ANZCTR - Registration

Registration number

ACTRN12624000877583

Ethics application status

Approved

Date submitted

30/06/2024

Date registered

18/07/2024

Date last updated

1/09/2024

Date data sharing statement initially provided

18/07/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

NSW Government-Sponsored Clinical Trial: Management of Dermatology Conditions by Community Pharmacists

Scientific title

Evaluation of Community Pharmacists Management of patients with Acute exacerbations of Atopic Dermatitis (6 months to 65 years), Impetigo (12 months and above), Mild-Plaque Psoriasis and Herpes Zoster (18 years and above): PATH-DERM

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

PATH-DERM (PATHway to access: DERM management)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Herpes Zoster

Acute Exacerbations of Mild Plaque Psoriasis

Mild to Moderate Atopic Dermatitis

Impetigo

Condition category

Condition code

Skin

Dermatological conditions

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The overall aim of this study is to evaluate the clinical and economic impact and implementation of a service model (intervention) delivered by community pharmacists in New South Wales (NSW) and 15 pharmacies in the Australian Capital Territory (ACT), managing four skin conditions for individuals presenting with a suspected diagnosis – Impetigo, Atopic Dermatitis, Mild Plaque Psoriasis and Herpes Zoster. The intervention will be provided under a NSW Health Authority allowing participating NSW pharmacists to supply medications as part of the trial.. For ACT, a discretionary licence will be approved for participating pharmacies. (https://www.act.gov.au/health/businesses/licences-permits-and-registration/medicines-and-poisons-licences/apply-for-a-medicines-poisons-therapeutic-goods-licence-permit).

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 is separated in four components, each covering one dermatological condition, and have the following learning objectives:

Herpes Zoster Course:
- Identify the scope of practice of a pharmacist in the management of Herpes Zoster (Shingles) within professional and legislative frameworks.
- Recognise the anatomy, physiology and pathophysiology and understand the epidemiology of Herpes Zoster (Shingles)
- Identify the signs and symptoms of Herpes Zoster (Shingles).
- Outline the relevant examination skills and patient history to confirm a diagnosis.
- Apply an approved clinical pathway to the management of Herpes Zoster (Shingles) in conjunction with documentation, follow-up and referral pathways.

Acute Exacerbations of Mild Plaque Psoriasis Course:
- Describe the scope of practice of a pharmacist in the management of acute exacerbations of mild plaque psoriasis in adults within professional and legislative frameworks.
- Apply the anatomy, physiology and pathophysiology to the signs, symptoms and potential risks of mild plaque psoriasis.
- Demonstrate history and examination skills to confirm acute exacerbations of mild plaque psoriasis.
- Apply an approved clinical pathway to the management of acute exacerbations of mild plaque psoriasis in conjunction with a patient, including documentation, follow-up and referral pathways.

Mild to Moderate Atopic Dermatitis Course:
- Identify the scope of practice of a pharmacist in the management of mild to moderate atopic dermatitis within professional and legislative frameworks.
- Apply the anatomy, physiology and pathophysiology to the signs, symptoms and potential risks of untreated atopic dermatitis.
- Demonstrate history and examination skills, and order relevant pathology, testing, and evaluate these findings, to confirm a diagnosis.
- Apply an approved clinical pathway to the management of atopic dermatitis in conjunction with a patient, including documentation, follow-up and referral pathways.

Impetigo Course:
- Recognise the scope of practice of a pharmacist in the management of impetigo within professional and legislative frameworks.
- Recall anatomy, physiology and pathophysiology as it relates to the signs, symptoms and potential risks of untreated impetigo.
- Demonstrate history and examination skills and evaluate these findings to confirm a diagnosis.
- Apply an approved clinical pathway to the management of impetigo.

The PSA training module is also divided by condition and covers the following learning objectives:

Herpes Zoster Course:
- Describe the clinical features and complications of herpes zoster (shingles).
- Explain the transmission and prevention of herpes zoster (shingles).
- Identify the pharmacotherapy options for managing acute pain associated with herpes zoster (shingles).
- Discuss the need for referral to a medical practitioner in certain cases of herpes zoster (shingles).

