BACKGROUND Uterine fibroids are non-cancerous overgrowths of the smooth muscle in the uterus. As they grow, some cause problems such as heavy menstrual bleeding, pelvic pain, discomfort during sexual intercourse, and rarely pregnancy complications or difficulty becoming pregnant. Multiple treatment options are available. The lack of comparative evidence demonstrating superiority of any one treatment means that choosing the best option is sensitive to individual preferences. Women with fibroids wish to consider treatment trade-offs. Tools known as patient decision aids (PDAs) are effective in increasing patient engagement in the decision-making process. However, the implementation of PDAs in routine care remains challenging. Our aim is to use a multi-component implementation strategy to implement the uterine fibroids Option Grid™ PDAs at five organizational settings in the USA. METHODS We will conduct a randomized stepped-wedge implementation study where five sites will be randomized to implement the uterine fibroid Option Grid PDA in practice at different time points. Implementation will be guided by the Consolidated Framework for Implementation Research (CFIR) and Normalization Process Theory (NPT). There will be a 6-month pre-implementation phase, a 2-month initiation phase where participating clinicians will receive training and be introduced to the Option Grid PDAs (available in text, picture, or online formats), and a 6-month active implementation phase where clinicians will be expected to use the PDAs with patients who are assigned female sex at birth, are at least 18 years of age, speak fluent English or Spanish, and have new or recurrent symptoms of uterine fibroids. We will exclude postmenopausal patients. Our primary outcome measure is the number of eligible patients who receive the Option Grid PDAs. We will use logistic and linear regression analyses to compare binary and continuous quantitative outcome measures (including survey scores and Option Grid use) between the pre- and active implementation phases while adjusting for patient and clinician characteristics. DISCUSSION This study may help identify the factors that impact the implementation and sustained use of a PDA in clinic workflow from various stakeholder perspectives while helping patients with uterine fibroids make treatment decisions that align with their preferences. TRIAL REGISTRATION Clinicaltrials.gov , NCT03985449. Registered 13 July 2019, https://clinicaltrials.gov/ct2/show/NCT03985449.

中文翻译：

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子宫肌瘤选项网格的实施有助于跨五个组织环境的患者决策：随机阶梯楔形研究方案。

背景技术子宫肌瘤是子宫平滑肌的非癌性过度生长。随着它们的生长，有些会引起一些问题，例如月经大量出血、骨盆疼痛、性交不适，以及罕见的妊娠并发症或怀孕困难。有多种治疗方案可供选择。缺乏比较证据证明任何一种治疗方法的优越性意味着选择最佳选择对个人偏好很敏感。患有肌瘤的女性希望考虑治疗权衡。患者决策辅助工具 (PDA) 可以有效提高患者对决策过程的参与度。然而，PDA 在日常护理中的实施仍然具有挑战性。我们的目标是使用多组件实施策略在美国的五个组织机构中实施子宫肌瘤 Option Grid™ PDA。方法 我们将进行一项随机阶梯楔形实施研究，其中五个地点将被随机分配，在不同时间点在实践中实施子宫肌瘤 Option Grid PDA。实施将以实施研究综合框架（CFIR）和规范化过程理论（NPT）为指导。将有一个为期 6 个月的预实施阶段、一个为期 2 个月的启动阶段，参与的临床医生将接受培训并向其介绍 Option Grid PDA（以文本、图片或在线格式提供），以及为期 6 个月的积极阶段在实施阶段，临床医生将使用 PDA 来治疗出生时被指定为女性、年满 18 岁、能说流利英语或西班牙语、有新发或复发性子宫肌瘤症状的患者。我们将排除绝经后患者。我们的主要结果指标是接受 Option Grid PDA 的合格患者数量。我们将使用逻辑回归和线性回归分析来比较实施前阶段和实施阶段之间的二元和连续定量结果测量（包括调查分数和选项网格使用），同时根据患者和临床医生的特征进行调整。讨论 这项研究可能有助于从不同利益相关者的角度确定影响临床工作流程中 PDA 实施和持续使用的因素，同时帮助子宫肌瘤患者做出符合其偏好的治疗决策。试验注册 ClinicalTrials.gov，NCT03985449。2019 年 7 月 13 日注册，https://clinicaltrials.gov/ct2/show/NCT03985449。