Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000481673
Ethics application status
Approved
Date submitted
19/04/2023
Date registered
12/05/2023
Date last updated
28/04/2024
Date data sharing statement initially provided
12/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of the HIRAID (Trademark) Aged Care Nursing Framework on the Quality and Safety of Residential Aged Care
Scientific title
Adapting, implementing and evaluating the effectiveness of the nursing framework HIRAID (Trademark) Aged Care on the quality of nursing care and resident health outcomes in residential aged care facilities
Secondary ID [1] 309017 0
None
Universal Trial Number (UTN)
Trial acronym
HIRAID (Trademark) Aged Care
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Aged care nursing 329061 0
Quality and safety of nursing 329062 0
Ageing 329063 0
Condition category
Condition code
Public Health 326043 326043 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: HIRAID (Trademark) Aged Care Step-Wedge Clustered Randomised Controlled Trial

Materials: The intervention will involve the delivery of HIRAID (Trademark) Aged Care practice, education and training materials to aged care nurses. HIRAID (Trademark) Aged Care is a seven-component framework (History, Identify Red Flags, Assessment, Intervention, Diagnostics, Reassessment and Communication) adapted from the HIRAID (Trademark) nursing framework, which was originally developed for, and implemented in, emergency departments.

History: Collect residents' health history, identify immediate problem/s, understand resident's values, preferences, goals of care.
Identify Red Flags: Historical and physiological indicators to recognise serious illness and notify GP ASAP. Consider referral to in-reach services.
Assessment: Physical examination beginning with primary survey, the focused assessment and vital signs.
Intervention: Should be evidence-based and prioritised based on assessment.
Diagnostics: To gain clinical picture and inform treatment decisions.
Reassessment: Evaluate care and monitor patient progress. Maintain a structured approach and repeat at appropriate intervals.
Communication: With residents, families, clinicians. Use structured approach for clinical handover, with graded assertiveness to escalate if needed. Accurate and comprehensive clinical documentation.

Registered nurses will be trained and certified in the HIRAID (Trademark) Aged Care, which will be implemented into the RACFs standard model of practice and care. Materials delivered may vary slightly between facilities and this will be informed by a comprehensive implementation strategy to determine what material modalities will best suit each facility (this is further details in 'Tailoring and personalisation'). Overall, HIRAID (Trademark) Aged Care materials will take a combination of the following forms: an informational booklet, a training workbook to be completed in a face-to-face workshop, a learning module (which will transfer the contents of the workshop into a self-directed module with both online and material components), paper templates, electronic templates integrated into the facilities’ electronic medical system, posters and reference cards attached to work lanyards.

Procedures: Training will be implemented in two stages and will occur consecutively within the intervention period. The first stage will involve a one-day ‘train-the-trainer’ session whereby clinical nurse educators/consultants (CNE, CNC) are trained to implement the HIRAID (Trademark) Aged Care framework, as well as to deliver this training and supervise its successful uptake for the nursing staff in their facilities. This process ensures the long-term delivery of the intervention in the facility even with the turnover of nursing staff. This training will be facilitated by research implementation nurses, who correspond directly with the research team. These implementation nurses will also be integral for overseeing the onsite implementation fidelity of the intervention (e.g. whether training was administered to the correct standard and whether all supporting materials like posters, booklets and cards have been distributed). As such, the second stage involves the training the remainder of the nursing workforce within each facility. This will take the form of a one-day practical workshop where nurses are provided with all education materials (i.e. booklet, workbook, documentation templates) and learn how to apply the framework to their practice. After this workshop, documentation templates (paper and, where relevant, electronic) will be integrated into the facility. For example, if paper documentation templates were previously used, these would be replaced with paper based HRIAID (Trademark) Aged Care templates. If the facility used an electronic documentation system, the HIRAID (Trademark) Aged Care template will be added in an appropriate format into this system. Nurses will be able to refresh their learning of the framework through both practice and through online learning resources, environmental cues (e.g. reference cards, posters) and behavioural reinforcement strategies (e.g. positive reinforcement from CNEs, documentation auditing, simulation training).

