Some uterine fibroids give rise to heavy menstrual bleeding, pelvic pain, discomfort during sexual intercourse, pregnancy complications, and/or difficulty becoming pregnant. Uterine fibroids, non-cancerous overgrowths of the smooth muscle in the uterus, develop in nearly half of all women of reproductive age. 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. 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. Our primary outcome measure is the number of eligible patients who receive the Option Grid PDAs. 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. Implementation will be guided by the Consolidated Framework for Implementation Research (CFIR) and Normalization Process Theory (NPT). 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. 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.
However, the implementation of PDAs in routine care remains challenging. Tools known as patient decision aids (PDAs) are effective in increasing patient engagement in the decision-making process. Women with fibroids wish to consider treatment trade-offs. The lack of comparative evidence demonstrating superiority of any one treatment means that choosing the best option is sensitive to individual preferences. Multiple treatment options are available. 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. Uterine fibroids are non-cancerous overgrowths of the smooth muscle in the uterus.
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