Pragmatic cluster randomised cohort cross-over trial to determine the effectiveness of bridging from emergency to regular contraception: the Bridge-It study protocol

Cameron, S. T. et al. (2019) Pragmatic cluster randomised cohort cross-over trial to determine the effectiveness of bridging from emergency to regular contraception: the Bridge-It study protocol. BMJ Open, 9(10), e029978. (doi: 10.1136/bmjopen-2019-029978) (PMID:31672711) (PMCID:PMC6830607)

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Abstract

Introduction: Oral emergency contraception (EC) can prevent unintended pregnancy but it is important to start a regular method of contraception. Women in the UK usually access EC from a pharmacy but then need a subsequent appointment with a general practitioner or a sexual and reproductive health (SRH) service to access regular contraception. Unintended pregnancies can occur during this time. Methods and analysis: Bridge-It is a pragmatic cluster randomised cohort cross-over trial designed to determine whether pharmacist provision of a bridging supply of a progestogen-only pill (POP) plus rapid access to a local SRH clinic, results in increased uptake of effective contraception and prevents more unintended pregnancies than provision of EC alone. Bridge-It involves 31 pharmacies in three UK regions (London, Lothian and Tayside) aiming to recruit 626–737 women. Pharmacies will give EC (levonorgestrel) according to normal practice and recruit women to both intervention and the control phases of the study. In the intervention phase, pharmacists will provide the POP (desogestrel) and offer rapid access to an SRH clinic. In the control phase, pharmacists will advise women to attend a contraceptive provider for contraception (standard care). Women will be asked 4 months later about contraceptive use. Data linkage to abortion registries will provide abortion rates over 12 months. The sample size is calculated on the primary outcome of effective contraception use at 4 months (yes/no) with 90% power and a 5% level of significance. Abortion rates will be an exploratory secondary analysis. Process evaluation includes interviews with pharmacists, SRH clinicians and women. Cost-effectiveness analysis will use a healthcare system perspective and be expressed as incremental cost-effectiveness ratio. Ethics and dissemination: Ethical approval was received from South East Scotland REC June 2017. Results will be published in peer-reviewed journals and conference presentations. Trial registration number: ISRCTN70616901.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Patterson, Mrs Susan and McDaid, Professor Lisa
Authors: Cameron, S. T., Baraitser, P., Glasier, A., McDaid, L., Norrie, J., Radley, A., Stephenson, J., Trussell, J., Battison, C., Cameron, S., Cowle, K., Forrest, M., Gilson, R., Goulao, B., Johnstone, A., McDonald, A., Morelli, A., Patterson, S., Sally, D., and Stewart, N.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > MRC/CSO SPHSU
Journal Name:BMJ Open
Publisher:BMJ Publishing Group
ISSN:2044-6055
ISSN (Online):2044-6055
Published Online:30 October 2019
Copyright Holders:Copyright © 2019 The Authors
First Published:First published in BMJ Open 9(10): e029978
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
174342A randomised controlled trial to determine the effectiveness of bridging from emergency to regular contraception: The 'Bridge-it' study TRIAL CI - PROFESSOR SHARON CAMERONLisa McDaidNational Institute for Health Research (NIHR)15/113/01HW - MRC/CSO Social and Public Health Sciences Unit