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Trial registered on ANZCTR


Registration number
ACTRN12622001024730
Ethics application status
Approved
Date submitted
21/06/2022
Date registered
22/07/2022
Date last updated
22/02/2023
Date data sharing statement initially provided
22/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Quality family planning services and referrals in community pharmacy: Expanding pharmacists’ scope of practice (The ALLIANCE Trial)
Scientific title
The ALLIANCE Trial: testing the effect of expanding pharmacists’ current scope of practice on uptake of effective contraception among women seeking an emergency contraception pill or early medical abortion medicines using a stepped-wedge pragmatic cluster randomised controlled trial in community pharmacy
Secondary ID [1] 305605 0
None
Universal Trial Number (UTN)
Trial acronym
ALLIANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
unintended pregnancy 324034 0
contraception 324035 0
Condition category
Condition code
Reproductive Health and Childbirth 321538 321538 0 0
Contraception
Public Health 324160 324160 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ALLIANCE trial provides an opportunity to use the pharmacy setting to increase contraceptive knowledge, access, and use among women presenting to pharmacies for an emergency contraceptive pill (ECP) or MS-2 Step (mifepristone + misoprostol) early medical abortion (EMA) medicines.

The intervention consists of the following:
1) High-quality, person-centred, effectiveness-based contraceptive counselling, delivered by a community pharmacist to a woman in a private consultation room, as part of a billed consultation. This will be delivered individually in a single 20-30minute session. The pharmacist will go over the woman's contraceptive options from most to least effective and discuss what will be the most appropriate to meet her needs.
2) Referral to a contraception provider will be provided to the woman after the contraceptive counseling session, if the woman has decided on a method and would like a referral.

Fidelity checking, a component of the process evaluation of the trial, will be carried out at the end of the study through interviews with pharmacists and women.
Intervention code [1] 322004 0
Treatment: Other
Intervention code [2] 322005 0
Behaviour
Intervention code [3] 322006 0
Prevention
Comparator / control treatment
Pharmacists will dispense ECP or MS-2 Step as per usual care. 'Usual care' refers to pharmacist's current practice and standards when it comes to the provision of medicines, health information and counselling. This is based upon the Pharmaceutical Society of Australia's 'Professional Practice Standards-Version 5' which outlines that pharmacists are expected to provide "evidence-based, unbiased and accurate medicines and healthcare information that is appropriate to the audience". When it comes ECP dispensing, the most recent practice guidance for pharmacists encompasses the following tasks though 'usual care' may not involve all these components in practice: the pharmacist should consider their professional obligations in accordance with professional practice standards and other professional guidance; the pharmacist should gather patient information to assess the patient’s need and suitability for ECP, potential drug interactions and contraindications. If appropriate, the pharmacist should then supply ECP and counsel on the following points as deemed necessary and appropriate by the pharmacist: How to use, Adverse effects, Ongoing contraception, Pregnancy testing, Sexually transmitted infection; and supply written information, if appropriate.
Control group
Active

Outcomes
Primary outcome [1] 329304 0
Use of 'effective' (hormonal or intrauterine) contraception. Information will be collected through a study-specific online survey provided to all women participants. The survey is developed based on the Bridge-It trial surveys.
Timepoint [1] 329304 0
Four months after EC or MS-2 Step
Secondary outcome [1] 402075 0
Rate of unintended pregnancy. Information will be collected through a study-specific online survey provided to all women participants. The survey is developed based on the Bridge-It trial surveys.
Timepoint [1] 402075 0
12-months after EC or MS-2 Step
Secondary outcome [2] 402076 0
Rate of abortion. Information will be collected through a study-specific online survey provided to all women participants. The survey is developed based on the Bridge-It trial surveys.
Timepoint [2] 402076 0
12-months after EC or MS-2 Step
Secondary outcome [3] 402077 0
Continuation of contraception. Information will be collected through a study-specific online survey provided to all women participants. The survey is developed based on the Bridge-It trial surveys.
Timepoint [3] 402077 0
12-months after EC or MS-2 Step
Secondary outcome [4] 402078 0
Cost-effectiveness. Data from the women participant's surveys will be used to calculate cost-effectiveness. Information will be collected through a study-specific online survey provided to all women participants. The survey is developed based on the Bridge-It trial surveys.
Timepoint [4] 402078 0
12-months after EC or MS-2 Step
Secondary outcome [5] 402079 0
Implementation evaluation. This will be assessed through semi-structured interviews with participating pharmacists and women participants, logs kept by academic detailers about the academic detailing session they deliver to participating pharmacists, participating pharmacists' engagement and posts to the online community of practice, AusCAPPS.
Timepoint [5] 402079 0
12-months after EC or MS-2 Step

