Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001482752
Ethics application status
Approved
Date submitted
7/10/2022
Date registered
25/11/2022
Date last updated
25/11/2022
Date data sharing statement initially provided
25/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the effectiveness, feasibility and impact of an embedded rural emergency department Nurse Practitioner model of care
Scientific title
Examining the effectiveness, feasibility and impact of an embedded rural emergency department Nurse Practitioner model of care
Secondary ID [1] 308104 0
None
Universal Trial Number (UTN)
Trial acronym
RED-NP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
All Emergency Department Presentations (Level 3-5) as defined by the Australasian Triage Scale (ATS). 327801 0
Pain-Acute 328004 0
Abdominal Pain 328005 0
Pain-Chest 328006 0
Fall-Unspecified 328007 0
Injury-Limb 328008 0
Nausea and Vomiting 328009 0
Mental Health Disorder 328010 0
Respiratory Disorder 328011 0
Condition category
Condition code
Injuries and Accidents 324872 324872 0 0
Other injuries and accidents
Mental Health 325066 325066 0 0
Other mental health disorders
Cardiovascular 325067 325067 0 0
Other cardiovascular diseases
Musculoskeletal 325068 325068 0 0
Other muscular and skeletal disorders
Respiratory 325069 325069 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 325182 325182 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of two components: the Emergency Department Nursing Practitioner (ED-NP) Model of Care (MoC) and the Implementation strategies.

1. The ED-NP MoC is focused on providing safe, equitable, and timely service to rural communities accessing emergency care. The role involves a hybrid advanced nursing MoC that includes nursing care, diagnostic activities, intervention-based treatments, and the use of medicines. The role is underpinned by robust clinical governance systems and compliance with PD 2020_034 Nurse Practitioners in NSW, an NP scope of practice, key performance indicators, evaluation measures, and directives for escalation of care. The model is focused on the Australasian Triage Scale (ATS) category 3-5 (low acuity) presentations. The rural Nurse Practitioner position will be developed to respond to local community needs for each of the participating sites (Bingarra Multipurpose Medical Centre, Gunnedah Hospital, Glenn Inness Hospital, and Wee Waa Hospital) located within Hunter New England Local Health District NSW, Australia, and the individual Nurse Practitioner's endorsed scope of practice.

The Nurse Practitioner will be accredited to provide First Line Emergency Care for Category Triage 1 and Triage 2 presentations to the Emergency Department to undertake assessment and implement treatment plans in line with the Rural Adult Emergency Clinical Guidelines and Rural Paediatric Emergency Clinical Guidelines in collaboration with Referral (Armidale, Tamworth, and John Hunter) Hospitals Emergency Department's Fellow Australiasian College Emergency Medicine (FACEM), and Retrieval Services via Telehealth.

Based on historical service data for each of the participating sites the majority (>85%) of the Nurse Practitioners' service interventions will be directed toward providing autonomous emergency services for Triage 3,4, and 5 (low acuity conditions) categories for children and adults presenting with; minor wounds, superficial burns, uncomplicated throat infections, and tonsillitis uncomplicated ear problems such as otitis external, otitis media or foreign body in the auditory canal, children (>2 yrs) or adults presenting with diarrhoea or constipation, mild gastroenteritis, adults presenting with uncomplicated urinary tract infection, minor wounds not complicated by tendon, nerve injury requiring closure, musculoskeletal and soft tissue injuries such as sprains, soft tissue injury, bites, fractures, uncomplicated fractures, eye problems including conjunctivitis, unembedded foreign body, flash burn, and skin infections including uncomplicated abscess, paronychia, and cellulitis. Complicated conditions/presentations for example burns involving the face, throat, genitals, joints, or extensive burns, peri-tonsillar abscess and/or imminent airway obstruction, wounds with tendon/nerve involvement, fractures requiring specialist intervention or sedation will be dealt with collaboratively with the FACEM medical officers accessed via My Emergency Doctor 24/7 on-call support and when appropriate by accessing specialist clinicians and retrieval services from larger regional hospitals and tertiary referral centers located within the Hunter New England Local Health District.

The proposed model of care differs from current standard care in that an endorsed Nurse Practitioner will be responsible for autonomously triaging, assessing, diagnosing, and delivering treatment for Triage Category 3-5 (low acuity) presentations, and collaborating with FACEM and specialist services for Triage Category 1-2 (high acuity) presentation, compared to the current model that includes variable and unreliable medical staffing of participating sites emergency departments that result in extensive wait times for patients to receive care, expensive inter-hospital transfers for low acuity conditions, patients traveling long distances to access care, and delays in treatment for life-threatening conditions.

The intervention will be implemented over a 12-month period.

2. The implementation strategies will be refined and targeted through engagement with key stakeholders, (healthcare providers, general practitioners, emergency care clinicians from supporting regional hospitals, experienced nurse practitioners, health service executives and managers, and Aboriginal health service clinicians and health workers) over an 8-week period prior to implementation. These will be identified through a local service-wide survey of healthcare providers from each participating site. The survey will be constructed utilising the Theoretical Domains Framework (TDF) and will be instrumental in identifying potential barriers to implementing the model.

Service, facility, clinician, and community stakeholder consultation occurred in the 12 months leading into the study. This stakeholder engagement has been instrumental in developing the proposed model of care, requisite clinical, service, and professional supports for the incumbent nurse practitioners, an agreed scope of practice for the respective sites that respond to community needs, professional and governance infrastructures to ensure quality, safe and effective care provisions, and a business case to support the model.

The study will be undertaken over 24 months and will include a 12-month pre-implementation and 12 months post-implementation period. Uptake and adherence to the intervention will be monitored by reviewing service level activity data, and NSW emergency treatment performance.
Intervention code [1] 324548 0
Treatment: Other
Comparator / control treatment
A clustered pre-post study design will be utilised to evaluate the feasibility, effectiveness and cost-consequence of the rural emergency department nurse practitioner model of care. Base-line Emergency Department service activity data will be collected from each participating site for a period of 12 months prior to and post-implementation for all presentations -Triage Categories 1-5 to quantify: numbers of presentations, inter-hospital transfers, collaborative consultations, inter-hospital transfers, and NSW Health Emergency Treatment Performance (ETP) indicators including re-presentations to ED within 48hrs, did not wait, left at own risk, “off stretcher” time, patient in ED >4hrs and numbers of Business Continuity Plans activated. Costs related to service provision 12 months pre and post-implementation including, transfer (ambulance, air hospital transport) and GP, VMO and Locum costs.
Control group
Active

Outcomes
Primary outcome [1] 332698 0
Number of low acuity (triage category 3-5) presentations (episodes of care) requiring inter-hospital transfer to access emergency care.
Data extracted from participating Emergency Department site's service monthly reporting activity data
Timepoint [1] 332698 0
Base-line activity data will be collected from each site for a period of 12 months prior to and 12 months post implementation of model of care
Secondary outcome [1] 414561 0
Effectiveness- 1. Time to stabilise and transfer Triage Category 1-2 (life-threatening) presentations.
Assessed using NSW Health Emergency Treatment Performance (ETP) indicators access via participating Emergency Department site service reporting activity data
Timepoint [1] 414561 0
Base-line activity data will be collected from each site for a period of 12 months prior to and 12 months post implementation of model of care
Secondary outcome [2] 414562 0
Effectiveness- 2. Length of Emergency Department stay >4 hrs
Assessed using NSW Health Emergency Treatment Performance (ETP) indicators access via participating Emergency Department site service reporting activity data
Timepoint [2] 414562 0
Base-line activity data will be collected from each site for a period of 12 months prior to and 12 months post implementation of the model of care
Secondary outcome [3] 415083 0
Effectiveness-3. Off Stretcher time.
Assessed using NSW Health Emergency Treatment Performance (ETP) indicators access via participating Emergency Department site service reporting activity data
Timepoint [3] 415083 0
Base-line activity data will be collected from each site for a period of 12 months prior to and 12 months post implementation of the model of care
Secondary outcome [4] 415084 0
Effectiveness- 4. Emergency Department representation <48hrs.
Assessed using NSW Health Emergency Treatment Performance (ETP) indicators access via participating Emergency Department site service reporting activity data
Timepoint [4] 415084 0
Base-line activity data will be collected from each site for a period of 12 months prior to and 12 months post implementation of the model of care
Secondary outcome [5] 415085 0
Effectiveness-5. "Did not Wait"Assessed using NSW Health Emergency Treatment Performance (ETP) indicators access via participating Emergency Department site service reporting activity data
Timepoint [5] 415085 0
Base-line activity data will be collected from each site for a period of 12 months prior to and 12 months post implementation of the model of care
Secondary outcome [6] 415086 0
Effectiveness-6. "left at own risk".
Performance (ETP) indicators access via participating Emergency Department site service reporting activity data
Timepoint [6] 415086 0
Base-line activity data will be collected from each site for a period of 12 months prior to 12 months post implementation of the model of care
Secondary outcome [7] 415087 0
Effectiveness-7. The number of Local Business Continuity Plans initiated for patients presenting with (Triage category 3-5).
Accessed via participating Emergency Department/Service reporting activity data.
Timepoint [7] 415087 0
Base-line activity data will be collected from each site for a period of 12 months prior to and after the implementation of the model of care
Secondary outcome [8] 415088 0
Experience/Acceptability/Satisfaction: Patient and Carer
Post-implementation survey. The survey is based on a previously validated tool (Jennings et al 2009; 15:213-218) that has been modified for this study to capture the emergency department context and to canvas patient and career experience and satisfaction related to the rural emergency department nurse practitioner intervention.
Timepoint [8] 415088 0
The survey will be disseminated to patients and careers presenting to participating emergency departments with triage category 3-5 conditions who received care by the nurse practitioner within 72 hours of their emergency department discharge (5% of total emergency department presentation per month for a 3-month period across all sites, approx. 40/month) at 3-6 months post implementation.

