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Information about ongoing health services research and public health projects

Patient osteoarthritis careplan to inform optimal treatment
Investigator (PI): Franklin, Patricia D
Performing Organization (PO): (Current): Northwestern University, Feinberg School of Medicine, Department of Orthopaedic Surgery / (312) 926-4444
(Past): University of Massachusetts, Medical School, Department of Orthopedics and Physical Rehabilitation / (508) 334-9750
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2024
Record Source/Award ID: PCORI/IHS-1507-31714 ; PCORI/IHS-1507-31714-IC
Funding: Total Award Amount: $6,425,928
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Does a Web-Based Decision Aid Help Patients and Their Doctors Decide How to Treat Hip and Knee Arthritis? This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final. What is the research about? Hip and knee arthritis are the most common causes of disability in the United States. These types of arthritis affect more than two-thirds of adults over the age of 65. When medicine and physical therapy no longer help with arthritis pain and disability, many patients think about having joint replacement surgery. However, it is hard for patients to know how they will benefit from surgery or what the risks of surgery are for them. Decision aids help people choose between two or more healthcare options based on what is most important to them. In this study, the research team is creating and testing a web-based decision aid to help patients figure out their treatment goals and choose a treatment. For example, some patients may want to have less pain or be more active. The team wants to see if patients who use the decision aid feel more satisfied with their decisions and have less pain than patients who don’t use it. Patients note that support from peers who have thought about joint replacement is important when choosing an arthritis treatment, as well as support from their doctors. The research team wants to compare how the decision aid works for patients who receive peer support in addition to the decision aid versus for those who use the decision aid alone. Who can this research help? Findings from this study may help doctors and surgeons decide whether to offer the decision aid to help patients choose an arthritis treatment. What is the research team doing? The research team is carrying out this study with a network of orthopedic surgeons in several states. The study has two parts. In the first part, the team is assigning surgeons by chance to provide either the decision aid or usual care. In the usual care group, doctors and patients talk about patients’ knee pain and activities. They also talk about risk factors, such as smoking, and about whether surgery is the best choice. In the decision aid group, the decision aid helps patients understand the benefits and risks of different arthritis treatments. It also creates a personalized report that patients can discuss with their surgeons and primary care doctors. After each patient meets with a surgeon, the team sends copies of the report to the patient’s regular doctor. In the second part of the study, the research team is assigning surgeons by chance to provide patients with either the decision aid plus a peer support website or the decision aid alone. The research team is comparing patients’ satisfaction with their treatment between groups. They are also comparing patients’ pain, symptoms, quality of life, and ability to move and exercise after treatment. Patients, orthopedists, physical therapists, and clinicians help design and test the decision aid. Research methods at a glance Design Element Description Design Cluster randomized controlled trial Population English-speaking adults age 18 and older who are seeking care at participating surgeons’ practices for knee or hip osteoarthritis (OA) Interventions/ Comparators Arthritis care through Shared Decision (ASK) OA Careplan (decision aid that provides patients and surgeons with patient-reported outcome scores, risk factors, and feedback reports for shared decision making) Enhanced ASK OA Careplan (OA Careplan plus individual predicted outcomes, access to peer support website, and ability to review decision aid with primary care physician) Usual care (patients and surgeons can see patient-reported outcome scores but do not receive a careplan) Outcomes Primary: satisfaction with treatment decisions, pain relief at 6 months Secondary: functional gain, pain relief at 12 months Timeframe 6-month follow-up for primary outcomes
Abstract Archived: Two-thirds of adults over 65 years of age suffer with knee or hip osteoarthritis (OA) and its associated pain and disability. When the pain is no longer controlled with medication and physical therapy, OA patients face the decision of whether to undergo total joint replacement surgery (TJR). OA patients report that it is difficult to know how their individual symptoms will benefit from surgery, or what risks TJR brings. We propose to automate an OA Careplan for patients and surgeons to use together when making decisions about TJR or further non-operative care. The OA Careplan will include individualized pain and function measures trended over time, estimated benefits and risks of TJR, evidence-based information to guide patient-surgeon decisions, and patient goals. In addition, patients report that peer and primary care support are important when making TJR decisions. Patients and clinicians need new system solutions to provide individualized, patient-centered information to guide care decisions in advanced knee and hip OA. We propose to refine and test an existing web-based, individually tailored system to inform OA patient and surgeon decisions. Patients, orthopedists, physical therapists, and primary care clinicians will refine the design, content, and usability of a real-time, web-based individual OA Careplan to guide TJR and non-operative OA care decisions. The OA Careplan uses enhanced clinical information technology to deliver a real-time, decision support tool with evidence-based data to inform optimal knee and hip OA care, including TJR and non-operative strategies. The OA Careplan is based on standardized patient-reported measures. OA Careplan use and impact will be evaluated within the established FORCE-TJR orthopedic network with over 230 surgeons in 28 states. In the initial phase of the study, a random sample of 40 surgeons with 4,000 patients will receive (or not) the tailored OA Careplan. In the second phase, community-based peer and primary care physician (PCP) support will be added to the standard OA Careplan and the combined impact evaluated in another 4,000 patients. We hypothesize that the OA Careplan will improve the interaction of informed, activated patients and prepared clinicians to enhance decision process and quality and that informed decisions will improve the quality of OA care and outcomes. Second, we hypothesize that the OA Careplan plus peer and PCP support will enhance the impact. Results will guide future OA Careplan implementation to ensure optimal health care for patients with advanced knee and hip OA, and lessons can be extrapolated to other elective surgical decisions.

MeSH Terms:
  • Aged
  • Arthroplasty /*methods
  • Automation
  • Community Health Services /organization & administration
  • Decision Making
  • Decision Support Systems, Clinical
  • Decision Support Techniques
  • Disabled Persons
  • Evidence-Based Medicine
  • Humans
  • Osteoarthritis /*therapy
  • Osteoarthritis, Hip /surgery
  • Osteoarthritis, Knee /surgery
  • Pain Management
  • Primary Health Care /organization & administration
  • Program Development
  • Quality of Health Care
  • Surgical Procedures, Operative
Country: United States || United States
State: Massachusetts || Illinois
Zip Code: 01655 / 60611
UI: 20163115
CTgovId: NCT03102580
Project Status: Ongoing
Record History: ('2021: Project extended to 2024. 2020: Abstract archived and replaced; Start date changed to 2019 per PCORI due to institutional change. 2019: Project extended to 2023. 2018: Project final year changed from 2022 to 2018.',)