Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports

Low Back Pain Clinical Trial

— LIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015455
• Other study ID #: 44083
• Secondary ID: UH3AR0667951UH2A
• Status: Completed
• Phase: N/A
• Start date: October 1, 2013
• Est. completion date: December 14, 2018

Study information

• Verified date: January 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 250401
• Est. completion date: December 14, 2018
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Imaging of lumbar spine requested by primary care provider

Exclusion Criteria:

• Age < 18years

Related Conditions & MeSH terms

• Back Pain
• Backache
• Low Back Pain
• Lumbar Pain

Intervention

Other:
• Epidemiologic benchmarks included in lumbar imaging reports
Epidemiologic benchmarks inserted into lumbar imaging reports

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan
United States	Mayo Clinic Health Systems	Minneapolis	Minnesota
United States	Kaiser Permanente of Northern California	Oakland	California
United States	Group Health Cooperative	Seattle	Washington

Sponsors (8)

Lead Sponsor	Collaborator
University of Washington	Henry Ford Health System, Kaiser Permanente, Mayo Clinic, National Center for Complementary and Integrative Health (NCCIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Jarvik JG, Comstock BA, James KT, Avins AL, Bresnahan BW, Deyo RA, Luetmer PH, Friedly JL, Meier EN, Cherkin DC, Gold LS, Rundell SD, Halabi SS, Kallmes DF, Tan KW, Turner JA, Kessler LG, Lavallee DC, Stephens KA, Heagerty PJ. Lumbar Imaging With Reportin — View Citation

Jarvik JG, Meier EN, James KT, Gold LS, Tan KW, Kessler LG, Suri P, Kallmes DF, Cherkin DC, Deyo RA, Sherman KJ, Halabi SS, Comstock BA, Luetmer PH, Avins AL, Rundell SD, Griffith B, Friedly JL, Lavallee DC, Stephens KA, Turner JA, Bresnahan BW, Heagerty — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Back-pain Related Estimated Payer Costs	Payer costs were not evaluated due to funding constraints.	12 months
Secondary	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
Secondary	Relative Value Unit (RVU) for Spine-related Interventions at 24 Months	24-month outcomes were not evaluated due to funding constraints	24 months
Secondary	Opioid Prescriptions at 24 Months	24-month outcomes were not evaluated due to funding constraints	24 months
Secondary	Cross-sectional Imaging at 24 Months	24-month outcomes were not evaluated due to funding constraints	24 months
Secondary	Back-pain Related Estimated Payer Costs at 24 Months	24-month outcomes were not evaluated due to funding constraints	24 months
Secondary	Spine- Related Surgical Interventions	24-month outcomes were not evaluated due to funding constraints	24 months