Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000639426
Ethics application status
Approved
Date submitted
13/02/2025
Date registered
17/06/2025
Date last updated
17/06/2025
Date data sharing statement initially provided
17/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the implementation of a hospital inpatient nursing framework: HIRAID® (History including Infection risk, Red flags, Assessment, Interventions, Diagnostics, reassessment, and communication) Inpatient
Scientific title
Implementation evaluation of an evidence-informed hospital inpatient nursing framework (HIRAID® Inpatient): a stepped-wedge cluster RCT
Secondary ID [1] 313935 0
NHMRC GNT2037072
Universal Trial Number (UTN)
Trial acronym
HIRAID® Inpatient
Linked study record
This study builds on and translates established existing evidence in emergency nursing care using the emergency nursing framework HIRAID® (History including Infection risk, Red flags, Assessment, Interventions, Diagnostics, reassessment, and communication). Registration of prior study: ACTRN12621001456842

Health condition
Health condition(s) or problem(s) studied:
Hospital inpatients (medical, surgical, aged care, respiratory, cardiac, neurology) 336630 0
patient deterioration 336667 0
Condition category
Condition code
Surgery 333132 333132 0 0
Other surgery
Cardiovascular 333164 333164 0 0
Other cardiovascular diseases
Neurological 333165 333165 0 0
Other neurological disorders
Musculoskeletal 333166 333166 0 0
Other muscular and skeletal disorders
Public Health 333425 333425 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clinical Trial:

This study will use an effectiveness-implementation hybrid design, including a Stepped–Wedge cluster Randomised Control Trial (SW-cRCT). The hybrid approach allows testing of the implementation strategy at the same time as observing the outcomes of the intervention. A SW-cRCT design is appropriate for health service interventions as it simplifies data collection procedures, better supports logistical processes, accommodates temporal issues and optimises resource use. Approximately 18m of data collection for intervention and control.

The SW-cRCT will follow four steps. Facilities will be assigned to one of four clusters, with all clusters beginning in the control phase (Step 1), where baseline data and behavioural diagnostics will be collected. This step will take between 3-12 months, dependant on the cluster. A context-specific implementation strategy will be developed based on the information collected at baseline and behavioural diagnostics.

Next (step 2), the HIRAID® Inpatient intervention will be implemented with nursing staff over three months.

Step 3 will include official post-intervention data collection, lasting between 3-12 months, depending on the cluster. Each facility’s trial, from baseline data collection (step 1) to the end of outcome measurement (end of step 3)– is estimated to take 18 months. The SW-cRCT for all four clusters is estimated to also take about 18m depending on individual clusters.

Finally in Step 4, data from all sources will be integrated, and the process of review, knowledge translation and dissemination will commence. Partners will be consulted to evaluate and produce the final HIRAID® Inpatient toolkit. Initial stages of effectiveness-implementation evaluation and refinement for upscale will commence.

Study Plan
Type II effectiveness-implementation hybrid study to measure the effect (effectiveness) and uptake (implementation) of HIRAID® on patient, staff and health service outcomes including a stepped-wedge clustered randomised Control Trial (SW-cRCT) ~18m (of data collection for intervention and control).:

Developing/adaptation of implementation strategies
Cluster-specific modifiable implementation strategies will be developed (pre step 1) using the Theoretical Domains Framework (TDF) and Behaviour Change Wheel (BCW) for approximately 9m prior to the start of the SW-cRCT, with implementation components being ready to deploy 3m later, alingning with the end of cluster 1's baseline data. Behavioural diagnostics, through nurse surveys and focused groups, will identify enablers and barriers to implementing HIRAID® Inpatient. The nursing workforce positions are Registered Nurses, Nurse Unit Managers, Clinical Nurse Consultants, Nurse Practitioners and Clinical Nurse Educators. All hospital inpatient nurses employed permanently (full and part-time) and casual staff on the study wards will be invited to complete the survey. Semi-structured focus group interviews with consenting ward leaders and nurses will be conducted on-site and audio recorded. Qualitative data will be collected through these focus groups to gain a deeper understanding of the barriers and enablers to HIRAID® Inpatient implementation identified in the survey by exploring aggregated survey responses. Findings will be mapped to the TDF and BCW, to inform the development, adaptation, and preparation of site-specific strategies. The BCW will be used to connect enablers and barriers to specific intervention functions and techniques for sustained behaviour change.