Acute Exacerbations of Mild Plaque Psoriasis Course:
- Recognise the clinical features associated with mild plaque psoriasis.
- Evaluate the various treatment options available for mild plaque psoriasis and understand the goals of management.
- Discuss the role of pharmacists, in the assessment, referral, and management of plaque psoriasis.

Mild to Moderate Atopic Dermatitis Course:
- Recognise the clinical features associated with atopic dermatitis.
- Evaluate the various treatment options available for atopic dermatitis and understand the goals of management.
- Discuss the role of pharmacists in the assessment, referral, and management of atopic dermatitis.

Impetigo Course:
- Recognise the clinical features associated with impetigo.
- Evaluate the treatment options available for impetigo and understand the goals of management.
- Discuss the role of pharmacists, in the assessment, referral, and management of impetigo.

The University developed modules are intended to cover NSW legislative specific content, the clinical guidelines, research requirements, how to prescribe, and antimicrobial stewardship.

The learning objectives for the Introduction to Prescribing course are to:
- Describe the process of taking a medical history, utilising clinical decision-making, formulating a provisional diagnosis and prioritising issues.
- Collaborate and engage effectively with individuals from different cultures, tailoring consultations to individual consumers and their needs.
- Recognise the importance of tailoring consultations to individual consumers and their needs.

The learning objectives for the three recorded presentations are to:

Introduction
- Identify the specific legislative requirements and regulations imposed by the NSW Health Authority and ACT Health Licence applicable to the dermatology trial.
• Requirements needed for pharmacies to participate in the dermatology trial.
• Restricted substances involved in the dermatology trial.
• Regulatory and compliance requirements for the supply of these substances.
- Understand the professional requirements and responsibilities of pharmacists participating in the dermatology trial.
- Identify the financial incentives and support available for participating pharmacies and pharmacists in the dermatology trial.
- Discuss the potential costs for participating pharmacies and pharmacists in the dermatology trial.
- Describe the technological tools and software platforms used in the delivery of the dermatology service.
- Explain the criteria and processes for enrolling patients in the dermatology trial.
• Consent requirements for pharmacies and pharmacists to participate in the trial.
• Informed consent process for patients engaging in the service.
• Workflow involved in delivering the dermatology service.

Clinical Guidelines
- Outline the components of the dermatology conditions clinical practice guidelines.
- Recognise the ‘red flags’ and ‘referral’ points.
- Explain the treatment options available under the NSW Health Authority and ACT License.

Antimicrobial Resistance and Stewardship
- Recognise the common pathogens of skin and soft tissue infections.
- Recognise the risks of antimicrobial resistance in relation to mupirocin.
- Outline antimicrobial stewardship principles in relation to dicloxacillin; flucloxacillin; cefalexin; trimethoprim + sulfamethoxazole.
- Recognise the risks of acute rheumatic fever and rheumatic heart disease in relation to impetigo.
- Outline the resistance potential of antivirals.

MedAdvisor will also provide training to participating pharmacists as part of the contractual agreement with the University of Newcastle on the use of the software.

This training is delivered online. The training only needs to be completed once and may take up to 10 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.

Pharmacies and pharmacists must comply with three main obligations:
- The pharmacist will comply with the Clinical Guidelines, 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 and ACT Licence):
• 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 7-14 days depending on the condition.

Pharmacy consultation
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 is willing to participate.
- Provision of the Patient information sheet and informed consent form.

The pharmacist will undertake a structured consultation with the patient in the community pharmacy, anticipated to take 10-20 minutes, applying the co-designed clinical guidelines which considers the recommendations from the Australian Therapeutic Guidelines.

