Trial Review

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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
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
Secondary ID [1] 286455 0
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 294636 0
Condition category
Condition code
Injuries and Accidents 294933 294933 0 0
Other injuries and accidents
Public Health 294934 294934 0 0
Health promotion/education
Public Health 295098 295098 0 0
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] 291536 0
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] 294691 0
Number of falls, self-reported by patients using daily fall calendar mailed on a monthly basis
Timepoint [1] 294691 0
Over 12 months of patient participation
Primary outcome [2] 294692 0
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] 294692 0
At baseline, and at 3 months and 12 months after intervention commencement
Secondary outcome [1] 313868 0
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] 313868 0
At 12 months after intervention commencement
Secondary outcome [2] 313869 0
Use of health and community services will be self-reported by patients on monthly calendar
Timepoint [2] 313869 0
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] 9405 0
2110 - Hunters Hill
Recruitment postcode(s) [2] 9406 0
2111 - Henley
Recruitment postcode(s) [3] 9407 0
2111 - Huntleys Cove
Recruitment postcode(s) [4] 9408 0
2111 - Gladesville
Recruitment postcode(s) [5] 9409 0
2110 - Woolwich
Recruitment postcode(s) [6] 9410 0
2112 - Ryde
Recruitment postcode(s) [7] 9411 0
2113 - North Ryde
Recruitment postcode(s) [8] 9412 0
2113 - East Ryde
Recruitment postcode(s) [9] 9413 0
2114 - West Ryde
Recruitment postcode(s) [10] 9414 0
2067 - Chatswood West
Recruitment postcode(s) [11] 9415 0
2114 - Denistone
Recruitment postcode(s) [12] 9416 0
2112 - Denistone East
Recruitment postcode(s) [13] 9417 0
2114 - Denistone West
Recruitment postcode(s) [14] 9418 0
2122 - Eastwood
Recruitment postcode(s) [15] 9419 0
2121 - Epping
Recruitment postcode(s) [16] 9420 0
2113 - Macquarie Park
Recruitment postcode(s) [17] 9421 0
2109 - Macquarie University
Recruitment postcode(s) [18] 9422 0
2122 - Marsfield
Recruitment postcode(s) [19] 9423 0
2114 - Meadowbank
Recruitment postcode(s) [20] 9424 0
2114 - Melrose Park
Recruitment postcode(s) [21] 9425 0
2112 - Putney
Recruitment postcode(s) [22] 9426 0
2111 - Tennyson Point
Recruitment postcode(s) [23] 9427 0
2159 - Arcadia
Recruitment postcode(s) [24] 9428 0
2077 - Asquith
Recruitment postcode(s) [25] 9429 0
2119 - Beecroft
Recruitment postcode(s) [26] 9430 0
2081 - Berowra
Recruitment postcode(s) [27] 9431 0
2082 - Berowra Heights
Recruitment postcode(s) [28] 9432 0
2082 - Berowra Waters
Recruitment postcode(s) [29] 9433 0
2083 - Brooklyn
Recruitment postcode(s) [30] 9434 0
2157 - Canoelands
Recruitment postcode(s) [31] 9435 0
2118 - Carlingford
Recruitment postcode(s) [32] 9436 0
2154 - Castle Hill
Recruitment postcode(s) [33] 9437 0
2119 - Cheltenham
Recruitment postcode(s) [34] 9438 0
2126 - Cherrybrook
Recruitment postcode(s) [35] 9439 0
2081 - Cowan
Recruitment postcode(s) [36] 9440 0
2083 - Dangar Island
Recruitment postcode(s) [37] 9441 0
2158 - Dural
Recruitment postcode(s) [38] 9442 0
2159 - Fiddletown
Recruitment postcode(s) [39] 9443 0
2157 - Forest Glen
Recruitment postcode(s) [40] 9444 0
2159 - Galston
Recruitment postcode(s) [41] 9445 0
2156 - Glenhaven
Recruitment postcode(s) [42] 9446 0
2157 - Glenorie
Recruitment postcode(s) [43] 9447 0
2077 - Hornsby
Recruitment postcode(s) [44] 9448 0
2077 - Hornsby Heights
Recruitment postcode(s) [45] 9449 0
2775 - Laughtondale
Recruitment postcode(s) [46] 9450 0
2756 - Maroota
Recruitment postcode(s) [47] 9451 0
2158 - Middle Dural
Recruitment postcode(s) [48] 9452 0
2079 - Mount Colah
Recruitment postcode(s) [49] 9453 0
2080 - Mount Kuring-Gai
Recruitment postcode(s) [50] 9454 0
2076 - Normanhurst
Recruitment postcode(s) [51] 9455 0
2121 - North Epping
Recruitment postcode(s) [52] 9456 0
2120 - Pennant Hills
Recruitment postcode(s) [53] 9457 0
2775 - Singletons Mill
Recruitment postcode(s) [54] 9458 0
2120 - Thornleigh
Recruitment postcode(s) [55] 9459 0
2076 - Wahroonga
Recruitment postcode(s) [56] 9460 0
2077 - Waitara
Recruitment postcode(s) [57] 9461 0
2125 - West Pennant Hills
Recruitment postcode(s) [58] 9462 0
2120 - Westleigh
Recruitment postcode(s) [59] 9463 0
2775 - Wisemans Ferry
Recruitment postcode(s) [60] 9464 0
2071 - East Killara
Recruitment postcode(s) [61] 9465 0
2070 - East Lindfield
Recruitment postcode(s) [62] 9466 0
2072 - Gordon
Recruitment postcode(s) [63] 9467 0
2071 - Killara
Recruitment postcode(s) [64] 9468 0
2070 - Lindfield
Recruitment postcode(s) [65] 9469 0
2069 - Roseville
Recruitment postcode(s) [66] 9470 0
2074 - South Turramurra
Recruitment postcode(s) [67] 9471 0
2073 - Pymble
Recruitment postcode(s) [68] 9472 0
2075 - St Ives
Recruitment postcode(s) [69] 9473 0
2075 - St Ives Chase
Recruitment postcode(s) [70] 9474 0
2074 - Turramurra
Recruitment postcode(s) [71] 9475 0
2074 - Warrawee
Recruitment postcode(s) [72] 9476 0
2070 - Lindfield West
Recruitment postcode(s) [73] 13255 0
2101 - Elanora Heights
Recruitment postcode(s) [74] 13256 0
2101 - Narrabeen
Recruitment postcode(s) [75] 13257 0
2084 - Terrey Hills
Recruitment postcode(s) [76] 13258 0
2088 - Mosman
Recruitment postcode(s) [77] 13259 0
2089 - Neutral Bay
Recruitment postcode(s) [78] 13260 0
2087 - Forestville
Recruitment postcode(s) [79] 13261 0
2086 - Frenchs Forest
Recruitment postcode(s) [80] 13262 0
2107 - Avalon
Recruitment postcode(s) [81] 13263 0
2106 - Newport
Recruitment postcode(s) [82] 13264 0
2103 - Mona Vale
Recruitment postcode(s) [83] 13265 0
2100 - Brookvale
Recruitment postcode(s) [84] 13266 0
2153 - Baulkham Hills
Recruitment postcode(s) [85] 13267 0
2151 - North Rocks
Recruitment postcode(s) [86] 13268 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 291023 0
Government body
Name [1] 291023 0
Australian Government National Health and Medical Research Council
Country [1] 291023 0
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] 289738 0
None
Name [1] 289738 0
Address [1] 289738 0
Country [1] 289738 0
Other collaborator category [1] 278426 0
Government body
Name [1] 278426 0
Sydney North Primary Health Network
Address [1] 278426 0
Building B, 207 Pacific Hwy, St Leonards NSW 2065
Country [1] 278426 0
Australia
Other collaborator category [2] 278427 0
Government body
Name [2] 278427 0
Clinical Excellence Commission (NSW Fall Prevention Program)
Address [2] 278427 0
Level 17, McKell Building. 2-24 Rawson Place, Sydney NSW 2000
Country [2] 278427 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292605 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 292605 0
Ethics committee country [1] 292605 0
Australia
Date submitted for ethics approval [1] 292605 0
Approval date [1] 292605 0
19/11/2014
Ethics approval number [1] 292605 0
2014/848

