NCT02015455

Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250,401 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Low Back Pain
• Back Pain
• Lumbar Pain
• Backache

Interventions

Type	Name	Description
OTHER	Epidemiologic benchmarks included in lumbar imaging reports	Epidemiologic benchmarks inserted into lumbar imaging reports

Timeline

• Start date: 2013-10-01
• Primary completion: 2018-12-14
• Completion: 2018-12-14
• First posted: 2013-12-19
• Last updated: 2022-02-14
• Results posted: 2022-02-14

Locations

4 sites across 1 country: United States