Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports (LIRE)

University of Washington

Status: Completed

Conditions: Back Pain; Backache; Lumbar Pain; Low Back Pain

Treatments: Other: Epidemiologic benchmarks included in lumbar imaging reports

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02015455

UH3AR066795 (U.S. NIH Grant/Contract)

44083

1UH2AT007766-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250,401 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Imaging of lumbar spine requested by primary care provider

Exclusion criteria

• Age < 18years

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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250,401 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Epidemiologic benchmarks included in lumbar imaging reports

Treatment:

Other: Epidemiologic benchmarks included in lumbar imaging reports

Usual Care Arm

No Intervention group

Description:

Clinics with typical lumbar imaging reports (no epidemiologic benchmarks included)