Clinical trial NCT05282927: Implementing Group Physical Therapy (PT) for Veterans With Knee Osteoarthritis (Group PT): Function QUERI 2.0
Official title: Implementing a Group Physical Therapy Program for Veterans With Knee Osteoarthritis: Function QUERI 2.0 (QUE 20-023)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis of Knee
Functional Independence
Quality of Life
Implementation Science
Veterans
Group Physiotherapy
Physical Therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-03-16
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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).

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 12 months.

Eligibility criteria: 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.

Primary outcomes:
measure: Penetration
timeFrame: 7-12 months
Secondary outcomes:
measure: Fidelity
timeFrame: 7-12 months
measure: Adoption
timeFrame: 7-12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Kelli Dominick Allen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Durham VA Medical Center, Durham, NC
name: Courtney H Van Houtven, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Durham VA Medical Center, Durham, NC
name: Susan N. Hastings, MD MHSc
role: PRINCIPAL_INVESTIGATOR
References: