Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000323426
Ethics application status
Approved
Date submitted
3/03/2016
Date registered
11/03/2016
Date last updated
23/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Home assessment visits prior to discharge from hospital for patients after hip fracture: A randomised controlled trial
Scientific title
Home assessment visits prior to discharge from hospital on rates of falls and re-admission to hospital for patients after hip fracture: A randomised controlled trial
Secondary ID [1] 288436 0
Unknown
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip fracture 297456 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297649 297649 0 0
Occupational therapy
Injuries and Accidents 298069 298069 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will receive a hospital-based initial interview by the occupational therapist on admission to hospital, consistent with usual care. The duration of the interview may be approximately 30 to 60 minutes depending on the participant and their occupational, social and environmental status. The interview will be part of the hospital-based discharge planning and will focus on developing rapport, gathering information about the participant's occupational performance and their home environment. The participants will then receive a single home visit, in which an occupational therapist will accompany the participant on a short visit prior to discharge from hospital. The home assessment will be conducted between 1 and 5 days prior to expected discharge date or whenever the participant has recovered sufficiently to be able to participate, or within 24 hours post discharge for patients discharged directly from acute settings with insufficient notice to arrange a home visit. The home assessment visit takes approximately 1 hour and provides an opportunity for the participant to practise activities of daily living and includes the provision of education, advice and recommendations on equipment, home adaptations and available community services. The home assessment visit will be completed using a home assessment report form and recommendations and actions will be recorded on a home assessment summary form. The occupational therapist will assist in organising the hire of equipment or referral to community services that are identified as being required as a result of the home assessment visit and the discharge planning process.
Intervention code [1] 293767 0
Rehabilitation
Comparator / control treatment
The participants in the control group will receive hospital-based discharge planning only. This will include an initial interview by an occupational therapist on admission to hospital. The duration of the interview may be approximately 30 to 60 minutes depending on the participant and their occupational, social and environmental status. The Home Falls and Accidents Screening Tool (Home Fast) will also be completed either during the initial interview or at a separate time depending on the health and the fatigue levels of the participant. This tool may take approximately 20 to 30 minutes to complete and will be used to gather information about the participant's occupational performance and their home environment and to provide a basis for discussion of ability to manage day to day activities at home consistent with usual occupational therapy management of this patient group. The use of the Home Fast tool provides consistency to the protocol and ensures that all participants in the control group are being asked the same questions. Additional sessions may be required depending on the issues raised during the assessment process. During the additional sessions the occupational therapist will provide education about the safe use of adaptive equipment to assist in the home, simulation and practise of activities of daily living as appropriate within the hospital setting and provision of information about available community services. The occupational therapist will document any recommendations and actions on a home assessment summary form. The occupational therapist will assist in organising the hire of equipment or referral to community services that are identified as being required for discharge as a result of the interview and discharge planning process.
Control group
Active

Outcomes
Primary outcome [1] 297203 0
Number of falls reported by participants
Timepoint [1] 297203 0
1 month and 6 months post discharge
Primary outcome [2] 297204 0
Number of readmissions to the health service by data linkage to medical records
Timepoint [2] 297204 0
1 month and 6 months post discharge
Primary outcome [3] 297601 0
Number of overnight stays in the health service by data linkage to medical records
Timepoint [3] 297601 0
1 month and 6 months post discharge
Secondary outcome [1] 320336 0
Anxiety and concern about falling measured using the Falls Efficacy Scale (FES)
Timepoint [1] 320336 0
Baseline, 1 month and 6 months post discharge
Secondary outcome [2] 320346 0
Participation and limitations in activities of daily living measured using the Functional Autonomy Measurement System (SMAF)
Timepoint [2] 320346 0
Baseline, 1 month and 6 months post discharge
Secondary outcome [3] 320347 0
Activity limitations in personal activities of daily living measured using the Functional Independence Measure (FIM)
Timepoint [3] 320347 0
Baseline, 1 month and 6 months post discharge
Secondary outcome [4] 320348 0
Activity limitations in instrumental activities of daily living measured using the Nottingham Extended Activities of Daily Living Scale (NEADL)
Timepoint [4] 320348 0
Baseline, 1 month and 6 months post discharge
Secondary outcome [5] 320349 0
Health-related quality of life measured using the EuroQOL EQ5D
Timepoint [5] 320349 0
Baseline, 1 month and 6 months post discharge
Secondary outcome [6] 320350 0
Cost minimisation analysis to compare the direct health service costs for the usual care group compared to the intervention group assessed by combining health service patient administration and cost records
Timepoint [6] 320350 0
On discharge and 1 month post discharge
Secondary outcome [7] 321556 0
Cost utility analysis will combine the health service cost data and quality of life utility index data (EQ-5D utility index) to report the incremental cost effectiveness ratio for the cost per quality adjusted life year
Timepoint [7] 321556 0
On discharge and 1 month post discharge
Secondary outcome [8] 321557 0
Cost effectiveness analysis will combine the health service cost data and functional status data (Functional Independence Measure) to report the incremental cost effectiveness ratio and will include the cost per 22 point change in Functional Independence Measure score to represent the cost for a minimal clinically important difference in function.
Timepoint [8] 321557 0
On discharge and 1 month post discharge

