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

NCT03102580 | Completed Results

• 2 other identifiers: IHS-1507-31714PCORI IHS 1507-3174
• Study Type: interventional
• Target: 5,713
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee; Osteoarthritis, Hip

Keywords

Shared Decision Making

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Differences in Pain Relief at 6 Months After Enrollment

  6 month followup

• Difference in Functional Gain at 6 Months

  6 month follow-up

Study Arms (2)

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.

Other: OA Care Plan

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.

Interventions

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.

OA Care Plan Intervention

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (11)

• 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.

  PMID: 24196662 BACKGROUND

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

  PMID: 17308549 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.

  PMID: 25339125 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.

  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.

  PMID: 19360453 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.

  PMID: 26488698 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.

  PMID: 26488691 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.

  PMID: 24975039 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.

  PMID: 17403800 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.

  PMID: 23209900 BACKGROUND

• 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.

  PMID: 35999585 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Patricia Franklin, MD (Professor, Medical Social Sciences and PI)
• Organization: Northwestern University Feinberg School of Medicine

patricia.franklin@northwestern.edu

312-503-4348

Study Officials

• Patricia D Franklin, MD MBA MPH

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director Clinical and Outcomes Research, Department of Orthopedics and Physical Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: January 28, 2017
• First Posted: April 5, 2017
• Study Start: November 1, 2017
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: February 2, 2026
• Results First Posted: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)