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

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05282927

Collaborator

(none)

Enrollment

Location

Arms

39.3

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Other: Implementation Strategy: Foundational REP Other: Implementation Strategy: Enhanced REP (enREP)	N/A

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 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.

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 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 (n=16) 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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)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)

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jun 21, 2022

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Sep 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Foundational REP 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 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.
Experimental: Enhanced REP 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 consist of 3 to 4 tailored modules including a barrier/needs assessment and facilitation, a process of interactive problem solving and support that occurs in a context of a supportive interpersonal relationship. Facilitators will follow a table specifying identified barriers to implementation, along with potential aligned strategies to overcome the barriers, and examples in the context of the EBP. Facilitation will be provided by Function QUERI team members.	Other: 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.

Arm

Intervention/Treatment

Active Comparator: Foundational REP

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

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.

Experimental: Enhanced REP

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 consist of 3 to 4 tailored modules including a barrier/needs assessment and facilitation, a process of interactive problem solving and support that occurs in a context of a supportive interpersonal relationship. Facilitators will follow a table specifying identified barriers to implementation, along with potential aligned strategies to overcome the barriers, and examples in the context of the EBP. Facilitation will be provided by Function QUERI team members.

Other: 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.

Outcome Measures

Primary Outcome Measures

Penetration [12 months (cumulative)]
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).

Secondary Outcome Measures

Fidelity [12 months (cumulative)]
Fidelity will be the average number of group PT sessions attended by patients who enroll in the program.
Adoption [12 months (cumulative)]
Adoption will be defined as: 1) Delivery of Group PT as a clinical service by the VA Medical Center, 2) Enrollment of at least 10 patients (indicating a reasonable flow of patients during an early implementation phase), and 3) Including at least 5 new patients within the last 2 months of a 6-month period (indicating continued implementation rather than early adoption followed by discontinuation).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participating sites must meet the following criteria: at least 2 outpatient physical therapists, and space to conduct group sessions (which is typically available at any site that delivers outpatient PT). 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durham VA Medical Center, Durham, NC	Durham	North Carolina	United States	27705

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator: 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