Eligibility
Key inclusion criteria
People will be invited to participate provided they meet the following inclusion criteria:-
a) Admitted as an inpatient to an Eastern Health hospital
b) Adults greater than or equal to 50 years of age because from 50 years of age risk of falling and incidence rates of hip fracture rise dramatically
c) Primary diagnosis of hip fracture as determined by the International Classification of Diseases, 10th edition codes S72.00 - S72.11
d) Living in a private residence in the community prior to the hip fracture
e) Not demonstrating risk factors at admission that would suggest a length of stay greater than 28 days (eg. Particularly complex social situation or extensive co-morbidities)
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are:
a) Admitted from a residential care facility because this population would not be expected to receive a home assessment visit
b) Patients who fracture their hip during an inpatient admission because this would not be a primary diagnosis
c) Assessed as having impaired cognition and do not have a carer or responsible person who can give informed consent
d) Planned to be discharged to a residential aged care facility because a home visit would not normally be considered as a component of the discharge plan for these patients
e) Living in a location more than 1 hour by car from the hospital because it would not be practical to complete a home assessment visit due to distance

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)
Sealed opaque envelopes will be prepared by an independent researcher with no role in recruitment or assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned using a permuted block design with a computer random number generator (www.randomization.com).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary dependent variable of falls frequency was used to determine sample size. Based on previous studies and setting power at 80% and alpha at 5%, a sample size of 37 is required in each group to detect a clinically significant difference of 32% reduction in falls frequency in the intervention group.

Falls as the primary outcome, will be examined in four ways: i) number of fallers, ii) number of multiple fallers, iii) falls rate and time to first fall, iv) relative risk (RR) will be calculated to compare number of fallers and number of multiple fallers between the two groups. The falls rate by use of negative binomial regression expressed as an incident rate ratio.

Between group differences of the other primary and secondary outcomes will be analysed with analysis of covariance of scores at 1 month and 6 months. The baseline scores will be used as the covariate. Intention to treat analysis will be performed for all participants in the study using all available data.

The cost minimisation analysis shall report a mean difference with confidence intervals. Within this analysis the health service cost data shall be modelled to reflect the actual occupational therapy resource utilisation during the original admission.

The cost effectiveness of an intervention is presented in the form of an incremental cost effectiveness ratio (ICER), which represents the cost-per-benefit of an intervention. An ICER is calculated by dividing the incremental cost of an intervention by the incremental benefit of the intervention. The uncertainty of the estimates will be calculated using the bootstrapping method. Results shall also be presented as a point estimate with confidence ellipses as well as a cost effectiveness acceptability curve to represent the willingness to pay for the change in quality of life or functional status.

Cost effectiveness shall also include the cost per quality adjusted life year (QALY) saved. QALYs combine information about length and quality of life to produce a generic measure of health outcome with quality of life measured by the EQ-5D. Cost effectiveness shall also include cost per 22 point change in the Functional Independence Measure (FIM) score to represent the cost for a minimal clinically important difference in function. The results shall also be presented as a point estimate with confidence ellipses as well as cost effectiveness acceptability curve to represent the willingness to pay for the change in QALY or functional status.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/03/2016
Actual
2/05/2016
Date of last participant enrolment
Anticipated
30/06/2017
Actual
8/12/2016
Date of last data collection
Anticipated
31/08/2017
Actual
16/08/2017
Sample size
Target
74
Accrual to date
Final
77
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5211 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 5212 0
Wantirna Health - Wantirna
Recruitment hospital [3] 5213 0
Maroondah Hospital - Ringwood East
Recruitment hospital [4] 5214 0
Peter James Centre - Forest Hill
Recruitment hospital [5] 5215 0
Angliss Hospital - Upper Ferntree Gully
Recruitment postcode(s) [1] 12680 0
3128 - Box Hill
Recruitment postcode(s) [2] 12681 0
3152 - Wantirna
Recruitment postcode(s) [3] 12682 0
3134 - Ringwood
Recruitment postcode(s) [4] 12683 0
3131 - Forest Hill
Recruitment postcode(s) [5] 12684 0
3156 - Ferntree Gully

Funding & Sponsors
Funding source category [1] 292795 0
Government body
Name [1] 292795 0
Eastern Health
Country [1] 292795 0
Australia
Funding source category [2] 292796 0
University
Name [2] 292796 0
La Trobe University
Country [2] 292796 0
Australia
Primary sponsor type
Individual
Name
Professor Nicholas Taylor
Address
Allied Health Clinical Research Office
Box Hill Hospital
5 Arnold Street, Box Hill, Victoria, 3128
Country
Australia
Secondary sponsor category [1] 291533 0
None
Name [1] 291533 0
Address [1] 291533 0
Country [1] 291533 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294290 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 294290 0
Ethics committee country [1] 294290 0
Australia
Date submitted for ethics approval [1] 294290 0
17/12/2015
Approval date [1] 294290 0
24/02/2016
Ethics approval number [1] 294290 0
E33-2015

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

Contacts
Principal investigator
Name 63142 0
Prof Nicholas Taylor
Address 63142 0
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora, Victoria, 3086
Country 63142 0
Australia
Phone 63142 0
+61394795860
Fax 63142 0
Email 63142 0
[email protected]
Contact person for public queries
Name 63143 0
Kylee Lockwood
Address 63143 0
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora, Victoria, 3086
Country 63143 0
Australia
Phone 63143 0
+61390952443
Fax 63143 0
Email 63143 0
[email protected]
Contact person for scientific queries
Name 63144 0
Kylee Lockwood
Address 63144 0
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora, Victoria, 3086
Country 63144 0
Australia
Phone 63144 0
+61390952443
Fax 63144 0
Email 63144 0
[email protected]

No information has been provided regarding IPD availability


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
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