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.
Subject(s)
Contraceptive Agents , Pharmacists , Scope of Practice , Female , Humans , Pregnancy , Australia , Counseling , Referral and Consultation , Pragmatic Clinical Trials as TopicABSTRACT
INTRODUCTION: A substantial proportion of hospital admissions and readmissions are directly attributable to preventable medication-related harm. Interventions that reduce these harms could avert significant suffering and healthcare costs. OBJECTIVES: The Discharge Medications Reconciliation (DCMedsRec) trial will evaluate a structured medication reconciliation service by community pharmacists post hospital discharge on the risk of 30-day unplanned readmission. Electronic access to the Hospital Discharge Summary via My Health Record will underpin this service. METHODS: DCMedsRec is a non-blinded randomised controlled trial of an intervention by community pharmacists within 30 days of hospital discharge in Melbourne, Australia. Patients discharged from hospital will be assessed by a hospital pharmacist for trial eligibility. If eligible, patients will be randomised to either a control or intervention group by sequentially marked sealed envelopes. Intervention patients receive an invitation to the DCMedsRec service at a participating community pharmacy, who will be reimbursed. Control patients will receive usual care. A Number Needed to Treat of 20 will require 293 DCMedsRec interventions to achieve 80% power. With a predicted 30% uptake, a minimum sample of 977 in the intervention arm is required. OUTCOMES: The primary outcome will be the rate of 30-day unplanned hospital readmission in intervention (DCMedsRec) versus usual care groups. Secondary analyses will evaluate the economic impact of the intervention and a qualitative thematic analysis of the experience and value of the service for both patients and service providers (community pharmacists). ANALYSIS: An intention-to-treat analysis will be used to assess intervention efficacy and results will be reported using risk ratios with 95% confidence intervals. Cost-effectiveness analysis will compare within-trial costs and outcomes of the DCMedsRec versus usual care from a health-system perspective. TRIAL REGISTRATION AND FUNDING: This trial is registered with the Australian and New Zealand Clinical Trials Register and funded by the Australian Digital Health Agency.
