Development of an Osteoarthritis (OA) Care Plan to Improve Process and Quality of OA Treatment Decisions
Condition: Osteo Arthritis Knee; Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Hip; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Knee and hip osteoarthritis (OA) is the most common cause of disability in the U.S. and
      affects more than 60% of adults over 65 years. As the burden of knee and hip OA increases
      among aging adults, more patients are deciding to have joint replacement surgery. However, no
      clear guidelines exist for patients to determine if or when to undergo total joint
      replacement (TJR).

      The investigators plan to develop a web-based system that will provide individualized patient
      OA Care Plans that will help patients make informed decisions about how to treat their
      arthritis. The investigators will be using this system with patients to see if they find it
      useful.

      The investigators believe that the OA Care plan will improve the process and quality of OA
      treatment decisions and the quality of OA care.
    

Detailed description: 
      The investigators propose to prospectively randomize orthopedists, with their patients, to
      receive (or not) a real-time, web-based system intervention: the OA Care plan. The OA Care
      plan will include individualized, patient-centric information: (1) trended patient-reported
      OA pain and function, (2) tailored estimates of likely TJR benefits and risks based on a
      contemporary US cohort of 25,000 TJR patients (FORCE-TJR Registry), (3) evidence-based
      information for non-operative care, and (4) individual patient goals.

      Specific Aims include:

      Aim 1. Patients and their Caregivers/Trusted Others will refine the design, content, and
      usability of a real-time, web-based individual OA Care plan to guide TJR and non-operative OA
      care decisions.

      Aim 2. Randomize 26 orthopedists, and their patients, to receive the OA Care plan at the time
      of orthopedic consultation (intervention) vs. usual care (control) and compare (a) OA care
      decision process and quality and (b) quality of OA care as measured by pain relief and
      functional gain in the two arms at 6 and 12 months after the decision, and assess the impact
      of decision quality on quality of OA care.

      Aim 3. Randomize 36 orthopedists, and their patients, to receive the OA Care plan plus peer,
      family, and primary care physician support (OA Care plan+Support; intervention) vs. the OA
      Care plan alone and compare the quality of OA care decision and quality of care (pain relief,
      functional gain) in the two arms.

      Based on the components of the Chronic Care Model, this technology-delivered, individualized
      OA Care plan will enable patients and clinicians to make treatment decisions based on patient
      symptoms, goals, and comparative effectiveness evidence. The investigators hypothesize that
      OA Care plan users, as compared to usual care, will report greater decision quality for both
      TJR or non-operative care, and better quality of care (less OA pain, greater function).
      Further, the investigators anticipate incremental effectiveness of the OA Care plan+Support
      (peer, family, and primary care support) on the same outcomes. Study results will guide
      future OA Care plan implementation to assure optimal healthcare for patients with advanced
      knee and hip OA. Finally, lessons learned from the evaluation of this automated
      patient-centric decision support system can be extended beyond OA and TJR to other elective
      surgical procedures to engage informed patients to make optimal individual decisions.
    

Intervention name(s): OA Care Plan
Intervention type(s): Other
Intervention description(s): Patient and surgeon will receive the OA Care Plan (currently under development). This Care Plan will inform Shared Decision for treatment of moderate to sever OA, including surgical and non-surgical options.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Surgeon offices will be randomized to Usual Care or Intervention sites. During Aim 2, after completing the surveys in the clinic, usual care patients and surgeons will have the ability to see PRO scores, but will NOT receive feedback (no OA Care Plan). This is the current standard of care in orthopedic clinics. For intervention sites, the patient and surgeon will receive the OA Care Plan.
During Aim 3, Usual Care sites will receive the OA Care Plan, and Intervention sites will receive the Enhanced OA Care Plan, including access to Patient Peer Support website and PCP reports (currently under development). All surgeons that used the OA Care plan in Aim 2 will be invited to participate in the Enhanced OA Care plan in Aim 3.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Shared Decision Making