None listed
Conditions
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.
Interventions
The 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 15 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 prepared through an
The 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 15 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 prepared through an appox 6 hour online training program (either through the Australasian College of Pharmacy or Pharmaceutical Society of Australia). Furthermore, there are specific research training modules to ensure efficiency in the consultation process, patient consent, recruitment of patients and quality data collection. Learning objectives for ACP training module: • “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.” The University developed modules objectives are: • Recognise the key requirements for pharmacies who are authorised to deliver the UTI service. • Recognise the restricted substances in the Authority and the requirements for supply. • Recognise the requirements for patient participation in the trial including eConsent. • Outline the components of the UTI clinical management protocol. • Define packaging and labelling requirements of empirical antibiotics. • 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 and recognise the importance of Antimicrobial Resistance (AMR). This training is delivered online through short videos. may take up to 4 hours depending on progress. 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 structured consultation is summarised as follows: • Participant eligibility assessment, in which the pharmacist will assess if the patient meets the inclusion/exclusion criteria. • 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 UTI. • After the clinical assessment, the pharmacist will determine the management approach which may include treatment, or GP or ED referral. • The pharmacist will share a record of the supply with the patient’s usual treating medical practitioner (via fax, secure messaging software, provision of a letter to the patient, or any other approved secure means by NSW Health), following consent by the patient. • The pharmacist will comply with the ‘Management Protocol’and must keep a clinical record for 7 years that contains (as per NSW Health Authority): • sufficient information to identify the patient; • date of the treatment; • name of the pharmacist; • any information known to the pharmacist that is relevant to the patient’s diagnosis or treatment • 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. 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 the participant 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. 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 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. 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). Implementation strategy There will be follow up training and ongoing support for pharmacies and pharmacists as part of a implementation strategy. Practice change facilitators will visit pharmacies answer any queries, ensure quality data, and collect implementation data. The implementation component 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. 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.
Sponsors
The University of Newcastle
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Exclusion criteria
Individuals who are not female and/or aged <18 years or >65 years.
Outcome results
None listed