Clinical trial NCT02260401: Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis
Official title: Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-10-09
Enrollment: 165
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

none

Primary outcomes:
measure: Utilization of ESI
timeFrame: 24 months
Secondary outcomes:
measure: Healthcare Utilization
timeFrame: 24 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: