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Completed

NCT Number: NCT02015455

Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports

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.

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Key information

Conditions

Low Back Pain Back Pain Backache Lumbar Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente of Northern California, Oakland, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Imaging of lumbar spine requested by primary care provider

Exclusion criteria

  • Age < 18years

Treatment and study plan

Epidemiologic benchmarks included in lumbar imaging reports

Other

Epidemiologic benchmarks inserted into lumbar imaging reports

Primary outcomes

  1. 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

  1. Number of Participants With Opioid Prescription Within 12 Months of Index Imaging

    Time frame: 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.

  2. Number of Participants With Opioid Prescription Within 90 Days of Index Imaging

    Time frame: 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.

  3. Number of Participants With an Opioid Prescription Within 30 Days of Index Imaging

    Time frame: 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.

  4. Number of Participants With Cross-sectional Imaging Within 12 Months of Plain Film Index Imaging

    Time frame: 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.

  5. Number of Participants With Cross-sectional Imaging Within 90 Days of Plain Film Index Imaging

    Time frame: 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.

  6. Back-pain Related Estimated Payer Costs

    Time frame: 12 months

    Payer costs were not evaluated due to funding constraints.

  7. Number of Participants With Spine Surgery Within 18 Month of Index Imaging

    Time frame: 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.

  8. Relative Value Unit (RVU) for Spine-related Interventions at 24 Months

    Time frame: 24 months

    24-month outcomes were not evaluated due to funding constraints

  9. Opioid Prescriptions at 24 Months

    Time frame: 24 months

    24-month outcomes were not evaluated due to funding constraints

  10. Cross-sectional Imaging at 24 Months

    Time frame: 24 months

    24-month outcomes were not evaluated due to funding constraints

  11. Back-pain Related Estimated Payer Costs at 24 Months

    Time frame: 24 months

    24-month outcomes were not evaluated due to funding constraints

  12. Spine- Related Surgical Interventions

    Time frame: 24 months

    24-month outcomes were not evaluated due to funding constraints

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: LIRE

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2013
Registry last updated
Feb 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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