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临床试验/NCT03523793
NCT03523793已完成不适用

Health System Implementation of Clinical Practice Guidelines for Neck and Low Back Pain in Outpatient Physical Therapy Settings

University of Florida2 个研究点 分布在 1 个国家目标入组 1,441 人开始时间: 2018年8月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,441
试验地点
2
主要终点
Numeric Pain Rating Scale (NPRS)

研究概览

简要总结

This study will investigate implementation of a process to enhance Clinical Practice Guideline (CPG) adherence to limit unwarranted variability in initial treatment decisions with high potential for providing more effective and efficient physical therapy management for patients with neck and low back pain.

详细描述

Effective implementation of CPGs to augment initial clinical decision making during physical therapy management of patients with spine related musculoskeletal pain will have several important goals: 1) improve patient pain and disability outcomes, 2) limit over utilization of physical therapy services, and 3) increase adherence to limit unwarranted variation in clinical practice. This proposed pilot study proposal will test if a multifaceted intervention strategy for implementation of neck and low back CPG meets these goals and provide necessary data for larger system wide implementation efforts.

Specific Aim 1: Determine if physical therapy clinics that receive neck and low back pain (LBP) clinical practice guideline (CPG) training are associated with improved patient outcomes compared to those that have not received training. Neck and LBP specific disability and pain intensity will be assessed at intake, on a weekly basis and at discharge (Specific Aim 1a). Secondary patient outcomes will consist of patient satisfaction scores (Specific Aim 1b). Statistical analyses will evaluate for temporal effects of training considering the stepped wedge study design.

Specific Aim 2: Determine if multifaceted interventions for CPG implementation positively impacts physical therapist beliefs, attitudes, knowledge and behaviors over time. CPG adherence (by clinicians) will be indirectly assessed using quantitative and qualitative methods consisting of: 1) clinician checklists, 2) clinician questionnaires, 3) quality indicators, and 4) total proportion outcome measure assessments (Specific Aim 2).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Receiving outpatient physical therapy for a diagnosis covered in previously published CPGs for neck or LBP
  • Able to read and comprehend English language (necessary for completion of self-report e-forms)

排除标准

  • Any diagnosis indicating systemic involvement
  • Widespread chronic pain syndrome
  • Neuropathic pain syndromes
  • Neurological disorders.

结局指标

主要结局

Numeric Pain Rating Scale (NPRS)

时间窗: 68 weeks

Numeric Pain Rating Scale (NPRS) Pain intensity will be rated using a NPRS, ranging from "0" (no pain) to "10" (worst pain imaginable). Patients will be asked to rate their current pain intensity, as well as their best and worst level of pain intensity over the past 24 hours. These 3 pain ratings will averaged and used as the NPRS variable in this study.

Oswestry Disability Index (ODI)

时间窗: 68 weeks

The Oswestry Disability Index (ODI), which has 10 items that assesses how low back pain affects common daily activities. The ODI has a range of 0% "no disability due to low back pain" to 100% "completely disabled due to low back pain", with higher scores indicating higher disability from low back pain.

Neck Disability Index (NDI)

时间窗: 68 weeks

The Neck Disability Index (NDI), which has 10 items that assesses how neck pain affects common daily activities. The NDI has a range of 0% "no disability due to neck pain" to 100% "completely disabled due to neck pain", with higher scores indicating higher disability from neck pain.

次要结局

  • Rehabilitation Outpatient Division Patient Satisfaction Survey(68 weeks)
  • Evidence-Based Practice Questionnaire (EBPQ)(68 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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