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 one of the four dermatological conditions, in line with the approved clinical guidelines. 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 the approved clinical guidelines 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 medications: If a medication is prescribed, the patient will be provided with the relevant Consumer Medicines Information and/or a self-care card. The medications available for prescribing will depend on the skin condition as indicated by the NSW Authority and ACT Licence.
3. Appropriate and timely referral, if required, according to the following categories by the clinical guidelines:
- Referred to an Emergency Department – the patient’s condition requires immediate medical attention by the emergency department or an urgent care clinic.
- Referred to a GP – the patient’s condition requires medical review with a medical practitioner at the next available appointment is appropriate due to patient circumstances (comorbidity, chronic disease etc.)
- Referred for further investigation – the patient’s condition may be suitable for treatment by the pharmacist; however, referral is warranted to further investigate the condition or for testing.
- Referred outside of the trial – the patient is outside the scope of the trial by eligibility criteria and needs medical evaluation.
- Referred for further treatment – the patient needs treatment that is outside the scope of the medicines that can be prescribed by pharmacists.
The reason for referral must be clearly communicated verbally and in writing to the patient and provided with the appropriate referral documentation using the secure communications software when the patient is able to indicate a regular GP to contact. This communication will also include information regarding advise and treatment received.
4. Provision of follow up advice (e.g., expectation around duration of symptoms which should respond to appropriate treatment therapy within 7 - 14 days depending on the condition) and to see GP urgently if their symptoms worsened or no improvement, if symptoms persist after treatment, symptoms reoccur or if further symptoms manifest.

The participant will usually present via a walk-in approach with symptoms that may be reflective of one of the four dermatological conditions, 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 or if they experience any adverse events.

Patients assessed as eligible to participate in the trial will be followed up at different time frames depending on the condition. The follow up will include a brief survey administered by The George Institute either via SMS message or email with a link to a case report form using George Data Systems (GDS). Information will be collected on the primary outcome measure of symptom resolution/relief rate, any additional care provided, changes to treatment, service satisfaction and overall experience of care. Basic demographic (educational level, employment status, cultural status) and clinical information (condition, reason for consult, symptom description, other professional visits and other medications use) will also be captured. The follow up survey will be sent to patients by SMS and/or email, 7 or 14 days after the consultation depending on the condition:
- 7 days for Impetigo, Psoriasis and Herpes Zoster (Shingles)
- 14 days for Atopic Dermatitis.

Up to 3 reminders will be sent to all patients that do not complete the survey at two, four and six days after the initial sending date. Patients that do not complete the survey after these reminders will be assumed as lost to follow up and will not be contacted further.

Financial implications for patients
In NSW, the cost of the consultation with patients ($35) will be paid for by the NSW Government to pharmacies, irrespective of the outcome of the consultation. The patient will meet out of pocket expenses for any medicines or products provided.
In the ACT, the cost of the consultation will be paid for by the patient receiving the service to pharmacies, irrespective of the outcome of the consultation. The patient will also meet out of pocket expenses for any medicines or products provided.
The approved pharmacist will be trained to clearly communicate all costs that may be involved in receiving treatment at the earliest point possible and throughout the consultation. Medicines will not be subsidised by the Pharmaceutical Benefits Scheme (PBS). A statement has been included in the in the patient information statement and consent form so that the patient is informed of any costs associated with receiving the service.

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 monthly. 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]

Treatment: Other

Intervention code [2]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Self-reported 7-day or 14-day symptom free rate depending on the condition as reported by patients at follow up.

Timepoint [1]

This data will be collected by a researcher at 7- or 14-day patient follow up via the patient's preferred method (SMS, email or phone call). Up to 3 reminders will be sent to all patients that do not complete the survey at two, four and six days after the initial sending date.

Secondary outcome [1]

Types of medication supplied for each condition by pharmacists. This is a participant specific outcome and a composite outcome related to all trial participants.

Timepoint [1]

Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team after initiation of the program.

Secondary outcome [2]

Adherence rates to treatment protocol. This is a pharmacy-specific outcome.

Timepoint [2]

Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team after initiation of the program.

Secondary outcome [3]

Numbers of patients supplied medications by pharmacists. This is a participant specific outcome.

