Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001222437
Ethics application status
Approved
Date submitted
25/08/2016
Date registered
5/09/2016
Date last updated
5/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Risk screening in the emergency department and educating older people of future falls.
Scientific title
Assessing the efficacy of a short screening instrument in predicting future falls and the effectiveness of falls education of older people in an emergency department.
Secondary ID [1] 289933 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 299911 0
Condition category
Condition code
Injuries and Accidents 299809 299809 0 0
Fractures
Physical Medicine / Rehabilitation 299810 299810 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves determining the efficacy of the Two Item Falls Risk Screening Tool and the Falls Risk for Older People in the Community (FROP Com) Screen and is a prospective single centre clinical trial of scripted falls risk education compared with usual treatment.

On presenting to the Emergency Department (ED) all older persons over 65 years will be seen by the Care Coordination Team (Occupational Therapists and Physiotherapists) for assessment. This will include the two item screening tool and FROP Com Screen (plus intervention to determine their appropriateness to be discharged home.) The medical history and physical assessment data would be obtained. Information collected would include demographic factors, medical conditions, medications and pre-morbid functional status.

On agreement to go into the trial the older person would be placed into either the control group or intervention group. The control group will receive usual practice i.e. review of individual falls risk factors, provision of a falls information pack and referral to outpatient and community services. The Intervention group will receive usual practice plus additional feedback on their future risk of falling as per the results of the two item screening tool and a scripted falls prevention education message. The treating Occupational Therapist or Physiotherapist will administer this message verbally in the ED at bedside. It will take approximately 10 minutes.

Both the Control and Intervention groups will be further divided into people presenting to ED with falls and those with a non fall diagnosis.

This intervention will be provided face-to-face, on a one off basis in the Emergency Department. It consists of administration of feedback on the participants future risk of falling (as per the Two Item Screening Tool Results) and the scripted falls prevention message. The Two Item Screening Tool provides a single score out of 3 indicating a participants future risk of falling.

The scripted falls prevention education message highlights the serious nature of falls, consequences of falls and that falls can be reduced or prevented. It encourages participants to take action to decrease their risk of future falls.
Intervention code [1] 295727 0
Early detection / Screening
Intervention code [2] 295728 0
Prevention
Comparator / control treatment
The Control group will receive usual practice involving standard intervention to assist with safe discharge home. If an older person presents with a fall the usual practice and standard intervention involves completion of a FROP Com, review of individual falls risk factors, provision of a falls information pack and referral to outpatient and community services.
Control group
Active

Outcomes
Primary outcome [1] 299410 0
Proportion of participants who experience a fall within the following 6 months post discharge. This will be assessed via monthly participant phone calls completed by an Occupational Therapist and will rely on participant self report.
Timepoint [1] 299410 0
6 months post index admission
Secondary outcome [1] 327088 0
Number of falls. This will be assessed via monthly participant phone calls completed by an Occupational Therapist and will rely on participant self report.
Timepoint [1] 327088 0
6 months post index admission
Secondary outcome [2] 327089 0
Deaths
Timepoint [2] 327089 0
6 months post index admission
Secondary outcome [3] 327090 0
Physical Status via modified FIM FAM measured in the Emergency Department and at 6 months by an Occupational Therapist or Physiotherapist.
Timepoint [3] 327090 0
In the Emergency Department and at 6 months post index admission
Secondary outcome [4] 327091 0
Hospital readmissions via participant self report in the monthly post discharge phone calls for the 6 month follow up period and confirmed via hospital computer records.
Timepoint [4] 327091 0
6 months post index admission
Secondary outcome [5] 327092 0
Emergency Department Presentations via participant self report in the monthly post discharge phone calls for the 6 month follow up period and confirmed via hospital computer records.
Timepoint [5] 327092 0
6 months post index admission
Secondary outcome [6] 327093 0
Medication changes via comparison between Emergency Department assessment and participant self reported changes at 6 months post discharge.
Timepoint [6] 327093 0
Assessment in the ED and at 6 months post index admission
Secondary outcome [7] 327094 0
Community Service Use as assessed in the Emergency Department by the Occupational Therapist and Physiotherapist. This is compared to the assessment at 6 months involving participant self report.
Timepoint [7] 327094 0
As measured in the ED and compared to community service use at 6 months post index admission.

