Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports (LIRE)
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|ClinicalTrials.gov Identifier: NCT02015455|
Recruitment Status : Unknown
Verified October 2018 by Jeffrey G. Jarvik, MD, MPH, University of Washington.
Recruitment status was: Active, not recruiting
First Posted : December 19, 2013
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain Back Pain Lumbar Pain Backache||Other: Epidemiologic benchmarks included in lumbar imaging reports||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250000 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Lumbar Imaging With Reporting of Epidemiology: A Pragmatic Cluster Randomized Trial|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||December 2018|
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)
- 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
- Opioid prescriptions [ Time Frame: 90 days ]Opioid prescriptions at 90 days
- Opioid prescriptions [ Time Frame: 30 days ]Opioid prescriptions at 30 days
- Cross-sectional imaging [ Time Frame: 12 months ]CT or MR imaging of the back performed on patients up to 12 months after randomization.
- Cross-sectional imaging [ Time Frame: 90 days ]CT or MR imaging of the back performed on patients up to 90 days 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|