跳至主要内容
临床试验/NCT02260401
NCT02260401已完成不适用

Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis

University of Washington1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2013年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
165
试验地点
1
主要终点
Utilization of ESI

研究概览

简要总结

Spinal stenosis is one of the most common causes of low back pain among older adults and can result in significant disability. Despite this, it still isn't known which treatments are most effective or what outcomes are most important to these older adults. Through a Patient Centered Outcomes Research Institute (PCORI) contract, the investigators are building on the existing infrastructure of an AHRQ-funded (ARRA CHOICE award) comparative effectiveness research (CER) trial of epidural steroid injections (ESI) for spinal stenosis (the LESS trial) to address several critical research questions. The proposed study will answer the following key questions. Do decision aids tailored to older adults with spinal stenosis change patient decision-making regarding subsequent treatments? Do patients respond differently at subsequent outcome assessments time-points after receiving tailored decision aids that contain their own individual outcome data from prior treatments? The investigators hypothesize that providing these individualized reports will allow patients to make more informed choices regarding subsequent treatments, leading to reduced use of ineffective treatments and improved outcomes overall.

详细描述

LESS trial participants will be randomized to receive the individualized outcome report before the 18-month interview or after the 24-month follow up. Both groups will be asked to rank outcome domains of most importance to them, to answer questions regarding their beliefs about receiving future treatments for spinal stenosis and to complete the standard self-reported outcomes questionnaire. In addition, we will ask the study participants whether the information presented in the individualized report was helpful in deciding their future epidural injection treatments as well as if the content of the reports was easy to understand. At 24 months, we will repeat the interview and the outcomes assessment. We will again compare the groups in terms of their responses to determine if there are lasting differences in how patients who received the individualized reports make decisions regarding future treatments and respond to the self-reported outcomes questions. In addition, we will compare healthcare utilization between the two groups from 18 months to 24 months to determine if providing the individualized outcomes reports changed treatment utilization (i.e., do people who receive the report undergo fewer subsequent injections or other treatments for pain?). We hypothesize that providing these individualized reports will allow patients to make more informed choices regarding subsequent treatments, leading to reduced use of ineffective treatments and improved outcomes overall.

研究设计

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

入排标准

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

入选标准

  • Patients already enrolled in the LESS trial will be eligible for participation in the LESSER trial

排除标准

  • 未提供

研究组 & 干预措施

Individualized Reports after 24 months

No Intervention

Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.

Individualized report

Experimental

Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.

干预措施: Individualized report (Other)

结局指标

主要结局

Utilization of ESI

时间窗: 24 months

We will measure whether or not providing these individualized reports to patients impacts patients decision-making regarding use of epidural steroid injections between 18 and 24 months

次要结局

  • Healthcare Utilization(24 months)

研究者

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

Janna Friedly

Assistant Professor, Rehabilitation Medicine

University of Washington

研究点 (1)

Loading locations...

相似试验