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

Not Applicable

Recruiting

• Conditions: Herpes Zoster; Acute Exacerbations of Mild Plaque Psoriasis; Mild to Moderate Atopic Dermatitis; Impetigo; Skin - Dermatological conditions; Public Health - Health service research

• Registration Number: ACTRN12624000877583
• Lead Sponsor: The University of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-18
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 22857

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 in

Exclusion Criteria

Individuals outside the age range for each condition.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported 7-day or 14-day symptom free rate depending on the condition as reported by patients at follow up.[The data will be collected by a researcher via the patient's preferred method (SMS, email or phone call). 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.]