ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000503921

Ethics application status

Approved

Date submitted

19/04/2011

Date registered

13/05/2011

Date last updated

11/03/2014

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]

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

Fall related injury in older adults

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Public Health

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]

Early detection / Screening

Intervention code [2]

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]

Number of falls in a 12 month follow up period (measured using falls calendar data)

Timepoint [1]

monthly for 12 months for every participant

Primary outcome [2]

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]

monthly for 12 months for every participant

Secondary outcome [1]

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]

Within 12 months follow-up period for each participant

Secondary outcome [2]

Use of NSW Ambulance Service including time on scene (routinely collected Ambulance Service data)

Timepoint [2]

Within 12 months follow-up period for each participant

Secondary outcome [3]

Any ED presentation or hospitalisation including DRG and LOS data (measured using calendar data and corroborated with CHeReL data)

Timepoint [3]

Within 12 months follow-up period for each participant

Secondary outcome [4]

Use of community services, GP visits, HMRs, ACAT referrals, use of PACS services, specialists visits (measured using monthly calendar data)

Timepoint [4]

Within 12 months follow-up period for each participant

Secondary outcome [5]

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]

At Baseline and 6 months assessment

Secondary outcome [6]

Quality of Life at baseline and follow-up measured using the EQ5D

Timepoint [6]

At Baseline, 6 and 12 months

Secondary outcome [7]

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]

Assessed at 6 and 12 months for entire study duration

Secondary outcome [8]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

6/04/2011

Actual

7/04/2011

Date of last participant enrolment

Anticipated

30/04/2014

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

234

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

2031

Recruitment postcode(s) [2]

2035

Recruitment postcode(s) [3]

2026

Recruitment postcode(s) [4]

2020

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NSW Health Promotion Demonstration Research Grants Scheme 2010/2011 HP10/09

Address [1]

NSW Health Department
Strategic Research and Development Branch
Centre for Health Advancement NSW Health
Locked Mail Bag 961
North Sydney
NSW 2059

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Professor Stephen Lord

Address [1]

Neuroscience Research Australia
Barker Street, Randwick, NSW 2031

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Dr Jason Bendall

Address [2]

Ambulance Research Institute, Ambulance Service of NSW.
Level 1, Building 127 Church Street, Lilyfield
Rozelle, NSW, 2039

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Dr Anne Tiedemann

Address [3]

The George Institute for International Health
Level 7, 341 George Street
Sydney NSW 2000

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Professor Gideon Caplan

Address [4]

Prince of Wales Hospital
High Street, Randwick NSW 2031

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

Dr Kirsten Howard

Address [5]

University of Sydney
Edward Ford Building, A27
Camperdown, NSW 2006

Country [5]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Prince Alfred Hospital Ethics Review Committee

Ethics committee address [1]

Research Development Office Level 3, Building 92 Royal Prince Alfred Hospital Missenden Road CAMPERDOWN NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/11/2010

Approval date [1]

11/02/2011

Ethics approval number [1]

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

A/Prof Jacqueline Close

Address

Neuroscience Research Australia,
Barker Street
Randwick NSW
2031

Country

Australia

Phone

+61 2 9399 1055

Fax

j.close@neura.edu.au

Contact person for public queries

Name

Associate Professor Jacqueline Close

Address

Neuroscience Research Australia
Barker Street, Randwick NSW 2031

Country

Australia

Phone

+61 2 9399 1055

Fax

+61293991204

j.close@neura.edu.au

Contact person for scientific queries

Name

Associate Professor Jacqueline Close

Address

Neuroscience Research Australia
Barker Street, Randwick NSW 2031

Country

Australia

Phone

+61 2 9399 1055

Fax

+61 2 93991204

j.close@neura.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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		https://academic.oup.com/ageing/article/46/2/200/2... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Intervention to prevent further falls in older people who call an ambulance as a result of a fall: a protocol for the iPREFER randomised controlled trial.	2013
Embase	A multidisciplinary intervention to prevent subsequent falls and health service use following fall-related paramedic care: A randomised controlled trial.	2017	https://dx.doi.org/10.1093/ageing/afw190
Embase	Linking health service utilisation and mortality data - unravelling what happens after fall-related paramedic care.	2022	https://dx.doi.org/10.1093/ageing/afab254

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically