Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Low Back Pain, Back Pain, Lumbar Pain, Backache

Intervention / Treatment
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* Other: Epidemiologic benchmarks included in lumbar imaging reports


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Imaging of lumbar spine requested by primary care provider Exclusion Criteria: Age < 18years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Epidemiologic benchmarks included in lumbar imaging reports | Other: Epidemiologic benchmarks included in lumbar imaging reports<br>* Epidemiologic benchmarks inserted into lumbar imaging reports<br>|
| No Intervention: Usual Care Arm<br>Clinics with typical lumbar imaging reports (no epidemiologic benchmarks included) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Value Unit (RVU) for Spine-related Interventions | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Opioid Prescription Within 12 Months of Index Imaging | 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. | 12 months | 
| Number of Participants With Opioid Prescription Within 90 Days of Index Imaging | 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. | 90 days | 
| Number of Participants With an Opioid Prescription Within 30 Days of Index Imaging | 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. | 30 days | 
| Number of Participants With Cross-sectional Imaging Within 12 Months of Plain Film Index Imaging | 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. | 12 months | 
| Number of Participants With Cross-sectional Imaging Within 90 Days of Plain Film Index Imaging | 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. | 90 days | 
| Back-pain Related Estimated Payer Costs | Payer costs were not evaluated due to funding constraints. | 12 months | 
| Number of Participants With Spine Surgery Within 18 Month of Index Imaging | 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. | 18 months | 
| Relative Value Unit (RVU) for Spine-related Interventions at 24 Months | 24-month outcomes were not evaluated due to funding constraints | 24 months | 
| Opioid Prescriptions at 24 Months | 24-month outcomes were not evaluated due to funding constraints | 24 months | 
| Cross-sectional Imaging at 24 Months | 24-month outcomes were not evaluated due to funding constraints | 24 months | 
| Back-pain Related Estimated Payer Costs at 24 Months | 24-month outcomes were not evaluated due to funding constraints | 24 months | 
| Spine- Related Surgical Interventions | 24-month outcomes were not evaluated due to funding constraints | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pragmatic trial, stepped-wedge design, cluster-randomized trial