The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the central hypothesis that the ICP will reduce pain interference with normal activities and improve physical function, as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Short Form scores when compared to the CCP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,817
Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation
Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient
Patients with a higher risk of developing chronic or persistent back pain will be identified using the nine question risk stratification start back screening tool (SBST) and will receive six additional weeks of physical activity instructions and additional pain modulation treatments as needed.
Durham VA
Durham, North Carolina, United States
Change in Pain Interference Measure
The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure pain interference. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates greater pain interference.
Time frame: Baseline, three months post baseline
Change in Physical Function Measure
The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure physical function. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates better physical function.
Time frame: Baseline, three months post baseline
Change in Sleep Disturbance
The PROMIS Short form scores will be collected in the medical record by the provider at baseline, and three months post baseline to measure sleep disturbance. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates greater sleep disturbance.
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the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol
the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient
the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.
Time frame: Baseline, three months post baseline
Change in Patient Reported Outcomes--PROMIS Sleep Disturbance
The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure sleep disturbance. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates greater sleep disturbance.
Time frame: Baseline, three, six, and twelve months
Number of Participants With Opioid Use--Chronic User
Opioid use will be defined at baseline and 12 months post baseline as a binary variable based on whether a chronic opioid user or not at baseline and at twelve months. Opioid use is chronic if participant had at least one prescription with a total day supply of at least 120 days or if there were at least 10 prescription fills in the 12 months prior to the specified timepoint (baseline, 12 months post baseline).
Time frame: Baseline, twelve months post baseline
Change in Opioid Use - Morphine Dose
Opioid use--morphine dose will be defined at baseline and 12 months post baseline as a continuous variable measuring morphine equivalents for opioid dose at baseline and twelve months. Change in total milligrams of morphine equivalents (MME) use is reported.
Time frame: Baseline, twelve months post baseline
Change in Patient Reported Outcomes--PROMIS Pain Interference
The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure pain interference. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates greater pain interference.
Time frame: Baseline, three, six, and twelve months
Change in Patient Reported Outcomes--PROMIS Physical Function
The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure physical function. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates better physical function.
Time frame: Baseline, three, six, and twelve months