Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000336684
Ethics application status
Approved
Date submitted
21/03/2014
Date registered
27/03/2014
Date last updated
17/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
RESPOND—A patient-centred program to prevent secondary falls in older people presenting to the emergency department (ED) with a fall: Protocol for a multi-centre randomised controlled trial
Scientific title
A multi-centre randomised controlled trial to determine the effect of a patient-centred falls prevention program—RESPOND— compared to standard care on fall, fall injury and ED re-presentation rates in community dwelling people aged 60 to 90 years presenting to the ED with a fall
Secondary ID [1] 284302 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental falls 291451 0
Fall injuries 291452 0
Condition category
Condition code
Physical Medicine / Rehabilitation 291821 291821 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 291822 291822 0 0
Other injuries and accidents
Musculoskeletal 291823 291823 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be delivered by a RESPOND clinician who is a registered health professional. The RESPOND program incorporates: (1) home-based risk factor assessment; (2) education, coaching, goal setting and follow-up telephone support for management of one or more of four risk factors with evidence of effective interventions; and (3) healthcare provider communication and community linkage as summarised below.

(1) Home-based risk factor assessment
The RESPOND clinician will visit the participant at their home within two weeks of discharge from hospital to perform the risk assessment. At this visit, the RESPOND clinician will perform a falls risk factor assessment using the validated FROP-Com (Falls Risk for Older People in the Community) tool, a detailed falls risk assessment tool for use in the community setting.

(2) Education, coaching, goal setting and follow-up telephone support for management of one or more of four risk factors with evidence of effective interventions
The RESPOND program targets four risk factors with a robust evidence-base: poor balance and/or loss of strength; vision impairment; long-time use of benzodiazepines; and poor bone health. Risk factor education and management will be provided at the baseline home visit and follow-up telephone phone calls. It will be supported by provision of four education leaflets that have been developed specifically for the project and include simple information on risk factors and positive health messages relating to management options.

The RESPOND clinician will use motivational interviewing to assist in selection of risk factors for management. They will act as a ‘coach’ to support the participant to understand assessment findings, make guided decisions about how they will action recommendations and referrals, and to assist in tailoring care plans to address barriers identified. At the initial assessment the RESPOND clinician will support the participant to establish goals that target chosen risk factors. Risk factor goals will be mutually agreed and will be based on each participant’s individual risk factor profile, social factors and work/family commitments.

Many RESPOND participants will have already participated in some form of falls risk assessment and may have existing recommendations and referrals from ED staff or other clinicians. In this instance, RESPOND clinicians will not duplicate assessments or recommendations but instead aim to optimise participant’s knowledge and participation.

(3) Healthcare provider communication and community linkage
During the coaching sessions, the RESPOND clinician will encourage participants to discuss their action plan with their general practitioners, specialist physicians or other primary care providers involved in their care. The RESPOND clinician will refer (as appropriate) each participant to their chosen program/s and provide ongoing support and trouble shooting by telephone regarding access to these programs. A simple written report including the participants falls risk status as determine by the FROP-Com assessment (low, medium or high falls risk), goals and action plan will be sent to each participant’s GP following the baseline assessment. The RESPOND clinician will communicate similar information by letter to other healthcare providers participants are consulting for falls-related factors.

The patient–centred approach of RESPOND means the content, duration and frequency of the coaching sessions provided to each participant will be unique. However, in total RESPOND aims to provide an average of 10 hours coaching, of which 45 minutes delivered face-to-face at the first home visit and the remainder delivered by telephonefor each intervention participant. The clinician will provide an initial 45 minute face-to-face session, followed by a minimum of two 45 minute follow-up phone calls. The first follow-up phone call will be provided within two weeks of the intervention home visit being completed. The second follow-up phone call will be made within three months of the first intervention home visit. The RESPOND program intervention will be implemented over six months and participants followed up for a further six months.
Intervention code [1] 289026 0
Rehabilitation
Intervention code [2] 289068 0
Prevention
Comparator / control treatment
All study participants will undergo a falls risk assessment and be provided with a falls risk assessment summary. Control participants will receive standard care from all health professionals who are involved in their management within the ED and in the primary care setting during the 12-month follow up. No treatments will be withheld. Care in ED may consist of investigations and multi-disciplinary assessment within the ED, referral to other health professionals and services, and post-discharge telephone contact by a nurse. A letter detailing a summary of individual falls assessment and risk status will be provided to the control participant’s general practitioner following the baseline assessment. Where the participant indicates moderate or severe anxiety or depression on the EQ-5D, this will be flagged in the GP letter.
Control group
Active

