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OpenTrials
Completed

NCT Number: NCT03102580

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

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.

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Key information

Age range

40 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Differences in Decision Conflict Scale With ASK vs Usual Care

    Time frame: 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 outcomes

  1. Differences in Pain Relief at 6 Months After Enrollment

    Time frame: 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.

  2. Difference in Functional Gain at 6 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

Patient Osteoarthritis Care Plan To Inform Optimal Treatment

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Apr 5, 2017
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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