Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001222538
Ethics application status
Approved
Date submitted
6/09/2024
Date registered
8/10/2024
Date last updated
8/10/2024
Date data sharing statement initially provided
8/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Communication in the ward round
Scientific title
Evaluation Of A Personal Outpatient Worksheet And Educational Resource (POWER) Form for communication in a ward setting – A single site, open label, randomised controlled trial
Secondary ID [1] 312922 0
None
Universal Trial Number (UTN)
Trial acronym
POWER (Personal Outpatient Worksheet and Educational Reference)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General Surgery 335085 0
clinical communication 335086 0
Medical Error 335087 0
Health Service Research 335089 0
Condition category
Condition code
Surgery 331588 331588 0 0
Other surgery
Public Health 331965 331965 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention (POWER form) is a is a 5 point prompt sheet/checklist given to a patient prior to the ward round. It is designed to encourage patients to engage with their team and understand their clinical issues. (Please see a PDF copy of the form attached to this application).
The five points on the form are:
- What is my medical issue (or what do we suspect)?
- What are the treatment options (or further tests)
- How does this impact my ability to work/eat/exercise?
- What are the risks/benefits of treatment (or what happens if I don’t have treatment)?
- Who is involved in my treatment and when will it occur?

Once randomised patients receiving the intervention will be given the form at least five minutes prior to their ward round encounter. The form will be printed and given to the patient with a pen and clipboard so that patients have the option of taking their own notes during the consultation. Patients do not have to complete the checklist but they are encouraged to seek answers to the five prompts prior to the team leaving their bedside.

A ward round encounter typically takes between two and fifteen minutes.

The ward round encounter will be recorded by a video camera and use of the intervention will be evident on the video footage.

Intervention code [1] 329456 0
Treatment: Other
Comparator / control treatment
This intervention will be compared with patients not receiving a form and participating in standard or usual care on the surgical ward round.
Standard care involves the treating team reviewing the patient at their bedside without the patient being given a POWER form. This typically involves a focussed history, examination, reviewing of relevant results and formulation of a treatment plan.
Control group
Active

Outcomes
Primary outcome [1] 339328 0
Patient knowledge
Timepoint [1] 339328 0
Within 4 hours after completion of the ward round
Secondary outcome [1] 439509 0
Shared Decision Making
Timepoint [1] 439509 0
Within 24 hours after completion of the ward round.
Secondary outcome [2] 439510 0
Patient satisfaction
Timepoint [2] 439510 0
Within 4 hours after completion of the ward round

Eligibility
Key inclusion criteria

Patients admitted to any Surgical Ward at The Queen Elizabeth Hospital. Any patient 18 years or older, who has the capacity to consent to participation, and has signed and understood the consent form.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Declining to participate
• Patients held in isolation rooms such as those for multi-resistant organisms, confirmed or potential respiratory tract infections, COVID-19 or gastroenteritis
• Patients under the age of 18

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/10/2024
Actual
Date of last participant enrolment
Anticipated
23/12/2024
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 27081 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 43150 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 317354 0
Hospital
Name [1] 317354 0
The Queen Elizabeth Hospital
Country [1] 317354 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital
Address
Country
Australia
Secondary sponsor category [1] 319815 0
None
Name [1] 319815 0
Address [1] 319815 0
Country [1] 319815 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316085 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 316085 0
Ethics committee country [1] 316085 0
Australia
Date submitted for ethics approval [1] 316085 0
20/06/2024
Approval date [1] 316085 0
04/09/2024
Ethics approval number [1] 316085 0
19728

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

Contacts
Principal investigator
Name 136734 0
Prof Guy Maddern
Address 136734 0
The Queen Elizabeth Hospital, 28 Woodville Rd, Woodville South, SA, 5011
Country 136734 0
Australia
Phone 136734 0
+61 8 82226973
Fax 136734 0
Email 136734 0
guy.maddern@adelaide.edu.au
Contact person for public queries
Name 136735 0
Dr Matheesha Herath
Address 136735 0
The Queen Elizabeth Hospital, 28 Woodville Rd, Woodville South, SA, 5011
Country 136735 0
Australia
Phone 136735 0
+61 8 82227045
Fax 136735 0
Email 136735 0
matheesha.herath@sa.gov.au
Contact person for scientific queries
Name 136736 0
Dr Matheesha Herath
Address 136736 0
The Queen Elizabeth Hospital, 28 Woodville Rd, Woodville South, SA, 5011
Country 136736 0
Australia
Phone 136736 0
+61 8 82227045
Fax 136736 0
Email 136736 0
matheesha.herath@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per HREC


What supporting documents are/will be available?




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.