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Trial registered on ANZCTR


Registration number
ACTRN12614000913673
Ethics application status
Approved
Date submitted
7/03/2013
Date registered
27/08/2014
Date last updated
27/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Telehealth for Residential Aged Care Facilities: A Pragmatic Controlled Trial
Scientific title
In new residents in long term care facilities, does a telehealth service providing geriatric consultation, compared to usual care, improve health outcomes
Secondary ID [1] 282088 0
NHMRC ID APP1048098
Universal Trial Number (UTN)
U1111-1140-3718
Trial acronym
Tele-LTCF Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Function 288590 0
Ageing 288591 0
Condition category
Condition code
Mental Health 288919 288919 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 292133 292133 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A comprehensive geriatric assessment will be carried out via videoconferencing. The geriatric consultation is a direct interaction between the resident and the doctor. Generally the facility nurse is also available during the consultation.

Residents will be referred for assessment by their GP, or a clinical practice nurse.

Assessment data will be collected by the facility nurse and made available for the geriatrician for a single assessment. The assessment data is a modified version of the interRAI Long Term Care Assessment tool. It includes information about geriatric syndromes, function and cognition, medications, and activities of daily living. The facility nurse will also make available to the geriatrician the GP referral letter, any recent pathology results, and facility documentation if there is key health information applicable to the issue under consideration (ie. a behavior chart, if the resident is being assessed for BPSD).

The geriatrician will assess the resident via video conference. The geriatrician reads all the documentation provided by the GP and/or the facility nurse. The video conference then includes discussion with the resident and family (if the family is present). The geriatrician will ask questions to prompt responses that illicit additional information that is required. The geriatrician may ask the resident to walk so that gait can be observed. This consultation is very similar to what would happen if a resident went for a private consultation with a geriatrician in an out patient clinic. The duration is usually one hour, but may be more or less depending on the needs of the resident.

The resident will undertake on geriatric consultation via video conference. After that, there may be additional consultations in response to the medical needs of the resident (i.e. if the geriatrician recommends a change in medication, it is possible that a review will be scheduled to ensure that change is positive). All consultations are optional for the resident.

The intervention will be facility based (available to all residents at the facility who would benefit from a geriatric consultation). Consent for the evaluation of the intervention will be sought from individual residents. The study will continue for 2 years or until the total sample has been recruited (whichever occurs first). 88 residents will be recruited from each site (both new residents and existing residents).
Intervention code [1] 286693 0
Prevention
Comparator / control treatment
Usual care: residents will enter the residential care and access medical services as required and when available. The sample at each control site will include 88 residents (both new and existing residents).
Control group
Active

Outcomes
Primary outcome [1] 289047 0
Decrease in number of external health care visits (emergency department, hospital admissions, ambulatory clinics). The outcome will be assessed by reviewing records of admission at the facility level, and collecting State held data on admissions to acute care and emergency department episodes of care.
Timepoint [1] 289047 0
6 months
Secondary outcome [1] 301635 0
Reduction in hospital bed days utilized and hospital associated costs
Timepoint [1] 301635 0
6 months
Secondary outcome [2] 309434 0
Reduction in the number of medications prescribed
Timepoint [2] 309434 0
6 months
Secondary outcome [3] 309435 0
Improved resident quality of care scores derived from Quality Indicators
Timepoint [3] 309435 0
6 months
Secondary outcome [4] 309436 0
Greater access to specialist services, measured by the number of specialist consultations (telehealth and conventional)
Timepoint [4] 309436 0
6 months
Secondary outcome [5] 309437 0
Improved resident and family perception of clinical care.
For a specific period in the trial (2 months), consecutive residents will be asked to complete a short satisfaction questionnaire. During the same period, five families will be contacted by telephone, following a family member's video conference, and asked a short number of questions regarding their perception of the contribution of VC to clinical care.
During the same period, the same number of residents and family members will be contacted in the control sites and asked questions about their perception of the quality of clinical care (similar to the intervention sites but without VC questions).
Timepoint [5] 309437 0
6 months
Secondary outcome [6] 309438 0
Improved staff satisfaction in relation to clinical care.
Two focus groups will be held with staff. One just as the trial is commencing and one later in the trial (at the same time as the other stakeholder surveys are being completed). The questions will focus on the perception of the quality of clinical care. These focus groups will be held at both control and intervention sites, to assist in gauging the extent to which the VC consultation impacts perceptions of the quality of clinical care.
Timepoint [6] 309438 0
6 months
Secondary outcome [7] 309439 0
Reduced cost of escorts and specialized transport for external consultations. All external health care visits that require a facility employed escort will have the time the staff member left the facility recorded as well as the time of the staff members return. This is standard documentation in a residential care facility. This information will be used to calculate the cost of escorting.
Timepoint [7] 309439 0
6 months

Eligibility
Key inclusion criteria
Residents of long term care facilities (or residential care facility)
Referred by GP
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Resident (or secondary decision maker) unable to give consent
No referral from GP or nurse practitioner received

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of facilities to intervention or control is not concealed.
Randomisation occurs at the facility level (pragmatic control study at practice level) as the intervention can not be provided with a variation at an individual level (due to contamination effects).
All sites (N=10) will be checked for capacity to participate in either the intervention or control group,and will be allocated in 1:1 ratio to intervention and control arms, balancing for the centre size based on bed numbers.

