Development of an Osteoarthritis (OA) Care Plan to Improve Process and Quality of OA Treatment Decisions
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|ClinicalTrials.gov Identifier: NCT03102580|
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : March 12, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteo Arthritis Knee Osteoarthritis, Hip||Other: OA Care Plan||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6000 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
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.
|Masking:||None (Open Label)|
|Official Title:||Patient Osteoarthritis Care Plan To Inform Optimal Treatment|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||February 17, 2022|
|Estimated Study Completion Date :||February 17, 2023|
Experimental: 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.
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.
No Intervention: 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.
- Differences in Satisfaction with Treatment Decisions [ Time Frame: 1 month post decision ]Differences in Number of Participants with Moderate to High Satisfaction with Their Treatment Decisions using the Decisional Conflict Scale by arm
- Differences in pain relief at 6 months [ Time Frame: 6 month follow-up ]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
- Differences in functional gain at 6 months [ Time Frame: 6 month follow-up ]Differences in Pretreatment to 6-month post decision functional gain, using the HOOS or KOOS Activities of Daily Living (ADL) scale by arm
- Differences in pain relief at 12 months [ Time Frame: 12 month follow-up ]Differences in Pretreatment to 12-month post decision pain relief, using the HOOS or KOOS pain scale by arm
- Differences in functional gain at 12 months [ Time Frame: 12 month follow-up ]Differences in Pretreatment to 12-month post decision functional gain, using the HOOS or KOOS ADL scale by arm
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102580
|Contact: Patricia D Franklin, MD MBA MPHfirstname.lastname@example.org|
|Contact: Betsy M Costello, BSemail@example.com|
|United States, Massachusetts|
|University of Massachusetts Medical SChool||Recruiting|
|Worcester, Massachusetts, United States, 01655|
|Contact: Patricia D Franklin, MBA, MD, MPH|
|Principal Investigator:||Patricia D Franklin, MD MBA MPH||University of Massachusetts, Worcester|