Implementing Group Physical Therapy (PT) for Veterans With Knee Osteoarthritis (Group PT): Function QUERI 2.0 — Group PT  

Knee Osteoarthritis Clinical Trial

Official title: Implementing a Group Physical Therapy Program for Veterans With Knee Osteoarthritis: Function QUERI 2.0 (QUE 20-023)

Status Active, not recruiting

Clinical Trial Summary

Implementing Group Physical Therapy (PT) for Veterans with Knee Osteoarthritis (OA): Function QUERI 2.0 (Group PT) aims to implement, evaluate and sustain Group PT in 16 VA sites using a type III effectiveness-implementation hybrid design framework, which will compare implementation strategies while also gathering information about the clinical intervention and related outcomes.

Clinical Trial Description

Knee OA is a common and often disabling health condition that affects 14 million people in the US, and rates are about twice as high among Veterans than the general population. Forty-three percent of VA healthcare users report a diagnosis of arthritis (primarily OA), and of these, 63% report activity limitations due to joint symptoms. The prevalence of OA is expected to rise dramatically over the next several decades, and this will place increasing demand on the VA to provide core, evidence-based components of knee OA care, including PT. Many of the negative effects of knee OA can be successfully mitigated through PT, a recommended core component of treatment; however, many VA healthcare users with knee OA do not receive PT, and a key barrier is the high demand for PT services in the VA. Therefore, it is important to implement efficient, effective models of physical therapy care delivery for Veterans with knee OA.

Group PT for knee osteoarthritis (OA) is a 6-session group outpatient program developed by an interdisciplinary team of investigators, clinicians and administrators at the Durham VA and funded by the VA Quality Enhancement Research Initiative (QUE 20-023). In a previously conducted (at the Durham VA) randomized controlled trial (RCT) comparing group-based PT vs. traditional individual PT for knee OA, group PT resulted in equivalent or greater improvements in pain and functional outcomes compared with individual PT. This is important because the group-based model provides care to more Veterans with fewer staffing resources, thereby increasing access and efficiency.

In this trial, the investigators plan to implement the group PT clinical program at a minimum of 16 VA medical centers using a type III effectiveness-implementation hybrid design framework ,with sites enrolled and randomized to receive standard implementation support (foundational Replicating Effective Programs or foundational REP) or a higher-intensity implementation support (enhanced REP), including additional facilitation, self-organization, and team building support for sites that do not meet adoption goals at 6 months or sustainment goals at 9 months.

Objectives. The investigators plan to develop scalable approaches to implement and sustain Group PT as well as evaluate implementation with foundational REP versus the enhanced-implementation strategy (enhanced REP).

Key questions: What are stakeholder perspectives on key resources required for program delivery and sustainability? What are appropriate adaptations including incorporation of telehealth within Group PT? Are there differences in implementation outcomes (adoption, penetration, fidelity) at 6 and 12 months (primary) between arms? What are effectiveness outcomes (function, pain) at implementing sites? How do sites experience implementation strategies in each arm? What baseline organizational characteristics are associated with sites that don't meet adoption benchmarks? The investigators also plan to conduct an explanatory sequential mixed method design that includes qualitative data collection and analysis that will not be reported here.

Methodology. To evaluate implementation, the investigators will randomize sites 1:1 to either foundational REP or enhanced REP (enREP). The investigators will use generalized linear models to examine the effect of foundational vs. enhanced REP on implementation outcomes at 6 and 12 months. ;

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT05282927
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 21, 2022
• Completion date: September 30, 2025