Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12621001456842
Ethics application status
Approved
Date submitted
12/08/2021
Date registered
25/10/2021
Date last updated
16/11/2023
Date data sharing statement initially provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of the HIRAID emergency nursing program on patient and hospital outcomes
Scientific title
Effectiveness-implementation hybrid design including a step–wedge cluster randomised control trial (SW-cRCT) to evaluate the outcomes of the implementation of HIRAID at scale (effectiveness) and strategies that enable optimal uptake of HIRAID (implementation)
Secondary ID [1] 304979 0
NHMRC 2005403
Universal Trial Number (UTN)
Trial acronym
HIRAID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emergency nursing 323132 0
Condition category
Condition code
Emergency medicine 320709 320709 0 0
Other emergency care
Public Health 321067 321067 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The framework ‘History, Identify red flags, Assessment, Interventions, Diagnostics, communication and reassessment’ (HIRAID) is a mixed methods pre-intervention / post-intervention study aiming to evaluate the impact of the implementation of HIRAID. There will be four steps to test the study hypotheses during the five years we estimate it will take for the framework to be rolled out across all participating clusters/sites:

Step 1 - Behavioural Diagnostics and Baseline data: Short surveys will be distributed to all nursing staff to collect baseline data to inform implementation. Similarly, surveys for patient care experience, nursing communication and medical officer satisfaction with request for medical review, or handover, will be distributed during step 1. All of the pre-implementation surveys across participating sites will be managed via REDCap (Research Electronic Data Capture), and will take no longer than 15 minutes to complete.
It is estimated that the baseline data collection and behavioural diagnostics will take around 12 months for each participating cluster/site.

Step 2 - Implementation strategy development: Behavioural diagnostic data collected in step one will inform the implementation strategy for each participating cluster. The implementation strategy will be developed in consultation with end users, nurse educators and executive through and iterative process.
It is estimated that the implementation strategy development will take approximately 6 months for each participating cluster/site.

Step 3 - Implementation of HIRAID: A staged roll out of the HIRAID emergency nursing framework across participating clusters/sites will take place. Roll out will be undertaken using strategies identified as effective in other health districts and previous feasibility research and informed by baseline data as outlined in step 2. These strategies will be applied consistently to ensure implementation fidelity, this will be achieved through HIRAID nurse facilitators or clinical champions. The facilitators will be part of the existing workforce of each site and in a position where they will be able to facilitate the change as part of their roles, such as the site Clinical Nurse Educators (CNEs) and Clinical Nurse Consultants (CNCs), some of whom are study investigators.
HIRAID Training: HIRAID education will be rolled out by the site Clinical Nurse Educators (CNEs) and Clinical Nurse Consultants (CNCs) following the ‘train the trainer’ education. The HIRAID education program will be integrated into the education calendar at each site by the CNEs and CNCs and will consist of the following elements:
1) An available participant workbook: to guide ED nurse educators to teach the HIRAID assessment framework as part of an interactive group workshop.
2) An e-learning module: a 20-30 minutes HIRAID-specific module already developed by the NSW Ministry of Health.
3) A short education face to face workshop (or online based on local context/circumstances): a 45-minute workshop to go through each component of the framework, to reflect on and discuss the role of the ED nurse in performing initial patient assessment; discuss the importance of a structured approach to initial nursing assessment in the ED; provide a brief overview of the HIRAID framework to another colleague; and understand what is expected of participants during the HIRAID workshop. The workshops across participating clusters/sites will use lecture, power point presentation, handout/poster/reference cards/practical examples and group discussions.
4) A 1-day train the trainer session to reflect on and discuss the role of the ED nurse in performing initial patient assessment; discuss the importance of a structured approach to initial nursing assessment in the ED; to understand the cyclic nature of the framework and how components may be performed singularly or simultaneously; to apply the HIRAID framework to preform/model structured patient assessments and to deliver short education on HIRAID to peers.
Implementation Fidelity: Site HIRAID nurse facilitators or clinical champions will attend weekly implementation team meetings of an hour maximum, facilitated by the cluster/site nursing unit manager and asked about any implementation complications or adjustments.
It is estimated that the actual implementation of HIRAID will take approximately 12-18 months for each participating cluster/site.
Step 4 - Evaluation of HIRAID implementation and effectiveness: Surveys used in baseline data collection to assess patient/ carer satisfaction and medical officer satisfaction (step 1) will be repeated among similar populations and will evaluate the implementation strategies developed in step 2, from the end user perspective. These 15-minute surveys will contribute to the evaluation of implementation strategies and the dose of interventions, in conjunction with other data sources.
To further explore the results of the intervention, 20–30-minute semi-structured interviews with emergency nurses will take place.
It is estimated that the evaluation of HIRAID will take approximately 12-18 months for each participating cluster/site.
Intervention code [1] 321374 0
Behaviour
Intervention code [2] 321629 0
Diagnosis / Prognosis
Comparator / control treatment
No control group per se. The control group for each participating cluster/site is themselves prior to the implementation of HIRAID. We have used the word randomisation in regards to the random roll out of the framework across participating clusters/sites.
In terms of the duration of each step, step 1 (retrospective medical record review and data collection) will have a duration of six months. Step 2 (implementation strategy development) will have a duration of three months. Step 3 (intervention implementation) will have a duration of six months for each site (three months for education, training and auditing) plus six months for follow up surveys for staff and patients in addition to records review up to 12 months post implementation (step 4, evaluation of HIRAID effectiveness and implementation.
Control group
Active

