ALLIANCE (Quality Family Planning Services and Referrals in Community Pharmacy: Expanding Pharmacists’ Scope of Practice): A protocol for a stepped-wedge trial

Problem

Women who seek emergency contraceptive (EC) or early medical abortion (EMA) are at high risk of subsequent unintended pregnancies. Community pharmacists in Australia have been dispensing over the counter EC since 2004 and about 10% also dispense EMA. Pharmacists are therefore well placed to use dispensing conversations to provide contraceptive advice to these women. However, a lack of training in effectiveness-based contraceptive advice, local resources and funding to provide such services currently impedes pharmacists from providing this care. ALLIANCE will determine whether expanding community pharmacist’s scope of practice to deliver a billable consultation involving high quality, structured, patient-centred, effectiveness-based contraceptive advice and a referral to a contraceptive provider results in increased use of subsequent effective contraception amongst women seeking EC or EMA, and reduced unintended pregnancy.

Approach

ALLIANCE is a pragmatic stepped-wedge cluster randomised trial involving community pharmacists across three states in Australia. To participate, pharmacists must have a private consultation room within their practice. The intervention will be co-designed with consumers and pharmacy stakeholders via a stakeholder workshop. Then, participating pharmacists will receive implementation training as online education, educational outreach, identification of referral pathways to contraceptive providers and peer-support through an online community of practice. Participating pharmacists will recruit women as they present for EC or EMA and deliver the intervention to them (contraceptive counselling +/- referral).

We will collect data from women at four and twelve months following the consultation through an online survey about the use of effective contraception and the rate of pregnancies or abortions (12 months only) after consultation. We will also interview all pharmacists and 20 women regarding their experiences of the trial and supplement these with a review of training logs and participant engagement on the community of practice. Finally, we will undertake a within-trial economic evaluation from the Australian health provider perspective, to determine the costs and benefits of the ALLIANCE intervention on the rates of hormonal and long-acting reversible contraception (LARC) usage compared to usual care.

Findings

The primary outcome is self-reported use of effective contraception (hormonal or intrauterine device) four months after EC or EMA. Secondary outcomes are rates of unintended pregnancy, abortion and continued contraceptive use at 12-months after EC or EMA. Additional trial outcomes will seek to understand “what worked for whom in what circumstances and why”, and to evaluate whether the intervention is cost-effective compared to usual care.

Consequences

If successful, our intervention will equip community pharmacists with the resources, networks, knowledge and skills to expand their scope of practice to deliver high quality, structured, patient-centred, effectiveness-based contraceptive advice. This should result in higher rates of use of effective contraception, thereby addressing a key government priority of increasing access to contraceptives.