Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000015347
Ethics application status
Approved
Date submitted
7/01/2008
Date registered
11/01/2008
Date last updated
8/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Multimedia patient education for preventing accidental falls amongst older hospital patients
Scientific title
Multimedia patient education versus usual care for preventing accidental falls amongst older hospital patients
Secondary ID [1] 280097 0
Nil
Universal Trial Number (UTN)
Nil known
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental Falls 2667 0
Condition category
Condition code
Injuries and Accidents 2788 2788 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in group one will watch a DVD and read a booklet which will educate patients on how to minimise falls risk in hospital. In addition, this group will receive their usual care. Patients in group two will also receive this intervention and in addition, will also receive further face to face personal education from a health professional. The health professionals will have discretion over the duration of each patient session - session lengths will range between 15 and 35 minutes. The total number of sessions provided through the content of the program is intended to be covered in 4 sessions and will vary between patients. The variability will range from 1 to 4 sessions. This is reflective of differences between and within individual patients' conditions such that on one day they may not feel well enough to have a session, or only be able to manage a short duration of discussion, but on other days may tolerate longer sessions. Up to three follow-up sessions will be provided in a week. Education sessions will occur during admission at a varied time according to a patient’s medical condition. Therefore patients will receive up to 4 sessions over their whole admission, but times of delivery and frequency of delivery will vary from patient to patient.
Intervention code [1] 2409 0
Prevention
Comparator / control treatment
Patients in the control group will receive their usual care. On the Orthopaedic Unit at Princess Alexandra Hospital (PAH) and on the Medical Ward at Swan Districts Hospital (SDH) this consists of 24 hour availability of nursing and medical care, daily physiotherapy, and referrals to other allied health professionals as required. On the Geriatric Assessment and Rehabilitation Unit (GARU) and Swan Districts Hospital Restorative Unit (SDH RU) there are also daily occupational therapy sessions, and social work assessment and management provided. At the Princess Alexandra Hospital (PAH) a local falls risk assessment tool that has not been validated is used and orange arm bands are provided to patients assessed as being at high risk for falls. A local falls risk screening tool is used by the nursing staff at Swan Districts Hospital (SDH) on patients' admissions and nursing staff are alerted to patients assessed as being at high risk for falls.
Control group
Active

Outcomes
Primary outcome [1] 3672 0
Accidental falls (event rate of falls measured in events per time units) as measured during the participants period of inpatient hospital care (the start of this observation period will be taken from the point of randomisation rather than the date of admission as it may take approximately 2 days to gain consent for participation, particularly where family members have to be approached).
Timepoint [1] 3672 0
From time of enrolment to discharge from hospital, In-hospital falls incidence will be gained from patient history review of notes by the Research Assistant (RA) on a weekly basis. This will include review of computerized hospital incident reports, and weekly follow-up questioning by the Research Assistant (RA). Where a patient has a Length of stay of less than one week questioning will occur before discharge.
Secondary outcome [1] 6203 0
Proportion of patients incurring one or more in-hospital falls (fallers incidence measured in person units). Rate of fall-related injury during the participants in-hospital rate of falls.
Timepoint [1] 6203 0
From time of enrolment to discharge from hospital In-hospital falls incidence will be gained from patient history review of notes by the RA on a weekly basis, computerized hospital incident reports, and from weekly follow-up questioning by RA. Where a patient has a Length of stay of less than one week questioning will occur before discharge.

Eligibility
Key inclusion criteria
Patients admitted to participating wards who are over 60 years old and able to participate voluntarily and provide signed informed consent or access to an appropriate family member/guardian or carer who can provide signed informed consent
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < than 60 years

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 participant will be approached for consent by a research assistant. Once consent is provided the baseline data will be collected. A separate research assistant / project investigator (blinded to baseline data) will then open a randomly ordered opaque envelope containing the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence will be developed by the project principal investigator using a computerised random number generator who will then produce the opaque sealed envelopes that contain the random allocation sequence. The project principal investigator will not be involved in participant recruitment or opening the opaque envelopes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1206
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 539 0
6055
Recruitment postcode(s) [2] 540 0
6056
Recruitment postcode(s) [3] 541 0
4102