Outcomes
Primary outcome [1] 328533 0
Change in patient deterioration within 72 hours of admission via Emergency Department (ED).
Timepoint [1] 328533 0
Audit of records collected retrospectively for each site for up 12 months prior to intervention.
Primary outcome [2] 328534 0
Change in time to first analgesia in ED (triage time to first dose) for patients presenting with abdominal, hip, limb or chest pain by audit of medical records.
Timepoint [2] 328534 0
Audit of medical records from 12 months prior to intervention commencement to 12 months post intervention.
Primary outcome [3] 328535 0
Patient/carers ED experience assessment using a study-specific survey via 15 minutes follow-up call.
Timepoint [3] 328535 0
Assessed within two weeks of patient discharge and up to three months prior to intervention commencement.
Secondary outcome [1] 399339 0
Acute treatment costs associated with patient deterioration within 72 hours of admission to ED by reviewing performance and casemix data.
Timepoint [1] 399339 0
Audit of records from 12 months prior to intervention commencement to 12 months post-intervention commencement
Secondary outcome [2] 399343 0
Pain score to one-hour post analgesia administration, as per pain score documented in the electronic medical record system (10-point VAS).
Timepoint [2] 399343 0
Assessed in all patients that fit criteria and whom received analgesia 12 months pre-intervention and then 12- months post-intervention.

Secondary outcome [3] 399344 0
Nurse and medical officer satisfaction with patient assessment and provision of nursing care using a study-specific 15 minutes nursing and medical staff survey, respectively.
Timepoint [3] 399344 0
Nurse and medical officer satisfaction will be measured within 3 months pre-intervention and 6 months post-intervention.

Eligibility
Key inclusion criteria
There are six different populations, with key inclusion criteria for this study:

Source 1: Patient’s with clinical deterioration in 72 hours - medical record review:
- Rapid response equal or less than 72 hours post Emergency Department Discharge (EDD)
- Rapid response call
- Admitted via Emergency Department (includes admission to ward via interhospital transfer direct from ED within Southern NSW LHD)

Source 2: Patient presenting to ED with painful conditions:
Clinical records of patients meeting one or more of the study inclusion criteria, and no exclusion criteria, will be reviewed retrospectively.
- Presented to ED and given a triage category 2, 3, 4 or 5; AND
- Presented to the ED with chest pain, abdominal pain, hip or limb pain

Source 3: Patient or carer:
All patients presenting to the ED, meeting study inclusion criteria will be provided with a participant information sheet for the study.
- Patient, or carer of a patient admitted to the ED during study period;
- Patient/ carer over 18 years of age.

