Backache, Back Pain, Low Back Pain, Lumbar Pain
Conditions
Keywords
pragmatic trial, stepped-wedge design, cluster-randomized trial
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.
Interventions
OTHEREpidemiologic benchmarks included in lumbar imaging reports
Epidemiologic benchmarks inserted into lumbar imaging reports
Sponsors
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)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Imaging of lumbar spine requested by primary care provider
Exclusion criteria
* Age \< 18years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Value Unit (RVU) for Spine-related Interventions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Opioid Prescription Within 90 Days of Index Imaging | 90 days | 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. |
| Number of Participants With an Opioid Prescription Within 30 Days of Index Imaging | 30 days | 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. |
| Number of Participants With Cross-sectional Imaging Within 12 Months of Plain Film Index Imaging | 12 months | 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. |
| Number of Participants With Cross-sectional Imaging Within 90 Days of Plain Film Index Imaging | 90 days | 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. |
| Back-pain Related Estimated Payer Costs | 12 months | Payer costs were not evaluated due to funding constraints. |
| Number of Participants With Opioid Prescription Within 12 Months of Index Imaging | 12 months | 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. |
| Relative Value Unit (RVU) for Spine-related Interventions at 24 Months | 24 months | 24-month outcomes were not evaluated due to funding constraints |
| Opioid Prescriptions at 24 Months | 24 months | 24-month outcomes were not evaluated due to funding constraints |
| Cross-sectional Imaging at 24 Months | 24 months | 24-month outcomes were not evaluated due to funding constraints |
| Back-pain Related Estimated Payer Costs at 24 Months | 24 months | 24-month outcomes were not evaluated due to funding constraints |
| Spine- Related Surgical Interventions | 24 months | 24-month outcomes were not evaluated due to funding constraints |
| Number of Participants With Spine Surgery Within 18 Month of Index Imaging | 18 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Of 250,401 enrolled participants, 238,886 met inclusion and exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Control Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention. | 117,455 |
| Intervention Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention. | 121,431 |
| Total | 238,886 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Customized 18-39 | 21237 Participants | 22105 Participants | 43342 Participants |
| Age, Customized 40-60 | 45032 Participants | 44995 Participants | 90027 Participants |
| Age, Customized >60 | 51186 Participants | 54331 Participants | 105517 Participants |
| At Least One Opioid Prescription Prior to Index | 32225 Participants | 29306 Participants | 61531 Participants |
| Charlson Comorbidity Index (CCI) 0 | 75106 Participants | 77973 Participants | 153079 Participants |
| Charlson Comorbidity Index (CCI) 1 | 20675 Participants | 21193 Participants | 41868 Participants |
| Charlson Comorbidity Index (CCI) 2 | 11451 Participants | 11760 Participants | 23211 Participants |
| Charlson Comorbidity Index (CCI) 3 or higher | 10223 Participants | 10505 Participants | 20728 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17754 Participants | 18475 Participants | 36229 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19867 Participants | 19276 Participants | 39143 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 79834 Participants | 83680 Participants | 163514 Participants |
| Female Healthcare Professional | 62840 Participants | 62680 Participants | 125520 Participants |
| Healthcare Professional Age | 49.42 years STANDARD_DEVIATION 8.63 | 49.22 years STANDARD_DEVIATION 8.71 | 49.32 years STANDARD_DEVIATION 8.67 |
| Healthcare Professional Specialty Family Medicine | 56795 Participants | 60277 Participants | 117072 Participants |
| Healthcare Professional Specialty Internal Medicine | 59684 Participants | 60158 Participants | 119842 Participants |
| Healthcare Professional Specialty Other | 976 Participants | 996 Participants | 1972 Participants |
| Health Care Professional Type DO | 8131 Participants | 9157 Participants | 17288 Participants |
| Health Care Professional Type Extender (eg NP, PA) | 3965 Participants | 4109 Participants | 8074 Participants |
| Health Care Professional Type MD | 105359 Participants | 108165 Participants | 213524 Participants |
| Imaging Finding Status Clinically important finding | 17558 Participants | 16590 Participants | 34148 Participants |
| Imaging Finding Status LIRE finding without clinically important finding | 72127 Participants | 77065 Participants | 149192 Participants |
| Imaging Finding Status None | 27770 Participants | 27776 Participants | 55546 Participants |
| Imaging Modality Computed Tomography | 494 Participants | 449 Participants | 943 Participants |
| Imaging Modality Magnetic Resonance | 23496 Participants | 22012 Participants | 45508 Participants |
| Imaging Modality Radiograph | 93465 Participants | 98970 Participants | 192435 Participants |
| Primary Insurance at Index Commercial | 65375 Participants | 66368 Participants | 131743 Participants |
| Primary Insurance at Index Medicaid or state-subsidized | 5546 Participants | 6510 Participants | 12056 Participants |
| Primary Insurance at Index Medicare | 44362 Participants | 46479 Participants | 90841 Participants |
| Primary Insurance at Index Self-pay | 731 Participants | 570 Participants | 1301 Participants |
| Primary Insurance at Index Unknown or not reported | 1324 Participants | 1373 Participants | 2697 Participants |
| Primary Insurance at Index VA | 117 Participants | 131 Participants | 248 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 806 Participants | 880 Participants | 1686 Participants |
| Race (NIH/OMB) Asian | 13311 Participants | 13197 Participants | 26508 Participants |
| Race (NIH/OMB) Black or African American | 11919 Participants | 11649 Participants | 23568 Participants |
| Race (NIH/OMB) More than one race | 459 Participants | 546 Participants | 1005 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 905 Participants | 709 Participants | 1614 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13624 Participants | 15308 Participants | 28932 Participants |
| Race (NIH/OMB) White | 76431 Participants | 79142 Participants | 155573 Participants |
| Region of Enrollment United States | 117455 participants | 121431 participants | 238886 participants |
| Sex: Female, Male Female | 67915 Participants | 69458 Participants | 137373 Participants |
| Sex: Female, Male Male | 49534 Participants | 51965 Participants | 101499 Participants |
| Site A | 6950 Participants | 7388 Participants | 14338 Participants |
| Site B | 96275 Participants | 100729 Participants | 197004 Participants |
| Site C | 7846 Participants | 7726 Participants | 15572 Participants |
| Site D | 6384 Participants | 5588 Participants | 11972 Participants |
| Socioeconomic Status Index (SSI) | 56.79 units on a scale STANDARD_DEVIATION 6.29 | 56.76 units on a scale STANDARD_DEVIATION 6.56 | 56.78 units on a scale STANDARD_DEVIATION 6.43 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 958 / 117,455 | 953 / 121,431 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 12,885 / 117,455 | 13,289 / 121,431 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Relative Value Unit (RVU) for Spine-related Interventions | 3.53 spine-related RVU |
| Intervention | Relative Value Unit (RVU) for Spine-related Interventions | 3.56 spine-related RVU |
p-value: 0.5495% CI: [-2.9, 1.5]Mixed Models Analysis
Secondary
Back-pain Related Estimated Payer Costs
Payer costs were not evaluated due to funding constraints.
Time frame: 12 months
Secondary
Back-pain Related Estimated Payer Costs at 24 Months
24-month outcomes were not evaluated due to funding constraints
Time frame: 24 months
Secondary
Cross-sectional Imaging at 24 Months
24-month outcomes were not evaluated due to funding constraints
Time frame: 24 months
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.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With an Opioid Prescription Within 30 Days of Index Imaging | 31035 Participants |
| Intervention | Number of Participants With an Opioid Prescription Within 30 Days of Index Imaging | 27165 Participants |
p-value: 0.0295% CI: [0.91, 0.99]Mixed Models Analysis
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Cross-sectional Imaging Within 12 Months of Plain Film Index Imaging | 18179 Participants |
| Intervention | Number of Participants With Cross-sectional Imaging Within 12 Months of Plain Film Index Imaging | 19069 Participants |
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.
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Cross-sectional Imaging Within 90 Days of Plain Film Index Imaging | 12228 Participants |
| Intervention | Number of Participants With Cross-sectional Imaging Within 90 Days of Plain Film Index Imaging | 13099 Participants |
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Opioid Prescription Within 12 Months of Index Imaging | 46220 Participants |
| Intervention | Number of Participants With Opioid Prescription Within 12 Months of Index Imaging | 41205 Participants |
p-value: 0.0495% CI: [0.91, 1]Mixed Models Analysis
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.
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Opioid Prescription Within 90 Days of Index Imaging | 37322 Participants |
| Intervention | Number of Participants With Opioid Prescription Within 90 Days of Index Imaging | 32873 Participants |
p-value: 0.0295% CI: [0.9, 0.99]Mixed Models Analysis
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.
Time frame: 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Spine Surgery Within 18 Month of Index Imaging | 3753 Participants |
| Intervention | Number of Participants With Spine Surgery Within 18 Month of Index Imaging | 3785 Participants |
p-value: 0.7495% CI: [0.91, 1.07]Mixed Models Analysis
Secondary
Opioid Prescriptions at 24 Months
24-month outcomes were not evaluated due to funding constraints
Time frame: 24 months
Secondary
Relative Value Unit (RVU) for Spine-related Interventions at 24 Months
24-month outcomes were not evaluated due to funding constraints
Time frame: 24 months
Secondary
Spine- Related Surgical Interventions
24-month outcomes were not evaluated due to funding constraints
Time frame: 24 months