Osteoarthritis, Hip, Osteo Arthritis Knee
Conditions
Keywords
Shared Decision Making
Brief 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.
Interventions
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.
Sponsors
Study design
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.
Eligibility
Inclusion criteria
* All new patients to participating surgeon's practice for the purpose of evaluation of knee or hip OA are possible participants. * Patients must be 40 years of age or older and able to provide informed consent.
Exclusion criteria
* Inflammatory arthritis, such as rheumatoid or psoriatic arthritis * Recent knee or hip injury as purpose for visit * Pregnant women * Prisoners * Non-English speaking subjects- As we are refining and testing a web-based system intervention that provides individualized patient OA Care plans to improved shared decision making between patients and providers, for research purposes we must assure that the 'counseling' between the surgeon and patient will be in their native language. Once we have identified what materials work at the end of the study, we will translate materials into Spanish.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Decision Conflict Scale With ASK vs Usual Care | 1 month post decision | The Decision Conflict Scale (DCS) is a validated self-report instrument that assesses uncertainty in healthcare decision making. The DCS consists of 16 items, each rated on a 5-point Likert scale. Scores are summed and transformed to a total score from 0 (no conflict) to 100 (high conflict). Lower scores indicate less decisional conflict (better outcome), and higher scores reflect greater decisional conflict (worse outcome). Mean (standard deviation) DCS scores are reported by study arm/group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Pain Relief at 6 Months After Enrollment | 6 month followup | Pain relief was assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS) for knee OA patients and the Hip disability and Osteoarthritis Outcome Score (HOOS) for hip OA patients. The HOOS/KOOS is a broadly used 100 point scale (0-100) with 100 reflecting the maximum score and best health status for OA patients. The items are combined into two health domains: Pain and ADL (function/activities of daily living). The pain and ADL domains are scored 0-100 independently (with 100 reflecting the best health status for either pain or ADL). The domains scores are not additive. |
| Difference in Functional Gain at 6 Months | 6 month follow-up | Functional gain was assessed using the Activities of Daily Living (ADL) domain of the Knee injury and Osteoarthritis Outcome Score (KOOS) for knee OA, and the Hip disability and Osteoarthritis Outcome Score (HOOS) for hip OA. The HOOS/KOOS is a broadly used 100 point scale (0-100) with 100 reflecting the maximum score and best health status for OA patients. The items are combined into two health domains: Pain and ADL (function/activities of daily living). The pain and ADL domains are scored 0-100 independently (with 100 reflecting the best health status for either pain or ADL). The domains scores are not additive. |
Countries
United States
Contacts
Northwestern University Feinberg School of Medicine
Participant flow
Recruitment details
The study recruited diverse settings and patients by (1) location, (2) practice type, and (3) patient volume. Thirteen sites and 36 surgeons enrolled 5713 patients. Sites were situated in 11 states, 6 were non-academic sites (50%). Patients were \> 40 years of age and provided consent in English or Spanish; had a primary diagnosis of OA in a hip or knee and reported moderate or severe pain or functional limitation on the joint-specific standardized PROs included in the ASK assessment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.6 years STANDARD_DEVIATION 9.4 |
| Mean OA Pain - Knee/Hip Injury and Osteoarthritis Outcome Score (KOOS/HOOS) | 39.3 score on a scale STANDARD_DEVIATION 16.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 9 Participants |
| Race (NIH/OMB) Asian | 28 Participants |
| Race (NIH/OMB) Black or African American | 335 Participants |
| Race (NIH/OMB) More than one race | 111 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 28 Participants |
| Race (NIH/OMB) White | 4998 Participants |
| Sex: Female, Male Female | 3495 Participants |
| Sex: Female, Male Male | 1738 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4,477 | 0 / 1,236 |
| other Total, other adverse events | 0 / 4,477 | 0 / 1,236 |
| serious Total, serious adverse events | 0 / 4,477 | 0 / 1,236 |