Outcomes
Primary outcome [1] 291741 0
Rate of falls per person-year in the 12 month follow-up. Falls will be recorded on the participants’ monthly falls calendar and verified by a monthly telephone follow-up.
Timepoint [1] 291741 0
6 and 12 months post ED presentation
Primary outcome [2] 291742 0
Rate of fall injuries per person-year in the 12 month follow-up. Fall injuries will be recorded on the participants’ monthly falls calendar and verified by a monthly telephone follow-up.
Timepoint [2] 291742 0
6 and 12 months post ED presentation
Secondary outcome [1] 307378 0
Rate of ED re-presentations per person-year in the 12 month follow-up. ED re-presentations will be recorded on the participants’ monthly falls calendar and verified by a monthly telephone follow-up and audit of hospital administrative data.
Timepoint [1] 307378 0
At 6 and 12 months post ED presentation
Secondary outcome [2] 307380 0
Rate of hospital admissions per person-year in the 12 month follow-up. Hospital admissions will be recorded on participant calendar and verified by a monthly telephone follow-up and audit of hospital administrative data.
Timepoint [2] 307380 0
At 6 and 12 months post ED presentation
Secondary outcome [3] 307381 0
Rate of fractures per person-year in the 12 month follow-up. Fractures are required to be confirmed by radiological investigation and will be recorded on the participants’ monthly falls calendar and verified by a monthly telephone follow-up and hospital administrative data were available (not all fractures are expected to result in hospitalisation).
Timepoint [3] 307381 0
At 6 and 12 months post ED presentation
Secondary outcome [4] 307382 0
Change in falls risk status assessed by the FROP-COM assessment
Timepoint [4] 307382 0
At baseline, and at 6 and 12 months post ED presentation
Secondary outcome [5] 307383 0
Change in Falls Efficacy as assessed by Falls Efficacy Scale International
Timepoint [5] 307383 0
At baseline, and at 6 and 12 months post ED presentation
Secondary outcome [6] 307384 0
Change in health-related quality of life assessed using the EQ-5D questionnaire
Timepoint [6] 307384 0
At baseline, and at 6 and 12 months post ED presentation

Eligibility
Key inclusion criteria
Community-dwelling persons, aged 60 to 90 years who present to the Royal Perth and Alfred Hospital EDs with a fall, and who are planned to be discharged directly home from the hospital within 72 hours, will be recruited.
Minimum age
60 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be excluded if they: live further than 50 kilometres from the study site, are to be discharged to high-level residential aged-care, require palliative care or have a terminal illness, require hands-on assistance to walk, are unable to use a telephone, need an interpreter, have cognitive impairment (MMSE<23), display social aggression or have a history of psychoses.

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)
Enrolment
Electronic records will be screened daily by research staff in the ED to identify potential participants based on age, living status (home as opposed to residential aged care), presenting diagnosis and distance of home from the hospital. Medical records of persons over 60 years of age who have presented to ED with a fall will then be viewed to determine those who meet the inclusion criteria of planned discharge home within 72 hours. Once medical record screening has been completed potential participants will be approached and verbal consent sought to conduct verbal screening. During the interaction the research staff member will determine whether the individual requires an interpreter, is able to use the telephone, has a hearing impairment or requires physical assistance from another person to be mobile. Cognitive ability will be determined by the Mini Mental State Examination scores applying a cut-off score of <23. Potential participants who have a physical impairment or injury that limits upper limb function will have the MMSE score adjusted as per the tool handbook.
Eligible participants at this stage will be provided with an overview of the study. Interested potential participants will be given further written information about the study burden, and requested to provide written consent to participate.

Treatment Allocation
Enrolled participants will be randomly assigned into one of the two groups, intervention (RESPOND) or control (usual care), using a web-based randomisation service. Research staff will not be involved in setting up the randomisation sequence and will be unaware of the next group allocation at the time that they request a participant’s group assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stata statistical software will be used by the study statistician to generate the randomisation sequence. Permuted block randomisation stratified by site will be used to ensure equal numbers across groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
Outcome analyses will be undertaken on an intention-to-treat basis by a statistician blinded to group allocation. Differences in falls, fall injuries and ED re-presentation rates will be compared between groups using negative binomial regression including a variable for adjustment by site. A significance level of p< 0.05 will be used for all analyses. The multifactorial design (participants will choose different risk factors and strategies) means it is not possible to discern the effects of any single intervention on the primary outcomes.

