Trial from ANZCTR


Trial ID ACTRN12608000015347
Trial Status: Registered
Date Submitted: 7/01/2008
Date Registered: 11/01/2008
Prospectively registered

Page 1

Public title Multimedia patient education for preventing accidental falls amongst older hospital patients
Update:
 
Reason:
 
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Multimedia patient education versus usual care for preventing accidental falls amongst older hospital patients
Update:
 
Reason:
 
Secondary ID [1] 280097 0
Nil
Update:
 
Reason:
 
UTN Nil known
Update:
 
Reason:
 
Trial acronym
Update:
 

Page 2

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

Page 3

Descriptions 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.
Update:
 
Reason:
 
Intervention Code:
Prevention 2409 0
Update:
 
Reason:
 
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.
Update:
 
Reason:
 
Control group Active
Update:
 
Reason:
 

Page 4

Primary Outcome: 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). 3672 0
Update:
 
Reason:
 
Timepoint: 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. 3672 0
Update:
 
Reason:
 
Secondary Outcome: 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. 6203 0
Update:
 
Reason:
 
Timepoint: 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. 6203 0
Update:
 
Reason:
 

Page 5

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
Update:
 
Reason:
 
Minimum age 60 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Maximum age No limit
Update:
 
Reason:
 
Update:
 
Reason:
 
Gender Both males and females
Update:
 
Reason:
 
Healthy volunteers? No
Update:
 
Reason:
 
Key exclusion criteria Age < than 60 years
Update:
 
Reason:
 

Page 6

Study type Interventional
Update:
 
Reason:
 
Purpose of the study Treatment
Update:
 
Allocation to intervention Randomised controlled trial
Update:
 
Reason:
 
Describe the 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.
Update:
 
Reason:
 
Describe the 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.
Update:
 
Reason:
 
Masking / blinding Open (masking not used)
Update:
 
Reason:
 
Who is / are masked / blinded (choose all that apply)


Update:
       
Reason:
 
Assignment Parallel
Update:
 
Reason:
 
Other design features
Update:
 
Reason:
 
Type of endpoint(s) Safety
Update:
 
Reason:
 
Statistical Methods/Analysis
Update:
 
Reason:
 

Page 7

Phase Not Applicable
Update:
 
Reason:
 
Anticipated date of first participant enrolment 31/01/2008
Update:
 
Reason:
 
Date of first participant enrolment
Update:
 
Reason:
 
Anticipated date last participant recruited/enrolled
Update:
 
Reason:
 
Actual date last participant recruited/enrolled
Update:
 
Reason:
 
Target sample size 1206
Update:
 
Reason:
 
Recruitment status Closed: follow-up complete
Update:
 
Reason:
 

Recruitment in Australia

Recruitment state(s)
Update:
 
Reason:
 
Postcode: 6055 539 0
Update:
 
Reason:
 
Postcode: 6056 540 0
Update:
 
Reason:
 
Postcode: 4102 541 0
Update:
 
Reason:
 

Recruitment outside Australia

Page 8

Funding Source: Government body 2931 0
Update:
 
Reason:
 
Name: National Health and Medical Research Council 2931 0
Update:
 
Reason:
 
Address: National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
2931 0
Update:
 
Reason:
 
Country: Australia 2931 0
Update:
 
Reason:
 
Primary Sponsor University
Update:
 
Reason:
 
Name: University of Queensland
Update:
 
Reason:
 
Address: c/o Faculty of Health Sciences
School of Health and Rehabilitation Sciences
The University of Queensland
Brisbane QLD 4072
Update:
 
Reason:
 
Country: Australia
Update:
 
Reason:
 
Secondary Sponsor: None 2644 0
Update:
 
Reason:
 
Name: 2644 0
Update:
 
Reason:
 
Address: 2644 0
Update:
 
Reason:
 
Country: 2644 0
Update:
 
Reason:
 
Other Collaborator: Individual 117 0
Update:
 
Reason:
 
Name: Professor Keith Hill 117 0
Update:
 
Reason:
 
