PCORI funds Dissemination and Implementation (D&I) projects to increase awareness and promote the use of PCORI research findings to improve healthcare practices and health outcomes. This project is proposing to conduct D&I activities for the results of the research project: Which Treatments for Uterine Fibroids Have the Best Results?
1. What research finding is this project disseminating?
Original PCORI Study: The project team plans to use evidence from the study by PI Priscilla Velentgas, MS, PhD, of treatments for uterine fibroids (PCORI contract CE-12-11-4430). This study produced new information about: surgical procedures for uterine fibroids; the length of time before women presented with recurring problems; and the percentage of women seeking care for fibroids within two years of a first procedure. The team will integrate this new evidence into new Option Grid and Picture Option Grid encounter decision aids, thus replacing the existing tool, which lacks the full range of options.
SDM Approach: The project team will use a multicomponent shared decision making (SDM) implementation strategy. The researchers have prior evidence of the effectiveness of this strategy across multiple practice settings. The strategy will be guided by the Consolidated Framework for Implementation Research (CFIR) and the Normalization Process Theory (NPT), which the team has used in the past to guide implementation efforts. The SDM strategy will include four components: assessment of organizational readiness for SDM and the generation of a tailored strategy at each site to address potential organizational barriers to implementation; online or in-person training of participating clinical teams, including initial coaching and supervision; implementation of a paper-based text or picture version and/or a web-based interactive Option Grid encounter decision aid; and, where possible, integration of new evidence and the SDM approach into existing clinical practice guidelines.
2. Why is this research finding important?
Patient-Centered Dilemma: Uterine fibroids are a noncancerous overgrowth of smooth muscle in the wall of the uterus—they are one of the most common health issues for women. As fibroids grow, they can cause problems, like heavy menstrual bleeding, pelvic pain, a need to pass urine frequently, discomfort during sexual intercourse, and difficulty becoming pregnant. Fibroids can also cause problems during pregnancy, such as miscarriage, preterm birth, and an increased risk of cesarean birth. Women with fibroids report a lower quality of life and significant financial burden. Multiple treatments are available; some address symptoms through medication while others (i.e., endometrial ablation) work by partially removing an inner layer of the uterine wall. Another option is to remove the fibroid (or part of it) in a process known as myomectomy, or to block some of the blood supply to the uterus through uterine artery embolization or high-intensity ultrasound. The wide range of possible treatments means that there are trade-offs for women in terms of cost, recovery, and the impact on fertility, to name only a few factors. Choosing the best way to manage symptomatic uterine fibroids is therefore particularly sensitive to the priorities and preferences of individual women. Sharing decisions between patients and clinical teams ensures that women select the treatment that is best aligned with their informed preferences. The gynecologists who wish to be part of this project welcomed the idea of using new Option Grids in clinical settings, especially those versions in Spanish and with images.
3. What is the goal of the dissemination project?
Objective: The project team will incorporate new comparative effectiveness evidence about uterine fibroid treatment (see section A.2, Project Strategy) into a multicomponent implementation strategy that integrates: an assessment of organizational readiness for SDM; clinician SDM training; the use of Option and Picture Option Grid decision aids; and the integration of PCOR-derived evidence into existing clinical practice guidelines for the treatment of uterine fibroids.
Specific Aim 1: The team will evaluate the impact and fidelity of a multicomponent SDM implementation strategy for the care of women who seek treatment for uterine fibroids, at five diverse gynecology settings and across socioeconomic strata.
Specific Aim 2: The researchers will examine, using the Consolidated Framework for Implementation Research and the Normalization Process Theory, which contextual characteristics determine the success of sustaining a multicomponent SDM strategy.
4. What is the project team doing?
The implementation strategy targets two user groups. User group 1 includes patients with symptomatic uterine fibroids (new or recurrent) who are: assigned female (sex) at birth; at least 18 years of age; speak English or Spanish; have the ability to complete short surveys online independently or assisted by a caregiver; and are not postmenopausal or suspected to have a malignancy. User group 2 will include healthcare professionals who will provide care to women with symptomatic uterine fibroids during the project period at participating implementation sites. The five implementation sites are: Brigham and Women’s Hospital, Boston, Massachusetts (Site PI: Raymond Anchan, MD, PhD); Mayo Clinic, Rochester, Minnesota (Site PI: Regan Theiler, MD, PhD); Montefiore Medical Center, Bronx, New York (Site PI: Erika Banks, MD); Barnes-Jewish Hospital, WUSTL, St. Louis, Missouri (Site PI: Tessa Madden, MD); and Dartmouth-Hitchcock Obstetrics and Gynecology, Lebanon, New Hampshire (Clinic Site Lead: Tina Foster, MD, MPH). At each of the clinical sites, at least five gynecologists will introduce the uterine fibroid tools to eligible patients during the clinic visit. Given the diversity of settings, the team is confident that both the clinicians and the patients will be representative of broader populations. Eligible patients will review the content of the patient decision aid on their own ahead of time, and again during the visit with their healthcare professional in order to discuss the treatment options that are best aligned with the patient’s informed preferences, involving family members when relevant. Patients will also be encouraged to take a copy of the tool home.
5. How will the project team evaluate their dissemination activities?
The project team will determine the effectiveness of implementation by calculating the percentage of patients who receive the SDM intervention and whether the process of implementation is sustained or “normalized” to become part of the routine workflow at the five implementation sites. The researchers recognize that merely providing the Option Grid patient decision aid is not sufficient evidence that SDM has occurred; the team, therefore, proposes using Observer OPTION-5 to evaluate patient-clinician interactions in samples of clinical encounters in the pre-implementation and active implementation phases. A patient-reported measure of SDM (CollaboRATE) will provide data to assess the impact of the SDM strategy on the interactional process. In more detailed analyses, the team will focus on whether the Fibroid Option Grid is used (or not used) to facilitate SDM in the clinical encounter. The team will develop a statistical model to examine the effect of variables such as patient health literacy, insurance status, health status, age, and race. The researchers will compare symptom scores (UFS-QOL) and patient reports of resource utilization between pre-implementation and active implementation phases.
6. How is the project team involving patients and others in this dissemination project?
The relevance of this topic was identified by patients involved in creating the first version of the Uterine Fibroid Option Grid. From that point onward, the project team has engaged with an increasing number of patients and other stakeholders, including the panel that supported Velentgas’ recent PCORI study. The researchers have recruited five patients to be part of the current project team and have representation from the Fibroid Foundation and the National Uterine Fibroids Foundation.
7. How will this project help ensure future uptake and use of PCORI results?
The five participating sites represent pioneers in patient-centered care and are willing collaborators in designing this study. They are committed to using tools designed to facilitate SDM with patients from diverse and lower socioeconomic (SES) communities. The new version of the Uterine Fibroid Option Grid (and Picture Option Grid) will not only be up-to-date, but will be continuously maintained by the evidence summarization process that underpins EBSCO Health products and thus capable of online distribution across all healthcare systems in the United States and beyond.
Learn more about PCORI’s Dissemination and Implementation program here.
Related PCORI-funded Research Project
Note: Results from the original project have completed PCORI’s Peer Review and are available here.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.