Trial registered on ANZCTR


Trial ID
ACTRN12611000503921
Ethics application status
Approved
Date submitted
19/04/2011
Date registered
13/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fit to be Left at Home - An alternate model of care to safely assess, intervene and prevent future falls and fall related injury in older people who are not transported to hospital after calling an ambulance as a result of a fall.
Scientific title
Fit to be Left at Home - An alternate model of care to safely assess, intervene and prevent future falls and fall related injury in older people who are not conveyed to hospital after calling an ambulance as a result of a fall.
Secondary ID [1] 259771 0
Nil
Universal Trial Number (UTN)
U1111-1119-8974
Trial acronym
iPREFER
Intervention to PREvent Falls after Emergency Response
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls in older adults 261352 0
Fall related injury in older adults 261353 0
Condition category
Condition code
Injuries and Accidents 259511 259511 0 0
Other injuries and accidents
Public Health 266008 266008 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will be assessed for risk factors for falls and fractures. This will include medical and medication history, falls and fracture history, cognitive (GPCog) and physical function (IADL) and an objective measure of falls risk – QuickScreen. Physical activity will be measured using the IPAQ and the home environment will be assessed using the Homefast assessment scale. Quality of Life will be measured using the EQ5D and affect using the GDS-15. The anticipated duration of the initial assessment is approximately 60 minutes. At the end of the assessment, the researcher will generate a list of risk factors identified and written suggestions as to how they might be addressed using a template and capacity for free text to individualise some advice.
The intervention group will then receive falls prevention strategies based on risk factors identified. The clinical researcher will pro-actively work with the older person to ensure that risk factors are addressed and interventions carried out.
Exercise in the form of strength and balance training will be recommended and it is anticipated that the majority of the intervention group will be offered this intervention. This will be in the form of the Otago Exercise Program and delivered by the PACS service physiotherapist. Participants will also be referred on to local evidence-based exercise programs (not all delivered through health care) to ensure that they continue exercising on completion of the Otago Exercise Program.
Issues related to safety in the home environment will be referred to the PACS Occupational Therapist.
People with poor vision (and no recent visual assessment) will be referred to their usual eye-care provider or a local optometrist.
Participants taking medications known to increase falls risk will be referred to their GP and encouraged to discuss the ongoing need for these medications. A Home Medication Review will also be encouraged particularly where there is evidence of impaired cognition or any reported difficulties taking medications. A template will be designed to minimise any additional work for GPs. PACS nurses will ensure that appropriate changes are followed through and assist in any issues arising regarding medication
For complex patients with multiple problems, a referral to the POW falls clinic or POW aged care clinics will be organised. Again, a template will be designed to aid with the referral process and minimise additional work for the local GP.
Participants from the intervention group will be asked to fill out an Attitudes to Falls-Related Interventions Scale, to possibly identify and then address the specific concerns raised by particular individuals.
Participants will be reassessed after 6 months using a shorted version of the initial assessment tool. Assessment is estimated to take about 30-45 minutes. Reassessment will be completed by a researcher blinded to group allocation and will be conducted at the participants home. Further, participants will be followed up using monthly calendars and reply paid envelopes for a period of 12 months. Information will be collected with respect to falls, fall related injury, subsequent use of the ambulance service or hospital system and any visits to health care providers in the community. The monthly falls calenders are a single page questionnaire with only 2 questions. Participants are asked to fill it out either after using health care services or after having a fall, or at the end of the month if the participant did not fall. This process is estimated to take no more than 5 minutes.
Intervention code [1] 264205 0
Early detection / Screening
Intervention code [2] 264206 0
Prevention
Comparator / control treatment
The control group will receive standard ambulance care and will additionally be assessed for risk factors for falls and fractures. This will include medical and medication history, falls and fracture history, cognitive (GPCog) and physical function (IADL) and an objective measure of falls risk – QuickScreen. Physical activity will be measured using the IPAQ and the home environment will be assessed using the Homefast assessment scale. Quality of Life will be measured using the EQ5D and affect using the GDS-15. The anticipated duration of the initial assessment is approximately 60 minutes. At the end of the assessment, the researcher will generate a list of risk factors identified and written suggestions as to how they might be addressed using a template and capacity for free text to individualise some advice.
The control group will then receive a written copy of the risk factors identified during the baseline assessment. They will be encouraged to discuss the results with their local GP or other relevant health care provider.
Participants will be reassessed after 6 months using a shorted version of the initial assessment tool. Assessment is estimated to take about 30-45 minutes. Reassessment will be completed by a researcher blinded to group allocation and conducted at the participants home. Further, participants will be followed up using monthly calendars and reply paid envelopes for a period of 12 months. Information will be collected with respect to falls, fall related injury, subsequent use of the ambulance service or hospital system and any visits to health care providers in the community. The monthly falls calenders are a single page questionnaire with only 2 questions. Participants are asked to fill it out either after using health care services or after having a fall, or at the end of the month if the participant did not fall. This process is estimated to take no more than 5 minutes.
Control group
Active