Eligibility
Key inclusion criteria
PHARMACISTS
Those working in community pharmacies, located in either metropolitan, regional or rural areas of NSW, VIC and the NT, that have: A) Quality Care Pharmacy Program (QCPP) accreditation; B) A private consultation room; C) At least one pharmacist who works at least 30 hours per week (0.8 FTE) willing to commit to participation, D) participating pharmacist is accredited to dispense MS 2-Step (medical abortion medicines) and; E) consent from the pharmacy owner for the pharmacy to participate.

CONSUMERS
Any woman** attending the pharmacy for the purpose of purchasing the ECP or to fill a prescription for MS-2 Step, who: 1) Gives informed consent to participate in and adhere to trial requirements, and; 2) Is willing to give contact details and be contacted by phone/SMS/e-mail to complete a survey at baseline, and at 4 months and 12 months after receiving ECP or MS-2 Step (i.e. after entering the study).
**Consistent with current emergency contraception guidelines, there will be no age restriction (minimum or maximum age) on participants. Consumers seeking emergency contraception or MS-2 Step would be of reproductive age.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women requiring interpreting services

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be carried out by the trial statistician who will not be involved in recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation will allocate clusters (n=37 pharmacies) to receive the intervention in 5 steps using a computer generated minimisation procedure, with 7-8 pharmacies crossing from control to intervention at each step to balance allocation of clusters with respect to state and location (regional/rural and metro regions). Pharmacies will be randomised once all 37 pharmacies have been recruited. Pharmacies will not be blinded to their intervention status. Since all clusters eventually receive the intervention, data from clusters in the control phases (usual care) will be compared with data from clusters that have received the intervention. There will be a transition period of 2 months for each pharmacy group when the ALLIANCE trial intervention is implemented. Data collected during the transition period will not contribute to the final analysis.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped-wedge cluster randomised trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE CALCULATION
The study requires 35 pharmacies (clusters) and 1260 women participants to detect an increase in the use of effective contraception use from 35% to 50% with 80% power and a two-sided level of significance of 5%. An intracluster correlation of 0.1 is assumed as observed in the ACCORd study. The ALLIANCE trial will recruit a total of 37 pharmacies and 1554 women participants (6 in each pharmacy in each trial period, allowing for a dropout rate at the women participant level of 14% ). The sample size calculation was conducted using the Shiny CRT app.

DATA ANALYSIS
Trial outcomes: Logistic regression models, with random effects for pharmacy and fixed effects for time, stratification factors and intervention status, will be the main analyses for the primary and secondary outcomes.
Cost-effectiveness: Incremental cost-effectiveness ratios (ICERs) will be plotted on a cost-effectiveness plane and compared against similar interventions. Bootstrapping will be used to estimate a distribution around the mean costs and outcomes and to calculate confidence intervals around the incremental cost-effectiveness ratio. One-way sensitivity analyses will be conducted around key variables and a probabilistic sensitivity analysis will estimate the joint uncertainty in all parameters.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/03/2023
Actual
Date of last participant enrolment
Anticipated
20/05/2024
Actual
Date of last data collection
Anticipated
4/05/2025
Actual
Sample size
Target
1554
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,VIC

