Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Total Prescribed Opioid Dosage |
The Investigators will compare total opioid dosage (morphine equivalents) in the 24 months after baseline. In order to be able to compare opioid doses across classes, the Investigators will use a standard formula to calculate morphine equivalents from the CDC Morphine Equivalent Factors. Within 24 months after baseline, the Investigators will determine morphine equivalent dose. |
Up to approximately 24 Months |
|
Other |
PROMIS Global 10 (v1.2) - Physical Health |
The PROMIS Global-10 is a 10 item PRO questionnaire which has response options presented as 5-point rating scales; Results are used to calculate a global physical health score and global mental health score with higher scores indicating better health.Patient Reported Outcomes Measurement Information System Global Health Short Form Range: 0 - 100 |
Up to approximately 24 Months |
|
Other |
PROMIS Global 10 (v1.2) - Mental Health |
The PROMIS Global-10 is a 10 item PRO questionnaire which has response options presented as 5-point rating scales; Results are used to calculate a global physical health score and global mental health score with higher scores indicating better health.Patient Reported Outcomes Measurement Information System Global Health Short Form Range: 0 - 100 |
Up to approximately 24 Months |
|
Other |
Number of LBP-related Imaging and Diagnostic Tests |
The Investigators will collect any imaging and diagnostic tests from the time from enrollment through 24 months or study end. These measures will be extracted from the electronic health record using ICD and CPT codes. The imaging and diagnostics include magnetic resonance imaging, computed tomography, plain film x-rays, discography, electromyography, and nerve conduction studies. |
Up to approximately 24 Months |
|
Other |
Number of LBP-related Injection Procedures |
The Investigators will collect any LBP-related injection procedures conducted from the time from enrollment until 24 months or study end. These procedures will be extracted by the electronic health record using ICD and CPT codes. The injection procedure types include fascia, facet joint, intervertebral disc, and muscle. |
Up to approximately 24 Months |
|
Other |
Number of LBP-related Surgical Procedures |
The Investigators will collect any LBP-related surgical procedures conducted from the time from enrollment until 24 months or study end. These surgical procedures will be extracted by the electronic health record using ICD and CPT codes. The surgical procedure types include discectomy, fusion, and decompression. |
Up to approximately 24 Months |
|
Other |
Number of LBP-related Medical Prescriptions |
The Investigators will collect any LBP-related medication prescriptions from the time from enrollment until 24 months or study end. These medication prescriptions will be extracted from the electronic health record using commonly used codes during routine clinical practice. The medication types include opioids, NSAIDS, muscle relaxers, anticonvulsants, and SNRIs |
Up to approximately 24 Months |
|
Other |
Number of LBP-related Provider Visits |
The Investigators will collect any provider visits from the time from enrollment until 24 months or study end. These visits will be extracted by the electronic health record using ICD and CPT codes |
Up to approximately 24 Months |
|
Other |
Number of Hospital Admissions |
The Investigators will collect any hospital admissions from the time from enrollment through 24 months or study end. These admissions will be extracted by the electronic health record using ICD and CPT codes. The admission types include routine, emergency, and elective. |
Up to approximately 24 Months |
|
Other |
Number of Emergency Room Visits |
The Investigators will collect any emergency room visits from the time from enrollment until 24 months or study end. These visits will be extracted by the electronic health record using ICD and CPT codes. |
Up to approximately 24 Months |
|
Primary |
Change in Pain Interference as measured by PROMIS (Patient-Reported Outcomes Measurement Information System) |
The Investigators will compare the change in PROMIS Pain Interference scores, individually, from baseline to 3- month follow-up between usual care and intervention arms. |
Baseline, 3 Months |
|
Primary |
Change in Physical Function as measured by PROMIS (Patient-Reported Outcomes Measurement Information System) |
The Investigators will compare the change in PROMIS Physical Function scores, individually, from baseline to 3- month follow-up between usual care and intervention arms. |
Baseline, 3 Months |
|
Secondary |
NIH Low Back Pain Questions |
The NIH LBP questions consist of 2-items that were developed by the NIH Task Force and are used determined patients' chronicity with LBP |
Baseline, 12 Months |
|
Secondary |
Patient Satisfaction |