This reduction in fall injuries is considered clinically significant.

Outcome analyses will be undertaken on an intention-to-treat basis by a statistician blinded to group allocation. Differences in falls, fall injuries and ED re-presentation rates will be compared between groups using negative binomial regression including a variable for adjustment by site. A significance level of p< 0.05 will be used for all analyses. The multifactorial design (participants will choose different risk factors and strategies) means it is not possible to discern the effects of any single intervention on the primary outcomes.

Reference: Russell MA, Hill KD, Day LM, Blackberry I, Schwartz J, Giummarra MJ, et al. A randomized controlled trial of a multifactorial falls prevention intervention for older fallers presenting to emergency departments. J Am Geriatr Soc. 2010 Dec;58(12):2265-74.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2014
Actual
31/03/2014
Date of last participant enrolment
Anticipated
31/03/2015
Actual
30/06/2015
Date of last data collection
Anticipated
Actual
31/07/2016
Sample size
Target
528
Accrual to date
Final
543
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment hospital [1] 2211 0
The Alfred - Prahran
Recruitment hospital [2] 2212 0
Royal Perth Hospital - Perth

Funding & Sponsors
Funding source category [1] 288936 0
Government body
Name [1] 288936 0
The Australian National Health and Medical Research Council
Country [1] 288936 0
Australia
Funding source category [2] 288937 0
Government body
Name [2] 288937 0
Health Networks Branch, Department of Health, WA
Country [2] 288937 0
Australia
Funding source category [3] 288938 0
Government body
Name [3] 288938 0
Aged and Continuing Care Directorate, Department of Health, WA
Country [3] 288938 0
Australia
Funding source category [4] 288939 0
University
Name [4] 288939 0
Curtin University
Country [4] 288939 0
Australia
Funding source category [5] 288940 0
Government body
Name [5] 288940 0
Injury Control Council of Western Australia (ICCWA)
Country [5] 288940 0
Australia
Funding source category [6] 288941 0
Hospital
Name [6] 288941 0
Royal Perth Hospital
Country [6] 288941 0
Australia
Funding source category [7] 288942 0
Other Collaborative groups
Name [7] 288942 0
The George Institute for Global Health
Country [7] 288942 0
Australia
Funding source category [8] 288943 0
Hospital
Name [8] 288943 0
The Alfred Hospital
Country [8] 288943 0
Australia
Funding source category [9] 288944 0
University
Name [9] 288944 0
Monash University
Country [9] 288944 0
Australia
Funding source category [10] 288945 0
Charities/Societies/Foundations
Name [10] 288945 0
The Royal Perth Hospital Medical Research Foundation
Country [10] 288945 0
Australia
Funding source category [11] 288946 0
Other Collaborative groups
Name [11] 288946 0
Centre for Clinical Research in Emergency Medicine
Country [11] 288946 0
Australia
Primary sponsor type
University
Name
The Falls and Bone Health Team, Health Services Research Unit, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University
Address
The Alfred Centre, Level 6, 99 Commercial Road,
Melbourne, VIC 3004
Country
Australia
Secondary sponsor category [1] 287624 0
None
Name [1] 287624 0
Address [1] 287624 0
Country [1] 287624 0
Other collaborator category [1] 277885 0
Government body
Name [1] 277885 0
Health Networks Branch, Department of Health, WA
Address [1] 277885 0
Second Floor, C Block, 189 Royal Street, East Perth WA 6004
Country [1] 277885 0
Australia
Other collaborator category [2] 277886 0
Government body
Name [2] 277886 0
Aged and Continuing Care Directorate, Department of Health, WA
Address [2] 277886 0
189 Royal Street, East Perth WA 6004
Country [2] 277886 0
Australia
Other collaborator category [3] 277887 0
University
Name [3] 277887 0
Curtin University
Address [3] 277887 0
Kent Street, Bentley WA 6102
Country [3] 277887 0
Australia
Other collaborator category [4] 277888 0
Government body
Name [4] 277888 0
Injury Control Council of Western Australia (ICCWA)
Address [4] 277888 0
2 Delhi Street, West Perth WA 6005
Country [4] 277888 0
Australia
Other collaborator category [5] 277889 0
Hospital
Name [5] 277889 0
Royal Perth Hospital
Address [5] 277889 0
197 Wellington Street Perth WA 6000
Country [5] 277889 0
Australia
Other collaborator category [6] 277890 0
Other Collaborative groups
Name [6] 277890 0
The George Institute for Global Health
Address [6] 277890 0
Level 13, 321 Kent Street, Sydney NSW 2000
Country [6] 277890 0
Australia
Other collaborator category [7] 277891 0
Hospital
Name [7] 277891 0
The Alfred Hospital
Address [7] 277891 0
55 Commercial Road, Melbourne VIC 3004
Country [7] 277891 0
Australia
Other collaborator category [8] 277892 0
University
Name [8] 277892 0
Monash University
Address [8] 277892 0
DEPM, Level 6, The Alfred Centre, 99 Commercial Road, Melbourne VIC 3004
Country [8] 277892 0
Australia
Other collaborator category [9] 277893 0
Charities/Societies/Foundations
Name [9] 277893 0
The Royal Perth Hospital Medical Research Foundation
Address [9] 277893 0
197 Wellington St Perth WA 6000
Country [9] 277893 0
Australia
Other collaborator category [10] 277894 0
Other Collaborative groups
Name [10] 277894 0
Centre for Clinical Research in Emergency Medicine
Address [10] 277894 0
Department of Emergency Medicine, Royal Perth Hospital, GPO Box X2213, Perth WA 6001
Country [10] 277894 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290759 0
The Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 290759 0
Ethics committee country [1] 290759 0
Australia
Date submitted for ethics approval [1] 290759 0
Approval date [1] 290759 0
29/10/2013
Ethics approval number [1] 290759 0
32/12 for project 439/13
Ethics committee name [2] 290760 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [2] 290760 0
Ethics committee country [2] 290760 0
Australia
Date submitted for ethics approval [2] 290760 0
Approval date [2] 290760 0
01/11/2013
Ethics approval number [2] 290760 0
13-128
Ethics committee name [3] 290761 0
Monash University Human Research Ethics Committee
Ethics committee address [3] 290761 0
Ethics committee country [3] 290761 0
Australia
Date submitted for ethics approval [3] 290761 0
Approval date [3] 290761 0
07/01/2014
Ethics approval number [3] 290761 0
CF13/3869 - 2012001975

