Knee OsteoarthritisGroup PTNCT05282927

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

A study testing Implementation Strategy: Foundational REP and Implementation Strategy: Enhanced REP (enREP) in people with Knee Osteoarthritis, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Implementation Strategy: Foundational REP and Implementation Strategy: Enhanced REP (enREP)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 21 Jun 2022to 18 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875

Other trials in United States

About this study

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

Read the 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.

Conditions: Knee Osteoarthritis
Being tested: Implementation Strategy: Foundational REP, Implementation Strategy: Enhanced REP (enREP)
Keywords: Osteoarthritis of Knee, Functional Independence, Quality of Life, Implementation Science, Veterans, Group Physiotherapy, Physical Therapy
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Implementation Strategy: Foundational REPOther
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)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.

Study groups in NCT05282927
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Implementation Strategy: Enhanced REP (enREP)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 7-12 months

Secondary outcomes (2)

Fidelity
Fidelity will be the average number of group PT sessions attended by patients who enroll in the program.
Measured: 7-12 months
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.
Measured: 7-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 202218 May 2024

First posted16 Mar 2022
Study start21 Jun 2022
Primary completion18 May 2024
Study completion18 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
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)
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05282927
Sponsor's protocol ID: QUX 21-003
Other IDs: QUE 20-023
Acronym: Group PT
Status last verified: Apr 2025
First submitted: 7 Mar 2022
Last updated: 10 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: A de-identified, anonymized dataset will be available upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will be stored \& maintained in an approved, secured location as described in the VA Research Data Inventory Form. The study statistician will create de-identified, publication-specific datasets that includes all variables presented in the study publication. 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.

Publications

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.
PubMed 41037266
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.
PubMed 37828564
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.
PubMed 36029028

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee

All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementing a Group Physical Therapy Program for Veterans With Knee Osteoarthritis: Function QUERI 2.0 (QUE 20-023)
ClinicalTrials.gov ID: NCT05282927
Acronym / sponsor ID: Group PT / QUX 21-003
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis of Knee, Functional Independence, Quality of Life, Implementation Science, Veterans, Group Physiotherapy, Physical Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 21 Jun 2022 (actual)
Primary completion: 18 May 2024 (actual)
Study completion: 18 May 2024 (actual)
First posted: 16 Mar 2022 (actual)
Results: Posted 10 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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)

Arm	Type	Receives
Foundational REP	Active comparator	Other: Implementation Strategy: Foundational REPFoundational 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.
Enhanced REP	Experimental	Other: Implementation Strategy: Enhanced REP (enREP)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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Implementation Strategy: Foundational REPThe 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.	Other	Foundational REP
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.	Other	Enhanced REP

Primary outcome

Penetration
Time frame: 7-12 months
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).

2 secondary outcomes

Fidelity
Time frame: 7-12 months
Adoption
Time frame: 7-12 months

Results and safety

Results posted to the registry on 10 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Foundational REP	–	–
Enhanced REP	–	–

Primary outcome: Penetration

Time frame: 7-12 months. Mean (Standard Deviation). Unit: patients per month

Measure	Foundational REP n = NA	Enhanced REP n = NA
Value	1.41 (1.15)	1.13 (0.94)

Foundational REP vs Enhanced REP: Mean Difference (Net): -0.05 (95% CI -1.07 to 0.98), p = 0.92, Regression, Linear

Population analysed: Data were collected at the site level. The unit of analysis for this study is VA facilities.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Analysis was at the site level and there were no possible adverse events.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Foundational REP	0 of 0	0 of 0	0
Enhanced REP	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41037266Allen 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.
Derived from this study: PubMed 37828564Webb 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.
Derived from this study: PubMed 36029028Hughes 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.
Durham VA Optimizing Function and Independence QUERILink provided by the sponsor.
Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset will be available upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will be stored \& maintained in an approved, secured location as described in the VA Research Data Inventory Form. The study statistician will create de-identified, publication-specific datasets that includes all variables presented in the study publication. 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.

Related trials for Knee Osteoarthritis

Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Penetration (time frame: 7-12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05282927, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.