Implementing a Group Physical Therapy Program for Veterans (GroupPT): Function QUERI 3.0

VA Office of Research and Development

Status: Begins enrollment in 7 months

Conditions: Knee Osteoarthritis

Treatments: Other: Implementation Strategy: Reach+Equity Bundle; Other: Implementation Strategy: Foundational Support

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT07215572

QUX 25-002

Details and patient eligibility

About

Implementing Group Physical Therapy for Veterans with Knee Osteoarthritis (Group PT): Function QUERI 3.0 aims to compare implementation approaches while also gathering information on clinical effects of the EBP in its new context. The overall goal is to address a key priority within the implementation science field - identifying and refining metrics for equity and impact. The overall goal is to implement, evaluate, and sustain GroupPT in 20 VA facilities using a type III effectiveness-implementation hybrid study framework and parallel CRT design.

Full description

Background/Purpose. Exercise-based PT is a key component of guideline concordant knee OA management. However, PT is underutilized for knee OA, resulting in missed opportunities to improve outcomes for the many Veterans with this health condition. A key challenge is the high demand for PT services for knee OA, paired with limited availability of PT services, which can lead to long wait times for Veterans or high community care costs for the VA. Group-based delivery of PT for knee OA can enhance access and efficiency. Following the RCT that supported the effectiveness of Group PT relative to individual PT, the Durham Veterans Affairs Healthcare System (DVAHCS) offered Group PT as a clinical service, and found that patients achieved clinically relevant improvements in pain and functional outcomes that were comparable to those observed in the RCT. Most recently, the investigators conducted a 19-site trial comparing implementation strategies to support delivery of Group PT in the VA. Overall, 16 sites successfully delivered a Group PT program, enrolling a total of 366 Veterans. There were clinically relevant improvements in pain interference and functional outcomes among participating Veterans.

Aims:

Aim 1: Refine foundational REP and Reach+Equity to support implementation of Group PT.

Key Questions: How can the Reach+Equity bundle be optimized to facilitate equitable reach? What are shareholder perspectives on refinements needed for Group PT foundational REP activities, as well as strategies to enhance equitable reach (Reach+Equity bundle)? Aim 2: Evaluate implementation of Group PT with foundational REP versus foundational REP and Reach+Equity. Key Questions: Are there differences in implementation outcomes (reach, fidelity, adoption, cost) at six, 12 and 18 months between arms? Is reach representative of patients experiencing knee OA at participating sites (equitable reach) and does this differ between foundational REP and Reach+Equity arms? Are there differences in effectiveness outcomes (function, pain) between arms? How do sites experience implementation strategies in each arm?

Methodology. To evaluate implementation of Group PT (Aim 2), the investigators will randomize sites (n=20) 1:1 to either foundational support or foundational support plus the Reach+Equity bundle. Implementation activities will occur over a 12-month period. Foundational REP will feature an extensive Implementation Toolkit that includes specific guidance for EBP delivery (e.g., flow of the class, specific exercises, didactic content), along with comprehensive patient resources including videos to guide home exercise. The Reach+Equity bundle will include: 1) external facilitation (provide an outside perspective to help sites identify barriers, develop effective strategies, and navigate complex change processes particularly through the lens of achieving equitable reach); 2) equity in implementation toolkit (guide that supports awareness and consideration of health equity during the implementation process); and 3) equity-focused data-driven monitoring (inform progress regarding equitable reach-related goals). The Group PT sessions includes 6 sessions that include exercise and educational content. Patients will be eligible for Group PT if they have a clinician diagnosis of symptomatic knee OA and ineligible if they have a substantial fall risk or co-occurring health conditions that would make participation in a group exercise class unsafe. The primary follow-up outcome time point will be 18 months; metrics will also be evaluated at 6 and 12 months. Implementation outcomes include: Reach (primary), defined as the number of patients initiating Group PT, Fidelity, defined as the average number of sessions attended by patients who initiate the EBP, and Adoption, defined as launching a Group PT program and enrolling 5 Veterans. Effectiveness Outcomes/Quality Metrics will be collected during the Group PT sessions and documented in the electronic health record. These outcomes include the PROMIS Pain Interference and Function scales, a 30-second chair stand test, and patient satisfaction. Generalized linear models will be used to examine the effect of foundational vs. Reach+Equity on reach and fidelity. Generalized linear mixed effect models will be used to compare effective outcomes between implementation arms.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Sites are eligible to participate if they have:

• 2 outpatient PT clinicians (one primary and one back-up) for delivering Group PT
• space to conduct group sessions (if delivering Group PT in person) or ability to conduct visits via telehealth (video)

Patients will be eligible for Group PT if they have a clinician diagnosis of symptomatic knee OA.

Exclusion criteria

• Site will be ineligible to participate if they are already conducting a group physical therapy class for patients with knee OA.
• Patients will be ineligible for Group PT if they have a substantial fall risk or co-occurring health conditions that would make participation in a group exercise class unsafe.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Foundational Support

Active Comparator group

Description:

Foundational Support uses the Replicating Effective Program (REP) implementation strategy and includes 5 elements that were developed and tested in our prior Function QUERI work: shareholder engagement, Group PT toolkit, Online shared resources (SharePoint) access for clinical program training materials, data reports to assist sites with tracking their data, and Diffusion Networks to promote peer-to-peer sharing and implementation support.

Treatment:

Other: Implementation Strategy: Foundational Support

Reach+Equity Bundle

Experimental group

Description:

The Reach+Equity bundle will include the same activities as foundational support plus the Reach+Equity bundle activities which include: 1) external facilitation (provide an outside perspective to help sites identify barriers, develop effective strategies, and navigate complex change processes particularly through the lens of achieving equitable reach); 2) equity in implementation toolkit (guide that supports awareness and consideration of health equity during the implementation process); and 3) equity-focused data-driven monitoring (inform progress regarding equitable reach-related goals).

Treatment:

Other: Implementation Strategy: Reach+Equity Bundle