Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports



Status:Active, not recruiting
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:10/14/2018
Start Date:April 2014
End Date:December 2018

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Lumbar Imaging With Reporting of Epidemiology: A Pragmatic Cluster Randomized Trial

The overall goal of the Lumbar Image Reporting with Epidemiology (LIRE) is to perform a
large, pragmatic, cluster randomized controlled trial to determine the effectiveness of a
simple, inexpensive and easy to deploy intervention - insertion of epidemiological benchmarks
into lumbar spine imaging reports - at reducing subsequent tests and treatments. The
investigator's main hypothesis is that for patients referred from primary care providers,
inserting epidemiological evidence in lumbar spine imaging reports will reduce subsequent
diagnostic and therapeutic interventions, including cross-sectional imaging (MR/CT), opioid
prescriptions, spinal injections and surgery.

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.

Inclusion Criteria:

- Imaging of lumbar spine requested by primary care provider

Exclusion Criteria:

- Age < 18years
We found this trial at
4
sites
Detroit, Michigan 48202
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Detroit, MI
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Minneapolis, Minnesota
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Minneapolis, MN
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Oakland, California 94612
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Oakland, CA
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Seattle, Washington 98112
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Seattle, WA
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