| Primary | Change in Pain Interference | The total Brief Pain Inventory (BPI) interference sub-scale score is our primary outcome measure. Pain interference was calculated as the mean of the 7 pain-interference items (scale ranged 0-10; higher scores indicate greater pain interference). | Some participants dropped out of the study prior to completing the 12-month assessment. Other participants either failed to complete the 12-month assessment or elected to not answer specific questions. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Whole Health Team (WHT) Intervention Arm | The WHT intervention arm includes four core elements: 1) An interdisciplinary WHT collaborating with primary care; 2) Personalized Health Planning with prioritization of multi-modal non-pharmacological and CIH pain management approaches; 3) Whole Health Coaching sessions to assist patients in developing and implementing a Personalized Health Plan for chronic pain care; and 4) the web/mobile Whole Health Resource Directory provided to patient participants (in addition to their providers) to support non-pharmacologic/CIH chronic pain care. | | OG001 | Primary Care Group Education (PC-GE) Intervention Arm | Primary Care Group Education (PC-GE) iss the comparator arm, which is an abbreviated form of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) adapted for group use in primary care. | | OG002 | Usual Primary Care (UPC) Arm | In VA, patient-aligned care teams (PACTs) or primary care is step 1 of VA's Stepped Care Model in the treatment of chronic pain. PCPs are expected to possess the requisite skill set for management of common chronic pain-causing conditions, which includes biopsychosocial assessment, multi-modal treatment, and coordination of specialty pain care after shared-decision making that incorporates patient preferences and values. Participants randomized to this arm will continue to have their PCP and PACT serve in this role. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0004.91± 0.16
- OG0015.49± 0.18
- OG0025.69± 0.20
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Reference Group: Primary Care Group Education (PC-GE) Intervention Arm | Regression, Linear | Adjusted for baseline BPI, time, time*treatment, randomization stratification variables. | .02 | To control for multiple comparisons, P<0.03 was used as a significance threshold for comparing whole health team vs. cognitive behavioral therapy. | Mean Difference (Final Values) | -0.58 | | | 2-Sided | 95 | -1.11 | -0.05 | | | Values are differences in least-squares means. | | Superiority |
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| Secondary | Change in Pain Severity | Change in pain severity was measured using the pain severity subscale from the Brief Pain Inventory (BPI). Pain severity was calculated as the mean of the 4 pain-severity items (scores ranged 0-10; higher scores indicate greater pain severity). | Some participants dropped out of the study prior to completing the 12-month assessment. Other participants either failed to complete the 12-month assessment or elected to not answer specific questions. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Whole Health Team (WHT) Intervention Arm | The WHT intervention arm includes four core elements: 1) An interdisciplinary WHT collaborating with primary care; 2) Personalized Health Planning with prioritization of multi-modal non-pharmacological and CIH pain management approaches; 3) Whole Health Coaching sessions to assist patients in developing and implementing a Personalized Health Plan for chronic pain care; and 4) the web/mobile Whole Health Resource Directory provided to patient participants (in addition to their providers) to support non-pharmacologic/CIH chronic pain care. | | OG001 | Primary Care Group Education (PC-GE) Intervention Arm | Primary Care Group Education (PC-GE) iss the comparator arm, which is an abbreviated form of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) adapted for group use in primary care. |
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| Secondary | Functioning (VR-12 Physical Component Score) | The investigators will assess functioning and quality of life using the THE VETERANS RAND 12-ITEM HEALTH SURVEY (VR-12). VR-12 scores were calculated using an algorithm provided by developers (available upon request). Functioning was determined using the physical component score. Subscales were developed to have a mean of 50 with a standard deviation of 10 in the reference population. Higher scores indicate better physical or mental functioning. Reported scores are adjusted means with corresponding standard errors, estimated using the LSMEANS statement in SAS 9.4 PROC GLIMMIX. | Some participants dropped out of the study prior to completing the 12-month assessment. Other participants either failed to complete the 12-month assessment or elected to not answer specific questions. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Whole Health Team (WHT) Intervention Arm | The WHT intervention arm includes four core elements: 1) An interdisciplinary WHT collaborating with primary care; 2) Personalized Health Planning with prioritization of multi-modal non-pharmacological and CIH pain management approaches; 3) Whole Health Coaching sessions to assist patients in developing and implementing a Personalized Health Plan for chronic pain care; and 4) the web/mobile Whole Health Resource Directory provided to patient participants (in addition to their providers) to support non-pharmacologic/CIH chronic pain care. | | OG001 | Primary Care Group Education (PC-GE) Intervention Arm |
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| Secondary | Quality of Life (VR-12 Mental Component Score) | The investigators will assess functioning and quality of life using the THE VETERANS RAND 12-ITEM HEALTH SURVEY (VR-12). VR-12 scores were calculated using an algorithm provided by developers (available upon request). Quality of life was determined using the mental component score. Subscales were developed to have a mean of 50 with a standard deviation of 10 in the reference population. Higher scores indicate better physical or mental functioning. Reported scores are adjusted means with corresponding standard errors, estimated using the LSMEANS statement in SAS 9.4 PROC GLIMMIX. | Some participants dropped out of the study prior to completing the 12-month assessment. Other participants either failed to complete the 12-month assessment or elected to not answer specific questions. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Whole Health Team (WHT) Intervention | WHT was an interdisciplinary, individualized pain care intervention informed by the VA Whole Health Model. The WHT included three members: a physician or nurse practitioner who could prescribe pain medication and refer patients to non-pharmacologic pain care; another clinician who could directly provide integrative pain care such as a physical therapist or chiropractor; and one wellness coach. WHT members met briefly each week to coordinate patients' care. Coaches met with patients first and educated them about the eight domains of Whole Health: sleep, nutrition, physical activity, emotional health, personal development, environment, spirituality, and social support. Coaches asked patients to consider "what matters most to them" and what they would be willing to change that might improve pain (such as weight loss for knee pain in overweight patients). Next, during an initial visit, clinicians assessed patients' pain complaints and medical history, provided integrative pain care, and collaboratively developed treatment plans aligned with patients' personal values and life goals. After these initial visits, coaches delivered at least eight weekly telephone coaching sessions to support patients' goal attainment. Over the 12-month follow-up period, patients completed at least three clinician follow-up visits for pain management, and one final discharge planning visit. Patients could attend additional coaching and clinician visits if needed over the 12-month follow-up period. |
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| Secondary | PROMIS Sleep Disturbance | The investigators will assess sleep and fatigue symptoms using the PROMIS - Sleep Disturbance. Sleep disturbance was scored as the sum of individual items, with items 2,3,7, and 8 reversed prior to summation (range 8-40; higher scores indicate greater sleep disturbance). The investigators will be screening for suicidality using the final question of the PHQ-9. | Some participants dropped out of the study prior to completing the 12-month assessment. Other participants either failed to complete the 12-month assessment or elected to not answer specific questions. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Whole Health Team (WHT) Intervention Arm | The WHT intervention arm includes four core elements: 1) An interdisciplinary WHT collaborating with primary care; 2) Personalized Health Planning with prioritization of multi-modal non-pharmacological and CIH pain management approaches; 3) Whole Health Coaching sessions to assist patients in developing and implementing a Personalized Health Plan for chronic pain care; and 4) the web/mobile Whole Health Resource Directory provided to patient participants (in addition to their providers) to support non-pharmacologic/CIH chronic pain care. | | OG001 | Primary Care Group Education (PC-GE) Intervention Arm | Primary Care Group Education (PC-GE) iss the comparator arm, which is an abbreviated form of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) adapted for group use in primary care. |
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| Secondary | Engagement in a Greater Number of Non-pharmacological Pain Management Activities | Past-year use of complementary therapies and self-management practices was measured using the Nonpharmacological and Self-Care Approaches from PMC (NSCAP). Categories of nonpharmacological activities included: 1. Acupuncture; 2. Manipulation; 3. Massage; 4. Yoga; 5. Tai Chi/Qigong; 6. Exercise; 7. Relaxation techniques; 8. Meditation/mindfulness; 9. Psychotherapy/counseling; or 10. Other. Each category was counted only once. | Some participants dropped out of the study prior to completing the 12-month assessment. Other participants either failed to complete the 12-month assessment or elected to not answer specific questions. | Posted | | Least Squares Mean | Standard Error | # of Nonpharmacological Approaches Used | | 12 months | | | | ID | Title | Description |
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| OG000 | Whole Health Team (WHT) Intervention Arm | The WHT intervention arm includes four core elements: 1) An interdisciplinary WHT collaborating with primary care; 2) Personalized Health Planning with prioritization of multi-modal non-pharmacological and CIH pain management approaches; 3) Whole Health Coaching sessions to assist patients in developing and implementing a Personalized Health Plan for chronic pain care; and 4) the web/mobile Whole Health Resource Directory provided to patient participants (in addition to their providers) to support non-pharmacologic/CIH chronic pain care. | | OG001 | Primary Care Group Education (PC-GE) Intervention Arm | |
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| Secondary | Suicidal Ideation | Suicidal ideation was a single item analyzed as binary (yes/no) taken from the final question of the 9-item Patient Health Questionnaire (PHQ-9) which asked if participants have been bothered during the last 2 weeks by "Thoughts that you would be better off dead or of hurting yourself in some way." Values are reported from the 12-month assessment. The table indicates how many participants endorsed those thoughts "Several days", "More than half the days," and "Nearly every day" compared with "Not at all". | Some participants dropped out of the study prior to completing the 12-month assessment. Other participants either failed to complete the 12-month assessment or elected to not answer specific questions. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
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| OG000 | Whole Health Team (WHT) Intervention | WHT was an interdisciplinary, individualized pain care intervention informed by the VA Whole Health Model. The WHT included three members: a physician or nurse practitioner who could prescribe pain medication and refer patients to non-pharmacologic pain care; another clinician who could directly provide integrative pain care such as a physical therapist or chiropractor; and one wellness coach. WHT members met briefly each week to coordinate patients' care. Coaches met with patients first and educated them about the eight domains of Whole Health: sleep, nutrition, physical activity, emotional health, personal development, environment, spirituality, and social support. Coaches asked patients to consider "what matters most to them" and what they would be willing to change that might improve pain (such as weight loss for knee pain in overweight patients). Next, during an initial visit, clinicians assessed patients' pain complaints and medical history, provided integrative pain care, and collaboratively developed treatment plans aligned with patients' personal values and life goals. After these initial visits, coaches delivered at least eight weekly telephone coaching sessions to support patients' goal attainment. Over the 12-month follow-up period, patients completed at least three clinician follow-up visits for pain management, and one final discharge planning visit. Patients could attend additional coaching and clinician visits if needed over the 12-month follow-up period. |
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| Secondary | Decreased Use of Higher-risk Pain Medications, Including Opioids or High-risk Combinations of Pain Medications (i.e., Co-prescription of Opioids and Benzodiazepines) | The investigators will utilize the VA administrative data/databases to obtain information on prescription medications, including generic name, dispensing information, dose, and instructions. Decreased opioid dose (Morphine Equivalent Daily Dose, MEDD) from baseline (binary: yes/no). | Some participants dropped out of the study prior to completing the 12-month assessment. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
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| OG000 | Whole Health Team (WHT) Intervention Arm | The WHT intervention arm includes four core elements: 1) An interdisciplinary WHT collaborating with primary care; 2) Personalized Health Planning with prioritization of multi-modal non-pharmacological and CIH pain management approaches; 3) Whole Health Coaching sessions to assist patients in developing and implementing a Personalized Health Plan for chronic pain care; and 4) the web/mobile Whole Health Resource Directory provided to patient participants (in addition to their providers) to support non-pharmacologic/CIH chronic pain care. | | OG001 | Primary Care Group Education (PC-GE) Intervention Arm | Primary Care Group Education (PC-GE) iss the comparator arm, which is an abbreviated form of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) adapted for group use in primary care. |
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| Secondary | BPI Total Score | The total BPI score was calculated as the mean of all 11 items (range 0-10; higher scores indicate greater overall pain). | Some participants dropped out of the study prior to completing the 12-month assessment. Other participants either failed to complete the 12-month assessment or elected to not answer specific questions. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Whole Health Team (WHT) Intervention | WHT was an interdisciplinary, individualized pain care intervention informed by the VA Whole Health Model. The WHT included three members: a physician or nurse practitioner who could prescribe pain medication and refer patients to non-pharmacologic pain care; another clinician who could directly provide integrative pain care such as a physical therapist or chiropractor; and one wellness coach. WHT members met briefly each week to coordinate patients' care. Coaches met with patients first and educated them about the eight domains of Whole Health: sleep, nutrition, physical activity, emotional health, personal development, environment, spirituality, and social support. Coaches asked patients to consider "what matters most to them" and what they would be willing to change that might improve pain (such as weight loss for knee pain in overweight patients). Next, during an initial visit, clinicians assessed patients' pain complaints and medical history, provided integrative pain care, and collaboratively developed treatment plans aligned with patients' personal values and life goals. After these initial visits, coaches delivered at least eight weekly telephone coaching sessions to support patients' goal attainment. Over the 12-month follow-up period, patients completed at least three clinician follow-up visits for pain management, and one final discharge planning visit. Patients could attend additional coaching and clinician visits if needed over the 12-month follow-up period. |
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| Secondary | Anxiety (GAD-7) | Anxiety was measured using the Generalized Anxiety Disorder 7-item measure (GAD-7). This was scored as the sum of 7 items (range 0-21; higher scores indicate greater anxiety.) | Some participants dropped out of the study prior to completing the 12-month assessment. Other participants either failed to complete the 12-month assessment or elected to not answer specific questions. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Whole Health Team (WHT) Intervention Arm | The WHT intervention arm includes four core elements: 1) An interdisciplinary WHT collaborating with primary care; 2) Personalized Health Planning with prioritization of multi-modal non-pharmacological and CIH pain management approaches; 3) Whole Health Coaching sessions to assist patients in developing and implementing a Personalized Health Plan for chronic pain care; and 4) the web/mobile Whole Health Resource Directory provided to patient participants (in addition to their providers) to support non-pharmacologic/CIH chronic pain care. | | OG001 | Primary Care Group Education (PC-GE) Intervention Arm | Primary Care Group Education (PC-GE) iss the comparator arm, which is an abbreviated form of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) adapted for group use in primary care. | | OG002 |