Secondary outcome [9] 415089 0
Experience/Acceptability/Satisfaction: Health care professionals (Nurse Practitioners, local health care professionals from participating sites, including visiting medical officers, general practitioners, health service managers, Aboriginal Health workers, and FACEMS.
Post-implementation focus-group (qualitative) interviews.
Focus group interviews will be conducted with 8-10 participants, purposively selected to represent service, geographical, discipline and roles of attendees. The interviews will be conducted face-to-face or online via MS Teams in response to participants preferences. All focus groups will be moderated by experience qualitative researchers who will utilise a semi-structured interview to guide discussions.
Timepoint [9] 415089 0
The Focus groups will be conducted with Nurse Practitioners at 2-3 months and 9-12 months post implementation
Focus group interviews with all other health care professionals will be undertaken 9-12 months post implementation
Secondary outcome [10] 415090 0
Economic analysis- efficiency and affordability.
Assessed by using a prospective trial-based cost-consequence analysis (CCA) of the intervention at each site utilising changes in primary and secondary outcomes pre and post-implementation. The economic analysis will identify, measure and value resource use pre and post-implementation primarily utilising hospital administrative datasets as well as data available on primary and other support services use and medical transfer costs.
Timepoint [10] 415090 0
The CCA will be conducted over a 24-month study period.

Eligibility
Key inclusion criteria
1. People (> 18years); parents/carers of children (<18years) who have presented to EDs for emergency assessment/care 6 months post implementation.
2. Clinicians, local General Practitioners, Visiting Medical Officers, Locums responsible for delivering/supporting emergency care delivery within participating sites,
3. Health Service executives and managers responsible for overseeing/supporting the nurse practitioner model of care in study sites.


Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-English speaking participants if interpreter services are not accessible.

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



Intervention assignment
Other
Other design features
A multi-site, two-phased hybrid Type 2 comparative effectiveness implementation study. Phase one will include a cross-sectional survey and focus groups to support collaborative efforts to refine the Nurse Practitioner scope of practice, and identify barriers and facilitators to implementing the model of care in four rural emergency departments in Hunter New England Local Health District. Phase two will include a clustered pre-post effectiveness study, a cost-consequence economic evaluation of the model of care, and a formative evaluation of the implementation strategies. The approach supports the simultaneous application of an experimental pre-post study design to test the intervention's effectiveness, whilst concurrently allowing for formative evaluations to answer critical questions related to the feasibility of the implementation strategies, acceptability, impact, and adaptions required to optimise the potential for translation and impact.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data Analysis: Clustered pre-post effectiveness-implementation study-i) Sample size and statistical power: Assuming an average sample size of 4455 occasions of service per 12 month period per site at the 4 sites, and conservatively assuming 50% of these will be a (Category 3-5) requiring transfer to specialist facilities within the Local Health District, The study will have 90% power to detect an absolute 2% decrease in the proportion of these services that require transfer to specialist facilities, with a type 1 error rate of 5%. ii) Statistical methods: Differences between pre and post intervention period occasions of service (Category 3-5) requiring transfer to a specialist facility within each site will be compared using a segmented regression analysis. The data will be aggregated to the month level, and the monthly rates of transfer will be modelled with a trend term in the pre period, an intervention effect at the start of the post intervention period, and a term for the difference in slopes between the pre and post period. The model will include a fixed effect for site, and initially no interaction between intervention effects and site. Differential site effects will be assessed in an exploratory analysis. This analyses will allow for a potential secular trend pre intervention which would otherwise bias a pre-post comparison. Using the same (or very similar) 12 month periods for pre and post intervention will control for potential seasonal effects. Secondary outcomes will also be aggregated to the monthly level and analysed using the same modelling approach as for the primary outcome. Qualitative data collected from open-ended questions, focus group interviews the course study will be de-identified, and thematically analysed.

