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| ID | Type | Description | Link |
|---|---|---|---|
| PCORI IHS 1507-3174 | Other Grant/Funding Number | PCORI |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OA Care Plan Intervention | Experimental | For intervention sites, the patient and surgeon will receive the OA Care Plan (currently under development). The OA Care plan with have Patient Reported Outcomes, feedback reports, and risk factors for shared decision making. |
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| Usual care | No Intervention | As collection of Patient Reported Outcomes (PROs) is considered standard of care in orthopedics (CMS mandate, Bundled Payment requirements, and reporting for Qualified Clinical Data Registry requirement for example), usual care patients and surgeons will have the ability to see PRO scores. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OA Care Plan | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Decision Conflict Scale With ASK vs Usual Care | 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. | 1 month post decision |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Pain Relief at 6 Months After Enrollment | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia D Franklin, MD MBA MPH | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24196662 | Background | Centers for Disease Control and Prevention (CDC). Prevalence of doctor-diagnosed arthritis and arthritis-attributable activity limitation--United States, 2010-2012. MMWR Morb Mortal Wkly Rep. 2013 Nov 8;62(44):869-73. | |
| 17308549 | Background | NIH Consensus Statement on total knee replacement. NIH Consens State Sci Statements. 2003 Dec 8-10;20(1):1-34. |
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There is no plan to make individual participant data available to other researchers
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | OA Care Plan Intervention | For intervention sites, the patient and surgeon received the OA Care Plan with Patient Reported Outcomes, feedback reports, and risk factors for shared decision making. |
| FG001 | Usual Care | As collection of Patient Reported Outcomes (PROs) is considered standard of care in orthopedics (CMS mandate, Bundled Payment requirements, and reporting for Qualified Clinical Data Registry requirement for example), usual care patients and surgeons will view PRO scores as presented in the electronic health record. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
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| Phase 2 |
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Adults >40 years of age with knee or hip osteoarthritis at initial evaluation by an orthopedic surgeon.
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| ID | Title | Description |
|---|---|---|
| BG000 | OA Care Plan Intervention | For intervention sites, the patient and surgeon will receive the OA Care Plan (currently under development). The OA Care plan with have Patient Reported Outcomes, feedback reports, and risk factors for shared decision making. OA Care Plan: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Differences in Decision Conflict Scale With ASK vs Usual Care | 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. | Patients >40 years of age with knee or hip osteoarthritis and initial evaluation by orthopedic surgeon. | Posted | Mean | Standard Deviation | Score on a scale | 1 month post decision |
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The 5713 enrolled patients were followed for 12 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OA Care Plan Intervention | All enrolled participants were systematically assessed for deaths, serious adverse events, and other adverse events throughout the 12-month study period via patient reports, feedback, and clinical evaluation at regular study visits. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Franklin, MD (Professor, Medical Social Sciences and PI) | Northwestern University Feinberg School of Medicine | 312-503-4348 | patricia.franklin@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2021 | Jun 25, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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.
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| 6 month followup |
| Difference in Functional Gain at 6 Months | 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. | 6 month follow-up |
| 25339125 | Background | Dowsey MM, Nikpour M, Dieppe P, Choong PF. Associations between pre-operative radiographic osteoarthritis severity and pain and function after total hip replacement : Radiographic OA severity predicts function after THR. Clin Rheumatol. 2016 Jan;35(1):183-9. doi: 10.1007/s10067-014-2808-7. Epub 2014 Oct 24. |
| Background | Nguyen US, Ayers,D.C., Li,W., Harrold L, Franklin PD. Pre-operative Pain and Function: Profiles of Selected TKR Patients among US Surgeons. Amer Coll Rheum 2014. |
| 19360453 | Background | Kurtz SM, Lau E, Ong K, Zhao K, Kelly M, Bozic KJ. Future young patient demand for primary and revision joint replacement: national projections from 2010 to 2030. Clin Orthop Relat Res. 2009 Oct;467(10):2606-12. doi: 10.1007/s11999-009-0834-6. Epub 2009 Apr 10. |
| 26488698 | Background | Katz JN. Parachutes and Preferences--A Trial of Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1668-9. doi: 10.1056/NEJMe1510312. No abstract available. |
| 26488691 | Background | Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. A Randomized, Controlled Trial of Total Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1597-606. doi: 10.1056/NEJMoa1505467. |
| 24975039 | Background | Katz JN. Editorial: appropriateness of total knee arthroplasty. Arthritis Rheumatol. 2014 Aug;66(8):1979-81. doi: 10.1002/art.38688. No abstract available. |
| 17403800 | Background | Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222. |
| 23209900 | Background | Cubukcu D, Sarsan A, Alkan H. Relationships between Pain, Function and Radiographic Findings in Osteoarthritis of the Knee: A Cross-Sectional Study. Arthritis. 2012;2012:984060. doi: 10.1155/2012/984060. Epub 2012 Nov 19. |
| 35999585 | Derived | Stern BZ, Pila S, Joseph LI, Rothrock NE, Franklin PD. Patients' perspectives on the benefits of feedback on patient-reported outcome measures in a web-based personalized decision report for hip and knee osteoarthritis. BMC Musculoskelet Disord. 2022 Aug 23;23(1):806. doi: 10.1186/s12891-022-05764-1. |
| NOT COMPLETED |
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| BG001 | Usual Care | As collection of Patient Reported Outcomes (PROs) is considered standard of care in orthopedics (CMS mandate, Bundled Payment requirements, and reporting for Qualified Clinical Data Registry requirement for example), usual care patients and surgeons will have the ability to see PRO scores. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Mean OA Pain - Knee/Hip Injury and Osteoarthritis Outcome Score (KOOS/HOOS) | Baseline pain 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. | Mean | Standard Deviation | score on a scale |
|
| OG001 | Usual Care | As collection of Patient Reported Outcomes (PROs) is considered standard of care in orthopedics (CMS mandate, Bundled Payment requirements, and reporting for Qualified Clinical Data Registry requirement for example), usual care patients and surgeons will have the ability to see PRO scores. |
|
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| Secondary | Differences in Pain Relief at 6 Months After Enrollment | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 month followup |
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|
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| Secondary | Difference in Functional Gain at 6 Months | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 month follow-up |
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| 0 |
| 4,477 |
| 0 |
| 4,477 |
| 0 |
| 4,477 |
| EG001 | Usual Care | All enrolled participants were systematically assessed for deaths, serious adverse events, and other adverse events throughout the 12-month study period via patient reports, feedback, and clinical evaluation at regular study visits. | 0 | 1,236 | 0 | 1,236 | 0 | 1,236 |
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| D012216 |
| Rheumatic Diseases |