Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001066572
Ethics application status
Approved
Date submitted
19/08/2024
Date registered
3/09/2024
Date last updated
3/09/2024
Date data sharing statement initially provided
3/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
IMplementing clinical Pathways for Acute Care in Tasmania (IMPACT)
Scientific title
Co-designing and evaluating the implementation of clinical pathways for acute care in Tasmania
Secondary ID [1] 312785 0
MRF2018041
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chest pain 334840 0
fractured neck of femur 334841 0
stroke 334842 0
sepsis 334843 0
Condition category
Condition code
Emergency medicine 331397 331397 0 0
Other emergency care
Cardiovascular 331438 331438 0 0
Coronary heart disease
Injuries and Accidents 331439 331439 0 0
Fractures
Stroke 331440 331440 0 0
Ischaemic
Stroke 331441 331441 0 0
Haemorrhagic
Public Health 331442 331442 0 0
Health service research
Infection 331443 331443 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In partnership with the health sector in each Tasmanian ED, we will identify, and explore the factors influencing practice variation for clinical pathways used in these EDs and develop targeted implementation strategies as part of an Implementation and Evaluation Toolkit (IET). An established, proven theory informed, co-designed approach to developing the strategies will be used. Using the Theoretical Domains Framework (TDF), qualitative interviews or focus groups will explore individual and organisational factors that contribute to variations in practice at each location. The TDF incorporates a range of behaviour change theories for use in implementation research. The validated TDF has demonstrated strong explanatory and predictive powers across health care, including acute care settings, and is particularly useful when selecting interventions to improve practice. Implementation strategies will be co-designed with clinicians at each hospital, taking into consideration the likelihood of the strategies impacting the identified influencing factors (grouped by TDF domains), evidence of their effectiveness and their acceptability/feasibility in the hospital setting. Assessments of ex-ante cost-effectiveness will also be used to support decision-making.

The intervention will be an implementation toolkit for 4 clinical pathways used in ED: 1) Chest Pain 2) Suspected Stroke 3) Fractured Neck of Femur and 4) Suspected Sepsis.

The intervention will be co-designed with clinicians. The toolkit has therefore yet to be developed and may be different at each site.
Broadly, the physical or informational materials used will include education activities by champions within the health service, changes to how and where clinical pathways are accessed as well as audit and feedback as part of service delivery.

The intervention will be delivered by the research team in conjunction with health service staff.

The mode of delivery will be multimodal - education, system changes to how pathways are accessed and technology changes to incorporate audit and feedback into routine care.

The number of times that the intervention will be delivered will be determined following co design and understanding of health service workload and built in implementation strategies. We aim to implement the toolkit over a 6 month period prior to evaluation.

the location of the intervention will be all four Tasmanian public EDs: North West Regional Hospital, Mersey Community Hospital, Launceston General Hospital and royal Hobart Hospital EDs.
Intervention code [1] 329314 0
Treatment: Other
Intervention code [2] 329353 0
Behaviour
Comparator / control treatment
This is a health service implementation study where the intervention is a co-designed implementation toolkit.

To determine baseline performance characteristics, we will retrospectively ascertain all points on the clinical pathways for patients who were eligible for the pathway. For the period 1 January 2021 to 31 December 2021, data from 200 eligible patient medical records (100 from THS-South (Royal Hobart Hospital), 50 from THS-N (Launceston General Hospital) and 50 from THS-NW (North West Regional Hospital and Mersey Community Hospital), identified by triage descriptors and confirmed by chart review, will be extracted, recording variables relevant for each of the four clinical pathways, and indicators of adherence to the pathways determined. This approach is being used as it offers a pragmatic and feasible design largely limited by the analogue medical records system used by the health services. Key outcome data include length of stay in EDs, 28-day representation to EDs, hospital length of stay, in-hospital complications, and death.
Control group
Historical

Outcomes
Primary outcome [1] 339145 0
Clinical pathway compliance
Timepoint [1] 339145 0
1 year of baseline data (1 Jan 2021 to 31 Dec 2021) and 1 year of data commencing 6 months after implementation of the co-designed toolkit
Secondary outcome [1] 438753 0
Sustainability of implementation toolkit
Timepoint [1] 438753 0
18 months post implementation and 24 months post implementation

Eligibility
Key inclusion criteria
the measure of outcomes will include 4 specific pathways: chest pain, suspected stroke, suspected sepsis and fractured neck of femur

All patients within the study period who are eligible for one of these four pathways will be included in the study.

eligibility includes:

1) Chest pain pathway: triage description including chest pain as a presenting complaint
2) Suspected stroke pathway: triage description including suspicion of stroke as an assessment
3) Fractured Neck of Femur: Diagnosis of fractured neck of femur for that ED episode
4) Suspected sepsis pathway: blood cultures ordered by treating clinician
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have been treated and transferred between study EDs

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2026
Actual
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
29/02/2028
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 317218 0
Government body
Name [1] 317218 0
Medical Research Futures Fund, Department of Health and Aged Care
Country [1] 317218 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Country
Australia
Secondary sponsor category [1] 319489 0
Hospital
Name [1] 319489 0
Royal Hobart Hospital
Address [1] 319489 0
Country [1] 319489 0
Australia
Secondary sponsor category [2] 319491 0
Hospital
Name [2] 319491 0
Launceston General Hospital
Address [2] 319491 0
Country [2] 319491 0
Australia
Secondary sponsor category [3] 319492 0
Hospital
Name [3] 319492 0
Mersey Community Hospital
Address [3] 319492 0
Country [3] 319492 0
Australia
Secondary sponsor category [4] 319493 0
Hospital
Name [4] 319493 0
North West Regional Hospital
Address [4] 319493 0
Country [4] 319493 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315953 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 315953 0
Ethics committee country [1] 315953 0
Australia
Date submitted for ethics approval [1] 315953 0
09/03/2023
Approval date [1] 315953 0
19/05/2023
Ethics approval number [1] 315953 0

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

Contacts
Principal investigator
Name 136330 0
A/Prof Viet Tran
Address 136330 0
Emergency Department, Royal Hobart Hospital, 48 Liverpool Street, Hobart TAS 7000
Country 136330 0
Australia
Phone 136330 0
+61 431225509
Fax 136330 0
Email 136330 0
v.tran@utas.edu.au
Contact person for public queries
Name 136331 0
Viet Tran
Address 136331 0
Emergency Department, Royal Hobart Hospital, 48 Liverpool Street, Hobart TAS 7000
Country 136331 0
Australia
Phone 136331 0
+61 431225509
Fax 136331 0
Email 136331 0
v.tran@utas.edu.au
Contact person for scientific queries
Name 136332 0
Viet Tran
Address 136332 0
Emergency Department, Royal Hobart Hospital, 48 Liverpool Street, Hobart TAS 7000
Country 136332 0
Australia
Phone 136332 0
+61 431225509
Fax 136332 0
Email 136332 0
v.tran@utas.edu.au

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?

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.