Survey: The survey will involve distributing four emails to eligible participants: one initial invitation when the survey opens, and one reminder email weekly until after the initial invitation and until the survey closes. Participants will have four weeks from the first invitation to consider participation and to complete the survey. After completing the electronic survey pre-intervention, nurses will also be invited to participate in a focus group with a member of the research team. This will collect more comprehensive, qualitative data on nurses’ perception of the intervention and enabler / barriers to HIRAID® Inpatient and its implementation.

Focus groups: Semi structured focus group interviews with consenting ward leaders and nurses will be conducted on site that will be audio recorded. Qualitative data will be collected via focus groups to provide a greater understanding of the barriers and enablers to HIRAID® Inpatient implementation identified in the survey by exploring aggregated survey responses. Focus groups are commonly used in health research to gain more understanding of phenomena. Four to six focus groups (or until data saturation) will be conducted for each cluster. It is anticipated four to eight participants will be involved in each focus group. The focus groups will be conducted in a private room away from the clinical area to minimise distraction but enable clinicians in an emergency to quickly return to the clinical area. The focus groups will be conducted over a three-month period.

The final implementation strategy will be refined using behaviour change techniques taxonomy and the APEASE criteria as baseline data is collected (Steps 1-2). This method that was successfully applied to the implementation of HIRAID® in the ED. Once survey results are integrated, the new findings will be mapped to the TDF to enable a comprehensive, targeted theory-informed approach to the development of the implementation strategy. The TDF is used to identify determinants of behaviour and provide comprehensive and systematic approaches to intervention implementation. The mapped TDF domains will be integrated into the BCW, through linking to intervention function(s). The BCW is a validated series of tools for developing behaviour change interventions and shown to improve the sustained success of clinical interventions. Intervention functions form part of the BCW and are designed to influence behaviour by addressing capability, opportunity, and motivation. If items cross multiple TDF domains and, or intervention functions, the research team will resolve this through a discussion, led by a senior member of the research team with extensive experience in the use of the TDF and behaviour change theories.

Education and training of nursing staff
All nursing staff will receive pedagogically informed (1) education regarding the theory and practice of HIRAID® Inpatient. The education approach will be co-designed with experts from the participating organisations and will be grounded in principles of constructive alignment (2-4) backwards design(5) and scaffolded learning (6). HIRAID® Inpatient training will initially be provided to senior/ management/ Clinical Nurse Consultant (CNC)/ Clinical Nurse Educator (CNE) staff at each site, followed by separate sessions for the remaining Registered Nurse (RN) and Enrolled Nurse (EN) workforce. Senior RNs will also complete HIRAID® Inpatient Instructor training, to independently deliver HIRAID® Inpatient training, ensuring sustainability. Completion of HIRAID® Inpatient training will be mandatory for all new nursing staff, this will be integrated into orientation and onboarding programs through the established instructor base.

Integration of HIRAID® framework into hospital systems
HIRAID® Inpatient documentation templates will be incorporated into local electronic and paper-based documentation systems. A standardised template will be created for HIRAID® Inpatient, will include fields and prompts for all framework elements. Integration will be adapted based on local factors, such as use of electronic or paper-based documentation, and in the case of electronic documentation, the product(s) used (e.g. PowerChart), automation features, and compatibility with existing tools. The documentation templates will be designed to streamline assessment documentation, minimise duplication, administrative burdens, and redundancies for hospital ward nurses.