Economic analysis: The efficiency and affordability of the Model of Care will be assessed using a prospective trial-based cost-consequence analysis (CCA) of the intervention operating at each implementation site. The CCA will be conducted over the 24-month study period, utilising changes in primary and secondary outcomes pre and post the implementation. The economic analysis will identify, measure and value resource use pre and post implementation primarily utilising hospital administrative datasets (as well as data available on primary and other support service use and medical transfer costs). The CCA is included to reflect the range of trial outcomes and their consequences assessed from a societal perspective, with a focus on measurable outcomes. The analysis will utilise changes in reported patient and workforce experience, using validated survey tools. The CCA will present the results as a scorecard. Affordability of the program will be calculated using budget impact analysis over a standard accounting cycle and is designed to assist decision making for the translation of cost-effective and affordable models of care.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2022
Actual
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
3/12/2024
Actual
Sample size
Target
2227
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23296 0
Bingara Multipurpose Service - Bingara
Recruitment hospital [2] 23297 0
Gunnedah District Hospital - Gunnedah
Recruitment hospital [3] 23298 0
Glen Innes District Hospital - Glen Innes
Recruitment hospital [4] 23299 0
Wee Waa Community Hospital - Wee Waa
Recruitment postcode(s) [1] 38669 0
2404 - Bingara
Recruitment postcode(s) [2] 38670 0
2380 - Gunnedah
Recruitment postcode(s) [3] 38671 0
2370 - Glen Innes
Recruitment postcode(s) [4] 38672 0
2388 - Wee Waa

Funding & Sponsors
Funding source category [1] 312359 0
Government body
Name [1] 312359 0
Hunter New England Local Health District
Country [1] 312359 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Lookout Rd, New Lambton NSW 2305
Country
Australia
Secondary sponsor category [1] 313922 0
None
Name [1] 313922 0
Address [1] 313922 0
Country [1] 313922 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311719 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 311719 0
Ethics committee country [1] 311719 0
Australia
Date submitted for ethics approval [1] 311719 0
31/08/2022
Approval date [1] 311719 0
23/09/2022
Ethics approval number [1] 311719 0
2022/ETH01796

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

Contacts
Principal investigator
Name 122122 0
A/Prof Michelle Giles
Address 122122 0
Nursing and Midwifery Research Centre, Gate Cottage, Building 6
James Fletcher Hospital, 72 Watt Street, Newcastle NSW 2300
Country 122122 0
Australia
Phone 122122 0
+61 2 49246702
Fax 122122 0
Email 122122 0
[email protected]
Contact person for public queries
Name 122123 0
Michelle Giles
Address 122123 0
Nursing and Midwifery Research Centre, Gate Cottage, Building 6
James Fletcher Hospital, 72 Watt Street, Newcastle NSW 2300
Country 122123 0
Australia
Phone 122123 0
+61 2 49246702
Fax 122123 0
Email 122123 0
[email protected]
Contact person for scientific queries
Name 122124 0
Michelle Giles
Address 122124 0
Nursing and Midwifery Research Centre, Gate Cottage, Building 6
James Fletcher Hospital, 72 Watt Street, Newcastle NSW 2300
Country 122124 0
Australia
Phone 122124 0
+61 2 49246702
Fax 122124 0
Email 122124 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
IPD will not be shared


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.