Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000929606p
Ethics application status
Submitted, not yet approved
Date submitted
7/07/2023
Date registered
29/08/2023
Date last updated
29/08/2023
Date data sharing statement initially provided
29/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Nurse Practitioner Program within Aged Care Facilities
Scientific title
eNPAC: Evaluation of a pilot Nurse Practitioner Program to enhance primary care of residents of Aged Care facilities.
Secondary ID [1] 309658 0
Nil known
Universal Trial Number (UTN)
Trial acronym
eNPAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic illness 329999 0
Condition category
Condition code
Public Health 326907 326907 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pilot Nurse Practitioner (NP) Program is being evaluated at Residential Aged Care Facilities (RACFs) in the Hunter New England Local Health District. This program is designed to supplement the primary health care provided by General Practitioners (GPs) in RACFs as a means of providing more efficient access to services as they are needed by RACF residents.
In this pilot intervention, NPs with collaborative GP agreements are to routinely visit 5 RACF sites. Services provided by the NPs fall within their usual scope of care, with the intervention assessing the feasibility and acceptability of these services being delivered in an RACF context. This means that the NPs do not require any additional training and will not be providing any 'new' service, but rather that the service will be newly implemented in this setting.


RACFs in the intervention group will have access to the NP service. NPs seek a collaborative agreement from GPs of residents within these RACFs. This allows the NP to work collaboratively with the GP to provide primary care services. NPs are eligible to bill the Medicare Benefits Schedule for a range of services, and there are no costs incurred by residents.

NPs will attend each intervention RACF 0.5-2 days a week (depending on number of residents) and be available to provide services for residents whose doctors have signed the agreement. Services will vary based on residents’ needs but may include advance care planning, wound management, chronic disease care, medication management, and referral. NPs will provide care as required to the residents, meaning that individual care sessions will typically range from 20 minutes to 1 hour, but will be dependent on the varying needs of each resident over time. The service is aimed at increasing timely access to primary care within the residential aged care setting.
The NP program will run for 12 months at each intervention facility. The NPs will log their patient care files and details of their sessions with residents in the facility resident files. These files will be used to monitor uptake and adherence to the program.
Intervention code [1] 326092 0
Prevention
Intervention code [2] 326093 0
Treatment: Other
Comparator / control treatment
Five Residential Aged Care facilities matched to the Intervention facilities on factors such as the number of beds and workplace structure will serve as the Control Group for this study. The Control RACFs do not have a Nurse Practitioner providing services at the facility, compared to the Intervention RACFs which have an active Nurse Practitioner service. Both control and intervention sites will maintain their otherwise usual care services provided by General Practitioners who visit the site on a needs basis.
Control group
Active

Outcomes
Primary outcome [1] 335245 0
Reach:
The proportion of eligible residents in intervention RACFs who accessed at least one NP service. This is calculated as the number of residents accessing the NP service divided by the total number of residents at RACF whose GPs signed agreements. Resident access to NP services will be obtained by an audit of resident care files, while the number of GPs with collaborative agreements with NPs. These collaborative agreements are signed and kept in project records with HPC including data on those who do not sign.
Timepoint [1] 335245 0
Post-Intervention, at the conclusion of the 12-month NP intervention trial. Data will be collected and analysed within 1 month post-completion.
Primary outcome [2] 335382 0
Reach:
The range and type of services provided by the NPs, e.g., medication review, review post-hospital discharge, and advanced care planning. This data will be obtained from an audit of resident care files held by HPC.
Timepoint [2] 335382 0
Post-Intervention, at the conclusion of the 12-month NP intervention trial. Data will be collected and analysed within 1 month post-completion.
Primary outcome [3] 335383 0
Reach:
The proportion of eligible residents at each RACF who receive more than one NP service. This data will be obtained from an audit of resident care files held by HPC.
Timepoint [3] 335383 0
Post-Intervention, at the conclusion of the 12-month NP intervention trial. Data will be collected and analysed within 1 month post-completion
Secondary outcome [1] 424216 0
Reach (PRIMARY outcome)
The proportion of GPs affiliated with participating RACFS that use the service. This is calculated as the number of GPs and NPs signing collaborative agreements divided by the total number of GPs from the RACF. This information was obtained as part of the project establishment and agreement with facilities. HPC hold this data and copies of agreements and details of those who did not sign agreement.
Timepoint [1] 424216 0
Post-Intervention, at the conclusion of the 12-month NP intervention trial. Data will be collected and analysed within 1 month post-completion.
Secondary outcome [2] 424217 0
Acceptability (PRIMARY outcome)

Satisfaction: How satisfied are the stakeholders (residents, RNs, GPs) with the NP service.

Confidence: Does the implementation of the NP service improve RACF staff confidence?

