Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000882628
Ethics application status
Approved
Date submitted
27/07/2023
Date registered
16/08/2023
Date last updated
16/08/2023
Date data sharing statement initially provided
16/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
NSW Government-Sponsored Clinical Trial: Management of Urinary Tract Infections by Community Pharmacists
Scientific title
Effect of Management of Urinary Tract Infections in Women aged 18-65 years by Community Pharmacists on Self-reported 7-day symptom free rate: PATH-UTI
Secondary ID [1] 309426 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PATH-UTI (PATHway to access: UTI management)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary tract infections 329684 0
Condition category
Condition code
Renal and Urogenital 326582 326582 0 0
Other renal and urogenital disorders
Public Health 327829 327829 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The overall aim of this study is to evaluate the implementation and impact of a service model (intervention) over a 10-month study period, delivered by community pharmacists in NSW and 5 pharmacies in ACT, managing UTIs for a specific patient cohort (women aged between 18 years and 65 years) presenting with symptoms consistent with an uncomplicated UTI.

Intervention description
The intervention is multicomponent:

Pharmacist training
Prior to service delivery, pharmacists will be clinically prepared through a training program (either through the Australasian College of Pharmacy or Pharmaceutical Society of Australia) to apply best practice standard of care. Furthermore, study specific research training modules will be completed by pharmacists to ensure efficiency in the consultation process, patient consent, recruitment of patients, timely referral, and quality data collection.

The ACP training module covers the following learning objectives:
• “Describe the basis for the development of urinary tract infections including anatomy of the female urinary tract, pathogenesis, and microbiology
• Outline the key clinical features of urinary tract infections
• Describe the differential diagnosis of urinary tract infections
• Discuss antibiotic treatment of urinary tract infections
• Describe the role of over the counter products in the management of urinary tract infections
• Outline the pharmacist workflow in the management of uncomplicated cystitis.”

The PSA training module covers the following learning objectives:
• “Discuss the classification and differential diagnosis of urinary tract infections.
• Describe the anatomy of the female urinary tract system, risk factors, pathogenesis, and microbiology of urinary tract infection.
• Outline the key clinical features of cystitis.
• Discuss the choice of antibiotic treatment of cystitis.
• Explain the role of over-the-counter products in the management of cystitis.
• Describe the requirements of a urinary tract infection community pharmacy service.”

These training modules are delivered online. The training needs to be completed once only and may take up to 6 hours depending on progress. The training modules are available to complete up to 3 weeks prior relative to intervention delivery.

The University developed modules are intended to cover NSW legislative specific content, the clinical management protocol and research requirements.
• Recognise the key requirements for pharmacies who are authorised to deliver the UTI service.
• Recognise the key requirements for pharmacists involved in the delivery of the UTI service.
• Recognise the restricted substances in the Authority and the requirements for supply.
• Recognise the requirements for patient participation in the trial and service.
• Outline patient participant involvement in the trial.
• Recognise the requirements for eConsent.
• Outline the components of the UTI clinical management protocol.
• Outline the stepwise approach to managing patients with UTIs.
• Recognise the ‘red flags’ and ‘referral’ points.
• Explain the treatment options available for managing patients with a UTI.
• Define packaging and labelling requirements of empirical antibiotics.
• Outline criteria for determining if a women is pregnant.
• Outline how to record UTI consultations in MedAdvisor.
• Recognise the payment method for remuneration of service delivery via MedAdvisor.
• Recognise that supply of medicines or other products is at patient expense.
• Define Antimicrobial Resistance (AMR).
• Recognise the importance of addressing AMR.
• Describe the mechanisms of AMR.
• Outline Antimicrobial Stewardship (AMS).
This training is delivered online through short videos. The training only needs to be completed once and may take up to 4 hours depending on progress. This training is available to complete up to 3 weeks prior relative to intervention delivery.
Once pharmacists have confirmed their completion of these mandatory training during the consenting process, they will be an ‘approved pharmacist’ which under the NSW Health Authority certifies them to provide the consultation service.

Pharmacy consultation
The pharmacist will undertake a structured consultation, anticipated to take 10 minutes, with the patient in the community pharmacy guided by an IT program applying a co-designed clinical management protocol which considers the recommendations from the Australian Therapeutic Guidelines. The clinical management protocol has been subject to co-design between community pharmacists and senior general practitioners.

The structured consultation is summarised as follows:

• Participant eligibility assessment, in which the pharmacist will assess if the patient meets the inclusion/exclusion criteria to participate in the study.

• Service offering, during which the pharmacist will explain the features of the study and will ask the patient if she/they is willing to participate.

• Provision of the Patient information sheet and informed consent form.

• During the clinical assessment of the patient, the pharmacist will elicit relevant clinical information, including medical conditions, medication history and assessed for the possibility of uncomplicated lower UTI, in line with the agreed treatment protocols. If the patient is a usual patient of the pharmacy, their medication dispensing history may be checked on the computer record, if not a patient medication history will be performed. Further information may be obtained from the patients’ Electronic Health Record (EHR).

• After the clinical assessment, the pharmacist will use an agreed clinical management protocol to determine the management approach which may include treatment, or GP or ED referral:

1. Provision of conservative management and self-care advice (e.g., symptom control, future prevention advice),

2. Supply of antibiotics: trimethoprim, nitrofurantoin, cefalexin may be supplied under the service for this study and in accordance with the developed clinical management protocol and the NSW Health Authority. If a medication is prescribed, the patient will be provided with the relevant Consumer Medicines Information and/or a self-care card.

3. Appropriate and timely referral, if required, according to the following categories:
- Urgent referral – the patient’s condition requires immediate medical attention by a medical practitioner or emergency department.
- General referral – the patient’s condition may be suitable for self-treatment, however medical review with a medical practitioner at the next available appointment is appropriate due to patient circumstances (comorbidity, chronic disease etc.)
- Considered referral – the patient’s condition is suitable for treatment by the pharmacist; however, referral is warranted if symptoms do not resolve within a defined time period.
The reason for referral must be clearly communicated verbally and in writing to the patient and provided with the appropriate referral documentation.

4. Provision of follow up advice (e.g., expectation around duration of symptoms which should respond to appropriate antibiotic therapy within 48 hours; and to see GP urgently if their symptoms worsened or no improvement, if symptoms persist 48–72 hours after starting antibiotic treatment, symptoms reoccur within 2 weeks after finishing antibiotic treatment or symptoms develop that are not symptoms of an acute UTI.

• The pharmacist will share a record of the supply with the patient’s usual treating medical practitioner or medical practice (via fax, secure messaging software, provision of a letter to the patient, or any other approved secure means by NSW Health), where the patient has one, following consent by the patient.

• The pharmacist will comply with the ‘Management Protocol’, including that the pharmacist makes a record in MedAdvisor pharmacy software, or an approved system by the Ministry of Health, regarding the supply (as per NSW Health Authority).

• The pharmacist must keep a clinical record for 7 years that contains (as per NSW Health Authority):
• sufficient information to identify the patient;
• the date of the treatment;
• the name of the pharmacist who undertook the consultation;
• any information known to the pharmacist that is relevant to the patient’s diagnosis or treatment (for example, information concerning the patient’s medical history);
• any clinical opinion reached by the pharmacist;
• actions taken by the pharmacist;
• particulars of any medication supplied for the patient (such as form, strength and amount);
• notes as to information or advice given to the patient in relation to any treatment proposed by the pharmacist who is treating the patient;
• any consent given by a patient to the treatment proposed.

• The pharmacist will ask for the patients consent to be followed up by the research team at 7 days.

The participant will usually present via a walk-in approach with symptoms that may be reflective of a UTI, although can make appointments if required. The first step will be the pharmacist to request that the patient read the Participant Information Statement and understand the consenting process using an electronic device (e.g., mobile phone). This information will be accessed by the participant scanning a pharmacy specific QR code via this device. If they do not have a mobile device, then the pharmacy will offer to use an alternate device e.g., iPad or similar. If the participant, after reading the Participant Information Statement, provides consent (copies of which will be sent to the participants email address), the pharmacist will then proceed with the consultation, guided by an IT program, in a private consultation room in the pharmacy. Following this consultation, the pharmacist will make the appropriate clinical decisions and provide advice to the participant. This will be a single consultation, although the patient may be advised to consult their medical practitioner if symptoms persist 48–72 hours after starting antibiotic treatment or if they experience any adverse events.

The participant will be sent a 7 follow up survey (via SMS, email or phone call) to elicit adherence to medications and/or referral advice. A sample of participants will also be invited to participate in a semi-structured interview if they have indicated on their consent form they wish to participate.