Timepoint [3]

Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team after initiation of the program.

Secondary outcome [4]

Numbers of patients provided self-care advice. This is a participant specific outcome.

Timepoint [4]

Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team after initiation of the program.

Secondary outcome [5]

Numbers of patients referred to another health professional. This is a participant specific outcome.

Timepoint [5]

Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team after initiation of the program.

Secondary outcome [6]

Reasons for patient referral to another health professional. This is a participant specific outcome.

Timepoint [6]

Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team after initiation of the program.

Secondary outcome [7]

Estimated duration of consultation. This is a pharmacy specific outcome.

Timepoint [7]

Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team after initiation of the program.

Secondary outcome [8]

Patient follow-up rate. This is a participant specific outcome.

Timepoint [8]

7- or 14-day patient follow up data depending on the condition will be assessed initially monthly and then every two months using the data supplied to the research team after the start of the program.

Secondary outcome [9]

Patient adverse events. This is a participant specific outcome.

Timepoint [9]

7- or 14-day patient follow up data depending on the condition will be assessed initially monthly and then every two months using the data supplied to the research team after the start of the program.

Secondary outcome [10]

Patient experience. This is a participant specific outcome.

Timepoint [10]

7- or 14-day patient follow up data depending on the condition will be assessed initially monthly and then every two months using the data supplied to the research team after the start of the program.

Secondary outcome [11]

Net benefit in terms of implementation costs and cost savings arising from more efficient treatment pathways. This will be assessed as a composite outcome.

Timepoint [11]

To be completed at the end of the trial (6 months or by reaching 22,857 patients)

Secondary outcome [12]

Cost-consequence results accounting for patient experience measures, relevant safety outcomes and implementation measures.

Timepoint [12]

To be completed at the end of the trial (6 months or by reaching 22,857 patients)

Secondary outcome [13]

Implementation outcome 1: Reach, as patient demographics (gender, DOB, education, employment status)

Timepoint [13]

This data will be collected by a researcher at 7- or 14-day patient follow up depending on the condition via their preferred method, indicated at the time of asking for consent (SMS, email or phone call).

Secondary outcome [14]

Implementation outcome 2: Determinants (Barriers and Facilitators) and Strategies.

Timepoint [14]

Practice change facilitators will assess adherence to protocol as part of their pharmacy contacts at least once per pharmacy during the trial.

Secondary outcome [15]

Implementation outcome 3: Fidelity, as adherence rates to treatment protocol regarding classification of appropriateness of medications for the four conditions as aligned with clinical practice guidelines.

Timepoint [15]

Practice change facilitators will assess adherence to protocol as part of their pharmacy contacts at least once per pharmacy during the trial.

Secondary outcome [16]

Self-reported 7-day symptom free rate for Impetigo as reported by patients at follow up.

Timepoint [16]

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). Up to 3 reminders will be sent to all patients that do not complete the survey at two, four and six days after the initial sending date.

Secondary outcome [17]

Self-reported 7-day symptom free rate for Acute Exacerbations of Mild Plaque Psoriasis as reported by patients at follow up.

Timepoint [17]

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). Up to 3 reminders will be sent to all patients that do not complete the survey at two, four and six days after the initial sending date.

Secondary outcome [18]

Self-reported 7-day symptom free rate for Herpes Zoster (shingles) as reported by patients at follow up.

Timepoint [18]

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). Up to 3 reminders will be sent to all patients that do not complete the survey at two, four and six days after the initial sending date.

Secondary outcome [19]

Self-reported 14-day symptom free rate for Mild to Moderate Atopic Dermatitis as reported by patients at follow up.

Timepoint [19]

This data will be collected by a researcher at 14-day patient follow up via the patient's preferred method (SMS, email or phone call). Up to 3 reminders will be sent to all patients that do not complete the survey at two, four and six days after the initial sending date.

Secondary outcome [20]

Types of medication supplied for Atopic Dermatitis by pharmacists. This is a participant specific outcome.