There is no blinding of the allocation to intervention at an individual as the intervention is provided to all residents at a facility. Facilities were randomised according to a protocol which required that all 10 facilities were able and willing to participate as either the intervention or control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study centres will be allocated to intervention and control groups with adequate balancing of centre sizes in terms of bed numbers.

Initial allocation is based upon a computer generated random sampling codes, conditional upon study centre sizes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size of 10 facilities is pragmatic, based on our assessment of the logistics of establishing 5 suitable intervention sites within an affordable budget in a 4 year study period.

Intention to treat analysis approach will be adopted for the analyses of all primary and secondary outcomes of this study. All analyses will use the individual resident as the unit of analysis. The centre-level analyses will be conducted only when appropriate. Mixed effect negative binomial distribution regression model will be used to compare the number of ED visits or clinic visits, with adjustments for the centre effects. The bootstrapped estimates of standard errors will be obtained and the resultant p-values will be reported. Resident-level number of medications prescribed will also be analysed using the same method(s). Appropriate non-parametric regression techniques will be used to analyse the other secondary outcomes.
The cost-data and the QoL data will be compared between the study groups using a quartile regression technique, to enable inferences to be made on the difference in median level of these skewed cost and QoL data.
Separate analyses will be conducted with data from existing residents (non-new entries) in the care houses. A formal statistical analysis plan will be developed which will describe the analysis principles and techniques to analyse all primary, secondary and cost related data in this study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2014
Actual
Date of last participant enrolment
Anticipated
30/06/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
880
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 286865 0
Government body
Name [1] 286865 0
National Health and Medical Research Council
Country [1] 286865 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Centre for Online Health
Building 33, Level 2
Princess Alexandra Hospital
Ipwich Road
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 285657 0
Individual
Name [1] 285657 0
Dr. Melinda Martin-Khan
Address [1] 285657 0
Centre for Research in Geriatric Medicine
Building 33, Level 2
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country [1] 285657 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288925 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 288925 0
The University of Queensland
Brisbane QLD 4072
Ethics committee country [1] 288925 0
Australia
Date submitted for ethics approval [1] 288925 0
13/03/2014
Approval date [1] 288925 0
03/04/2014
Ethics approval number [1] 288925 0
2014000471
Ethics committee name [2] 291519 0
UNITING CARE QUEENSLAND HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [2] 291519 0
Level 5
193 North Quay
Brisbane QLD 4000
Ethics committee country [2] 291519 0
Australia
Date submitted for ethics approval [2] 291519 0
01/05/2014
Approval date [2] 291519 0
05/08/2014
Ethics approval number [2] 291519 0
MARTIN-KHAN16514

Summary
Brief summary
This study will examine the effectiveness of telehealth to reduce utilisation of external health services by residents in long term care. These services include visits to emergency departments, hospital admissions and visits to specialists in an ambulatory clinic settings.
The model under scrutiny involves geriatrician and gerontic nurse supported comprehensive geriatric assessment and care planning, supplemented by a wide range of telehealth enabled specialist disciplines, into the residential aged care setting. It is designed to address a series of problems encountered by clinicians and administrators within Residential Aged Care Facilities (RACF) in Australia, including inadequate access to specialists; professional isolation of nurses; sub-optimal care standards; and avoidable use of hospital services in emergencies. In this introductory section, these issues are delineated and the service model designed to overcome them is described.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38370 0
Prof Leonard C Gray
Address 38370 0
Centre for Online Health
Building 33, Level 2
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 38370 0
Australia
Phone 38370 0
+61 7 3176 5530
Fax 38370 0
Email 38370 0
[email protected]
Contact person for public queries
Name 38371 0
Melinda Martin-Khan
Address 38371 0
Centre for Online Health
Building 33, Level 2
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 38371 0
Australia
Phone 38371 0
+61 7 3176 5530
Fax 38371 0
Email 38371 0
[email protected]
Contact person for scientific queries
Name 38372 0
Melinda Martin-Khan
Address 38372 0
Centre for Online Health
Building 33, Level 2
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 38372 0
Australia
Phone 38372 0
+61 7 3176 5530
Fax 38372 0
Email 38372 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23262Statistical analysis plan  [email protected]

Results publications and other study-related documents

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