The intervention will be provided under the NSW Health Authority allowing participating NSW pharmacists to supply medications as part of the trial.
(https://www.health.nsw.gov.au/pharmaceutical/Documents/pharmacist-uti-authority.PDF). For ACT, a discretionary licence will be approved for participating pharmacies. (https://www.health.act.gov.au/sites/default/files/2023-02/Medicines%20Poisons%20Therapeutic%20Goods%20Licence%20Application.pdf).

The cost of the consultation with patients ($20) will be paid for by the NSW Government to pharmacies, irrespective of the outcome of the consultation. The patient will need to pay for any medicines or products provided. In the ACT, there may be a cost to the consultation which will be paid for by the patient receiving the service, irrespective of the outcome of the consultation.

Implementation strategy
There will be follow up training and ongoing support for pharmacies and pharmacists as part of a translational and implementation strategy through the study period. Practice change facilitators will visit these pharmacies to provide ongoing support, answer any queries, ensure quality data is being collected, and collect implementation data. The implementation component of the study will be underpinned by the Consolidated Framework for Implementation Research (CFIR), in particular the use of an adapted implementation model for community pharmacy. Implementation factors (barriers, causes and facilitators) and the Dougherty strategy classification systems, adapted to community pharmacy, will be used.

The ongoing support system will be through a practice change facilitator assigned as a research support to each pharmacy involved in the trial. On average, the facilitator will contact the pharmacy on a monthly basis. Pharmacies will be classified as low, medium or high contact based on several parameters including number of monthly consultations, number of pharmacists delivering the intervention, and the fidelity of consultation data. Targeted additional contacts will occur depending on this classification.
Intervention code [1] 325858 0
Treatment: Other
Intervention code [2] 325859 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334437 0
Self-reported 7-day symptom free rate: defined as the complete absence of urinary tract infection symptoms.
Timepoint [1] 334437 0
This data will be collected by a researcher at 7 day patient follow up via the patient's preferred method (SMS, email or phone call). There will be reminders if no response, at days 9, 11 and 13 days, with a maximum of 5 attempts.
Secondary outcome [1] 420618 0
Primary care utilisation: MBS records, including pathology items, will be used to measure use of general practice services prior up to 12 months pre- and 12 months post the registration date. This is a participant specific outcome.
Timepoint [1] 420618 0
Trends over the 12-month interval before and 12 months after initiation of the program.
Secondary outcome [2] 420619 0
Medication utilisation: Antibiotic prescribing during the trial will be assessed. PBS records for prescribed antibiotics will be analysed to assess claims made in the 12 months prior to registration to the pharmacy trial and over the next 12 months post registration. This is a participant specific outcome.
Timepoint [2] 420619 0
Trends over the 12-month interval before and 12 months after initiation of the program.
Secondary outcome [3] 420620 0
Hospital utilisation: Admitted Patient Data Collection (APDC) data will be used to assess hospitalisation trends over the 12-month interval before and 12 months after initiation of the program. This is a participant specific outcome.
Timepoint [3] 420620 0
Trends over the 12-month interval before and 12 months after initiation of the program.
Secondary outcome [4] 424528 0
All-cause hospitalisations per 100 persons: Admitted Patient Data Collection (APDC) data will be used to assess hospitalisation trends over the 12-month interval before and 12 months after initiation of the program. This is a participant specific outcome.
Timepoint [4] 424528 0
Trends over the 12-month interval before and 12 months after initiation of the program.
Secondary outcome [5] 424529 0
Avoidable (or “potentially preventable”) hospital admissions per 100 persons: Admitted Patient Data Collection (APDC) data will be used to assess hospitalisation trends over the 12-month interval before and 12 months after initiation of the program. This is a participant specific outcome.
Timepoint [5] 424529 0
Trends over the 12-month interval before and 12 months after initiation of the program.
Secondary outcome [6] 424530 0
Avoidable hospital admissions per 100 persons for genitourinary conditions: Admitted Patient Data Collection (APDC) data will be used to assess hospitalisation trends over the 12-month interval before and 12 months after initiation of the program. This is a participant specific outcome.
Timepoint [6] 424530 0
Trends over the 12-month interval before and 12 months after initiation of the program.
Secondary outcome [7] 424531 0
Acute hospital admissions per 100 persons: Admitted Patient Data Collection (APDC) data will be used to assess hospitalisation trends over the 12-month interval before and 12 months after initiation of the program. This is a participant specific outcome.
Timepoint [7] 424531 0
Trends over the 12-month interval before and 12 months after initiation of the program.
Secondary outcome [8] 424532 0
Length of stay for acute hospital admissions per 100 persons: Admitted Patient Data Collection (APDC) data will be used to assess hospitalisation trends over the 12-month interval before and 12 months after initiation of the program. This is a participant specific outcome.
Timepoint [8] 424532 0
Trends over the 12-month interval before and 12 months after initiation of the program.
Secondary outcome [9] 425192 0
Bed days for acute hospital admissions per 100 persons: Admitted Patient Data Collection (APDC) data will be used to assess hospitalisation trends over the 12-month interval before and 12 months after initiation of the program. This is a participant specific outcome.
Timepoint [9] 425192 0
Trends over the 12-month interval before and 12 months after initiation of the program.
Secondary outcome [10] 425193 0
