PCORI funds implementation projects to promote the use of findings from PCORI-funded studies. This project focuses on implementing findings from the completed PCORI-funded research project: Comparing Ways to Help Patients Decide Whether to Have Surgery to Replace a Knee or Hip
1. What were the results from the original PCORI-funded research study?
The DECIDE-OA study was a randomized trial comparing different decision support interventions with 1,124 patients with hip and knee osteoarthritis at three sites. Surgeons were randomly assigned to receive a Patient Preference Report (a short report that included patients’ goals and treatment preference) or not, and patients were randomly assigned to receive one of two decision aids (DAs)—a long, detailed video DA or a short, interactive DA. The majority of patients (67.2 percent) made informed patient-centered decisions, and that primary outcome did not vary significantly between the DA groups (p = 0.97) or between the surgeon groups (p = 0.23). Knowledge scores were higher for the short-DA group (mean difference = 9 percent; p < 0.001). Overall, the surgeons were highly satisfied and reported that the majority (88.7 percent) of the visits were of normal duration or shorter. Both DAs in this trial were effective; however, the considerable benefits of decision aids are not realized in routine care because of very limited uptake. The DECIDE-OA study was the first study to compare two high-quality decision aids head-to-head, the first to provide evidence on the effectiveness of the short DA, and the first to use National Quality Forum-endorsed measures of shared decision making to evaluate the impact. Despite the many differences between the tools, both had similar effectiveness. This important finding means that sites have flexibility in choosing the tool that will work best for their local setting.
2. Why is this research finding important?
Orthopedic conditions, such as osteoarthritis and low back pain, are a major cause of disability, and surgery is a common treatment (e.g., more than 1 million hip and knee replacements are done in the United States each year). Clinical guidelines for treatment of osteoarthritis and low back pain emphasize the importance of informing patients about their surgical and nonsurgical options and engaging in shared decision making to determine the best treatment. However, evidence suggests that 20 percent of these elective procedures may be done on patients who would not choose it if they were informed and given the choice. Operating on an inadequately informed patient is a serious medical error, and results in increased costs, reduced safety, and worse health outcomes.
3. What is the goal of this project?
The objective is to improve the quality of elective surgery decisions by implementing patient decision aids into routine orthopedic care for four conditions: hip and knee osteoarthritis, lumbar herniated disc, and spinal stenosis. To do this, the project team plans to:
Aim 1: Reach 50 percent of eligible patients with decision aids at four hospitals affiliated with Partners HealthCare. The implementation will build on existing resources and will allow for flexibility in the design of workflows to adapt to local practice patterns at two academic and two community hospitals.
Aim 2: Host a Shared Decision Making Learning Collaborative (SDM-LC) with a dozen sites to extend generalizability of the implementation. The project team plans to reach a total of 20,000 patients with DAs across the sites through this project.
Aim 3: Develop an Orthopedic SDM Implementation Toolkit to support widespread implementation. The toolkit will provide examples of workflows, access to online training videos, and guidance around a core set of evaluation metrics. The team will work with the American Academy of Orthopedic Surgeons and other stakeholder partners to distribute it widely.
4. What is the project team doing?
The team is using the Consolidated Framework for Implementation Research (CFIR), Continuous Quality Improvement methods, and the RE-AIM framework to guide its implementation and evaluation activities. The implementation project will have three main parts. In phase 1, the implementation activities will focus on four sites affiliated with Partners HealthCare, including two of the original DECIDE-OA study sites and two additional sites that are similar in structure and patient population. These sites share a common electronic medical record, have strong leadership support, and have access to the Healthwise decision aids. Some have prior experience using DAs and, as indicated in the many letters of support from chiefs of orthopedic surgery, surgeons, and practice managers, all have demonstrated readiness to implement DAs into routine care. In phase 2 of the project, the team will launch a 15-month Orthopedic SDM Learning Collaborative (SDM-LC) to facilitate implementation across the four Partners HealthCare sites plus eight additional sites. Sites in the SDM-LC will need to have access to high-quality DAs (the Health Dialog or Healthwise DAs used in the DECIDE-OA study, or a DA that has been certified by Washington State), to identify clinical and administrative champions, and have a strong interest in implementing DAs. This phase will expand generalizability, by including rural sites, sites not affiliated with Partners HealthCare, sites outside the Northeast, and sites implementing different DAs. In phase 3, the investigators will distill the insights and experience from phase 1 and the SDM-LC into an Orthopedic SDM Implementation Toolkit. The toolkit will provide concrete examples of workflows, access to online training videos for clinicians and staff, and guidance around a core set of evaluation metrics to monitor progress and impact. At the end of the project, the team plans to have reached 20,000 patients with DAs, will have reliable, sustainable strategies for implementation in orthopedics, and will have a toolkit ready to support wider implementation.
5. How is the team evaluating this project?
The team will use the RE-AIM framework to guide the evaluation plan. The RE-AIM framework assesses an intervention’s potential for dissemination and public health impact using five criteria:
- Reach (assessed by number of DAs delivered to patients)
- Effectiveness (assessed with patient-reported outcomes Shared Decision Making Process survey and Informed, Patient-Centered Surgery)
- Adoption (assessed by the number of clinicians and staff that participated in training and number that have delivered a DA)
- Implementation (assessed by proportion of DAs delivered to eligible patients, proportion delivered at least one week prior to surgery, time, and cost associated with delivery)
- Maintenance (assessed by intention of site champions to continue DA use and report of number of DAs delivered after SDM-LC ends). Sites will provide monthly reports on DA usage, and that data will be supplemented by surveys and interviews with clinicians, staff, and patients.
6. How is the team involving patients and others in making sure the findings reach people who can use them?
The MGH Health Decision Sciences Center (HDSC), led by Karen Sepucha, PhD (PI), has a standing patient advisory committee (PAC) that was critical in the design of the original DECIDE-OA study, and has been involved in the design of this proposal. The team’s patient partners will be involved in the project in several ways, such as attending local site visits to help with training, participating in the learning sessions, and assisting in the development of the toolkit. In addition, Sepucha has engaged leadership (department chairs and chiefs), surgeons, primary care physicians, practice managers, office managers, and front-line staff who will be involved in ensuring successful implementation of the DAs at each site. The American Academy of Orthopedic Surgeons (AAOS), the largest orthopedic specialty society, is a stakeholder partner and will be involved in identifying sites for the SDM-LC, ensuring the toolkit appeals to its members, and disseminating the toolkit to its 39,000 members.
7. How will this project help ensure future uptake and use of findings from patient-centered outcomes research?
Patient decision aids are an effective approach to integrating evidence, including findings from patient-centered outcomes research, into routine care. Through this project, the investigators will have strong examples from real practices for implementation of DAs. The SDM-LC will reach 20,000 patients with DAs at a dozen diverse sites over three years. The Orthopedic SDM Toolkit will distill key insights from this experience and provide guidance to sites that are interested in implementing DAs and shared decision making in their practice. Although the project is focused on DAs for four orthopedic topics, the lessons may be applicable to implementing decision support in other clinical areas. Further, future projects may be able to adapt the toolkit for other topics, types of decision support, and other practices.
Related PCORI-funded Research Project
*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.