Resolving the Burden of Low Back Pain in Military Service Members and Veterans: A Pragmatic Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Usual Care Condition
- Conditions
- Low Back Pain
- Sponsor
- Sara Gorczynski
- Enrollment
- 4039
- Locations
- 1
- Primary Endpoint
- Disability
- Status
- Active, Not Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
The RESOLVE trial will provide a pragmatic approach to evaluate whether Physical Therapy Clinical Practice Guideline adherence can reduce pain, disability and downstream healthcare utilization for low back pain within the Departments of Defense and Veterans Affairs healthcare systems.
Detailed Description
Physical therapy (PT) is frequently used for the management of low back pain (LBP) within the U.S. Departments of Defense (DoD) and Veterans Affairs (VA). However, variations in PT practice patterns and utilization of ineffective interventions lower the quality and increase the cost of care. Although, adherence to the clinical practice guidelines (CPGs) can improve outcomes and cost effectiveness of LBP care, PT CPG adherence rates remain below 50%. The RESOLVE trial will evaluate the effectiveness of an active PT CPG implementation strategy using an education/audit/feedback model for reducing pain, disability, medication use and cost of LBP care within the DoD and VA healthcare systems. The RESOLVE trial will include 3300 to 7260 patients with LBP from five DoD and VA medical facilities, using a stepped-wedge study design. An education/audit/feedback model will be used to encourage the physical therapists to better adhere to the PT CPG recommendations. The primary outcomes of disability and pain intensity will be measured with the Oswestry Disability Index and the Defense and Veterans Pain Rating Scale. Secondary outcomes will include the LBP-related medical resource utilization and biopsychosocial predictors of PT outcomes. Statistical analyses will be based on intention to treat principles and will use linear mixed models to compare treatment conditions, and examine the interactions between treatment and sub-grouping status. The RESOLVE trial will provide a pragmatic approach to evaluate whether PT CPG adherence can reduce pain, disability and downstream healthcare utilization for LBP within the DoD and VA healthcare systems.
Investigators
Sara Gorczynski
Site Principal Investigator
United States Naval Medical Center, San Diego
Eligibility Criteria
Inclusion Criteria
- •Receiving physical therapy care for low back pain in an outpatient physical therapy setting
Exclusion Criteria
- Not provided
Arms & Interventions
Usual Care Condition
During the usual care condition the therapists will be instructed "to act as usual," that is, to read the guidelines on low back pain if they have read previous published guidelines and not read these guidelines if they have not read any other guidelines.
CPG+PIPT Condition
An active Clinical Practice Guidelines (CPG) implementation strategy will be utilized with an education component in Psychologically Informed Physical Therapy (PIPT) with peer opinion leaders and a monthly audit/feedback on CPG adherence rates and patient outcomes
Intervention: Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedback
Outcomes
Primary Outcomes
Disability
Time Frame: Every two weeks over course of PT treatment, up to 12 weeks
Change in Oswestry Disability Index (ODI)
Pain Intensity
Time Frame: Every two weeks over course of PT treatment, up to 12 weeks
Change in Defense and Veterans Pain Rating Scale (DVPRS) score
Secondary Outcomes
- Healthcare Utilization(One year)
- Analgesic Medication Use(One year)