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

NCT ID: NCT07215572

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-10-01
• Study Completion Date: 2030-09-30

Brief Summary

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.

Detailed 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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Foundational Support

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.

Group Type: ACTIVE_COMPARATOR

Implementation Strategy: Foundational Support

Intervention Type: OTHER

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.

Reach+Equity Bundle

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).

Group Type: EXPERIMENTAL

Implementation Strategy: Reach+Equity Bundle

Intervention Type: OTHER

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).

Interventions

Implementation Strategy: Foundational Support

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.

Intervention Type: OTHER

Implementation Strategy: Reach+Equity Bundle

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).

Intervention Type: OTHER

Other Intervention Names

Foundational REP; Enhanced Support

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelli Dominick Allen, PhD

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center, Durham, NC

Locations

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Countries

United States

Central Contacts

Caitlin B Kappler, MSW

Role: CONTACT

Caitlin.Kappler@va.gov

(919) 286-6936

Facility Contacts

Heidi D Bassani

Role: primary

Heidi.Bassani@va.gov

(919) 286-0411

Other Identifiers

QUX 25-002

Identifier Type: -

Identifier Source: org_study_id