Low Back Pain, Veterans Family
Conditions
Keywords
clinical pathway, veterans, low back pain
Brief summary
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.
Interventions
BEHAVIORALPain modulation with physical pain treatment
Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation
BEHAVIORALTelephone delivered self-management counseling for increasing physical activity
Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient
BEHAVIORALTelephone delivered behavioral treatment for participants with high risk for continued disability
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.
BEHAVIORALPatient preference treatment protocol
the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol
BEHAVIORALNonpharmacological guideline adherent treatment protocol
the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient
BEHAVIORALFacilitated referrals to existing VA or non-VA pain management resources
the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.
Sponsors
Durham VA Medical Center
University of North Carolina, Chapel Hill
National Center for Complementary and Integrative Health (NCCIH)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The only blinded members of the project include the VA research and Duke Clinical Research Institute (DCRI) research staff members administering the consent and follow up survey data collection processes. All other team members will be unblinded due to the pragmatic design.
Intervention model description
This study is a 4-year cluster randomized pragmatic trial comparing the effectiveness of a sequenced, multi-modal integrated care pathway for lower back pain (LBP) to a care management by pain navigator program for LBP. The study target population is veterans seeking services for lower back pain in participating VA clinics. We plan to enroll 16 VA clinics randomized in a 1:1 Ratio using a covariate constrained randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinic eligibility: * Volunteer and return signed clinic participation agreement * Availability of clinical personnel willing to deliver the treatment interventions (in either arm). * Staff and location need to be distinct from other enrolled clinics. * Clinics can have a variable number of providers, but together meet criteria for range of monthly visits for low back pain. Participant Survey Eligibility Criteria: Inclusion Criteria: 1. Age \>= 18 2. Seeking care for LBP with or without radiating symptoms from a participating VA primary care clinic 3. Provider determines LBP is appropriate for conservative management 4. Referred to integrated ICP pathway or CCP pathway by participating clinic provider
Exclusion criteria
1. Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults) 2. No documented phone number in the electronic health record.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Interference Measure | Baseline, three months post baseline | 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. |
| Change in Physical Function Measure | Baseline, three months post baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Reported Outcomes--PROMIS Sleep Disturbance | Baseline, three, six, and twelve months | 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. |
| Change in Sleep Disturbance | Baseline, three months post baseline | 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. |
| Number of Participants With Opioid Use--Chronic User | Baseline, twelve months post baseline | 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). |
| Change in Opioid Use - Morphine Dose | Baseline, twelve months post baseline | 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. |
| Change in Patient Reported Outcomes--PROMIS Pain Interference | Baseline, three, six, and twelve months | 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. |
| Change in Patient Reported Outcomes--PROMIS Physical Function | Baseline, three, six, and twelve months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Reported Outcomes--Pain Intensity, Enjoyment of Life, General Activity (PEG) Screening Tool | Baseline, three, six, and twelve months | The PEG screening tool scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure pain intensity. The PEG form asks the participant to rate a series of pain intensity related questions on a scale of 0-10 with 0 representing a better outcome. The total score is the sum of responses to the three questions and is missing if any of the three questions is missing. The range of possible values is 0-30. |
| Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2) | Baseline, three, six, and twelve months | Pain Self-Efficacy Questionnaire from the PSEQ-2 form will be collected by the interviewers at baseline, three, six, and twelve months post baseline and will evaluate self-efficacy on a scale of 0-6 with zero representing a worse outcome. The total score is the sum of responses to the two questions and is missing if either of the two questions is missing. The range of possible values is 0-12. |
| Change in Patient Reported Outcomes--Depressed Mood | Baseline, three, six, and twelve months | The Patient Health Questionnaire-2 (PHQ2) form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure depressed mood. The PHQ2 form asks the participant to answer two questions about potential depressed mood within the past week with ratings between 0 and 3. The total score is the sum of responses to the two questions and is missing if either of the two questions is missing. The range of possible values is 0-6. A higher score indicates greater depressed mood. |
| Change in Patient Reported Outcomes--Quality of Life | Baseline, three, six, and twelve months | The EuroQoL five-item quality of life questionnaire, EQ-5D-5L, will be administered by interviewers at baseline, three, six, and twelve months post baseline to measure quality of life. The EQ-5D-5L asks the participant five questions related to quality of life on a scale of 1-5. If all questions are answered, the responses are concatenated to form a 5-digit state in the order mobility, self care, usual activities, pain discomfort, anxiety/depression. This 5-digit state is then converted to an index between 0 and 1. A higher score indicates greater quality of life. |
| Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C) | Baseline, three, six, and twelve months | The AUDIT-C form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure alcohol use. The AUDIT-C form asks the participant to rate three alcohol use questions on a scale of 0-4 with zero representing a better outcome. The total score is the sum of the non-missing responses to the three questions, with range of possible values 0-12. |
| Change in Patient Reported Outcomes--Catastrophizing | Baseline, three, six, and twelve months | Catastrophizing questions from the NIH recommended minimum data set will be collected by the interviewers at baseline, three, six, and twelve months post baseline and will evaluate catastrophizing with two agree (1) / disagree (0) questions. Responses marked as DK/Ref/Missing are coded as missing. Responses are then summed across the two questions; possible outcome values are 0, 1, 2. A higher score indicates greater catastrophizing. |
Countries
United States
Participant flow
Pre-assignment details
A subset of the overall population was recruited to participate in a series of telephone surveys.
