Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2013 |
| End Date: | September 2015 |
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.
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.
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.
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.
Inclusion Criteria:
Patients already enrolled in the LESS trial will be eligible for participation in the
LESSER trial
Exclusion Criteria:
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