Trial Outcomes & Findings for Implementing Group Physical Therapy (PT) for Veterans With Knee Osteoarthritis (Group PT): Function QUERI 2.0 (NCT NCT05282927)
NCT ID: NCT05282927
Last Updated: 2025-04-10
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
7-12 months
Results posted on
2025-04-10
Participant Flow
VA facilities (medical centers, community based outpatient clinics, and smaller clinics) were enrolled in three successive cohorts from June 2021 to February 2023.
Unit of analysis: VA Facilities
Participant milestones
| Measure |
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.
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 (EnREP). 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.
|
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 at 9 months, 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.
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 higher intensity strategies, for sites not meeting program benchmarks (defined as EnREP), which directly influence teams' capacity and skills to effectively self-organize and problem-solve, will lead to higher implementation adoption, penetration, fidelity, and value.
|
|---|---|---|
|
Overall Study
STARTED
|
0 9
|
0 10
|
|
Overall Study
COMPLETED
|
0 9
|
0 9
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data was collected at the site level and these characteristics were not relevant and not collected.
Baseline characteristics by cohort
| Measure |
Foundational REP
n=9 VA Facilities
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.
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.
|
Enhanced REP
n=10 VA Facilities
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.
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.
|
Total
n=19 VA Facilities
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
NA VA Facilities
n=9 VA Facilities
|
NA VA Facilities
n=10 VA Facilities
|
NA VA Facilities
n=19 VA Facilities
|
|
Sex: Female, Male
Female
|
—
|
—
|
0 VA Facilities
Data was collected at the site level and these characteristics were not relevant and not collected.
|
|
Sex: Female, Male
Male
|
—
|
—
|
0 VA Facilities
Data was collected at the site level and these characteristics were not relevant and not collected.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
NA VA Facilities
n=9 VA Facilities
|
NA VA Facilities
n=10 VA Facilities
|
NA VA Facilities
n=19 VA Facilities
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
NA VA Facilities
n=9 VA Facilities
|
NA VA Facilities
n=10 VA Facilities
|
NA VA Facilities
n=19 VA Facilities
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
NA VA Facilities
n=9 VA Facilities
|
NA VA Facilities
n=10 VA Facilities
|
NA VA Facilities
n=19 VA Facilities
|
|
Region of Enrollment
United States: Northeast
|
2 VA Facilities
n=9 VA Facilities
|
2 VA Facilities
n=10 VA Facilities
|
4 VA Facilities
n=19 VA Facilities
|
|
Region of Enrollment
United States: Midwest
|
0 VA Facilities
n=9 VA Facilities
|
2 VA Facilities
n=10 VA Facilities
|
2 VA Facilities
n=19 VA Facilities
|
|
Region of Enrollment
United States: South
|
5 VA Facilities
n=9 VA Facilities
|
3 VA Facilities
n=10 VA Facilities
|
8 VA Facilities
n=19 VA Facilities
|
|
Region of Enrollment
United States: West
|
2 VA Facilities
n=9 VA Facilities
|
3 VA Facilities
n=10 VA Facilities
|
5 VA Facilities
n=19 VA Facilities
|
|
Facility Complexity
High Complexity (1a)
|
5 VA Facilities
n=9 VA Facilities
|
6 VA Facilities
n=10 VA Facilities
|
11 VA Facilities
n=19 VA Facilities
|
|
Facility Complexity
Medium-Low Complexity (1b, 1c, 2, 3)
|
4 VA Facilities
n=9 VA Facilities
|
4 VA Facilities
n=10 VA Facilities
|
8 VA Facilities
n=19 VA Facilities
|
|
Implementation Experience
Quite a lot or a fair bit
|
8 VA Facilities
n=9 VA Facilities
|
7 VA Facilities
n=10 VA Facilities
|
15 VA Facilities
n=19 VA Facilities
|
|
Implementation Experience
Some
|
1 VA Facilities
n=9 VA Facilities
|
2 VA Facilities
n=10 VA Facilities
|
3 VA Facilities
n=19 VA Facilities
|
|
Implementation Experience
Very little or none
|
0 VA Facilities
n=9 VA Facilities
|
1 VA Facilities
n=10 VA Facilities
|
1 VA Facilities
n=19 VA Facilities
|
|
Rurality
High
|
1 VA Facilities
n=9 VA Facilities
|
3 VA Facilities
n=10 VA Facilities
|
4 VA Facilities
n=19 VA Facilities
|
|
Rurality
Low
|
8 VA Facilities
n=9 VA Facilities
|
7 VA Facilities
n=10 VA Facilities
|
15 VA Facilities
n=19 VA Facilities
|
PRIMARY outcome
Timeframe: 7-12 monthsPopulation: Data were collected at the site level. The unit of analysis for this study is VA facilities.
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).
Outcome measures
| Measure |
Foundational REP
n=9 VA Facilities
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.
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.
|
Enhanced REP
n=10 VA Facilities
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.
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.
|
|---|---|---|
|
Penetration
|
1.41 patients per month
Standard Deviation 1.15
|
1.13 patients per month
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: 7-12 monthsPopulation: Data were collected at the site level. The unit of analysis for this study is VA facilities. Fidelity was only relevant to patients that attended Group PT sessions; therefore, calculations only included sites that held a Group PT class (Foundational sites = 7, Enhanced sites = 9) and capped class attendance at 6 classes maximum (although sites could allow patients to attend more than 6 classes).
Fidelity will be the average number of group PT sessions attended by patients who enroll in the program.
Outcome measures
| Measure |
Foundational REP
n=7 VA Facilities
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.
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.
|
Enhanced REP
n=9 VA Facilities
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.
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.
|
|---|---|---|
|
Fidelity
|
4.22 Classes per patient
Standard Deviation 0.90
|
5.01 Classes per patient
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: 7-12 monthsPopulation: Data were collected at the site level. The unit of analysis for this study is VA facilities. Program adoption is a binary outcome defined as delivery of Group PT as a clinical service (delivery of at least 1 Group PT class) by the VA Medical Center, and enrollment of at least 5 patients.
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.
Outcome measures
| Measure |
Foundational REP
n=9 VA Facilities
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.
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.
|
Enhanced REP
n=10 VA Facilities
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.
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.
|
|---|---|---|
|
Adoption
|
6 Number of VA facilities that adopted
|
6 Number of VA facilities that adopted
|
Adverse Events
Foundational REP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced REP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kelli Allen
Durham VA Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT)
Phone: 919-286-0411
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place