Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000257561p
Ethics application status
Not yet submitted
Date submitted
11/12/2023
Date registered
15/03/2024
Date last updated
15/03/2024
Date data sharing statement initially provided
15/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Recommendations on Hospital Falls Prevention and Management
Scientific title
Qualitative Analysis of Consensus Based Recommendations on Hospital Falls Prevention and Management
Secondary ID [1] 311058 0
Nil
Universal Trial Number (UTN)
Trial acronym
H-Falls
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 332177 0
Frailty 332178 0
Condition category
Condition code
Injuries and Accidents 328895 328895 0 0
Fractures
Injuries and Accidents 328896 328896 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Delphi consensus study to derive priorities for future Guidelines for Falls Prevention in Hospitals. The participants will be health professionals. They will be invited to participate in up to 4 data collection questionnaires (over a 2-month period) conducted via email and then an online consensus meeting (Teams or Zoom). Each questionnaire will have around 8 sections and will take no more than 15 minutes. The research team will administer the questionnaires and consensus meeting. The study will be conducted over 2 months, with the initial baseline questionnaire followed by up to 3 additional Delphi questionnaire rounds and then a final online consensus meeting at 2 months after the baseline questionnaire.
Intervention code [1] 327504 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336707 0
Falls Prevention and Management Methods
Timepoint [1] 336707 0
Baseline, then at fortnightly intervals up to 3 additional Delphi questionnaire rounds by email and then a final online consensus meeting 2 months after the baseline questionnaire.
Secondary outcome [1] 429380 0
Agreement
Timepoint [1] 429380 0
Agreement across all questions will be determined at the online consensus meeting 2 months after the baseline questionnaire.

Eligibility
Key inclusion criteria
Participants will be registered health professionals or consumers with lived experience of hospital falls
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be registered health professionals or consumers with lived experience of hospital falls

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
As per modified Delphi methods:
1. Analysis will be performed at the completion of each survey round. This will form the content of the subsequent round’s survey.
2. Likert ratings for each item will be analysed quantitatively and expressed as a percentage for each of the five Likert categories, together with 25, 50 and 75 percentiles (median and IQR).
3. Following a priori consensus levels, each item will either be included in the final Delphi list, excluded from the survey or forwarded to the subsequent round to undergo re-rating.
4. Free-text, qualitative comments will be thematically analyzed and grouped using software. The interim results will either inform new items in the subsequent round or be addressed in the publication Discussion.
5. Survey rounds will be repeated up to four times or until no new items are generated from the qualitative data and termination criteria are met for any remaining non-consensus items. Inter-round stability of an item according to its median and IQR score will determine termination criteria. If scores decrease or remain unchanged between a current and previous round, the item will be excluded; if scores increase then the item will be forwarded to the subsequent round for re-rating.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/05/2024
Actual
Date of last participant enrolment
Anticipated
8/06/2024
Actual
Date of last data collection
Anticipated
10/07/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315314 0
University
Name [1] 315314 0
La Trobe University
Country [1] 315314 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive Bundoora 3186
Country
Australia
Secondary sponsor category [1] 317364 0
Other Collaborative groups
Name [1] 317364 0
Victorian Falls Prevention Alliance
Address [1] 317364 0
MACH, The University of Melbourne PArkville
Country [1] 317364 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 314743 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 314743 0
Ethics committee country [1] 314743 0
Australia
Date submitted for ethics approval [1] 314743 0
29/03/2024
Approval date [1] 314743 0
Ethics approval number [1] 314743 0

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

Contacts
Principal investigator
Name 130898 0
Prof Meg Morris
Address 130898 0
La Trobe University, 1 Kingsbury Drive Bundoora VIC 3086
Country 130898 0
Australia
Phone 130898 0
+61433405662
Fax 130898 0
Email 130898 0
m.morris@latrobe.edu.au
Contact person for public queries
Name 130899 0
Meg Morris
Address 130899 0
La Trobe University, 1 Kingsbury Drive Bundoora VIC 3086
Country 130899 0
Australia
Phone 130899 0
+61433405662
Fax 130899 0
Email 130899 0
m.morris@latrobe.edu.au
Contact person for scientific queries
Name 130900 0
Meg Morris
Address 130900 0
La Trobe University, 1 Kingsbury Drive Bundoora VIC 3086
Country 130900 0
Australia
Phone 130900 0
+61433405662
Fax 130900 0
Email 130900 0
m.morris@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data
When will data be available (start and end dates)?
End of trial approximately August 2024. Data will be available for 5 years after publication.
Available to whom?
Case-by-case basis at the discretion of Primary Investigator
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
m.morris@latrobe.edu.au


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.