Emergency presentations: Emergency Department Data Collection (EDDC) data will be used to assess emergency and urgent care presentation trends over the 12-month interval before and 12 months after initiation of the program. This is a participant specific outcome.
Timepoint [10] 425193 0
Trends over the 12-month interval before and 12 months after initiation of the program.
Secondary outcome [11] 425194 0
Total Emergency Department presentations per 100 persons: Emergency Department Data Collection (EDDC) data will be used to assess emergency and urgent care presentation trends over the 12-month interval before and 12 months after initiation of the program. This is a participant specific outcome.
Timepoint [11] 425194 0
Trends over the 12-month interval before and 12 months after initiation of the program.
Secondary outcome [12] 425195 0
Presentations per 100 persons for genitourinary conditions: Emergency Department Data Collection (EDDC) data will be used to assess emergency and urgent care presentation trends over the 12-month interval before and 12 months after initiation of the program. This is a participant specific outcome.
Timepoint [12] 425195 0
Trends over the 12-month interval before and 12 months after initiation of the program.
Secondary outcome [13] 425196 0
Adherence rates to treatment protocol will be assessed by practice change facilitators conducting regular pharmacy monitoring. This is a pharmacy-specific outcome.
Timepoint [13] 425196 0
Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied from the IT program to the research team.
Secondary outcome [14] 425197 0
Rates of switching to alternative antibiotics by GP. This is a participant specific outcome.
Timepoint [14] 425197 0
This will be assessed by assessing patient consultation data and PBS records for prescribed antibiotics by other providers.
Secondary outcome [15] 425198 0
Antibiotic adherence and completion of course. This is a participant specific outcome.
Timepoint [15] 425198 0
Pharmacy consultation data and data from the 7 day patient follow up survey designed specifically for this study will be assessed initially monthly and then every two months using the data supplied to the research team.
Secondary outcome [16] 425199 0
Numbers of patients supplied antibiotics by pharmacists. This is a participant specific outcome.
Timepoint [16] 425199 0
Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team.
Secondary outcome [17] 425200 0
Numbers of patients provided self-care advice. This is a participant specific outcome.
Timepoint [17] 425200 0
Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team.
Secondary outcome [18] 425201 0
Numbers of patients referred to another health professional. This is a participant specific outcome.
Timepoint [18] 425201 0
Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team.
Secondary outcome [19] 425202 0
Reasons for patient referral to another health professional. This is a participant specific outcome.
Timepoint [19] 425202 0
Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team.
Secondary outcome [20] 425203 0
Supply of first-line antibiotics for UTI as a percentage of total antibiotic supply for UTI. This is a participant specific outcome.
Timepoint [20] 425203 0
Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team.
Secondary outcome [21] 425204 0
Estimated duration of consultation. This is a pharmacy specific outcome.
Timepoint [21] 425204 0
Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team.
Secondary outcome [22] 425205 0
7 day patient follow-up rate. This is a participant specific outcome.
Timepoint [22] 425205 0
7 day patient follow up data will be assessed initially monthly and then every two months using the data supplied to the research team.
Secondary outcome [23] 425206 0
Patient adverse events (e.g. itching or a mild rash, diarrhoea, loss of appetite, nausea or vomiting, stomach cramps or pain). This is a participant specific outcome.
Timepoint [23] 425206 0
This data will be collected by a researcher at 7 day patient follow up via their preferred method (SMS, email or phone call).
Secondary outcome [24] 425207 0
Self-reported patient experience: A survey on patient experience will be used to determine patient experience, designed specifically for this study following a brief narrative review of the literature. This is a participant specific outcome.
Timepoint [24] 425207 0
This data will be collected by a researcher at 7 day patient follow up via their preferred method, indicated at the time of asking for consent (SMS, email or phone call).
Secondary outcome [25] 425208 0
Perspectives and experiences of a sample of patients captured through semi-structured interviews. This is a participant specific outcome.
Timepoint [25] 425208 0
This data will be collected by a researcher during semi-structured interviews with a sample of patients at 6 month and 10 month timepoints throughout the trial period.
Secondary outcome [26] 425209 0
Implementation fidelity: to assess the degree to which an intervention is delivered as intended and will be assessed by practice change facilitators conducting regular pharmacy monitoring. This is a pharmacy-specific outcome.
Timepoint [26] 425209 0
Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team.
Secondary outcome [27] 425210 0
Reach: defined as the absolute number, proportion and representativeness of a study sample. This is a pharmacy-specific outcome.
Timepoint [27] 425210 0
Pharmacy consultation data will be assessed monthly using the data supplied to the research team.
Secondary outcome [28] 425211 0
Adoption of the new service: defined as the absolute number, proportion and representativeness of pharmacies and pharmacists that are willing to initiate the service.
Timepoint [28] 425211 0
Pharmacy consultation data will be assessed monthly using the data supplied to the research team.
Secondary outcome [29] 425212 0
Net benefit in terms of implementation costs and cost savings arising from more efficient treatment pathways. This is an economic outcome.
Timepoint [29] 425212 0
This will be assessed using multiple data sources including MBS records for 12 months pre and post intervention.
Secondary outcome [30] 425213 0
Cost-consequence results accounting for patient experience measures, relevant safety outcomes and implementation measures. This is an economic outcome.
Timepoint [30] 425213 0
This will be assessed using multiple data sources including MBS records for 12 months pre and post intervention.

