Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001036505
Ethics application status
Approved
Date submitted
7/08/2024
Date registered
27/08/2024
Date last updated
27/08/2024
Date data sharing statement initially provided
27/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Does using a transdisciplinary assessment save staff time compared to usual allied health assessments for patients with stroke and medical conditions?
Scientific title
Evaluate the benefits of a transdisciplinary assessment compared to usual allied health assessments for patients with stroke and medical conditions
Secondary ID [1] 312702 0
2023002925
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12621000380897 is the study proceeding the current study. The current study is the translational piece of the body of work.

Health condition
Health condition(s) or problem(s) studied:
Stroke 334728 0
Transient Ischaemic Attack 334729 0
Medical conditions 334730 0
Condition category
Condition code
Stroke 331289 331289 0 0
Ischaemic
Stroke 331290 331290 0 0
Haemorrhagic
Public Health 331291 331291 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transdisciplinary Initial Neurological Screening Assessment (TINSA):
The TINSA is an assessment which combines assessments and tasks of routine physiotherapy, occupational therapy, social work, and speech pathology assessments. It has replaced discipline-specific assessments (occupational therapy, physiotherapy, speech pathology, and social work) at the Mater Hospital Brisbane, and acts as a trigger for referrals to allied health professionals. The TINSA has been tested by a clinical pre-/post- study at the Mater Hospital Brisbane, and results showed improved time-efficiency and cost savings without affecting the quality of care (patient safety and outcomes). The TINSA is administered by a trained occupational therapist or physiotherapist. For patients receiving the TINSA, this involves verbal questions, a brief communication screen and a physical assessment (including a mobility assessment). When the TINSA is used, patients will experience less duplication of assessment questions and tasks. After the assessment, the administering allied health professional (e.g., occupational therapist or physiotherapist) will make referrals to the wider Allied Health team, as per their clinical training and judgement. After the novel TINSA has been administered and subsequent allied health referrals made, allied health input (i.e. the treatment, re-assessment, discharge panning, follow-up) will continue as per usual care. If no further allied health is indicated after the TINSA, the assessor can discharge the patient (i.e. safe to return home). In this study, the TINSA will be modified (as necessary to suit the local setting) and implemented in the study sites, replacing discipline-specific allied health assessments. At each site, a clinical pathway will be developed, as a strategy to ensure adherence to the intervention. The TINSA will be used for all patients admitting during pre-determined time periods at each study site (during the 2 month transition period, and the 2-4 month post-implementation period). Usual allied health assessment will be used for all patients during the 2-4 month pre-implementation period.

Competency training for the TINSA:
9 eLearning modules are available to health professionals via the Queensland Health learning management system (iLearn). The training modules provide information on how to perform tests, asks questions, and clinical reasoning across the domains of vision/perception, communication assessment, respiratory assessment, mood, upper/lower limbs assessment, shoulder precautions, functional mobility assessment, Timed Up and Go test, and the 10 meter walk test. Each module includes written information, videos on task/question administration, and a knowledge check quiz. These resources were developed as part of an earlier study that evaluated the TINSA at the Mater Hospital Brisbane (ACTRN12621000380897). The resources have now been transferred onto iLearn and are available for Queensland Health and external professionals. The designated allied health professional/s (e.g., occupational therapists and physiotherapists) complete the competency training before administering the TINSA with patients. The modules take approximately 10-30 minutes each and are completed when the professional is able. In the study, a 2 month transition period will be used to allow for sufficient time to complete the training. After completing the eLearning modules, the allied health professional will complete the TINSA under supervision until they are marked as 'competent' according to the competency assessment criteria (copy available online: https://doi.org/10.14264/1749adb, pp80-81). The training can be re-completed at any time, at the discretion of the allied health professional, to ensure maintenance of skills. The mandatory competency training is a strategy to ensure the TINSA is delivered in a safe and standardized way.

Implementation manual:
An implementation manual for transdisciplinary approaches in healthcare was developed following a previous study (ACTRN12621000380897) and is available online https://doi.org/10.14264/1749adb. The implementation manual will guide the local team to modify the TINSA to suit their local setting and patient presentations. The implementation manual involves three stages to 1) plan and prepare, 2) implement and evaluate, and 3) sustain and expand. In this study, stages 1 and 2 will be followed during weekly team meetings prior to the implementation of the TINSA.