Funding & Sponsors
Funding source category [1] 309967 0
Government body
Name [1] 309967 0
The Department of Industry, Science, Energy and Resources
Country [1] 309967 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Building 1/270 Ferntree Gull Road,
Notting Hill, VIC 3168
Country
Australia
Secondary sponsor category [1] 312724 0
Commercial sector/Industry
Name [1] 312724 0
Pharmaceutical Society of Australia
Address [1] 312724 0
381 Royal Parade
PARKVILLE VIC 3052
Country [1] 312724 0
Australia
Secondary sponsor category [2] 312725 0
Government body
Name [2] 312725 0
Gippsland Primary Health Network
Address [2] 312725 0
11 Seymour St
Traralgon VIC 3844
Country [2] 312725 0
Australia
Secondary sponsor category [3] 312726 0
University
Name [3] 312726 0
Centre for Excellence in Rural Sexual Health
Address [3] 312726 0
The University of Melbourne
Grattan Street,
Parkville VIC 3010
Country [3] 312726 0
Australia
Secondary sponsor category [4] 312727 0
Other Collaborative groups
Name [4] 312727 0
Jean Hailes for Women's Health
Address [4] 312727 0
Level 4, 176 Wellington Parade
East Melbourne VIC 3002
Country [4] 312727 0
Australia
Secondary sponsor category [5] 312728 0
Other Collaborative groups
Name [5] 312728 0
Family Planning New South Wales
Address [5] 312728 0
8 Holker Street
Newington NSW 2127
Country [5] 312728 0
Australia
Secondary sponsor category [6] 312729 0
Other Collaborative groups
Name [6] 312729 0
Sexual Health Victoria
Address [6] 312729 0
Level 1, 94 Elizabeth St,
Melbourne VIC 3000
Country [6] 312729 0
Australia
Secondary sponsor category [7] 312730 0
Commercial sector/Industry
Name [7] 312730 0
Australian Pharmaceutical Industries LTD
Address [7] 312730 0
250 Camberwell Road
Camberwell, VIC 3124
Country [7] 312730 0
Australia
Secondary sponsor category [8] 312731 0
Other Collaborative groups
Name [8] 312731 0
Family Planning Welfare Association Northern Territory
Address [8] 312731 0
Corner Caryota Court & Dickward Drive
Coconut Grove NT 0810
Country [8] 312731 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309679 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 309679 0
Monash Research Office
26 Sports Walk, Monash University,
Clayton, VIC 3800
Ethics committee country [1] 309679 0
Australia
Date submitted for ethics approval [1] 309679 0
23/06/2022
Approval date [1] 309679 0
10/08/2022
Ethics approval number [1] 309679 0
MUHREC#34563

Summary
Brief summary
Community pharmacies are accessible health services where the public can access the ECP over-the-counter and have their MS-2 Step prescriptions for EMA filled. All women should receive information about and be offered effective contraception as part of their care when seeking ECP and EMA: this is because delayed contraceptive provision is associated with higher odds of repeat unintended pregnancy. The study's primary aim is to compare the subsequent uptake of effective contraception (hormonal or intrauterine) in women seeking EC or MS-2Step medicines, who receive the ALLIANCE community pharmacy-based intervention with those who do not receive the intervention. We will utilise a pragmatic stepped-wedge cluster randomised trial across three Australian states. In the intervention phase, women purchasing EC or medical abortion medicines will be offered contraceptive counselling and referral to contraceptive providers when appropriate. Pharmacists will be supported through: online education, academic detailing (co-designed with consumers and pharmacy stakeholders), assistance identifying referral pathways, peer-support through AusCAPPS online community of practice and remuneration. It is anticipated that this trial will equip community-based pharmacists with the resources, networks, knowledge and skills to expand their scope of practice to include the delivery of high-quality, patient-centred, effectiveness-based contraceptive counselling. This will result in improved access to and more effective use of contraception by Australian women, and reduce their risk of subsequent unintended pregnancy after ECP or EMA.
Trial website
https://www.spherecre.org/the-alliance-trial
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115014 0
Prof Danielle Mazza
Address 115014 0
Department of General Practice, School of Public and Preventive Medicine, Monash University
Level 5, 553 St Kilda Rd, Melbourne, VIC 3004, Australia
Country 115014 0
Australia
Phone 115014 0
+61399024496
Fax 115014 0
Email 115014 0
[email protected]
Contact person for public queries
Name 115015 0
Danielle Mazza
Address 115015 0
Department of General Practice, School of Public and Preventive Medicine, Monash University
Level 5, 553 St Kilda Rd, Melbourne, VIC 3004, Australia
Country 115015 0
Australia
Phone 115015 0
+61399024496
Fax 115015 0
Email 115015 0
[email protected]
Contact person for scientific queries
Name 115016 0
Anisa Assifi
Address 115016 0
Department of General Practice, School of Public and Preventive Medicine, Monash University
Level 5, 553 St Kilda Rd, Melbourne, VIC 3004, Australia
Country 115016 0
Australia
Phone 115016 0
+61 399050545
Fax 115016 0
Email 115016 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
15913Study protocol    The study protocol is currently in development and... [More Details]
15915Ethical approval    MUHREC no. 34563



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseExpanding community pharmacists' scope of practice in relation to contraceptive counselling and referral: a protocol for a pragmatic, stepped-wedge, cluster randomised trial (ALLIANCE).2023https://dx.doi.org/10.1136/bmjopen-2023-073154
N.B. These documents automatically identified may not have been verified by the study sponsor.