Chronic Pain
Conditions
Brief summary
The overarching goal of this Pain Management Collaboratory Demonstration project is to test a new Whole Health paradigm for chronic pain care, emphasizing non-pharmacological pain self-management that is hypothesized to reduce pain symptoms and improve overall functioning and quality of life in Veterans. In UH3 Aim 1, the investigators will conduct a 12-month pragmatic effectiveness trial at 6 VA sites across the country to test whether veterans with moderate to severe chronic pain randomized to receive the Whole Health Team (WHT) intervention are more likely than those receiving Primary Care Group Education (PC-GE) to: Hypothesis 1: Experience improved pain interference (primary outcome), pain intensity, functioning and quality of life (secondary outcomes); Hypothesis 2: Decrease use of higher-risk pain medications, including opioids, or high-risk combinations; Hypothesis 3: Engage in a greater number of non-pharmacological pain management activities; and Hypothesis 4: Experience improved mental health-related symptoms, including sleep problems and suicidality. In addition, both the WHT and PC-GE arms will be compared to a third group of veterans randomized to Usual Primary Care (UPC, Control) on the same primary and secondary outcomes above. After the baseline assessment, masked telephone assessments will be administered to participants at 3, 6, 9, and 12 months. UH3 Aim 2 is to conduct a process evaluation of the two active interventions (WHT and PC-GE) and a budget impact analysis that includes costs to implement and execute the two active interventions as well as the control condition (UPC) to inform the development of an implementation toolkit for scaling and dissemination. Eligible participants are veterans reporting moderate to severe chronic pain present every day or nearly every day for ≥ 6 months. The total sample size for the population is based on our main study aim/hypothesis and is N=764. This breaks down to n=343 in the WHT intervention, n=339 in the PC-GE intervention, and N=82 in the Usual Primary Care arm (Control). Results of this UG3/UH3 Pain Management Collaboratory Demonstration project will contribute to the overall mission of the NIH/VA/DoD initiative to build national-level infrastructure that supports non-pharmacologic pain management in veterans and military service personnel.
Interventions
BEHAVIORALWhole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm
Participants will be randomly assigned at the individual level to either WHT, PC-GE or Usual Primary Care, stratified by site, sex, and use of prescribed opioids for chronic pain. The follow-up period for the three arms will be 12 months. The primary outcome is change in pain interference. Secondary outcomes include change in pain intensity, functioning, quality of life, changes in use of pain medications, including opioids (if applicable) and changes in nonpharmacological pain self-management activities. After the baseline assessment, masked telephone assessments will be administered to participants at 3, 6, 9, and 12 months.
Sponsors
San Francisco Veterans Affairs Medical Center
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants must meet the following inclusion criteria to be enrolled in the study: * Assigned to a VA PCP; * Report pain present every day or nearly every day for ≥ 6 months using a phone eligibility screener; and * PEG score of ≥ 5 (including at baseline assessment)
Exclusion criteria
Candidates with any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Interference | 12 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Severity | 12 months | 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). |
| Functioning (VR-12 Physical Component Score) | 12 months | 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. |
| Quality of Life (VR-12 Mental Component Score) | 12 months | 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. |
| PROMIS Sleep Disturbance | 12 months | 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. |
| Engagement in a Greater Number of Non-pharmacological Pain Management Activities | 12 months | 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. |
| Suicidal Ideation | 12 months | 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". |
| Decreased Use of Higher-risk Pain Medications, Including Opioids or High-risk Combinations of Pain Medications (i.e., Co-prescription of Opioids and Benzodiazepines) | 12 months | 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). |
| BPI Total Score | 12 months | The total BPI score was calculated as the mean of all 11 items (range 0-10; higher scores indicate greater overall pain). |
| Anxiety (GAD-7) | 12 months | 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.) |
| Depression (PHQ-9) | 12 months | 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). |
| Positive PTSD Screen (PC-PTSD-5) | 12 months | 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. |
| Substance Use (TAPS-2) | 12 months | 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. |
| Patient Global Impression of Change (PGIC) | 12 months | 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. |
| Alcohol Use (AUDIT-C) | 12 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKaren H Seal, MD
San Francisco VA Health Care System
Participant flow
Recruitment details
Patients were identified for recruitment using the national VA EHR containing sociodemographic data. Other recruitment strategies included clinician and self-referrals. Potentially eligible patients were mailed study information.
Pre-assignment details
Study coordinators contacted potentially eligible veterans by telephone for eligibility screening. After reviewing charts for additional exclusion criteria, coordinators enrolled patients, obtained informed consent, and collected baseline data from eligible veteran patients, all by telephone. 793 participants consented and enrolled in the study and 764 were randomized to one of the three study arms.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 60.5 Year STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Opioid use at time of enrollment No opioid usage | 255 Participants |
| Opioid use at time of enrollment Opioid usage | 194 Participants |
| Pain Interference (BPI) | 6.5 scores on a scale STANDARD_DEVIATION 1.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants |
| Race (NIH/OMB) Asian | 17 Participants |
| Race (NIH/OMB) Black or African American | 171 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 33 Participants |
| Race (NIH/OMB) White | 196 Participants |
| Sex/Gender, Customized Female | 256 Participants |
| Sex/Gender, Customized Male | 223 Participants |
| Sex/Gender, Customized Non-Binary/Third gender | 0 Participants |
| Sex/Gender, Customized Prefer to self-describe | 0 Participants |
| Sex/Gender, Customized Transgender | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 343 | 1 / 339 | 1 / 82 |
| other Total, other adverse events | 164 / 343 | 160 / 339 | 38 / 82 |
| serious Total, serious adverse events | 78 / 343 | 57 / 339 | 18 / 82 |
Outcome results
None listed