Musculoskeletal Pain
Conditions
Keywords
Musculoskeletal Pain, Walking, African American, Telephone Coaching, Pedometer
Brief summary
The long term goal is to improve the quality and equity of chronic pain treatment among VA patients. The primary objective of this study is to improve pain outcomes among black VA patients with chronic, musculoskeletal (MSK) pain, who experience poorer pain treatment and outcomes than their white counterparts. The work proposed is expected to result in a non-pharmacological intervention, delivered by telephone, designed to reduce pain and improve functioning among black patients with MSK pain, by promoting walking. This intervention is specifically designed to address factors that contribute to MSK pain among black Veterans; however, the investigators expect that it will also benefit non-black Veterans. The proposed research is innovative, in its use of proactive outreach and recent advances in self-regulation strategies (such as Action Planning) to help black Veterans overcome psychological, environmental, utilization-related, and provider-related barriers that contribute to pain.
Detailed description
BACKGROUND/RATIONALE: Chronic musculoskeletal (MSK) pain is one of the most common conditions among Veterans, affecting approximately 60% of those seen in VA primary care. Although perceived effectiveness of chronic pain treatment is low among all VA patients, black patients are less likely than whites to perceive their treatment as effective, and are more likely to experience functional limitations due to pain. There is growing consensus that chronic pain is best addressed by a biopsychosocial approach that acknowledges the role of psychological and environmental contributors to pain, some of which differ by race and hence contribute to disparities. For example, blacks experience greater pain-related fear and lower self-efficacy in coping with pain (psychological contributors), and neighborhoods that make physical activity difficult (environmental contributors). However, there is a lack of effective interventions to improve pain treatment among minority patients, particularly those that target psychological and environmental contributors. OBJECTIVES: The long term goal is to improve the quality and equity of pain treatment in order to improve pain outcomes for all Veterans. The objective of this application is to test the effectiveness of a multi-component intervention that specifically targets known barriers to effective pain care among black Veterans with chronic MSK pain. The primary hypothesis is that a telephone-delivered intervention, which emphasizes walking and incorporates Action Planning, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) techniques, and the use of pedometers, will improve core chronic pain outcomes in black Veterans. Secondarily, we will determine whether our intervention also benefits non-black patients with MSK. METHODS: The investigators propose a randomized trial to test the effectiveness of the intervention compared with usual care (UC) among 500 patients with chronic MSK pain, with a minimum of 250 Black participants. Patients from the Atlanta VAMC will be identified using administrative data. Patients will be screened by phone, and, if eligible, will be mailed the baseline survey to complete and mail back. Eligible patients who complete the baseline survey will be randomly assigned to the usual care (UC) or intervention condition (IC). Intervention participants will receive a pedometer-mediated walking intervention that will incorporate Action Planning and the use of MI and CBT techniques. The intervention will be delivered in 6 telephone counseling sessions over three months. Patients in the UC condition will receive an informational brochure and a pedometer. The study is powered to find a difference between the IC and UC groups within the black and non-black groups. The primary outcome is chronic pain-related physical functioning, assessed by the revised Roland and Morris Disability Questionnaire, a measure recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). We will also examine whether the intervention improves other IMMPACT-recommended domains (pain intensity, emotional functioning, and ratings of overall improvement). Secondary objectives include examining potential mediators targeted by the intervention, exploring whether the intervention affects service utilization and use of opioid analgesics, and exploring whether the intervention reduces racial disparities in pain outcomes. Measures will be assessed by mail and phone survey at baseline, 3 months, and 6 months. Data analysis of primary aims will follow intent-to-treat methodology. FINDINGS: None at this time. STATUS: Focus groups were conducted at the Atlanta VAMC in September and October 2015. These focus groups provided valuable information that led us to refine our recruitment materials. Focus groups also yielded important information for our counselors, including potential communication barriers and barriers to walking. During January - April 2016, we conducted a pilot test of our intervention with 3 participants. We began the trial on July 2016. Recruitment and randomization were completed in June 2019. The intervention activities were completed in September 2019. Follow-up survey data collection is currently ongoing. IMPACT: The work proposed is expected to result in a non-pharmacological intervention, delivered by telephone, designed to reduce pain and improve functioning among black patients with MSK pain, by promoting walking.
Interventions
BEHAVIORALIntervention Condition
Intervention participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Intervention participants will receive a pedometer-mediated walking intervention that will incorporate Action Planning and the use of MI and CBT techniques. The intervention will be delivered in 6 telephone counseling sessions over three months.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Eligible patients must receive care at the Atlanta VAMC and * have back, hip or knee pain for a duration of at least 6 months, * moderate-severe pain intensity and interference with function (defined as a PEG score of 5 or greater), * self-reported ability to walk at least 1 block, and * must be able to communicate effectively by telephone (no cognitive disability). The investigators will not exclude patients who are on medication or receiving interventions to treat their chronic pain. The investigators will include the approximately 10% of patients who have no race data; race data will be collected on the brief screening survey.
Exclusion criteria
The investigators will not include any vulnerable populations or those who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 6 Months | Assessed at baseline and 6 months | 30% improvement on the Roland Morris Disability Questionnaire \[RMDQ\]) from baseline over the 6-month follow-up period. Minimum value: 0. Maximum value: 11. Higher scores indicate greater disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression at 6 Months | Baseline and 6 months | Change in Depression at 6 months assessed by 8-item Patient Health Questionnaire (PHQ-8). Min=0, max=24, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months. |
| Mean Change in Average Daily Total Steps at 6 Months | baseline and 6 months | Pedometer data recorded over past 7 days on patient logs The investigators will assess mean change in this outcome from baseline to 6 months. |
| 30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 3 Months | Baseline and 3 months | 30% improvement on the Roland Morris Disability Questionnaire \[RMDQ\]) from baseline over the 3-month follow-up period. Minimum = 0 Maximum = 11 Higher scores indicate greater disability The investigators will assess change in this outcome from baseline to 3 months. |
| Change in Brief Pain Intensity Scale at 3 Months | Baseline and 3 months | Pain intensity assessed by Brief Pain Intensity Scale Min=0, max=10, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months. |
| Change in Generalized Anxiety Disorder, at 3 Months | Baseline and 3 months | Change in Generalized Anxiety Disorder (GAD-7). Min=0, max=21, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months. |
| Change in Depression Using 3 Month | Baseline and 3 months | Change in Depression at 3 months using the 8-item Patient Health Questionnaire (PHQ-8) Min=0, max=24, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months. |
| Overall Improvement Assessed by Patient Global Impression of Change Scale at 3 Months | 3 months | Single item measure of patient global impression of change. The investigators will assess this outcome using the 3-month assessment. Min=1, max=7, higher scores indicate worse outcome |
| Mean Change in Average Daily Total Steps, at 3 Months | 3 months | Pedometer data recorded over past 7 days on patient logs. The investigators will assess mean change in this outcome from baseline to 3 months. |
| Change in Brief Pain Intensity Scale at 6 Months | Baseline and 6 months | Pain intensity assessed by change in Brief Pain Intensity Scale at 6 months. Min=0, max=10, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months. |
| Change in Generalized Anxiety Disorder at 6 Months | Baseline and 6 months | Change in Generalized Anxiety Disorder assessed by 7-item Generalized Anxiety Disorder scale (GAD-7) Min=0, max=21, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months. |
| Overall Improvement Assessed by Patient Global Impression of Change Scale at 6 Months | 6 months | Single item measure of patient global impression of change. The investigators will assess this outcome at 6 months. Min=1, max=7, higher scores indicate worse outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain-related Fear Avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) Scale 1 at 6 Months. | 6 months | Pain-related Fear Avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) Scale 1 at 6 months. Min=0, max=24, higher scores indicate worse outcome. |
| Marcus Social Support Questions | 6 months | Family Social Support for Exercise at 6 months Min: 0 Max: 40 Higher scores indicate greater social support. |
| Service Utilization Treatment Quality at 6 Months | 6 months | Rating of quality of pain care received at the VA. Scale 1 (poor) to 5 (excellent) |
| Opioid Use for Pain Treatment at 6 Months | 6 months | Use of Opioids for pain treatment - Yes/No. |
| Subjective Social Status | 3 months | Ladder representing subjective social status Min: 1; Max: 10 Higher numbers indicated greater subjective social status |
| Pain Self-efficacy Questionnaire (PSEQ) at 6 Months | 6 months | Pain self-efficacy questionnaire (PSEQ) at 6 months Min: 10; Max: 60 Higher scores reflect stronger self-efficacy beliefs |
| Exercise Self-efficacy- Exercise Regularity Scale at 6 Months | 6 months | Exercise self-efficacy and regularity scale at 6 months Min=1, max=10, higher scores indicate better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Usual Care Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys. | 249 |
| Arm 2: Intervention Group Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring. | 251 |
| Total | 500 |
Baseline characteristics
| Characteristic | Arm 1: Usual Care | Arm 2: Intervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 83 Participants | 81 Participants | 164 Participants |
| Age, Categorical Between 18 and 65 years | 166 Participants | 170 Participants | 336 Participants |
| Age, Continuous | 59.4 years STANDARD_DEVIATION 10.9 | 59.6 years STANDARD_DEVIATION 11.1 | 59.4 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 2 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 241 Participants | 248 Participants | 489 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Region of Enrollment United States | 249 Participants | 251 Participants | 500 Participants |
| Sex: Female, Male Female | 66 Participants | 58 Participants | 124 Participants |
| Sex: Female, Male Male | 183 Participants | 193 Participants | 376 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 249 | 0 / 250 |
| other Total, other adverse events | 0 / 249 | 0 / 251 |
| serious Total, serious adverse events | 0 / 249 | 0 / 250 |
Outcome results
Primary
30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 6 Months
30% improvement on the Roland Morris Disability Questionnaire \[RMDQ\]) from baseline over the 6-month follow-up period. Minimum value: 0. Maximum value: 11. Higher scores indicate greater disability.
Time frame: Assessed at baseline and 6 months
Population: Primary Analysis completed in Black participants only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Usual Care | 30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 6 Months | 38 participants w/ >= 30% improvement |
| Arm 2: Intervention Group | 30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 6 Months | 46 participants w/ >= 30% improvement |
Comparison: measured change as a responder yes/no (30% or greater improvement from baseline).p-value: 0.0995% CI: [0.94, 2.77]Regression, Logistic
Secondary
30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 3 Months
30% improvement on the Roland Morris Disability Questionnaire \[RMDQ\]) from baseline over the 3-month follow-up period. Minimum = 0 Maximum = 11 Higher scores indicate greater disability The investigators will assess change in this outcome from baseline to 3 months.
Time frame: Baseline and 3 months
Population: Analysis completed in Black participants only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Usual Care | 30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 3 Months | 34 participants w/ >= 30% improvement |
| Arm 2: Intervention Group | 30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 3 Months | 40 participants w/ >= 30% improvement |
Comparison: measured change as a responder yes/no (30% or greater improvement from baseline).p-value: 0.1695% CI: [0.85, 2.62]Regression, Logistic
Secondary
Change in Brief Pain Intensity Scale at 3 Months
Pain intensity assessed by Brief Pain Intensity Scale Min=0, max=10, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months.
Time frame: Baseline and 3 months
Population: Analysis completed in Black participants only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Usual Care | Change in Brief Pain Intensity Scale at 3 Months | 0.02 units on a scale | Standard Error 0.14 |
| Arm 2: Intervention Group | Change in Brief Pain Intensity Scale at 3 Months | -0.58 units on a scale | Standard Error 0.15 |
p-value: 0.00295% CI: [-0.99, -0.23]Regression, Linear
Secondary
Change in Brief Pain Intensity Scale at 6 Months
Pain intensity assessed by change in Brief Pain Intensity Scale at 6 months. Min=0, max=10, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months.
Time frame: Baseline and 6 months
Population: Analysis completed in Black participants only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Usual Care | Change in Brief Pain Intensity Scale at 6 Months | -0.24 change in score on a scale | Standard Error 0.14 |
| Arm 2: Intervention Group | Change in Brief Pain Intensity Scale at 6 Months | -0.45 change in score on a scale | Standard Error 0.15 |
p-value: 0.3495% CI: [-0.62, 0.21]Regression, Linear
Secondary
Change in Depression at 6 Months
Change in Depression at 6 months assessed by 8-item Patient Health Questionnaire (PHQ-8). Min=0, max=24, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months.
Time frame: Baseline and 6 months
Population: Analysis completed in Black participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Usual Care | Change in Depression at 6 Months | -0.96 change in score on a scale | Standard Error 0.38 |
| Arm 2: Intervention Group | Change in Depression at 6 Months | -1.56 change in score on a scale | Standard Error 0.4 |
p-value: 0.2895% CI: [-1.68, 0.49]Regression, Linear
Secondary
Change in Depression Using 3 Month
Change in Depression at 3 months using the 8-item Patient Health Questionnaire (PHQ-8) Min=0, max=24, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months.
Time frame: Baseline and 3 months
Population: Analysis completed in Black participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Usual Care | Change in Depression Using 3 Month | -1.27 units on a scale | Standard Error 0.42 |
| Arm 2: Intervention Group | Change in Depression Using 3 Month | -0.79 units on a scale | Standard Error 0.43 |
p-value: 0.4195% CI: [-0.66, 1.62]Regression, Linear
Secondary
Change in Generalized Anxiety Disorder, at 3 Months
Change in Generalized Anxiety Disorder (GAD-7). Min=0, max=21, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months.
Time frame: Baseline and 3 months
Population: Analysis completed in Black participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Usual Care | Change in Generalized Anxiety Disorder, at 3 Months | -0.75 units on a scale | Standard Error 0.42 |
| Arm 2: Intervention Group | Change in Generalized Anxiety Disorder, at 3 Months | -0.39 units on a scale | Standard Error 0.44 |
p-value: 0.5495% CI: [-0.79, 1.51]Regression, Linear
Secondary
Change in Generalized Anxiety Disorder at 6 Months
Change in Generalized Anxiety Disorder assessed by 7-item Generalized Anxiety Disorder scale (GAD-7) Min=0, max=21, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months.
Time frame: Baseline and 6 months
Population: Analysis completed in Black participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Usual Care | Change in Generalized Anxiety Disorder at 6 Months | -0.43 change in score on a scale | Standard Error 0.41 |
| Arm 2: Intervention Group | Change in Generalized Anxiety Disorder at 6 Months | -0.95 change in score on a scale | Standard Error 0.43 |
p-value: 0.3895% CI: [-1.69, 0.65]Regression, Linear
Secondary
Mean Change in Average Daily Total Steps, at 3 Months
Pedometer data recorded over past 7 days on patient logs. The investigators will assess mean change in this outcome from baseline to 3 months.
Time frame: 3 months
Population: Analysis completed in Black participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Usual Care | Mean Change in Average Daily Total Steps, at 3 Months | 92.97 change in number of steps | Standard Error 207.63 |
| Arm 2: Intervention Group | Mean Change in Average Daily Total Steps, at 3 Months | 633.75 change in number of steps | Standard Error 219.56 |
p-value: 0.0695% CI: [-28.77, 1110.33]Regression, Linear
Secondary
Mean Change in Average Daily Total Steps at 6 Months
Pedometer data recorded over past 7 days on patient logs The investigators will assess mean change in this outcome from baseline to 6 months.
Time frame: baseline and 6 months
Population: Analysis completed in Black participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Usual Care | Mean Change in Average Daily Total Steps at 6 Months | 397.21 change in number of steps | Standard Error 220.03 |
| Arm 2: Intervention Group | Mean Change in Average Daily Total Steps at 6 Months | 591.11 change in number of steps | Standard Error 243.02 |
p-value: 0.5695% CI: [-454.93, 842.73]Regression, Linear
Secondary
Overall Improvement Assessed by Patient Global Impression of Change Scale at 3 Months
Single item measure of patient global impression of change. The investigators will assess this outcome using the 3-month assessment. Min=1, max=7, higher scores indicate worse outcome
Time frame: 3 months
Population: Analysis completed in Black participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Usual Care | Overall Improvement Assessed by Patient Global Impression of Change Scale at 3 Months | 4.51 units on a scale | Standard Error 0.13 |
| Arm 2: Intervention Group | Overall Improvement Assessed by Patient Global Impression of Change Scale at 3 Months | 3.79 units on a scale | Standard Error 0.13 |
p-value: <0.000195% CI: [-1.07, -0.38]Regression, Linear
Secondary
Overall Improvement Assessed by Patient Global Impression of Change Scale at 6 Months
Single item measure of patient global impression of change. The investigators will assess this outcome at 6 months. Min=1, max=7, higher scores indicate worse outcome.
