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| ID | Type | Description | Link |
|---|---|---|---|
| UH3AR066795 | U.S. NIH Grant/Contract | View source | |
| 1UH2AT007766-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| Henry Ford Health System | OTHER |
| Kaiser Permanente | OTHER |
| Oregon Health and Science University |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Epidemiologic benchmarks included in lumbar imaging reports |
|
| Usual Care Arm | No Intervention | Clinics with typical lumbar imaging reports (no epidemiologic benchmarks included) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidemiologic benchmarks included in lumbar imaging reports | Other | Epidemiologic benchmarks inserted into lumbar imaging reports |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey G Jarvik, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente of Northern California | Oakland | California | United States | |||
| Henry Ford Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26493088 | Result | 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. | |
| 32886121 | Result |
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Of 250,401 enrolled participants, 238,886 met inclusion and exclusion criteria.
Participants were enrolled from 4 health systems if they had lumbar spine imaging ordered by a primary care provider that occurred between October 2013 and September 2016.
| ID | Title | Description |
|---|---|---|
| FG000 | Control | Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention. |
| FG001 | Intervention | Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Step 0 - Oct 2013 to Mar 2014 |
| ||||||||||||||||
| Step 1 - Apr 2014 to Sep 2014 |
| ||||||||||||||||
| Step 2 - Oct 2014 to Mar 2015 |
| ||||||||||||||||
| Step 3 - Apr 2015 to Sep 2015 |
| ||||||||||||||||
| Step 4 - Oct 2015 to Mar 2016 |
| ||||||||||||||||
| Step 5 - Apr 2016 to Sep 2016 |
|
These are analyzed participant who met all inclusion criteria and did not have any exclusions.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention. |
| BG001 | Intervention | Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | spine-related RVU | 12 months |
|
The adverse events for this trial were all-cause mortality within 6 months of index imaging and emergency department visit (yes/no) within 90 days of index imaging.
Emergency department visit within 90 days of index imaging is reported in the serious adverse event section. The outcome was captured through the health system medical records.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Department visit within 90 days of index imaging | General disorders | Systematic Assessment | Emergency Department visits were identified in the health systems' medical records. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sandra K Johnston, PhD, RN Executive Administrative Director- CLEAR Center | University of Washington | 206-221-7444 | stonesk@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 11, 2019 | Aug 12, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2019 | Aug 12, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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| 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. |
| 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. | 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. | 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. | 90 days |
| Back-pain Related Estimated Payer Costs | Payer costs were not evaluated due to funding constraints. | 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. | 18 months |
| Relative Value Unit (RVU) for Spine-related Interventions at 24 Months | 24-month outcomes were not evaluated due to funding constraints | 24 months |
| Opioid Prescriptions at 24 Months | 24-month outcomes were not evaluated due to funding constraints | 24 months |
| Cross-sectional Imaging at 24 Months | 24-month outcomes were not evaluated due to funding constraints | 24 months |
| Back-pain Related Estimated Payer Costs at 24 Months | 24-month outcomes were not evaluated due to funding constraints | 24 months |
| Spine- Related Surgical Interventions | 24-month outcomes were not evaluated due to funding constraints | 24 months |
| Detroit |
| Michigan |
| United States |
| Mayo Clinic Health Systems | Minneapolis | Minnesota | United States |
| Group Health Cooperative | Seattle | Washington | United States |
| 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. |
| 34535520 | Derived | 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. |
| 33595635 | 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. |
| 33559061 | 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. |
| 26772801 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Does not include 14 patients (<0.1%) with other or unknown gender. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Site | Count of Participants | Participants |
|
| Imaging Modality | Count of Participants | Participants |
|
| Charlson Comorbidity Index (CCI) | The index range is 0-24 with higher values representing a greater burden of disease. The following contribute to the index with values in parentheses: congestive heart failure (2), dementia (2), chronic pulmonary disease (1), rheumatologic disease (1), mild liver disease (2) or moderate to severe liver disease (4), diabetes with chronic complications (1), hemiplegia or paraplegia (2), renal disease (1), malignant cancer (2 or 6 if metastatic solid tumor), and AIDS/HIV (4). Presence of a comorbidity was obtained from diagnosis codes in the year preceding index imaging. | Count of Participants | Participants |
|
| Imaging Finding Status | Count of Participants | Participants |
|
| At Least One Opioid Prescription Prior to Index | Count of Participants | Participants |
|
| Primary Insurance at Index | Count of Participants | Participants |
|
| Socioeconomic Status Index (SSI) | Does not include 6810 patients (2.7%) with unknown SSI due to missing participant address or matching geocoding information. Sites mapped participant address to FIPS code at the block-group level using geocoding software. These codes were mapped to socioeconomic indices derived from data available from the 2010 Census Summary File 1 and the American Community Survey, 2007 to 2011, 5-year estimate data. SSI ranges from 14 to 79. Higher SSI values indicate higher levels of socioeconomic status. | Mean | Standard Deviation | units on a scale |
|
| Health Care Professional Type | Count of Participants | Participants |
|
| Healthcare Professional Specialty | Count of Participants | Participants |
|
| Female Healthcare Professional | Count of Participants | Participants |
|
| Healthcare Professional Age | Provider age was not available for the providers of 424 participants. | Mean | Standard Deviation | years |
|
Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention. |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 90 days |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Back-pain Related Estimated Payer Costs | Payer costs were not evaluated due to funding constraints. | Not Posted | 12 months | Participants |
| Secondary | 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. | Posted | Count of Participants | Participants | 18 months |
|
|
|
|
| Secondary | Relative Value Unit (RVU) for Spine-related Interventions at 24 Months | 24-month outcomes were not evaluated due to funding constraints | Not Posted | 24 months | Participants |
| Secondary | Opioid Prescriptions at 24 Months | 24-month outcomes were not evaluated due to funding constraints | Not Posted | 24 months | Participants |
| Secondary | Cross-sectional Imaging at 24 Months | 24-month outcomes were not evaluated due to funding constraints | Not Posted | 24 months | Participants |
| Secondary | Back-pain Related Estimated Payer Costs at 24 Months | 24-month outcomes were not evaluated due to funding constraints | Not Posted | 24 months | Participants |
| Secondary | Spine- Related Surgical Interventions | 24-month outcomes were not evaluated due to funding constraints | Not Posted | 24 months | Participants |
| 958 |
| 117,455 |
| 12,885 |
| 117,455 |
| 0 |
| 0 |
| EG001 | Intervention | Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention. | 953 | 121,431 | 13,289 | 121,431 | 0 | 0 |
|
Not provided
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| C |
|
| D |
|
| Magnetic Resonance |
|
| 2 |
|
| 3 or higher |
|
| Clinically important finding |
|
| Commercial |
|
| VA |
|
| Self-pay |
|
| Unknown or not reported |
|
| Extender (eg NP, PA) |
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| Other |
|