191881
Universal Trial Number (UTN)
U1111-1260-3383
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical and/or cognitive impairment 320862 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318310 318310 0 0
Physiotherapy
Physical Medicine / Rehabilitation 318311 318311 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
When wards transition to experimental conditions (i.e. My Therapy), all patients will continue with their usual rehabilitation plan. In addition, the patient's usual Occupational Therapist (OT) and Physiotherapist (PT) will provide patients with a sub-set of usual care exercises and activities to be practiced independently (where it is deemed safe and appropriate), outside of supervised sessions. These exercises and activities may be performed in the patients’ rooms on the ward or other designated independent practice areas.

The intervention will be progressed as required throughout the rehabilitation admission and can be updated by the occupational therapist and physiotherapist as often as required, based on the clinical judgement of the therapist as to when they are ready to progress or require modifications to their progress.

The number of repetitions and sets will be specified, and can be updated by the OT and PT as often as required. While a goal will be set for the amount of independent practice, it is the patient who decides the number of sessions, the durations of the sessions and the number of repetitions. The total duration of the intervention will vary depending upon the length of the patient’s rehabilitation admission, up to a maximum of 48 weeks. The intervention will commence on admission to rehabilitation or shortly following admission, and conclude on discharge from rehabilitation.

The exercises and activities will be delivered to patients via a program called ‘Physiotherapy Exercises (PTX)®’. The treating clinician will log into PTX, select the My Therapy exercises and activities for the individual patient, and then send the My Therapy program to the patient via SMS or email (or they can print out the My Therapy program as a booklet). Patients will use their own device to access the exercises.

Examples of exercises and activities may include: Calf raises in standing, knee extension while seated, lower body dressing practice. Additional materials include adjuncts to the prescribed tasks and exercises such as written cognitive tasks, hand weights and TheraBand.

To measure adoption of My Therapy, each of the eight wards will be audited in week three of each six-week block by the site coordinator. The audit will capture information regarding the number of patients on the ward and the number of patients engaged in the My Therapy program for experimental wards. For a subset of 120 participants, a self-reported activity log will be used to assess or monitor adherence to the intervention. Adherence will also be monitored via an audit of the patient’s PTX account, where they can record task completion.
To ensure there is no cross-contamination between the control condition and the experimental condition, any patients who experience both the control and experimental condition at the point of transition to the experimental condition, will be excluded. This “wash out” period is expected to last up to 18 days, which is the state average length of stay for rehabilitation in-patients in public health.
Intervention code [1] 319543 0
Rehabilitation
Comparator / control treatment
The control treatment is usual care by OTs and PTs within rehabilitation settings. This comprises a full assessment of each patient by OTs and PTs to develop a rehabilitation plan that is guided by patient-centred goals. Patients will participate in supervised rehabilitation sessions throughout their rehabilitation stay. Examples of exercises and activities may include: Calf raises in standing, knee extension while seated, memory tasks, lower body dressing practice.

There may be a combination of one-on-one or group therapy, depending on patient ability and each site’s existing practice. The frequency and duration of sessions will depend on each site’s existing practice and levels of allied health funding.

A service profile survey will be conducted by the site coordinator on each of the eight wards during week one of each six-week block to understand the characteristics of each rehabilitation ward (e.g staffing ratios, inpatient vs home-based ward). An audit in week three of each six-week block will capture information regarding the number of patients on the ward and the number of patients with an independent practice program. In addition, an audit of the medical records or therapy timetables of 40 consenting participants (five per ward) will be undertaken over seven consecutive days in week four of blocks one, five and nine to understand these characteristics and adherence to the control treatment. A new sample of 40 participants will be audited in each block, with a total number of participants over the course of the trial being 120.
Control group
Active

