Skip to main content
Clinical Trials/NCT02015455
NCT02015455CompletedNot Applicable

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

University of Washington4 sites in 1 country250,401 target enrollmentStarted: October 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Experimental

Epidemiologic benchmarks included in lumbar imaging reports

Intervention: Epidemiologic benchmarks included in lumbar imaging reports (Other)

Usual Care Arm

No Intervention

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeffrey G. Jarvik, MD, MPH

Professor

University of Washington

Study Sites (4)

Loading locations...

Similar Trials