Source 4: Staff surveys-nursing:
All nursing staff permanently employed in the EDs/ MPS across each LHD, pre and post implementation, will be invited by their ED/MPS Manager, Medical Director or Research Nurse via email to participate.

Source 5: Staff surveys-medical staff:
All medical staff, employed on a regular basis, will be invited to complete a survey related to medical staff satisfaction related to clinical handover pre and post the intervention.

Source 6: Nursing staff interviews:
All nursing staff employed in the EDs/ MPS across each LHD, during the implementation period will be eligible to participate. Staff who complete the nursing survey post will have the opportunity to indicate their willingness to participate and provide contact details (phone and/ or email) to the researchers.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are six different populations for this study:

Source 1: Patient’s with clinical deterioration in 72 hours - medical record review:
Exclusion Criteria
- ICU admission prior to call
- Operation prior to call

Source 2: Patient presenting to ED with painful conditions:
- Triage category 1
- Patients receiving a team response in the ED e.g. trauma team response, stroke, etc

Source 3: Patient or carer:
- patient, or carers of patients, at end-of-life care; OR
- triage category 1; OR
- patients/ carers with cognitive impairment (eg. intoxication, dementia).

Source 4: Staff surveys-nursing:
Nil

Source 5: Staff surveys-medical staff:
Nil

Source 6: Nursing staff interviews:
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)
Given the study design as a Stepped Wedge Cluster RCT with a small number of clusters involved, a pragmatic approach with simple randomisation using a randomisation algorithm was used to achieve an allocation of clusters into different steps while maintaining a certain degree of randomness.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
We will use an effectiveness-implementation hybrid design including a step–wedge cluster randomised control trial (SW-cRCT) with interventions being commenced at three month intervals across three Australian States to evaluate: i) the outcomes of the implementation of HIRAID at scale (effectiveness) and ii) strategies that enable optimal uptake of HIRAID (implementation). 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 considered appropriate for implementation evaluations of health service interventions as it simplifies data collection procedures, better supports logistical processes, aligns with ethical principles, accommodates temporal issues and optimises financial constraints. The SW-cRCT addresses the ethical dilemmas of RCT design where essential investigations and/or best-practice treatments may be withheld from control participants under usual care. In this complex health setting, a SW-cRCT design supports the project team and ED partners’ preferences not to withhold use of HIRAID from any site. The pragmatic trial based on our pilot data will greatly enable translation of best practice evidence, since all participating sites will receive education and training in the intervention (HIRAID). The study will also include an analysis on factors influencing future implementation, ecological validity, usability and relevance.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Behavioural diagnostics:
Survey results assessing the 14 domains of influence on behaviour will be analysed to inform the implementation tool-kit for each LHD. 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.

Implementation:
Survey data collected to evaluate implementation will be analysed using descriptive statistics to determine the level of fidelity and feedback from study sites.
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.

HIRAID effectiveness/ Clinical outcomes:
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.
Baseline diagnostic data, effectiveness and implementation data will be integrated with studies replicated at other sites to inform using the behaviour change wheel to produce an adaptable national HIRAID implementation tool-kit.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/11/2021
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
3200
Accrual to date
3140
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 20183 0
Crookwell District Hospital - Crookwell
Recruitment hospital [2] 20184 0
Goulburn Base Hospital - Goulburn
Recruitment hospital [3] 20185 0
Yass District Hospital - Yass
Recruitment hospital [4] 20186 0
Queanbeyan District Hospital - Queanbeyan
Recruitment hospital [5] 20187 0
Braidwood Multi Purpose Service - Braidwood
Recruitment hospital [6] 20188 0
Batemans Bay Hospital - Batemans Bay
Recruitment hospital [7] 20189 0
Moruya District Hospital - Moruya
Recruitment hospital [8] 20190 0
Cooma Hospital & Health Service - Cooma
Recruitment hospital [9] 20191 0
Bega District Hospital - Bega
Recruitment hospital [10] 20192 0
Pambula District Hospital - Pambula
Recruitment hospital [11] 20193 0
Bombala Multi Purpose Service - Bombala
Recruitment hospital [12] 20194 0
Ballina District Hospital - Ballina
Recruitment hospital [13] 20195 0
Bonalbo Hospital - Bonalbo
Recruitment hospital [14] 20196 0
Byron District Hospital - Byron Bay
Recruitment hospital [15] 20197 0
Casino and District Memorial Hospital - Casino
Recruitment hospital [16] 20198 0
Grafton Base Hospital - Grafton
Recruitment hospital [17] 20199 0
Kyogle Memorial Multi Purpose Service - Kyogle
Recruitment hospital [18] 20200 0
Lismore Base Hospital - Lismore
Recruitment hospital [19] 20201 0
Maclean District Hospital - Maclean
Recruitment hospital [20] 20202 0
Murwillumbah District Hospital - Murwillumbah
Recruitment hospital [21] 20203 0
Nimbin Multi Purpose Service - Nimbin
Recruitment hospital [22] 20204 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [23] 20205 0
Urbenville Health Service - Urbenville
Recruitment hospital [24] 20206 0
Westmead Hospital - Westmead
Recruitment hospital [25] 20207 0
Auburn Hospital & Community Health Services - Auburn
Recruitment hospital [26] 20208 0
Blacktown Hospital - Blacktown
Recruitment hospital [27] 20209 0
Mount Druitt Hospital - Mount Druitt
Recruitment hospital [28] 20212 0
Box Hill Hospital - Box Hill
Recruitment hospital [29] 20213 0
Maroondah Hospital - Ringwood East
Recruitment hospital [30] 20214 0
Angliss Hospital - Upper Ferntree Gully
Recruitment postcode(s) [1] 34913 0
2583 - Crookwell
Recruitment postcode(s) [2] 34914 0
2580 - Goulburn
Recruitment postcode(s) [3] 34915 0
2582 - Yass
Recruitment postcode(s) [4] 34916 0
2620 - Queanbeyan
Recruitment postcode(s) [5] 34917 0
2622 - Braidwood
Recruitment postcode(s) [6] 34918 0
2536 - Batemans Bay
Recruitment postcode(s) [7] 34919 0
2537 - Moruya
Recruitment postcode(s) [8] 34920 0
2630 - Cooma
Recruitment postcode(s) [9] 34921 0
2550 - Bega
Recruitment postcode(s) [10] 34922 0
2549 - Pambula
Recruitment postcode(s) [11] 34923 0
2632 - Bombala
Recruitment postcode(s) [12] 34924 0
2478 - Ballina
Recruitment postcode(s) [13] 34925 0
2469 - Bonalbo
Recruitment postcode(s) [14] 34926 0
2481 - Byron Bay
Recruitment postcode(s) [15] 34927 0
2470 - Casino
Recruitment postcode(s) [16] 34928 0
2460 - Grafton
Recruitment postcode(s) [17] 34929 0
2474 - Kyogle
Recruitment postcode(s) [18] 34930 0
2480 - Lismore
Recruitment postcode(s) [19] 34931 0
2463 - Maclean
Recruitment postcode(s) [20] 34932 0
2484 - Murwillumbah
Recruitment postcode(s) [21] 34933 0
2480 - Nimbin
Recruitment postcode(s) [22] 34934 0
2485 - Tweed Heads
Recruitment postcode(s) [23] 34935 0
2475 - Urbenville
Recruitment postcode(s) [24] 34936 0
2145 - Westmead
Recruitment postcode(s) [25] 34937 0
2144 - Auburn
Recruitment postcode(s) [26] 34938 0
2148 - Blacktown
Recruitment postcode(s) [27] 34939 0
2770 - Mount Druitt
Recruitment postcode(s) [28] 34942 0
3128 - Box Hill
Recruitment postcode(s) [29] 34943 0
3135 - Ringwood East
Recruitment postcode(s) [30] 34944 0
3156 - Upper Ferntree Gully