Who will deliver: The first stage of training delivery (to CNE/CNCs) will be delivered by experienced members of the research team. Primarily, several members of the research team have been involved in the development and implementation of the original HIRAID (Trademark) intervention in EDs. These members were also involved in the tailoring of the implementation strategy, educational materials and workshops for various EDs and are all registered nurses with extensive experience in the field. The CNE/CNCs will then be responsible for delivering the HIRAID (Trademark) Aged Care training to nurses in their respective facilities. This will be performed in collaboration of the research implementation nurses (who are members of the research team and also act as onsite liaisons for each participating facility). Suitable CNE/CNCs will be identified for each of the facilities by the AI representative for each RACF. Staff in these positions are senior registered nurses who already work at the facility and who hold established responsibilities for managing the facility’s nursing workforce. Research implementation nurses will be specifically hired for purpose of overseeing the implementation of the intervention. These staff are also required to be registered nurses, have over at least 10 years of experience in practice and meet other criteria that will be established during the hiring process.

Mode of delivery: As mentioned above, this intervention will employ are several modes of to facilitate framework retention and integration. The training will be provided in a combination of a face-to-face workshop, online correspondence and supported with both physical and online learning resources. Training for CNC/CNEs will be slightly more comprehensive, as they will also be required to deliver and supervise the training in general nursing staff. Training for the general nursing staff will generally take the form of a one-day face-to-face workshop and the continued delivery of physical and e-learning materials throughout the intervention to ensure successful uptake.

Frequency and duration of delivery: The ‘train-the-trainer’ session for CNE/CNCs is a one-day workshop that will be delivered once at the commencement of the intervention period. This will be completed prior to the one-day face-to-face workshop for the remainder of the general nursing workforce. For both CNE/CNCs and the general nursing workforce, this is where most of the training in HIRAID (Trademark) Aged Care will be imparted. Subsequent methods of reinforcement, such as individual training, completion of the learning module, documentation audits, environmental cues, simulation training sessions may all be implemented over a 6-month period depending on the facility. In particular, individual training and the one-time completion of the learning module will be a mandatory requirement for all new RNs employed to the facility and will be provided during their orientation. The frequency of these strategies will be informed by the implementation strategy developed for each facility prior to introducing the framework, as well as through regular (fortnightly) review of implementation fidelity with research implementation nurses.

Location: All face-to-face training will be carried onsite at each participating facility. A room to conduct the training will be arranged with each facility ahead of time and then visited and prepared by whoever is conducting the session. Additionally, the whole facility will then be involved in the intervention through the introduction of documentation templates and environmental cues. Finally, the e-learning aspect of the training will be made available online on a predetermined server managed by the research team.

Tailoring and personalisation: The HIRAID (Trademark) Aged Care framework will not be adapted for specific facilities, groups or individuals. However, the modes and frequency of delivery may vary based of facility characteristics, resident case-mix, staff demographics, infrastructure and other external factors. Prior to introducing the intervention, an implementation strategy will be developed for each facility. This strategy will be informed by a combination of nursing staff surveys and behavioural analytics obtained during the baseline data collection process. These surveys will help us identify the likely facilitators and barriers to the intervention and plan for potential solutions and modifications to how the intervention will be executed. For example, while some facilities may use electronic systems for recording resident health data, others may still rely on paper records. Therefore, documentation templated for HIRAID (Trademark) Aged Care will need to be appropriately adapted to suit the recording systems used.

Implementation fidelity: Fidelity of the intervention will be assessed by onsite research implementation nurses. A documentation template and log to record the implementation strategies that have been employed will be used to consistently document the intervention across all participating facilities. These documents will be collated and presented at regular team meetings with the research team, where we can assess the aspects in which the intervention can be improved.
Intervention code [1] 325458 0
Behaviour
Comparator / control treatment
This Step-Wedge Clustered Randomised Controlled Trial will have a pre-post design. This means that all facilities will be allocated into four clusters and each cluster will begin in the control pre-intervention group, where baseline measures will be taken. No training will be rolled out during the pre-intervention stage and all baseline measures will be taken over a 6-month period as RNs provide the standard practice of care. The intervention will then be incrementally rolled out into each cluster at three-month intervals, until facilities in all clusters have received the intervention. Outcome measures will be taken over a 12-month period post-intervention.
Control group
Active

Outcomes
Primary outcome [1] 334016 0
Incidence of resident clinical deterioration events caused by nursing assessment and care. Clinical deterioration is measured directly through residents that receive a rapid response call, which can be identified through the review of resident health records. The cause of clinical deterioration will be determined using the criteria described in the previously validated Clinical Excellence Commission’s Human Factors Classification Framework for Patient Safety.
Timepoint [1] 334016 0
Incidence of nurse-related resident clinical deterioration will be measured for a 6-month baseline data collection period pre-intervention, and during a 12-month data collection period post-intervention.
Primary outcome [2] 334017 0
Incidence of clinically inappropriate transfer of resident to the hospital/ED. This will be measured through review of resident health records which will record all transfer events. The 'inappropriateness' of transfer will the assessed according to a previously established criteria developed by Codde et al. (2010).
Timepoint [2] 334017 0
Incidence of clinically inappropriate transfer of resident to the hospital/ED will be measured for a 6-month baseline data collection period pre-intervention, and during a 12-month data collection period post-intervention.
Primary outcome [3] 334018 0
Incidence of adverse National Aged Care Mandatory Quality Indicators (e.g. pressure injuries, falls, unplanned weight loss, major injury, incontinence) established by the Quality Indicator (QI) Program and the Australian Government Department of Health and Aged Care. Incidence of these indicators will be measured directly through review of resident health records.
Timepoint [3] 334018 0
Incidence of adverse National Aged Care Mandatory Quality Indicators will be measured for a 6-month baseline data collection period pre-intervention, and during a 12-month data collection period post-intervention.
Secondary outcome [1] 419089 0
Resident and carer satisfaction with nursing care will be measured using Schmidt's Perceptions of Nursing Care Survey (SPNCS). This is a composite outcome, assessing the overall satisfaction of nursing care from aged care consumers.
Timepoint [1] 419089 0
This outcome will be measured both pre- and post-intervention. The pre-intervention survey will be distributed approximately one month prior to intervention commencement and data will be collected from residents and carers over a period of three weeks. The post-intervention survey will be distributed approximately one month into the post-intervention period and will similarly collect data over a three-week period.
Secondary outcome [2] 419090 0
Nurse staff satisfaction with communication. Satisfaction with communication will be measured using a previously validated instrument used in the evaluation of HIRAID (Trademark).
Timepoint [2] 419090 0
Data for satisfaction with communication will be collected using an online survey that will be distributed at pre- and post-intervention. The pre-intervention survey will be distributed approximately two months prior to intervention and data will be collected from nursing staff over a period of three weeks. The post-intervention survey will be distributed approximately one month into the post-intervention period and will similarly collect data over three weeks.
Secondary outcome [3] 421528 0
Resident and carer perception of person-centredness of care using the Person-Centred Practice Inventory-Care (PCPI-C). This is a composite outcome, assessing the overall perception of the person-centredness of care from aged care consumers.
Timepoint [3] 421528 0
This outcome will be measured both pre- and post-intervention. The pre-intervention survey will be distributed approximately one month prior to intervention commencement and data will be collected from residents and carers over a period of three weeks. The post-intervention survey will be distributed approximately one month into the post-intervention period and will similarly collect data over a three-week period.
Secondary outcome [4] 421531 0
Medical staff satisfaction with communication. Satisfaction with communication will be measured using a previously validated instrument used in the evaluation of HIRAID (Trademark).
Timepoint [4] 421531 0
Data for satisfaction with communication will be collected using an online survey that will be distributed at pre- and post-intervention. The pre-intervention survey will be distributed approximately two months prior to intervention and data will be collected from medical staff over a period of three weeks. The post-intervention survey will be distributed approximately one month into the post-intervention period and will similarly collect data over three weeks.
Secondary outcome [5] 421532 0
The quality (correctness) of nursing documentation will be assessed a modified D-Catch tool designed for auditing nursing documents.
Timepoint [5] 421532 0
The quality of nursing documentation will be assessed over the 6-month baseline data collection period pre-intervention, and over the 12-month data collection period post-intervention.
Secondary outcome [6] 421613 0
The quantity (completeness) of nursing documentation will be assessed a modified D-Catch tool designed for auditing nursing documents.
Timepoint [6] 421613 0
The quantity of nursing documentation will be assessed over the 6-month baseline data collection period pre-intervention, and over the 12-month data collection period post-intervention.

Eligibility
Key inclusion criteria
Residents:
They are a resident who currently resides in one of the participating residential aged care facilities and; they have the cognitive capacity to communicate with the implementation research nurse and complete the study or; they have a legal carer/guardian/family member who is able to complete the study of their behalf.

Carers:
They are a legal carer/guardian/family member of a resident who currently resides in one of the participating residential aged care facilities and; they are over 18 years of age.

Nursing staff:
They are a registered or enrolled nurse who is currently permanently employed in one of the participating residential aged care facilities and; the are over 18 years of age.

Medical staff:
They are a registered medical practitioner who is currently permanently employed in one of the participating residential aged care facilities and; the are over 18 years of age.

Research implementation nurses:
They are a registered nurse who was hired for the research investigation for the purpose of overseeing the implementation of the intervention and it's implementation fidelity across their designated facilities.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residents:
Those who do not have the cognitive capacity to participate/complete in the research in accordance with NHMRC Human Research Ethics Guidelines and; do not have a legal carer/guardian/family member who is available/willing to complete the study of their behalf.

Carers:
Under 18 years of age.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Facilities will be allocated into four clusters, which will decide when they commence crossover from the control condition (pre-intervention) into the intervention condition.

Clusters will be determined by facility bed number. Facilities with over 100 beds will be randomly allocated evenly into two of the four clusters, and facilities with less than 100 beds will be randomly allocated evenly into the two remaining clusters. Simple randomisation using a randomisation table created by computer software will be used to determine which clusters facilities are allocated to, as well as when each of the four clusters are crossed over into the intervention. All clusters will start in the control (pre-intervention) condition and end in the intervention condition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
This is a step wedge clustered randomised controlled trial. It is similar to a crossover design where all participants start in the control condition and then crossover into the intervention - thereby acting as their own control. In a step wedge, the timing for when this crossover happens is staggered, such that each cluster of facilities will crossover into the intervention one after the one at set intervals (3 months). Similarly, the commencement of baseline measurement and outcome measurement will also be staggered based on when the intervention begins.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Calculations

Objective 1: 20% reduction in preventable resident deterioration events due to nursing assessment and care.
Using the conventional two-arm RCT to estimate the unadjusted sample size with a baseline prevalence of 35% and the intervention effect for a reduction of at least 10%, an unadjusted sample of about 350 patients in each arm is needed to provide 80% power at a 2-tail significance level of 5% and the ratio between the intervention and control groups of 1 to 1. Assuming further 10% attrition the total unadjusted sample size required is about 385 per arm. With a Step-Wedged design, the sample size is adjusted with the calculation of design effect and an intraclass correlation within cluster of 0.03 to about 230 per arm and a total of 460.

Objective 2: 20% reduction in clinically inappropriate transfer of residents to an emergency department. Based on the conventional two-arm RCT for estimating the unadjusted sample size with a baseline prevalence of 35% and intervention effect for a reduction of at least 10%. The study requires an unadjusted sample of about 350 patients in each arm to provide 80% power at a 2-tail significance level of 5% and the ratio between the intervention and control groups is 1 to 1. Assuming further 10% attrition the total unadjusted sample size required is about 385 per arm. With a Step-Wedged design, the sample size is adjusted with the calculation of design effect and an intraclass correlation within cluster of 0.03 to about 230 per arm and a total of 460.

Objective 3: 20% reduction in adverse National Aged Care Mandatory Quality Indicators. Using conventional two-arm RCT to estimate the unadjusted sample size with a baseline prevalence of 30% and the effect of the intervention for a reduction of at least 10%, an unadjusted sample of about 350 patients in each arm to needed to provide 80% power at a 2-tail significance level of 5% with the ratio between the intervention and control groups of 1 to 1. Assuming further 10% attrition the total unadjusted sample size required is about 385 per arm. With a Step-Wedged design, the sample size is adjusted with the calculation of design effect and an intraclass correlation within cluster of 0.03 to about 246 per arm and a total of 492.