Outcomes
Primary outcome [1] 262315 0
Number of falls in a 12 month follow up period (measured using falls calendar data)
Timepoint [1] 262315 0
monthly for 12 months for every participant
Primary outcome [2] 262316 0
Number of fall related injuries in the 12 month follow up period, measured using falls calendar data on which participants are asked to record any falls including any injuries suffered. Further patient's health care service use will be recorded and retrieved using the Centre for Health Record Linkage, to which patients consent to at baseline.
Timepoint [2] 262316 0
monthly for 12 months for every participant
Secondary outcome [1] 273518 0
Number of falls requiring ED attendance and/or hospitalisation (measured using calendar data and corroborated with NSW Centre for Health Record Linkage (CHeReL) data)
Timepoint [1] 273518 0
Within 12 months follow-up period for each participant
Secondary outcome [2] 273519 0
Use of NSW Ambulance Service including time on scene (routinely collected Ambulance Service data)
Timepoint [2] 273519 0
Within 12 months follow-up period for each participant
Secondary outcome [3] 273520 0
Any ED presentation or hospitalisation including DRG and LOS data (measured using calendar data and corroborated with CHeReL data)
Timepoint [3] 273520 0
Within 12 months follow-up period for each participant
Secondary outcome [4] 273521 0
Use of community services, GP visits, HMRs, ACAT referrals, use of PACS services, specialists visits (measured using monthly calendar data)
Timepoint [4] 273521 0
Within 12 months follow-up period for each participant
Secondary outcome [5] 273522 0
Uptake and adherence to recommendations, measured by a questionnaire with a three point scale which asks whether participants have followed recommendations completely, partially or not a all, for each individual recommendation listed following the baseline assessment.
Timepoint [5] 273522 0
At Baseline and 6 months assessment
Secondary outcome [6] 273523 0
Quality of Life at baseline and follow-up measured using the EQ5D
Timepoint [6] 273523 0
At Baseline, 6 and 12 months
Secondary outcome [7] 273524 0
Cost savings in regards to falls prevented, 000 call avoided, ED presentation avoided, hospital admission avoided, Quality adjusted life years gained. Cost savings are assessed from an institution's (hospital, the general health system etc) perspective
Timepoint [7] 273524 0
Assessed at 6 and 12 months for entire study duration
Secondary outcome [8] 273525 0
Specific health service costs associated with this approach and cost savings due to health outcome improvements through implementing this approach. Cost savings are assessed from an institution's (hospital, the general health system etc) perspective
Timepoint [8] 273525 0
After 12 month study participation or until lost to follow-up.

Eligibility
Key inclusion criteria
Elderly fallers, aged 65+
Attended to by ambulance service due to a fall
Not conveyed to hospital
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with cognitive impairment who do not have a regular carer because of the issue of consent and accurate recall of fall events
Participants with limited English language skills, who have no carer to translate for the duration of the study, which would prevent them from giving informed consent, complete assessments and understand instructions if in the intervention group.

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)
Randomisation will occur after the baseline assessment has been undertaken but whilst the researcher is with the participant. Group allocation will be concealed from all study investigators and staff using consecutively numbered sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be achieved using computer generated random numbers and randomly permuted block sizes. The single centralised randomisation schedule will be developed by a colleague with no involvement in the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy

Recruitment
Anticipated date of first participant enrolment
6/04/2011
Actual date of first participant enrolment
7/04/2011
Anticipated date last participant enrolled
30/04/2014
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
234
Actual sample size
Recruitment status
Recruiting
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3867 0
2031
Recruitment postcode(s) [2] 3868 0
2035
Recruitment postcode(s) [3] 3869 0
2026
Recruitment postcode(s) [4] 3870 0
2020

Funding & Sponsors
Funding source category [1] 264702 0
Government body
Name [1] 264702 0
NSW Health Promotion Demonstration Research Grants Scheme 2010/2011 HP10/09
Address [1] 264702 0
NSW Health Department
Strategic Research and Development Branch
Centre for Health Advancement NSW Health
Locked Mail Bag 961
North Sydney
NSW 2059
Country [1] 264702 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Jacqueline Close
Address
Neuroscience Research Australia
Barker Street, Randwick, NSW 2031
Country
Australia
Secondary sponsor category [1] 263834 0
None
Name [1] 263834 0
Address [1] 263834 0
Country [1] 263834 0
Other collaborator category [1] 251881 0
Individual
Name [1] 251881 0
Professor Stephen Lord
Address [1] 251881 0
Neuroscience Research Australia
Barker Street, Randwick, NSW 2031
Country [1] 251881 0
Australia
Other collaborator category [2] 251882 0
Individual
Name [2] 251882 0
Dr Jason Bendall
Address [2] 251882 0
Ambulance Research Institute, Ambulance Service of NSW.
Level 1, Building 127 Church Street, Lilyfield
Rozelle, NSW, 2039
Country [2] 251882 0
Australia
Other collaborator category [3] 251883 0
Individual
Name [3] 251883 0
Dr Anne Tiedemann
Address [3] 251883 0
The George Institute for International Health
Level 7, 341 George Street
Sydney NSW 2000
Country [3] 251883 0
Australia
Other collaborator category [4] 251884 0
Individual
Name [4] 251884 0
Professor Gideon Caplan
Address [4] 251884 0
Prince of Wales Hospital
High Street, Randwick NSW 2031
Country [4] 251884 0
Australia
Other collaborator category [5] 251885 0
Individual
Name [5] 251885 0
Dr Kirsten Howard
Address [5] 251885 0
University of Sydney
Edward Ford Building, A27
Camperdown, NSW 2006
Country [5] 251885 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266697 0
Royal Prince Alfred Hospital Ethics Review Committee
Ethics committee address [1] 266697 0
Research Development Office Level 3, Building 92 Royal Prince Alfred Hospital Missenden Road CAMPERDOWN NSW 2050
Ethics committee country [1] 266697 0
Australia
Date submitted for ethics approval [1] 266697 0
16/11/2010
Approval date [1] 266697 0
11/02/2011
Ethics approval number [1] 266697 0
HREC/10/RPAH/616

Summary
Brief summary
In 2008-2009 the Ambulance Service of NSW responded to 672,000 emergency incidents. For the same period, “falls” was the reported problem to triple zero operators in almost 90,000 cases with those 65+ comprising 58% of all fallers. The non-conveyance rate for older fallers is 23% however little is known about the outcomes for these people. Work undertaken in the UK reported similar rates of non-conveyance and also demonstrated that 47% of older people not conveyed following a fall are re-attended by the Ambulance Service within two weeks.
This study proposes to test the hypothesis that: rapid, timely and tailored intervention in older people who are not conveyed to hospital following a fall will lead to a significant reduction in future falls, fall related injury and unplanned use of emergency and acute hospital services.
A randomised controlled trial design (n=234) will be used to test the impact of rapid access to a comprehensive assessment and intervention program. The study population will consist of people aged 65+ years who live in Randwick, Botany or Waverly, are attended by an ambulance as a result of a fall and who are considered to be appropriate to be left at home. Follow-up telephone contact will be made with all non-conveyed fallers initially to establish that there has been no acute deterioration in their health or level of function following their fall. Consenting patients will undergo a baseline assessment in their home within 72hrs of initial attendance and be provided with a written report with regard to falls risk factors identified.
Intervention: The intervention group will receive falls prevention strategies based on the risk factors identified. The clinical researcher will pro-actively work with the older person to ensure that risk factors are addressed and interventions carried out. This will involve close liaison with the local Post Acute Care Service who will be part of delivering interventions including an evidence based exercise program and home safety assessment.
Follow-up: Both the control and intervention groups will be followed up using monthly calendars and reply paid envelopes for a period of 6 months. Information will be collected with respect to falls, fall related injury, subsequent use of the ambulance service or hospital system and any visits to health care providers in the community. At the end of the six months, all participants will be reassessed by a researcher blinded to group allocation.
Outcomes: The primary outcome measure will be the number of fallers and falls in the 6 month follow up period (measured using falls calendar data)
Additional secondary outcome measures include: Number of falls requiring ED attendance and/or hospitalisation measured using calendar data and corroborated with NSW Centre for Health Record Linkage (CHeReL) data), Use of NSW Ambulance Service including time on scene (routinely collected Ambulance Service data) and re-attendance rates, Any ED presentation or hospitalisation including DRG and LOS data (measured using calendar data and corroborated with CHeReL data), Use of community services – GP visits, HMRs, ACAT referrals, use of PACS services etc (measured using monthly calendar data), Uptake and adherence to recommendations (based on initial and final assessments), Quality of Life at baseline and follow-up measured using the EQ5D
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 32335 0
A/Prof Jacqueline Close
Address 32335 0
Neuroscience Research Australia,
Barker Street
Randwick NSW
2031
Country 32335 0
Australia
Phone 32335 0
+61 2 9399 1055
Fax 32335 0
Email 32335 0
j.close@neura.edu.au
Contact person for public queries
Name 15582 0
A/Prof Associate Professor Jacqueline Close
Address 15582 0
Neuroscience Research Australia
Barker Street, Randwick NSW 2031
Country 15582 0
Australia
Phone 15582 0
+61 2 9399 1055
Fax 15582 0
+61293991204
Email 15582 0
j.close@neura.edu.au
Contact person for scientific queries
Name 6510 0
A/Prof Associate Professor Jacqueline Close
Address 6510 0
Neuroscience Research Australia
Barker Street, Randwick NSW 2031
Country 6510 0
Australia
Phone 6510 0
+61 2 9399 1055
Fax 6510 0
+61 2 93991204
Email 6510 0
j.close@neura.edu.au