Natural Product Use Among Veterans with Chronic Pain: A Qualitative Study of Attitudes and Communication with Healthcare Providers.

BACKGROUND: Despite mixed evidence regarding the safety and efficacy of natural products, many are marketed for pain and related symptoms. Use of these products is prevalent among veterans, who have disproportionately high rates of chronic pain. To date, however, there is limited research on veterans' beliefs and attitudes about natural products and their communication with healthcare providers about their natural product use. OBJECTIVE: To explore how veterans experiencing chronic pain make decisions about natural product use, to investigate veterans' beliefs about the safety and efficacy of these products, and to examine veterans' experiences discussing natural products with their providers. DESIGN: Qualitative sub-study conducted as a supplement to a pragmatic randomized controlled trial for chronic pain management. PARTICIPANTS: Twenty veterans experiencing chronic pain who reported using natural products for pain management or related health concerns. APPROACH: Qualitative interviews with veterans were conducted over the phone and audio-recorded. Interviews were guided by an original semi-structured interview guide and qualitative data were analyzed using a template-based rapid analysis technique. KEY RESULTS: Veterans with chronic pain may perceive natural products as safer than pharmaceutical products and may prefer to use natural products. Talking with providers about natural products is important to veterans, who would like information regarding the safety and potential for interaction of natural products with pharmaceutical products. However, veterans were frequently disappointed with these conversations. Veterans felt their providers demonstrated biases against natural products, which negatively impacted patient-provider relationships. CONCLUSIONS: Veterans wish to have more productive conversations with providers about natural products. They value providers' open-mindedness towards natural products and transparency about limitations in their knowledge. Suggestions for how providers and healthcare systems might better support veterans interested in natural products are discussed.

Military Sexual Trauma and Menopause Symptoms Among Midlife Women Veterans.

BACKGROUND: Sexual assault and/or sexual harassment during military service (military sexual trauma (MST)) can have medical and mental health consequences. Most MST research has focused on reproductive-aged women, and little is known about the long-term impact of MST on menopause and aging-related health. OBJECTIVE: Examine associations of MST with menopause and mental health outcomes in midlife women Veterans. DESIGN: Cross-sectional. PARTICIPANTS: Women Veterans aged 45-64 enrolled in Department of Veterans Affairs (VA) healthcare in Northern California between March 2019 and May 2020. MAIN MEASURES: Standardized VA screening questions assessed MST exposure. Structured-item questionnaires assessed vasomotor symptoms (VMS), vaginal symptoms, sleep difficulty, depressive symptoms, anxiety symptoms, and posttraumatic stress disorder (PTSD) symptoms. Multivariable logistic regression analyses examined associations between MST and outcomes based on clinically relevant menopause and mental health symptom thresholds. KEY RESULTS: Of 232 participants (age = 55.95 ± 5.13), 73% reported MST, 66% reported VMS, 75% reported vaginal symptoms, 36% met criteria for moderate-to-severe insomnia, and almost half had clinically significant mental health symptoms (33% depressive symptoms, 49% anxiety, 27% probable PTSD). In multivariable analyses adjusted for age, race, ethnicity, education, body mass index, and menopause status, MST was associated with the presence of VMS (OR 2.44, 95% CI 1.26-4.72), vaginal symptoms (OR 2.23, 95% CI 1.08-4.62), clinically significant depressive symptoms (OR 3.21, 95% CI 1.45-7.10), anxiety (OR 4.78, 95% CI 2.25-10.17), and probable PTSD (OR 6.74, 95% CI 2.27-19.99). Results did not differ when military sexual assault and harassment were disaggregated, except that military sexual assault was additionally associated with moderate-to-severe insomnia (OR 3.18, 95% CI 1.72-5.88). CONCLUSIONS: Exposure to MST is common among midlife women Veterans and shows strong and independent associations with clinically significant menopause and mental health symptoms. Findings highlight the importance of trauma-informed approaches to care that acknowledge the role of MST on Veteran women's health across the lifespan.

Association of psychiatric disorders with clinical diagnosis of long COVID in US veterans.

BACKGROUND: Psychiatric disorders may be a risk factor for long COVID, broadly defined as COVID-19 conditions continuing three months post-acute infection. In US Veterans with high psychiatric burden, we examined associations between psychiatric disorders and clinical diagnosis of long COVID. METHODS: We conducted a retrospective cohort study using health records from VA patients with a positive SARS-CoV-2 test from February 2020 to February 2023. Generalized linear models estimated associations between any psychiatric disorder and likelihood of subsequent diagnosis with long COVID (i.e. two or more long COVID clinical codes). Models were adjusted for socio-demographic, medical, and behavioral factors. Secondary models examined individual psychiatric disorders and age-stratified associations. RESULTS: Among 660 217 VA patients with positive SARS-CoV-2 tests, 56.3% had at least one psychiatric disorder diagnosis and 1.4% were diagnosed with long COVID. Individuals with any psychiatric disorder had higher risk for long COVID diagnosis in models adjusted for socio-demographic factors, vaccination status, smoking, and medical comorbidities (relative risk, RR = 1.28, 95% CI 1.21-1.35), with the strongest associations in younger individuals. Considering specific disorders, depressive, anxiety, and stress-related disorders were associated with increased risk for long COVID diagnoses (RRs = 1.36-1.48), but associations were in the opposite direction for substance use and psychotic disorders (RRs = 0.78-0.88). CONCLUSIONS: Psychiatric disorder diagnoses were associated with increased long COVID diagnosis risk in VA patients, with the strongest associations observed in younger individuals. Improved surveillance, treatment, and prevention for COVID-19 and its long-term sequelae should be considered for individuals with psychiatric conditions.

Integration of Health Coaches in a Whole Health Team Model of Chronic Pain Care: a Qualitative Study.

OBJECTIVE: Health coaching has shown promise in helping patients manage their chronic disease and in improving health outcomes, yet the implementation of health coaching in healthcare systems is understudied. Further, evidence suggests that interdisciplinary care teams may be more effective in treating chronic pain than usual care. As such, we sought to examine the benefits and drawbacks to embedding health coaches within interdisciplinary pain care teams ("Whole Health Teams"). DESIGN: As part of a multisite clinical trial (at five Veterans Health Administration sites) investigating the effectiveness of a Whole Health Team (WHT) approach to care for patients with chronic pain, qualitative interviews gathered data on how the experience of treating patients in the WHT differed from the experience treating patients outside the WHT, as well as provider experiences coordinating patient care within the WHT. PARTICIPANTS: Twenty-two WHT members, study investigators, and study coordinators. APPROACH: Data were analyzed using a rapid analysis approach. RESULTS: Overall, stakeholders perceived considerable synergy within the interdisciplinary pain care team. Each provider brought a different perspective to the patient's health concerns, which stakeholders felt was valuable and increased patient progress towards goals. The team model was also viewed as efficient because everyone was committed to working together and communicating as a team. Logistically, however, stakeholders noted challenges to working as a team, especially regarding patient goal setting. Furthermore, multiple stakeholders believed the care team model required a high degree of dedication to teamwork and communication among its members to be successful. CONCLUSIONS: Embedding health coaches within interdisciplinary pain care teams may improve care processes and accelerate patient progress. Successful implementation would require adequate training, role clarification, and expectation setting to facilitate good communication across all care team members. Additional research is needed to evaluate the clinical outcomes of integrating health coaches on WHTs versus other implementation approaches.

Effectiveness and comparative effectiveness of evidence-based psychotherapies for posttraumatic stress disorder in clinical practice.

BACKGROUND: While evidence-based psychotherapy (EBP) for posttraumatic stress disorder (PTSD) is a first-line treatment, its real-world effectiveness is unknown. We compared cognitive processing therapy (CPT) and prolonged exposure (PE) each to an individual psychotherapy comparator group, and CPT to PE in a large national healthcare system. METHODS: We utilized effectiveness and comparative effectiveness emulated trials using retrospective cohort data from electronic medical records. Participants were veterans with PTSD initiating mental healthcare (N = 265 566). The primary outcome was PTSD symptoms measured by the PTSD Checklist (PCL) at baseline and 24-week follow-up. Emulated trials were comprised of 'person-trials,' representing 112 discrete 24-week periods of care (10/07-6/17) for each patient. Treatment group comparisons were made with generalized linear models, utilizing propensity score matching and inverse probability weights to account for confounding, selection, and non-adherence bias. RESULTS: There were 636 CPT person-trials matched to 636 non-EBP person-trials. Completing ⩾8 CPT sessions was associated with a 6.4-point greater improvement on the PCL (95% CI 3.1-10.0). There were 272 PE person-trials matched to 272 non-EBP person-trials. Completing ⩾8 PE sessions was associated with a 9.7-point greater improvement on the PCL (95% CI 5.4-13.8). There were 232 PE person-trials matched to 232 CPT person-trials. Those completing ⩾8 PE sessions had slightly greater, but not statistically significant, improvement on the PCL (8.3-points; 95% CI 5.9-10.6) than those completing ⩾8 CPT sessions (7.0-points; 95% CI 5.5-8.5). CONCLUSIONS: PTSD symptom improvement was similar and modest for both EBPs. Although EBPs are helpful, research to further improve PTSD care is critical.

Association of Vitamin D Status and COVID-19-Related Hospitalization and Mortality.

BACKGROUND: The relationship between vitamin D status and COVID-19-related clinical outcomes is controversial. Prior studies have been conducted in smaller, single-site, or homogeneous populations limiting adjustments for social determinants of health (race/ethnicity and poverty) common to both vitamin D deficiency and COVID-19 outcomes. OBJECTIVE: To evaluate the dose-response relationship between continuous 25(OH)D and risk for COVID-19-related hospitalization and mortality after adjusting for covariates associated with both vitamin D deficiency and COVID-19 outcomes. DESIGN: Retrospective cohort study. PATIENTS: Veteran patients receiving care in US Department of Veteran Affairs (VA) health care facilities with a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test and a blood 25(OH)D test between February 20, 2020, and November 8, 2020, followed for up to 60 days. MAIN MEASURES: Exposure was blood 25(OH)D concentration ascertained closest to and within 15 to 90 days preceding an index positive SARS-CoV-2 test. Co-primary study outcomes were COVID-19-related inpatient hospitalization requiring airborne, droplet, contact, or other isolation and mortality ascertained within 60 days of an index positive SARS-CoV-2 test. KEY RESULTS: Of 4,599 veterans with a positive SARS-CoV-2 test, vitamin D deficiency (< 20 ng/mL) was identified in 665 (14.5%); 964 (21.0%) were hospitalized; and 340 (7.4%) died. After adjusting for all covariates, including race/ethnicity and poverty, there was a significant independent inverse dose-response relationship between increasing continuous 25(OH)D concentrations (from 15 to 60 ng/mL) and decreasing probability of COVID-19-related hospitalization (from 24.1 to 18.7%, p=0.009) and mortality (from 10.4 to 5.7%, p=0.001). In modeling 25(OH)D as a log-transformed continuous variable, the greatest risk for hospitalization and death was observed at lower 25(OH)D concentrations. CONCLUSIONS: Continuous blood 25(OH)D concentrations are independently associated with COVID-19-related hospitalization and mortality in an inverse dose-response relationship in this large racially and ethnically diverse cohort of VA patients. Randomized controlled trials are needed to evaluate the impact of vitamin D supplementation on COVID-19-related outcomes.

Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial.

BACKGROUND/AIMS: When participants in individually randomized group treatment trials are treated by multiple clinicians or in multiple group treatment sessions throughout the trial, this induces partially nested clusters which can affect the power of a trial. We investigate this issue in the Whole Health Options and Pain Education trial, a three-arm pragmatic, individually randomized clinical trial. We evaluate whether partial clusters due to multiple visits delivered by different clinicians in the Whole Health Team arm and dynamic participant groups due to changing group leaders and/or participants across treatment sessions during treatment delivery in the Primary Care Group Education arm may impact the power of the trial. We also present a Bayesian approach to estimate the intraclass correlation coefficients. METHODS: We present statistical models for each treatment arm of Whole Health Options and Pain Education trial in which power is estimated under different intraclass correlation coefficients and mapping matrices between participants and clinicians or treatment sessions. Power calculations are based on pairwise comparisons. In practice, sample size calculations depend on estimates of the intraclass correlation coefficients at the treatment sessions and clinician levels. To accommodate such complexities, we present a Bayesian framework for the estimation of intraclass correlation coefficients under different participant-to-session and participant-to-clinician mapping scenarios. We simulated continuous outcome data based on various clinical scenarios in Whole Health Options and Pain Education trial using a range of intraclass correlation coefficients and mapping matrices and used Gibbs samplers with conjugate priors to obtain posteriors of the intraclass correlation coefficients under those different scenarios. Posterior means and medians and their biases are calculated for the intraclass correlation coefficients to evaluate the operating characteristics of the Bayesian intraclass correlation coefficient estimators. RESULTS: Power for Whole Health Team versus Primary Care Group Education is sensitive to the intraclass correlation coefficient in the Whole Health Team arm. In these two arms, an increased number of clinicians, more evenly distributed workload of clinicians, or more homogeneous treatment group sizes leads to increased power. Our simulation study for the intraclass correlation coefficient estimation indicates that the posterior mean intraclass correlation coefficient estimator has less bias when the true intraclass correlation coefficients are large (i.e. 0.10), but when the intraclass correlation coefficient is small (i.e. 0.01), the posterior median intraclass correlation coefficient estimator is less biased. CONCLUSION: Knowledge of intraclass correlation coefficients and the structure of clustering are critical to the design of individually randomized group treatment trials with partially nested clusters. We demonstrate that the intraclass correlation coefficient of the Whole Health Team arm can affect power in the Whole Health Options and Pain Education trial. A Bayesian approach provides a flexible procedure for estimating the intraclass correlation coefficients under complex scenarios. More work is needed to educate the research community about the individually randomized group treatment design and encourage publication of intraclass correlation coefficients to help inform future trial designs.

Veterans receiving a second course of cognitive processing therapy or prolonged exposure therapy: is it better to switch or stay the same?