Outcomes
Primary outcome [1] 326279 0
Functional status, assessed using the Functional Independence Measure (FIM). Data from the FIM will be reported as the proportion of patients who achieve a minimally clinical important difference (MCID) in FIM (22 points)
Timepoint [1] 326279 0
The FIM will be collected at patient admission and discharge from rehabilitation for all patients on participating wards.
Primary outcome [2] 326280 0
Incremental cost effectiveness ratios (ICERs), comparing experimental and control groups using the health service cost as the numerator and the utility data (QALYs) or effectiveness data (FIM) as the denominator.
Timepoint [2] 326280 0
The EQ-5D-5L and FIM will be collected at patient admission and discharge from rehabilitation. Health service utilisation and costs, including the rehabilitation length of stay, acute transfers within the rehabilitation stay and unplanned re-admissions within the 30 days post discharge will be extracted by the Costing Unit of participating hospitals six months after the end of the trial.
Primary outcome [3] 326625 0
Functional status, assessed using the Functional Independence Measure (FIM). Change in FIM from admission to discharge will also be reported.
Timepoint [3] 326625 0
The FIM will be collected at patient admission and discharge from rehabilitation for all patients on participating wards.
Secondary outcome [1] 390884 0
Quality of life, assessed using the EQ-5D-5L. EQ5D-5L scores will be converted to a utility index based on an Australian population to report quality adjusted life years (QALYs).
Timepoint [1] 390884 0
EQ-5D-5L data will be collected at admission and discharge for all patients on participating wards.
Secondary outcome [2] 390885 0
Rehabilitation length of stay, reported as number of overnight stays between the rehabilitation admission and discharge dates. Admission and discharge on the same date will be given a length of stay of one day. Transfer to an acute ward due to medical instability or the need for a procedure will only be reported if it involves an overnight stay (reported as acute length of stay). A transfer to an acute ward for >48 hours (two overnight stays) will be considered a discharge from rehabilitation.
Timepoint [2] 390885 0
These data will be extracted from the medical record at discharge from rehabilitation for all patients on participating wards and confirmed via costing units of participating hospitals six months after the end of the trial.
Secondary outcome [3] 390886 0
Total time in hospital (combined acute and rehabilitation length of stay)
Timepoint [3] 390886 0
These data will be extracted from the medical record at discharge from rehabilitation for all patients on participating wards and confirmed via costing units of participating hospitals six months after the end of the trial.
Secondary outcome [4] 390887 0
Days at home up to 30 days after surgery (DAH30) for surgical patients. Data extracted from patient medical records.
Timepoint [4] 390887 0
30 days after surgery.
Secondary outcome [5] 390888 0
Hospital re-admissions to the same health service one month (30 days) post-discharge (yes/no)
Timepoint [5] 390888 0
30 days after discharge
Secondary outcome [6] 390889 0
Discharge accommodation, categorised as home, transitional care, new admission to residential care or hospital, or death (no accommodation).
Timepoint [6] 390889 0
These data will be extracted from the medical record at discharge from rehabilitation for all patients on participating wards.
Secondary outcome [7] 390890 0
Need for post-discharge rehabilitation services (yes/no).
Timepoint [7] 390890 0
These data will be extracted from the medical record at discharge from rehabilitation for all patients on participating wards.
Secondary outcome [8] 390891 0
Adverse events (falls), assessed as the number of falls and the number of serious falls during admission (composite measure)
Timepoint [8] 390891 0
These data will be extracted from the medical record at six-week intervals on participating wards.
Secondary outcome [9] 390892 0
Cost of implementation will be recorded to inform future adoption and scaling of My Therapy and to understand the cost of the My Therapy intervention independent of the health service costs for each rehabilitation patient. Resource utilisation will include the Physiotools licences, exercise materials purchased specifically for My Therapy, education for staff and patients, site coordinator time, marketing and communication, as well as therapist time to prescribe and progress My Therapy. It will not include incidental nursing or medical time spent encouraging patient participation in My Therapy
Timepoint [9] 390892 0
The My Therapy implementation costs will be collected via survey in week six of each six-week block and presented as a cost per rehabilitation ward. Survey was designed specifically for this study.
Secondary outcome [10] 390893 0
Self-efficacy: To measure participants’ feelings of self-management, acceptability of My Therapy and motivation to complete their tasks and exercises independently, 40 participants (five per ward) will complete the Exercise Self Efficacy Scale (ESES)
Timepoint [10] 390893 0
A new sample of up to 40 participants will complete the survey on the seventh day of week four of blocks one, five and nine, with a total number of participants over the course of the trial being 120. This measure will be administered between days 7 and 14 of patients' rehabilitation admission.
Secondary outcome [11] 392185 0
Length of stay for each readmission to the same health service one month (30 days) post-discharge
Timepoint [11] 392185 0
30 days after discharge
Secondary outcome [12] 392186 0
Self-management: To understand the impact of My Therapy on self-management a short survey (designed for the study) will be administered.
Timepoint [12] 392186 0
40 consenting participants (five per each ward) will complete the survey during blocks one, five and nine. The total number of participants over the course of the trial will be 120. This measure will be administered between days 7 and 14 of patients' rehabilitation admission.
Secondary outcome [13] 392188 0
Activity: A paper-based activity log will be completed to indicate whether participants have completed their My Therapy program (or independent practice of exercises on control wards), quantity of time committed to the My Therapy program and whether they completed all, some or none of their program.
Timepoint [13] 392188 0
40 participants (five per ward), covering both the experimental and the control wards, will complete the log in the first week of their rehabilitation admission and continue for 7 days, in week four of blocks one, five and nine, The total number of participants over the course of the trial will be 120.
Secondary outcome [14] 392189 0
Activity levels: A subgroup of patients from Alfred Health and Eastern Health will be asked to wear an accelerometer-based activity monitor on the anterior, middle thigh (activPAL). The monitor will objectively measure their standing time and steps.
Timepoint [14] 392189 0
Up to 12 participants (with a total sample of 36 participants over the course of the trial) will be asked to wear the activPAL for 24-hour monitoring in the first week of their rehabilitation admission over seven consecutive days in week four of blocks one, five and nine.

Eligibility
Key inclusion criteria
• All patients undergoing rehabilitation on the selected rehabilitation wards during the trial period (of any rehabilitation diagnosis);
• Patients aged 18+ years
• Patients who speak English or any other languages able to be supported through interpreter services;
• Patients without cognitive impairment or patients with a cognitive impairment (when a next of kin/guardian/authorised person is available to opt-out on behalf of the patient).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients already admitted to the ward at the point of transition from the control to the experimental period (as these patients will be exposed to both conditions, leading to data contamination).
• Any patients without a current Medicare card

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size

The sample size calculation is based on the primary outcome measure (the Functional Independence Measure [FIM]) using findings from the previous My Therapy pilot study which found that double the proportion of patients in the My Therapy group (22%) achieved a MCID in function (FIM) from admission to discharge, compared to usual care (10%) The sample size is based on a two-tailed alpha of 0.05, power of 0.99, as well as an intraclass correlation coefficient (ICC) of 0.005 (established from a previous rehabilitation study). Using these parameters, the total sample size required is 2,160 patients.

With an average of 25 beds per ward, length of stay of 18.5 days and a data collection period of 54 weeks, each rehabilitation ward will contribute around 485 patients. This is reduced to 340 when an opt-out rate of 30% is assumed. If each of the 8 rehabilitation wards contributes 340 patients across the 54 weeks of data collection, the total of 2,716 will exceed the sample size requirement for the primary outcome measure of the proportion of people who achieve a MCID in FIM.

The sample size calculation allows for planned bed closures over the Christmas period and censoring of patients already admitted to the ward at the point of transition from the control to the experimental period to avoid contamination of data analysis, as these patients will be exposed to both conditions.

Data analyses

Analyses will only include data from patients who were admitted and discharged during the ward's control period or experimental period. Patients already admitted to the ward at the point of crossover from the control to the experimental period will be censored to avoid contamination of data analysis as these patients will be exposed to both conditions. Similarly, patient still admitted to the rehabilitation wards at the end point of the study will not be included. Each analysis will use individual patient level data, will be clustered within the ward, and will use the length of time (in weeks) the cluster has been exposed to the experimental conditions as an effect modifier. Length of time for exposure to the experimental conditions is an important consideration when an intervention may take time to settle into usual practice and where there may be a cumulative effect. Analyses will be conducted on an intention to treat basis.

Clinical evaluation

The primary analysis will compare the FIM and the utility index score between the control and the experimental groups. Health related quality of life scores from the EQ-5D-5L will be converted from raw scores to a utility index based on an Australian population to report quality adjusted life years (QALYs). The proportion of people who achieve a minimally clinical important difference (MCID) of 22 points in FIM will be analysed using mixed effects logistic regression, and the change in FIM score and QALYs will be analysed using mixed effects linear regression. Length of stay will also be analysed via a linear regression model. While not powered for a secondary analysis, there will be an exploratory secondary analysis of the same outcome measures within each of the clusters. Other secondary outcomes will be compared between groups using univariable analyses. All outcomes will be reported with 95% confidence intervals and analyses will assume a significance of p<0. 05.

