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

Bridge-It Study Group

Research output: Contribution to journalArticle

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.

Original languageEnglish
Article numbere029978
Number of pages8
JournalBMJ Open
Volume9
Issue number10
DOIs
Publication statusPublished - 30 Oct 2019

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Reproductive Health
Contraception
Cross-Over Studies
Emergencies
Postcoital Contraception
Pharmacists
Induced Abortion
Pharmacies
Progestins
Contraceptive Agents
Pregnancy
Cost-Benefit Analysis
Reproductive Health Services
Desogestrel
Levonorgestrel
Information Storage and Retrieval
Scotland
Sample Size
General Practitioners
Registries

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

In: BMJ Open, Vol. 9, No. 10, e029978, 30.10.2019.

Research output: Contribution to journalArticle

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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.",
author = "Cameron, {Sharon Tracey} and Paula Baraitser and Anna Glasier and Lisa McDaid and John Norrie and Andrew Radley and Stephenson, {Judith M} and James Trussell and Claire Battison and Sarah Cameron and Kathleen Cowle and Mark Forrest and Richard Gilson and Beatriz Goulao and Anne Johnstone and Alison McDonald and Alessandra Morelli and Susan Patterson and Deirdre Sally and Nicola Stewart and {Bridge-It Study Group}",
note = "Funding The Bridge-It study is funded by the National Institute for Health Research’s Health Technology Assessment Programme. HTA Project:15/113/01. Contributors STC, AG, JN, LM, AR, PB, JMS and JT developed the original protocol. STC, CB, MF, RG, AMD, BG, AJ, AM, SP, DS,NS and KC contributed to later stages of study design. STC wrote the draft of the protocol with significant input from all authors at all stages. All authors contributed, read and approved the final manuscript. Competing interests AG is a member of HRA Pharma scientific advisory board. PB is a Clinical Director of the not-for profit community interest company SH:24 that provides online sexual health services in partnership with the NHS. AR received research grants, educational grants and consultancy with Gilead Research grants from Roche and BMS Educational grants from Abbvie. JN is Deputy Chair of the NIHR/HTA General Board Committee. NIHR/HTA funded this research.",
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T1 - Pragmatic cluster randomised cohort cross-over trial to determine the effectiveness of bridging from emergency to regular contraception

T2 - the Bridge-It study protocol

AU - Cameron, Sharon Tracey

AU - Baraitser, Paula

AU - Glasier, Anna

AU - McDaid, Lisa

AU - Norrie, John

AU - Radley, Andrew

AU - Stephenson, Judith M

AU - Trussell, James

AU - Battison, Claire

AU - Cameron, Sarah

AU - Cowle, Kathleen

AU - Forrest, Mark

AU - Gilson, Richard

AU - Goulao, Beatriz

AU - Johnstone, Anne

AU - McDonald, Alison

AU - Morelli, Alessandra

AU - Patterson, Susan

AU - Sally, Deirdre

AU - Stewart, Nicola

AU - Bridge-It Study Group

N1 - Funding The Bridge-It study is funded by the National Institute for Health Research’s Health Technology Assessment Programme. HTA Project:15/113/01. Contributors STC, AG, JN, LM, AR, PB, JMS and JT developed the original protocol. STC, CB, MF, RG, AMD, BG, AJ, AM, SP, DS,NS and KC contributed to later stages of study design. STC wrote the draft of the protocol with significant input from all authors at all stages. All authors contributed, read and approved the final manuscript. Competing interests AG is a member of HRA Pharma scientific advisory board. PB is a Clinical Director of the not-for profit community interest company SH:24 that provides online sexual health services in partnership with the NHS. AR received research grants, educational grants and consultancy with Gilead Research grants from Roche and BMS Educational grants from Abbvie. JN is Deputy Chair of the NIHR/HTA General Board Committee. NIHR/HTA funded this research.

PY - 2019/10/30

Y1 - 2019/10/30

N2 - 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.

AB - 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.

U2 - 10.1136/bmjopen-2019-029978

DO - 10.1136/bmjopen-2019-029978

M3 - Article

C2 - 31672711

VL - 9

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 10

M1 - e029978

ER -