Objective 4: 5% increase in satisfaction with care reported by resident or carer and RACF person-centred culture. Based on the study design of 2 independent groups comparison in the control and intervention phases, the sample size is calculated with the baseline means (s.d.) of 4.4 (1.0), an effect of an increased in satisfaction by 5% to 4.62, and a ratio between groups of 1:1. It is estimated that a sample of 342 per arm and a total of 684 participants is needed to provide the study with 80% power with a type I error rate of 5% and an attrition rate of 5%.

Objective 5: 10% increase the quantity (completeness) and quality (correctness) of nursing documentation, and nursing and medical satisfaction with clinical handover. Based on the study design of 2 independent groups comparison in the control and intervention phases with a baseline proportion of correct medical records as 50% and an effect of intervention of at least 10% increase (i.e. 60%), a sample of about 410 per arm and a total of 820 records is needed. For completeness, assuming the baseline proportion of the completed medical records as 35% and an effect of 10% increase (i.e. 45%), a sample of about 400 per arm and a total of 800 records is required.

Data Analysis Plan

Behavioural diagnostics: Data from the behavioural diagnostics survey collected in Step 1 assessing the 14 domains of influence on behaviour will be analysed to inform the implementation toolkit for each RACF organisation. Quantitative items will be considered facilitators if they are positively worded with greater or equal to 70% agreement with a statement. Qualitative themes will be considered facilitators or barriers based on positively or negatively worded statements. Sub-analyses will be conducted to identify specific barriers or facilitators by location to tailor implementation.

Intervention effectiveness: Survey data collected to evaluate implementation will be analysed using descriptive statistics to determine the level of fidelity and feedback from study sites. A combination of Generalised Linear Mixed Models and interrupted time series analysis, using segmented regression to account for secular trends will be used. Analyses will be unadjusted and adjusted for relevant confounders such as patient characteristics and study site. SPSS V25 will be used and the alpha set to <0.05. An economic evaluation will be undertaken to understand system-wide implications of any potential reduction in treatment costs associated with fewer adverse patient events and improved time to treatment associated with the introduction of HIRAID (Trademark) Aged Care.

The data collected from interviews will be analysed using qualitative methodology. The interview will be transcribed verbatim prior to content analysis of the transcript. The qualitative software program NVivo 12 will be used to facilitate the coding of participant interview responses; responses will be coded line by line, and content analysis will be used to develop the thematic organisation of responses.

Implementation fidelity: Data will be analysed using descriptive statistics to determine the level of implementation fidelity. A process evaluation will also be conducted to assess for the fidelity and success of the implementation across sites. Fidelity controls will be deployed for internal and external validity of implementation and will be measured through formal feedback measures during implementation, including audits, implementation logs and team meetings. Facilitators will independently complete intervention fidelity scoring of the degree the behaviour change mechanisms were implemented (0 = not implemented, 1 = partially implemented, 2 = fully implemented). Adaptations for each mechanism will also be scored (1 = just as planned, to 4 = many changes from plan).

Extrapolation modelling: Discrete event simulation (stochastic) extrapolation modelling will also be undertaken following modelling best practice recommendations to estimate local and other system-wide implications (costs and effects) of sustained implementation of HIRAID (Trademark) Aged Care (versus non-adoption) over 5 and 10 year time horizons (discounting at 5% consistent with Australian recommendations) using trial data, Australian RACF profiles and published literature to inform assumptions (and probabilistic sensitivity analyses).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/01/2024
Actual
1/04/2024
Date of last participant enrolment
Anticipated
15/03/2025
Actual
Date of last data collection
Anticipated
15/09/2026
Actual
Sample size
Target
1200
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 39662 0
2763 - Quakers Hill
Recruitment postcode(s) [2] 39663 0
2148 - Blacktown
Recruitment postcode(s) [3] 39664 0
2151 - North Parramatta
Recruitment postcode(s) [4] 39665 0
2160 - Merrylands
Recruitment postcode(s) [5] 39666 0
2034 - South Coogee
Recruitment postcode(s) [6] 39667 0
2232 - Sutherland
Recruitment postcode(s) [7] 39668 0
2032 - Daceyville
Recruitment postcode(s) [8] 39669 0
2035 - Maroubra
Recruitment postcode(s) [9] 39670 0
2145 - Greystanes
Recruitment postcode(s) [10] 39671 0
2761 - Plumpton
Recruitment postcode(s) [11] 39672 0
2122 - Marsfield
Recruitment postcode(s) [12] 39673 0
2750 - Penrith
Recruitment postcode(s) [13] 39674 0
2074 - North Turramurra
Recruitment postcode(s) [14] 39675 0
2130 - Summer Hill
Recruitment postcode(s) [15] 39676 0
2093 - Manly Vale
Recruitment postcode(s) [16] 39677 0
2161 - Guildford
Recruitment postcode(s) [17] 39678 0
2147 - Seven Hills
Recruitment postcode(s) [18] 39679 0
2145 - Pendle Hill
Recruitment postcode(s) [19] 39680 0
2508 - Stanwell Park
Recruitment postcode(s) [20] 39681 0
2766 - Rooty Hill
Recruitment postcode(s) [21] 39682 0
2144 - Auburn

Funding & Sponsors
Funding source category [1] 313229 0
Government body
Name [1] 313229 0
National Health and Medical Research Council MRFF – Clinician Researchers Initiative – 2022 Clinician Researchers: Nurses, Midwives and Allied Health Grant
Country [1] 313229 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 315479 0
None
Name [1] 315479 0
Address [1] 315479 0
Country [1] 315479 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312459 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 312459 0
Ethics committee country [1] 312459 0
Australia
Date submitted for ethics approval [1] 312459 0
16/03/2023
Approval date [1] 312459 0
18/04/2023
Ethics approval number [1] 312459 0
2023/ETH00523

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

Contacts
Principal investigator
Name 124742 0
Prof Ramon Z. Shaban
Address 124742 0
University Address: RC Mills Building (A26), Office 164, University of Sydney, Camperdown. NSW 2006
LHD Address: Office 5239D, Level 5, Central Acute Services Building (K Block) Westmead Hospital. Corner Hawkesbury Road and Darcy Rd, Westmead NSW 2145
Country 124742 0
Australia
Phone 124742 0
+61 02 8627 3117
Fax 124742 0
Email 124742 0
[email protected]
Contact person for public queries
Name 124743 0
Ramon Z. Shaban
Address 124743 0
University Address: RC Mills Building (A26), Office 164, University of Sydney, Camperdown. NSW 2006
LHD Address: Office 5239D, Level 5, Central Acute Services Building (K Block) Westmead Hospital. Corner Hawkesbury Road and Darcy Rd, Westmead NSW 2145
Country 124743 0
Australia
Phone 124743 0
+61 02 8627 3117
Fax 124743 0
Email 124743 0
[email protected]
Contact person for scientific queries
Name 124744 0
Ramon Z. Shaban
Address 124744 0
University Address: RC Mills Building (A26), Office 164, University of Sydney, Camperdown. NSW 2006
LHD Address: Office 5239D, Level 5, Central Acute Services Building (K Block) Westmead Hospital. Corner Hawkesbury Road and Darcy Rd, Westmead NSW 2145
Country 124744 0
Australia
Phone 124744 0
+61 02 8627 3117
Fax 124744 0
Email 124744 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
This study will collect several types of data from participants in the form of both survey responses and personal health data. To protect the privacy and confidentiality of participants, no individual participant data will be made public.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18923Study protocolA study protocol will be prepared and submitted for publication in a relevant journal. It is expected that this protocol will be accepted and be made publicly available by early 2024. [email protected]
18924Ethical approvalEthics approval has been obtained. The HREC and approval number will be made available on all publications related to the study. [email protected] 385421-(Uploaded-18-04-2023-13-12-37)-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.