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Trial registered on ANZCTR

Registration number

ACTRN12615000401550

Ethics application status

Approved

Date submitted

8/04/2015

Date registered

29/04/2015

Date last updated

18/07/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

A cluster randomised controlled trial to evaluate the effectiveness of an integrated general practice fall prevention process compared with usual care on GP practice change and the rate of falls in older people residing in the community

Scientific title

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

iSOLVE (Integrated Solutions for Sustainable Fall Prevention)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Falls in community-dwelling older people

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Public Health

Health promotion/education

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

1) An algorithm/decision tool is used to facilitate GPs in identifying, assessing and managing patients at risk of falling who are presenting to GP practices. To facilitate integration of the iSOLVE algorithm, face-to-face, one-hour academic detailing will be offered to GPs involved. Further, an electronic clinical decision support tool will be offered to GP practices involved. This electronic tool is developed as part of the iSOLVE project to integrate the processes into general practice systems and software to facilitate workflow.

The decision making tool is adapted from STEADi, a primary care resource for fall prevention developed by the Centres for Disease Control in the United States, using the American Geriatrics Society’s Clinical Practice Guidelines, and has been updated using the Cochrane Database on community fall prevention.

2) Identifying older people: People aged 65 years and over who have had a fall will be identified through auditing GP practice database for patients’ over 65 years and presentation to GP practice for an appointment.

3) Fall risk identification: The patients will be invited to complete the ‘Stay Independent’ brochure in the GP practice waiting room prior to their GP appointment. This will provide an initial screening of risk factors to alert the GP.

4) Fall risk assessment: Patients who have identified a risk factor as per the ‘Stay Independent’ brochure will have the risk factor assessed by a GP.

5) Fall risk management: The GP will tailor a management plan based on the patient’s risk factor by referring to the algorithm, clinical decision tool and referral pathway developed as part of the iSOLVE project. Depending on the algorithm this may trigger further assessment by the GP such as a medication review or hypotension or dizziness. The GP will initiate an appropriate referral, based on the algorithm, to local fall prevention services for example exercise professional for prescription of strength and balance exercise, occupational therapist for home safety intervention, pharmacy medication reviews, Stepping On fall prevention programs or cataract surgery. GPs are encouraged to follow up on subsequent usual visits or addition visits if needed at the discretion of the GP. The GPs will tailor the duration of each consultation as appropriate for the GP and the patient.

At the end of 12 months, the patients will be asked what fall prevention activities (e.g. exercise, home safety adaptations, medication review, cataract extraction) have been recommended by their GP and have been undertaken by them.

6) As part of the wider project, the iSOLVE team will engage with fall prevention service providers within the Northern Sydney Medicare Local (NSML) catchment area (study area) to facilitate referral pathways with GP practices. Education workshops will also be offered to fall prevention service providers in the study area.

Intervention code [1]

Prevention

Comparator / control treatment

Usual general practice care: The control group will not be provided with education or information about falls prevention or with any of the iSOLVE decision tools.

Control group

Active

Outcomes

Primary outcome [1]

Number of falls, self-reported by patients using daily fall calendar mailed on a monthly basis

Timepoint [1]

Over 12 months of patient participation

Primary outcome [2]

Change in fall prevention management by GPs as assessed by survey completed by GPs. The survey has been designed specifically for this study and has undergone pilot testing for readability and relevance.

Timepoint [2]

At baseline, and at 3 months and 12 months after intervention commencement

Secondary outcome [1]

Proportion of participants with improved medication management in patients as measured by type, number, dose and patient’s understanding of medications using a validated deprescribing questionnaire (PATD)

Timepoint [1]

At 12 months after intervention commencement

Secondary outcome [2]

Use of health and community services will be self-reported by patients on monthly calendar

Timepoint [2]

Over 12 months of patient participation

Eligibility

Key inclusion criteria

For older people: 65 years or older, having a fall in the past year or worried about falling, and residing in the community.

For GPs: currently practising in the North Sydney Medicare Local area

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

For older people:
Unable to understand study information or complete the falls surveillance forms
Has an unstable medical condition
Moderate to severe dementia (measured by the Short Portable Mental Status Questionnaire)

For GPs:
Not currently practising or practising outside the NSML area.

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)

Recruitment of GP practices:

GP practices servicing patients 65 years and older will be recruited in collaboration with the Northern Sydney Medicare Local (NSML). NSML will email or mail the study flyer to GPs inviting them to participate in the project. The study information will also be provided through NSML newsletters, practice networks and forums conducted within the NSML catchment area.
GP practices will be randomised to either the intervention or control arm once recruitment procedures are completed and informed consent is provided. This will be achieved using opaque concealed envelopes. The project manager will inform the GP practice if they are in the control or intervention group. The research assistant recruiting patients in the practice and collecting all follow up data for the study will be blinded to GP practice group allocation.
GPs and GP practice staff will not be involved in patient recruitment. They will also be blinded to which of their patients are enrolled into the study.