Cognitive processing therapy (CPT) and prolonged exposure therapy (PE) are effective psychotherapies for post-traumatic stress disorder (PTSD). However, these treatments also have high rates of dropout and non-response. Therefore, patients may need a second course of treatment. We compared outcomes for patients who switched between CPT/PE and those who repeated CPT/PE during a second course of treatment. We collected data from Iraq and Afghanistan war veterans (n = 2,958) who received a second course of CPT/PE in the Veterans Health Administration from 2001 to 2017 and had symptom outcomes (PTSD checklist; PCL). We measured the association between treatment sequence and change in PCL score over the second course of treatment using hierarchical Bayesian regression, adjusted for sociodemographic and clinical characteristics. All treatment sequences showed a significant reduction in PCL score over time (ß = -4.80; HDI95: -5.74, -3.86). Veterans who switched from CPT to PE had modestly greater PCL reductions during the second course than those who repeated CPT. However, no significant difference in PCL change during the second course was observed between veterans who repeated PE and those who switched from PE to CPT. Veterans participating in a second course of CPT/PE can benefit, and switching treatment may be slightly more beneficial following CPT.

Menopausal Hormone Therapy and Suicide in a National Sample of Midlife and Older Women Veterans.

BACKGROUND: Among midlife and older women, menopause symptoms and menopausal hormone therapy have been linked to mental health disorders and other comorbidities related to suicide. However, the role of hormone therapy as a prognostic factor of suicide risk is largely unknown. OBJECTIVES: To examine associations between menopausal hormone therapy, suicide attempts, and suicide among midlife and older women Veterans. RESEARCH DESIGN: In this longitudinal analysis of national Veterans Health Administration data from women Veterans aged 50 years and above, we used Fine-Gray proportional hazards models to examine associations between menopausal hormone therapy (prescribed in 2012-2013) and incident suicide attempts and suicide (index date-2016). MEASURES: Menopausal hormone therapy and psychoactive medications from pharmacy records; suicide attempts and suicide from national suicide data repositories; demographic variables, medical and psychiatric diagnoses, and substance use disorders from electronic medical record data and International Classification Diagnoses-9-CM codes. RESULTS: In this national sample of 291,709 women Veterans (mean age 60.47, SD 9.81), 6% were prescribed menopausal hormone therapy at baseline. Over an average of 4.5 years, 2673 had an incident suicide attempt (93%) or death by suicide (7%). Adjusting for age, race, and medical diagnoses, menopausal hormone therapy was associated with increased risk of suicide attempt (hazard ratio 1.41; 95% confidence interval, 1.22-1.64) and over 2-fold increased risk of death by suicide (hazard ratio 2.47; 95% confidence interval, 1.58-3.87). Associations with death by suicide remained significant after accounting for psychiatric comorbidity and psychoactive medications. CONCLUSIONS: Menopausal hormone therapy may be an important indicator of suicide risk among midlife and older women.

Women Veterans' Experiences with Integrated, Biopsychosocial Pain Care: A Qualitative Study.

OBJECTIVES: Biopsychosocial, integrated pain care models are increasingly implemented in the Veterans Health Administration to improve chronic pain care and reduce opioid-related risks, but little is known about how well these models address women veterans' needs. DESIGN: Qualitative, interview-based study. SETTING: San Francisco VA Health Care System Integrated Pain Team (IPT), an interdisciplinary team that provides short-term, personalized chronic pain care emphasizing functional goals and active self-management. SUBJECTS: Women with chronic pain who completed ≥3 IPT sessions. METHODS: Semistructured phone interviews focused on overall experience with IPT, perceived effectiveness of IPT care, pain care preferences, and suggested changes for improving gender-sensitive pain care. We used a rapid approach to qualitative thematic analysis to analyze interviews. RESULTS: Fourteen women veterans (mean age 51 years; range 33-67 years) completed interviews. Interviews revealed several factors impacting women veterans' experiences: 1) an overall preference for receiving both primary and IPT care in gender-specific settings, 2) varying levels of confidence that IPT could adequately address gender-specific pain issues, 3) barriers to participating in pain groups, and 4) barriers to IPT self-management recommendations due to caregiving responsibilities. CONCLUSIONS: Women veterans reported varied experiences with IPT. Recommendations to improve gender-sensitive pain care include increased provider training; increased knowledge of and sensitivity to women's health concerns; and improved accommodations for prior trauma, family and work obligations, and geographic barriers. To better meet the needs of women veterans with chronic pain, integrated pain care models must be informed by an understanding of gender-specific needs, challenges, and preferences.

Tailored to Fit: How an Implementation Framework Can Support Pragmatic Pain Care Trial Adaptation for Diverse Veterans Affairs Clinical Settings.