The Investigators will assess patient satisfaction with care using a single item used in prior spine studies including SPORT: "Overall, how satisfied are you with the care you received for your back pain? Very satisfied, Somewhat satisfied, Neutral, Somewhat dissatisfied, Very dissatisfied. |
3 Months |
|
Secondary |
Perceived Improvement |
The Investigators will measure global improvement using a one-item scale that has been used in prior pragmatic trials of low back pain: "Compared to your first visit, your low back pain is much worse, a little worse, about the same, a little better, moderately better, much better or completely gone. |
3 Months |
|
Secondary |
Patient Experience |
The Investigators will compare patient experience with the clinical care between groups at 3 months using a modified satisfaction with outpatient physiotherapy instrument. Domains compared will include expectations, clinician, communication, health organization, and treatment satisfaction. Physiotherapy outpatient satisfaction questionnaire (modified), score range: 32 to 160. Higher score indicates a better outcome. |
3 Months |
|
Secondary |
Total Prescribed Opioid Dosage |
The Investigators will compare total opioid dosage (morphine equivalents) in the 12 months after baseline. In order to be able to compare opioid doses across classes, the Investigators will use a standard formula to calculate morphine equivalents from the CDC Morphine Equivalent Factors. Within 12 months after baseline, the Investigators will determine morphine equivalent dose. |
Baseline, 3 Months, 6 Months, 12 Months |
|
Secondary |
PROMIS Global 10 (v1.2) - Physical Health |
The PROMIS Global-10 is a 10 item PRO questionnaire which has response options presented as 5-point rating scales; Results are used to calculate a global physical health score and global mental health score with higher scores indicating better health.Patient Reported Outcomes Measurement Information System Global Health Short Form Range: 0 - 100 |
Baseline, 3 Months, 6 Months, 12 Months |
|
Secondary |
PROMIS Global 10 (v1.2) - Mental Health |
The PROMIS Global-10 is a 10 item PRO questionnaire which has response options presented as 5-point rating scales; Results are used to calculate a global physical health score and global mental health score with higher scores indicating better health.Patient Reported Outcomes Measurement Information System Global Health Short Form Range: 0 - 100 |
Baseline, 3 Months, 6 Months, 12 Months |
|
Secondary |
Number of LBP-related Imaging and Diagnostic Tests |
The Investigators will collect any imaging and diagnostic tests from the time from enrollment through 12 months or study end. These measures will be extracted from the electronic health record using ICD and CPT codes. The imaging and diagnostics include magnetic resonance imaging, computed tomography, plain film x-rays, discography, electromyography, and nerve conduction studies. |
Up to approximately 12 Months |
|
Secondary |
Number of LBP-related Injection Procedures |
The Investigators will collect any LBP-related injection procedures conducted from the time from enrollment until 12 months or study end. These procedures will be extracted by the electronic health record using ICD and CPT codes. The injection procedure types include fascia, facet joint, intervertebral disc, and muscle. |
Up to approximately 12 Months |
|
Secondary |
Number of LBP-related Surgical Procedures |
The Investigators will collect any LBP-related surgical procedures conducted from the time from enrollment until 12 months or study end. These surgical procedures will be extracted by the electronic health record using ICD and CPT codes. The surgical procedure types include discectomy, fusion, and decompression. |
Up to approximately 12 Months |
|
Secondary |
Number of LBP-related Medical Prescriptions |
The Investigators will collect any LBP-related medication prescriptions from the time from enrollment until 12 months or study end. These medication prescriptions will be extracted from the electronic health record using commonly used codes during routine clinical practice. The medication types include opioids, NSAIDS, muscle relaxers, anticonvulsants, and SNRIs. |
Up to approximately 12 Months |
|
Secondary |
Number of LBP-related Provider Visits |
The Investigators will collect any provider visits from the time from enrollment until 12 months or study end. These visits will be extracted by the electronic health record using ICD and CPT codes |
Up to approximately 12 Months |
|
Secondary |
Number of Hospital Admissions |
The Investigators will collect any hospital admissions from the time from enrollment through 12 months or study end. These admissions will be extracted by the electronic health record using ICD and CPT codes. The admission types include routine, emergency, and elective. |
Up to approximately 12 Months |
|
Secondary |
Number of Emergency Room Visits |
The Investigators will collect any emergency room visits from the time from enrollment until 12 months or study end. These visits will be extracted by the electronic health record using ICD and CPT codes. |
Up to approximately 12 Months |
|