Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001360202
Ethics application status
Approved
Date submitted
24/07/2018
Date registered
13/08/2018
Date last updated
29/05/2023
Date data sharing statement initially provided
25/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The HOME Rehab Trial: comparing the effectiveness of occupational therapy homevisit discharge planning to in-hospital consultations to improve participation after stroke
Scientific title
The HOME Rehab trial: comparing the effectiveness of occupational therapy homevisit discharge planning to in-hospital consultations to improve participation after stroke
Secondary ID [1] 295645 0
None
Universal Trial Number (UTN)
Trial acronym
The HOME Rehab Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 308983 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307884 307884 0 0
Occupational therapy
Stroke 307885 307885 0 0
Haemorrhagic
Stroke 307886 307886 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A home-based predischarge consultation followed by a 4 week postdischarge support package is provided by a trained occupational therapist following randomisation. Using standardised assessment and manualised procedures, the intervention is tailored by the occupational therapist to each participant’s pattern of functional loss and unique home and community environments as well as their personally meaningful goals. The program commences with:
(1) Predischarge both groups will receive a family-led home environment assessment. Families of both groups will be loaned a tablet computer or digital camera to complete a home safety checklist and take photos of areas of the home that the participant would need or wish to access on return home.
(2) Predischarge both groups will receive a confidence and discharge planning (30 minutes) assessment (considered best practice) using the Discharge Planning Assessment Tool (DPAT) early in hospitalisation.
(3) Predischarge participants in the intervention group will receive one predischarge homevisit (approximately 90 minutes). Using standardised assessment and manualised procedures, environmental modification and equipment will be recommended and, when accepted, installed before discharge as per usual hospital policies.
(4) Postdischarge participants in the intervention group will receive two home or community based occupational therapy interventions (approximately 75 minutes each) over the first 2-week period following discharge. The first postdischarge homevisit will occur in the first week post discharge and the second posdischrage homevisit will occur in the second week postdischarge. Interventions will progress in complexity from daily activities to community participation based on the participant’s goals. Two booster sessions will be conducted over the telephone during the final two weeks prior to end-of-study outcome evaluation. The fist telephone call will be conducted in the third week post discharge and the second telephone call will be conducted in the fourth week post discharge. Wherever possible, one of the postdischarge sessions will include the participant’s General Practitioner (GP) (either by joint appointment, telephone or follow-up letter).
Results of the occupational therapy intervention for both groups will be shared with the rehabilitation team. Both groups will receive rehabilitation and medical care as usually provided by other professionals. This study will not affect discharge dates, which will continue to be decided upon by the patients’ treating multidisciplinary team as per the hospitals usual protocols.
Adherence to the intervention will be monitored with the use of session attendance checklists, a resource use diary, and detailed intervention checklists that describe the specific intervention components required to be delivered at each of the intervention sessions.
Intervention code [1] 301961 0
Rehabilitation
Intervention code [2] 301962 0
Treatment: Other
Comparator / control treatment
A hospital-based predischarge consultation is provided by a trained occupational therapist following randomisation. Similar to the intervention group, the control group will receive one 30-minute in-hospital predischarge confidence and discharge planning session using the Discharge Planning Assessment Tool (DPAT) plus a predischarge family-led home environment assessment. Using standardised assessment and manualised procedures, environmental modification and equipment will be recommended and, when accepted, provided before discharge as per usual hospital policies. The difference between the control and intervention is that the participant only receives an in-hospital consultation as a means to plan for discharge and the participant will not receive an occupational therapy home assessment. Teams will not provide a home assessment prior to discharge and will not refer participants to community-based occupational therapy for the purpose of a home assessment.
Control group
Active

Outcomes
Primary outcome [1] 306856 0
Activity participation, as measured by the Nottingham Extended Activities of Daily Living (NEADL)
Timepoint [1] 306856 0
Baseline (within 3 days of recruitment), 4 weeks post discharge (primary), and 6 months post discharge
Secondary outcome [1] 349956 0
Readmissions to hospital (number). Data will be collected from 1) a self-report form provided to the individual; 2) frequency of emergency presentations and hospital readmissions and reason for admission will be recorded from data obtained from hospital administrative datasets held by State Health Departments and collected using data linkage.
Timepoint [1] 349956 0
4 weeks post discharge, and 6 months post discharge
Secondary outcome [2] 349957 0
Cost effectiveness of the pre-discharge home visit package.

