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Trial registered on ANZCTR


Registration number
ACTRN12623000089639
Ethics application status
Approved
Date submitted
13/01/2023
Date registered
25/01/2023
Date last updated
25/01/2023
Date data sharing statement initially provided
25/01/2023
Date results information initially provided
25/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the impact of using a novel patient prompting document on communication in the surgical outpatient clinic
Scientific title
A pilot study to assess patient knowledge, satisfaction and engagement when using a novel patient prompting document in surgical consultation
Secondary ID [1] 308731 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgery 328675 0
Communication barriers in surgical clinic 328676 0
Condition category
Condition code
Surgery 325681 325681 0 0
Other surgery
Public Health 325739 325739 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: The intervention being studied is a generalised patient prompting document or question prompt list (QPL). It is an 8 point document containing questions that a patient may want to ask their surgeon. (eg. what is the name of my surgeon?) It is an A4 piece of paper with room for notes. The document will be given to patients (see below) prior to visiting their surgeon by a member of the research team. They will be encouraged to ask those and any other questions they may have of their surgeon. 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] 325199 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] 333539 0
Patient knowledge - This will be assessed by a structured telephone survey that includes questions listed on the prompting document or QPL.

Timepoint [1] 333539 0
Follow up phone consult will be 1 week post consultation
Primary outcome [2] 333540 0
Patient engagement - The video recording of the consultation will be assessed by two independent blinded reviewers who will score the level of patient participation on the OPTION 12 scale.
Timepoint [2] 333540 0
Video review post consultation
Primary outcome [3] 333592 0
Anxiety - This will be assessed using a 3 point likert scale during follow up phone consultation.
Timepoint [3] 333592 0
1 week post consultation.
Secondary outcome [1] 417459 0
Satisfaction - This will be assessed using a 3 point Likert scale during follow up phone consultation. (Additional primary outcome)
Timepoint [1] 417459 0
1 week phone call post consultation.
Secondary outcome [2] 417766 0
Consultation dynamics (composite outcome). Retrospective video review will be conducted by 2x members of the research team blinded to cohort allocation. They will determine: Talk time; eye gaze; number of questions asked; and, content discussed.
Timepoint [2] 417766 0
During consultation via video review.

Eligibility
Key inclusion criteria
Patient Participants
Patients scheduled for surgical consultations from October 2021- March 2022 at The Queen Elizabeth 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
This was a pilot study and a sample size of 50 was estimated to be adequate for significant results.

Descriptive data was described using mean and standard deviation (±SD) for age, median and interquartile range (IQR) for consultation duration and OPTION-12 scoring, and frequency and percentage for sex and companion present. Consultation duration and OPTION-12 scoring was analysed using a Wilcoxon Rank Sum Test as this variable was not normally distributed. Linear mixed-effects models were used to investigate the association between total talk time of patient, consultant, and companion, then mutual eye gaze time between patient and consultant (in four separate models) versus QPL group (experiment/control). A negative binomial Generalised Estimating Equations (GEE) model was used to investigate the association between groups and the number of questions asked in four separate models (total, by patient, by surgeon, and by companion). A negative binomial GEE model was used to investigate the association between groups and the total number of correct recall items. A binary logistic GEE model was used to investigate the association between groups and patient recall of the individual recall items- treatment, benefit, risks, expenses, and name of surgeon (in five separate models). An ordinal logistic GEE model was used to investigate the association between groups and patient reported anxiety.
For each outcome, an unadjusted model and an adjusted model controlling for sex and age were performed. All statistical analyses excluding those for patient age and consultation duration controlled for clustering on surgeon identification. A global P value of <0.05 was considered statistically significant for all analyses.
The statistical software used was SAS On Demand for Academics (SAS Institute Inc. 2021).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/11/2021
Date of last participant enrolment
Anticipated
Actual
31/03/2022
Date of last data collection
Anticipated
Actual
30/06/2022
Sample size
Target
50
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 23813 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 39261 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 312955 0
University
Name [1] 312955 0
The University of Adelaide
Country [1] 312955 0
Australia
Primary sponsor type
Individual
Name
Professor Guy Maddern
Address
The University of Adelaide
Division of Surgery
Level 6A - The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia
5011
Country
Australia
Secondary sponsor category [1] 314646 0
None
Name [1] 314646 0
NA
Address [1] 314646 0
NA
Country [1] 314646 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312229 0
Central Adelaide Local Health Network Human Research and Ethics Committee
Ethics committee address [1] 312229 0
37 Woodville Rd, Woodville South SA 5011
Ethics committee country [1] 312229 0
Australia
Date submitted for ethics approval [1] 312229 0
30/09/2021
Approval date [1] 312229 0
13/10/2021
Ethics approval number [1] 312229 0
15447

Summary
Brief summary
Presenting to a surgical outpatient clinic can be a stressful experience for patients. Disparity in education levels, perceived power imbalances and other factors can result in the patient feeling unsatisfied or confused at the completion of the consultation. We propose a randomised controlled study; whereby, the participant is placed into either the intervention group and will receive a pre-designed patient prompting document, or they are placed in the control group. The outpatient consultation will be audio-video recorded. Within 7 days of the consultation the participant will be contacted by telephone to discuss their experience. The purpose is to analyse the utility of a patient prompting document in improving patient understanding, increased patient empowerment and facilitating successful outpatient consultations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123914 0
Prof Guy Maddern
Address 123914 0
The University of Adelaide - Division of Surgery
Level 6A. The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia
5011
Country 123914 0
Australia
Phone 123914 0
+61 8 8222 6973
Fax 123914 0
+61 8 8222 6028
Email 123914 0
[email protected]
Contact person for public queries
Name 123915 0
Guy Maddern
Address 123915 0
The University of Adelaide - Division of Surgery
Level 6A. The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia
5011
Country 123915 0
Australia
Phone 123915 0
+61 8 8222 6973
Fax 123915 0
+61 8 8222 6028
Email 123915 0
[email protected]
Contact person for scientific queries
Name 123916 0
Guy Maddern
Address 123916 0
The University of Adelaide
Division of Surgery
Level 6A - The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia
5011
Country 123916 0
Australia
Phone 123916 0
+61 8 8222 6973
Fax 123916 0
+61 8 8222 6028
Email 123916 0
[email protected]

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 will be compiled and published in an international peer reviewed medical journal. This will include synthesised compiled summaries of all primary and secondary endpoints.
When will data be available (start and end dates)?
Data will be publicly available once the manuscript is published (Anticipated Early/mid 2023)
As per our HREC regulations all data will be stored for 15 years (Until October 2036) on an encrypted hard drive in the Division of Surgery and The Queen Elizabeth Hospital.
Available to whom?
Additional de-identified data (beyond what is published) will be available to appropriate researchers by contacting the corresponding author. The research team strives to protect the confidentiality of our study participants. Data sharing requests may need to be reviewed by our local HREC.
Available for what types of analyses?
Researchers conducting a systematic review and meta-analysis are welcome to contact the corresponding author if de-identified data is required.
How or where can data be obtained?
Data can be obtained by contacting the Principal Investigator on [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18042Ethical approval    385214-(Uploaded-13-01-2023-11-08-40)-Study-related document.pdf
18043Study protocol    385214-(Uploaded-13-01-2023-11-08-59)-Study-related document.docx
18044Informed consent form    385214-(Uploaded-13-01-2023-11-09-14)-Study-related document.docx



Results publications and other study-related documents

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