Development of an Osteoarthritis (OA) Care Plan to Improve Process and Quality of OA Treatment Decisions

Osteoarthritis, Hip Clinical Trial

Official title:

Patient Osteoarthritis Care Plan To Inform Optimal Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102580
• Other study ID #: IHS-1507-31714
• Secondary ID: PCORI IHS 1507-3
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: April 4, 2023

Study information

• Verified date: May 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5713
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 99 Years

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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

Katz JN. Editorial: appropriateness of total knee arthroplasty. Arthritis Rheumatol. 2014 Aug;66(8):1979-81. doi: 10.1002/art.38688. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

NIH Consensus Statement on total knee replacement. NIH Consens State Sci Statements. 2003 Dec 8-10;20(1):1-34. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in Satisfaction with Treatment Decisions	Differences in Number of Participants with Moderate to High Satisfaction with Their Treatment Decisions using the Decisional Conflict Scale by arm	1 month post decision
Primary	Differences in pain relief at 6 months	Differences in Pretreatment to 6-month post decision pain relief, using the Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee Injury and Osteoarthritis Outcome Score(KOOS) pain scale by arm	6 month follow-up
Secondary	Differences in functional gain at 6 months	Differences in Pretreatment to 6-month post decision functional gain, using the HOOS or KOOS Activities of Daily Living (ADL) scale by arm	6 month follow-up
Secondary	Differences in pain relief at 12 months	Differences in Pretreatment to 12-month post decision pain relief, using the HOOS or KOOS pain scale by arm	12 month follow-up
Secondary	Differences in functional gain at 12 months	Differences in Pretreatment to 12-month post decision functional gain, using the HOOS or KOOS ADL scale by arm	12 month follow-up