Low Back PainLIRENCT02015455
Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports
A study testing Epidemiologic benchmarks included in lumbar imaging reports in people with Low Back Pain and Back Pain, run by University of Washington at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Back Pain, Lumbar Pain
- What is being tested?
- Epidemiologic benchmarks included in lumbar imaging reports
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250,401 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Oct 2013to 14 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Imaging of lumbar spine requested by primary care provider
Who cannot join
- Age < 18years
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Henry Ford Health System
Detroit, Michigan
Mayo Clinic Health Systems
Minneapolis, Minnesota
Kaiser Permanente of Northern California
Oakland, California
Group Health Cooperative
Seattle, Washington
About this study
Official title: Lumbar Imaging With Reporting of Epidemiology: A Pragmatic Cluster Randomized Trial
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.
Read the 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
- Being tested
- Epidemiologic benchmarks included in lumbar imaging reports
- Keywords
- pragmatic trial, stepped-wedge design, cluster-randomized trial
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidemiologic benchmarks included in lumbar imaging reportsOther
Epidemiologic benchmarks inserted into lumbar imaging reports
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Epidemiologic benchmarks included in lumbar imaging reports Receives: Other: Epidemiologic benchmarks included in lumbar imaging reports |
| Usual Care Arm | No intervention | Clinics with typical lumbar imaging reports (no epidemiologic benchmarks included) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (12)
Number of Participants With Opioid Prescription Within 12 Months of Index Imaging
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.
Measured: 12 months
Number of Participants With Opioid Prescription Within 90 Days of Index Imaging
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.
Measured: 90 days
Number of Participants With an Opioid Prescription Within 30 Days of Index Imaging
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.
Measured: 30 days
Number of Participants With Cross-sectional Imaging Within 12 Months of Plain Film Index Imaging
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.
Measured: 12 months
Number of Participants With Cross-sectional Imaging Within 90 Days of Plain Film Index Imaging
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.
Measured: 90 days
Back-pain Related Estimated Payer Costs
Payer costs were not evaluated due to funding constraints.
Measured: 12 months
Number of Participants With Spine Surgery Within 18 Month of Index Imaging
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.
Measured: 18 months
Relative Value Unit (RVU) for Spine-related Interventions at 24 Months
24-month outcomes were not evaluated due to funding constraints
Measured: 24 months
Opioid Prescriptions at 24 Months
24-month outcomes were not evaluated due to funding constraints
Measured: 24 months
Cross-sectional Imaging at 24 Months
24-month outcomes were not evaluated due to funding constraints
Measured: 24 months
Back-pain Related Estimated Payer Costs at 24 Months
24-month outcomes were not evaluated due to funding constraints
Measured: 24 months
Spine- Related Surgical Interventions
24-month outcomes were not evaluated due to funding constraints
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study start1 Oct 2013
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 250,401 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- 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)
- Responsible party
- Principal investigator, Jeffrey G. Jarvik, MD, MPH, University of Washington
- Investigators
- Jeffrey G Jarvik, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015455
- Sponsor's protocol ID
- 44083
- Other IDs
- UH3AR066795, 1UH2AT007766-01
- Acronym
- LIRE
- Status last verified
- Jan 2022
- First submitted
- 6 Dec 2013
- Last updated
- 14 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26493088Jarvik 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.
PubMed 32886121Gold 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.
PubMed 34535520Suri 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.
PubMed 33595635Marcum 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.
PubMed 33559061Johnson 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.
PubMed 26772801
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Imaging With Reporting of Epidemiology: A Pragmatic Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT02015455
- Acronym / sponsor ID
- LIRE / 44083
- Conditions
- Low Back Pain, Back Pain, Lumbar Pain, Backache
- Keywords
- pragmatic trial, stepped-wedge design, cluster-randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250,401 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- 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)
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Posted 14 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Epidemiologic benchmarks included in lumbar imaging reportsEpidemiologic benchmarks included in lumbar imaging reports |
| Usual Care Arm | No intervention | –Clinics with typical lumbar imaging reports (no epidemiologic benchmarks included) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Imaging of lumbar spine requested by primary care provider
Key exclusion criteria (1 listed)
- Age < 18years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidemiologic benchmarks included in lumbar imaging reportsEpidemiologic benchmarks inserted into lumbar imaging reports | Other | Intervention Arm |
Primary outcome
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.
12 secondary outcomes
Number of Participants With Opioid Prescription Within 12 Months of Index Imaging
Time frame: 12 months
Number of Participants With Opioid Prescription Within 90 Days of Index Imaging
Time frame: 90 days
Number of Participants With an Opioid Prescription Within 30 Days of Index Imaging
Time frame: 30 days
Number of Participants With Cross-sectional Imaging Within 12 Months of Plain Film Index Imaging
Time frame: 12 months
Number of Participants With Cross-sectional Imaging Within 90 Days of Plain Film Index Imaging
Time frame: 90 days
Back-pain Related Estimated Payer Costs
Time frame: 12 months
Number of Participants With Spine Surgery Within 18 Month of Index Imaging
Time frame: 18 months
Relative Value Unit (RVU) for Spine-related Interventions at 24 Months
Time frame: 24 months
Opioid Prescriptions at 24 Months
Time frame: 24 months
Cross-sectional Imaging at 24 Months
Time frame: 24 months
Back-pain Related Estimated Payer Costs at 24 Months
Time frame: 24 months
Spine- Related Surgical Interventions
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26493088Jarvik 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.
- Results publication: PubMed 32886121Jarvik 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.
- Derived from this study: PubMed 34535520Gold 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.
- Derived from this study: PubMed 33595635Suri 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.
- Derived from this study: PubMed 33559061Marcum 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.
- Derived from this study: PubMed 26772801Johnson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey G Jarvik, MD, MPH principal investigator
University of Washington
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidemiologic benchmarks included in lumbar imaging reports in people with Low Back Pain and Back Pain, run by University of Washington at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Value Unit (RVU) for Spine-related Interventions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02015455, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.