Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports

NCT ID: NCT02015455

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250401 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-01
• Study Completion Date: 2018-12-14

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.

Conditions

Low Back Pain; Back Pain; Lumbar Pain; Backache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention Arm

Epidemiologic benchmarks included in lumbar imaging reports

Group Type: EXPERIMENTAL

Epidemiologic benchmarks included in lumbar imaging reports

Intervention Type: OTHER

Epidemiologic benchmarks inserted into lumbar imaging reports

Usual Care Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Epidemiologic benchmarks included in lumbar imaging reports

Epidemiologic benchmarks inserted into lumbar imaging reports

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Imaging of lumbar spine requested by primary care provider

Exclusion Criteria

• Age < 18years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Henry Ford Health System

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey G. Jarvik, MD, MPH

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey G Jarvik, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Kaiser Permanente of Northern California

Oakland, California, United States

Henry Ford Health System

Detroit, Michigan, United States

Mayo Clinic Health Systems

Minneapolis, Minnesota, United States

Group Health Cooperative

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 26493088 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32886121 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34535520 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33595635 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33559061 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26772801 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

UH3AR066795

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1UH2AT007766-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

44083

Identifier Type: -

Identifier Source: org_study_id