Program costs of delivering each intervention will be summarised and included in estimating to average costs per patient treated in each arm of the study and total costs. The perspective of costs will be societal, with patient out-of-pocket costs, carer time and productivity impacts (e.g. ability to work) included. The primary outcome measure for the cost-effectiveness study will be the incremental cost per clinically significant improvement in NEADL. The secondary outcome measure will include estimating the net cost per Quality Adjusted Life Years gained based on data from the EQ5D-5L data and information on survival.
Timepoint [2] 349957 0
Baseline, 4 weeks, 6 months and 12 months post discharge
Secondary outcome [3] 349959 0
Activity participation (Modified Rankin Scale)
Timepoint [3] 349959 0
Baseline, 4 weeks, 6 months and 12 months post discharge
Secondary outcome [4] 349960 0
Health Related Quality of Life (EQ-5D-5L)
Timepoint [4] 349960 0
Baseline, 4 weeks, 6 months and 12 months post discharge
Secondary outcome [5] 405379 0
Carer Burden measured using the "Carer Experience Scale"
Timepoint [5] 405379 0
Baseline, 4 weeks, and 6 months post discharge
Secondary outcome [6] 405380 0
Quality of care transition (Care Transition Measure-3)
Timepoint [6] 405380 0
4 weeks post discharge

Eligibility
Key inclusion criteria
- diagnosis of stroke (confirmed by brain imaging, or where unavailable or unclear, from a neurologist or stroke-specialist medical professional);
- independent in activities of daily living prior to stroke (premorbid Rankin score equal or less than 2);
- admitted for inpatient rehabilitation;
- expected return to live in a private residence within the community (own home, independent living unit or living with family) after discharge from hospital;
- absence of severe co-morbid disease (as assessed by a score less than 8 on the Charlson co-morbidity index)
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- need for major home modifications
- planned discharge to aged care facility, or to a private residence where family will provide full assistance with all self-care
- planned discharge to an address 2 hours or greater from the recruiting hospital site;
- significant cognitive impairment (as assessed by a score of more than 5 adjusted errors on the Short Portable Mental Status Questionnaire);
- bariatric patients (as assessed as a Body Mass Index of 45 or more);
- illness likely to be associated with a life expectancy of less than 12 months (as estimated by a score of 3 or less on a modified version of the Implicit Illness Severity Scale);
- moderate to severe aphasia (as assessed by the NIHSS Best Language rating of greater than or equal to 2);
- unable to participate in recovery / rehabilitation goals for any other clinical reasons.

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 independent online randomisation service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A permuted block randomization process will be used within each strata using random block sizes. The randomization creation process (including block sizes) and resulting schedule will be set, held and managed centrally external to the investigators (LCh, The University of Melbourne) and will be managed using REDCap (ResearchElectronic Data Capture).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
All stroke admissions to participating hospitals will be screened by research staff who have no relationship with potential participants, to determine eligibility. Cognitive and aphasia screening will be undertaken if they have not already been recorded in patient medical records. Research staff will obtain informed consent from the potential participant while they are an inpatient in rehabilitation (and person responsible as necessary, in the situation that the potential participant has 4 or 5 adjusted errors on SPMSQ). Written information about the study will be provided to participants.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the primary hypothesis, differences in mean change in NEADL (baseline minus follow-up) will be compared between groups using ANCOVA model with change as an outcome, group as a factor and baseline value of NEADL as a covariate. Treatment of missing data will be based on the satisfiability of missingness at random assumptions, and will be based on the intention to treat strategy as per White et al36. Similar analyses will be conducted for continuous secondary outcomes. Binomial secondary outcomes (i.e. readmission) will be analysed using a logistic regression model with the readmission (Y/N) as an outcome and group as an input and age and stroke severity (as per NEADL) as covariates. Effect of patient characteristics on outcomes will be explored by including relevant terms in models. Standard diagnostic plots will be used to check model assumptions. The heterogeneity of effect across sites will be tested using a corresponding random effect model with centre as a random effect.
Cost description analyses of each care pathway (e.g control or experimental) using patient-level resource use data will be detailed using EXCEL or STATA software. Program costs of delivering each intervention will be summarised and included in estimating to average costs per patient treated in each arm of the study and total costs. Subsequently, an incremental cost effectiveness analysis will be performed. The perspective of costs will be societal, with patient out-of-pocket costs, carer time and productivity impacts (e.g. ability to work) included. The primary outcome measure for the cost-effectiveness study will be the incremental cost per clinically significant improvement in NEADL. The secondary outcome measure will include estimating the net cost per Quality Adjusted Life Years gained based on data from the EQ5D-5L data and information on survival. QALYs will be estimated and compared using the methods described by Billingham and Abrams. A utility score will be generated from an EQ-5D questionnaire, which ranges from 1 (where a patient reports no problems for all five questions) to -0•59 (where a patient reports severe problems for all five questions). The average utility score will be calculated at every assessment timepoint and a mean QALY per group estimated taking into account the change from baseline. A protocol for standardised resource use data collection will be used costed for the reference year 2021. Where prices in 2021 are unavailable, adjustment to the real price will be made using the published health sector specific deflator/inflators published by the Australian Institute of Health and Welfare.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/08/2018
Actual
27/08/2018
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
360
Accrual to date
260
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 11500 0
Caulfield Hospital - Caulfield
Recruitment hospital [2] 21552 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 21553 0
Mt Wilga Private Hospital - Hornsby
Recruitment hospital [4] 21554 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [5] 21555 0
Royal Talbot Rehabilitation Centre - Kew
Recruitment hospital [6] 21556 0
Sacred Heart Hospice - Darlinghurst
Recruitment postcode(s) [1] 36465 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 36462 0
2077 - Hornsby
Recruitment postcode(s) [3] 36463 0
3081 - Heidelberg West
Recruitment postcode(s) [4] 36464 0
3101 - Kew
Recruitment postcode(s) [5] 23524 0
3162 - Caulfield
Recruitment postcode(s) [6] 36461 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 300226 0
Government body
Name [1] 300226 0
National Health and Medical Research Council - NHMRC Project grant 1141561
Country [1] 300226 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Central Clinical School, 99 Commercial Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 299637 0
None
Name [1] 299637 0
Address [1] 299637 0
Country [1] 299637 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301049 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 301049 0
The Alfred
55 Commercial Road
Prahran, VIC 3181
Ethics committee country [1] 301049 0
Australia
Date submitted for ethics approval [1] 301049 0
13/02/2018
Approval date [1] 301049 0
17/04/2018
Ethics approval number [1] 301049 0
HREC/17/Alfred/236 (Local Reference: 30/18)