Recruitment of patients within participating GP practices:

Two recruitment methods will be employed:
1) Mailouts: Lists of patients aged 65 years and over from each participating GP practice will be generated using case record software if available at the participating GP practices. Letters will be sent out by the GP practice inviting participation until 20 patients per practice consent to participate. The same letter will be used for intervention and control arm to maintain blinded recruitment.
2) Waiting room: Potential participants will also be identified when they attend the participating GP practices and provided with a flyer about the project. The blinded research assistant will approach and recruit potential patients in GP practice waiting room.

The blinded research assistant will complete recruitment procedures with the patients (e.g. patient information, informed consent and explanation of trial procedure). Next, the project manager will be informed of patient recruitment and will contact the patient to inform the patient of group allocation according to randomisation at GP practice level.

The project manager will request for patients not to reveal their participation in the study to their GPs or staff at the GP practice to ensure GP practices are blinded from patient allocation. This is intended to minimise bias in health care provision by the GPs and GP practice staff as the GPs will be asked to administer the intervention to all their older patients aged 65 years and over as appropriate (note, this trial is a translational project and the intent is that they will adopt the process as usual care). However, this does not blind the GP to being in the intervention arm.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

An independent statistician not involved in recruiting the GP practices will generate the randomisation sequence using a pre-determined block design.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Multilevel models will be used for all analyses to account for the cluster randomisation. The number of falls per person-year will be analysed using negative binomial regression models to estimate the difference in rates between the groups after one year (primary outcome). All analyses will be pre-planned, conducted while masked to group allocation and will use an intention-to-treat approach. Survey analysis will include frequency and descriptive statistics.

Sample size estimate to achieve primary outcome 1 (number of falls). This cluster randomised trial of 28 GP practices will have 80% power to detect as significant at the 2-sided 5% level a 15% between group difference in the proportion of subjects falling, from 50% in the control group to 35% in the intervention group (30% relative reduction). We have assumed 50% will fall in the control group, based on previous trials. A reduction to 35% is feasible, as a reduction of this size was found in previous meta-analysis.[1] Assuming a cluster size of 20 participants per GP practice, an intra-cluster correlation coefficient (ICC=0.01) and a 15% loss of participants we require 26 clusters with a total of 520 patients. In all, 28 GP practices (560 participants) will be recruited to allow for possible loss during the 12-month follow-up.

1. Robertson MC, Campbell AJ, Gardner MM, Devlin N. Preventing injuries in older people by preventing falls: a meta-analysis of individual-level data. Journal of the American Geriatrics Society 2002;50(5):905-11.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/05/2015

Actual

25/06/2015

Date of last participant enrolment

Anticipated

31/12/2016

Actual

1/02/2017

Date of last data collection

Anticipated

31/05/2018

Actual

26/06/2018

Sample size

Target

560

Accrual to date

Final

560

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2110 - Hunters Hill

Recruitment postcode(s) [2]

2111 - Henley

Recruitment postcode(s) [3]

2111 - Huntleys Cove

Recruitment postcode(s) [4]

2111 - Gladesville

Recruitment postcode(s) [5]

2110 - Woolwich

Recruitment postcode(s) [6]

2112 - Ryde

Recruitment postcode(s) [7]

2113 - North Ryde

Recruitment postcode(s) [8]

2113 - East Ryde

Recruitment postcode(s) [9]

2114 - West Ryde

Recruitment postcode(s) [10]

2067 - Chatswood West

Recruitment postcode(s) [11]

2114 - Denistone

Recruitment postcode(s) [12]

2112 - Denistone East

Recruitment postcode(s) [13]

2114 - Denistone West

Recruitment postcode(s) [14]

2122 - Eastwood

Recruitment postcode(s) [15]

2121 - Epping

Recruitment postcode(s) [16]

2113 - Macquarie Park

Recruitment postcode(s) [17]

2109 - Macquarie University

Recruitment postcode(s) [18]

2122 - Marsfield

Recruitment postcode(s) [19]

2114 - Meadowbank

Recruitment postcode(s) [20]

2114 - Melrose Park

Recruitment postcode(s) [21]

2112 - Putney

Recruitment postcode(s) [22]

2111 - Tennyson Point

Recruitment postcode(s) [23]

2159 - Arcadia

Recruitment postcode(s) [24]

2077 - Asquith

Recruitment postcode(s) [25]

2119 - Beecroft

Recruitment postcode(s) [26]

2081 - Berowra

Recruitment postcode(s) [27]

2082 - Berowra Heights

Recruitment postcode(s) [28]