Funding & Sponsors
Funding source category [1] 2931 0
Government body
Name [1] 2931 0
National Health and Medical Research Council
Country [1] 2931 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
c/o Faculty of Health Sciences
School of Health and Rehabilitation Sciences
The University of Queensland
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 2644 0
None
Name [1] 2644 0
Address [1] 2644 0
Country [1] 2644 0
Other collaborator category [1] 117 0
Individual
Name [1] 117 0
Professor Keith Hill
Address [1] 117 0
National Ageing Research Institute
PO Box 31
Parkville VIC 3052
Country [1] 117 0
Australia
Other collaborator category [2] 118 0
Individual
Name [2] 118 0
Associate Professor Kryss McKenna
Address [2] 118 0
c/o School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia QLD 4067
Country [2] 118 0
Australia
Other collaborator category [3] 119 0
Individual
Name [3] 119 0
Dr Sandra Brauer
Address [3] 119 0
c/o School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia QLD 4067
Country [3] 119 0
Australia
Other collaborator category [4] 120 0
Individual
Name [4] 120 0
Dr Tammy Hoffmann
Address [4] 120 0
c/o School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia QLD 4067
Country [4] 120 0
Australia
Other collaborator category [5] 121 0
Individual
Name [5] 121 0
Dr David Oliver
Address [5] 121 0
Senior Lecturer
Institute of Health Sciences
Reading UK
Ph: +44 (0) 118 378 6851
Country [5] 121 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4872 0
Medical Research Ethics Committee, University of Queensland
Ethics committee address [1] 4872 0
The University of Queensland
St Lucia QLD 4067
Ethics committee country [1] 4872 0
Australia
Date submitted for ethics approval [1] 4872 0
Approval date [1] 4872 0
15/11/2007
Ethics approval number [1] 4872 0
2007000148
Ethics committee name [2] 4873 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [2] 4873 0
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba QLD 4102
Ethics committee country [2] 4873 0
Australia
Date submitted for ethics approval [2] 4873 0
Approval date [2] 4873 0
Ethics approval number [2] 4873 0
Number 2006/173

Summary
Brief summary
The study aimed to investigate the efficacy of providing individual patient education with trained health professional follow up in addition to usual care compared with usual care alone in reducing inpatient falls among older hospital patients. The results showed that multimedia education with trained health professional follow up reduces falls in a sub group of older patients with intact cognition.
Trial website
Trial related presentations / publications
Haines TP, Hill AM, Hill KD, McPhail S, Oliver D, Brauer SG, Hoffmann T, Beer C: Patient education to prevent falls amongst older hospital inpatients: a randomized controlled trial. Arch Intern Med2011;171(6):516-524. doi:10.1001/archinternmed.2010.444
Public notes

Contacts
Principal investigator
Name 28269 0
Address 28269 0
Country 28269 0
Phone 28269 0
Fax 28269 0
Email 28269 0
Contact person for public queries
Name 11426 0
Associate Professsor Terry P. Haines
Address 11426 0
Director, Allied Health Research Unit, Southern Health Director of Research, Southern Physiotherapy Clinical School, Physiotherapy Department, Monash University, Victoria Australia
Country 11426 0
Australia
Phone 11426 0
+61 (0) 3 92651774
Fax 11426 0
+61 3 9265 1577
Email 11426 0
terrence.haines@med.monash.edu.au
Contact person for scientific queries
Name 2354 0
Dr Terry P. Haines
Address 2354 0
Director, Allied Health Research Unit, Southern Health Director of Research, Southern Physiotherapy Clinical School, Physiotherapy Department, Monash University, Victoria Australia
Country 2354 0
Australia
Phone 2354 0
+61 (0) 3 92651774
Fax 2354 0
+61 3 9265 1577
Email 2354 0
terrence.haines@med.monash.edu.au

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
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Documents added automatically
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