Summary
Brief summary
Each year more than 10,000 Australian stroke survivors are admitted to rehabilitation to improve independence. Occupational therapy assessments conducted before discharge aim to enable a safe independent transition from hospital to home, however there is no evidence that home visits improve outcomes for stroke survivors. The HOME trial will address this evidence gap with the aim of determining the effectiveness, and cost effectiveness of an occupational therapy discharge planning intervention consisting of three occupational therapy sessions primarily conducted in the home. This multicentre, randomised controlled trial will recruit 360 patients with a confirmed diagnosis of stroke admitted for inpatient rehabilitation. Patients will receive either the HOME intervention, or an inhospital predischarge planning package. The primary hypothesis is that the HOME intervention will improve functional participation levels at 4 weeks, 6 and 12 months, compared to predischarge planning package. Secondary hypotheses are that the HOME intervention will result in fewer hospital readmissions at 6 months postdischarge, and will be less costly than an occupational therapy predischarge home visit package.
Trial website
https://hometrial.com.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85706 0
Prof Natasha Lannin
Address 85706 0
Department of Neuroscience, Central Clinical School, The Alfred Centre, 99 Commercial Road, Prahran VIC 3181
Country 85706 0
Australia
Phone 85706 0
(+61) 3 9479 6745
Fax 85706 0
Email 85706 0
natasha.lannin@monash.edu
Contact person for public queries
Name 85707 0
Prof Natasha Lannin
Address 85707 0
Department of Neuroscience, Central Clinical School, The Alfred Centre, 99 Commercial Road, Prahran VIC 3181
Country 85707 0
Australia
Phone 85707 0
(+61) 3 9479 6745
Fax 85707 0
Email 85707 0
natasha.lannin@monash.edu
Contact person for scientific queries
Name 85708 0
Prof Natasha Lannin
Address 85708 0
Department of Neuroscience, Central Clinical School, The Alfred Centre, 99 Commercial Road, Prahran VIC 3181
Country 85708 0
Australia
Phone 85708 0
(+61) 3 9479 6745
Fax 85708 0
Email 85708 0
natasha.lannin@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
Patient consent to sharing data for purposes beyond the trial was not sought at time of HREC approval, therefore it is not possible to share IPD.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of occupational therapy home visit discharge planning on participation after stroke: Protocol for the HOME Rehab trial.2021https://dx.doi.org/10.1136/bmjopen-2020-044573
N.B. These documents automatically identified may not have been verified by the study sponsor.