Supporting materials
Several strategies willl be tailored to address hospital-specific barriers will be deployed to support implementation. Co-designed educational materials will provide easy access to learning and support. Environmental cues such as posters and reference cards will offer immediate reminders of HIRAID® Inpatient structure and elements. Implementation Research nurses and nurse champions from the nursing workforce will positively reinforce adoption. Research implementation nurses will conduct fortnightly audits of nursing documentation to monitor uptake, maintain a record of implementation strategies executed within their allocated cluster, provide updates, identify teaching opportunities and address implementation issues.

1. Shaban RZ CK, Fry M, McCormack B, Parker D, Lam MK, Low LF, Jeon YH, Waters D, Lindley RI, Watson K, Dunsmore M, Considine J, Squillacioti G, Thompson L, Smith A, Begum M, Dalton JA, Ramsden C, Glennan J, Viengkham C. . Nurse-led framework to improve the safety and quality of residential aged care (HIRAID® Aged Care): protocol for a stepped-wedge cluster randomised controlled trial. Trials. 2024;25(1):737.
2. Biggs J, Tang C. Constructive alignment: An outcomes-based approach to teaching anatomy. Teaching anatomy: A practical guide: Springer; 2014. p. 31-8.
3. Biggs J, Tang C, editors. Applying constructive alignment to outcomes-based teaching and learning. Training material for “quality teaching for learning in higher education” workshop for master trainers, Ministry of Higher Education, Kuala Lumpur; 2010.
4. Biggs J. Enhancing teaching through constructive alignment. Higher education. 1996;32(3):347-64.
5. Wiggins GP, McTighe J. Understanding by design: Ascd; 2005.
6. Wood D, Bruner JS, Ross G. The role of tutoring in problem solving. Journal of child psychology and psychiatry. 1976;17(2):89-100.
Intervention code [1] 330524 0
Treatment: Other
Comparator / control treatment
Participants in the control group will receive usual care. Usual care is defined as current nurse assessment, management and documentation practices for the local site.
Control group
Active

Outcomes
Primary outcome [1] 340683 0
Change in rapid response team activation due to patient deterioration related to nursing care
Timepoint [1] 340683 0
Due to the stepped nature of the protocol each cluster will be collected over an 18m period (with a 3month break of data collection), totalling 15m of data collection of combined control and intervention data. This ratio will change depending on the cluster allocation with the minimum collection of either being 3m and the maximum being 12m.
Primary outcome [2] 340684 0
Change in Rate per 1000 patient days of healthcare-associated infection (HAC03).
Timepoint [2] 340684 0
Due to the stepped nature of the protocol each cluster will be collected over an 18m period (with a 3month break of data collection), totalling 15m of data collection of combined control and intervention data. This ratio will change depending on the cluster allocation with the minimum collection of either being 3m and the maximum being 12m.
Primary outcome [3] 340685 0
Change in Hospital Acquired Complication (HAC06)
Timepoint [3] 340685 0
Due to the stepped nature of the protocol each cluster will be collected over an 18m period (with a 3month break of data collection), totalling 15m of data collection of combined control and intervention data. This ratio will change depending on the cluster allocation with the minimum collection of either being 3m and the maximum being 12m.
Secondary outcome [1] 444794 0
Change in events causing patient harm or near miss
Timepoint [1] 444794 0
Due to the stepped nature of the protocol each cluster will be collected over an 18m period (with a 3month break of data collection), totalling 15m of data collection of combined control and intervention data. This ratio will change depending on the cluster allocation with the minimum collection of either being 3m and the maximum being 12m.
Secondary outcome [2] 444795 0
Change in experience of care reported by patient or carer (Primary outcome)
Timepoint [2] 444795 0
Due to the stepped nature of the protocol each cluster will be collected over an 18m period (with a 3month break of data collection), totalling 15m of data collection of combined control and intervention data. This ratio will change depending on the cluster allocation with the minimum collection of either being 3m and the maximum being 12m.
Secondary outcome [3] 444796 0
Change in quality of nurse communication and handover (Primary outcome)
Timepoint [3] 444796 0
Due to the stepped nature of the protocol each cluster will be collected over an 18m period (with a 3month break of data collection), totalling 15m of data collection of combined control and intervention data. This ratio will change depending on the cluster allocation with the minimum collection of either being 3m and the maximum being 12m.
Secondary outcome [4] 444797 0
The cost-effectiveness of HIRAID® Inpatient will be studied.
Timepoint [4] 444797 0
Due to the stepped nature of the protocol each cluster will be collected over an 18m period (with a 3month break of data collection), totalling 15m of data collection of combined control and intervention data. This ratio will change depending on the cluster allocation with the minimum collection of either being 3m and the maximum being 12m.
Secondary outcome [5] 445719 0
Reach will be determined by the number, proportion, and representativeness of individuals willing to participate in the HIRAID® Inpatient program.
Timepoint [5] 445719 0
The HIRAID® implementation strategy evaluation plan will be guided by the RE-AIM framework. This will be assessed after the data is cleaned and integrated (which will be after all clusters complete intervention data collection). It will take approximately 12m.
Secondary outcome [6] 448475 0
Adoption of HIRAID® Inpatient implementation will be explored. (settings level) The number of sites eligible and willing to initiate a program, and why (Individual level) Delivery staff invited to participate, and characteristics of participants) and intervention adoption rate
Timepoint [6] 448475 0
The HIRAID® implementation strategy evaluation plan will be guided by the RE-AIM framework. This will be assessed after the data is cleaned and integrated (which will be after all clusters complete intervention data collection). It will take approximately 12m.
Secondary outcome [7] 448476 0
Dose of HIRAID® Inpatient implementation will be explored.
Timepoint [7] 448476 0
The HIRAID® implementation strategy evaluation plan will be guided by the RE-AIM framework. This will be assessed after the data is cleaned and integrated (which will be after all clusters complete intervention data collection). It will take approximately 12m.
Secondary outcome [8] 448477 0
The fidelity of HIRAID® Inpatient implementation will be explored.
Timepoint [8] 448477 0
The HIRAID® implementation strategy evaluation plan will be guided by the RE-AIM framework. This will be assessed after the data is cleaned and integrated (which will be after all clusters complete intervention data collection). It will take approximately 12m.
Secondary outcome [9] 448516 0
Sustainability of HIRAID® Inpatient implementation will be explored.
Timepoint [9] 448516 0
The HIRAID® implementation strategy evaluation plan will be guided by the RE-AIM framework. This will be assessed after the data is cleaned and integrated (which will be after all clusters complete intervention data collection). It will take approximately 12m.

Eligibility
Key inclusion criteria
There are four different populations that will be examined for this study: admitted patients (H1, H2, H3 and H6), patients and carers (H4), nursing/allied/medical staff (H5) and nursing facilitators (H7).


1a. Patients with preventable clinical deterioration related to nursing care (H1).
To address H1 (20% reduction in rapid response team activation due to preventable patient deterioration), all patients admitted to the ward with a deterioration call, with no exclusion criteria, will be included in the study. All patients where there was a Rapid response/ MET call will be identified through standard procedures used in each LHD and provided to site research nurses. Each RRT activation is recorded in local databases which will be used to identify patients for medical record review.

1b,. Patients with a Hospital Acquired Complications (H2).
- Hospital acquired complication data from inpatients of a study ward.

1c. Patients subjected to events causing harm or near miss (H3).
- Harm/near miss data from inpatients of a study ward.

2. Inpatients (or their carers) of a study ward (H4).
- A convenience sample of patients, or carers, who meet the study inclusion criteria will be invited to participate in the Patient/carer experience survey. The research nurse will screen a potential patients/carer for suitability for enrolment in the study.

Inclusion criteria:
a. Patient, or carer of a patient admitted to the ward during study period;
b. patient/ carer over 18 years of age.

3. (i) Permanently/fixed term employed (a) nursing, (b) senior medical and (c) allied health staff. (H5)
- Satisfaction with the quality of the information transferred from nursing staff during handover, and (ii) nurse confidence in patient assessment and escalation of care will be sought from nurses, and medical and allied health staff through a stay survey.

4. Nurse facilitators (Implementation fidelity)
- Clinical nurse consultants/ clinical nurse educators employed to assist with education and roll out will be invited to participate in evaluation of implementation fidelity.


Participants and eligibility criteria

Nursing staff
All permanent and fixed term employee nursing staff of partner organisations will complete HIRAID® Inpatient training to implement the framework in routine practice. Nursing staff will also be invited to participate in the evaluation of the intervention (i.e. surveys on quality of information in handovers and confidence in patient assessment and escalation of care). To be eligible, nurses must be employed by a participating hospital during the study period and have received the HIRAID® Inpatient training. Sampling will be stratified based on the bed numbers of each ward.

Medical staff
Medical and allied healthcare staff employed or contracted by partnering organisations will be eligible to participate in the evaluation of the intervention with no exclusions. Participation will include the completion of surveys and interviews to understand how the intervention has changed their working relationship and communication with inpatient nursing staff.

Inpatients (or their carers) of a study ward
All patients admitted to the ward that meet study inclusion criteria will be provided with a participant information sheet for the study. Patients will be excluded from the study if they are at end-of-life care or if they (or their carers) have cognitive impairment If the patient is under 18, we will approach their carer if the carer is over 18. If the carer present is not over 18, we will not approach them. If the patient is not clinically suitable to approach, for example in significant pain, cognitive impairment and so on, the carer will be approached if present and appropriate as confirmed by the treating clinician. If the patient declines to participate, the carer will not be approached. A waiver of consent has been approved for the collection of de-identified inpatient data, which will include medical records, care plans, charts, progress notes, and all associated documentation pertaining to clinical deterioration, incidents, and hospital transfers. Inpatients will also be able to participate in surveys and interviews. Surveys will take approximately 10-15 minutes to complete.

Inpatient facilitators
All implementation officers and nurse facilitators will be included to evaluate implementation fidelity, as they will be responsible for the implementation of HIRAID® Inpatient. Evaluation of our behaviour-change informed strategy will be informed by the RE-AIM Scoring Instrument and measured using data from (i) the post HIRAID® implementation nurse survey, (ii) HIRAID® Facilitator surveys, and (iii) documentation audits.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are only exclusion criteria for patients (or their carers) of a study ward for H4 - experience with nursing care.

Exclusion criteria:
a. carer under 18 years of age; OR
b. patient, or carers of patients, at end-of-life care; OR
c. Patients/carers with cognitive impairment (e.g. intoxication, dementia).

Nursing staff:
Those who are not employed within the facility or are under 18 years of age.

Medical staff:
Those who are not employed within the facility or are under 18 years of age.

Research implementation nurses:
Nil.