2082 - Berowra Waters

Recruitment postcode(s) [29]

2083 - Brooklyn

Recruitment postcode(s) [30]

2157 - Canoelands

Recruitment postcode(s) [31]

2118 - Carlingford

Recruitment postcode(s) [32]

2154 - Castle Hill

Recruitment postcode(s) [33]

2119 - Cheltenham

Recruitment postcode(s) [34]

2126 - Cherrybrook

Recruitment postcode(s) [35]

2081 - Cowan

Recruitment postcode(s) [36]

2083 - Dangar Island

Recruitment postcode(s) [37]

2158 - Dural

Recruitment postcode(s) [38]

2159 - Fiddletown

Recruitment postcode(s) [39]

2157 - Forest Glen

Recruitment postcode(s) [40]

2159 - Galston

Recruitment postcode(s) [41]

2156 - Glenhaven

Recruitment postcode(s) [42]

2157 - Glenorie

Recruitment postcode(s) [43]

2077 - Hornsby

Recruitment postcode(s) [44]

2077 - Hornsby Heights

Recruitment postcode(s) [45]

2775 - Laughtondale

Recruitment postcode(s) [46]

2756 - Maroota

Recruitment postcode(s) [47]

2158 - Middle Dural

Recruitment postcode(s) [48]

2079 - Mount Colah

Recruitment postcode(s) [49]

2080 - Mount Kuring-Gai

Recruitment postcode(s) [50]

2076 - Normanhurst

Recruitment postcode(s) [51]

2121 - North Epping

Recruitment postcode(s) [52]

2120 - Pennant Hills

Recruitment postcode(s) [53]

2775 - Singletons Mill

Recruitment postcode(s) [54]

2120 - Thornleigh

Recruitment postcode(s) [55]

2076 - Wahroonga

Recruitment postcode(s) [56]

2077 - Waitara

Recruitment postcode(s) [57]

2125 - West Pennant Hills

Recruitment postcode(s) [58]

2120 - Westleigh

Recruitment postcode(s) [59]

2775 - Wisemans Ferry

Recruitment postcode(s) [60]

2071 - East Killara

Recruitment postcode(s) [61]

2070 - East Lindfield

Recruitment postcode(s) [62]

2072 - Gordon

Recruitment postcode(s) [63]

2071 - Killara

Recruitment postcode(s) [64]

2070 - Lindfield

Recruitment postcode(s) [65]

2069 - Roseville

Recruitment postcode(s) [66]

2074 - South Turramurra

Recruitment postcode(s) [67]

2073 - Pymble

Recruitment postcode(s) [68]

2075 - St Ives

Recruitment postcode(s) [69]

2075 - St Ives Chase

Recruitment postcode(s) [70]

2074 - Turramurra

Recruitment postcode(s) [71]

2074 - Warrawee

Recruitment postcode(s) [72]

2070 - Lindfield West

Recruitment postcode(s) [73]

2101 - Elanora Heights

Recruitment postcode(s) [74]

2101 - Narrabeen

Recruitment postcode(s) [75]

2084 - Terrey Hills

Recruitment postcode(s) [76]

2088 - Mosman

Recruitment postcode(s) [77]

2089 - Neutral Bay

Recruitment postcode(s) [78]

2087 - Forestville

Recruitment postcode(s) [79]

2086 - Frenchs Forest

Recruitment postcode(s) [80]

2107 - Avalon

Recruitment postcode(s) [81]

2106 - Newport

Recruitment postcode(s) [82]

2103 - Mona Vale

Recruitment postcode(s) [83]

2100 - Brookvale

Recruitment postcode(s) [84]

2153 - Baulkham Hills

Recruitment postcode(s) [85]

2151 - North Rocks

Recruitment postcode(s) [86]

2148 - Blacktown

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government National Health and Medical Research Council

Address [1]

Location: 16 Marcus Clarke Street, Canberra City ACT 2600
Postal: GPO Box 1421, Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney, Faculty of Health Sciences

Address

Location: 75 East Street, Lidcombe, NSW 2141
Postal: PO Box 170, Lidcombe NSW 1825

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Government body

Name [1]

Sydney North Primary Health Network

Address [1]

Building B, 207 Pacific Hwy, St Leonards NSW 2065

Country [1]

Australia

Other collaborator category [2]

Government body

Name [2]

Clinical Excellence Commission (NSW Fall Prevention Program)

Address [2]

Level 17, McKell Building. 2-24 Rawson Place, Sydney NSW 2000

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Research Integrity, Research Portfolio, Level 6, Jane Foss Russell, The University of Sydney, NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

19/11/2014

Ethics approval number [1]

2014/848

Summary

Brief summary

Researchers in allied health and primary care are partnering with Northern Sydney Medicare Local and the NSW State Falls Program (Clinical Excellence Commission) to establish a multi-disciplinary pathway model for fall prevention. The aim is to establish integrated processes and pathways at the levels of practitioner, practice, and program to identify older people at risk of falls and engage a whole of primary care approach to fall prevention.  

Few older people are asked by their general practitioner (GP) about falls or are offered interventions to prevent falls. For those that do, few base their falls prevention practice on recognised clinical guidelines. Primary care physicians report a number of barriers including time and educational materials. A major problem for evidence uptake is that studies which test fall interventions provided within a research context have much better outcomes than trials reflecting usual practice which rely on referral to usual health care providers. Studies have consistently shown that referral alone is not effective.  This is because in reality few community-based organisations regularly offer evidence-based falls prevention services.
We aim to form collaborative, information rich, working arrangements with GPs and allied health service providers. Our model aims to: improve access to appropriate fall prevention interventions for older people, ensure ongoing knowledge acquisition and sustainable action by healthcare professionals and organisations, using a multidisciplinary team approach to fall prevention that is integrated and translatable nationally.  

This cluster randomised trial is part of a hybrid translational project. The trial will evaluate if the intervention can change GP referral and management practices for falls prevention and if this will result in reducing falls for their older patients.

Trial website

http://sydneynorthhealthnetwork.org.au/partnerships/isolve-project/

Trial related presentations / publications

4) Lovarini M, Clemson L, Tiedemann A, Tan A. Achieving practice change in fall prevention: the iSOLVE project. Oral presentation given at the 26th National Conference and Exhibition of Occupational Therapy Australia; 2015 July 1-3; Melbourne, Australia. Journal citation for abstract: (2015), Oral presentations – Wednesday 1st July 2015. Australian Occupational Therapy Journal, 62: 34–67. doi: 10.1111/1440-1630.12212

5) Mackenzie L, Clemson L, Tan A. Preventing falls in the community by engaging with general practitioners in evidence-based falls prevention screening, assessment and interventions: the iSOLVE project. Oral presentation given at the International Association of Gerontology and Geriatrics Congress; 2015 October 19-22; Chiang Mai, Thailand. 

6) Clemson L, Mackenzie L, Roberts C, Lovarini M, Willis K, Poulos R, Sherrington C, Tan A, Peiris D, Pit S, Tiedemann A, Lam M, Pond D, Simpson J, Stanton C, Sfiligoi D, Lovitt L, White F. Establishing pathways to implement evidence-based fall prevention in primary care: iSOLVE. Poster presentation at the 4th NHMRC Symposium on Research Translation; 2015 October 27-28; Sydney, Australia. 

7) Clemson L, Mackenzie L, Roberts C, Poulos R, Tan A, Tran N, Sherrington C, Lovarini M, Tiedemann A, Pit S, Willis K, Lam M, Pond D, Peiris D. The iSOLVE project, establishing pathways to implement and sustain evidence based fall prevention in primary care: Developing decision tools and primary care resources. Oral presentation given at the National Primary Health Care Conference; 2015 November 2-4; Canberra, Australia.

8) Clemson L, Mackenzie L, Roberts C, Poulos R, Tan A, Tran N, Sherrington C, Lovarini M, Tiedemann A, Pit S, Willis K, Lam M, Pond D, Peiris D. The iSOLVE project, establishing pathways to implement and sustain evidence based fall prevention in primary care: Developing decision tools and primary care resources. Oral presentation given at the Gerontological Society of America Annual Scientific Meeting; 2015 November 18-22; Orlando, United States.

Public notes

None

Attachments [1]

/AnzctrAttachments/368286-Medicare Local Newsletter Sept 2014 pg 9.pdf

Contacts

Principal investigator

Name

Prof Lindy Clemson

Address

Faculty of Health Sciences, Cumberland Campus, The University of Sydney, 75 East Street, Lidcombe NSW 2141.

Country

Australia

Phone

+61 2 9351 9372

Fax

[email protected]

Contact person for public queries

Name

Lindy Clemson

Address

Location: Faculty of Health Sciences, Cumberland Campus, The University of Sydney, 75 East Street, Lidcombe NSW 2141.

Postal: The University of Sydney, Faculty of Health Sciences, PO Box 170, Lidcombe NSW 1825

Country

Australia

Phone

+61 2 93519372

Fax

[email protected]

Contact person for scientific queries

Name

Lindy Clemson

Address

Faculty of Health Sciences, Cumberland Campus, The University of Sydney, 75 East Street, Lidcombe NSW 2141.

Country

Australia

Phone

+61 2 9351 9372

Fax

[email protected]

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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Strategies for recruitment in general practice settings: the iSOLVE fall prevention pragmatic cluster randomised controlled trial.	2019	https://dx.doi.org/10.1186/s12874-019-0869-7

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

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