Participants by arm
| Arm | Count |
|---|---|
| Integrated Care Pathway The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA. | 811 |
| Coordinated Care Management Pathway The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain. | 1,006 |
| Total | 1,817 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study (All Participants) | Lost to Follow-up | 350 | 469 |
| Survey Subset | Lost to Follow-up | 134 | 120 |
Baseline characteristics
| Characteristic | Coordinated Care Management Pathway | Total | Integrated Care Pathway |
|---|---|---|---|
| Age, Continuous | 52.0 years STANDARD_DEVIATION 15.6 | 51.7 years STANDARD_DEVIATION 15.3 | 53.4 years STANDARD_DEVIATION 15.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 48 Participants | 95 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 920 Participants | 1686 Participants | 766 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 27 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants | 12 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 83 Participants | 249 Participants | 166 Participants |
| Race (NIH/OMB) More than one race | 24 Participants | 37 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 8 Participants | 12 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 30 Participants | 56 Participants | 27 Participants |
| Race (NIH/OMB) White | 326 Participants | 1169 Participants | 300 Participants |
| Region of Enrollment United States | 1006 Participants | 1817 Participants | 811 Participants |
| Sex: Female, Male Female | 44 Participants | 109 Participants | 65 Participants |
| Sex: Female, Male Male | 896 Participants | 1597 Participants | 701 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 516 | 2 / 480 |
| other Total, other adverse events | 12 / 516 | 20 / 480 |
| serious Total, serious adverse events | 18 / 516 | 30 / 480 |
Outcome results
Primary
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
Population: Participants with data collected at both timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Care Pathway | Change in Pain Interference Measure | -2.67 T-score | Standard Deviation 7.22 |
| Coordinated Care Management Pathway | Change in Pain Interference Measure | -2.04 T-score | Standard Deviation 6.73 |
p-value: 0.16997.5% CI: [-1.55, 0.37]Mixed Models Analysis
Primary
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
Population: Participants with data collected at both timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Care Pathway | Change in Physical Function Measure | 1.87 T-score | Standard Deviation 5.7 |
| Coordinated Care Management Pathway | Change in Physical Function Measure | 1.44 T-score | Standard Deviation 5.14 |
p-value: 0.13997.5% CI: [-0.33, 1.52]Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Care Pathway | Change in Opioid Use - Morphine Dose | -2.62 MME | Standard Deviation 36.3 |
| Coordinated Care Management Pathway | Change in Opioid Use - Morphine Dose | -2.69 MME | Standard Deviation 52.3 |
p-value: 0.26295% CI: [-7.52, 2.18]Mixed Models Analysis
Secondary
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
Population: Participants with data collected collected at both timepoints needed to calculate a change.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Integrated Care Pathway | Change in Patient Reported Outcomes--PROMIS Pain Interference | Baseline to 6 months | -1.64 T-score | Standard Deviation 6.29 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--PROMIS Pain Interference | Baseline to 3 months | -1.44 T-score | Standard Deviation 6.19 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--PROMIS Pain Interference | Baseline to 12 months | -1.77 T-score | Standard Deviation 6.5 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--PROMIS Pain Interference | Baseline to 3 months | -1.10 T-score | Standard Deviation 6.08 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--PROMIS Pain Interference | Baseline to 6 months | -1.22 T-score | Standard Deviation 6.69 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--PROMIS Pain Interference | Baseline to 12 months | -1.31 T-score | Standard Deviation 6.65 |
Comparison: Baseline to 3 monthsp-value: 0.3797.5% CI: [-1.31, 0.5]Mixed Models Analysis
Comparison: Baseline to 6 monthsp-value: 0.2497.5% CI: [-1.54, 0.39]Mixed Models Analysis
