Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000738729
Ethics application status
Approved
Date submitted
20/04/2022
Date registered
23/05/2022
Date last updated
26/04/2023
Date data sharing statement initially provided
23/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimizing telemedicine delivery in out-patients
Scientific title
A qualitative study exploring the strengths and limitations of telemedicine in outpatient clinics.
Secondary ID [1] 306970 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ambulatory (outpatient) care using telemedicine. 326038 0
Condition category
Condition code
Public Health 323395 323395 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is using an exploratory, qualitative approach to generate understanding of the benefits and limitations of telemedicine. One-on-one interviews will be conducted with patients. carers, medical specialists and administrators. Interviews will last for 45 minutes and can be conducted in-person, via Zoom/Teams call, or over the phone, depending on the participant's preference. A Research Assistant working with the study team will be responsible for conducting the interviews.
Each participant will attend a single 45 minute interview.
Intervention code [1] 323411 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331137 0
1. Identifying the benefits and limitations of telemedicine. This will be done by using one-on-one, 45-minute, audio-recorded, semi-structured interviews using study-specific questionnaire. The future role of this mode of delivery in patient care will be inferred from the benefits and limitations identified.
Timepoint [1] 331137 0
Participants who have experienced and/or been involved in out-patient telemedicine appointments since January 2020. The outcome will be assessed relative to the participant only once at the time of enrolment after the one-on-one interview has been conducted.
Secondary outcome [1] 408947 0
Patients' perceptions of the benefits and limitations of telemedicine
Timepoint [1] 408947 0
The outcome will be assessed by analysing the audio recordings of the one-on-one, semi-structured interviews using a specific interview guide. Interviews will last for around 45 minutes.
Interviews can be conducted in-person, over the phone or by videoconference (Zoom/Teams), depending on the preference of the participant.
The outcome will be assessed once only at the time of enrolment.
Secondary outcome [2] 409710 0
Carers' perceptions of the benefits and limitations of telemedicine
Timepoint [2] 409710 0
The outcome will be assessed by analysing the audio recordings of the one-on-one, semi-structured interviews using a specific interview guide. Interviews will last for around 45 minutes.
Interviews can be conducted in-person, over the phone or by videoconference (Zoom/Teams), depending on the preference of the participant.
The outcome will be assessed once only at the time of enrolment.
Secondary outcome [3] 409711 0
Specialists' perceptions of the benefits and limitations of telemedicine.
Timepoint [3] 409711 0
The outcome will be assessed by analysing the audio recordings of the one-on-one, semi-structured interviews using a specific interview guide. Interviews will last for around 45 minutes.

Interviews can be conducted in-person, over the phone or by videoconference (Zoom/Teams), depending on the preference of the participant.
The outcome will be assessed once only at the time of enrolment.
Secondary outcome [4] 409712 0
Administrators' perceptions of the benefits and limitations of telemedicine
Timepoint [4] 409712 0
The outcome will be assessed by analysing the audio recordings of the one-on-one, semi-structured interviews using a specific interview guide. Interviews will last for around 45 minutes.

Interviews can be conducted in-person, over the phone or by videoconference (Zoom/Teams), depending on the preference of the participant.
The outcome will be assessed once only at the time of enrolment.
Secondary outcome [5] 409713 0
Positive and negative benefits when comparing virtual and face-to-face care.
Timepoint [5] 409713 0
The outcome will be assessed by analysing the audio recordings of the one-on-one, semi-structured interviews using a specific interview guide.

Interviews can be conducted in-person, over the phone or by videoconference (Zoom/Teams), depending on the preference of the participant.
The outcome will be assessed once only at the time of enrolment.
Secondary outcome [6] 409714 0
Concerns or issues that need to be considered in the future implementation of telemedicine in NSW public healthcare settings.
Timepoint [6] 409714 0
The outcome will be assessed by analysing the audio recordings of the one-on-one, semi-structured interviews using a specific interview guide.

Interviews can be conducted in-person, over the phone or by videoconference (Zoom/Teams), depending on the preference of the participant.
The outcome will be assessed once only at the time of enrolment.

Eligibility
Key inclusion criteria
a. Adults aged 18 or above.
b. Received or participated in an initial consultation or follow-up visit at a participating institution, as a patient, carer, specialist physician, or as a clinical nurse consultant in a participating institution since January 2020.
c. Health administrators such as practice managers, administration officers, medical secretaries, hospital general managers and directors of medical services working at a participating institution since January 2020.
d. No specific indication or contraindication to telemedicine or face-to-face care.
e. Able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. People who are unable to communicate in English in the interviews.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Transcripts will be imported into NVivo for coding and analysis using a coding hierarchy comprising demographic, deductive and inductive codes. Each transcript will be coded in its entirety to the demographic codes relevant to the interviewee (e.g., age, gender, type of medical service, country of birth). Line-by-line coding will then be undertaken to assign deductive and inductive codes to chunks of text within the transcripts. Deductive codes are those that are derived from the literature and reflect existing knowledge on the topic. Inductive codes emerge from the data during the analysis process and represent the novel findings of the research.
Thematic analysis of the coded dataset will be undertaken using the constant comparative method.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/02/2022
Date of last participant enrolment
Anticipated
Actual
18/08/2022
Date of last data collection
Anticipated
Actual
23/08/2022
Sample size
Target
100
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311250 0
Commercial sector/Industry
Name [1] 311250 0
Avant Foundation
Country [1] 311250 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
Level 5, 1 King Street, Newtown, NSW 2042
Country
Australia
Secondary sponsor category [1] 312645 0
None
Name [1] 312645 0
Address [1] 312645 0
Country [1] 312645 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310765 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 310765 0
Ethics committee country [1] 310765 0
Australia
Date submitted for ethics approval [1] 310765 0
Approval date [1] 310765 0
08/10/2021
Ethics approval number [1] 310765 0

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

Contacts
Principal investigator
Name 118782 0
Prof Christine Jenkins
Address 118782 0
The George Institute for Global Health
Level 5, 1 King Street, Newtown, NSW 2042
Country 118782 0
Australia
Phone 118782 0
+61 280524465
Fax 118782 0
Email 118782 0
christine.jenkins@sydney.edu.au
Contact person for public queries
Name 118783 0
Agnivo Sengupta
Address 118783 0
The George Institute for Global Health
Level 5, 1 King Street, Newtown, NSW 2042
Country 118783 0
Australia
Phone 118783 0
+61 2 8052 4555
Fax 118783 0
Email 118783 0
asengupta@georgeinstitute.org.au
Contact person for scientific queries
Name 118784 0
Agnivo Sengupta
Address 118784 0
The George Institute for Global Health
Level 5, 1 King Street, Newtown, NSW 2042
Country 118784 0
Australia
Phone 118784 0
+61 2 8052 4555
Fax 118784 0
Email 118784 0
asengupta@georgeinstitute.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Given the qualitative nature of the data and the potential for some of the clinicians to be recognisable if their transcripts are read in their entirety, the data will not be made publicly
available.


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.