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Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports (LIRE)

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ClinicalTrials.gov Identifier: NCT02015455
Recruitment Status : Active, not recruiting
First Posted : December 19, 2013
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
Mayo Clinic
Henry Ford Health System
Kaiser Permanente
Oregon Health and Science University
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Jeffrey G. Jarvik, MD, MPH, 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.

Condition or disease Intervention/treatment Phase
Low Back Pain Back Pain Lumbar Pain Backache Other: Epidemiologic benchmarks included in lumbar imaging reports Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Lumbar Imaging With Reporting of Epidemiology: A Pragmatic Cluster Randomized Trial
Study Start Date : April 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Arm
Epidemiologic benchmarks included in lumbar imaging reports
Other: Epidemiologic benchmarks included in lumbar imaging reports
Epidemiologic benchmarks inserted into lumbar imaging reports

No Intervention: Usual Care Arm
Clinics with typical lumbar imaging reports (no epidemiologic benchmarks included)



Primary Outcome Measures :
  1. Relative Value Unit (RVU) for spine-related interventions [ Time Frame: 12 months ]
    Composite of diagnostic and treatment interventions related to the low back pain


Secondary Outcome Measures :
  1. Opioid prescriptions [ Time Frame: 12 months ]
    Opioid prescriptions at 12 months

  2. Opioid prescriptions [ Time Frame: 90 days ]
    Opioid prescriptions at 90 days

  3. Opioid prescriptions [ Time Frame: 30 days ]
    Opioid prescriptions at 30 days

  4. Cross-sectional imaging [ Time Frame: 12 months ]
    CT or MR imaging of the back performed on patients up to 12 months after randomization.

  5. Cross-sectional imaging [ Time Frame: 90 days ]
    CT or MR imaging of the back performed on patients up to 90 days after randomization.

  6. Back-pain related estimated payer costs [ Time Frame: 12 months ]
  7. Spine- related surgical interventions [ Time Frame: 12 months ]
    Interventions such as injections or lumbar surgeries

  8. Relative Value Unit (RVU) for spine-related interventions at 24 months [ Time Frame: 24 months ]
  9. Opioid Prescriptions at 24 months [ Time Frame: 24 months ]
  10. Cross-sectional Imaging at 24 months [ Time Frame: 24 months ]
  11. Back-pain related estimated payer costs at 24 months [ Time Frame: 24 months ]
  12. Spine- related surgical interventions [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Imaging of lumbar spine requested by primary care provider

Exclusion Criteria:

  • Age < 18years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015455


Locations
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United States, California
Kaiser Permanente of Northern California
Oakland, California, United States
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States
United States, Minnesota
Mayo Clinic Health Systems
Minneapolis, Minnesota, United States
United States, Washington
Group Health Cooperative
Seattle, Washington, United States
Sponsors and Collaborators
University of Washington
Mayo Clinic
Henry Ford Health System
Kaiser Permanente
Oregon Health and Science University
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Jeffrey G Jarvik, MD, MPH University of Washington

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeffrey G. Jarvik, MD, MPH, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02015455     History of Changes
Other Study ID Numbers: 44083
UH3AR066795 ( U.S. NIH Grant/Contract )
1UH2AT007766-01 ( U.S. NIH Grant/Contract )
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

Keywords provided by Jeffrey G. Jarvik, MD, MPH, University of Washington:
pragmatic trial
stepped-wedge design
cluster-randomized trial

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms