Clinical trial NCT02015455: Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports
Official title: Lumbar Imaging With Reporting of Epidemiology: A Pragmatic Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Back Pain
Lumbar Pain
Backache
Keywords: pragmatic trial
stepped-wedge design
cluster-randomized trial
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Henry Ford Health System
name: Kaiser Permanente
name: Oregon Health and Science University
name: National Institutes of Health (NIH)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2013-12-19
Enrollment: 250401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* Imaging of lumbar spine requested by primary care provider

Exclusion Criteria:

* Age \< 18years

Primary outcomes:
measure: Relative Value Unit (RVU) for Spine-related Interventions
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With Opioid Prescription Within 12 Months of Index Imaging
timeFrame: 12 months
measure: Number of Participants With Opioid Prescription Within 90 Days of Index Imaging
timeFrame: 90 days
measure: Number of Participants With an Opioid Prescription Within 30 Days of Index Imaging
timeFrame: 30 days
measure: Number of Participants With Cross-sectional Imaging Within 12 Months of Plain Film Index Imaging
timeFrame: 12 months
measure: Number of Participants With Cross-sectional Imaging Within 90 Days of Plain Film Index Imaging
timeFrame: 90 days
measure: Back-pain Related Estimated Payer Costs
timeFrame: 12 months
measure: Number of Participants With Spine Surgery Within 18 Month of Index Imaging
timeFrame: 18 months
measure: Relative Value Unit (RVU) for Spine-related Interventions at 24 Months
timeFrame: 24 months
measure: Opioid Prescriptions at 24 Months
timeFrame: 24 months
measure: Cross-sectional Imaging at 24 Months
timeFrame: 24 months
measure: Back-pain Related Estimated Payer Costs at 24 Months
timeFrame: 24 months
measure: Spine- Related Surgical Interventions
timeFrame: 24 months
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente of Northern California
state: California
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: Mayo Clinic Health Systems
state: Minnesota
city: Seattle
country: United States
facility: Group Health Cooperative
state: Washington
Study officials:
affiliation: University of Washington
name: Jeffrey G Jarvik, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Reporting Of Epidemiology (LIRE)--Protocol for a pragmatic cluster randomized trial. Contemp Clin Trials. 2015 Nov;45(Pt B):157-163. doi: 10.1016/j.cct.2015.10.003. Epub 2015 Oct 19.
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 PJ. The Effect of Including Benchmark Prevalence Data of Common Imaging Findings in Spine Image Reports on Health Care Utilization Among Adults Undergoing Spine Imaging: A Stepped-Wedge Randomized Clinical Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2015713. doi: 10.1001/jamanetworkopen.2020.15713.
citation: Gold LS, Marcum ZA, Meier EN, Turner JA, James KT, Kallmes DF, Luetmer PH, Griffith B, Sherman KJ, Friedly JL, Suri P, Deyo RA, Johnston SK, Avins AL, Heagerty PJ, Jarvik JG. Patient, Provider, and Clinic Characteristics Associated with Opioid and Non-Opioid Pain Prescriptions for Patients Receiving Low Back Imaging in Primary Care. J Am Board Fam Med. 2021 Sep-Oct;34(5):950-963. doi: 10.3122/jabfm.2021.05.210033.
citation: Suri P, Meier EN, Gold LS, Marcum ZA, Johnston SK, James KT, Bresnahan BW, O'Reilly M, Turner JA, Kallmes DF, Sherman KJ, Deyo RA, Luetmer PH, Avins AL, Griffith B, Heagerty PJ, Rundell SD, Jarvik JG, Friedly JL. Providing Epidemiological Data in Lumbar Spine Imaging Reports Did Not Affect Subsequent Utilization of Spine Procedures: Secondary Outcomes from a Stepped-Wedge Randomized Controlled Trial. Pain Med. 2021 Jun 4;22(6):1272-1280. doi: 10.1093/pm/pnab065.
citation: Marcum ZA, Gold LS, James KT, Meier EN, Turner JA, Kallmes DF, Cherkin DC, Deyo RA, Sherman KJ, Luetmer PH, Avins AL, Griffith B, Friedly JL, Suri P, Heagerty PJ, Jarvik JG. Effects of Including Epidemiologic Data in Lumbar Spine Imaging Reports on Prescribing Non-Opioid Medications for Pain. J Gen Intern Med. 2021 Aug;36(8):2237-2243. doi: 10.1007/s11606-021-06627-6. Epub 2021 Feb 8.
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