BACKGROUND: Veterans Affairs (VA) has rolled out a holistic, multicomponent Whole Health care model nationwide, yet no pragmatic trials have been conducted in real-world clinical settings to compare its effectiveness against other evidence-based approaches for chronic pain management in veterans. OBJECTIVES: We describe the adaptation of the first large pragmatic randomized controlled trial of the Whole Health model for chronic pain care for diverse VA clinical settings. RESEARCH DESIGN: Informed by the Promoting Action on Research Implementation in Health Systems implementation framework, we conducted qualitative semistructured interviews to obtain feedback on trial design from VA leadership, frontline clinicians, and veterans with chronic pain at 5 VA enrollment sites. Next, we convened in-person evidence-based quality improvement (EBQI) meetings with study stakeholders (including frontline clinicians and administrators) at each site to discuss study design; review interview themes; and identify site-specific barriers, facilitators, and approaches to implementation. Ethnographic observations from EBQI meetings provided additional insight into implementation strategies. SUBJECTS: Seventy-four veteran and VA staff stakeholders were interviewed; 71 stakeholders participated in EBQI meetings. RESULTS: At each site, unique clinical contexts and varying resources for Whole Health and pain care delivery affected plans for trial implementation. We present examples of local adaptations that emerged through the formative evaluation process to facilitate implementation and yield a more pragmatic trial design. CONCLUSIONS: A systematic formative evaluation can facilitate engagement and buy-in of study stakeholders. Locally tailored pragmatic implementation strategies may improve the likelihood of successful trial execution as well as future implementation of evidence-based pain care approaches in real-world clinical settings.

Opioid Reduction and Risk Mitigation in VA Primary Care: Outcomes from the Integrated Pain Team Initiative.

BACKGROUND: National guidelines advise decreasing opioids for chronic pain, but there is no guidance on implementation. OBJECTIVE: To evaluate the effectiveness of an Integrated Pain Team (IPT) clinic in decreasing opioid dose and mitigating opioid risk. DESIGN: This study prospectively compared two matched cohorts receiving chronic pain care through IPT (N = 147) versus usual primary care (UPC, N = 147) over 6 months. Patients were matched on age, sex, psychiatric diagnoses, and baseline opioid dose. PATIENTS: Veterans receiving care at a VA medical center or VA community-based clinics. INTERVENTION: Interdisciplinary IPT, consisting of a collocated medical provider, psychologist, and pharmacist embedded in VA primary care providing short-term biopsychosocial management of veterans with chronic pain and problematic opioid use. MAIN MEASURES: Change in opioid dose expressed as morphine equivalent daily dose (MEDD) and opioid risk mitigation evaluated at baseline, 3 months, and 6 months. KEY RESULTS: Compared with veterans receiving UPC, those followed by IPT had a greater mean MEDD decrease of 42 mg versus 8 mg after 3 months and 56 mg versus 17 mg after 6 months. In adjusted analysis, compared with UPC, veterans in IPT achieved a 34-mg greater mean reduction at 3 months (p = 0.002) and 38-mg greater mean reduction at 6 months (p = 0.003). Nearly twice as many patients receiving care through IPT versus UPC reduced their daily opioid dose by ≥50%, representing more than a two-fold improvement at 3 months, which was sustained at 6 months [odds ratio = 2.03; 95% CI = 1.04-3.95, p = 0.04]. Significant improvements were also demonstrated in opioid risk mitigation by 6 months, including increased urine drug screen monitoring, naloxone kit distribution, and decreased co-prescription of opioids and benzodiazepines (all p values < 0.001). CONCLUSIONS: Interdisciplinary biopsychosocial models of pain care can be embedded in primary care and lead to significant improvements in opioid dose and risk mitigation.

Evidence-based psychotherapy trends among posttraumatic stress disorder patients in a national healthcare system, 2001-2014.

BACKGROUND: Although evidence-based psychotherapies (EBPs) for posttraumatic stress disorder (PTSD) were implemented starting in 2005 in the veterans health administration (VHA), the largest national healthcare system in the U.S., the rate of initiation (uptake) and prevalence of these treatments in each calendar year have not been determined. We aimed to elucidate two metrics of EBP utilization, uptake and prevalence, following implementation. METHODS: Cohort study of Iraq and Afghanistan veterans in VHA (N = 181,620) with a PTSD diagnosis and ≥1 psychotherapy-coded outpatient visit from 2001 to 2014. Using natural language processing techniques, annual and cumulative uptake and prevalence rates from 2001 to 2014 were calculated for each of the two EBPs for PTSD, cognitive processing therapy (CPT) and prolonged exposure (PE) therapy. RESULTS: Annual uptake of CPT increased during most years, reaching a maximum of 11.1%. Annual uptake of PE showed little change until 2008 and then increased, reaching a maximum of 4.4%. The annual prevalence of CPT increased throughout the study, reaching a maximum of 14.6%. The annual prevalence of PE increased to a maximum of 5.0% in 2010, but then flattened and declined. Annual uptake of minimally adequate CPT increased a to maximum of 5% in 2014. Annual uptake of minimally adequate PE increased to a maximum of 1.2% in 2010. The cumulative prevalence of CPT was 19.9% and cumulative prevalence for PE was 7.5%. CONCLUSIONS: Access to EBPs for PTSD modestly increased for Iraq and Afghanistan veterans after nationwide implementation efforts. Further expanding the reach to veterans is critical, given low rates of minimally adequate EBPs for PTSD.