Eligibility
Key inclusion criteria
Pharmacies and pharmacists recruited must meet the eligibility criteria (defined below) to participate in the study, reflecting the criteria set by the Authority under Section 10 Poisons and Therapeutic Good Act 1966 Clauses 170 and 171 of the Poisons and Therapeutic Goods Regulation 2208.

Community pharmacies
A community pharmacy in NSW or ACT must have a service room, consulting room, or area consistent with the following:

“An ‘approved pharmacy’ means a pharmacy or class of pharmacies, approved in writing by the Chief Health Officer, which has a service room, consulting room, or area consistent with the following:
o the room or area is not to be used as a dispensary, storeroom, staff room or retail area,
o fully enclosed and provides adequate privacy (a divider or curtain in a dispensary, storeroom, staff room or retail area is not acceptable),
o has adequate lighting,
o is maintained at a comfortable ambient temperature,
o has a hand sanitisation facility,
o has ready access to a hand washing facility, and
o has sufficient floor area, clear of equipment and furniture, to accommodate the person receiving the consultation and an accompanying person, and to allow the pharmacist adequate space to manoeuvre.”

Pharmacies must have access to MedAdvisor to complete clinical record keeping for the purposes of the clinical trial assessment.

Pharmacists
The eligibility criteria for an approved pharmacist to participate in the study, which includes that the pharmacist must be:

“employed or engaged in an ‘approved pharmacy’ who has successfully completed the following training:
• Australasian College of Pharmacy Uncomplicated Cystitis Treatment – Pharmacist Training; or
• Pharmaceutical Society of Australia Managing uncomplicated cystitis; and
• A series of study training module(s) that have been approved by the Chief Health Officer for the purposes of the clinical trial.”

A pharmacist is eligible to participate if they hold general registration as a pharmacist with the Australian Health Practitioner Regulation Agency (AHPRA). Pharmacists with provisional registration (intern pharmacists) and pharmacists with conditions on their registration are not eligible to participate in the trial.

The pharmacy must have at least one eligible pharmacist who is willing to provide their voluntary consent to participate, for the pharmacy to be eligible, and that there is always a pharmacist available to deliver the service during all opening hours of the pharmacy.

Patients
Eligible patients will be females aged between 18 years and 65 years presenting to community pharmacies in NSW, and 5 pharmacies in the ACT, with symptoms associated with an uncomplicated urinary tract infection.
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who are not female and/or aged <18 years or >65 years.

