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临床试验/NCT02015455
NCT02015455已完成不适用

Lumbar Imaging With Reporting of Epidemiology: A Pragmatic Cluster Randomized Trial

University of Washington4 个研究点 分布在 1 个国家目标入组 250,401 人开始时间: 2013年10月1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
250,401
试验地点
4
主要终点
Relative Value Unit (RVU) for Spine-related Interventions

研究概览

简要总结

The overall goal of the Lumbar Image Reporting with Epidemiology (LIRE) is to perform a large, pragmatic, cluster randomized controlled trial to determine the effectiveness of a simple, inexpensive and easy to deploy intervention - insertion of epidemiological benchmarks into lumbar spine imaging reports - at reducing subsequent tests and treatments. The investigator's main hypothesis is that for patients referred from primary care providers, inserting epidemiological evidence in lumbar spine imaging reports will reduce subsequent diagnostic and therapeutic interventions, including cross-sectional imaging (MR/CT), opioid prescriptions, spinal injections and surgery.

详细描述

The long-term public health significance is that a simple, inexpensive intervention has the potential to substantially reduce unnecessary and expensive care for back pain patients. Importantly, this approach could be applied to a wide range of other conditions and other diagnostic tests (e.g. other imaging tests, laboratory tests, genetic testing). If this study is positive, adding epidemiologic benchmarks to diagnostic test reporting could become the dominant paradigm for communicating all diagnostic information.

To test this hypothesis, the investigators propose to conduct a pragmatic cluster, randomized controlled trial, randomly assigning primary care clinics at four large health systems to receive either standard lumbar spine imaging reports or reports containing epidemiological benchmarks for common imaging findings. The investigators will use a novel stepped wedge randomization scheme that temporally randomizes sites, allowing within-site before/after comparisons in addition to between-site comparisons, while assuring that all sites will eventually receive the intervention. The primary outcome will be a metric of back-related intervention intensity. The primary analysis will occur at the clinic level and not the patient level.

This pragmatic trial will demonstrate both the feasibility of randomly assigning clinics within large health systems as well as the feasibility of passively collecting outcomes data up to two years after enrollment using the robust electronic medical records systems available at each health system.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
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

  • Imaging of lumbar spine requested by primary care provider

排除标准

  • Age < 18years

结局指标

主要结局

Relative Value Unit (RVU) for Spine-related Interventions

时间窗: 12 months

Spine-related RVUs are a composite measure of back pain interventions that combine the overall intensity of resource utilization for back pain care in a single metric. Each spine-related procedure has an RVU associated with it representing the relative cost of the work and practice components of the procedure. The outcome measure includes the sum of the RVUs of inpatient and outpatient procedures in the year following index imaging. The Medicare conversion factor during the study period was approximately $35/RVU.

次要结局

  • Number of Participants With an Opioid Prescription Within 30 Days of Index Imaging(30 days)
  • Relative Value Unit (RVU) for Spine-related Interventions at 24 Months(24 months)
  • Number of Participants With Opioid Prescription Within 12 Months of Index Imaging(12 months)
  • Back-pain Related Estimated Payer Costs at 24 Months(24 months)
  • Number of Participants With Opioid Prescription Within 90 Days of Index Imaging(90 days)
  • Back-pain Related Estimated Payer Costs(12 months)
  • Spine- Related Surgical Interventions(24 months)
  • Number of Participants With Cross-sectional Imaging Within 12 Months of Plain Film Index Imaging(12 months)
  • Number of Participants With Cross-sectional Imaging Within 90 Days of Plain Film Index Imaging(90 days)
  • Cross-sectional Imaging at 24 Months(24 months)
  • Number of Participants With Spine Surgery Within 18 Month of Index Imaging(18 months)
  • Opioid Prescriptions at 24 Months(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey G. Jarvik, MD, MPH

Professor

University of Washington

研究点 (4)

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