Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03102580
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Patricia Franklin, University of Massachusetts, Worcester

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.


Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Osteoarthritis, Hip Other: OA Care Plan Not Applicable

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8000 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
Official Title: Patient Osteoarthritis Care Plan To Inform Optimal Treatment
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : April 16, 2021
Estimated Study Completion Date : October 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 18 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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Patricia D Franklin, MD MBA MPH 508-856-5946 patricia.franklin@northwestern.edu
Contact: Betsy M Costello, BS 855-993-6723 betsy.costello@umassmed.edu

Locations
Layout table for location information
United States, Massachusetts
University of Massachusetts Medical SChool Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Patricia D Franklin, MBA, MD, MPH         
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Layout table for investigator information
Principal Investigator: Patricia D Franklin, MD MBA MPH University of Massachusetts, Worcester

Publications:
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.

Layout table for additonal information
Responsible Party: Patricia Franklin, Professor and Director Clinical and Outcomes Research, Department of Orthopedics and Physical Rehabilitation, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03102580     History of Changes
Other Study ID Numbers: IHS-1507-31714
PCORI IHS 1507-3174 ( Other Grant/Funding Number: PCORI )
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patricia Franklin, University of Massachusetts, Worcester:
Shared Decision Making
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Hip
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases