Thursday, April 25, 2024
4/25/2024
Many studies have documented deficiencies in quality of care for knee and hip osteoarthritis (OA), particularly with respect to lifestyle (e.g., weight management and exercise) and rehabilitative components, which are “strongly recommended,” first-line treatments. Primary drivers of these deficiencies in care are the lack of standardized models for OA management and the limited time available during routine clinic visits to address non-pharmacological aspects of OA care. The long-term goal of our research is to conduct a rigorous, multi- site randomized controlled trial (RCT) of a guideline-concordant OA care model, built on clinic-community partnership and designed for widespread implementation and sustainability in the U.S. The OA Clinic- Community CARE Model (OA CARE) will address all recommended components of knee / hip OA care, include interventions for both patients and primary care providers (PCPs), and utilize a tailored approach that efficiently matches treatments with patients’ needs. The patient component of OA CARE will include evidence- based weight management and exercise programs for all participants (delivered through the YMCA), as well as tailored referrals to physical therapy, additional weight management or nutrition services, sleep-related services and psychological services. The PCP component of OA CARE will include a video-based summary of current OA treatment guidelines (with emphasis on practical application), collaboration on patients’ referrals to specific services described above, and progress reports on enrolled patients. This exploratory clinical trial will achieve critical steps toward conducting a multi-site RCT of OA CARE. We will enroll 60 patients with symptomatic knee or hip OA and overweight / obesity who are not currently meeting physical activity recommendations. Participants will be randomized to OA CARE or a usual care control group. We will accomplish the following specific aims: Aim 1. Assess the feasibility and acceptability of OA CARE. Feasibility metrics will include recruitment rate, completion rates for weight loss and exercise program visits to the YMCA, utilization of tailored services and proportion of participants completing follow-up assessments. Acceptability of OA CARE will be evaluated from both patient and PCP perspectives. Aim 2. Obtain preliminary data on the efficacy of OA CARE with respect to the primary outcome of change in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. The WOMAC will be administered at baseline, 6- months and 12-months, along with secondary outcomes including body weight, physical activity, physical function, sleep and psychological measures. Outcomes will be statistically analyzed between groups across the follow-up time points using general linear mixed models.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).