Focus Group (healthcare providers):
At the end of the transdisciplinary implementation and data collection phase, acute stroke unit/medical ward staff will be invited by the local study coordinator to participate in a once-off, online, 60 minute Focus Group (via work email, staff meetings/huddles, and verbal invitations). Recruitment will occur over two weeks at each study site. It is estimated that a maximum of 20 staff will be asked to participate (i.e., all allied health, nursing, medical staff working on the ward). Interested staff will reply and nominate a suitable date/time. We are aiming to recruit a maximum of 8 Focus Group participants per site. At this point, the local study coordinator will organise the Focus Groups by sending Outlook diary invitations with a Zoom link for the Focus Group and the PICF for healthcare staff to read and consider before providing written consent. The Principal Investigator (AM) will facilitate and later transcribe the online Focus Group with healthcare staff. A Co-investigator (LL) will assist with the Focus Group. The role will be to alert the Principal Investigator of any matters that may not have been noted by the focus group facilitator and which need to be addressed before the end of the Focus Group; and to take notes of any non-verbal or other matters that may arise. This method will ensure that the Focus Group method obtains its aims and objectives. In the focus group, topics discussed will be the utility of the TINSA and the implementation experience.
Intervention code [1] 329231 0
Treatment: Other
Comparator / control treatment
Usual allied health discipline-specific assessments.

Usual allied health assessment are separate and discipline-specific assessments (e.g., by the speech pathologist, social worker, occupational therapist and physiotherapist as per usual practice).
Control group
Active

Outcomes
Primary outcome [1] 339044 0
Total time spent completing allied health assessment (in minutes). This includes time taken to read the Current Attendance Record (CAR), plus time taken to administer the initial assessment, plus time taken to record results after assessment administration.
Timepoint [1] 339044 0
The initial occasion of service by allied health (i.e., on admission) when the TINSA is being completed.
Secondary outcome [1] 438369 0
Number of face-to-face occasions of service by allied health professionals.
Timepoint [1] 438369 0
From inpatient admission into the hospital to discharge from the hospital.
Secondary outcome [2] 438375 0
Length of hospital stay.
Timepoint [2] 438375 0
Day/time admitted and discharged from hospital.
Secondary outcome [3] 438376 0
Number of allied health professionals involved in care.
Timepoint [3] 438376 0
From inpatient admission into the hospital to discharge from the hospital.
Secondary outcome [4] 438377 0
Number of allied health referrals generated/documented per each initial allied health assessment (TINSA).
Timepoint [4] 438377 0
At the conclusion of each initial allied health assessment (TINSA).
Secondary outcome [5] 438380 0
Time allied health referrals were actioned/documented.
Timepoint [5] 438380 0
Time/day of admission to hospital and time/day when allied health referrals documented.
Secondary outcome [6] 438381 0
Number of allied health referrals documented by not actioned
Timepoint [6] 438381 0
From inpatient admission into the hospital to discharge from the hospital.
Secondary outcome [7] 438382 0
Time of referral to subacute option such as rehabilitation (if required)
Timepoint [7] 438382 0
Time/date of admission to hospital and time/day when referral to subacute option is documented.
Secondary outcome [8] 438383 0
Discharge destination
Timepoint [8] 438383 0
Discharge from hospital
Secondary outcome [9] 438384 0
Function
Timepoint [9] 438384 0
On admission and discharge from hospital.
Secondary outcome [10] 438385 0
Functional outcomes at 3 months
Timepoint [10] 438385 0
3 months after hospital admission
Secondary outcome [11] 438386 0
Time allied health initial assessment completed
Timepoint [11] 438386 0
Time/date of admission to hospital and time/day when initial assessment completed.
Secondary outcome [12] 438387 0
Time when allied health rehabilitation/treatment commenced
Timepoint [12] 438387 0
Time/date of admission to hospital and time/date of the first rehabilitation/treatment session.
Secondary outcome [13] 438388 0
Inpatient falls
Timepoint [13] 438388 0
From inpatient admission into the hospital to discharge from the hospital.
Secondary outcome [14] 438389 0
Unplanned readmission within 30 days unrelated to a new episode of care
Timepoint [14] 438389 0
30 days after discharge from hospital
Secondary outcome [15] 438390 0
Utility of the transdisciplinary assessment
Timepoint [15] 438390 0
Audit will be completed after discharge from hospital; staff focus group held at the end of the post-implementation period (i.e., 8 months after study commencement).
Secondary outcome [16] 438391 0
Successful implementation of the transdisciplinary assessment
Timepoint [16] 438391 0
Working party meetings will occur throughout the study period on a weekly basis (a total of 10 months, from 2 months before the pre-implementation period to the end of the post-implementation period); the staff focus group will occur at the end of the post-implementation period (i.e., 8 months after study commencement).
Secondary outcome [17] 438392 0
Patient/carer consumer perceptions of the transdisciplinary assessment and study results
Timepoint [17] 438392 0
Before and after the 8-month study period, scheduled for the months of September 2024 and October 2025.

Eligibility
Key inclusion criteria
1) Working party members will include the local study coordinator who invites other staff to join if they are:
• Clinical healthcare professionals working on the acute stroke unit/medical ward during the study period
• Clinical managers of staff involved in the study
• Other staff employed at the study site with local/expert knowledge to contribute (e.g., education specialists, clinician-researchers, stroke specialists)

2) Patient/carer consumers are eligible to provide feedback on the transdisciplinary assessment and study results if they:
• Have experienced stroke assessment as a hospital inpatient or carer, at any Queensland hospital. For example, consumers could be current/previous patients, carers, or consumer representatives.
• Be able to use technology independently or with carer assistance (i.e., access/watch/listen to a video and read/respond to online survey questions)
• Attend for 2 sessions of 60-90 minutes (with breaks if required)
• Understand/read/write in English
• Consumers will not require training to participate and can be supported by a carer.

3) Patients with stroke/medical conditions are eligible to participate if they:
• Admit to the participating acute stroke unit/medical ward with confirmed/suspected stroke (acute stroke unit) or a medical condition (medical ward) during the study period and business hours (i.e., Monday–Friday)
• Receive allied health assessment/s
• A third-party interpreter is available when patients do not speak English
• Have not previously been included in the study

4) Healthcare staff are eligible to participate in the focus group if they:
• Have worked on the participating acute stroke units or medical ward during the study period
• Have worked in a clinical role, clinical manager role, working party member, and/or local study facilitator role during the study period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient exclusion criteria:
• Patients who are admitted over a weekend (Saturday and Sunday) or on a public holiday.
• Patients with stroke who are not transferred to the Acute Stroke Unit or medical ward.
• Patients who do not speak English where a third-party professional interpreter is unavailable to assist with translation.
• Patients who have already been included in the study at an earlier time point (i.e., have been readmitted).
• Patients without cognitive capacity to provide consent (criteria for Hollywood Private medical ward only)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Patient participants will receive usual allied health assessment if admitted during the pre-implementation phase, and transdisciplinary allied health assessment if admitted during the transition and post-implementation phases.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size calculation (acute stroke unit): Most Queensland hospitals have 75-349 stroke admissions per year (AuSCR, 2023), which would equal 38-175 admissions/site over the 6-month study period. With these numbers, we can feasibly recruit 48 patients (i.e., 24 participants/acute stroke unit). With 2 clusters, choosing a significance level of 0.05, assuming a within cluster standard deviation of 22 minutes and intraclass correlation of 0.10, the study would be 83.1% powered to detect a 35-minute difference in assessment time. The calculation was completed using PASS 2020. The standard deviation of 22 minutes is based on the overall standard deviation (21.5 minutes) for staff assessment time when usual assessment and transdisciplinary assessment were compared in a previous study at the Mater Hospital Brisbane. The 35-minute difference is based on the time savings achieved in a previous study at the Mater Hospital Brisbane and is stated in the primary hypothesis.

Analysis
Primary outcome (assessment time): Data will be summarised for sites individually/combined, pre- and post-implementation, for the acute stroke units and the medical ward. Descriptive statistics will be presented using frequency/percent for categorical variables, means/standard deviations or medians/interquartile ranges for continuous variables. Differences between assessment groups will be estimated using multivariable mixed effects linear and logistic regression. All analyses will be performed using Stata 15.1 (Stata Corp, College Station, TX) and a p-value <0.05 will be considered statistically significant. The primary analysis will consider the effect of TINSA on acute stroke units separately to the effect of TINSA on medical ward. However, if the data from acute stroke units and wards are comparable and data is available for all variables of interest, then we will perform additional exploratory analysis by combining the data and investigating whether the effect of the TINSA is different for acute stroke units and wards using an interaction term.