Eligibility
Key inclusion criteria
Over the age of 65 years
Seen by the Care Co-ordination Team - Occupational Therapist and Physiotherapist
Being discharged home after the Emergency department presentation
Cognitively able to understand and consent to the intervention
Competent in understanding English
Not residing in nursing home or requiring high level care
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non English speaking
Inability to consent
Residency in community residential aged care facilities

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation was used to allocate patients to the control or intervention group, with each 24 hour period used as the unit for allocation. A computer-generated, random number schedule was developed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
We estimated 104 patients were required in each group (Intervention group presented with a fall, Intervention group did not present with a fall, Control group presented with a fall and Control group did not present with a fall) to show a difference between control group falls proportion of 40% and intervention group of 20%, assuming 80% power and alpha 0.05. This includes an additional 10 % for patients lost to follow up or who withdraw.

Data on assessment results, times, reasons and outcome measures will be obtained and analyzed using SPSS version 20. Descriptive analysis using means with standard deviations, frequencies and proportions with 95% confidence intervals will be used where appropriate. The chi squared test will be used to compare categorical outcomes of the cohorts and Student’s t test or Wilcoxon signed rank test to compare continuous variables. Data analysis: Data were analysed using SPSS version 22 and SAS version 9.4. Descriptive statistics were used for demographic data, health characteristics and falls risk factor associations. The characteristics for each of the tools was derived by calculating sensitivity, specificity, positive (PPV) and negative predictive values (NPV). Receiver Operating Characteristics (ROC) curves were constructed and area under the curve (AUC) calculated.The investigators completing the data analysis will be blinded to the allocation group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/02/2014
Date of last participant enrolment
Anticipated
Actual
24/11/2014
Date of last data collection
Anticipated
Actual
4/05/2015
Sample size
Target
416
Accrual to date
Final
412
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6543 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 14130 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 294382 0
Hospital
Name [1] 294382 0
Sir Charles Gairdner Hospital Research Advisory Committee
Country [1] 294382 0
Australia
Primary sponsor type
Individual
Name
Annette Barton
Address
Sir Charles Gairdner Hospital
Occupational Therapy
G Block, Lower Ground Floor
Hospital Avenue
Nedlands, Perth WA 6009
Country
Australia
Secondary sponsor category [1] 293231 0
None
Name [1] 293231 0
Address [1] 293231 0
Country [1] 293231 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295805 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 295805 0
Ethics committee country [1] 295805 0
Australia
Date submitted for ethics approval [1] 295805 0
04/11/2013
Approval date [1] 295805 0
13/01/2014
Ethics approval number [1] 295805 0
2013-074

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

Contacts
Principal investigator
Name 68254 0
Mrs Annette Barton
Address 68254 0
Occupational Therapy
Sir Charles Gairdner Hospital
G Block, Lower Ground Floor
Hospital Avenue
Nedlands, Perth WA 6009
Country 68254 0
Australia
Phone 68254 0
+61 8 6457 2855
Fax 68254 0
Email 68254 0
Annette.Barton@health.wa.gov.au
Contact person for public queries
Name 68255 0
Kristie Harper
Address 68255 0
Occupational Therapy
Sir Charles Gairdner Hospital
G Block, Lower Ground Floor
Hospital Avenue
Nedlands, Perth WA 6009
Country 68255 0
Australia
Phone 68255 0
+61 8 6457 2855
Fax 68255 0
Email 68255 0
Kristie.Harper@health.wa.gov.au
Contact person for scientific queries
Name 68256 0
Kristie Harper
Address 68256 0
Occupational Therapy
Sir Charles Gairdner Hospital
G Block, Lower Ground Floor
Hospital Avenue
Nedlands, Perth WA 6009
Country 68256 0
Australia
Phone 68256 0
+61 8 6457 2855
Fax 68256 0
Email 68256 0
Kristie.Harper@health.wa.gov.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.