跳至主要内容
临床试验/NCT04494490
NCT04494490进行中(未招募)不适用

Resolving the Burden of Low Back Pain in Military Service Members and Veterans: A Pragmatic Clinical Trial

Sara Gorczynski1 个研究点 分布在 1 个国家目标入组 4,039 人开始时间: 2021年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
4,039
试验地点
1
主要终点
Disability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Receiving physical therapy care for low back pain in an outpatient physical therapy setting

排除标准

  • 未提供

研究组 & 干预措施

Usual Care Condition

No Intervention

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

Active Comparator

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

干预措施: Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedback (Behavioral)

结局指标

主要结局

Disability

时间窗: Every two weeks over course of PT treatment, up to 12 weeks

Change in Oswestry Disability Index (ODI)

Pain Intensity

时间窗: Every two weeks over course of PT treatment, up to 12 weeks

Change in Defense and Veterans Pain Rating Scale (DVPRS) score

次要结局

  • Healthcare Utilization(One year)
  • Analgesic Medication Use(One year)

研究者

发起方
Sara Gorczynski
申办方类型
Fed
责任方
Sponsor Investigator
主要研究者

Sara Gorczynski

Site Principal Investigator

United States Naval Medical Center, San Diego

研究点 (1)

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