Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports

NCT02015455 | Completed Results DMC

• 3 other identifiers: 44083UH3AR0667951UH2AT007766-01
• Study Type: interventional
• Target: 250,401
• Locations: 1 country
• Sites: 4

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.

Conditions

Low Back Pain; Back Pain; Lumbar Pain; Backache

Keywords

pragmatic trial; stepped-wedge design; cluster-randomized trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Number of Participants With Opioid Prescription Within 12 Months of Index Imaging

  12 months

• Number of Participants With Opioid Prescription Within 90 Days of Index Imaging

  90 days

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

  30 days

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

  12 months

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

  90 days

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Epidemiologic benchmarks included in lumbar imaging reports

Other: Epidemiologic benchmarks included in lumbar imaging reports

Usual Care Arm

NO INTERVENTION

Clinics with typical lumbar imaging reports (no epidemiologic benchmarks included)

Interventions

Epidemiologic benchmarks included in lumbar imaging reports OTHER

Epidemiologic benchmarks inserted into lumbar imaging reports

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Imaging of lumbar spine requested by primary care provider

You may not qualify if:

• Age \< 18years

Sponsors & Collaborators

• University of Washington: lead
• Mayo Clinic: collaborator
• Henry Ford Health System: collaborator
• Kaiser Permanente: collaborator
• Oregon Health and Science University: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (4)

Kaiser Permanente of Northern California

Oakland, California, United States

Location

Henry Ford Health System

Detroit, Michigan, United States

Location

Mayo Clinic Health Systems

Minneapolis, Minnesota, United States

Location

Group Health Cooperative

Seattle, Washington, United States

Location

Related Publications (6)

• 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.

  PMID: 26493088 RESULT

• 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.

  PMID: 32886121 RESULT

• 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.

  PMID: 34535520 DERIVED

• 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.

  PMID: 33595635 DERIVED

• 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.

  PMID: 33559061 DERIVED

• Johnson KE, Neta G, Dember LM, Coronado GD, Suls J, Chambers DA, Rundell S, Smith DH, Liu B, Taplin S, Stoney CM, Farrell MM, Glasgow RE. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016 Jan 16;17:32. doi: 10.1186/s13063-016-1158-y.

  PMID: 26772801 DERIVED

MeSH Terms

Conditions

Low Back Pain; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Opioid prescribing decreased in the United States during our study. Although we made multiple efforts to account for this potential confounding in our modeling, residual confounding may exist. We did not collect patient-reported outcomes (PRO), so we cannot comment on outcomes such as functional status, pain, or psychosocial functioning. The decision not to collect PRO data was deliberate, based on the recognition that it could jeopardize the feasibility of this large pragmatic trial.

Results Point of Contact

• Title: Dr. Sandra K Johnston, PhD, RN Executive Administrative Director- CLEAR Center
• Organization: University of Washington

stonesk@uw.edu

206-221-7444

Study Officials

• Jeffrey G Jarvik, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 19, 2013
• Study Start: October 1, 2013
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: February 14, 2022
• Results First Posted: February 14, 2022

Record last verified: 2022-01

Locations

US (4)