Expanding community pharmacists&#39; scope of practice in relation to contraceptive counselling and referral: a protocol for a pragmatic, stepped-wedge, cluster randomised trial (ALLIANCE)

Mazza, D; Assifi, AR; Hussainy, SY; Bateson, D; Johnston, S; Tomnay, J; Kasza, J; Church, J; Grzeskowiak, LE; Nissen, L; Cameron, ST

Expanding community pharmacists' scope of practice in relation to contraceptive counselling and referral: a protocol for a pragmatic, stepped-wedge, cluster randomised trial (ALLIANCE)

Author(s): Mazza, D; Assifi, AR; Hussainy, SY; Bateson, D; Johnston, S; Tomnay, J; Kasza, J; Church, J; Grzeskowiak, LE; Nissen, L; Cameron, ST;
Details: Publication Year 2023-08-31,Volume 13,Issue #8,Page e073154
Journal Title: BMJ Open
Publication Type: Protocol
Abstract: INTRODUCTION: Improving access to effective contraception has the potential to reduce unintended pregnancy and abortion rates. Community pharmacists could play an expanded role in contraceptive counselling and referral to contraceptive prescribers particularly when women are already attending community pharmacy to obtain emergency contraceptive pills (ECPs) or to have medical abortion (MA) medicines dispensed. The ALLIANCE trial aims to compare the subsequent uptake of effective contraception (hormonal or intrauterine) in women seeking ECP or MA medicines, who receive the ALLIANCE community pharmacy-based intervention with those who do not receive the intervention. METHODS AND ANALYSIS: ALLIANCE is a stepped-wedge pragmatic cluster randomised trial in Australian community pharmacies. The ALLIANCE intervention involves community pharmacists delivering structured, patient-centred, effectiveness-based contraceptive counselling (and a referral to a contraceptive prescriber where appropriate) to women seeking either ECPs or to have MA medicines dispensed. Women participants will be recruited by participating pharmacists. A total of 37 pharmacies and 1554 participants will be recruited. Pharmacies commence in the control phase and are randomised to transition to the intervention phase at different time points (steps). The primary outcome is the self-reported use of effective contraception at 4 months; secondary outcomes include use of effective contraception and the rate of pregnancies or induced abortions at 12 months. A process and economic evaluation of the trial will also be undertaken. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Monash University Human Research Ethics Committee (#34563). An explanatory statement will be provided and written consent will be obtained from all participants (pharmacy owner, pharmacist and women) before their commencement in the trial. Dissemination will occur through a knowledge exchange workshop, peer-reviewed journal publications, presentations, social media and conferences. TRIAL REGISTRATION NUMBER: ACTRN12622001024730.
Publisher: BMJ
Keywords: Female; Humans; Pregnancy; Australia; *Contraceptive Agents; Counseling; *Pharmacists; Referral and Consultation; *Scope of Practice; Pragmatic Clinical Trials as Topic; Preventive medicine; Public health; Primary Care; Reproductive medicine; Sexual medicine
Department(s): Pharmacy
PubMed ID: 37652588
Publisher's Version: https://doi.org/10.1136/bmjopen-2023-073154
Open Access at Publisher's Site: https://doi.org/10.1136/bmjopen-2023-073154
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2023-11-08 07:27:50

Last Modified: 2023-11-08 07:28:27