Comparison: Baseline to 12 monthsp-value: 0.3797.5% CI: [-1.43, 0.54]Mixed Models Analysis
Secondary
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
Population: Participants with data collected collected at both timepoints needed to calculate a change.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Integrated Care Pathway | Change in Patient Reported Outcomes--PROMIS Physical Function | Baseline to 3 months | -0.20 T-score | Standard Deviation 4.55 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--PROMIS Physical Function | Baseline to 6 months | 0.24 T-score | Standard Deviation 5.07 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--PROMIS Physical Function | Baseline to 12 months | -0.09 T-score | Standard Deviation 5.02 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--PROMIS Physical Function | Baseline to 3 months | -0.15 T-score | Standard Deviation 4.62 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--PROMIS Physical Function | Baseline to 6 months | 0.14 T-score | Standard Deviation 4.83 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--PROMIS Physical Function | Baseline to 12 months | 0.08 T-score | Standard Deviation 5.17 |
Comparison: Baseline to 3 monthsp-value: 0.72797.5% CI: [-0.51, 0.72]Mixed Models Analysis
Comparison: Baseline to 6 monthsp-value: 0.47897.5% CI: [-0.43, 0.91]Mixed Models Analysis
Comparison: Baseline to 12 monthsp-value: 0.89497.5% CI: [-0.75, 0.66]Mixed Models Analysis
Secondary
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
Population: Participants with data collected collected at both timepoints needed to calculate a change.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Integrated Care Pathway | Change in Patient Reported Outcomes--PROMIS Sleep Disturbance | Baseline to 3 months | -1.35 T-score | Standard Deviation 6.92 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--PROMIS Sleep Disturbance | Baseline to 6 months | -1.50 T-score | Standard Deviation 6.65 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--PROMIS Sleep Disturbance | Baseline to 12 months | -1.25 T-score | Standard Deviation 7.14 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--PROMIS Sleep Disturbance | Baseline to 3 months | -1.07 T-score | Standard Deviation 6.6 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--PROMIS Sleep Disturbance | Baseline to 6 months | -1.66 T-score | Standard Deviation 6.89 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--PROMIS Sleep Disturbance | Baseline to 12 months | -1.26 T-score | Standard Deviation 7.26 |
Comparison: Baseline to 3 monthsp-value: 0.40995% CI: [-1.37, 0.57]Mixed Models Analysis
Comparison: Baseline to 6 monthsp-value: 0.89995% CI: [-1.04, 0.91]Mixed Models Analysis
Comparison: Baseline to 12 monthsp-value: 0.94695% CI: [-1.01, 1.08]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, three months post baseline
Population: Participants with data collected at both timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Care Pathway | Change in Sleep Disturbance | -2.56 T-score | Standard Deviation 7.35 |
| Coordinated Care Management Pathway | Change in Sleep Disturbance | -2.06 T-score | Standard Deviation 8.01 |
p-value: 0.41795% CI: [-1.69, 0.72]Mixed Models Analysis
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Integrated Care Pathway | Number of Participants With Opioid Use--Chronic User | Baseline | 28 Participants |
| Integrated Care Pathway | Number of Participants With Opioid Use--Chronic User | 12 months | 22 Participants |
| Coordinated Care Management Pathway | Number of Participants With Opioid Use--Chronic User | Baseline | 36 Participants |
| Coordinated Care Management Pathway | Number of Participants With Opioid Use--Chronic User | 12 months | 26 Participants |
p-value: 0.99295% CI: [-4.62, 4.61]Regression, Logistic
Other Pre-specified
Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C)
The AUDIT-C form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure alcohol use. The AUDIT-C form asks the participant to rate three alcohol use questions on a scale of 0-4 with zero representing a better outcome. The total score is the sum of the non-missing responses to the three questions, with range of possible values 0-12.
