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

Knee Osteoarthritis Clinical Trial

— Group PT  

Official title:

Implementing a Group Physical Therapy Program for Veterans With Knee Osteoarthritis: Function QUERI 2.0 (QUE 20-023)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05282927
• Other study ID #: QUX 21-003
• Secondary ID: QUE 20-023
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: June 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Knee OA is a common and often disabling health condition that affects 14 million people in the US, and rates are about twice as high among Veterans than the general population. Forty-three percent of VA healthcare users report a diagnosis of arthritis (primarily OA), and of these, 63% report activity limitations due to joint symptoms. The prevalence of OA is expected to rise dramatically over the next several decades, and this will place increasing demand on the VA to provide core, evidence-based components of knee OA care, including PT. Many of the negative effects of knee OA can be successfully mitigated through PT, a recommended core component of treatment; however, many VA healthcare users with knee OA do not receive PT, and a key barrier is the high demand for PT services in the VA. Therefore, it is important to implement efficient, effective models of physical therapy care delivery for Veterans with knee OA.

Group PT for knee osteoarthritis (OA) is a 6-session group outpatient program developed by an interdisciplinary team of investigators, clinicians and administrators at the Durham VA and funded by the VA Quality Enhancement Research Initiative (QUE 20-023). In a previously conducted (at the Durham VA) randomized controlled trial (RCT) comparing group-based PT vs. traditional individual PT for knee OA, group PT resulted in equivalent or greater improvements in pain and functional outcomes compared with individual PT. This is important because the group-based model provides care to more Veterans with fewer staffing resources, thereby increasing access and efficiency.

In this trial, the investigators plan to implement the group PT clinical program at a minimum of 16 VA medical centers using a type III effectiveness-implementation hybrid design framework ,with sites enrolled and randomized to receive standard implementation support (foundational Replicating Effective Programs or foundational REP) or a higher-intensity implementation support (enhanced REP), including additional facilitation, self-organization, and team building support for sites that do not meet adoption goals at 6 months or sustainment goals at 9 months.

Objectives. The investigators plan to develop scalable approaches to implement and sustain Group PT as well as evaluate implementation with foundational REP versus the enhanced-implementation strategy (enhanced REP).

Key questions: What are stakeholder perspectives on key resources required for program delivery and sustainability? What are appropriate adaptations including incorporation of telehealth within Group PT? Are there differences in implementation outcomes (adoption, penetration, fidelity) at 6 and 12 months (primary) between arms? What are effectiveness outcomes (function, pain) at implementing sites? How do sites experience implementation strategies in each arm? What baseline organizational characteristics are associated with sites that don't meet adoption benchmarks? The investigators also plan to conduct an explanatory sequential mixed method design that includes qualitative data collection and analysis that will not be reported here.

Methodology. To evaluate implementation, the investigators will randomize sites 1:1 to either foundational REP or enhanced REP (enREP). The investigators will use generalized linear models to examine the effect of foundational vs. enhanced REP on implementation outcomes at 6 and 12 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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).

• The clinical outcomes assessment will include all patients enrolled in Group PT that meet inclusion criteria (clinical diagnosis of knee OA).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Implementation Strategy: Foundational REP
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.
• Implementation Strategy: Enhanced REP (enREP)
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.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 months (cumulative)
Secondary	Fidelity	Fidelity will be the average number of group PT sessions attended by patients who enroll in the program.	12 months (cumulative)
Secondary	Adoption	Adoption will be defined as: 1) Delivery of Group PT as a clinical service (delivery of at least 1 Group PT class) by the VA Medical Center, and 2) Enrollment of at least 5 patients within a 6-month period.	12 months (cumulative)

External Links

•   Durham VA Optimizing Function and Independence QUERI