This implementation project is complete.
PCORI implementation projects promote the use of findings from PCORI-funded studies in real-world healthcare and other settings. These projects build toward broad use of evidence to inform healthcare decisions.
This PCORI-funded implementation project used shared decision making, or SDM, to help women with uterine fibroids and their doctors make decisions about treatment.
|Uterine fibroids are growths in the uterus that are not cancer. They are a common health problem and can cause heavy bleeding, pain, problems with pregnancy, and preterm birth. Treatments are available for uterine fibroids; these treatments have different trade-offs.|
What was the goal of this implementation project?
Shared decision making, or SDM, is a process where patients and clinicians, like doctors or nurses, work together to make health decisions. Discussing the evidence for different treatments is usually part of SDM.
This project used evidence from a PCORI-funded research study to deliver an SDM program for uterine fibroid clinics across the country. The program helps patients with fibroids and their clinicians discuss the benefits and harms of different treatment options.
The original research study that produced this evidence compared three ways to treat fibroids:
- Myomectomy, a surgery to remove fibroids
- Uterine artery embolization, a procedure to block the flow of blood to fibroids
- Endometrial ablation, a procedure that removes a layer of the lining of the uterus
The three treatment options worked about the same to prevent or delay symptoms. Myomectomy and uterine artery embolization were better than endometrial ablation at helping patients avoid follow-up treatment.
What did this project do?
The project team worked with patient partners and women’s health clinics in five states to make the SDM program part of standard care. The states were Massachusetts, Minnesota, Missouri, New Hampshire, and New York. Most of the clinics saw patients with a new diagnosis of fibroids. The clinics were of different sizes. Patients who attended the clinics were racially and ethnically diverse. In one clinic, patients who were eligible for the program had low health literacy. Health literacy is the ability to find, understand, and use information to make health decisions.
The project team used the evidence on fibroid treatments to update an existing decision aid. Decision aids help people choose between two or more healthcare options based on what is most important to them. The updated decision aid could be used before, during, or after clinic visits. It was available in multiple formats, including a paper version or online. It was also available in English and Spanish.
To put the decision aid into use, the project team:
- Assessed clinics’ readiness to support patients and doctors in SDM about fibroid treatments.
- Helped each clinic identify which decision aid formats they wanted to use and how to make the decision aid part of routine care.
- Made the decision aid part of online systems that clinics use to share materials with patients.
- Trained 72 doctors, nurses, and other clinic staff on SDM and on how to deliver and use the decision aid.
- Adapted the decision aid to reflect new treatments and feedback received from clinics.
- Provided the clinics with ongoing support.
What was the impact of this project?
Use of the decision aid
Clinicians used the decision aid with 2,553 patients, or about 80% of eligible patients. Across the five clinics, 90% of clinicians used the decision aid with their patients.
SDM and healthcare outcomes
Among 781 patients who completed a survey after their visit, patient reports of SDM didn’t differ before versus after clinics started the decision aid program. Healthcare use, including outpatient, emergency room, urgent care, or hospital visits, also didn't differ before versus after clinics began using the program. The lack of change in SDM may have been due to some clinics were already using SDM as part of care.
Of the 496 patients who completed a survey after the SDM program was started, 62% reported receiving the decision aid. These patients reported higher levels of SDM than those who didn’t report receiving the decision aid (odds ratio [OR]= 1.52; 95% confidence interval [CI]: 1.09, 2.12).
Several challenges limited the use of the program by clinic staff as intended. During the COVID-19 pandemic, many clinics were short-staffed. As a result, staff were unable to take on new tasks, including identifying eligible patients and delivering the decision aid. Identifying eligible patients was also difficult because of problems using the clinics’ electronic health record, or EHR, and scheduling software. As a result of these challenges, many clinics relied on research staff to help provide the SDM program.
Cost of Implementation:
The project team examined the costs associated with putting the SDM approach in place at each of the five clinics.
The cost of implementing the intervention varied greatly across clinics, with total costs for each clinic ranging from about $14,000 to $70,000. Factors that influenced costs included clinic size, location, and ability to automate the identification of patients. Clinic personnel time was the largest cost, specifically time needed to identify eligible patients, send them the decision aid, and discuss it during the visit.
For more details, view this project’s Cost of Implementation Report, which will be posted here when available.PCORI supplemental funding supported project activities to capture and analyze the costs of implementation during this project. PCORI’s goal is to provide decision makers at future clinics or other sites with information they can use when considering the adoption of the intervention that was the focus of this PCORI-funded implementation project.
More about this implementation project:
Stakeholders Involved in This Project
Publicly Accessible Project Materials
The project team developed these materials, which may be available for free or require a fee to access. Please note that the materials do not necessarily represent the views of PCORI and that PCORI cannot guarantee their accuracy or reliability.
To document implementation:
To assess healthcare and health outcomes:
COVID-19-Related Project Activities
PCORI supplemental funding to support project activities to address needs evolving or emerging in the context of the COVID-19 public health crisis.
To reduce the risk of spreading the COVID-19 virus, many health systems shifted from in-person care to telehealth. Telehealth is a way to provide care to patients remotely using phone, video, or monitoring devices that can help manage care.
With the enhancement, the project team supported patients using telehealth to make decisions about treatments for uterine fibroids. Instead of having patients view the decision aid in person, clinics sent it directly to patients. The team worked with each clinic to figure out how the best way to offer the decision aid, such as online or by mailing a paper copy.
Related Journal Citations
Study Registration Information
Initial PCORI-Funded Research Study
This implementation project focuses on putting findings into practice from this completed PCORI-funded research study: Which Treatments for Uterine Fibroids Have the Best Results?
Related Dissemination and Implementation Project