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

NCT07215572 | Not Yet Recruiting

• 1 other identifier: QUX 25-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Veterans; Implementation Science; Functional Status; Physical Therapy; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Reach

  Reach (primary) will be defined as the number of patients initiating Group PT.

  18 months

Secondary Outcomes (8)

• Reach

  6 months

• Reach

  12 months

• Fidelity

  6 months

• Fidelity

  12 months

• Fidelity

  18 months

Other Outcomes (9)

• PROMIS Pain Interference

  6 months

• PROMIS Physical Function

  6 months

• PROMIS Pain Interference

  12 months

Study Arms (2)

Foundational Support

ACTIVE COMPARATOR

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.

Other: Implementation Strategy: Foundational Support

Reach+Equity Bundle

EXPERIMENTAL

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).

Other: Implementation Strategy: Reach+Equity Bundle

Interventions

Implementation Strategy: Foundational Support 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.

Also known as: Foundational REP

Foundational Support

Implementation Strategy: Reach+Equity Bundle 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).

Also known as: Enhanced Support

Reach+Equity Bundle

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Sites are eligible to participate if they have:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kelli Dominick Allen, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitlin B Kappler, MSW

CONTACT

(919) 286-6936; Caitlin.Kappler@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Parallel cluster-randomized trial (parallel-CRT): used in pragmatic evaluations of health program or policy interventions, where half the clusters (in this case, VA sites) are randomly assigned to two interventions: Foundational support only (active comparator) vs. Foundational support plus Reach+Equity Implementation Bundle (experimental).

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: October 10, 2025
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available upon request.
• Access Criteria: Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re- identify any individual whose data are included in the dataset.

Locations

US (1)