Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports

Not Applicable

Completed

Conditions: Low Back Pain
Back Pain
Lumbar Pain
Backache

Interventions: Other: Epidemiologic benchmarks included in lumbar imaging reports

Registration Number: NCT02015455

Lead Sponsor: University of Washington

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 250401

Inclusion Criteria

Imaging of lumbar spine requested by primary care provider

Exclusion Criteria

Age < 18years

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Epidemiologic benchmarks included in lumbar imaging reports	Epidemiologic benchmarks included in lumbar imaging reports

Primary Outcome Measures

Name	Time	Method
Relative Value Unit (RVU) for Spine-related Interventions	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 Outcome Measures

Name	Time	Method
Back-pain Related Estimated Payer Costs at 24 Months	24 months	24-month outcomes were not evaluated due to funding constraints
Number of Participants With Opioid Prescription Within 12 Months of Index Imaging	12 months	An indicator of one or more opioid prescriptions from a LIRE provider (a provider who ordered index imaging for one or more participants in the LIRE Trial) within 12 months of index imaging as reported in the health system medical record.
Number of Participants With Opioid Prescription Within 90 Days of Index Imaging	90 days	An indicator of one or more opioid prescriptions from a LIRE provider (a provider who ordered index imaging for one or more participants in the LIRE Trial) within 90 days of index imaging as reported in the health system medical record.
Back-pain Related Estimated Payer Costs	12 months	Payer costs were not evaluated due to funding constraints.
Spine- Related Surgical Interventions	24 months	24-month outcomes were not evaluated due to funding constraints
Number of Participants With Cross-sectional Imaging Within 12 Months of Plain Film Index Imaging	12 months	An indicator of one or more instances of cross-sectional imaging (MRI or CT) within 12 months of plain film index imaging. Participants with cross-sectional index imaging are excluded.
Number of Participants With Cross-sectional Imaging Within 90 Days of Plain Film Index Imaging	90 days	An indicator of one or more instances of cross-sectional imaging (MRI or CT) within 90 days of plain film index imaging. Participants with cross-sectional index imaging are excluded.
Cross-sectional Imaging at 24 Months	24 months	24-month outcomes were not evaluated due to funding constraints
Number of Participants With Spine Surgery Within 18 Month of Index Imaging	18 months	An indicator or one or more spine surgeries within 18 months of index imaging. Spine surgery includes decompression surgery, spinal fusion or proxies for spine fusion, or other surgeries involving the lumbar, sacral, or thoracic spine.
Opioid Prescriptions at 24 Months	24 months	24-month outcomes were not evaluated due to funding constraints
Number of Participants With an Opioid Prescription Within 30 Days of Index Imaging	30 days	An indicator of one or more opioid prescriptions from a LIRE provider (a provider who ordered index imaging for one or more participants in the LIRE Trial) within 30 days of index imaging as reported in the health system medical record.
Relative Value Unit (RVU) for Spine-related Interventions at 24 Months	24 months	24-month outcomes were not evaluated due to funding constraints

Trial Locations

Locations (4): Kaiser Permanente of Northern California
🇺🇸
Oakland, California, United States
Henry Ford Health System
🇺🇸
Detroit, Michigan, United States
Mayo Clinic Health Systems
🇺🇸
Minneapolis, Minnesota, United States
Group Health Cooperative
🇺🇸
Seattle, Washington, United States