Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports (LIRE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
| Condition | Intervention |
|---|---|
| Low Back Pain Back Pain Lumbar Pain Backache | Other: Epidemiologic benchmarks included in lumbar imaging reports |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: No masking Primary Purpose: Health Services Research |
| Official Title: | Lumbar Imaging With Reporting of Epidemiology: A Pragmatic Cluster Randomized Trial |
- Relative Value Unit (RVU) for spine-related interventions [ Time Frame: 12 months ]Composite of diagnostic and treatment interventions related to the low back pain
- Opioid prescriptions [ Time Frame: 12 months ]Opioid prescriptions at 12 months
- Cross-sectional imaging [ Time Frame: 12 months ]CT or MR imaging of the back performed on patients up to 12 months after randomization.
- Back-pain related estimated payer costs [ Time Frame: 12 months ]
- Spine- related surgical interventions [ Time Frame: 12 months ]Interventions such as injections or lumbar surgeries
- Relative Value Unit (RVU) for spine-related interventions at 24 months [ Time Frame: 24 months ]
- Opioid Prescriptions at 24 months [ Time Frame: 24 months ]
- Cross-sectional Imaging at 24 months [ Time Frame: 24 months ]
- Back-pain related estimated payer costs at 24 months [ Time Frame: 24 months ]
- Spine- related surgical interventions [ Time Frame: 24 months ]
| Estimated Enrollment: | 250000 |
| Study Start Date: | April 2014 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | October 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention Arm
Epidemiologic benchmarks included in lumbar imaging reports
|
Other: Epidemiologic benchmarks included in lumbar imaging reports
Epidemiologic benchmarks inserted into lumbar imaging reports
|
|
No Intervention: Usual Care Arm
Clinics with typical lumbar imaging reports (no epidemiologic benchmarks included)
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Imaging of lumbar spine requested by primary care provider
Exclusion Criteria:
- Age < 18years
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02015455
| United States, California | |
| Kaiser Permanente of Northern California | |
| Oakland, California, United States | |
| United States, Michigan | |
| Henry Ford Health System | |
| Detroit, Michigan, United States | |
| United States, Minnesota | |
| Mayo Clinic Health Systems | |
| Minneapolis, Minnesota, United States | |
| United States, Washington | |
| Group Health Cooperative | |
| Seattle, Washington, United States | |
| Principal Investigator: | Jeffrey G Jarvik, MD, MPH | University of Washington |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jeffrey G. Jarvik, MD, MPH, Professor, University of Washington |
| ClinicalTrials.gov Identifier: | NCT02015455 History of Changes |
| Other Study ID Numbers: |
1UH2AT007766-01 ( U.S. NIH Grant/Contract ) UH3AR066795 ( U.S. NIH Grant/Contract ) |
| Study First Received: | December 6, 2013 |
| Last Updated: | June 9, 2017 |
Keywords provided by Jeffrey G. Jarvik, MD, MPH, University of Washington:
|
pragmatic trial stepped-wedge design cluster-randomized trial |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on July 17, 2017


IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