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 377 377 0 0
/AnzctrAttachments/368286-Medicare Local Newsletter Sept 2014 pg 9.pdf

Contacts
Principal investigator
Name 56202 0
Prof Lindy Clemson
Address 56202 0
Faculty of Health Sciences, Cumberland Campus, The University of Sydney, 75 East Street, Lidcombe NSW 2141.
Country 56202 0
Australia
Phone 56202 0
+61 2 9351 9372
Fax 56202 0
Email 56202 0
[email protected]
Contact person for public queries
Name 56203 0
Lindy Clemson
Address 56203 0
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 56203 0
Australia
Phone 56203 0
+61 2 93519372
Fax 56203 0
Email 56203 0
[email protected]
Contact person for scientific queries
Name 56204 0
Lindy Clemson
Address 56204 0
Faculty of Health Sciences, Cumberland Campus, The University of Sydney, 75 East Street, Lidcombe NSW 2141.
Country 56204 0
Australia
Phone 56204 0
+61 2 9351 9372
Fax 56204 0
Email 56204 0
[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
SourceTitleYear of PublicationDOI
EmbaseStrategies for recruitment in general practice settings: the iSOLVE fall prevention pragmatic cluster randomised controlled trial.2019https://dx.doi.org/10.1186/s12874-019-0869-7
N.B. These documents automatically identified may not have been verified by the study sponsor.