Time frame: 6 months
Population: Analysis completed in Black participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Usual Care | Overall Improvement Assessed by Patient Global Impression of Change Scale at 6 Months | 3.87 units on a scale | Standard Error 0.14 |
| Arm 2: Intervention Group | Overall Improvement Assessed by Patient Global Impression of Change Scale at 6 Months | 4.26 units on a scale | Standard Error 0.13 |
p-value: 0.0595% CI: [0, 0.77]Regression, Linear
Other Pre-specified
Exercise Self-efficacy- Exercise Regularity Scale at 6 Months
Exercise self-efficacy and regularity scale at 6 months Min=1, max=10, higher scores indicate better outcome.
Time frame: 6 months
Population: Analysis completed in Black participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Usual Care | Exercise Self-efficacy- Exercise Regularity Scale at 6 Months | 4.45 score on a scale | Standard Error 0.22 |
| Arm 2: Intervention Group | Exercise Self-efficacy- Exercise Regularity Scale at 6 Months | 5.21 score on a scale | Standard Error 0.23 |
p-value: 0.0195% CI: [0.15, 1.36]Regression, Linear
Other Pre-specified
Marcus Social Support Questions
Family Social Support for Exercise at 6 months Min: 0 Max: 40 Higher scores indicate greater social support.
Time frame: 6 months
Population: Analysis completed in Black participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Usual Care | Marcus Social Support Questions | 10.37 score on a scale | Standard Error 0.41 |
| Arm 2: Intervention Group | Marcus Social Support Questions | 10.70 score on a scale | Standard Error 0.43 |
p-value: 0.5695% CI: [-0.8, 1.47]Regression, Linear
Other Pre-specified
Opioid Use for Pain Treatment at 6 Months
Use of Opioids for pain treatment - Yes/No.
Time frame: 6 months
Population: Analysis completed in Black participants only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Usual Care | Opioid Use for Pain Treatment at 6 Months | 79 participants who reported using Opioids |
| Arm 2: Intervention Group | Opioid Use for Pain Treatment at 6 Months | 80 participants who reported using Opioids |
p-value: 0.5695% CI: [0.66, 2.19]Regression, Logistic
Other Pre-specified
Pain-related Fear Avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) Scale 1 at 6 Months.
Pain-related Fear Avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) Scale 1 at 6 months. Min=0, max=24, higher scores indicate worse outcome.
Time frame: 6 months
Population: Analysis completed in Black participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Usual Care | Pain-related Fear Avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) Scale 1 at 6 Months. | 16.23 score on a scale | Standard Error 0.53 |
| Arm 2: Intervention Group | Pain-related Fear Avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) Scale 1 at 6 Months. | 15.17 score on a scale | Standard Error 0.55 |
p-value: 0.1595% CI: [-2.53, 0.39]Regression, Linear
Other Pre-specified
Pain Self-efficacy Questionnaire (PSEQ) at 6 Months
Pain self-efficacy questionnaire (PSEQ) at 6 months Min: 10; Max: 60 Higher scores reflect stronger self-efficacy beliefs
Time frame: 6 months
Population: Analysis completed in Black participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Usual Care | Pain Self-efficacy Questionnaire (PSEQ) at 6 Months | 32.22 score on a scale | Standard Error 1.08 |
| Arm 2: Intervention Group | Pain Self-efficacy Questionnaire (PSEQ) at 6 Months | 35.15 score on a scale | Standard Error 1.09 |
p-value: 0.0595% CI: [-0.01, 5.86]Regression, Linear
Other Pre-specified
Service Utilization Treatment Quality at 6 Months
Rating of quality of pain care received at the VA. Scale 1 (poor) to 5 (excellent)
Time frame: 6 months
Population: Analysis completed in Black participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Usual Care | Service Utilization Treatment Quality at 6 Months | 2.75 units on a scale | Standard Error 0.11 |
| Arm 2: Intervention Group | Service Utilization Treatment Quality at 6 Months | 2.89 units on a scale | Standard Error 0.12 |
p-value: 0.3895% CI: [-0.17, 0.46]Regression, Linear
Other Pre-specified
Subjective Social Status
Ladder representing subjective social status Min: 1; Max: 10 Higher numbers indicated greater subjective social status
Time frame: 3 months
Population: Analysis completed in Black participants only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Usual Care | Subjective Social Status | 5.13 units on a scale | Standard Error 0.19 |
| Arm 2: Intervention Group | Subjective Social Status | 5.47 units on a scale | Standard Error 0.19 |
p-value: 0.2195% CI: [-0.18, 0.84]Regression, Linear