Economic evaluation

All cost data will be inflated to AUD$ 2021/22 (final year of data collection) using CPI (http://www.abs.gov.au/ausstats) and will take a health service perspective.
For the primary outcome, the economic evaluation will be presented as a cost-utility and cost-effectiveness analyses, reporting i) the cost per MCID in FIM achieved; and ii) the cost per QALY gained. The cost will only report health service utilisation and costs; it will not include resources and costs for the running and governance of the project.

Health service utilisation and costs, including the rehabilitation length of stay, acute transfers within the rehabilitation stay and unplanned re-admissions within the 30 days post discharge, will be reported. The per-person cost of My Therapy participation, under business-as-usual conditions, will be added to the health service costs for patients in the intervention group (see secondary outcome of the economic evaluation). These costs will be combined with utility (EQ-5D-5L converted to a utility index) and effectiveness (FIM) data to establish the cost-utility and cost-effectiveness of My Therapy.

Mean cost difference will be determined between the two groups using a linear regression model to determine statistical significance.25 Incremental cost effectiveness ratios (ICERs) will be determined for both the FIM and utility index using the cost as the numerator and the utility or effectiveness data as the denominator. All analyses will use individual patient level data, will be clustered within the ward, and will use the length of time (in weeks) the cluster has been exposed to the experimental conditions as an effect modifier.

The ICER analysis for the cost per MCID achieved will be analysed using mixed effects logistic regression, and the ICER analysis for the cost per QALY gained will be analysed using mixed effects linear regression. Confidence intervals around the individual ICERs for utility and effectiveness will be calculated using the bootstrap method with 5,000 repetitions. Individual ICERs will use the central limit theorem to generate the confidence ellipses and the cost effectiveness acceptability curves (CEACs) to inform the probability that My Therapy is less costly and more beneficial compared with usual care alone.

For the secondary outcome, the economic evaluation will be presented as a cost-analysis to report the cost of implementation. Data will be presented within two time periods; (i) preparation period (prior to commencing My Therapy) as well as (ii) implementation period (on commencement of My Therapy). Periods (i) and (ii) together are considered the full cost of My Therapy, whereas just period (ii) is considered the costs under business as usual conditions.
As each ward will have a different time horizon for the preparation period and the implementation period pending on their point of randomisation, costs will be presented per patient (total costs divided by the total number of patients who participate in My Therapy), and per ward (total costs divided by the total number of wards; n=8) using independent t-tests (mean, standard deviation). Cost will be presented as a combined period (i) and (ii) to represent the full cost of My Therapy per person / per ward, as well as just period (ii) to represent the cost of business as usual conditions per person / per ward.

Resource utilisation will be reported as real and in-kinds costs and these will include the Physiotools licences and exercise materials purchased specifically for My Therapy (reported as market rate at the time of purchase); education for staff and patients, site coordinator time, marketing and communication, as well as therapist time to prescribe and progress My Therapy (staff costs based on EBA rates for Health Professionals). It will not include incidental nursing or medical time spent encouraging patient participation in My Therapy.

Process Evaluation

It is anticipated that descriptive statistics will be used to analyse all data from the process evaluation, in line with how to best report evidence when considering process evaluation methodology. Independent group t-tests or chi-squared tests will also be considered for quantitative data as appropriate. For participants who use activity monitors, should they be discharged within the week they are wearing the activity monitor, an average will be calculated based on the two days prior to discharge.

The qualitative data from staff focus groups will coded by two members of the research team. Themes will be identified through thematic analysis of the data adopting an interpretive description methodological approach to gain an understanding of the views of the participants. An inductive approach will be adopted to analyse focus group data and qualitative data within surveys. A third researcher will be engaged should a consensus not be able to be reached on the thematic analysis. NVivo software will be used to support the management and analysis of qualitative data. Triangulation of both quantitative and qualitative data will occur, resulting in a holistic summary and interpretation of the data. This will enable breadth and depth of the analysis of the implementation of My Therapy.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/04/2021
Actual
12/04/2021
Date of last participant enrolment
Anticipated
24/04/2022
Actual
18/04/2022
Date of last data collection
Anticipated
31/12/2022
Actual
31/12/2022
Sample size
Target
2160
Accrual to date
Final
3351
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18485 0
The Alfred - Melbourne
Recruitment hospital [2] 18486 0
Peter James Centre - Forest Hill
Recruitment hospital [3] 18487 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [4] 18488 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [5] 18489 0
Cabrini Brighton - Brighton
Recruitment hospital [6] 18490 0
The Victorian Rehabilitation Centre - Glen Waverley
Recruitment postcode(s) [1] 32803 0
3004 - Melbourne
Recruitment postcode(s) [2] 32804 0
3131 - Forest Hill
Recruitment postcode(s) [3] 32805 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [4] 32806 0
3144 - Malvern
Recruitment postcode(s) [5] 32807 0
3186 - Brighton
Recruitment postcode(s) [6] 32808 0
3150 - Glen Waverley

Funding & Sponsors
Funding source category [1] 307079 0
Government body
Name [1] 307079 0
NHMRC
Country [1] 307079 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Peninsula Campus, McMahons Rd, Frankston, VIC 3199
Country
Australia
Secondary sponsor category [1] 307648 0
University
Name [1] 307648 0
La Trobe University
Address [1] 307648 0
Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
Country [1] 307648 0
Australia
Other collaborator category [1] 281615 0
Hospital
Name [1] 281615 0
Alfred Health
Address [1] 281615 0
55 Commercial Rd, Melbourne VIC 3004
Country [1] 281615 0
Australia
Other collaborator category [2] 281616 0
Hospital
Name [2] 281616 0
Eastern Health
Address [2] 281616 0
5 Arnold St, Box Hill VIC 3128
Country [2] 281616 0
Australia
Other collaborator category [3] 281617 0
Hospital
Name [3] 281617 0
Cabrini Health
Address [3] 281617 0
181-183 Wattletree Rd, Malvern VIC 3144
Country [3] 281617 0
Australia
Other collaborator category [4] 281618 0
Hospital
Name [4] 281618 0
Healthscope
Address [4] 281618 0
Level 1, 312 St Kilda Rd, Melbourne VIC 3004
Country [4] 281618 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307197 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 307197 0
Ethics committee country [1] 307197 0
Australia
Date submitted for ethics approval [1] 307197 0
25/11/2020
Approval date [1] 307197 0
13/01/2021
Ethics approval number [1] 307197 0
69610

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106370 0
Dr Natasha Brusco
Address 106370 0
Rehabilitation, Ageing and Independent Living (RAIL) Research Centre
School of Primary and Allied Health Care
Monash University
Peninsula Campus
Frankston, VIC 3199
Country 106370 0
Australia
Phone 106370 0
+61 408 251 124
Fax 106370 0
Email 106370 0
Natasha.brusco@monash.edu
Contact person for public queries
Name 106371 0
Natasha Brusco
Address 106371 0
Rehabilitation, Ageing and Independent Living (RAIL) Research Centre
School of Primary and Allied Health Care
Monash University
Peninsula Campus
Frankston, VIC 3199
Country 106371 0
Australia
Phone 106371 0
+61 408 251 124
Fax 106371 0
Email 106371 0
Natasha.brusco@monash.edu
Contact person for scientific queries
Name 106372 0
Natasha Brusco
Address 106372 0
Rehabilitation, Ageing and Independent Living (RAIL) Research Centre
School of Primary and Allied Health Care
Monash University
Peninsula Campus
Frankston, VIC 3199
Country 106372 0
Australia
Phone 106372 0
+61 408 251 124
Fax 106372 0
Email 106372 0
Natasha.brusco@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocolBrusco, N.K., Ekegren, C.L., Taylor, N.F. et al. Self-managed occupational therapy and physiotherapy for adults receiving inpatient rehabilitation (‘My Therapy’): protocol for a stepped-wedge cluster randomised trial. BMC Health Serv Res 21, 811 (2021). https://doi.org/10.1186/s12913-021-06462-9https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-021-06462-9  The protocol for (a) the clinical and economic out... [More Details]
Study protocolWhittaker, S.L., Taylor, N.F., Hill, K.D. et al. Self-managed occupational therapy and physiotherapy for adults receiving inpatient rehabilitation (‘My Therapy’): protocol for a mixed-methods process evaluation. BMC Health Serv Res 21, 810 (2021). https://doi.org/10.1186/s12913-021-06463-8https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-021-06463-8 


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AISelf-managed occupational therapy and physiotherapy for adults receiving inpatient rehabilitation (‘My Therapy’): protocol for a mixed-methods process evaluation2021https://doi.org/10.1186/s12913-021-06463-8
N.B. These documents automatically identified may not have been verified by the study sponsor.