Project Summary

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 and Cost of Implementation publication. This publication was part of a special article collection, “The Cost of Implementation of Evidence-Based Practices” in the October 2023 issue of Medical Care.

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

  • A community advisory board that included patients with uterine fibroids and doctors who treat fibroids
  • The Fibroid Foundation
  • The National Uterine Fibroids Foundation
  • The American College of Obstetricians and Gynecologists
  • Representatives from patient advocacy and physician specialty organizations

Publicly Accessible Project Materials

  • Accessing the Online Uterine Fibroids Decision Aid: This short video is a guide to using the interactive uterine fibroid Option Grid tools through My Health Decisions by Dynamed.
  • Introduction to Shared Decision Making Video Series: These five short videos give an overview of SDM and how to use the Option Grid. They also discuss factors needed for successful implementation of SDM in different clinical contexts.
  • My Health Decisions Electronic Health Record Software Integration Guide: This written document is aimed at Information Technology (IT) teams. It explains how to integrate the My Health Decisions tools into the EHR.

For more information about these materials, please contact the project team at [email protected].

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.

Project Achievements

  • Integrated the decision aid into clinics’ Epic EHRs.
  • Translated the decision aid into Spanish.
  • Demonstrated the feasibility of using the decision aid in five clinics.
  • Reached 2,553 patients who have symptomatic uterine fibroids.
  • Created implementation resources for clinicians and an EHR integration guide for IT teams.

Implementation Strategies

  • Promoted SDM.
  • Assessed clinic readiness.
  • Adapted the decision aid to include updated evidence about treatments for uterine fibroids and translated the decision aid into Spanish.
  • Incorporated an online, interactive version of the decision aid into clinics’ EHR systems.
  • Adapted the SDM approach, including plans for decision aid integration, to work with clinics’ existing resources and workflows.
  • Provided educational materials to patients as part of the decision aid.
  • Trained clinical teams in SDM through in-person workshops and videoconferences.
  • Used a phased implementation approach, specifically a stepped wedge rollout.
  • Conducted clinic visits.
  • Provided technical assistance to clinics, including coaching.

Evaluation Measures 

To document implementation:

  • Organizational readiness
  • Barriers and facilitators to program implementation
  • Fidelity to the SDM process (audio-recorded visit encounters, patient surveys)
  • Number and proportion of eligible patients who use the decision aids (EHR data and clinician log).
  • Number of clinicians who use the decision aids (EHR data).

To assess healthcare and health outcomes:

  • Patient assessment of SDM (collaboRATE scores)
  • Patients’ fibroid symptoms
  • Patients’ health services utilization
  • Patients’ intended and received treatment

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.

Project Information

Glyn Elwyn, MD, PhD, FRCGP, MSc, MB BCh
Trustees of Dartmouth College
$2,837,498
Multi-Component Implementation of Shared Decision Making for Uterine Fibroids Across Socioeconomic Strata

Key Dates

June 2018
January 2023
2018
2023

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

Supporting Ongoing Use of Two Conversation Aids for Making Decisions about Early-Stage Breast Cancer Treatment -- The SHAIR Collaborative

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Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
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Last updated: February 22, 2024