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Comparative effectiveness of decision support strategies for joint replacement surgery
Investigator (PI): Sepucha, Karen
Performing Organization (PO): (Current): Massachusetts General Hospital, Department of Medicine, Division of General Internal Medicine / (617) 643-7568
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2020
Record Source/Award ID: PCORI/CDR-1503-28799
Funding: Total Award Amount: $1,731,032
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: For people living with pain and dealing with functional limitations due to knee or hip osteoarthritis, deciding whether to have joint replacement surgery can be challenging. Surgery can provide significant pain relief and improve function, but it carries a chance of serious complications and requires considerable time for recovery. Patients view these trade-offs differently. Some patients want to avoid surgery: "I want to go as long as I can before having the surgery. And so I am waiting. I can't bear the idea of them cutting into my bone and putting something artificial into my body." Whereas others are less willing to put up with functional limitations: "When I was diagnosed, I stopped running, but I continued skiing. I basically told myself that once I can't ski anymore, then it's probably time to have the surgery done." There is general consensus that total joint replacement surgery is appropriate for patients with severe daily pain, functional impairment, and X-ray evidence of disease, but it also is equally important that patients have a clear preference for it. Unfortunately, studies suggest that many patients facing this decision are not well informed, and that surgeons do not always listen to patients' goals and treatment preferences. As a result, about 20 percent to 30 percent of elective joint replacement procedures may be performed on patients who would not have chosen to have it. Interventions, such as patient decision aids, have been shown to improve the decision making process. In this study, decision aids from two leading vendors will be compared in a randomized trial, and we will examine the impact on decision making, treatment choices, and health outcomes. Patient partners have been directly involved in the design of the study and have selected the interventions. One decision aid is a long, linear program with comprehensive information and engaging interviews with patients and specialists. The comparator decision aid is short and interactive, focusing on only the key facts and engaging users through quizzes and worksheets. The patient partners also recommended including an intervention targeted at the surgeons. As a result, the surgeons participating in the study will also be randomized to receive a standard report of patient-reported outcome measures that includes pain, quality of life, and functioning, or an enhanced report that includes the standard information plus patients' goals and treatment preferences. The patient partners have agreed to be part of an advisory committee that will meet quarterly throughout the grant. In addition, we have engaged other key stakeholders in the design and conduct of the trial, including orthopedic surgeons, primary care providers, nurses, and hospital administrators. The results will not only add to the clinical evidence base and increase our understanding of how best to engage patients in difficult decisions, but will also provide actionable knowledge of use to administrators and surgeons across the country.
MeSH Terms:
  • Arthroplasty, Replacement, Hip /*methods
  • Choice Behavior
  • Comparative Effectiveness Research
  • Decision Making
  • * Decision Support Techniques
  • Humans
  • Outcome Assessment, Health Care
  • Pain
  • Patient Participation
  • Quality of Life
  • Randomized Controlled Trials as Topic
Country: United States
State: Massachusetts
Zip Code: 02114
UI: 20162043
CTgovId: NCT02729831
Project Status: Ongoing
Record History: ('2017: Project extended to 2020.',)