Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000585527
Ethics application status
Approved
Date submitted
28/03/2024
Date registered
8/05/2024
Date last updated
8/05/2024
Date data sharing statement initially provided
8/05/2024
Date results information initially provided
8/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Telehealth vs face-to-face consults in patients attending a Urological Oncology Clinic. A Randomised Controlled Trial.
Scientific title
Telehealth vs face-to-face consults in patients attending a Urological Oncology Clinic. A Randomised Controlled Trial.
Secondary ID [1] 311848 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Telehealth in Urological Oncology 333378 0
urological cancer 333546 0
Condition category
Condition code
Public Health 330071 330071 0 0
Health service research
Cancer 330226 330226 0 0
Bladder
Cancer 330227 330227 0 0
Kidney
Cancer 330228 330228 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this trial would be randomising patients (already known to the Crown Princess Mary Cancer Centre) in 1 of 2 study arms to a Telehealth consultation as the mode of consult for their next follow up appointment. This Telehealth appointment will be carried out via telephone calls during a booked in clinic appointment time. Patients data including name, DOB and MRN are collected from a third party offsite investigator utilising the hospitals booking system. Eligible patients will be contacted and the trial discussed with them, if they are agreeable, a patient information and consent form will be posted/emailed to the patients. Once consent is obtained, randomisation occurs using an online web-based generator. Patients are then informed of their allocation 24 hours prior to their next follow up appointment over the phone. For the clinicians providing the care, patients allocation will be placed in opaque sealed envelopes that the clinician will obtain just prior to each patients appointment time slot. Following this, patients either randomised to Telehealth or face-to-face will complete a validated questionnaire, delivered either online via a survey monkey link or a hard copy, respectively.
Intervention code [1] 328308 0
Treatment: Other
Comparator / control treatment
The Standard face-to-face consultations are the comparator/control for the purposes of this study and represent 1/2 study arms against which telehealths effectiveness will be compared via the use of validated questionnaires. Given the mode of delivery for each consultation at the Crown Princess Mary Cancer Centre in Westmead Hospital is conducted via face-to-face appointments in the urological oncology clinics, this will serve as a valid control group to compare the effectiveness of Telehealth via questionnaire responses against those completed by patients randomised to the standard face-to-face approach.
Control group
Placebo

Outcomes
Primary outcome [1] 337829 0
Patient satisfaction survey scores regarding Telehealth vs standard face-to-face consultation
Timepoint [1] 337829 0
Following next follow up appointment (usually occurring 2 weeks post enrolment) , patients randomised to the Telehealth group will be emailed a survey monkey link to their nominated email address the very same day. Approximately 2 weeks is given for responses, with reminders sent out at week 3 and week 4. For patients randomised to the face-to-face group: hard copies of the questionnaires are provided by reception staff at the conclusion of the appointment and placed in a tray at the reception desk prior to patients departing the clinic.
Secondary outcome [1] 433416 0
Patient assessment of the services provided (RFA bookings, investigations, follow up of results) with regards to either face-to-face or Telehealth consultations
Timepoint [1] 433416 0
Telehealth Study Arm: 2 weeks will be given following the email of the Survey Monkey Link (sent out on day of appointment) of the validated questionnaires. At week 3 and 4: reminder text messages will be sent out.
Face to Face study arm: not applicable as validated questionnaires will be provided in hard copy follow their appointment and collected in a tray available on the clinic reception desk prior to the patients exiting the clinic.

Eligibility
Key inclusion criteria
All patients within the clinic who require ongoing follow up.
No history of baseline confusion/severe cognitive impairment unless a carer is available to assist with telephone appointment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
New or initial referrals
History of non-compliance (multiple prior non-attendances to appointments in the past).
NESB (Non-English-Speaking-Background).
Patients who declined randomisation.
General outpatient or non-urological oncology clinics.

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)
Randomised via a web based computer generator and allocation concealed via sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer sequence generation
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/02/2023
Date of last participant enrolment
Anticipated
Actual
7/09/2023
Date of last data collection
Anticipated
Actual
22/09/2023
Sample size
Target
126
Accrual to date
Final
116
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26344 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 42317 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 316191 0
Hospital
Name [1] 316191 0
Westmead Hospital, Western Sydney Local Health District
Country [1] 316191 0
Australia
Primary sponsor type
Individual
Name
David Armany
Address
Country
Australia
Secondary sponsor category [1] 318377 0
None
Name [1] 318377 0
Address [1] 318377 0
Country [1] 318377 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315010 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315010 0
https://www.wslhd.health.nsw.gov.au/Education-Portal/Research/ethics-governance
Ethics committee country [1] 315010 0
Australia
Date submitted for ethics approval [1] 315010 0
23/08/2022
Approval date [1] 315010 0
09/09/2022
Ethics approval number [1] 315010 0

Summary
Brief summary
This is a study that will be used to evaluate how effective Telehealth is for patients who are already being followed up in a urological oncology clinic. You may be eligible for this study if you are already a patient who is regularly followed up at the Crown Princess Mary Cancer Centre in Westmead Hospital for a urological cancer condition. Unfortunately, if you are not yet known to the clinic or are awaiting to see a urologist for your first visit, you will not be eligible to participate.

Study Details
Patients who are eligible for the study will be contacted and informed about the trials aims and methods and informed consent will need to be provided should they wish to participate. Following this, participants will be randomised prior to their next follow up appointment to either a Telehealth group or the standard face-to-face appointment type. They will be notified of their allocation 24 hours prior to their appointment. At the end of the follow up appointment, participants will be asked to completed a validated questionnaire that will help quantify their responses with regards to effectiveness, services provided, efficiency and timing of the appointment, and overall satisfaction. These scores will be de-identified and anonymous.

By participating in this trial, we will be able to compare how effective patients find Telehealth vs face-to-face consultations for those suffering from common urological malignancies. We also will assess to see if there are any barriers to the widespread adoption of Telehealth for these common health conditions and if any adverse effects are encountered. This knowledge can help potentiate Telehealth's adaptation to other fields of surgical and medical disciplines as well as providing timely and more efficient care to a greater number of patients within the local health district.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133418 0
Dr David Armany
Address 133418 0
Crown Princess Mary Cancer Centre, Westmead Hospital: Corner Hawkesbury Road and Darch Road, Westmead NSW 2145
Country 133418 0
Australia
Phone 133418 0
+61 449984903
Fax 133418 0
Email 133418 0
David.armany@health.nsw.gov.au
Contact person for public queries
Name 133419 0
David Armany
Address 133419 0
Crown Princess Mary Cancer Centre, Westmead Hospital: Corner Hawkesbury Road and Darch Road, Westmead NSW 2145
Country 133419 0
Australia
Phone 133419 0
+61 449984903
Fax 133419 0
Email 133419 0
David.armany@health.nsw.gov.au
Contact person for scientific queries
Name 133420 0
David Armany
Address 133420 0
Crown Princess Mary Cancer Centre, Westmead Hospital: Corner Hawkesbury Road and Darch Road, Westmead NSW 2145
Country 133420 0
Australia
Phone 133420 0
+61 449984903
Fax 133420 0
Email 133420 0
David.armany@health.nsw.gov.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?
survey scores
When will data be available (start and end dates)?
Data is available immediately and available for 5 years.
Available to whom?
upon request to any government body or journal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator (Davidarmany72@gmail.com)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22011Study protocol  davidarmany72@gmail.com 387590-(Uploaded-28-03-2024-15-52-25)-Study-related document.docx



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.