Time frame: Baseline, three, six, and twelve months
Population: Participants with data collected collected at both timepoints needed to calculate a change.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Integrated Care Pathway | Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C) | Baseline to 3 months | -0.17 score on a scale | Standard Deviation 1.11 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C) | Baseline to 6 months | -0.17 score on a scale | Standard Deviation 1.35 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C) | Baseline to 12 months | -0.25 score on a scale | Standard Deviation 1.46 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C) | Baseline to 3 months | -0.14 score on a scale | Standard Deviation 1.36 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C) | Baseline to 6 months | -0.19 score on a scale | Standard Deviation 1.37 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C) | Baseline to 12 months | -0.18 score on a scale | Standard Deviation 1.49 |
Comparison: Baseline to 3 monthsp-value: 0.47795% CI: [-0.22, 0.1]Mixed Models Analysis
Comparison: Baseline to 6 monthsp-value: 0.87795% CI: [-0.19, 0.17]Mixed Models Analysis
Comparison: Baseline to 12 monthsp-value: 0.3695% CI: [-0.29, 0.11]Mixed Models Analysis
Other Pre-specified
Change in Patient Reported Outcomes--Catastrophizing
Catastrophizing questions from the NIH recommended minimum data set will be collected by the interviewers at baseline, three, six, and twelve months post baseline and will evaluate catastrophizing with two agree (1) / disagree (0) questions. Responses marked as DK/Ref/Missing are coded as missing. Responses are then summed across the two questions; possible outcome values are 0, 1, 2. A higher score indicates greater catastrophizing.
Time frame: Baseline, three, six, and twelve months
Population: Participants with data collected collected at both timepoints needed to calculate a change.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Integrated Care Pathway | Change in Patient Reported Outcomes--Catastrophizing | Baseline to 3 months | 0.08 score on a scale | Standard Deviation 0.66 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--Catastrophizing | Baseline to 6 months | 0.11 score on a scale | Standard Deviation 0.62 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--Catastrophizing | Baseline to 12 months | 0.05 score on a scale | Standard Deviation 0.72 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Catastrophizing | Baseline to 3 months | 0.08 score on a scale | Standard Deviation 0.71 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Catastrophizing | Baseline to 6 months | 0.07 score on a scale | Standard Deviation 0.76 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Catastrophizing | Baseline to 12 months | 0.09 score on a scale | Standard Deviation 0.77 |
Comparison: Baseline to 3 monthsp-value: 0.22295% CI: [-0.15, 0.04]Mixed Models Analysis
Comparison: Baseline to 6 monthsp-value: 0.98895% CI: [-0.1, 0.09]Mixed Models Analysis
Comparison: Baseline to 12 monthsp-value: 0.26995% CI: [-0.16, 0.05]Mixed Models Analysis
Other Pre-specified
Change in Patient Reported Outcomes--Depressed Mood
The Patient Health Questionnaire-2 (PHQ2) form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure depressed mood. The PHQ2 form asks the participant to answer two questions about potential depressed mood within the past week with ratings between 0 and 3. The total score is the sum of responses to the two questions and is missing if either of the two questions is missing. The range of possible values is 0-6. A higher score indicates greater depressed mood.
Time frame: Baseline, three, six, and twelve months
Population: Participants with data collected collected at both timepoints needed to calculate a change.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Integrated Care Pathway | Change in Patient Reported Outcomes--Depressed Mood | Baseline to 3 months | 0.02 score on a scale | Standard Deviation 1.44 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--Depressed Mood | Baseline to 6 months | 0.09 score on a scale | Standard Deviation 1.58 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--Depressed Mood | Baseline to 12 months | -0.01 score on a scale | Standard Deviation 1.57 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Depressed Mood | Baseline to 3 months | 0.04 score on a scale | Standard Deviation 1.6 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Depressed Mood | Baseline to 6 months | 0.02 score on a scale | Standard Deviation 1.58 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Depressed Mood | Baseline to 12 months | 0.02 score on a scale | Standard Deviation 1.6 |
Comparison: Baseline to 3 monthsp-value: 0.89595% CI: [-0.22, 0.2]Mixed Models Analysis
Comparison: Baseline to 6 monthsp-value: 0.43895% CI: [-0.13, 0.3]Mixed Models Analysis
Comparison: Baseline to 12 monthsp-value: 0.8995% CI: [-0.24, 0.21]Mixed Models Analysis
Other Pre-specified
Change in Patient Reported Outcomes--Pain Intensity, Enjoyment of Life, General Activity (PEG) Screening Tool
The PEG screening tool scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure pain intensity. The PEG form asks the participant to rate a series of pain intensity related questions on a scale of 0-10 with 0 representing a better outcome. The total score is the sum of responses to the three questions and is missing if any of the three questions is missing. The range of possible values is 0-30.