An Integrated Pain Team Model: Impact on Pain-Related Outcomes and Opioid Misuse in Patients with Chronic Pain.

OBJECTIVE: Biopsychosocial integrated pain team (IPT) care models are being implemented in Veterans Health Administration (VA) and other health care systems to address chronic pain and reduce risks related to long-term opioid therapy, with little evaluation of effectiveness to date. We examined whether IPT improves self-reported pain-related outcomes and opioid misuse. DESIGN: Single-group quality improvement study. SETTING: Large VA health care system. SUBJECTS: Veterans with chronic pain (N = 99, 84% male, mean age [SD] = 60 [13] years). METHODS: Using paired t tests and Wilcoxon matched-pairs signed-ranks tests, we examined pain experience (Brief Pain Inventory, Pain Catastrophizing Scale), opioid misuse (Current Opioid Misuse Measure), treatment satisfaction (Pain Treatment Satisfaction Scale), and pain management strategies among patients with chronic pain before and after three or more IPT encounters. RESULTS: After an average (SD) of 14.3 (9) weeks engaged in IPT, patients reported improvement in pain interference (mean [SD] = 46.0 [15.9] vs 40.5 [16.2], P < 0.001), pain catastrophizing (mean [SD] = 22.9 [13.0] vs 19.3 [14.1], P = 0.01), treatment satisfaction (i.e., "very satisfied" = 13.1% at baseline vs 25.3% at follow-up, P = 0.01), and reduced opioid misuse (mean [SD] = 11.0 [7.5] vs 8.2 [6.1], P = 0.01). Patients reported increased use of integrative (i.e., acupuncture, 11% at baseline vs 26% at follow-up, P < 0.01) and active pain management strategies (i.e., exercise, 8% at baseline vs 16% at follow-up, P < 0.01) and were less likely to use only pharmacological pain management strategies after IPT engagement (19% at baseline vs 5% at follow-up, P < 0.01). CONCLUSIONS: Biopsychosocial, integrated pain care may improve patient-centered outcomes related to opioid misuse and the subjective experience and nonpharmacological self-management of chronic pain.

Stakeholder Engagement in Pragmatic Clinical Trials: Emphasizing Relationships to Improve Pain Management Delivery and Outcomes.

BACKGROUND: The NIH-DOD-VA Pain Management Collaboratory (PMC) supports 11 pragmatic clinical trials (PCTs) on nonpharmacological approaches to management of pain and co-occurring conditions in U.S. military and veteran health organizations. The Stakeholder Engagement Work Group is supported by a separately funded Coordinating Center and was formed with the goal of developing respectful and productive partnerships that will maximize the ability to generate trustworthy, internally valid findings directly relevant to veterans and military service members with pain, front-line primary care clinicians and health care teams, and health system leaders. The Stakeholder Engagement Work Group provides a forum to promote success of the PCTs in which principal investigators and/or their designees discuss various stakeholder engagement strategies, address challenges, and share experiences. Herein, we communicate features of meaningful stakeholder engagement in the design and implementation of pain management pragmatic trials, across the PMC. DESIGN: Our collective experiences suggest that an optimal stakeholder-engaged research project involves understanding the following: i) Who are research stakeholders in PMC trials? ii) How do investigators ensure that stakeholders represent the interests of a study's target treatment population, including individuals from underrepresented groups?, and iii) How can sustained stakeholder relationships help overcome implementation challenges over the course of a PCT? SUMMARY: Our experiences outline the role of stakeholders in pain research and may inform future pragmatic trial researchers regarding methods to engage stakeholders effectively.

Whole Health Options and Pain Education (wHOPE): A Pragmatic Trial Comparing Whole Health Team vs Primary Care Group Education to Promote Nonpharmacological Strategies to Improve Pain, Functioning, and Quality of Life in Veterans-Rationale, Methods, and Implementation.

BACKGROUND: The Whole Health model of the U.S. Department of Veterans Affairs (VA) emphasizes holistic self-care and multimodal approaches to improve pain, functioning, and quality of life. wHOPE (Whole Health Options and Pain Education) seeks to be the first multisite pragmatic trial to establish evidence for the VA Whole Health model for chronic pain care. DESIGN: wHOPE is a pragmatic randomized controlled trial comparing a Whole Health Team (WHT) approach to Primary Care Group Education (PC-GE); both will be compared to Usual VA Primary Care (UPC). The WHT consists of a medical provider, a complementary and integrative health (CIH) provider, and a Whole Health coach, who collaborate with VA patients to create a Personalized Health Plan emphasizing CIH approaches to chronic pain management. The active comparator, PC-GE, is adapted group cognitive behavioral therapy for chronic pain. The first aim is to test whether the WHT approach is superior to PC-GE and whether both are superior to UPC in decreasing pain interference in functioning in 750 veterans with moderate to severe chronic pain (primary outcome). Secondary outcomes include changes in pain severity, quality of life, mental health symptoms, and use of nonpharmacological and pharmacological therapies for pain. Outcomes will be collected from the VA electronic health record and patient-reported data over 12 months of follow-up. Aim 2 consists of an implementation-focused process evaluation and budget impact analysis. SUMMARY: This trial is part of the Pain Management Collaboratory, which seeks to create national-level infrastructure to support evidence-based nonpharmacological pain management approaches for veterans and military service personnel.

