Group Physical Therapy for Knee Osteoarthritis

(Group PT Trial)

Overseen By Kelli D Allen, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Previous participation, Current group class, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 sessions

19 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kelli Dominick Allen, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Courtney H Van Houtven, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Susan N. Hastings, MD MHSc

Principal Investigator

Durham VA Medical Center, Durham, NC

Eligibility Criteria

This trial is for VA sites with staff to evaluate and lead group physical therapy, outpatient PT service, space for group sessions, and a signed agreement. Sites already offering knee OA classes or previously in Function QUERI are excluded.

Inclusion Criteria

Participating sites must submit a signed participation agreement

My healthcare facility has staff for evaluations and group classes.

My treatment center has space for group sessions.

Exclusion Criteria

The one Group PT site that previously participated in Function QUERI (ClinicalTrials.gov Identifier: NCT01058304) will be excluded from enrollment

My treatment center does not offer group classes for knee osteoarthritis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of Group PT at VA medical centers using foundational REP or enhanced REP strategies

12 months

Regular site visits and calls every 3 to 4 weeks

Treatment

Participants receive Group PT in a 6-session group outpatient program

6 sessions

Follow-up

Participants are monitored for adoption, penetration, and fidelity of the Group PT program

7-12 months

Treatment Details

Interventions

• Group Physical Therapy
• Implementation Strategy: Enhanced REP (enREP)
• Implementation Strategy: Foundational REP

Trial Overview The study tests two strategies (Foundational REP and Enhanced REP) to implement Group Physical Therapy at 16 VA sites for veterans with knee osteoarthritis using an effectiveness-implementation hybrid design framework.

Participant Groups

Group I: Enhanced REP Experimental Treatment 1 Intervention

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.

Group II: Foundational REP Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+