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)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This study will use a cohort study design, using mixed methods (quantitative and qualitative research) to assess clinical and economic indicators, implementation, and patient experience.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A mixed methods analytic approach will be applied.

Quantitative analysis
Descriptive statistics will be calculated for all study variables. Continuous variables will be reported using the appropriate measure of central tendency. Categorical variables will be summarized as proportions. Analyses will be conducted using SAS and R. The primary and secondary outcomes will be analysed with multivariable regression models adjusted for age, comorbidity count, hospitalisation in the 12 months prior to enrolment and Socio-Economic Indexes for Areas (SEIFA). Interim descriptive analyses of the 7-day follow up participant data will assess symptom resolution rates, use of other health care professionals including emergency department presentations and adverse events. Sub-group analyses will be conducted to examine variation in outcomes for the cohort will be assessed based a range of demographic and clinical characteristics. A separate ecological study will be conducted to assesses antimicrobial resistance.

Qualitative analysis
Self-reported patient experience will be examined at 6 and 10 months using qualitative methods. Interview transcripts will be imported into NVivo for thematic analysis. Initial open coding of transcripts will be undertaken iteratively by members of the research team. Themes and care quality measures will be presented to the broader research team and program implementers for final consensus.

Implementation outcomes analysis
The CFIR domains and sub-domains will be used to organise the data. Descriptive statistics be produced for all implementation outcomes. Links between implementation barriers and facilitators, their cause and implementation strategies will be visually represented using Sankey diagrams. A predictive resolution percentage will be calculated using random forest method for predicting effective strategies for all implementation barriers.

Economic analysis
The analysis will be conducted from a health service perspective (base case) and a societal perspective including direct and indirect costs from the health-consumer’s perspective - out of pocket expenses for any medicines or products provided, waiting time and travel time to attend treatment, productivity gains or time lost from work.

The scope of the within-study cost analysis is constrained by the design of the cohort study. Cost items associated with the co-design process, research and evaluation will be excluded. Resource use associated with the 2 components, pharmacy enrolment, training and support and pharmacy consultation, will be prospectively identified, measured and valued. In measuring resource use associated with delivery of the intervention, data will be collected from the research team, from the enrolled pharmacies and from the enrolled patients. Labour time will be measured using opportunity costs and valued based on Pharmacy Industry Award rates of pay, and average earnings for patients.

Health care resource use will be captured per the secondary outcomes of the study. Primary care resource use will be measured from MBS records and valued based on current Medicare Benefits Schedule listed prices. Medication use will be valued using Pharmaceutical Benefits Schedule listed prices, over-the counter medication will be valued using market prices. Hospital utilisation will be measured using the APDC and EDDC and valued based on Independent Health and Aged Care Pricing Authority (IHACPA) National Efficient Price tariffs.

Results from the economic analysis will be expressed as (1) net benefit in terms of implementation costs and cost savings arising from more efficient treatment pathways; and (2) cost-consequence results accounting for patient experience measures, relevant safety outcomes and implementation measures.

Decision uncertainty will be accounted for using parametric and non-parametric bootstrapping to generate uncertainty intervals around the net benefit result.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/07/2023
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
7/06/2024
Actual
Sample size
Target
12000
Accrual to date
273
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 313620 0
Government body
Name [1] 313620 0
NSW Government
Country [1] 313620 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 315413 0
Other
Name [1] 315413 0
The George Institute for Global Health
Address [1] 315413 0
Level 5, 1 King Street, Newtown NSW 2042
Country [1] 315413 0
Australia
Secondary sponsor category [2] 316301 0
Other
Name [2] 316301 0
Hunter Medical Research Institute
Address [2] 316301 0
Lot 1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country [2] 316301 0
Australia
Other collaborator category [1] 282713 0
University
Name [1] 282713 0
University of Technology Sydney
Address [1] 282713 0
15 Broadway, Ultimo NSW 2007
Country [1] 282713 0
Australia
Other collaborator category [2] 282764 0
University
Name [2] 282764 0
University of New England
Address [2] 282764 0
Elm Avenue, Armidale NSW 2351
Country [2] 282764 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312793 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 312793 0
University Drive, Callaghan NSW 2308
Ethics committee country [1] 312793 0
Australia
Date submitted for ethics approval [1] 312793 0
17/04/2023
Approval date [1] 312793 0
27/06/2023
Ethics approval number [1] 312793 0
H-2023-0119

Summary
Brief summary
The aim of this overall research is to evaluate the implementation, clinical and economic impact of a service model (intervention) delivered by community pharmacists in NSW, and 5 pharmacies in ACT, managing UTIs for a specific patient cohort (women aged between 18 years and 65 years) presenting with symptoms consistent with an uncomplicated UTI.

Specific objectives are to:
1. Assess implementation uptake of the intervention including the reach, fidelity and adoption of the intervention in community pharmacies, participant characteristics, and variation in uptake by geographic region.
2. Assess the clinical and experience outcomes for patients managed and/or treated by community pharmacists.
3. Assess the safety of the intervention and identify any risks that need to be addressed for future implementation.
4. Evaluate acceptability and feasibility of the intervention to pharmacists, other care providers and participants using the service.
5. Identify contextual enablers and constraints to access, adoption, fidelity delivery, impact, sustainability, and generalisability of the intervention.

The service will be tested with the aim of understanding the effectiveness of the service, appropriate use of antibiotics, impact on use of other health service resources and impact on supporting self-care. The implementation process and potential for future sustainability of the intervention will be investigated using an implementation science framework.

The study will use a cohort study design to assess the clinical and economic and implementation of the intervention in NSW and ACT over a 10-month study period. The intervention is multicomponent including Pharmacist training and support and a Pharmacy consultation applying a clinical management protocol. Pharmacies and pharmacists must meet the criteria of an 'approved pharmacy' and an 'approved pharmacist' outlined in the NSW Health Authority to participate.

The primary outcome will be self-reported 7-day symptom resolution rate. Secondary outcomes include rates of primary care utilisation, medication utilisation, hospital service utilisation, patient experience, and safety outcomes. Implementation outcomes will also be assessed to examine the fidelity, reach and adoption of the new service. Sub-group analyses will look at variation in outcomes based on participant demographics, geography, and clinical characteristics as well as pharmacy level characteristics. Semi-structured interviews with pharmacists and other stakeholders will be conducted to better understand barriers and facilitators to implementation of the service.
Trial website
1. https://www.health.nsw.gov.au/pharmaceutical/Pages/community-pharmacy-pilot.aspx

2. https://www.newcastle.edu.au/school/biomedical-sciences-and-pharmacy/research/centres-and-groups/nsw-community-pharmacy-trials
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125942 0
Dr Sarah Dineen-Griffin
Address 125942 0
College of Health, Medicine and Wellbeing
School of Biomedical Sciences and Pharmacy
The University of Newcastle
University Drive, Callaghan NSW 2308 Australia
Country 125942 0
Australia
Phone 125942 0
+61 2 4055 0155
Fax 125942 0
Email 125942 0
[email protected]
Contact person for public queries
Name 125943 0
Dr Sarah Dineen-Griffin
Address 125943 0
College of Health, Medicine and Wellbeing
School of Biomedical Sciences and Pharmacy
The University of Newcastle
University Drive, Callaghan NSW 2308 Australia
Country 125943 0
Australia
Phone 125943 0
+61 2 4055 0155
Fax 125943 0
Email 125943 0
[email protected]
Contact person for scientific queries
Name 125944 0
Prof David Peiris
Address 125944 0
The George Institute for Global Health
Level 5, 1 King Street Newtown NSW 2042
Country 125944 0
Australia
Phone 125944 0
+61 2 8052 4300
Fax 125944 0
Email 125944 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19503Study protocol  [email protected] 385721-(Uploaded-27-07-2023-22-44-40)-Study-related document.pdf
19506Informed consent form  [email protected] 385721-(Uploaded-27-07-2023-23-05-47)-Study-related document.pdf
19508Ethical approval  [email protected] 385721-(Uploaded-27-07-2023-22-53-54)-Study-related document.pdf
19509Other  [email protected] NSW Health Authority Clinical Management Protocol... [More Details] 385721-(Uploaded-27-07-2023-22-46-38)-Study-related document.PDF
19817Other  [email protected] NSW Health Authority Clinical Management Protocol... [More Details] 385721-(Uploaded-27-07-2023-23-14-25)-Study-related document.pdf
19818Other  [email protected] NSW Health Authority Clinical Management Protocol... [More Details] 385721-(Uploaded-27-07-2023-22-52-07)-Study-related document.pdf
19819Other  [email protected] NSW Health Authority Clinical Management Protocol... [More Details] 385721-(Uploaded-27-07-2023-22-52-57)-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.