Satisfaction and confidence will be collected as an aggregate measure via an NP service acceptability scale designed specifically for this study, based on the feasibility study framework of Bowen (2009).
Timepoint [2] 424217 0
Post-Intervention, at the conclusion of the 12-month NP intervention trial. Data will be collected and analysed within 1 month post-completion.
Secondary outcome [3] 424218 0
Acceptability (PRIMARY measure):

Benefits: What do stakeholders see as the benefits/ disadvantages of the service and opportunities for improving implementation? This will be obtained via semi-structured qualitative interview conducted either face-to-face (if possible) or via digital methods (i.e. zoom call) with a member of the research team trained in qualitative research and interview conduct.
Timepoint [3] 424218 0
Post-Intervention, at the conclusion of the 12-month NP intervention trial. Interviews will be collected within 1 month post-completion.
Secondary outcome [4] 424219 0
Feasibility (PRIMARY outcome)

The proportion of the total cost of employing NP that is covered by MBS billing. This is calculated as the proportion of cost of employment, minus the MBS billing contribution. This data is determined via an audit of the HPC financial records.
Timepoint [4] 424219 0
Post-Intervention, at the conclusion of the 12-month NP intervention trial. Data will be collected and analysed within 1 month post-completion.
Secondary outcome [5] 424220 0
Indices of resident primary health outcomes:
The number of Advanced care plans developed and documented for residents. This data is mandatorily collected by RACFs as part of the Aged Care Quality Framework and will be provided in de-identified format to the research team.
Timepoint [5] 424220 0
Data will be collected monthly for the 12 months prior to the intervention and 12 months during the intervention. This data will be obtained in one extraction from RACF medical records post-intervention at the conclusion of the 12-month NP intervention trial. The extraction will be completed by a RACF staff member and provided to the research team in de-identified format.
Secondary outcome [6] 424221 0
Indices of resident primary health outcomes:
Appropriate use of medication as indicated by Polypharmacy: Percentage of eligible residents prescribed 9 or more medications, and Antipsychotic use: Percentage of eligible residents prescribed antipsychotic medications. This data is mandatorily collected by RACFs as part of the Aged Care Quality Framework and will be provided in de-identified format to the research team.
Timepoint [6] 424221 0
Data will be collected monthly for the 12 months prior to the intervention and 12 months during the intervention. This data will be obtained in one extraction from RACF medical records post-intervention at the conclusion of the 12-month NP intervention trial. The extraction will be completed by a RACF staff member and provided to the research team in de-identified format.
Secondary outcome [7] 424222 0
Indices of resident primary health outcomes:
Hospitalisation as indicated by the percentage of eligible residents who had one or more ED presentations. This data is mandatorily collected by RACFS as part of the Aged Care Quality Framework and will be provided in de-identified format to the research team by a HNE research scientist
Timepoint [7] 424222 0
Data will be collected monthly for the 12 months prior to the intervention and 12 months during the intervention. This data will be obtained in one extraction from RACF medical records post-intervention at the conclusion of the 12-month NP intervention trial. The extraction is completed by a HNE data scientist.
Secondary outcome [8] 424223 0
Indices of resident primary health outcomes:
Hospitalisation, as indicated by the percentage of eligible residents who are admitted to hospital after ED presentation, This data is mandatorily collected by RACFS as part of the Aged Care Quality Framework and will be provided in de-identified format to the research team by a HNE research scientist
Timepoint [8] 424223 0
Data will be collected monthly for the 12 months prior to the intervention and 12 months during the intervention. This data will be obtained in one extraction from RACF medical records post-intervention at the conclusion of the 12-month NP intervention trial. The extraction is completed by a HNE data scientist.
Secondary outcome [9] 424224 0
Indices of resident primary health outcomes:
Hospitalisation, as indicated by the length of stay for hospitalisation after ED presentation. This data is mandatorily collected by RACFS as part of the Aged Care Quality Framework and will be provided in de-identified format to the research team by a HNE research scientist
Timepoint [9] 424224 0
Data will be collected monthly for the 12 months prior to the intervention and 12 months during the intervention. This data will be obtained in one extraction from RACF medical records post-intervention at the conclusion of the 12-month NP intervention trial. The extraction is completed by a HNE data scientist.
Secondary outcome [10] 424225 0
Indices of resident primary health outcomes:
Falls, as indicated by residents who have experienced 1 or more fall. This data is mandatorily collected by RACFS as part of the Aged Care Quality Framework and will be provided in de-identified format to the research team.
Timepoint [10] 424225 0
Data will be collected monthly for the 12 months prior to the intervention and 12 months during the intervention. This data will be obtained in one extraction from RACF medical records post-intervention at the conclusion of the 12-month NP intervention trial. The extraction will be completed by a RACF staff member and provided to the research team in de-identified format.
Secondary outcome [11] 424226 0
Indices of resident primary health outcomes:
Restraint, as indicated by the percentage of residents who needed to be restrained. This data is mandatorily collected by RACFS as part of the Aged Care Quality Framework and will be provided in de-identified format to the research team.
Timepoint [11] 424226 0
Data will be collected monthly for the 12 months prior to the intervention and 12 months during the intervention. This data will be obtained in one extraction from RACF medical records post-intervention at the conclusion of the 12-month NP intervention trial. The extraction will be completed by a RACF staff member and provided to the research team in de-identified format.
Secondary outcome [12] 424227 0
Indices of resident primary health outcomes:
Skin condition, as indicated by percentage of eligible residents who had incontinence-related skin deterioration. This data is mandatorily collected by RACFS as part of the Aged Care Quality Framework and will be provided in de-identified format to the research team.
Timepoint [12] 424227 0
Data will be collected monthly for the 12 months prior to the intervention and 12 months during the intervention. This data will be obtained in one extraction from RACF medical records post-intervention at the conclusion of the 12-month NP intervention trial. The extraction will be completed by a RACF staff member and provided to the research team in de-identified format.

Eligibility
Key inclusion criteria
Residential Aged Care Facilities (RACFs): To be included in the study RACFs will be located in the Greater Hunter Region, receive the Aged Care Emergency Program, and be willing to participate in the intervention (if an intervention site).

Aged Care Residents (intervention and control sites)

Residential Aged Care Participants will be aged 65 years and older, however, it is expected that most will be aged 85 years or older. These participants will contribute via access to routinely collected data held within their aged care files. Inclusion criteria: All residents living at a participating facility will be eligible to receive NP services if their GP signs a collaborative agreement and for data inclusion sourced from HNELHD

Residential Aged Care Facility (RACF) Registered Nurse (RN) staff

Registered nurses from intervention sites will be invited to participate in semi-structured interviews to contribute to the evaluation of the acceptability of the NP service. Inclusion criteria: RACF staff will be eligible if they have been employed at a participating intervention site during the trial period and are employed as a Registered Nurse.

General Practitioners

GPs who have patients that reside at an RACF intervention site will be invited to participate in a online/phone survey and/or an interview to contribute to the evaluation of the acceptability of the NP service. Inclusion criteria: GPs who have patients who reside at participating intervention RACFs and who have collaborative agreements with the NPs involved in the program will be eligible to participate.

Nurse Practitioners

The Nurse Practitioners involved in the implementation will be invited to participate in a qualitative interview to contribute to the evaluation of NP service implementation. Inclusion criteria: Nurse practitioners who are involved in delivery of the intervention will be eligible to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Aged Care Residents: Residents who are considered too unwell by RACF staff or who are unable to provide independent consent for the interview will be excluded following the Capacity to Consent process which clarifies that the participant understands what the research involves and is aware of what they are consenting to before consent is sought. This is completed using a structured Capacity to Consent form which asks the resident a number of specific questions about what the research will involve and checks for accuracy of understanding.

Residential Aged Care Facility (RACF) Registered Nurse (RN) staff : RACF staff who were employed at a participating intervention site but are not employed as Registered Nurses will be excluded from participation.

General Practitioners: GPs who have patients who reside at participating intervention RACFs but do not have collaborative agreements with NPs involved in the program will be excluded from participation.

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics including frequency analyses will be carried out for all Feasibility and Acceptability measures. Cost-analysis will be conducted to examine cost of the service per resident and overall cost per facility. Further, consideration of cost of admission to hospital between the control and intervention sites will be evaluated with assistance from health economics expert.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/10/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313851 0
University
Name [1] 313851 0
University of Newcastle
Country [1] 313851 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 315682 0
Charities/Societies/Foundations
Name [1] 315682 0
Hunter Primary Care
Address [1] 315682 0
7 Warabrook Boulevard, Warabrook NSW 2304
PO Box 572, Newcastle NSW 2300
Country [1] 315682 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312999 0
University of Newcastle Human Ethics Committee
Ethics committee address [1] 312999 0
Ethics committee country [1] 312999 0
Australia
Date submitted for ethics approval [1] 312999 0
15/06/2023
Approval date [1] 312999 0
Ethics approval number [1] 312999 0

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

Contacts
Principal investigator
Name 126634 0
A/Prof Michelle Kelly
Address 126634 0
University of Newcastle
Room W-132,
Behavioural Sciences Building
University Drive, Callaghan, NSW 2308
Country 126634 0
Australia
Phone 126634 0
+61 2 4921 6838
Fax 126634 0
Email 126634 0
[email protected]
Contact person for public queries
Name 126635 0
Michelle Kelly
Address 126635 0
University of Newcastle
Room W-132,
Behavioural Sciences Building
University Drive, Callaghan, NSW 2308
Country 126635 0
Australia
Phone 126635 0
+61 2 4921 6838
Fax 126635 0
Email 126635 0
[email protected]
Contact person for scientific queries
Name 126636 0
Michelle Kelly
Address 126636 0
University of Newcastle
Room W-132,
Behavioural Sciences Building
University Drive, Callaghan, NSW 2308
Country 126636 0
Australia
Phone 126636 0
+61 2 4921 6838
Fax 126636 0
Email 126636 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 data pertains to health records for residents at Aged Care centers that will not be shared publically.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19579Study protocol  [email protected] Contacting CI A/Prof Michelle Kelly
19580Ethical approval  [email protected] Contacting CI A/Prof Michelle Kelly



Results publications and other study-related documents

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Documents added automatically
No additional documents have been identified.