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)
Blinding
Given the nature of the intervention, it is impractical to blind investigators and staff delivering the intervention to the randomly assigned cluster allocation. However, researchers recording and evaluating outcomes for nurse-associated clinical deterioration events, hospital-acquired complications, and nursing documentation will remain blinded to the cluster and intervention sequencing. Additionally, participants not directly involved in delivering or receiving the intervention (i.e. inpatients, family of inpatients) will also be blinded to cluster allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation
Each cluster will be randomly allocated to one of four starting dates. Randomisation will be completed by the study statistician using computer-generated numbers. No participating wards will be able to influence the allocation before randomisation occurs, meaning concealment of the allocation sequence until participating wards are assigned. No further changes to clusters will be made once the allocation has been finalised to minimise risk of bias. We are unable to randomise sites to clusters because of geographical location and differences in clinical governance.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
This study will use an effectiveness-implementation hybrid design, including a Stepped–Wedge cluster Randomised Control Trial (SW-cRCT). The hybrid approach allows testing of the implementation strategy at the same time as observing the outcomes of the intervention. A SW-cRCT design is appropriate for health service interventions as it simplifies data collection procedures, better supports logistical processes, accommodates temporal issues and optimises resource use.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size/Power Calculations
Sample sizes have been calculated using most recent data from the study sites and/or previous work by the investigators in this field.
Hypothesis 1, 2, 3 and 6: Reductions in rapid response team activation, Hospital Acquired Complications, events causing patient harm or near miss, and cost of care:
To address hypotheses H1, H2, H3, and H6, medical record and cost data will be extracted from relevant systems for the period of 01/01/2026 to 30/06/2027 for each cluster. Sample size estimation was conducted collectively. To maximise the study's power in detecting true differences, should they exist, the largest sample size estimation is reported and will be used.
Based on the effect sizes specified in Hypotheses 1 (a 20% reduction in preventable deterioration events from baseline of 3.7%), 2 (a 10% reduction in Hospital Acquired Complications from the baseline of 0.269%), 3 (a 20% reduction events causing harm or near miss) with a type I error rate of 5% and power of 80%) and applying Woertman’s SW design estimate approach 41 with an intra-class correlation of 0.05. A total of 28,400 records will provide sufficient power in detecting true differences, should they exist. This amounts to about 3,550 patient records per cluster per data collection period (that is 7,100 patient records for the 2 data collection periods for each cluster). Given the extraction of population-level data from each cluster for this period, there should be enough records to satisfy the requirements.
Hypothesis 4 Improvement in reported patients/carers experience:
To detect a 10% improvement in patient experience from a baseline of 70% from two independent samples with a Type I error rate of 5% and a power of 80%. The total sample size required is 2,640. This means each data collection period will involve 330 patients/carers per cluster, totalling 660 patients/carers across the two periods for each cluster.
Hypothesis 5 Improvement in quality of nurse communication and handover:
Hypothesis 5 encompasses three sub-hypotheses: (i) satisfaction with the quality of information transferred from nursing staff during handover, (ii) nurse confidence in assessment and escalation of care, and (iii) quality of documentation. These will be addressed using data collected from two sources, necessitating two separate sample size estimations.
Sample size: Satisfaction of handover and confidence in assessment
The survey will be conducted before and after the intervention on two independent samples of staff. Since the same survey will be employed for the two sub-hypotheses, the large sample size estimate is reported and will be used. To detect a 10% improvement in handover satisfaction from a baseline of 75% and a 10% improvement of reported confidence in assessment from baseline of 8.2 (SD=2.0) with a Type I error rate of 5% and a power of 80%. The total sample size required is 1,200. This means each data collection period will involve 150 staff per cluster, totalling 300 staff across the two periods for each cluster.
Sample size: Quality of documentation
