Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000492550p
Ethics application status
Submitted, not yet approved
Date submitted
5/04/2024
Date registered
22/04/2024
Date last updated
22/04/2024
Date data sharing statement initially provided
22/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Gathering insights from healthcare professionals on designing AI-enabled robotic systems for Rapid Response Teams in Australian hospitals.
Scientific title
Characterisation of clinical care dynamics and the integration of human-robot collaboration in an Australian hospital setting with healthcare providers to inform the potential integration of collaborative robots in rapid response systems
Secondary ID [1] 311897 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emergency Care 333480 0
Condition category
Condition code
Emergency medicine 330155 330155 0 0
Other emergency care
Public Health 330156 330156 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
"Brief Name: Qualitative Study on the Integration of Robotic Systems in University of Canberra Hospitals

Objective: To explore and understand the requirements, integration process, challenges, and impacts of a novel robotic system within the healthcare delivery framework at the University of Canberra Hospital (UCH).

Participants: Hospital staff including medical professionals, nursing staff, and Allied Health professionals

Methodology: A qualitative research approach, utilizing a combination of semi-structured interviews, focus groups, and direct observations

Data Collection and Conditions Observed:

Semi-structured interviews will gather in-depth insights from staff involved with the Rapid Response System (RRS) and those interacting with the newly introduced robotic systems at UCH, focusing on experiences, perceptions, and suggestions.
Observations will be conducted focusing on RRS operations and the adoption and use of new robotic systems, capturing real-time interactions, challenges, and efficiencies.
Focus Groups will collect collective feedback from diverse stakeholders on the robotic systems’ design, impact, and potential areas for improvement, incorporating hands-on interactions with prototypes or models.


Observational Data Collected: Detailed qualitative data from interviews and focus groups, along with observational notes on the operational use and integration challenges of the robotic systems. Special attention will be paid to the acceptance, adaptation, and impact of these technologies on staff workload and patient outcomes.

Duration of Study: Duration of Study: The overall project is expected to take 12 months. The data collection phase will span over a period of 3 months, and the analysis and write-up is expected to take an additional 9 months."
Intervention code [1] 328367 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337908 0
Characterisation of current rapid response system clinical care team dynamics in the UC hospital setting
Timepoint [1] 337908 0
This primary outcome will be assessed at a single timepoint after observations and interviews have concluded.
Primary outcome [2] 337909 0
Understanding how UCH adopts and integrates new robotics technologies.
Timepoint [2] 337909 0
This primary outcome will be assessed at a single timepoint after observations and interviews have concluded.
Primary outcome [3] 337910 0
Specification of the design requirements for a collaborative robot tailored to enhance UCH's RRS system, based on identified needs and system integration criteria.
Timepoint [3] 337910 0
This primary outcome will be assessed at a single timepoint after focus groups have concluded.
Secondary outcome [1] 433669 0
NA
Timepoint [1] 433669 0
NA

Eligibility
Key inclusion criteria
Inclusion Criteria for Interviews and Focus Groups
Must be 18 years of age or older.
Hospital staff who have direct interaction or involvement with UCH’s
RRS team or its operations OR
New robotic systems being introduced at the hospital.
Proficient in English to ensure the effective communication and understanding of the project details and objectives during interviews and focus groups.


Inclusion Criteria for Observations
Must be actively involved in the RRS operations or the newly robotic systems at UCH at the time of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria for Interviews and Focus Groups
Individuals under the age of 18.
Individuals who are not hospital staff or affiliated with the UCH in a professional capacity.
Individuals without direct interaction or involvement with the RRS team or its operations, and those not involved with the new robotic systems being introduced at the hospital.
Lack of English proficiency which would preclude understanding of the survey or study materials.

Exclusion Criteria for Observations
Situations where the presence of observers could potentially interfere with the delivery of emergency care or the normal operation of the RRS team.
Areas not directly related to RRS operations or newly introduced robotic systems or where patient privacy could be compromised, to respect confidentiality and ethical considerations.
Individuals or areas where permission for observation has not been granted, either by the staff involved or through the hospital's administrative permissions.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2024
Actual
Date of last participant enrolment
Anticipated
15/08/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 26378 0
The University of Canberra Hospital: Specialist Centre for Rehabilitation, Recovery and Research - Bruce
Recruitment postcode(s) [1] 42350 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 316246 0
University
Name [1] 316246 0
Australian National University
Country [1] 316246 0
Australia
Funding source category [2] 316247 0
University
Name [2] 316247 0
University of Canberra
Country [2] 316247 0
Australia
Funding source category [3] 316248 0
Hospital
Name [3] 316248 0
University of Canberra Hospital
Country [3] 316248 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
Country
Australia
Secondary sponsor category [1] 318432 0
University
Name [1] 318432 0
University of Canberra
Address [1] 318432 0
Country [1] 318432 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315066 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 315066 0
Ethics committee country [1] 315066 0
Australia
Date submitted for ethics approval [1] 315066 0
09/04/2024
Approval date [1] 315066 0
Ethics approval number [1] 315066 0

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

Contacts
Principal investigator
Name 133566 0
Dr Balaji Bikshandi
Address 133566 0
Northwest Regional Hospital 23 Brickport Road Burnie, TAS 7320
Country 133566 0
Australia
Phone 133566 0
+61407624284
Fax 133566 0
Email 133566 0
[email protected]
Contact person for public queries
Name 133567 0
Amirhossein Asadi
Address 133567 0
Level 3 Birch Building, 35 Science Road, The Australian National University, Canberra, ACT 2600
Country 133567 0
Australia
Phone 133567 0
+61415169445
Fax 133567 0
Email 133567 0
[email protected]
Contact person for scientific queries
Name 133568 0
Amirhossein Asadi
Address 133568 0
Level 3 Birch Building, 35 Science Road, The Australian National University, Canberra, ACT 2600
Country 133568 0
Australia
Phone 133568 0
+61415169445
Fax 133568 0
Email 133568 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22118Study protocol    387627-(Uploaded-05-04-2024-16-23-25)-Study-related document.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.