Trial Outcomes & Findings for Pragmatic Trial of WHT vs. PC-GE to Promote Non-Pharmacological Strategies to Treat Chronic Pain in Veterans (NCT NCT04330365)

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.

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.

Pragmatic Trial of WHT vs. PC-GE to Promote Non-Pharmacological Strategies to Treat Chronic Pain in Veterans

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).

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).

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.

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.

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.

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 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".

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).

The total BPI score was calculated as the mean of all 11 items (range 0-10; higher scores indicate greater overall pain).

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.)

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 (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 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.

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 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.