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

University of Massachusetts, Worcester

Status: Completed

Conditions: Osteoarthritis, Hip; Osteo Arthritis Knee

Treatments: Other: OA Care Plan

Study type: Interventional

Funder types: Other

Identifiers

NCT03102580

PCORI IHS 1507-3174 (Other Grant/Funding Number)

IHS-1507-31714

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,713 patients

Sex: All

Ages: 40 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,713 participants in 2 patient groups

OA Care Plan Intervention

Experimental group

Description:

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.

Treatment:

Other: OA Care Plan

Usual care

No Intervention group

Description:

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.