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| Secondary | Depression (PHQ-9) | The Patient Health Questionnaire 9-item scale (PHQ-9) was used to measure depression. This was scored as the sum of 9 items (range 0-27; higher scores indicate greater depression). | Some participants dropped out of the study prior to completing the 12-month assessment. Other participants either failed to complete the 12-month assessment or elected to not answer specific questions. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Whole Health Team (WHT) Intervention | WHT was an interdisciplinary, individualized pain care intervention informed by the VA Whole Health Model. The WHT included three members: a physician or nurse practitioner who could prescribe pain medication and refer patients to non-pharmacologic pain care; another clinician who could directly provide integrative pain care such as a physical therapist or chiropractor; and one wellness coach. WHT members met briefly each week to coordinate patients' care. Coaches met with patients first and educated them about the eight domains of Whole Health: sleep, nutrition, physical activity, emotional health, personal development, environment, spirituality, and social support. Coaches asked patients to consider "what matters most to them" and what they would be willing to change that might improve pain (such as weight loss for knee pain in overweight patients). Next, during an initial visit, clinicians assessed patients' pain complaints and medical history, provided integrative pain care, and collaboratively developed treatment plans aligned with patients' personal values and life goals. After these initial visits, coaches delivered at least eight weekly telephone coaching sessions to support patients' goal attainment. Over the 12-month follow-up period, patients completed at least three clinician follow-up visits for pain management, and one final discharge planning visit. Patients could attend additional coaching and clinician visits if needed over the 12-month follow-up period. |
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| Secondary | Positive PTSD Screen (PC-PTSD-5) | Positive PTSD (binary outcome) was determined using the Primary Care Post-traumatic Stress Disorder 5-item (PC-PTSD-5) measure. An endorsement (yes/no) of ≥ 3 items for women and ≥4 items for men indicated probable PTSD. The table indicates how many participants screened positive for PTSD. | Some participants dropped out of the study prior to completing the 12-month assessment. Other participants either failed to complete the 12-month assessment or elected to not answer specific questions. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
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| OG000 | Whole Health Team (WHT) Intervention | WHT was an interdisciplinary, individualized pain care intervention informed by the VA Whole Health Model. The WHT included three members: a physician or nurse practitioner who could prescribe pain medication and refer patients to non-pharmacologic pain care; another clinician who could directly provide integrative pain care such as a physical therapist or chiropractor; and one wellness coach. WHT members met briefly each week to coordinate patients' care. Coaches met with patients first and educated them about the eight domains of Whole Health: sleep, nutrition, physical activity, emotional health, personal development, environment, spirituality, and social support. Coaches asked patients to consider "what matters most to them" and what they would be willing to change that might improve pain (such as weight loss for knee pain in overweight patients). Next, during an initial visit, clinicians assessed patients' pain complaints and medical history, provided integrative pain care, and collaboratively developed treatment plans aligned with patients' personal values and life goals. After these initial visits, coaches delivered at least eight weekly telephone coaching sessions to support patients' goal attainment. Over the 12-month follow-up period, patients completed at least three clinician follow-up visits for pain management, and one final discharge planning visit. Patients could attend additional coaching and clinician visits if needed over the 12-month follow-up period. |
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| Secondary | Substance Use (TAPS-2) | Substance use was measured using the Tobacco, Alcohol, and Substance Use (TAPS-2) tool. This outcome was binary (problem use was defined as 10+ cigarettes/day or any use within 30 minutes of waking). The table indicates how many participants were classified as having problematic substance use. | Some participants dropped out of the study prior to completing the 12-month assessment. Other participants either failed to complete the 12-month assessment or elected to not answer specific questions. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
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| OG000 | Whole Health Team (WHT) Intervention | WHT was an interdisciplinary, individualized pain care intervention informed by the VA Whole Health Model. The WHT included three members: a physician or nurse practitioner who could prescribe pain medication and refer patients to non-pharmacologic pain care; another clinician who could directly provide integrative pain care such as a physical therapist or chiropractor; and one wellness coach. WHT members met briefly each week to coordinate patients' care. Coaches met with patients first and educated them about the eight domains of Whole Health: sleep, nutrition, physical activity, emotional health, personal development, environment, spirituality, and social support. Coaches asked patients to consider "what matters most to them" and what they would be willing to change that might improve pain (such as weight loss for knee pain in overweight patients). Next, during an initial visit, clinicians assessed patients' pain complaints and medical history, provided integrative pain care, and collaboratively developed treatment plans aligned with patients' personal values and life goals. After these initial visits, coaches delivered at least eight weekly telephone coaching sessions to support patients' goal attainment. Over the 12-month follow-up period, patients completed at least three clinician follow-up visits for pain management, and one final discharge planning visit. Patients could attend additional coaching and clinician visits if needed over the 12-month follow-up period. |
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| Secondary | Patient Global Impression of Change (PGIC) | The Patient Global Impression of Change (PGIC) scale was used to measure patients' impressions of study impact. The PGIC is a one-item measure that asks, "How would you describe your overall status now compared to when you started in our study?" Response options include: (3) Very Much Improved, (2) Much Improved, (1) Minimally Improved, (0) No Change, (-1) Minimally Worse, (-2) Much Worse, or (-3) Very Much Worse. Scores range from -3 to 3, with 0 indicating no improvement, and higher scores indicating more improvement in impression of change. | Some participants dropped out of the study prior to completing the 12-month assessment. Other participants either failed to complete the 12-month assessment or elected to not answer specific questions. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Whole Health Team (WHT) Intervention | WHT was an interdisciplinary, individualized pain care intervention informed by the VA Whole Health Model. The WHT included three members: a physician or nurse practitioner who could prescribe pain medication and refer patients to non-pharmacologic pain care; another clinician who could directly provide integrative pain care such as a physical therapist or chiropractor; and one wellness coach. WHT members met briefly each week to coordinate patients' care. Coaches met with patients first and educated them about the eight domains of Whole Health: sleep, nutrition, physical activity, emotional health, personal development, environment, spirituality, and social support. Coaches asked patients to consider "what matters most to them" and what they would be willing to change that might improve pain (such as weight loss for knee pain in overweight patients). Next, during an initial visit, clinicians assessed patients' pain complaints and medical history, provided integrative pain care, and collaboratively developed treatment plans aligned with patients' personal values and life goals. After these initial visits, coaches delivered at least eight weekly telephone coaching sessions to support patients' goal attainment. Over the 12-month follow-up period, patients completed at least three clinician follow-up visits for pain management, and one final discharge planning visit. Patients could attend additional coaching and clinician visits if needed over the 12-month follow-up period. |
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| Secondary | Alcohol Use (AUDIT-C) | Alcohol problem use was measured using the Alcohol Use Disorders Identification Test Consumption (AUDIT-C). This scale contains 3 items which are added to yield scores with a range of 0-12, with higher scores indicating greater risk of high-risk alcohol use. Positive scores are defined using Version 3 cut-points of ≥ 3 for women and ≥ 4 for men. Scores for participants of all genders are reported in the table. | Some participants dropped out of the study prior to completing the 12-month assessment. Other participants either failed to complete the 12-month assessment or elected to not answer specific questions. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Whole Health Team (WHT) Intervention | WHT was an interdisciplinary, individualized pain care intervention informed by the VA Whole Health Model. The WHT included three members: a physician or nurse practitioner who could prescribe pain medication and refer patients to non-pharmacologic pain care; another clinician who could directly provide integrative pain care such as a physical therapist or chiropractor; and one wellness coach. WHT members met briefly each week to coordinate patients' care. Coaches met with patients first and educated them about the eight domains of Whole Health: sleep, nutrition, physical activity, emotional health, personal development, environment, spirituality, and social support. Coaches asked patients to consider "what matters most to them" and what they would be willing to change that might improve pain (such as weight loss for knee pain in overweight patients). Next, during an initial visit, clinicians assessed patients' pain complaints and medical history, provided integrative pain care, and collaboratively developed treatment plans aligned with patients' personal values and life goals. After these initial visits, coaches delivered at least eight weekly telephone coaching sessions to support patients' goal attainment. Over the 12-month follow-up period, patients completed at least three clinician follow-up visits for pain management, and one final discharge planning visit. Patients could attend additional coaching and clinician visits if needed over the 12-month follow-up period. |
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