Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875, United States
Location status: Recruiting
Location contact
Heidi D Bassani
CONTACT
Kelli Dominick Allen, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07215572
Implementing Group Physical Therapy for Veterans with Knee Osteoarthritis (Group PT): Function QUERI 3.0 aims to compare two implementation approaches for implementing Group PT in 20 VA facilities using a type III effectiveness-implementation hybrid study framework and parallel cluster randomized trial (CRT) design.
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Durham, North Carolina, 27705-3875, United States
Location status: Recruiting
Heidi D Bassani
CONTACT
Kelli Dominick Allen, PhD
PRINCIPAL_INVESTIGATOR
Background/Purpose. Exercise-based PT is a key component of guideline concordant knee OA management. However, PT is underutilized for knee OA, resulting in missed opportunities to improve outcomes for the many Veterans with this health condition. A key challenge is the high demand for PT services for knee OA, paired with limited availability of PT services, which can lead to long wait times for Veterans or high community care costs for the VA. Group-based delivery of PT for knee OA can enhance access and efficiency. Following an RCT that supported the effectiveness of Group PT relative to individual PT, the Durham Veterans Affairs Healthcare System (DVAHCS) offered Group PT as a clinical service, and found that patients achieved clinically relevant improvements in pain and functional outcomes that were comparable to those observed in the RCT. Most recently, the investigators conducted a 19-site trial comparing implementation strategies to support delivery of Group PT in the VA. Overall, 16 sites successfully delivered a Group PT program, enrolling a total of 366 Veterans. There were clinically relevant improvements in pain interference and functional outcomes among participating Veterans.
The overall goal of this trial is to evaluate implementation of Group PT with a foundational arm versus the Reach Equity and Collective Health (REACH) arm.
Methodology. To evaluate implementation of Group PT, the investigators will randomize sites (n=20) 1:1 to either the foundational arm or the REACH arm. Implementation activities will occur over a 12-month period. The Group PT program includes 6 sessions that include exercise and educational content. Patients will be eligible for Group PT if they have a clinician diagnosis of symptomatic knee OA and ineligible if they have a substantial fall risk or co-occurring health conditions that would make participation in a group exercise class unsafe. The primary follow-up outcome time-point will be 18 months; metrics will also be evaluated at 12 months (reach, patient engagement). Implementation outcomes include 1) Reach (primary), defined as the number of patients initiating Group PT, 2) Patient Engagement, defined as the average number of sessions attended by patients who initiate the EBP, and 3) Time to Adoption, defined as the time from baseline to launching a Group PT program and enrolling 5 Veterans. Generalized linear models will be used to examine the effect of Foundational vs. REACH arms on reach and patient engagement.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Sites are eligible to participate if they have:
Patients will be eligible for Group PT if they have a clinician diagnosis of symptomatic knee OA.
Exclusion criteria
The Foundational Arm includes the following activities: Toolkit, kickoff call, SharePoint, TEAMS channel, office hours calls, site specific data reports.
The REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports and external facilitation.
Time frame: 18 months
Reach will be defined as the number of patients initiating (completing the first session of) Group PT at a site.
Time frame: 12 months
Reach will be defined as the number of patients initiating (completing the first session of) Group PT at a site.
Time frame: 18 months
Time to Adoption will be defined as the time from baseline to the time at which a site crosses the adoption threshold (Adoption will be defined as launching a Group PT program and having ≥5 Veterans initiate Group PT). This will be computed for each site meeting the adoption criteria.
Time frame: 12 months
Patient engagement will be defined as the average number of sessions attended by patients who initiate Group PT at a site.
Time frame: 18 months
Patient engagement will be defined as the average number of sessions attended by patients who initiate Group PT at a site.
Contact information is provided by the study sponsor or research team.
VA Office of Research and Development
Fed
Implementing a Group Physical Therapy Program for Veterans With Knee Osteoarthritis: Function QUERI 3.0 (QUE 25-008)
Acronym: GroupPT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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