Implementing targeted expectant management in fertility care using prognostic modelling: a cluster randomized trial with a multifaceted strategy.

<bold>Study Question: </bold>What is the effectiveness of a multifaceted implementation strategy compared to usual care on improving the adherence to guideline recommendations on expectant management for couples with unexplained infertility?<bold>Summary Answer: </bold>The multifaceted implementation strategy did not significantly increase adherence to guideline recommendations on expectant management compared to care as usual.<bold>What Is Known Already: </bold>Intrauterine insemination (IUI) with or without ovarian hyperstimulation has no beneficial effect compared to no treatment for 6 months after the fertility work-up for couples with unexplained infertility and a good prognosis of natural conception. Therefore, various professionals and policy makers have advocated the use of prognostic profiles and expectant management in guideline recommendations.<bold>Study Design, Size, Duration: </bold>A cluster randomized controlled trial in 25 clinics in the Netherlands was conducted between March 2013 and May 2014. Clinics were randomized between the implementation strategy (intervention, n = 13) and care as usual (control, n = 12). The effect of the implementation strategy was evaluated by comparing baseline and effect measurement data. Data collection was retrospective and obtained from medical record research and a patient questionnaire.<bold>Participants/materials, Setting, Methods: </bold>A total of 544 couples were included at baseline and 485 at the effect measurement (247 intervention group/238 control group).<bold>Main Results and the Role Of Chance: </bold>Guideline adherence increased from 49 to 69% (OR 2.66; 95% CI 1.45-4.89) in the intervention group, and from 49 to 61% (OR 2.03; 95% CI 1.38-3.00) in the control group. Multilevel analysis with case-mix adjustment showed that the difference of 8% was not statistically significant (OR 1.31; 95% CI 0.67-2.59). The ongoing pregnancy rate within six months after fertility work-up did not significantly differ between intervention and control group (25% versus 27%: OR 0.72; 95% CI 0.40-1.27).<bold>Limitations Reasons For Caution: </bold>There is a possible selection bias, couples included in the study had a higher socio-economic status than non-responders. How this affects guideline adherence is unclear. Furthermore, when powering for this study we did not take into account the unexpected improvement of adherence in the control group.<bold>Wider Implications Of the Findings: </bold>Generalization of our results to other countries with recommendations on expectant management might be questionable because barriers for expectant management can be very different in other countries. Furthermore, due to a large variation in improved adherence rate in the intervention group it will be interesting to further analyse the process of implementation in each clinic with a process evaluation on professionals and couples' exposure to and experiences with the strategy.<bold>Study Funding/competing Interest(s): </bold>Supported by Netherlands Organisation for Health Research and Development (ZonMW, project number 171203005). No competing interests.<bold>Trial Registration Number: </bold>Dutch trial Register, www.trialregister.nl NTR3405.<bold>Trial Registration Date: </bold>19 April 2012.<bold>Date Of First Patient's Enrolment: </bold>10 July 2012. [ABSTRACT FROM AUTHOR]