Trial Outcomes & Findings for Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports (NCT NCT02015455)
NCT ID: NCT02015455
Last Updated: 2022-02-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
250401 participants
Primary outcome timeframe
12 months
Results posted on
2022-02-14
Participant Flow
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.
Of 250,401 enrolled participants, 238,886 met inclusion and exclusion criteria.
Unit of analysis: Clinics
Participant milestones
| Measure |
Control
Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.
|
Intervention
Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
|
|---|---|---|
|
Step 0 - Oct 2013 to Mar 2014
STARTED
|
48233 98
|
0 0
|
|
Step 0 - Oct 2013 to Mar 2014
Did Not Receive Intended Inclusion/Exclusion of Intervention Report Text
|
135 98
|
0 0
|
|
Step 0 - Oct 2013 to Mar 2014
COMPLETED
|
48233 98
|
0 0
|
|
Step 0 - Oct 2013 to Mar 2014
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 1 - Apr 2014 to Sep 2014
STARTED
|
24074 79
|
6455 19
|
|
Step 1 - Apr 2014 to Sep 2014
Did Not Receive Intended Inclusion/Exclusion of Intervention Report Text
|
390 79
|
2208 19
|
|
Step 1 - Apr 2014 to Sep 2014
COMPLETED
|
24074 79
|
6455 19
|
|
Step 1 - Apr 2014 to Sep 2014
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 2 - Oct 2014 to Mar 2015
STARTED
|
23139 59
|
16285 39
|
|
Step 2 - Oct 2014 to Mar 2015
Did Not Receive Intended Inclusion/Exclusion of Intervention Report Text
|
98 59
|
1511 39
|
|
Step 2 - Oct 2014 to Mar 2015
COMPLETED
|
23139 59
|
16285 39
|
|
Step 2 - Oct 2014 to Mar 2015
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 3 - Apr 2015 to Sep 2015
STARTED
|
14135 39
|
27661 59
|
|
Step 3 - Apr 2015 to Sep 2015
Did Not Receive Intended Inclusion/Exclusion of Intervention Report Text
|
72 39
|
4915 59
|
|
Step 3 - Apr 2015 to Sep 2015
COMPLETED
|
14135 39
|
27661 59
|
|
Step 3 - Apr 2015 to Sep 2015
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 4 - Oct 2015 to Mar 2016
STARTED
|
7874 21
|
31316 77
|
|
Step 4 - Oct 2015 to Mar 2016
Did Not Receive Intended Inclusion/Exclusion of Intervention Report Text
|
76 21
|
3742 77
|
|
Step 4 - Oct 2015 to Mar 2016
COMPLETED
|
7874 21
|
31316 77
|
|
Step 4 - Oct 2015 to Mar 2016
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 5 - Apr 2016 to Sep 2016
STARTED
|
0 0
|
39714 98
|
|
Step 5 - Apr 2016 to Sep 2016
Did Not Receive Intended Inclusion/Exclusion of Intervention Report Text
|
0 0
|
3512 98
|
|
Step 5 - Apr 2016 to Sep 2016
COMPLETED
|
0 0
|
39714 98
|
|
Step 5 - Apr 2016 to Sep 2016
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does not include 14 patients (\<0.1%) with other or unknown gender.
Baseline characteristics by cohort
| Measure |
Control
n=117455 Participants
Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.
|
Intervention
n=121431 Participants
Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
|
Total
n=238886 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-39
|
21237 Participants
n=117455 Participants
|
22105 Participants
n=121431 Participants
|
43342 Participants
n=238886 Participants
|
|
Age, Customized
40-60
|
45032 Participants
n=117455 Participants
|
44995 Participants
n=121431 Participants
|
90027 Participants
n=238886 Participants
|
|
Age, Customized
>60
|
51186 Participants
n=117455 Participants
|
54331 Participants
n=121431 Participants
|
105517 Participants
n=238886 Participants
|
|
Sex: Female, Male
Female
|
67915 Participants
n=117449 Participants • Does not include 14 patients (\<0.1%) with other or unknown gender.
|
69458 Participants
n=121423 Participants • Does not include 14 patients (\<0.1%) with other or unknown gender.
|
137373 Participants
n=238872 Participants • Does not include 14 patients (\<0.1%) with other or unknown gender.
|
|
Sex: Female, Male
Male
|
49534 Participants
n=117449 Participants • Does not include 14 patients (\<0.1%) with other or unknown gender.
|
51965 Participants
n=121423 Participants • Does not include 14 patients (\<0.1%) with other or unknown gender.
|
101499 Participants
n=238872 Participants • Does not include 14 patients (\<0.1%) with other or unknown gender.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17754 Participants
n=117455 Participants
|
18475 Participants
n=121431 Participants
|
36229 Participants
n=238886 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19867 Participants
n=117455 Participants
|
19276 Participants
n=121431 Participants
|
39143 Participants
n=238886 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
79834 Participants
n=117455 Participants
|
83680 Participants
n=121431 Participants
|
163514 Participants
n=238886 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
806 Participants
n=117455 Participants
|
880 Participants
n=121431 Participants
|
1686 Participants
n=238886 Participants
|
|
Race (NIH/OMB)
Asian
|
13311 Participants
n=117455 Participants
|
13197 Participants
n=121431 Participants
|
26508 Participants
n=238886 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
905 Participants
n=117455 Participants
|
709 Participants
n=121431 Participants
|
1614 Participants
n=238886 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11919 Participants
n=117455 Participants
|
11649 Participants
n=121431 Participants
|
23568 Participants
n=238886 Participants
|
|
Race (NIH/OMB)
White
|
76431 Participants
n=117455 Participants
|
79142 Participants
n=121431 Participants
|
155573 Participants
n=238886 Participants
|
|
Race (NIH/OMB)
More than one race
|
459 Participants
n=117455 Participants
|
546 Participants
n=121431 Participants
|
1005 Participants
n=238886 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13624 Participants
n=117455 Participants
|
15308 Participants
n=121431 Participants
|
28932 Participants
n=238886 Participants
|
|
Region of Enrollment
United States
|
117455 participants
n=117455 Participants
|
121431 participants
n=121431 Participants
|
238886 participants
n=238886 Participants
|
|
Site
A
|
6950 Participants
n=117455 Participants
|
7388 Participants
n=121431 Participants
|
14338 Participants
n=238886 Participants
|
|
Site
B
|
96275 Participants
n=117455 Participants
|
100729 Participants
n=121431 Participants
|
197004 Participants
n=238886 Participants
|
|
Site
C
|
7846 Participants
n=117455 Participants
|
7726 Participants
n=121431 Participants
|
15572 Participants
n=238886 Participants
|
|
Site
D
|
6384 Participants
n=117455 Participants
|
5588 Participants
n=121431 Participants
|
11972 Participants
n=238886 Participants
|
|
Imaging Modality
Radiograph
|
93465 Participants
n=117455 Participants
|
98970 Participants
n=121431 Participants
|
192435 Participants
n=238886 Participants
|
|
Imaging Modality
Computed Tomography
|
494 Participants
n=117455 Participants
|
449 Participants
n=121431 Participants
|
943 Participants
n=238886 Participants
|
|
Imaging Modality
Magnetic Resonance
|
23496 Participants
n=117455 Participants
|
22012 Participants
n=121431 Participants
|
45508 Participants
n=238886 Participants
|
|
Charlson Comorbidity Index (CCI)
0
|
75106 Participants
n=117455 Participants
|
77973 Participants
n=121431 Participants
|
153079 Participants
n=238886 Participants
|
|
Charlson Comorbidity Index (CCI)
1
|
20675 Participants
n=117455 Participants
|
21193 Participants
n=121431 Participants
|
41868 Participants
n=238886 Participants
|
|
Charlson Comorbidity Index (CCI)
2
|
11451 Participants
n=117455 Participants
|
11760 Participants
n=121431 Participants
|
23211 Participants
n=238886 Participants
|
|
Charlson Comorbidity Index (CCI)
3 or higher
|
10223 Participants
n=117455 Participants
|
10505 Participants
n=121431 Participants
|
20728 Participants
n=238886 Participants
|
|
Imaging Finding Status
None
|
27770 Participants
n=117455 Participants
|
27776 Participants
n=121431 Participants
|
55546 Participants
n=238886 Participants
|
|
Imaging Finding Status
LIRE finding without clinically important finding
|
72127 Participants
n=117455 Participants
|
77065 Participants
n=121431 Participants
|
149192 Participants
n=238886 Participants
|
|
Imaging Finding Status
Clinically important finding
|
17558 Participants
n=117455 Participants
|
16590 Participants
n=121431 Participants
|
34148 Participants
n=238886 Participants
|
|
At Least One Opioid Prescription Prior to Index
|
32225 Participants
n=117455 Participants
|
29306 Participants
n=121431 Participants
|
61531 Participants
n=238886 Participants
|
|
Primary Insurance at Index
Medicare
|
44362 Participants
n=117455 Participants
|
46479 Participants
n=121431 Participants
|
90841 Participants
n=238886 Participants
|
|
Primary Insurance at Index
Medicaid or state-subsidized
|
5546 Participants
n=117455 Participants
|
6510 Participants
n=121431 Participants
|
12056 Participants
n=238886 Participants
|
|
Primary Insurance at Index
Commercial
|
65375 Participants
n=117455 Participants
|
66368 Participants
n=121431 Participants
|
131743 Participants
n=238886 Participants
|
|
Primary Insurance at Index
VA
|
117 Participants
n=117455 Participants
|
131 Participants
n=121431 Participants
|
248 Participants
n=238886 Participants
|
|
Primary Insurance at Index
Self-pay
|
731 Participants
n=117455 Participants
|
570 Participants
n=121431 Participants
|
1301 Participants
n=238886 Participants
|
|
Primary Insurance at Index
Unknown or not reported
|
1324 Participants
n=117455 Participants
|
1373 Participants
n=121431 Participants
|
2697 Participants
n=238886 Participants
|
|
Socioeconomic Status Index (SSI)
|
56.79 units on a scale
STANDARD_DEVIATION 6.29 • n=114231 Participants • 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.
|
56.76 units on a scale
STANDARD_DEVIATION 6.56 • n=117845 Participants • 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.
|
56.78 units on a scale
STANDARD_DEVIATION 6.43 • n=232076 Participants • 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.
|
|
Health Care Professional Type
MD
|
105359 Participants
n=117455 Participants
|
108165 Participants
n=121431 Participants
|
213524 Participants
n=238886 Participants
|
|
Health Care Professional Type
DO
|
8131 Participants
n=117455 Participants
|
9157 Participants
n=121431 Participants
|
17288 Participants
n=238886 Participants
|
|
Health Care Professional Type
Extender (eg NP, PA)
|
3965 Participants
n=117455 Participants
|
4109 Participants
n=121431 Participants
|
8074 Participants
n=238886 Participants
|
|
Healthcare Professional Specialty
Family Medicine
|
56795 Participants
n=117455 Participants
|
60277 Participants
n=121431 Participants
|
117072 Participants
n=238886 Participants
|
|
Healthcare Professional Specialty
Internal Medicine
|
59684 Participants
n=117455 Participants
|
60158 Participants
n=121431 Participants
|
119842 Participants
n=238886 Participants
|
|
Healthcare Professional Specialty
Other
|
976 Participants
n=117455 Participants
|
996 Participants
n=121431 Participants
|
1972 Participants
n=238886 Participants
|
|
Female Healthcare Professional
|
62840 Participants
n=117455 Participants
|
62680 Participants
n=121431 Participants
|
125520 Participants
n=238886 Participants
|
|
Healthcare Professional Age
|
49.42 years
STANDARD_DEVIATION 8.63 • n=117217 Participants • Provider age was not available for the providers of 424 participants.
|
49.22 years
STANDARD_DEVIATION 8.71 • n=121245 Participants • Provider age was not available for the providers of 424 participants.
|
49.32 years
STANDARD_DEVIATION 8.67 • n=238462 Participants • Provider age was not available for the providers of 424 participants.
|
PRIMARY outcome
Timeframe: 12 monthsSpine-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.
Outcome measures
| Measure |
Control
n=117455 Participants
Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.
|
Intervention
n=121431 Participants
Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
|
|---|---|---|
|
Relative Value Unit (RVU) for Spine-related Interventions
|
3.53 spine-related RVU
Interval 2.68 to 5.08
|
3.56 spine-related RVU
Interval 2.71 to 5.12
|
SECONDARY outcome
Timeframe: 12 monthsAn 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.
Outcome measures
| Measure |
Control
n=117455 Participants
Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.
|
Intervention
n=121431 Participants
Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
|
|---|---|---|
|
Number of Participants With Opioid Prescription Within 12 Months of Index Imaging
|
46220 Participants
|
41205 Participants
|
SECONDARY outcome
Timeframe: 90 daysAn 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.
Outcome measures
| Measure |
Control
n=117455 Participants
Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.
|
Intervention
n=121431 Participants
Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
|
|---|---|---|
|
Number of Participants With Opioid Prescription Within 90 Days of Index Imaging
|
37322 Participants
|
32873 Participants
|
SECONDARY outcome
Timeframe: 30 daysAn 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.
Outcome measures
| Measure |
Control
n=117455 Participants
Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.
|
Intervention
n=121431 Participants
Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
|
|---|---|---|
|
Number of Participants With an Opioid Prescription Within 30 Days of Index Imaging
|
31035 Participants
|
27165 Participants
|
SECONDARY outcome
Timeframe: 12 monthsAn 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.
Outcome measures
| Measure |
Control
n=93465 Participants
Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.
|
Intervention
n=98970 Participants
Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
|
|---|---|---|
|
Number of Participants With Cross-sectional Imaging Within 12 Months of Plain Film Index Imaging
|
18179 Participants
|
19069 Participants
|
SECONDARY outcome
Timeframe: 90 daysAn 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.
Outcome measures
| Measure |
Control
n=93465 Participants
Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.
|
Intervention
n=98970 Participants
Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
|
|---|---|---|
|
Number of Participants With Cross-sectional Imaging Within 90 Days of Plain Film Index Imaging
|
12228 Participants
|
13099 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPayer costs were not evaluated due to funding constraints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsAn 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.
Outcome measures
| Measure |
Control
n=117455 Participants
Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.
|
Intervention
n=121431 Participants
Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
|
|---|---|---|
|
Number of Participants With Spine Surgery Within 18 Month of Index Imaging
|
3753 Participants
|
3785 Participants
|
SECONDARY outcome
Timeframe: 24 months24-month outcomes were not evaluated due to funding constraints
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months24-month outcomes were not evaluated due to funding constraints
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months24-month outcomes were not evaluated due to funding constraints
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months24-month outcomes were not evaluated due to funding constraints
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months24-month outcomes were not evaluated due to funding constraints
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 12885 serious events
Other events: 0 other events
Deaths: 958 deaths
Intervention
Serious events: 13289 serious events
Other events: 0 other events
Deaths: 953 deaths
Serious adverse events
| Measure |
Control
n=117455 participants at risk
Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.
|
Intervention
n=121431 participants at risk
Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
|
|---|---|---|
|
General disorders
Emergency Department visit within 90 days of index imaging
|
11.0%
12885/117455 • Number of events 12885 • 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.
|
10.9%
13289/121431 • Number of events 13289 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sandra K Johnston, PhD, RN Executive Administrative Director- CLEAR Center
University of Washington
Phone: 206-221-7444
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place