Timepoint [20]

Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team after initiation of the program.

Secondary outcome [21]

Types of medication supplied for Impetigo by pharmacists. This is a participant specific outcome.

Timepoint [21]

Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team after initiation of the program.

Secondary outcome [22]

Types of medication supplied for Mild-Plaque Psoriasis by pharmacists. This is a participant specific outcome.

Timepoint [22]

Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team after initiation of the program.

Secondary outcome [23]

Types of medication supplied for Herpes zoster by pharmacists. This is a participant specific outcome.

Timepoint [23]

Pharmacy consultation data will be assessed initially monthly and then every two months using the data supplied to the research team after initiation of the program.

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. 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.

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

Prior to service delivery, pharmacists will be prepared through an educational program. This program consists of the following training modules:

Australasian College of Pharmacy (ACP) modules on Impetigo, Atopic Dermatitis, Mild Plaque Psoriasis and Herpes Zoster; or

Pharmaceutical Society of Australia (PSA) module on dermatology conditions (Mild Plaque Psoriasis, Impetigo, Herpes Zoster and Atopic Dermatitis); and

Modules developed by the University of Newcastle for the clinical trial (Introduction, Clinical Practice Guidelines, Antimicrobial Resistance and Stewardship for Impetigo and Herpes Zoster, and Introduction to Prescribing).

Completing this educational program is expected to take between 8 and 10 hours in total.

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
Patients will be opportunistically recruited in participating community pharmacy. Consecutive patients will be identified on presentation to the community pharmacy with symptoms suggestive one of the four skin conditions and either: presenting symptoms requesting advice or self-selecting a product for symptoms for the conditions included in this study: Impetigo, Atopic Dermatitis, Mild Plaque Psoriasis and Herpes Zoster. The age requirements for participation vary depending on the condition:
- Mild to moderate atopic dermatitis, 6 months to 65 years old
- Herpes Zoster (Shingles), 18 years and older
- Impetigo, 12 month or above
- Mild plaque psoriasis, 18 years and older

If an individual meets the age requirements for their condition, the pharmacist may offer them participation in the trial and provide a consultation.

Minimum age

6 Months

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Individuals outside the age range for each condition.

Study design

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). Sub-group analyses will be conducted to examine variation in outcomes for the cohort to assess a range of demographic and clinical characteristics.

Qualitative analysis
Self-reported patient experience will be examined at 6 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 implementation component of the study will be underpinned by the Consolidated Framework for Implementation Research (CFIR), 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. This will build on the trial outcomes to determine scalability of the intervention. The CFIR domains and sub-domains will also 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.

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

19/07/2024

Actual

19/07/2024

Date of last participant enrolment

Anticipated

28/02/2025

Actual

Date of last data collection

Anticipated

31/03/2025

Actual

Sample size

Target

22857

Accrual to date

154

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NSW Government

Country [1]

Australia

Primary sponsor type

University

Name

The University of Newcastle

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

The George Institute for Global Health

Country [1]

Australia

Secondary sponsor category [2]

Other

Name [2]

Hunter Medical Research Institute

Country [2]

Australia

Secondary sponsor category [3]

Other

Name [3]

University of Technology Sydney

Country [3]

Australia

Secondary sponsor category [4]

Other

Name [4]

University of New England

Country [4]

Australia

Secondary sponsor category [5]

Other

Name [5]

Heart Research Institute

Country [5]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

http://www.newcastle.edu.au/research/research-services/human-ethics/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/12/2023

Approval date [1]

27/05/2024

Ethics approval number [1]

H-2024-0002

Summary

Brief summary

The overall aim of this study is to evaluate the clinical and economic impact and implementation of a service model (intervention) delivered by community pharmacists in New South Wales (NSW) and 15 pharmacies in the Australian Capital Territory (ACT), managing four skin conditions for individuals presenting with a suspected diagnosis – Impetigo, Atopic Dermatitis, Mild Plaque Psoriasis and Herpes Zoster.

