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

NCT05282927 | Completed Results

• 2 other identifiers: QUX 21-003QUE 20-023
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis of Knee; Functional Independence; Quality of Life; Implementation Science; Veterans; Group Physiotherapy; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Penetration

  Penetration is defined as the average number of patients enrolling in the group physical therapy (PT) program on a monthly basis (defined as completing at least one class).

  7-12 months

Secondary Outcomes (2)

• Fidelity

  7-12 months

• Adoption

  7-12 months

Study Arms (2)

Foundational REP

ACTIVE COMPARATOR

Foundational REP uses the Replicating Effective Program implementation strategy and includes 5 elements that were developed and tested in our prior Function QUERI work: Stakeholder engagement; Toolkit; SharePoint access for clinical program training materials; Data dashboard to assist sites with tracking their own data; and Diffusion Networks to promote peer-to-peer sharing and implementation support.

Other: Implementation Strategy: Foundational REP

Enhanced REP

EXPERIMENTAL

EnREP begins with the same activities as foundational REP. Sites that do not meet EBP-specific a priori benchmarks reflecting adoption within 6 months will continue with foundational REP and will receive higher intensity support for a period of 6 months (enREP). Additionally, sites randomized to enREP that met adoption benchmarks but did do not meet the sustainment benchmark, will also receive intensified implementation support for the remainder of the study period (3 months). The higher intensity support will include one-on-one calls approximately every 3 to 4 weeks between site implementation teams and a trained practice facilitator (from Function QUERI team). The facilitator will coach individual sites using techniques, processes, and activities to help teams make decisions and identify and solve problems. Facilitators' actions will depend on each site's needs and clinical context.

Other: Implementation Strategy: Enhanced REP (enREP)

Interventions

Implementation Strategy: Foundational REP OTHER

The goal is to test implementation intensification approaches for group PT sites that have not met implementation adoption benchmarks, specifically Foundational REP vs. Enhanced REP. The investigators propose that low intensity implementation support that promotes adapting Group PT for context and provides tools for ongoing evaluation (defined as foundational REP), will be sufficient for some but not all sites to successfully implement group PT as a clinical service.

Foundational REP

Implementation Strategy: Enhanced REP (enREP) OTHER

The goal is to test implementation intensification approaches for sites that have not met implementation adoption benchmarks, specifically Foundational REP vs. EnREP. The investigators posit that monitoring sites' progress and adding, for sites with low adoption, higher intensity strategies (defined as EnREP) that directly influence teams' capacity and skills to effectively self-organize and problem-solve will lead to higher implementation adoption, penetration, fidelity, and value.

Enhanced REP

Eligibility Criteria

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

You may qualify if:

• Participating sites must meet the following criteria: 1) Clinical personnel on staff to conduct initial evaluations and lead group classes (e,g, physical therapist, PT assistant, kinesiotherapist): this should include at least 1 primary person and 1 back-up person to cover all aspects of program delivery, 2) Offer outpatient PT service, 3) Space to conduct group sessions (if implementing in-person Group PT classes), and (4) Submission of a signed participation agreement.
• Enrolled sites will all be exposed to Foundational REP.
• Sites not meeting benchmarks for adoption or sustainment of Group PT will receive higher-intensity implementation support (Enhanced REP).

You may not qualify if:

• The one Group PT site that previously participated in Function QUERI (ClinicalTrials.gov Identifier: NCT01058304) will be excluded from enrollment in this study.
• Sites that are currently offering a group class specifically for knee OA will not be eligible to participate.

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

Related Publications (3)

• Allen KD, Webb S, Coffman CJ, Anderson L, Cummin G, Drake C, Tucker M, Webster A, Sperber N, Zullig LL, Hughes JM, Ballengee LA, Abbate LM, Hoenig H, Fullenkamp N, Van Houtven CH, Hastings SN. Implementation of Group Physical Therapy for Knee Osteoarthritis: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2535038. doi: 10.1001/jamanetworkopen.2025.35038.

  PMID: 41037266 DERIVED

• Webb S, Drake C, Coffman CJ, Sullivan C, Sperber N, Tucker M, Zullig LL, Hughes JM, Kaufman BG, Pura JA, Anderson L, Hastings SN, Van Houtven CH, Abbate LM, Hoenig H, Ballengee LA, Wang V, Allen KD. Group physical therapy for knee osteoarthritis: protocol for a hybrid type III effectiveness-implementation trial. Implement Sci Commun. 2023 Oct 12;4(1):125. doi: 10.1186/s43058-023-00502-7.

  PMID: 37828564 DERIVED

• Hughes JM, Zullig LL, Choate AL, Decosimo KP, Wang V, Van Houtven CH, Allen KD, Nicole Hastings S. Intensification of Implementation Strategies: Developing a Model of Foundational and Enhanced Implementation Approaches to Support National Adoption and Scale-up. Gerontologist. 2023 Mar 21;63(3):604-613. doi: 10.1093/geront/gnac130.

  PMID: 36029028 DERIVED

Related Links

• Durham VA Optimizing Function and Independence QUERI

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Kelli Allen
• Organization: Durham VA Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT)

Kelli.Allen@va.gov

919-286-0411

Study Officials

• Kelli Dominick Allen, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

• Courtney H Van Houtven, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

• Susan N. Hastings, MD MHSc

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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 medical centers) are randomly assigned to two interventions: Foundational REP (active comparator) vs. Enhanced REP (experimental)

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: June 21, 2022
• Primary Completion: May 18, 2024
• Study Completion: May 18, 2024
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• 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)