Quantitative secondary outcomes: Pre- and post-implementation data will be summarised for sites individually and together, for the acute stroke units and the medical ward. Descriptive statistics will be described using frequency/percent for categorical variables, means/standard deviations or medians/interquartile ranges for continuous variables. A cost estimation of time saved will use wage rates from the “Health Practitioners and Dental Officers (Queensland Health) Certified Agreement” and acute stroke unit/medical ward per diem cost.

Qualitative secondary outcomes: Multiple-choice questions and Likert scales will be calculated and descriptively summarised using numbers (N) and percentages (%), for the acute stroke units and medical ward. Open responses and qualitative text from online surveys (patient/carer consumers) will be coded using inductive content analysis in NVivo 12 Plus software (QSR International). Open responses and qualitative text from meeting minutes (working party group) and the Focus Group (healthcare staff) will be coded using thematic analysis in NVivo 12 Plus software (QSR International). For thematic analysis, the data will be considered collectively using a critical realism theoretical position (to understand experiences, perspectives, and opinions) and an inductive approach (i.e., data-driven, not driven by the research question or knowledge about the literature). Initial codes will be generated at the semantic level (i.e., not looking beyond what the participant has said), the initial codes will be sorted into potential themes, and the potential themes will be reviewed and then defined.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 26908 0
Caboolture Hospital - Caboolture
Recruitment hospital [2] 26909 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [3] 26910 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 42970 0
4510 - Caboolture
Recruitment postcode(s) [2] 42971 0
4020 - Redcliffe
Recruitment postcode(s) [3] 42972 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 317135 0
Government body
Name [1] 317135 0
Queensland Health Clinical Research Fellowship
Country [1] 317135 0
Australia
Funding source category [2] 317139 0
Other
Name [2] 317139 0
Mater Research Institute
Country [2] 317139 0
Australia
Primary sponsor type
Other
Name
Mater Misericordiae Ltd
Address
Country
Australia
Secondary sponsor category [1] 319406 0
None
Name [1] 319406 0
Address [1] 319406 0
Country [1] 319406 0
Other collaborator category [1] 283132 0
University
Name [1] 283132 0
University of Queensland
Address [1] 283132 0
Country [1] 283132 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315887 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 315887 0
Ethics committee country [1] 315887 0
Australia
Date submitted for ethics approval [1] 315887 0
14/06/2024
Approval date [1] 315887 0
16/07/2024
Ethics approval number [1] 315887 0

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

Contacts
Principal investigator
Name 136102 0
Ms Aleysha Martin
Address 136102 0
Mater Research Institute, Level 2 Aubigny Place, Raymond Terrace, South Brisbane, 4101, QLD.
Country 136102 0
Australia
Phone 136102 0
+61 457993248
Fax 136102 0
Email 136102 0
aleysha.martin@uq.edu.au
Contact person for public queries
Name 136103 0
Aleysha Martin
Address 136103 0
Mater Research Institute, Level 2 Aubigny Place, Raymond Terrace, South Brisbane, 4101, QLD.
Country 136103 0
Australia
Phone 136103 0
+61 457993248
Fax 136103 0
Email 136103 0
aleysha.martin@uq.edu.au
Contact person for scientific queries
Name 136104 0
Aleysha Martin
Address 136104 0
Mater Research Institute, Level 2 Aubigny Place, Raymond Terrace, South Brisbane, 4101, QLD.
Country 136104 0
Australia
Phone 136104 0
+61 457993248
Fax 136104 0
Email 136104 0
aleysha.martin@uq.edu.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?
Unidentifiable individual participant data underlying published results.
When will data be available (start and end dates)?
Available after all datasets are final (estimated late 2025), no end date.
Available to whom?
Available via UQ eSpace on a case-by-case basis at the discretion of the Principal Investigator and on reasonable request. E.g., sharing of data would be considered for clinician researchers/researchers who provide a relevant and methodologically sound proposal.
Available for what types of analyses?
The raw data will be made available on reasonable request for relevant and methodologically sound proposals, and for the purpose to achieve the aim/s in the proposal.
How or where can data be obtained?
Once published on UQ eSpace (data repository), permission can be requested to access the data, and a doi will be linked to the dataset. Before the IPD is available on UQ eSpace, the Principal Investigator can be contacted (Aleysha Martin, aleysha.martin@uq.edu.au).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24080Ethical approval    388261-(Uploaded-07-08-2024-16-04-43)-24-07-16_TINSATranslation_ERM-108414_HREC-approval-letter (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.