Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001489785p
Ethics application status
Submitted, not yet approved
Date submitted
8/11/2022
Date registered
29/11/2022
Date last updated
29/11/2022
Date data sharing statement initially provided
29/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Occupational Therapy Home Visiting service via virtual care
Scientific title
Does virtual delivery of an Occupational Therapy Home Visiting Service provide a non-inferior alternative to face-to-face delivery of the same service? A case control study
Secondary ID [1] 308025 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls related injuries 327705 0
Cognitive impairment 328204 0
Fractures 328205 0
Delirium 328206 0
Pressure injuries 328207 0
Hospital acquired functional decline 328208 0
Condition category
Condition code
Physical Medicine / Rehabilitation 324785 324785 0 0
Occupational therapy
Public Health 325257 325257 0 0
Health service research
Injuries and Accidents 325258 325258 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our approach is pragmatic and aims to integrate and measure the impact of virtual care in home visiting. We are yet to identify if virtual care delivers the same clinical outcomes for patients and the health system in the area of home visiting. For example, do patients receiving virtual care require the same number of intervention sessions to achieve the same clinical outcomes? We will determine:
• “when,” “how,” and “how much” care should be delivered virtually
• Differentiate between care journeys (based on patient diagnosis, referral reason, etc.)
• Design a holistic care model in which virtual and face-to-face care complement one another.
• Fine-tune the virtual experience to meet consumer expectations and drive satisfaction.
• Understand the cost implications for service provision and future resource implications.

This study aims to determine whether delivery of an occupational therapy home visiting service using a virtual care model reduces therapy time while being non-inferior to a traditional face-to-face model of care in regard to adverse events and is supported by patient satisfaction. A non-inferiority model will be utilised as we are interested in whether the new treatment (virtual care) is “not worse” than the existing treatment (face-to-face home visit delivery).

To reduce risk to patients and staff during the global pandemic, virtual care use was introduced into standard practice in early 2022. A hybrid model of virtual care includes a mixture of virtual care and face-to-face services, which is likely to be sustainable in future clinical practice. The majority of services are provided virtually (i.e. initial, cognitive and functional assessments, equipment education and set up, patient and carer education), with face-to-face utilised only if necessary (i.e. due to a patient’s inability to use virtual care, lack of patient ability or family support to set up equipment, clinical need, etc.). Therapists utilise Health Direct Video Call videoconferencing platform. There is no formal training required with resources available on the hospital intranet website as required.

All patients receive an initial risk screening introductory telephone call which will be completed within 5 days of referral and last approximately 30 minutes. This is followed by further appointments consisting of virtual care assessment (i.e. initial, functional or cognitive assessments) and intervention (i.e. patient and carer education, equipment setup) either via telephone or video (dependent on factors such as a patient’s needs, equipment availability, family support, patient’s preference, etc.) lasting approximately 60 minutes. Frequency of follow-up appointments will be determined on a case-by-case basis. If care is required post the 4-6 week follow up period it will be provided but not included in the results.

Two researchers will purposively case match participants by age and diagnosis from the occupational therapy department clinical database for patients that have received virtual care compared to a face-to-face home visiting service. Data extracted from the clinical database will include: date of referral, source of referral, type of assessment and intervention provided, mode of service delivery and reasons for escalation to a face-to-face home visit (if a case patient). The database also provides information on any encountered issues with virtual care such as technical or safety issues.

The Functional Independence Measure, Clinical Frailty Scale and Charlson Comorbidity Index will be used to describe patient function. Other covariates, such as sociodemographic data, diagnosis, comorbidities and referral reason will be obtained from medical records.

A subset of patients will be approached on the telephone or by mail post receiving a virtual care home visiting service to survey their satisfaction (Telehealth Usability Questionnaire). Purposive sampling strategy will be employed to recruit participants as researchers will select those participants who have received a virtual care home visit within two months to ensure patient recall.
Intervention code [1] 324506 0
Treatment: Other
Comparator / control treatment
Control patients will receive care consisting of one telephone call to arrange a home visiting time, followed by a face-to-face home visit. These patients may have then received one further follow-up telephone call only with no other virtual care service. Patients will have received care between 1 January 2020 - 31 December 2021 where this process was utilised as standard practice.
Control group
Historical

Outcomes
Primary outcome [1] 332640 0
Total therapy time from home visiting referral to discharge (including travel time). This will be extracted from Allied Health Statistics (AHS). Patients are discharged when the referral reason has been addressed and the patients have met therapy goals (approximately 4-6 weeks).
Timepoint [1] 332640 0
From time of referral to service discharge (approximately 4-6 weeks)
Secondary outcome [1] 414175 0
Number of patient adverse events consisting of falls, pressure injuries or incidence of delirium, hospital representations and admissions for patients receiving virtual care compared to face-to-face care. This information will be sourced from WebPAS and iSoft which are WA Health department IT systems as well as the occupational therapy department home visiting services database.
Timepoint [1] 414175 0
From time of referral to service discharge (approximately 4-6 weeks).
Secondary outcome [2] 414176 0
Number of occupational therapy contacts will be recorded from AHS
Timepoint [2] 414176 0
From time of referral to discharge from services (approximately 4-6 weeks)
Secondary outcome [3] 414177 0
Number of services delivered consisting of home modifications, equipment, training, rehabilitation provided, etc. This information will be gathered from the occupational therapy department home visiting service database.
Timepoint [3] 414177 0
From time of referral to service discharge (approximately 4-6 weeks).
Secondary outcome [4] 414178 0
Data on the number of days taken to complete home assessments from referral which will be gathered from the occupational therapy department home visiting database.
Timepoint [4] 414178 0
From time of referral to home assessment completed.
Secondary outcome [5] 414179 0
Number of safety incidents or technical issues encountered while using virtual care and if this resulted in a face-to-face visit. This information will be provided in the occupational therapy department home visiting database.
Timepoint [5] 414179 0
From time of referral to service discharge (approximately 4-6 weeks).
Secondary outcome [6] 414180 0
Patient satisfaction using the Telehealth Usability Questionnaire
Timepoint [6] 414180 0
To be completed at service discharge.
Secondary outcome [7] 414181 0
Billing costs (from institutional billing records) associated with therapy provision and any patient adverse events resulting in healthcare use.
Timepoint [7] 414181 0
Calculated at service discharge.
Secondary outcome [8] 415858 0
Number of scheduled appointments will be gathered from WebPAS and iSoft
Timepoint [8] 415858 0
From time of referral to discharge from services (approximately 4-6 weeks)
Secondary outcome [9] 415859 0
Number of ‘did not attends’ (DNA) will be gathered via WebPAS and iSoft
Timepoint [9] 415859 0
From time of referral to discharge from services (approximately 4-6 weeks)

Eligibility
Key inclusion criteria
Any patient recorded in the clinical home visiting database who has received an occupational therapy home assessment and intervention consisting of two or more occasions of service.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For the subset of patients to be surveyed regarding their telehealth experience, patients unable to provide consent to participate in the research i.e. diagnosed cognitive impairment (dementia), moderate to severe cognitive impairment, or recent (within the last week) hospital discharge following delirium or a psychosis will not be included. Additionally, these patients will have received a virtual care home visit within the last two months reducing bias with patient recall when completing the survey.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/12/2022
Actual
Date of last participant enrolment
Anticipated
4/12/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
528
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 312289 0
Hospital
Name [1] 312289 0
Sir Charles Gairdner Osborne Park Healthcare Group
Country [1] 312289 0
Australia
Primary sponsor type
Individual
Name
Dr Kristie Harper
Address
Occupational Therapy Department
G Block
Lower Ground Floor
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, WA, 6009
Country
Australia
Secondary sponsor category [1] 313831 0
Individual
Name [1] 313831 0
Toni Heinemann
Address [1] 313831 0
Osborne Park Hospital
Occupational Therapy Department
F Block
Osborne Place
Stirling, WA, 6021
Country [1] 313831 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311658 0
Sir Charles Gairdner and Osborne Park Healthcare Group Human Research Ethics Committee
Ethics committee address [1] 311658 0
Ethics committee country [1] 311658 0
Australia
Date submitted for ethics approval [1] 311658 0
09/09/2022
Approval date [1] 311658 0
Ethics approval number [1] 311658 0

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

Contacts
Principal investigator
Name 121886 0
Mrs Toni HEINEMANN
Address 121886 0
Osborne Park Hospital
Occupational Therapy Department
F Block
Osborne Place
Stirling, WA 6021
Country 121886 0
Australia
Phone 121886 0
+61 8 6457 8475
Fax 121886 0
Email 121886 0
[email protected]
Contact person for public queries
Name 121887 0
Toni HEINEMANN
Address 121887 0
Osborne Park Hospital
Occupational Therapy Department
F Block
Osborne Place
Stirling, WA 6021
Country 121887 0
Australia
Phone 121887 0
+61 8 6457 8475
Fax 121887 0
Email 121887 0
[email protected]
Contact person for scientific queries
Name 121888 0
Kristie Harper
Address 121888 0
Occupational Therapy Department
G Block
Lower Ground Floor
Sir Charles Gairdner Hospital
Hospital Avenue
Nedland, WA, 6009
Country 121888 0
Australia
Phone 121888 0
+61 8 64572855
Fax 121888 0
Email 121888 0
[email protected]

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?

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
No additional documents have been identified.