A national study of TBI and risk of suicide and unintended death by overdose and firearms.

Objective: Evidence guiding suicide-prevention efforts in patients with traumatic brain injury (TBI) is imperative. We evaluated association between TBI and risk of death by drug overdose and firearms, including suicide and unintentional injury.Methods: Cohort study of all patients 18 years and older in Veterans Health Administration databases from October 1, 2001 to December 31, 2014 with TBI diagnosis (N = 230,200), and age-matched 1:1 to random sample of patients without TBI (N = 230,200).Results: After adjusting for demographics, comorbidities, and accounting for competing risk of other deaths, hazard ratios for death by drug overdose were 1.40 (95% CI = 1.21-1.62) for mild TBI and 1.51 (95% CI = 1.31-1.74) for moderate-to-severe TBI, while hazard ratios for death by firearms were 1.09 (95% CI = 0.89-1.33) for mild TBI and 1.33 (95% CI = 1.10-1.60) for moderate-to-severe TBI. Risk of overdose death due to TBI severity was mainly observed for middle and older age groups.Conclusions: Findings suggest that veterans with mild and moderate-to-severe TBI are at increased risk of death by drug overdose and firearms, with overdose risk heightened with age. Data indicate that prevention efforts in patients with TBI include targeted means reduction.

Menopausal Symptoms and Higher Risk Opioid Prescribing in a National Sample of Women Veterans with Chronic Pain.

BACKGROUND: The greatest increases in long-term opioid use and opioid-related overdose mortality in recent years have been among women in midlife. Common menopausal symptoms broadly affect health and health care utilization in midlife, but their contribution to chronic pain management during this period is unknown. OBJECTIVE: To examine relationships between menopausal symptoms and long-term opioid prescription patterns among midlife women with chronic pain. DESIGN: Cross-sectional analysis of national Veterans Health Administration medical and pharmacy records (2014-2015). PARTICIPANTS: Women Veterans aged 45-64 with ≥ 1 outpatient visit and chronic pain diagnoses spanning ≥ 90 days. MAIN MEASURES: Long-term opioids (prescribed oral opioids for ≥ 90 days), high-dose long-term opioids (> 50 mg average morphine equivalent daily dose), and long-term opioids co-prescribed with central nervous system depressants (benzodiazepine and non-benzodiazepine sedative-hypnotics, gabapentin/pregabalin, muscle relaxants). Multivariable logistic regression models were used to examine associations between outcomes and menopausal symptoms (menopausal symptom-related diagnoses (i.e., "symptomatic menopausal states") on ≥ 2 encounters and/or menopausal hormone therapy, adjusting for race, age, body mass index, and mental health and substance use disorder diagnoses. KEY RESULTS: In this national sample of 104,984 midlife women Veterans with chronic pain (mean age 54.5, SD 5.4 years), 17% had evidence of menopausal symptoms, 51% were prescribed long-term opioids, 13% were prescribed high-dose long-term opioids, and 35% were co-prescribed long-term opioids and central nervous system depressants. In multivariable analyses, women with menopausal symptoms had increased odds of long-term opioids (OR 1.21, 95% CI 1.18-1.26), high-dose long-term opioids (OR 1.08, 95% CI 1.02-1.13), and long-term opioids co-prescribed with central nervous system depressants (sedative-hypnotics OR 1.25, 95% CI 1.22-1.30; gabapentin/pregabalin OR 1.23, 95% CI 1.20-1.27; muscle relaxants OR 1.24, 95% CI 1.20-1.28). CONCLUSIONS: Among midlife women Veterans with chronic pain, evidence of menopausal symptoms was associated with potentially risky long-term opioid prescription patterns, independent of known risk factors.

Posttraumatic Stress Disorder Severity and Insomnia-Related Sleep Disturbances: Longitudinal Associations in a Large, Gender-Balanced Cohort of Combat-Exposed Veterans.