The specific objectives of this study are to:
- 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.
- Assess the clinical outcomes and patient experience for patients managed by community pharmacists.
- Assess the safety of the intervention and identify any risks that need to be addressed for future implementation.
- Qualitatively assess the acceptability and feasibility of the intervention to pharmacists, other care providers and participants using the service.
- Identify contextual enablers and constraints to access, adoption, fidelity, delivery, impact, sustainability, and generalisability of the intervention.
- Conduct a health economic evaluation to determine the economic benefits.

The study will use a cohort study design to assess the clinical and economic impact and implementation of the intervention in NSW and ACT. Pharmacies will be onboarded from June 2024 to September 2024. This is due to administrative processes associated with MedAdvisor program installation, and the numbers of pharmacies that can be onboarded will be batched over this time. The study will be completed when 22,857 consults are reached or on 28 February 2025, whichever occurs first.

The intervention is multicomponent including Pharmacist training and support, and a Pharmacist-patient consultation, using an IT program, applying clinical guidelines. Pharmacies and pharmacists must meet the criteria of an ‘approved pharmacy’ and an ‘approved pharmacist’ outlined in the NSW Health Authority, or a licence in ACT, to participate.

Pharmacists and pharmacies will be provided follow up support as part of a translational/implementation strategy. Practice change facilitators will visit/contact these pharmacies during the study to provide ongoing support, answer any queries, ensure quality data is being collected, and collect implementation data. Pharmacies will be divided into low, medium and high contact, and this will depend on the number and nature of consultations delivered throughout the trial period.

The primary outcome will be symptom resolution/relief (completely resolved, improvement, no improvement or worsening) (based on self-report at 7-day or a 14 day follow up (depending on the skin condition)). This will be a composite measure based on patient self-reported data.

Trial website

https://www.health.nsw.gov.au/pharmaceutical/Pages/community-pharmacy-pilot.aspx

Public notes

https://www.newcastle.edu.au/school/biomedical-sciences-and-pharmacy/research/centres-and-groups/nsw-community-pharmacy-trials

Contacts

Principal investigator

Name

Dr Sarah Dineen-Griffin

Address

College of Health, Medicine and Wellbeing School of Biomedical Sciences and Pharmacy The University of Newcastle University Drive, Callaghan NSW 2308 Australia

Country

Australia

Phone

+61 2 4055 0155

Email

[email protected]

Contact person for public queries

Name

Sarah Dineen-Griffin

Address

College of Health, Medicine and Wellbeing School of Biomedical Sciences and Pharmacy The University of Newcastle University Drive, Callaghan NSW 2308 Australia

Country

Australia

Phone

+61 2 4055 0155

Email

[email protected]

Contact person for scientific queries

Name

Prof David Peiris

Address

The George Institute for Global Health Level 5, 1 King Street Newtown NSW 2042

Country

Australia

Phone

+61 2 8052 4300

Email

[email protected]

Doc. No.	Type	Link	Other Details	Attachment
23927	Study protocol			387981-(Uploaded-17-07-2024-15-13-43)-Dermatology Research Protocol v7 10 July 2024.pdf
23928	Ethical approval			387981-(Uploaded-25-06-2024-15-02-03)-BC04 Expedited Approval 27 May 2024.pdf
23929	Other		NSW Health Authority	387981-(Uploaded-30-06-2024-12-41-38)-AUTHOR~1.PDF
23930	Other	https://www.act.gov.au/health/businesses/licences-permits-and-registration/medicines-and-poisons-licences/apply-for-a-medicines-poisons-therapeutic-goods-licence-permit	ACT Health Licence under the Medicines, Poisons an... [More Details]
23932	Other		NSW Health Consumer Flyer	387981-(Uploaded-30-06-2024-12-41-38)-241454~1.PDF
24001	Other		Clinical Guidelines Dermatology	387981-(Uploaded-17-07-2024-15-13-08)-Clinical Practice Guidelines Dermatology Conditions Final Co-Design.pdf

Trial Review

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