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Trial registered on ANZCTR


Registration number
ACTRN12611000615987
Ethics application status
Approved
Date submitted
15/06/2011
Date registered
16/06/2011
Date last updated
7/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Transition from hospital to home: Effectiveness of an occupational therapy home visit discharge planning program for at-risk older adults
Scientific title
Occupational therapy home visit discharge planning compared to in-hospital consultation to improve functional independence in older adults: a randomised trial
Secondary ID [1] 260046 0
Not applicable
Secondary ID [2] 262388 0
Universal Trial Number (UTN)
Not applicable.
Trial acronym
HOME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Discharge planning by Occupational Therapists for older adults 265708 0
Condition category
Condition code
Public Health 265847 265847 0 0
Health service research
Physical Medicine / Rehabilitation 268237 268237 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants' randomised into the intervention group will meet with an occupational therapist in hospital to begin discharge planning. Session one will be completed in hospital taking approximately 60minutes. The OT will conduct a pre-discharge home visit (approximately five days prior to discharge) and families will be included where possible. The pre-discharge home visit is expected to take between 60-90minutes. At the pre-discharge home visit, the Occupational Therapist will collaboratively review the needs of the participant to safely return home by reviewing home environment and the participant's ability to carry out day to day activities. During the post discharge (which will occur up to a week post discharge, taking around 60-90minutes) home visit the Occupational Therapist will focus on improving participant's ability to manage at home and increasing independence. Two follow up calls will be conducted (at two weeks and four weeks after the post-discharge home visit) used to reinforce strategies, and identify and resolve challenges (these follow up calls are expected to last around 15 minutes).
Intervention code [1] 264463 0
Treatment: Other
Intervention code [2] 264475 0
Rehabilitation
Comparator / control treatment
The control group will receive an in-hospital consultation, conducted by an occupational therapist, which will facilitate discharge planning. The therapist will discuss the participant’s home environment and review their ability to carry out activities. All discharge planning will be facilitated from hospital.
Control group
Active

Outcomes
Primary outcome [1] 266627 0
Functional independence levels will be measured using the Nottingham Extended Activities of Daily Living (NEADL) scale (Nouri & Lincoln, 1987).
Timepoint [1] 266627 0
The primary outcome measure will be collected at baseline and primary end point of three months post intervention.
Primary outcome [2] 266635 0
Return to usual living post-discharge will be measured by a standardised self-report instrument, the Late Life Disability Index (LLDI).
Timepoint [2] 266635 0
The primary outcome measure will be collected at baseline and primary end point of three months post intervention.
Secondary outcome [1] 276114 0
Anxiety and concern about falling during the performance of a range of activities of daily living will be assessed using the International Falls Efficacy Scale (FES-I).
Timepoint [1] 276114 0
Collected at baseline and three months post intervention.
Secondary outcome [2] 276115 0
Physical activity will be assessed by (i) a question Do you get out of the house as often as you like? used successfully in a recent trial and, (ii) the physical activity sub-scale of the SF-36.
Timepoint [2] 276115 0
The outcome measure will be collected at baseline and primary end point of 3 months post intervention.
Secondary outcome [3] 276116 0
Falls and readmissions will be recorded. Participants will record on each day if they fall or not on a monthly self-report falls surveillance calendar. They will then mail the calendar at the end of each month. Readmissions to hospital and length of stay will be collected via data linkage and self report.
Timepoint [3] 276116 0
Participants readmissions and length of stay will be recorded at discharge from hospital until 4 months post discharge.
Secondary outcome [4] 276117 0
Patients independent functioning health state will be valued using the NEADL scale, and quality adjusted life years (QALYs), the latter derived from the SF-12V2.
Timepoint [4] 276117 0
NEADL and SF-12V2 collected at baseline and three months post intervention.
Secondary outcome [5] 276118 0
The main costs of treatment (per patient) will include the HOME intervention, equipment and support services used, subsequent hospital stays and use of other health (GP) and community services.
Timepoint [5] 276118 0
Start of HOME intervention until three months post intervention.
Secondary outcome [6] 276132 0
Health related quality of life will be measured by the Physical and Mental Health component scores of the SF-12V2 Health Status measure.
Timepoint [6] 276132 0
3 months post intervention.

Eligibility
Key inclusion criteria
People admitted to a participating ward who are expected to return to a community dwelling, have conversational English skills, absence of a significant cognitive impairment, and absence of severe co-morbid disease.
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if their mobility status has changed as a result of the event causing hospitalisation and thus now require supervision, assistance or there is a need for a wheelchair to mobilise. Participants will also be excluded if there was a known comprehensive occupational therapy home assessment in the last 6 months.

