Mazza Danielle, Amos Natalie, Watson Cathy J, McGeechan Kevin, Haas Marion, Peipert Jeffrey F, Lucke Jayne, Taft Angela, McNamee Kathleen, Black Kirsten I
Department of General Practice, Monash University, Melbourne, Victoria, Australia
Department of General Practice, Monash University, Melbourne, Victoria, Australia.
BMJ Open. 2020 Sep 22;10(9):e035895. doi: 10.1136/bmjopen-2019-035895.
Through addressing main barriers to the uptake of long-acting reversible contraceptives (LARCs) among Australian women, the Australian Contraceptive ChOice pRoject (ACCORd) trialled an educational intervention targeting general practitioners (GPs) and provided those in the intervention group with a rapid referral service for quick insertion. The cluster randomised controlled trial resulted in greater uptake of LARC in the intervention group. This protocol paper describes a longitudinal follow-up to the ACCORd Study to assess the long-term efficacy and cost-effectiveness of the intervention.
Women participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey. These participants will be invited to complete an additional follow-up survey 3 years post completion of their baseline interview. Based on the original ACCORd Study tools, the online survey will address long-term outcomes including contraceptive continuation rates and reproductive history, any unintended pregnancies, satisfaction and concerns with their current contraceptive method, and an assessment of quality of life. We will analyse data using binary regression models with generalised estimating equations and robust standard errors to account for clustering.
Demonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.
The ACCORd Study received approval from the Monash University Human Research Ethics Committee: CF16/188-201000080. Additionally, an amendment to conduct this 3-year longitudinal follow-up survey has been approved. The trial follow-up outcomes will be disseminated through formal academic pathways, including journal articles, national and international conferences and reports as well as using more 'mainstream' strategies such as seminars, workshops and media engagement. Additionally, outcomes will be communicated through policy briefs to Australian state and federal governments.
This trial is registered with the Australian and New Zealand Trials Registry ACTRN12615001346561. Recruitment and data collection have been completed for the baseline, 6-month and 12-month surveys. Data collection for the 3-year survey commenced in August 2019.
通过解决澳大利亚女性使用长效可逆避孕药(LARC)的主要障碍,澳大利亚避孕选择项目(ACCORd)对针对全科医生(GP)的教育干预措施进行了试验,并为干预组提供了快速转诊服务以便快速植入。这项整群随机对照试验使干预组对LARC的接受度更高。本方案文件描述了ACCORd研究的纵向随访,以评估该干预措施的长期疗效和成本效益。
女性参与者(ACCORd全科医生的患者)完成了基线、6个月和12个月的调查。这些参与者将被邀请在完成基线访谈3年后完成一次额外的随访调查。基于原始的ACCORd研究工具,在线调查将涉及长期结果,包括避孕持续率和生育史、任何意外怀孕情况、对当前避孕方法的满意度和担忧,以及生活质量评估。我们将使用带有广义估计方程和稳健标准误的二元回归模型分析数据,以考虑聚类情况。
证明该策略在这一队列澳大利亚初级保健患者中持续使用、减少意外怀孕的有效性和成本效益,将加强在更广泛传播这些策略以及在其他地方复制该研究方面的政策和项目紧迫性。
ACCORd研究获得了莫纳什大学人类研究伦理委员会的批准:CF16/188 - 201000080。此外,开展这项为期3年的纵向随访调查的修正案已获批准。试验随访结果将通过正式的学术途径传播,包括期刊文章、国内和国际会议及报告,以及使用更多“主流”策略,如研讨会、工作坊和媒体参与。此外,结果将通过政策简报传达给澳大利亚州和联邦政府。
本试验已在澳大利亚和新西兰试验注册中心注册,注册号为ACTRN12615001346561。基线、6个月和12个月调查的招募和数据收集已完成。3年调查的数据收集于2019年8月开始。