Address: National Ageing Research Institute
PO Box 31
Parkville VIC 3052
117 0
Update:
 
Reason:
 
Country: Australia 117 0
Update:
 
Reason:
 
Other Collaborator: Individual 118 0
Update:
 
Reason:
 
Name: Associate Professor Kryss McKenna 118 0
Update:
 
Reason:
 
Address: c/o School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia QLD 4067
118 0
Update:
 
Reason:
 
Country: Australia 118 0
Update:
 
Reason:
 
Other Collaborator: Individual 119 0
Update:
 
Reason:
 
Name: Dr Sandra Brauer 119 0
Update:
 
Reason:
 
Address: c/o School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia QLD 4067
119 0
Update:
 
Reason:
 
Country: Australia 119 0
Update:
 
Reason:
 
Other Collaborator: Individual 120 0
Update:
 
Reason:
 
Name: Dr Tammy Hoffmann 120 0
Update:
 
Reason:
 
Address: c/o School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia QLD 4067
120 0
Update:
 
Reason:
 
Country: Australia 120 0
Update:
 
Reason:
 
Other Collaborator: Individual 121 0
Update:
 
Reason:
 
Name: Dr David Oliver 121 0
Update:
 
Reason:
 
Address: Senior Lecturer
Institute of Health Sciences
Reading UK
Ph: +44 (0) 118 378 6851
121 0
Update:
 
Reason:
 
Country: United Kingdom 121 0
Update:
 
Reason:
 

Page 9

Has the study received approval from at least one Ethics Committee? Yes
Update:
 
Reason:
 
Ethics Committee name: Medical Research Ethics Committee, University of Queensland 4872 0
Update:
 
Reason:
 
Address: The University of Queensland
St Lucia QLD 4067
4872 0
Update:
 
Reason:
 
Country: Australia 4872 0
Update:
 
Reason:
 
Approval Date: 15/11/2007 4872 0
Update:
 
Reason:
 
Submitted Date: 4872 0
Update:
 
Reason:
 
HREC: 2007000148 4872 0
Update:
 
Reason:
 
Ethics Committee name: Princess Alexandra Hospital Human Research Ethics Committee 4873 0
Update:
 
Reason:
 
Address: Princess Alexandra Hospital
Ipswich Rd
Woolloongabba QLD 4102
4873 0
Update:
 
Reason:
 
Country: Australia 4873 0
Update:
 
Reason:
 
Approval Date: 4873 0
Update:
 
Reason:
 
Submitted Date: 4873 0
Update:
 
Reason:
 
HREC: Number 2006/173 4873 0
Update:
 
Reason:
 
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.
Update:
 
Reason:
 
Trial website
Update:
 
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
Update:
 
Public Notes
Update:
 

Page 10

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

Contact person for scientific queries
Title:
Update:
 
Reason:
 
2354 0
Name: Dr Terry P. Haines
Update:
 
Reason:
 
2354 0
Address: Director, Allied Health Research Unit, Southern Health Director of Research, Southern Physiotherapy Clinical School, Physiotherapy Department, Monash University, Victoria Australia
Update:
 
Reason:
 
2354 0
Country: Australia
Update:
 
2354 0
Reason:
 
Tel: +61 (0) 3 92651774
Update:
 
Reason:
 
2354 0
Fax: +61 3 9265 1577
Update:
 
Reason:
 
2354 0
Email: terrence.haines@med.monash.edu.au
Update:
 
Reason:
 
2354 0

Contact person responsible for updating information
Title:
Update:
 
Reason:
 
20498 0
Name: Anne-Marie Hill
Update:
 
Reason:
 
20498 0
Address: University Notre Dame Australia PO Box 1225 Fremantle WA 6959
Update:
 
Reason:
 
20498 0
Country: Australia
Update:
 
20498 0
Reason:
 
Tel: +61 8 94330239
Update:
 
Reason:
 
20498 0
Fax: +61 8 94330210
Update:
 
Reason:
 
20498 0
Email: anne-marie.hill@nd.edu.au
Update:
 
Reason:
 
20498 0
   

Addition Cancer fields
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason: