LIRE: Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT02015455
• Collaborator: Mayo Clinic (Other), Henry Ford Health System (Other), Kaiser Permanente (Other), Oregon Health and Science University (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)
• Enrollment: 250,401
• Locations: 4
• Arms: 2
• Actual Duration (Months): 62.4
• Patients Per Site: 62600.3
• Patients Per Site Per Month: 1002.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain; Back Pain; Lumbar Pain; Backache	Other: Epidemiologic benchmarks included in lumbar imaging reports	N/A

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

• Study Type: Interventional
• Actual Enrollment: 250401 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Lumbar Imaging With Reporting of Epidemiology: A Pragmatic Cluster Randomized Trial
• Actual Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Dec 14, 2018
• Actual Study Completion Date: Dec 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm Epidemiologic benchmarks included in lumbar imaging reports	Other: Epidemiologic benchmarks included in lumbar imaging reports; Epidemiologic benchmarks inserted into lumbar imaging reports
No Intervention: Usual Care Arm Clinics with typical lumbar imaging reports (no epidemiologic benchmarks included)

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. Back-pain Related Estimated Payer Costs [12 months]

   Payer costs were not evaluated due to funding constraints.

7. 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.

8. Relative Value Unit (RVU) for Spine-related Interventions at 24 Months [24 months]

   24-month outcomes were not evaluated due to funding constraints

9. Opioid Prescriptions at 24 Months [24 months]

   24-month outcomes were not evaluated due to funding constraints

10. Cross-sectional Imaging at 24 Months [24 months]

    24-month outcomes were not evaluated due to funding constraints

11. Back-pain Related Estimated Payer Costs at 24 Months [24 months]

    24-month outcomes were not evaluated due to funding constraints

12. Spine- Related Surgical Interventions [24 months]

    24-month outcomes were not evaluated due to funding constraints

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Imaging of lumbar spine requested by primary care provider

Exclusion Criteria:

• Age < 18years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente of Northern California	Oakland	California	United States
2	Henry Ford Health System	Detroit	Michigan	United States
3	Mayo Clinic Health Systems	Minneapolis	Minnesota	United States
4	Group Health Cooperative	Seattle	Washington	United States

Sponsors and Collaborators

• University of Washington
• 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)

Investigators

• Principal Investigator: Jeffrey G Jarvik, MD, MPH, University of Washington

Study Documents (Full-Text)

• Study Protocol - Nov 11, 2019
• Statistical Analysis Plan - Nov 11, 2019

More Information

Publications

None provided.

• Responsible Party: Jeffrey G. Jarvik, MD, MPH, Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT02015455
• Other Study ID Numbers: 44083; UH3AR066795; 1UH2AT007766-01
• First Posted: Dec 19, 2013
• Last Update Posted: Feb 14, 2022
• Last Verified: Jan 1, 2022

• Keywords provided by Jeffrey G. Jarvik, MD, MPH, Professor, University of Washington: pragmatic trial; stepped-wedge design; cluster-randomized trial
• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

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 Detail	Of 250,401 enrolled participants, 238,886 met inclusion and exclusion criteria.

Arm/Group Title	Control	Intervention
Arm/Group Description	Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.	Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
Period Title: Step 0 - Oct 2013 to Mar 2014
STARTED	48233	0
Did Not Receive Intended Inclusion/Exclusion of Intervention Report Text	135	0
COMPLETED	48233	0
NOT COMPLETED	0	0
Period Title: Step 0 - Oct 2013 to Mar 2014
STARTED	24074	6455
Did Not Receive Intended Inclusion/Exclusion of Intervention Report Text	390	2208
COMPLETED	24074	6455
NOT COMPLETED	0	0
Period Title: Step 0 - Oct 2013 to Mar 2014
STARTED	23139	16285
Did Not Receive Intended Inclusion/Exclusion of Intervention Report Text	98	1511
COMPLETED	23139	16285
NOT COMPLETED	0	0
Period Title: Step 0 - Oct 2013 to Mar 2014
STARTED	14135	27661
Did Not Receive Intended Inclusion/Exclusion of Intervention Report Text	72	4915
COMPLETED	14135	27661
NOT COMPLETED	0	0
Period Title: Step 0 - Oct 2013 to Mar 2014
STARTED	7874	31316
Did Not Receive Intended Inclusion/Exclusion of Intervention Report Text	76	3742
COMPLETED	7874	31316
NOT COMPLETED	0	0
Period Title: Step 0 - Oct 2013 to Mar 2014
STARTED	0	39714
Did Not Receive Intended Inclusion/Exclusion of Intervention Report Text	0	3512
COMPLETED	0	39714
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control	Intervention	Total
Arm/Group Description	Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.	Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.	Total of all reporting groups
Overall Participants	117455	121431	238886
Age, Customized (Count of Participants)
18-39	21237 18.1%	22105 18.2%	43342 18.1%
40-60	45032 38.3%	44995 37.1%	90027 37.7%
>60	51186 43.6%	54331 44.7%	105517 44.2%
Sex: Female, Male (Count of Participants)
Female	67915 57.8%	69458 57.2%	137373 57.5%
Male	49534 42.2%	51965 42.8%	101499 42.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	17754 15.1%	18475 15.2%	36229 15.2%
Not Hispanic or Latino	19867 16.9%	19276 15.9%	39143 16.4%
Unknown or Not Reported	79834 68%	83680 68.9%	163514 68.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	806 0.7%	880 0.7%	1686 0.7%
Asian	13311 11.3%	13197 10.9%	26508 11.1%
Native Hawaiian or Other Pacific Islander	905 0.8%	709 0.6%	1614 0.7%
Black or African American	11919 10.1%	11649 9.6%	23568 9.9%
White	76431 65.1%	79142 65.2%	155573 65.1%
More than one race	459 0.4%	546 0.4%	1005 0.4%
Unknown or Not Reported	13624 11.6%	15308 12.6%	28932 12.1%
Region of Enrollment (participants) [Number]
United States	117455 100%	121431 100%	238886 100%
Site (Count of Participants)
A	6950 5.9%	7388 6.1%	14338 6%
B	96275 82%	100729 83%	197004 82.5%
C	7846 6.7%	7726 6.4%	15572 6.5%
D	6384 5.4%	5588 4.6%	11972 5%
Imaging Modality (Count of Participants)
Radiograph	93465 79.6%	98970 81.5%	192435 80.6%
Computed Tomography	494 0.4%	449 0.4%	943 0.4%
Magnetic Resonance	23496 20%	22012 18.1%	45508 19.1%
Charlson Comorbidity Index (CCI) (Count of Participants)
0	75106 63.9%	77973 64.2%	153079 64.1%
1	20675 17.6%	21193 17.5%	41868 17.5%
2	11451 9.7%	11760 9.7%	23211 9.7%
3 or higher	10223 8.7%	10505 8.7%	20728 8.7%
Imaging Finding Status (Count of Participants)
None	27770 23.6%	27776 22.9%	55546 23.3%
LIRE finding without clinically important finding	72127 61.4%	77065 63.5%	149192 62.5%
Clinically important finding	17558 14.9%	16590 13.7%	34148 14.3%
At Least One Opioid Prescription Prior to Index (Count of Participants)
Count of Participants [Participants]	32225 27.4%	29306 24.1%	61531 25.8%
Primary Insurance at Index (Count of Participants)
Medicare	44362 37.8%	46479 38.3%	90841 38%
Medicaid or state-subsidized	5546 4.7%	6510 5.4%	12056 5%
Commercial	65375 55.7%	66368 54.7%	131743 55.1%
VA	117 0.1%	131 0.1%	248 0.1%
Self-pay	731 0.6%	570 0.5%	1301 0.5%
Unknown or not reported	1324 1.1%	1373 1.1%	2697 1.1%
Socioeconomic Status Index (SSI) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	56.79 (6.29)	56.76 (6.56)	56.78 (6.43)
Health Care Professional Type (Count of Participants)
MD	105359 89.7%	108165 89.1%	213524 89.4%
DO	8131 6.9%	9157 7.5%	17288 7.2%
Extender (eg NP, PA)	3965 3.4%	4109 3.4%	8074 3.4%
Healthcare Professional Specialty (Count of Participants)
Family Medicine	56795 48.4%	60277 49.6%	117072 49%
Internal Medicine	59684 50.8%	60158 49.5%	119842 50.2%
Other	976 0.8%	996 0.8%	1972 0.8%
Female Healthcare Professional (Count of Participants)
Count of Participants [Participants]	62840 53.5%	62680 51.6%	125520 52.5%
Healthcare Professional Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.42 (8.63)	49.22 (8.71)	49.32 (8.67)

Outcome Measures

1. Primary Outcome

Title	Relative Value Unit (RVU) for Spine-related Interventions
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.	Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
Measure Participants	117455	121431
Median (Inter-Quartile Range) [spine-related RVU]	3.53	3.56

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.54
	Comments
	Method	Mixed Models Analysis
	Comments	Adjusted for site, clinic size, age, sex, image modality, comorbidity, and site time trends. Random effects for clinic and provider.
Method of Estimation	Estimation Parameter	Percent Difference in Median
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95%; -2.9 to 1.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Percent difference in median of the intervention group with respect to the control group.

2. Secondary Outcome

Title	Number of Participants With Opioid Prescription Within 12 Months of Index Imaging
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.	Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
Measure Participants	117455	121431
Count of Participants [Participants]	46220 39.4%	41205 33.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments	A p-value <0.05 was considered significant.
	Method	Mixed Models Analysis
	Comments	Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio is for the intervention group with respect to the control group.

3. Secondary Outcome

Title	Number of Participants With Opioid Prescription Within 90 Days of Index Imaging
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.	Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
Measure Participants	117455	121431
Count of Participants [Participants]	37322 31.8%	32873 27.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments	The p-value is not adjusted for multiple comparisons.
	Method	Mixed Models Analysis
	Comments	Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.90 to 0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio is for the intervention group with respect to the control group.

4. Secondary Outcome

Title	Number of Participants With an Opioid Prescription Within 30 Days of Index Imaging
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.	Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
Measure Participants	117455	121431
Count of Participants [Participants]	31035 26.4%	27165 22.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments	The p-value is not adjusted for multiple comparisons.
	Method	Mixed Models Analysis
	Comments	Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.91 to 0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio is for the intervention group with respect to the control group.

5. Secondary Outcome

Title	Number of Participants With Cross-sectional Imaging Within 12 Months of Plain Film Index Imaging
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	Participants with plain film index imaging at a clinic prior to the randomized date at which the clinic started the intervention.	Participants with plain film index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
Measure Participants	93465	98970
Count of Participants [Participants]	18179 15.5%	19069 15.7%

6. Secondary Outcome

Title	Number of Participants With Cross-sectional Imaging Within 90 Days of Plain Film Index Imaging
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	Participants with plain film index imaging at a clinic prior to the randomized date at which the clinic started the intervention.	Participants with plain film index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
Measure Participants	93465	98970
Count of Participants [Participants]	12228 10.4%	13099 10.8%

7. Secondary Outcome

Title	Back-pain Related Estimated Payer Costs
Description	Payer costs were not evaluated due to funding constraints.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Number of Participants With Spine Surgery Within 18 Month of Index Imaging
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.	Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
Measure Participants	117455	121431
Count of Participants [Participants]	3753 3.2%	3785 3.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.74
	Comments	Statistical significance defined as P<0.05
	Method	Mixed Models Analysis
	Comments	Adjusted for site, clinic size, age, sex, image modality, comorbidity, site time trends. Random effects for clinic and provider.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio is for the intervention group with respect to the control group.

9. Secondary Outcome

Title	Relative Value Unit (RVU) for Spine-related Interventions at 24 Months
Description	24-month outcomes were not evaluated due to funding constraints
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	Opioid Prescriptions at 24 Months
Description	24-month outcomes were not evaluated due to funding constraints
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Secondary Outcome

Title	Cross-sectional Imaging at 24 Months
Description	24-month outcomes were not evaluated due to funding constraints
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	Back-pain Related Estimated Payer Costs at 24 Months
Description	24-month outcomes were not evaluated due to funding constraints
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Secondary Outcome

Title	Spine- Related Surgical Interventions
Description	24-month outcomes were not evaluated due to funding constraints
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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.
Arm/Group Title	Control		Intervention
Arm/Group Description	Participants with index imaging at a clinic prior to the randomized date at which the clinic started the intervention.		Participants with index imaging at a clinic on or after the randomized date at which the clinic started the intervention.
All Cause Mortality
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	958/117455 (0.8%)		953/121431 (0.8%)
Serious Adverse Events
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12885/117455 (11%)		13289/121431 (10.9%)
General disorders
Emergency Department visit within 90 days of index imaging	12885/117455 (11%)	12885	13289/121431 (10.9%)	13289
Other (Not Including Serious) Adverse Events
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.