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47114 0
A/Prof Anna Barker
Address 47114 0
Monash University, The Alfred Centre
DEPM, Level 6, 99 Commercial Road
Melbourne VIC 3004
Country 47114 0
Australia
Phone 47114 0
+61 39903 0946
Fax 47114 0
+61 3 9903 0556
Email 47114 0
[email protected]
Contact person for public queries
Name 47115 0
Darshini Ayton
Address 47115 0
Monash University, The Alfred Centre
DEPM, Level 6, 99 Commercial Road
Melbourne VIC 3004
Country 47115 0
Australia
Phone 47115 0
+61 399031660
Fax 47115 0
+61 3 9903 0556
Email 47115 0
[email protected]
Contact person for scientific queries
Name 47116 0
Anna Barker
Address 47116 0
Monash University, The Alfred Centre
DEPM, Level 6, 99 Commercial Road
Melbourne VIC 3004
Country 47116 0
Australia
Phone 47116 0
+61 39903 0946
Fax 47116 0
+61 3 9903 0556
Email 47116 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
EmbaseRESPOND--A patient-centred programme to prevent secondary falls in older people presenting to the emergency department with a fall: protocol for a multicentre randomised controlled trial.2015https://dx.doi.org/10.1136/injuryprev-2014-041271
EmbaseRESPOND: a patient-centred programme to prevent secondary falls in older people presenting to the emergency department with a fall-protocol for a mixed methods programme evaluation.2016https://dx.doi.org/10.1136/injuryprev-2014-041453
Dimensions AIMeasurement properties of the Health Literacy Questionnaire (HLQ) among older adults who present to the emergency department after a fall: a Rasch analysis2017https://doi.org/10.1186/s12913-017-2520-9
EmbaseEvaluation of RESPOND, a patient-centred program to prevent falls in older people presenting to the emergency department with a fall: A randomised controlled trial.2019https://dx.doi.org/10.1371/journal.pmed.1002807
N.B. These documents automatically identified may not have been verified by the study sponsor.