Few studies have investigated the range and severity of insomnia-related sleep complaints among veterans with posttraumatic stress disorder (PTSD), and the temporal association between insomnia and PTSD severity has yet to be examined. To examine these associations, a large, gender-balanced cohort of veterans (N = 1,649) of the Iraq and Afghanistan conflicts participated in longitudinal assessments of PTSD and insomnia-related symptoms over a period of 2.5 years following enrollment (range: 2-4 years). Data were obtained from multiple sources, including interviews, self-report assessments, and electronic medical record data. Three-fourths (74.0%) of veterans with PTSD diagnoses at Time 1 (T1) reported insomnia-related sleep difficulties on at least half the nights during the past 30 days, and one-third of participants had received a prescription for a sedative-hypnotic drug in the past year. Veterans without PTSD had fewer sleep problems overall, although the prevalence of sleep problems was high among all study participants. In longitudinal, cross-lagged panel models, the frequency of sleep problems at T1 independently predicted increases in PTSD severity at Time 2 (T2), B = 0.27, p < .001, after controlling for gender and relevant comorbidities. Conversely, T1 PTSD severity was associated with increasing sleep complaints at T2 but to a lesser degree, B = 0.04, p < .001. Moderately high rates of sedative-hypnotic use were seen in veterans with PTSD, with more frequent use in women compared to men (40.4% vs. 35.0%). Sleep complaints were highly prevalent overall and highlight the need for increased clinical focus on this area.

Spanish Abstracts by Asociación Chilena de Estrés Traumático (ACET) Gravedad del TEPT y Trastornos del Sueño Relacionados con el Insomnio: Asociaciones Longitudinales en una gran Cohorte, Balanceados por Género. de Veteranos Expuestos al Combate SUEÑO, INSOMNIO Y SEVERIDAD DE TEPT Pocos estudios han investigado el rango y la gravedad de las quejas del sueño relacionadas con el insomnio entre veteranos con trastorno de estrés postraumático (TEPT) y la asociación temporal entre el insomnio y la severidad del TEPT aún no se han examinado. Para examinar estas asociaciones, una gran cohorte de veteranos (N = 1,649) de los conflictos de Irak y Afganistán, balanceados por género, participaron en evaluaciones longitudinales de TEPT y síntomas relacionados con el insomnio durante un período de 2.5 años posteriores a la inscripción (rango: 2-4 años). Los datos se obtuvieron de múltiples fuentes, incluyendo entrevistas, autoevaluaciones y datos de registros médicos electrónicos. Tres cuartos (74.0%) de los veteranos con diagnóstico de TEPT en el tiempo 1 (T1) informaron dificultades de sueño relacionadas con el insomnio en al menos la mitad de las noches durante los últimos 30 días, y un tercio de los participantes habían recibido una prescripción de un fármaco sedante-hipnótico en el último año. Los veteranos sin TEPT tenían menos problemas de sueño en general, aunque la prevalencia de problemas de sueño fue alta entre todos los participantes del estudio. En los modelos longitudinales de panel con retardo cruzado, la frecuencia de los problemas de sueño en T1 predijeron independientemente aumentos en la severidad del TEPT en el Tiempo 2 (T2), B = 0.27, p <.001, después controlar por género y comorbilidades relevantes. Por el contrario, la gravedad del TEPT en T1 se asoció con un aumento de las quejas de sueño en T2 pero en menor grado, B = 0.04, p <.001. Se observaron tasas moderadamente altas de uso de hipnóticos-sedativos en veteranos con TEPT, con un uso más frecuente en mujeres comparadas con hombres (40.4% vs. 35.0%). En general las quejas de sueño fueron altamente prevalentes y destacan la necesidad de una mayor focalización clínica en esta área.

Gender Differences in Cardiovascular Risk Related to Diabetes and Posttraumatic Stress Disorder.

OBJECTIVES: To examine relationships between posttraumatic stress disorder (PTSD), diabetes, and cardiovascular disease (CVD) among older men and women. METHODS: In a national retrospective cohort study of Veterans aged ≥55 (n=2,789,264, 6% female), associations between PTSD and diabetes (2008-2011) and incident CVD (2012-2015) were assessed with gender-stratified Fine-Gray proportional hazard models, adjusted for demographics and medical comorbidities. RESULTS: Incident CVD was observed in 22% of men and 12% of women, and related to PTSD (men HR=1.05, 95% CI=1.04-1.06, Wald χ2=80.46, df=1, p<.001; women HR=1.47, 95% CI=1.38-1.57, Wald χ2=148.60, df=1, p<.001), diabetes (men HR=1.34, 95% CI=1.34-1.35, Wald χ2=9177.64, df=1, p<.001; women HR=1.49, 95% CI=1.44-1.55, Wald χ2=419.02, df=1, p<.001), and comorbid PTSD-diabetes (men HR=1.50, 95% CI=1.48-1.52, Wald χ2=4180.92, df=1, p<.001; women HR=1.96, 95% CI=1.80-2.12, Wald χ2=257.28, df=1, p<.001). CONCLUSIONS: CVD risk was increased with PTSD and diabetes, and strongly increased with comorbid PTSD-diabetes. Among women, PTSD and diabetes conferred equivalent CVD risk.