Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001124628
Ethics application status
Approved
Date submitted
24/09/2023
Date registered
31/10/2023
Date last updated
30/08/2024
Date data sharing statement initially provided
31/10/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
NSW Government-Sponsored Clinical Trial: Extended supply of Oral Contraceptive Pills (OCPs) by Community Pharmacists
Scientific title
Evaluation of the impact and implementation of a service model (intervention) delivered by community pharmacists in NSW (and 15 pharmacies in ACT) re-supplying specific oral contraceptive pills to women aged 18 to 35: PATH-OC
Secondary ID [1] 310664 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PATH-OC (PATHway to access: Oral Contraception)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Contraception 331569 0
Condition category
Condition code
Reproductive Health and Childbirth 328304 328304 0 0
Contraception
Public Health 328305 328305 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The overall aim of this 12-month study is to evaluate the clinical and economic impact and implementation of a service model (intervention) delivered by community pharmacists in NSW and 15 pharmacies in ACT, re-supplying specific oral contraceptive (OCP). Women must be aged between 18 to 35 years (inclusive), taking the pill for contraception purposes only, and has seen their GP/nurse practitioner for a review of their low-risk OCP in the last two years.
Pharmacist training; Prior to service delivery, pharmacists will be prepared through an approximately 6 hour online training program (either through the Australasian College of Pharmacy (ACP) or Pharmaceutical Society of Australia (PSA)). Study specific research training modules will also be completed to ensure efficiency in the consultation process, patient consent, recruitment of patients and quality data collection.

The PSA training module covers "Fundamentals of contraception" and "Continuation of Oral Contraception by Community Pharmacists- NSW Focus" with the following objectives:
• "Discuss the physiology of reproductive hormones and how contraceptive medicines work to achieve contraception.
• Compare the different types of contraceptive methods available in Australia.
• Recommend appropriate contraceptive method(s) based on individual needs, preferences and tailored medical history assessment.
• Compare the efficacy of different contraceptive methods to inform decision-making in clinical practice.
• Identify opportunities for pharmacists to engage in opportunistic screening initiatives for cervical cancer, breast cancer and sexually transmitted infections.
• Discuss the NSW Oral Contraceptive Trial Clinical Management Protocol for Combined Oral Contraception that pharmacists can use to assist people taking oral contraception."
The PSA course "is designed to provide pharmacists with in-depth knowledge and practical skills related to contraceptive counselling and clinical decision-making.

The ACP training module covers the following learning objectives:
• "Describe the scope of practice of a pharmacist in the management of hormonal contraceptives within professional and legislative frameworks.
• Apply knowledge of the female reproductive system to the use of hormonal contraceptives for the prevention of pregnancy.
• Demonstrate ability to take a reproductive and general history to identify risk for hormonal contraception and select and resupply eligible contraceptive for your patient requiring contraception.
• Apply an approved clinical pathway to the management of hormonal contraceptives in conjunction with a patient, including documentation, follow-up and referral pathways."

The University developed modules are intended to cover NSW legislative specific content, the clinical management protocol and research requirements. This training is delivered online through short videos and may take up to 4 hours depending on progress.
• Recognise the key requirements for pharmacies who are authorised to deliver the OC 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 OC clinical management protocol
• Outline criteria for determining if a women is pregnant
• Describe key considerations for ensuring patient safety in women taking oral contraceptive pills.
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. The structured consultation is summarised as follows:
• Participant eligibility assessment
• Service offering, during which the pharmacist will explain the features of the study
• Electronic 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. Further information may be obtained from the patients’ Electronic Health Record (EHR).
• Blood Pressure and BMI will be documented at the initial patient consultation.
• Non-pharmacological management may include:
(i) Referral to see their medical practitioner, Family Planning or Sexual Health.
(ii) Counselling on the importance of getting regular cervical screening tests, breast checks, and STI testing done.
(iii) Counselling on the OCP supplied, i.e.,
o How to take the OCP; What side effects to expect; How to manage adverse effects ; When the OCP is less effective; What to do in event of a missed pill.
(iv) Provision of a Consumer Medicines Information sheet.
(vi) Provision of advice and referral, of there is a concern that the patient may be at risk for or could have contracted a sexually transmitted disease through unprotected sex, an/ or if the patient indicates that she has been sexually assaulted.
• 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), where the patient has one, following consent
• The pharmacist must keep a clinical record for 7 years that contains:
• sufficient information to identify the patient;
• 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.
• Any medications will be dispensed via pharmacy dispensing software and labelled according to the legislative requirements outlined in the Poisons and Therapeutic Goods Regulation 2008.
• The pharmacist will remind the patient they will be followed up by the research team at 7 days.