The survey will be conducted before and after the intervention on two independent samples of documents. To detect a 10% improvement in documentation quality score from a baseline of 2.5 (SD=1.6) with a Type I error rate of 5% and a power of 80%. The total sample size required is 1,296. This means each data collection period will involve the review of 162 records, totalling 324 records across the two periods for each cluster.
Hypothesis 7 Nurse facilitator surveys (H7)
To evaluate implementation fidelity HIRAID® facilitators (Clinical nurse consultants/ clinical nurse educators) employed to assist with education and roll out will be invited to participate in evaluation of implementation fidelity. The number of staff to be involved in this process will be determined by each LHD.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2025
Actual
Date of last participant enrolment
Anticipated
31/01/2027
Actual
Date of last data collection
Anticipated
31/05/2027
Actual
Sample size
Target
21256
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 27615 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 27616 0
Shellharbour Hospital - Mount Warrigal
Recruitment hospital [3] 27617 0
Shoalhaven Hospital - Nowra
Recruitment hospital [4] 27618 0
Milton Ulladulla Hospital - Milton
Recruitment hospital [5] 27619 0
Westmead Hospital - Westmead
Recruitment hospital [6] 27622 0
Auburn Hospital & Community Health Services - Auburn
Recruitment hospital [7] 27623 0
Blacktown Hospital - Blacktown
Recruitment hospital [8] 27624 0
Maroondah Hospital - Ringwood East
Recruitment hospital [9] 27625 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [10] 27626 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 43788 0
2500 - Wollongong
Recruitment postcode(s) [2] 43789 0
2528 - Mount Warrigal
Recruitment postcode(s) [3] 43790 0
2541 - Nowra
Recruitment postcode(s) [4] 43791 0
2538 - Milton
Recruitment postcode(s) [5] 43792 0
2145 - Westmead
Recruitment postcode(s) [6] 43795 0
2144 - Auburn
Recruitment postcode(s) [7] 43796 0
2148 - Blacktown
Recruitment postcode(s) [8] 43797 0
3135 - Ringwood East
Recruitment postcode(s) [9] 43798 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [10] 43799 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 318420 0
Charities/Societies/Foundations
Name [1] 318420 0
HCF Research Foundation
Country [1] 318420 0
Australia
Funding source category [2] 318421 0
Charities/Societies/Foundations
Name [2] 318421 0
Thyne Reid Foundation
Country [2] 318421 0
Australia
Funding source category [3] 318452 0
Government body
Name [3] 318452 0
NHMRC
Country [3] 318452 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 320843 0
None
Name [1] 320843 0
Address [1] 320843 0
Country [1] 320843 0
Other collaborator category [1] 283427 0
Government body
Name [1] 283427 0
Illawarra Shoalhaven Local Health District
Address [1] 283427 0
Country [1] 283427 0
Australia
Other collaborator category [2] 283428 0
Government body
Name [2] 283428 0
Western Sydney Local Health District
Address [2] 283428 0
Country [2] 283428 0
Australia
Other collaborator category [3] 283431 0
Hospital
Name [3] 283431 0
Eastern Health
Address [3] 283431 0
Country [3] 283431 0
Australia
Other collaborator category [4] 283432 0
Government body
Name [4] 283432 0
Safer Care Victoria
Address [4] 283432 0
Country [4] 283432 0
Australia
Other collaborator category [5] 283436 0
Charities/Societies/Foundations
Name [5] 283436 0
The Australian College of Nursing
Address [5] 283436 0
Country [5] 283436 0
Australia
Other collaborator category [6] 283437 0
Government body
Name [6] 283437 0
The Australian Commission on Safety and Quality in Health Care
Address [6] 283437 0
Country [6] 283437 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317048 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 317048 0
Ethics committee country [1] 317048 0
Australia
Date submitted for ethics approval [1] 317048 0
14/11/2024
Approval date [1] 317048 0
19/12/2024
Ethics approval number [1] 317048 0
2024/ETH02575

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

Contacts
Principal investigator
Name 139822 0
Prof Kate Curtis
Address 139822 0
Rm 165, RC Mills Building A26 | The University of Sydney | NSW | 2006
Country 139822 0
Australia
Phone 139822 0
+61 2 8627 8906
Fax 139822 0
Email 139822 0
[email protected]
Contact person for public queries
Name 139823 0
Kate Curtis
Address 139823 0
Rm 165, RC Mills Building A26 | The University of Sydney | NSW | 2006
Country 139823 0
Australia
Phone 139823 0
+61 2 8627 8906
Fax 139823 0
Email 139823 0
[email protected]
Contact person for scientific queries
Name 139824 0
Kate Curtis
Address 139824 0
Rm 165, RC Mills Building A26 | The University of Sydney | NSW | 2006
Country 139824 0
Australia
Phone 139824 0
+61 2 8627 8906
Fax 139824 0
Email 139824 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Only aggregated data corresponding to the analysed variables across all study phases will be available.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    2024_PID02983 - 2024_ETH02575_ Application HREA - Approved.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.