Funding & Sponsors
Funding source category [1] 309367 0
Government body
Name [1] 309367 0
National Health and Medical Research Council
Country [1] 309367 0
Australia
Funding source category [2] 309386 0
Government body
Name [2] 309386 0
Southern NSW Local Health District
Country [2] 309386 0
Australia
Funding source category [3] 309387 0
Government body
Name [3] 309387 0
Northern NSW Local Health District
Country [3] 309387 0
Australia
Funding source category [4] 309388 0
Government body
Name [4] 309388 0
Western Sydney Local Health District
Country [4] 309388 0
Australia
Funding source category [5] 309389 0
Government body
Name [5] 309389 0
Eastern Health
Country [5] 309389 0
Australia
Funding source category [6] 309390 0
Hospital
Name [6] 309390 0
Royal Brisbane & Women's Hospital
Country [6] 309390 0
Australia
Funding source category [7] 309391 0
Charities/Societies/Foundations
Name [7] 309391 0
The Thyne Reid Foundation
Country [7] 309391 0
Australia
Funding source category [8] 309392 0
Government body
Name [8] 309392 0
Australian Commission on Safety and Quality in Health Care
Country [8] 309392 0
Australia
Funding source category [9] 309393 0
Other Collaborative groups
Name [9] 309393 0
College of Emergency Nursing Australasia
Country [9] 309393 0
Australia
Funding source category [10] 309394 0
Government body
Name [10] 309394 0
Australian Government Department of Health
Country [10] 309394 0
Australia
Funding source category [11] 309395 0
Government body
Name [11] 309395 0
Agency for Clinical Innovation
Country [11] 309395 0
Australia
Funding source category [12] 309396 0
Other Collaborative groups
Name [12] 309396 0
Australian College of Nursing
Country [12] 309396 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown Campus, Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 310651 0
None
Name [1] 310651 0
None
Address [1] 310651 0
None
Country [1] 310651 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309184 0
Greatern Western Human Research Ethics Committee
Ethics committee address [1] 309184 0
Ethics committee country [1] 309184 0
Australia
Date submitted for ethics approval [1] 309184 0
13/08/2020
Approval date [1] 309184 0
20/10/2020
Ethics approval number [1] 309184 0
2020/ETH02164

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

Contacts
Principal investigator
Name 113262 0
Prof Kate Curtis
Address 113262 0
Office 165. A26 building RC Mills Building, The University of Sydney, Camperdown Campus. Camperdown NSW 2006
Country 113262 0
Australia
Phone 113262 0
+61 2 9351 0604
Fax 113262 0
Email 113262 0
[email protected]
Contact person for public queries
Name 113263 0
Kate Curtis
Address 113263 0
Office 165. A26 building RC Mills Building, The University of Sydney, Camperdown Campus. Camperdown NSW 2006
Country 113263 0
Australia
Phone 113263 0
+61293510604
Fax 113263 0
Email 113263 0
[email protected]
Contact person for scientific queries
Name 113264 0
Kate Curtis
Address 113264 0
Office 165. A26 building RC Mills Building, The University of Sydney, Camperdown Campus. Camperdown NSW 2006
Country 113264 0
Australia
Phone 113264 0
+61 2 9351 0604
Fax 113264 0
Email 113264 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
Only aggregated data corresponding to the analysed variables across all study phases will be available. No individual data.


What supporting documents are/will be available?




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.