Female patients will be identified on presentation to the community pharmacy requesting re-supply of their oral contraceptive pill. Participants will be provided with two consent forms (one for the study and a second form from Services Australia allowing access to MBS and PBS data). They will be given the option of separate consent. The pharmacist will provide the participant with a location specific QR code for scanning on their mobile phone. This will open a secure webform hosted by the George Institute. The participant will then enter their personal details. They will then provide a finger signature and click submit for secure submission to The George Institute. The participant will be sent an SMS or email confirmation message with a validation code which they will provide to the pharmacy. Before consent may be obtained, pharmacists will provide the participant an opportunity to ask questions. On consent, 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 day follow up survey (via SMS, email or phone call as indicated by patient) to elicit adherence to medications and/or referral advice. A $20 fee will b 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.

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-ocp-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 as part of implementation strategy Practice change facilitators will visit participating pharmacies to 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), with 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.
Intervention code [1] 327072 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336153 0
Self-reported 7-day accessibility and acceptability of the service. This is a participant specific outcome.
Timepoint [1] 336153 0
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 [1] 427110 0
On time dispensing rates. This is a participant specific outcome.
Timepoint [1] 427110 0
Trends over 48 months: i.e. 36 months pre- and 12 months post- service delivery.
Secondary outcome [2] 427111 0
Primary care utilisation. This is a participant specific outcome.
Timepoint [2] 427111 0
Trends over 48 months: i.e. 36 months pre- and 12 months post- service delivery.
Secondary outcome [3] 427112 0
Adherence rates to treatment protocol. This is a pharmacy-specific outcome.
Timepoint [3] 427112 0
Initially monthly for the first 3 months and then every two months for the duration of the 12 month study period.
Secondary outcome [4] 427116 0
Hospitalisation for potential pill-related adverse events (e.g., thromboembolic disease). This is a participant specific outcome.
Timepoint [4] 427116 0
Trends over 48 months: i.e. 36 months pre- and 12 months post- service delivery.
Secondary outcome [5] 427117 0
Rates of STI tests undertaken. This is a participant specific outcome.
Timepoint [5] 427117 0
Trends over 48 months: i.e. 36 months pre- and 12 months post- service delivery.
Secondary outcome [6] 427118 0
Patient adverse events (e.g. breakthrough bleeding, nausea, headaches, abdominal cramping, breast tenderness, and increased vaginal discharge or decreased libido). This is a participant specific outcome.
Timepoint [6] 427118 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 [7] 427119 0
Perspectives and experiences of a sample of patients. This is a participant specific outcome.
Timepoint [7] 427119 0
6 month and 12 month timepoints throughout the 12 month trial period.
Secondary outcome [8] 427120 0
Implementation fidelity: to assess the degree to which an intervention is delivered. This is a pharmacy-specific outcome.
Timepoint [8] 427120 0
Initially monthly for the first 3 months and then every two months for the duration of the 12 month study period.
Secondary outcome [9] 427121 0
Reach: defined as the absolute number, proportion and representativeness of a study sample. This is a pharmacy-specific outcome.
Timepoint [9] 427121 0
Monthly during the 12 month intervention period.
Secondary outcome [10] 427122 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 [10] 427122 0
Monthly during the 12 month intervention period.
Secondary outcome [11] 427124 0
Net benefit in terms of implementation costs and cost savings arising from more efficient treatment pathways. This is an economic outcome.
Timepoint [11] 427124 0
Trends over 48 months: i.e. 36 months pre- and 12 months post- service delivery.
Secondary outcome [12] 427125 0
Cost-consequence results accounting for patient experience measures, relevant safety outcomes and implementation measures. This is an economic outcome.
Timepoint [12] 427125 0
Trends over 48 months: i.e. 36 months pre- and 12 months post- service delivery.

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
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, prior primary care utilisation in the 3 years prior to enrolment and Socio-Economic Indexes for Areas (SEIFA). 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 and 12 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.

