Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000075482
Ethics application status
Approved
Date submitted
19/12/2024
Date registered
24/01/2025
Date last updated
24/01/2025
Date data sharing statement initially provided
24/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the Effect of a Patient Worksheet on Communication In The Surgical Clinic
Scientific title
Evaluation of a Personal Outpatient Worksheet and Educational Reference (POWER) Form on Patient Knowledge and Engagement In Patients Aged 16 and Over Attending the Surgical Clinic
Secondary ID [1] 313585 0
None
Universal Trial Number (UTN)
Trial acronym
POWER - Personal Outpatient Worksheet and Educational Reference Form
Linked study record
Trial Id: ACTRN12623000089639 - This is the Pilot study for this trial.

Health condition
Health condition(s) or problem(s) studied:
Surgery 336136 0
Communication barriers 336137 0
Condition category
Condition code
Surgery 332685 332685 0 0
Other surgery
Public Health 332686 332686 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 their clinic appointment. 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 in step 11 of this registration).

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 surgical clinic appointment. 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.

This clinic appointment could be pre-operatively, or post operatively, or for non operative patients. It may occur at any point during that patient's healthcare journey as deemed appropriate by the treating team. The patients will be seen by either a surgical consultant or fellow.

A typical consultation can last anywhere between 5 - 45 minutes. The consultation will be filmed to evaluate form usage and consultation dynamics. Patients will receive a phone call 1 week post encounter to assess their experience using the form, their knowledge of their medical issue post consultation, their satisfaction, and their anxiety. This call will be conducted by a member of the research team and be between 5-10 minutes duration.
Intervention code [1] 330191 0
Behaviour
Comparator / control treatment
Patient's in the control group will be receiving standard or usual care. This involves an unmodified surgical consultation without use of the specific form being evaluated.
Control group
Active

Outcomes
Primary outcome [1] 340208 0
Patient knowledge
Timepoint [1] 340208 0
Follow up phone consult will be 1 week post consultation
Primary outcome [2] 340209 0
Patient engagement
Timepoint [2] 340209 0
Video review post consultation
Secondary outcome [1] 443302 0
Satisfaction
Timepoint [1] 443302 0
1 week phone call post consultation.
Secondary outcome [2] 443303 0
Consultation dynamics (composite outcome)
Timepoint [2] 443303 0
Video review post consultation.

Eligibility
Key inclusion criteria
Patient Participants
Patients scheduled for surgical consultations from at The Queen Elizabeth Hospital or Royal Adelaide Hospital. Any patient 16 years or older attending the outpatient surgical clinic, who has the capacity to consent to participation, and has signed and understood the consent form.

Staff participants
Staff participants will be eligible for inclusion in this study if employed by CALHN and any of the following criteria apply:
a. Surgical Staff Consultant (including heads of units, academic consultant surgeons)
b. Surgical Visiting Medical Officer
c. Surgical Fellow
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient's who require a translator. Patient's with cognitive impairment. Patients who have visual impairment or are unable to read English.

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)
A sealed opaque envelope system will be used to randomise patients.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation will occur via random number computer generation software. Envelopes will be prepared and sealed by two team members not involved in patient recruitment. Patient will be randomised in the order they consent to participate. Randomisation will occur in blocks of 4 and 6. The allocation will be placed in sealed, opaque, tamper proof envelopes. Envelopes will be numbered consecutively. When a patient signs consent, the “next” envelope will be opened and the patient assigned to the experimental group (prompt sheet) or the standard group.
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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
6/07/2022
Date of last participant enrolment
Anticipated
Actual
15/01/2025
Date of last data collection
Anticipated
5/02/2025
Actual
Sample size
Target
140
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318053 0
University
Name [1] 318053 0
The University of Adelaide
Country [1] 318053 0
Australia
Primary sponsor type
Individual
Name
Professor Guy Maddern - The University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 320406 0
None
Name [1] 320406 0
Address [1] 320406 0
Country [1] 320406 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316705 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 316705 0
Ethics committee country [1] 316705 0
Australia
Date submitted for ethics approval [1] 316705 0
16/09/2021
Approval date [1] 316705 0
25/05/2022
Ethics approval number [1] 316705 0
15447

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

Contacts
Principal investigator
Name 138730 0
Prof Guy Maddern
Address 138730 0
The University of Adelaide Department of Surgery, Level 6A, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, SA 5011
Country 138730 0
Australia
Phone 138730 0
+61 8 82226973
Fax 138730 0
Email 138730 0
[email protected]
Contact person for public queries
Name 138731 0
Guy Maddern
Address 138731 0
The University of Adelaide Department of Surgery, Level 6A, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, SA 5011
Country 138731 0
Australia
Phone 138731 0
+61 8 82226973
Fax 138731 0
Email 138731 0
[email protected]
Contact person for scientific queries
Name 138732 0
Guy Maddern
Address 138732 0
The University of Adelaide Department of Surgery, Level 6A, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, SA 5011
Country 138732 0
Australia
Phone 138732 0
+61 8 82226973
Fax 138732 0
Email 138732 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Ethics Approval.pdf
Study protocol    Evaluation of the POWER form QPL - Version 1.1 April 2022 - Copy.docx
Informed consent form    Patient prompt PICF_Participant_ V2 24 April 2022 cleaned.docx
Other    TQEH POWER form (2).pdf


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.