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)
The research assistant screens for inclusion criteria. If the person satisfies the criteria, the research assistant completes baseline assessment then will randomise the client using an online secure website. The participant and treating occupational therapist will then be notified of group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be stratified by site. At each site, participants will be stratified by age, (70-79, 80+). This will enable approximately equal numbers of these sub-populations to be assigned to each treatment (Portney & Watkins, 2009). A concealed randomisation sequence will also be used.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264954 0
Government body
Name [1] 264954 0
National Health and Medical Research Council
Address [1] 264954 0
Director, Research Administration Section
National Health and Medical Research Council
GPO Box 1421
CANBERRA ACT 2601
Country [1] 264954 0
Australia
Primary sponsor type
Individual
Name
Lindy Clemson
Address
The University of Sydney
PO BOX 170
LIDCOMBE NSW 1825
Country
Australia
Secondary sponsor category [1] 264050 0
None
Name [1] 264050 0
Address [1] 264050 0
Country [1] 264050 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266914 0
Ryde Rehabilitation Ethics Committe
Ethics committee address [1] 266914 0
Royal Rehabilitation Human Research Ethics Committee
PO BOX 6
RYDE NSW 1680
Ethics committee country [1] 266914 0
Australia
Date submitted for ethics approval [1] 266914 0
Approval date [1] 266914 0
30/06/2010
Ethics approval number [1] 266914 0
HREC/09/RRCS/07
Ethics committee name [2] 269135 0
Human Research Ethics Commitee, Western Sydney Local Health Network
Ethics committee address [2] 269135 0
Research Office, Room 1072, LEvel 1, Education Block
Westmead Hospital, Hawkesbury Road, Westmead NSW 2145
Ethics committee country [2] 269135 0
Australia
Date submitted for ethics approval [2] 269135 0
Approval date [2] 269135 0
05/05/2011
Ethics approval number [2] 269135 0
HREC2011/4/4.7(3317) AU RED HREC/11/WMEAD/93
Ethics committee name [3] 290781 0
Alfred Health Ethics Committee
Ethics committee address [3] 290781 0
Ground Floor, Linay Pavilion
The Alfred Hospital
55 Commerical Road
MELBOURNE VICTORIA 3004
Ethics committee country [3] 290781 0
Australia
Date submitted for ethics approval [3] 290781 0
Approval date [3] 290781 0
23/12/2011
Ethics approval number [3] 290781 0
512/11

Summary
Brief summary
The National Health and Medical Research Council (NHMRC) funded clinical trial will assess the effect of occupational therapy discharge planning for older adults on functional independence. The intervention will consist of in-hospital rapport building and discharge planning, a pre-discharge home visit, post discharge home visit and two follow up phone calls all completed by the same occupational therapist. 400 participants will be recruited from three hospital sites. Primary outcomes are functional independence and reintegration to normal living. Secondary outcomes include falls, physical acticity, health related quality of life, readmission rates and length of stay and self effciacy in every tasks. Cost effectiveness analysis of the program will also be undertaken.
Trial website
Trial related presentations / publications
Lannin, N. A., Clemson, L., McCluskey, A., Cameron, I., & Barras, S. (2007). Feasibility and results of a randomised pilot-study of pre-discharge occupational therapy home visits. BMC Health Services Research, 7(42).
Public notes

Contacts
Principal investigator
Name 32524 0
Prof Lindy Clemson
Address 32524 0
Ageing Work and Health Research Unit, University of Sydney
PO Box 170 LIDCOMBE NSW 1824
Country 32524 0
Australia
Phone 32524 0
+ 61 2 9351 9372
Fax 32524 0
Email 32524 0
lindy.clemson@sydney.edu.au
Contact person for public queries
Name 15771 0
Prof Lindy Clemson
Address 15771 0
University of Sydney
Faculty of Health Sciences, Ageing, Work and Health Unit
PO BOX 170
Lidcombe NSW 1825
Country 15771 0
Australia
Phone 15771 0
+61 2 9351 9372
Fax 15771 0
+61 2 93519672
Email 15771 0
lindy.clemson@sydney.edu.au
Contact person for scientific queries
Name 6699 0
Prof A/Prof Lindy Clemson
Address 6699 0
University of Sydney
Faculty of Health Sciences, Ageing, Work and Health Unit
PO BOX 170
LIDCOMBE NSW 1825
Country 6699 0
Australia
Phone 6699 0
+61 2 93519372
Fax 6699 0
+61 2 93519672
Email 6699 0
lindy.clemson@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary