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

Implementing a Group Physical Therapy Program for Veterans With Knee Osteoarthritis: Function QUERI 3.0 (QUE 25-008)

Implementing Group Physical Therapy for Veterans with Knee Osteoarthritis (Group PT): Function QUERI 3.0 aims to compare two implementation approaches for implementing Group PT in 20 VA facilities using a type III effectiveness-implementation hybrid study framework and parallel cluster randomized trial (CRT) design.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Implementation Strategy: Foundational Arm; Other: Implementation Strategy: REACH Arm

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 an 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.

The overall goal of this trial is to evaluate implementation of Group PT with a foundational arm versus the Reach Equity and Collective Health (REACH) arm.

Methodology. To evaluate implementation of Group PT, the investigators will randomize sites (n=20) 1:1 to either the foundational arm or the REACH arm. Implementation activities will occur over a 12-month period. The Group PT program 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 12 months (reach, patient engagement). Implementation outcomes include 1) Reach (primary), defined as the number of patients initiating Group PT, 2) Patient Engagement, defined as the average number of sessions attended by patients who initiate the EBP, and 3) Time to Adoption, defined as the time from baseline to launching a Group PT program and enrolling 5 Veterans. Generalized linear models will be used to examine the effect of Foundational vs. REACH arms on reach and patient engagement.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caitlin B Kappler, MSW; Phone Number: (919) 286-6936; Email: Caitlin.Kappler@va.gov

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705-3875
      • Recruiting
      • Durham VA Medical Center, Durham, NC
      • Contact: Heidi D Bassani; Phone Number: (919) 286-0411; Email: Heidi.Bassani@va.gov
      • Principal Investigator: Kelli Dominick Allen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REACH (Reach Equity And Collective Health) Arm; The REACH Arm will include the same activities as the foundational arm plus REACH activities: 1) external facilitation and 2) equity-focused data-driven monitoring.	Other: Implementation Strategy: REACH Arm; The REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports and external facilitation.
Active Comparator: Foundational Arm; Foundational Arm uses the Replicating Effective Program (REP) implementation strategy and includes 3 elements that were developed and tested in our prior Function QUERI work: program initiation, self-guided resources, and technical assistance.	Other: Implementation Strategy: Foundational Arm; The Foundational Arm includes the following activities: Toolkit, kickoff call, SharePoint, TEAMS channel, office hours calls, site specific data reports.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach	Reach will be defined as the number of patients initiating (completing the first session of) Group PT at a site.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach	Reach will be defined as the number of patients initiating (completing the first session of) Group PT at a site.	12 months
Time to Adoption	Time to Adoption will be defined as the time from baseline to the time at which a site crosses the adoption threshold (Adoption will be defined as launching a Group PT program and having ≥5 Veterans initiate Group PT). This will be computed for each site meeting the adoption criteria.	18 months
Patient Engagement	Patient engagement will be defined as the average number of sessions attended by patients who initiate Group PT at a site.	12 months
Patient Engagement	Patient engagement will be defined as the average number of sessions attended by patients who initiate Group PT at a site.	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Pain Interference	A self-reported measure that captures the consequences of pain on relevant aspects of life, including engagement with social, cognitive, emotional, physical, and recreational activities. Lower scores are better, indicating less pain interference. The investigators will use the PROMIS v1.1 Pain Interference Short form 4a.	6 months
PROMIS Physical Function	A self-reported measure that captures the difficulty of performing instrumental activities of daily living. Higher scores are better, indicating more physical function. The investigators will use the PROMIS Short form 4a PROMIS v2.0 Physical Function Short form 4a.	6 months
PROMIS Pain Interference	A self-reported measure that captures the consequences of pain on relevant aspects of life, including engagement with social, cognitive, emotional, physical, and recreational activities. Lower scores are better, indicating less pain interference. The investigators will use the PROMIS v1.1 Pain Interference Short form 4a.	12 months
PROMIS Pain Interference	A self-reported measure that captures the consequences of pain on relevant aspects of life, including engagement with social, cognitive, emotional, physical, and recreational activities. Lower scores are better, indicating less pain interference. The investigators will use the PROMIS v1.1 Pain Interference Short form 4a.	18 months
PROMIS Physical Function	A self-reported measure that captures the difficulty of performing instrumental activities of daily living. Higher scores are better, indicating more physical function. The investigators will use the PROMIS Short form 4a PROMIS v2.0 Physical Function Short form 4a.	12 months
PROMIS Physical Function	A self-reported measure that captures the difficulty of performing instrumental activities of daily living. Higher scores are better, indicating more physical function. The investigators will use the PROMIS Short form 4a PROMIS v2.0 Physical Function Short form 4a.	18 months
30-second Chair Stand Test	Number of times patient can stand up from a seated position and sit back down within 30 seconds.	6 months
30-second Chair Stand Test	Number of times patient can stand up from a seated position and sit back down within 30 seconds.	12 months
30-second Chair Stand Test	Number of times patient can stand up from a seated position and sit back down within 30 seconds.	18 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Kelli Dominick Allen, PhD, Durham VA Medical Center, Durham, NC

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2026
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: October 6, 2025
• First Submitted That Met QC Criteria: October 6, 2025
• First Posted (Actual): October 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; Veterans; Physical Therapy; Implementation Science; Functional Status
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: QUX 25-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A de-identified, anonymized dataset will be available upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will be stored & maintained in an approved, secured location as described in the VA Research Data Inventory Form. The statistician will create de-identified, publication-specific datasets that include variables from statistical models presented in publication. 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 is included in the dataset.
• IPD Sharing Time Frame: Available upon request.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No