Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, PO Box 22660, Amsterdam DD 1100, The Netherlands.
Implement Sci. 2013 May 20;8:53. doi: 10.1186/1748-5908-8-53.
Prognostic models in reproductive medicine can help to identify subfertile couples who would benefit from fertility treatment. Expectant management in couples with a good chance of natural conception, i.e., tailored expectant management (TEM), prevents unnecessary treatment and is therefore recommended in international fertility guidelines. However, current implementation is not optimal, leaving room for improvement. Based on barriers and facilitators for TEM that were recently identified among professionals and subfertile couples, we have developed a multifaceted implementation strategy. The goal of this study is to assess the effects of this implementation strategy on the guideline adherence on TEM.
METHODS/DESIGN: In a cluster randomized trial, 25 clinics and their allied practitioners units will be randomized between the multifaceted implementation strategy and care as usual. Randomization will be stratified for in vitro fertilization (IVF) facilities (full licensed, intermediate/no IVF facilities). The effect of the implementation strategy, i.e., the percentage guideline adherence on TEM, will be evaluated by pre- and post-randomization data collection. Furthermore, there will be a process and cost evaluation of the strategy. The implementation strategy will focus on subfertile couples and their care providers i.e., general practitioners (GPs), fertility doctors, and gynecologists. The implementation strategy addresses three levels: patient level: education materials in the form of a patient information leaflet and a website; professional level: audit and feedback, educational outreach visit, communication training, and access to a digital version of the prognostic model of Hunault on a website; organizational level: providing a protocol based on the guideline. The primary outcome will be the percentage guideline adherence on TEM. Additional outcome measures will be treatment-, patient-, and process-related outcome measures.
This study will provide evidence about the effectiveness and costs of a multifaceted implementation strategy to improve guideline adherence on TEM.
http://www.trialregister.nlNTR3405. This study is sponsored by ZonMW.
生殖医学中的预后模型可以帮助识别那些可能受益于生育治疗的不孕夫妇。对于那些有自然受孕良好机会的夫妇，即定制的期待管理（TEM），进行期待管理可以避免不必要的治疗，因此在国际生育指南中被推荐。然而，目前的实施情况并不理想，还有改进的空间。基于最近在专业人士和不孕夫妇中确定的 TEM 的障碍和促进因素，我们制定了一个多方面的实施策略。本研究的目的是评估该实施策略对 TEM 指南遵循率的影响。
方法/设计：在一项集群随机试验中，将 25 家诊所及其相关从业者单位随机分为多方面实施策略组和常规护理组。随机化将按体外受精（IVF）设施（完全许可、中级/无 IVF 设施）进行分层。通过预随机化和后随机化的数据收集来评估实施策略的效果，即 TEM 指南遵循率的百分比。此外，还将对该策略进行过程和成本评估。实施策略将侧重于不孕夫妇及其护理提供者，即全科医生（GP）、生育医生和妇科医生。实施策略针对三个层面：患者层面：以患者信息传单和网站的形式提供教育材料；专业层面：审核和反馈、教育外展访问、沟通培训，以及在网站上获得 Hunault 预后模型的数字版本；组织层面：提供基于指南的方案。主要结局将是 TEM 指南遵循率的百分比。额外的结局指标将是治疗、患者和过程相关的结局指标。
本研究将提供关于多方面实施策略提高 TEM 指南遵循率的有效性和成本的证据。
http://www.trialregister.nlNTR3405。本研究由 ZonMW 赞助。