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
27/09/2023
Date of last participant enrolment
Anticipated
27/09/2024
Actual
Date of last data collection
Anticipated
27/09/2024
Actual
Sample size
Target
88000
Accrual to date
93
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 314882 0
Government body
Name [1] 314882 0
NSW Government
Country [1] 314882 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 316880 0
Other
Name [1] 316880 0
The George Institute for Global Health
Address [1] 316880 0
Level 5, 1 King Street, Newtown NSW 2042
Country [1] 316880 0
Australia
Secondary sponsor category [2] 316884 0
Other
Name [2] 316884 0
Hunter Medical Research Institute
Address [2] 316884 0
Lot 1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country [2] 316884 0
Australia
Secondary sponsor category [3] 316885 0
Other
Name [3] 316885 0
University of Technology Sydney
Address [3] 316885 0
15 Broadway, Ultimo NSW 2007
Country [3] 316885 0
Australia
Secondary sponsor category [4] 316886 0
Other
Name [4] 316886 0
University of New England
Address [4] 316886 0
Elm Avenue, Armidale NSW 2351
Country [4] 316886 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313880 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 313880 0
University Drive, Callaghan NSW 2308
Ethics committee country [1] 313880 0
Australia
Date submitted for ethics approval [1] 313880 0
16/06/2023
Approval date [1] 313880 0
25/08/2023
Ethics approval number [1] 313880 0
H-2023-0234

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 NSW and 5 pharmacies in ACT, e-supplying specific oral contraceptive pills for a specific patient cohort over a 12-month study period. Women must be aged between 18 to 35 years (inclusive), taking the pill for contraception purposes only, and has seen their GP/nurse practitioner for a review of their low-risk oral contraceptive pill in the last two years.

Specific objectives are to:
1. Assess the accessibility and acceptability for patients managed and/or treated by community pharmacists.
2. 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.
3. Assess the clinical and experience outcomes for patients managed and/or treated by community pharmacists.
4. Assess the safety of the intervention and identify any risks that need to be addressed for future implementation.
5. Qualitatively assess the acceptability and feasibility of the intervention to pharmacists, other care providers and participants using the service.
6. Identify contextual enablers and constraints to access, adoption, fidelity delivery, impact, sustainability, and generalisability of the intervention.
7. Conduct a health economic evaluation to determine the economic benefits from the intervention.

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 12-month study period. The intervention is multicomponent including Pharmacist training and support and a Pharmacy consultation, using an IT program, 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.

Primary outcomes will be accessibility and acceptability of the service (based on self-report at 7-day follow up).
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 129650 0
Dr Sarah Dineen-Griffin
Address 129650 0
College of Health, Medicine and Wellbeing School of Biomedical Sciences and Pharmacy The University of Newcastle University Drive, Callaghan NSW 2308 Australia
Country 129650 0
Australia
Phone 129650 0
+61 2 4055 0155
Fax 129650 0
Email 129650 0
[email protected]
Contact person for public queries
Name 129651 0
Sarah Dineen-Griffin
Address 129651 0
College of Health, Medicine and Wellbeing School of Biomedical Sciences and Pharmacy The University of Newcastle University Drive, Callaghan NSW 2308 Australia
Country 129651 0
Australia
Phone 129651 0
+61 2 4055 0155
Fax 129651 0
Email 129651 0
[email protected]
Contact person for scientific queries
Name 129652 0
David Peiris
Address 129652 0
The George Institute for Global Health Level 5, 1 King Street Newtown NSW 2042
Country 129652 0
Australia
Phone 129652 0
+61 2 8052 4300
Fax 129652 0
Email 129652 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
20449Study protocol  [email protected] 386648-(Uploaded-13-10-2023-14-42-27)-Study-related document.pdf
20451Ethical approval  [email protected] 386648-(Uploaded-24-09-2023-11-54-35)-Study-related document.pdf
20452Other  [email protected] NSW Health Authority Clinical Management Protocol... [More Details] 386648-(Uploaded-24-09-2023-11-54-56)-Study-related document.pdf
20453Other  [email protected] NSW Health Authority Clinical Management Protocol... [More Details] 386648-(Uploaded-24-09-2023-11-55-14)-Study-related document.pdf
20454Other  [email protected] NSW Health Authority Clinical Management Protocol... [More Details] 386648-(Uploaded-24-09-2023-11-55-36)-Study-related document.pdf
20455Other  [email protected] NSW Health Authority Clinical Management Protocol... [More Details] 386648-(Uploaded-24-09-2023-11-55-48)-Study-related document.pdf
20456Other  [email protected] NSW Health Authority Clinical Management Protocol... [More Details] 386648-(Uploaded-24-09-2023-11-56-56)-Study-related document.pdf
20468Other  [email protected] NSW Health Authority Clinical Management Protocol... [More Details] 386648-(Uploaded-24-09-2023-11-57-11)-Study-related document.pdf



Results publications and other study-related documents

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