Time frame: Baseline, three, six, and twelve months
Population: Participants with data collected collected at both timepoints needed to calculate a change.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Integrated Care Pathway | Change in Patient Reported Outcomes--Pain Intensity, Enjoyment of Life, General Activity (PEG) Screening Tool | Baseline to 3 months | -0.35 score on a scale | Standard Deviation 1.89 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--Pain Intensity, Enjoyment of Life, General Activity (PEG) Screening Tool | Baseline to 6 months | -0.44 score on a scale | Standard Deviation 1.94 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--Pain Intensity, Enjoyment of Life, General Activity (PEG) Screening Tool | Baseline to 12 months | -0.38 score on a scale | Standard Deviation 2.09 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Pain Intensity, Enjoyment of Life, General Activity (PEG) Screening Tool | Baseline to 3 months | -0.42 score on a scale | Standard Deviation 1.94 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Pain Intensity, Enjoyment of Life, General Activity (PEG) Screening Tool | Baseline to 6 months | -0.42 score on a scale | Standard Deviation 2.05 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Pain Intensity, Enjoyment of Life, General Activity (PEG) Screening Tool | Baseline to 12 months | -0.38 score on a scale | Standard Deviation 2.15 |
Comparison: Baseline to 3 monthsp-value: 0.85895% CI: [-0.23, 0.28]Mixed Models Analysis
Comparison: Baseline to 6 monthsp-value: 0.68895% CI: [-0.32, 0.21]Mixed Models Analysis
Comparison: Baseline to 12 monthsp-value: 0.83395% CI: [-0.32, 0.26]Mixed Models Analysis
Other Pre-specified
Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2)
Pain Self-Efficacy Questionnaire from the PSEQ-2 form will be collected by the interviewers at baseline, three, six, and twelve months post baseline and will evaluate self-efficacy on a scale of 0-6 with zero representing a worse outcome. The total score is the sum of responses to the two questions and is missing if either of the two questions is missing. The range of possible values is 0-12.
Time frame: Baseline, three, six, and twelve months
Population: Participants with data collected collected at both timepoints needed to calculate a change.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Integrated Care Pathway | Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2) | Baseline to 3 months | -0.13 score on a scale | Standard Deviation 2.82 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2) | Baseline to 6 months | -0.08 score on a scale | Standard Deviation 2.73 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2) | Baseline to 12 months | -0.22 score on a scale | Standard Deviation 2.88 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2) | Baseline to 3 months | -0.38 score on a scale | Standard Deviation 3.02 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2) | Baseline to 6 months | -0.46 score on a scale | Standard Deviation 2.98 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2) | Baseline to 12 months | -0.39 score on a scale | Standard Deviation 2.9 |
Comparison: Baseline to 3 monthsp-value: 0.25995% CI: [-0.18, 0.64]Mixed Models Analysis
Comparison: Baseline to 6 monthsp-value: 0.06895% CI: [-0.03, 0.81]Mixed Models Analysis
Comparison: Baseline to 12 monthsp-value: 0.51495% CI: [-0.29, 0.57]Mixed Models Analysis
Other Pre-specified
Change in Patient Reported Outcomes--Quality of Life
The EuroQoL five-item quality of life questionnaire, EQ-5D-5L, will be administered by interviewers at baseline, three, six, and twelve months post baseline to measure quality of life. The EQ-5D-5L asks the participant five questions related to quality of life on a scale of 1-5. If all questions are answered, the responses are concatenated to form a 5-digit state in the order mobility, self care, usual activities, pain discomfort, anxiety/depression. This 5-digit state is then converted to an index between 0 and 1. A higher score indicates greater quality of life.
Time frame: Baseline, three, six, and twelve months
Population: Participants with data collected collected at both timepoints needed to calculate a change.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Integrated Care Pathway | Change in Patient Reported Outcomes--Quality of Life | Baseline to 3 months | -0.04 score on a scale | Standard Deviation 0.26 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--Quality of Life | Baseline to 6 months | 0.04 score on a scale | Standard Deviation 0.26 |
| Integrated Care Pathway | Change in Patient Reported Outcomes--Quality of Life | Baseline to 12 months | -0.04 score on a scale | Standard Deviation 0.26 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Quality of Life | Baseline to 3 months | -0.03 score on a scale | Standard Deviation 0.25 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Quality of Life | Baseline to 6 months | -0.04 score on a scale | Standard Deviation 0.25 |
| Coordinated Care Management Pathway | Change in Patient Reported Outcomes--Quality of Life | Baseline to 12 months | -0.02 score on a scale | Standard Deviation 0.26 |
Comparison: Baseline to 3 monthsp-value: 0.50895% CI: [-0.04, 0.02]Mixed Models Analysis
Comparison: Baseline to 6 monthsp-value: 0.99295% CI: [-0.03, 0.03]Mixed Models Analysis
Comparison: Baseline to 12 monthsp-value: 0.38995% CI: [-0.05, 0.02]Mixed Models Analysis