SW Government-Sponsored Clinical Trial: Extended supply of Oral Contraceptive Pills (OCPs) by Community Pharmacists
- Conditions
- Oral ContraceptionReproductive Health and Childbirth - ContraceptionPublic Health - Health service research
- Registration Number
- ACTRN12623001124628
- Lead Sponsor
- The University of Newcastle
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 88000
Pharmacies and pharmacists recruited in NSW 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 2008. Pharmacies and pharmacists recruited in ACT will be issued a discretionary licence to participate in the trial.
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 Continuation of Oral Contraception Course; or
• Pharmaceutical Society of Australia NSW – Contraception Essentials; 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
• Natal, cis females (capable of pregnancy).
• Aged 18 years of age or over and up to and including aged 35 years.
• Present to community pharmacies in NSW or pharmacies in ACT to obtain a continuing supply of their previously prescribed oral contraceptive pill.
• Patient has been initiated on an oral contraceptive pill by their GP (or other authorised prescribing health care professional) primarily for the indication of contraception and has been stabilised on that pill for 2 years continuously.
• Patient is taking an approved oral contraceptive pill listed in the NSW Health Authority.
• Patient has seen their GP (or other authorised prescribing health care professional) for a review of their oral contraceptive pill in the last 2 years.
• Individuals who are not female.
• Aged <18 years or >35 years.
• Patient has not been initiated on an oral contraceptive pill by their GP (or other authorised prescribing health care professional).
• Patient is not taking an approved oral contraceptive pill listed in the NSW Health Authority.
• Patient has not seen their GP (or other authorised prescribing health care professional) for a review of their oral contraceptive pill in the last 2 years.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Self-reported 7-day accessibility and acceptability of the service. This is a participant specific outcome.[This will be a composite measure based on patient self-reported data. It includes seven items adapted from existing questionnaires, including a validated questionnaire for perceived service quality in community pharmacies (two items) and studies of pharmacy prescribing for oral contraception, and other medications. It will cover the following domains: (a) trust and confidence in health and medical advice provided, (b) convenience, (b) privacy during discussion with pharmacy, and (b) overall satisfaction. Each item is scored on a 7-point Likert scale. Each domain will be equally weighted, and an aggregated score calculated and scaled to a maximum score of 100. This data will be collected 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 Measures
Name Time Method