Lumbar Imaging With Reporting of Epidemiology: A Pragmatic Cluster Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 250,401
- Locations
- 4
- Primary Endpoint
- Relative Value Unit (RVU) for Spine-related Interventions
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Imaging of lumbar spine requested by primary care provider
Exclusion Criteria
- •Age < 18years
Arms & Interventions
Intervention Arm
Epidemiologic benchmarks included in lumbar imaging reports
Intervention: Epidemiologic benchmarks included in lumbar imaging reports (Other)
Usual Care Arm
Clinics with typical lumbar imaging reports (no epidemiologic benchmarks included)
Outcomes
Primary Outcomes
Relative Value Unit (RVU) for Spine-related Interventions
Time Frame: 12 months
Spine-related RVUs are a composite measure of back pain interventions that combine the overall intensity of resource utilization for back pain care in a single metric. Each spine-related procedure has an RVU associated with it representing the relative cost of the work and practice components of the procedure. The outcome measure includes the sum of the RVUs of inpatient and outpatient procedures in the year following index imaging. The Medicare conversion factor during the study period was approximately $35/RVU.
Secondary Outcomes
- Number of Participants With Opioid Prescription Within 12 Months of Index Imaging(12 months)
- Number of Participants With an Opioid Prescription Within 30 Days of Index Imaging(30 days)
- Relative Value Unit (RVU) for Spine-related Interventions at 24 Months(24 months)
- Number of Participants With Opioid Prescription Within 90 Days of Index Imaging(90 days)
- Back-pain Related Estimated Payer Costs(12 months)
- Spine- Related Surgical Interventions(24 months)
- Number of Participants With Cross-sectional Imaging Within 12 Months of Plain Film Index Imaging(12 months)
- Number of Participants With Cross-sectional Imaging Within 90 Days of Plain Film Index Imaging(90 days)
- Cross-sectional Imaging at 24 Months(24 months)
- Number of Participants With Spine Surgery Within 18 Month of Index Imaging(18 months)
- Opioid Prescriptions at 24 Months(24 months)
- Back-pain Related Estimated Payer Costs at 24 Months(24 months)
Investigators
Jeffrey G. Jarvik, MD, MPH
Professor
University of Washington
