Provision of the progestogen-only pill by community pharmacies as bridging contraception for women receiving emergency contraception: the Bridge-it RCT

Abstract

Introduction Unless women start effective contraception after using emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies that are unable to provide ongoing contraception (apart from barrier methods which have high failure rates). This means that women need an appointment with a general practitioner or at a sexual and reproductive health clinic. We conducted a pragmatic cluster randomised cohort crossover trial to determine whether or not pharmacist provision of a bridging supply of a progestogen-only pill plus the invitation to attend a sexual and reproductive health clinic resulted in increased subsequent use of effective contraception (hormonal or intrauterine). Methods Twenty-nine pharmacies in three UK cities recruited women receiving emergency contraception (levonorgestrel). In the intervention, women received a 3-month supply of the progestogen-only pill (75 µg of desogestrel) plus a card that provided rapid access to a local sexual and reproductive health clinic. In the control arm, pharmacists advised women to attend their usual contraceptive provider. The primary outcome was reported use of an effective contraception (hormonal and intrauterine methods) at 4 months. Process evaluation was also conducted to inform any future implementation. Results The study took place December 2017 and June 2019 and recruited 636 women to the intervention (n = 316) and control groups (n = 320). There were no statistically significant differences in demographic characteristics between the groups. Four-month follow-up data were available for 406 participants: 63% (198/315) of the control group and 65% (208/318) of the intervention group. The proportion of participants reporting use of effective contraception was 20.1% greater (95% confidence interval 5.2% to 35.0%) in the intervention group (58.4%, 95% confidence interval 48.6% to 68.2%) than in the control group (40.5%, 95% confidence interval 29.7% to 51.3%) (adjusted for recruitment period, treatment arm and centre; p = 0.011). The proportion of women using effective contraception remained statistically significantly larger, when adjusted for age, current sexual relationship and history of past use of effective contraception, and was robust to the missing data. There were no serious adverse events. Conclusion Provision of a bridging supply of the progestogen-only pill with emergency contraception from a pharmacist and the invitation to a sexual and reproductive health clinic resulted in a significant increase in self-reported subsequent use of effective contraception. This simple intervention has the potential to prevent more unintended pregnancies for women after emergency contraception. Trial registration Current Controlled Trials ISRCTN70616901. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 27. See the NIHR Journals Library website for further project information.

Reporting involvement activities with children and young people in paediatric research: a framework analysis

“…The most common approach to involving CYP was through the medium of existing groups or networks, with 72% (23/32) choosing this approach. Of these 25, 60% (15/25) chose to access existing Young Person’s Advisory Groups (YPAGs) who have a remit to support the design and conduct of child health research [ 33 – 47 ], whilst 28% (8/25) reported some form of dialogue with existing youth forums such as, school advisory councils or care groups [ 36 , 38 , 39 , 48 – 51 ], including one study accessed individuals through a PPI network within a Sexual and Reproductive Health Service (no description was provided within the report of who was involved in the network) [ 52 ]. 25% (8/32) established their own formal advisory group [ 53 – 60 ].…”

“…25% (8/32) established their own formal advisory group [ 53 – 60 ]. Of the remaining studies two set up focus groups or meetings with CYP [ 55 , 60 ], two indicated they held one-off individual consultations with CYP [ 56 , 61 ], two involved CYP in Study Steering Committees [ 53 , 55 ], one reported involving young students in research training events held within a university [ 58 ], one reported involving CYP as mystery shoppers [ 52 ], and one report wasn’t clear on the chosen model [ 62 ].…”

“…At the phase of designing the research phase : 97% of the reports (31/32) described varying levels of involvement in the design stage of the research. 71% of these reports (22/31) described involvement at the consultation level, with only 9% (2/22) fully meeting the criteria [ 38 , 40 ], the remaining 91% (20/22) partially meeting the criteria [ 33 , 34 , 36 , 37 , 42 – 52 , 54 , 60 – 62 , 64 ]. Instead, 29% fully met the criteria (9/31) describing a collaborative approach [ 39 , 41 , 53 , 55 – 59 , 65 ].…”

Statistical analysis of publicly funded cluster randomised controlled trials: a review of the National Institute for Health Research Journals Library

“…Of the 100 primary outcomes reported in the 86 trials, the data type of most of the primary outcomes was continuous (63%, 63/100), followed by binary outcomes (28%), and then counts (5%), time-to-event [ 33 , 36 ] and percentage [ 37 , 38 ] were the least (2%, respectively). In the description of the statistical analysis of the primary outcomes of the cRCTs, a variety of phrases were used to describe the multilevel regression methods used to account for clustering, such as generalized linear mixed-model , two-level hierarchical model , mixed-effects , multilevel regression and two-level heteroscedastic linear regression model ; hence, we used a generic name “generalized linear mixed model (GLMM)” to cover all the multilevel regression methods.…”

“…Most of these analyses were carried out using individual participant outcomes. Only 2 trials used aggregated cluster level outcomes as data points in their primary analyses [ 31 , 38 ]. The different statistical methods used to account for the clustering of outcomes at the analysis phase are presented in Table 2 .…”