Design, methods, and recruitment outcomes of the Veterans' pain care organizational improvement comparative effectiveness (VOICE) study.

The Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) study is a 12-month pragmatic randomized comparative effectiveness trial conducted at ten United States Veterans Affairs (VA) health care sites. The overall goal was to test interventions to improve pain while reducing opioid use among VA patients with moderate-severe chronic pain despite treatment with long-term opioid therapy (LTOT). Aims were 1) to compare lower-intensity telecare collaborative pain management (TCM) versus higher-intensity integrated pain team management (IPT), and 2) to test the option of switching to buprenorphine (versus no option) in a high-dose subgroup. Recruitment challenges included secular trends in opioid prescribing and the COVID-19 pandemic. Participants were recruited over 3.5 years. Of 6966 potentially eligible patients, 4731 (67.9%) were contacted for telephone eligibility interview; of those contacted, 3398 (71.8%) declined participation, 359 (7.6%) were ineligible, 821 (24.2%) enrolled, and 820 (24.1%) were randomized. The most common reason for declining was satisfaction with pain care (n = 731). The most common reason for ineligibility was not having moderate-severe chronic pain (n = 110). Compared with the potentially eligible population, randomized participants were slightly younger, more often female, had similar prescribed opioids, and had similar or higher rates of pain and mental health diagnoses. The enrolled patient number was lower than the original target, but sufficient to power planned analyses. In conclusion, the VOICE trial enrolled a diverse sample similar to the population of VA patients receiving LTOT. Results will add substantially to limited existing evidence for interventions to improve pain while reducing opioid use. ClinicalTrials.gov identifier: NCT03026790.

Post-traumatic stress disorder and risk for hospitalization and death following COVID-19 infection.

Post-traumatic stress disorder (PTSD) is associated with an increased risk for physical illnesses and early mortality. However, we do not know if it also increases the risk for adverse outcomes of coronavirus disease 2019 (COVID-19). In this retrospective cohort study, we examined associations of PTSD and other psychiatric disorders with risk for hospitalization and death in the 60 days following a COVID-19 infection in 228,367 U.S. Department of Veteran Affairs (VA) patients who tested positive for COVID-19 between February 2020 and August 2021 (age m = 60.6, 89.5% male). Generalized linear models estimated associations of PTSD and other psychiatric disorders with outcomes following a positive SARS-CoV-2 test, adjusting for socio-demographic, medical, and behavioral factors. Among 228,367 VA patients, 25.6% had PTSD, and 28.2% had a psychiatric disorder other than PTSD. In the 60 days following a positive COVID-19 test, 15% of patients were hospitalized, and 6% died. Patients with PTSD had an increased risk for both hospitalization (adjusted relative risk, ARR = 1.18, 95% CI 1.15-1.21) and death (ARR = 1.13, 95% CI 1.08-1.19) relative to those with no psychiatric disorders, adjusting for socio-demographics. Estimates remained significant when models were additionally adjusted for medical comorbidities and smoking. Patients with other psychiatric disorders also had an increased risk of adverse COVID-19 outcomes, with larger effect sizes than PTSD in older (≥65 years) but not younger patients. In this large-scale study of VA patients, individuals with PTSD, and other psychiatric disorders, had heightened vulnerability to severe adverse outcomes of COVID-19; thus, individuals with PTSD should also be considered at higher risk for severe COVID-19 outcomes, and potentially prioritized for vaccination, screening, and early treatment intervention for COVID-19.

Association of Psychiatric Disorders With Incidence of SARS-CoV-2 Breakthrough Infection Among Vaccinated Adults.

Importance: Psychiatric disorders may be associated with an increased risk for SARS-CoV-2 breakthrough infection after vaccination, but no studies have tested this hypothesis. Objective: To evaluate whether past diagnoses of psychiatric disorders are associated with an increased incidence of SARS-CoV-2 breakthrough infection among fully vaccinated individuals. Design, Setting, and Participants: This retrospective cohort study included data from the administrative and electronic health records of US Department of Veterans Affairs (VA) patients from February 20, 2020, to November 16, 2021. Participants included 263 697 patients who accessed VA health care during the study period, had at least 1 SARS-CoV-2 test recorded in the electronic health record, had no record of SARS-CoV-2 infection prior to vaccination, and had completed a full SARS-CoV-2 vaccination regimen 14 days or more prior. Exposures: Psychiatric disorder diagnoses in the past 5 years, including depressive, posttraumatic stress, anxiety, adjustment, alcohol use, substance use, bipolar, psychotic, attention-deficit/hyperactivity, dissociative, and eating disorders. Main Outcomes and Measures: SARS-CoV-2 breakthrough infections, defined as positive SARS-CoV-2 tests, among fully vaccinated individuals. Results: Of 263 697 fully vaccinated VA patients (239 539 men [90.8%]; mean [SD] age, 66.2 [13.8] years), 135 481 (51.4%) had at least 1 psychiatric disorder diagnosis, and 39 109 (14.8%) developed a breakthrough infection. A diagnosis of any psychiatric disorder was associated with increased incidence of breakthrough infection, both in models adjusted for potential confounders (adjusted relative risk [aRR], 1.07; 95% CI, 1.05-1.09) and additionally adjusted for medical comorbidities and smoking (aRR, 1.03; 95% CI, 1.01-1.05). Most specific psychiatric disorder diagnoses were associated with an increased incidence of breakthrough infection, with the highest relative risk observed for adjustment disorder (aRR, 1.13; 95% CI, 1.10-1.16) and substance use disorders (aRR, 1.16; 95% CI, 1.12-1.21) in fully adjusted models. Stratifying the sample at 65 years of age revealed that associations between psychiatric diagnoses and incident breakthrough infection were present in both age groups but were stronger and robust to adjustment for medical comorbidities and smoking among older patients. Conclusions and Relevance: This cohort study suggests that psychiatric disorder diagnoses were associated with an increased incidence of SARS-CoV-2 breakthrough infection among VA patients, with the strongest associations observed for older individuals. Individuals with psychiatric disorders may be at heightened risk for contracting COVID-19 even after vaccination, suggesting the need for targeted prevention efforts.

“Then COVID happened…”: Veterans’ Health, Wellbeing, and Engagement in Whole Health Care During the COVID-19 Pandemic

Background Little is known about the COVID-19 pandemic’s impact on US military veterans’ health, wellbeing, and care engagement. Healthcare systems like VA need additional information about the pandemic’s biopsychosocial impacts and how a Whole Health approach may help to address them. Objective To examine how the pandemic has affected veterans’ health, wellbeing, and engagement in the VA Whole Health System of Care. Method We conducted qualitative interviews with 40 veterans at a large multicampus VA healthcare system during the pandemic. Informed by a Whole Health approach, interviews used open-ended questions to holistically explore pandemic impacts on mental and physical health, healthcare access and engagement, social support, coping strategies, and use of VA healthcare and wellness services. Interviews were conducted by telephone, audio-recorded, and analyzed using a matrix-based technique. Interviews were supplemented by an original survey assessing pandemic impacts;descriptive frequencies were calculated to describe and characterize the interviewed sample. Interview Results Nearly, all participating veterans described significant pandemic impacts on their wellbeing, especially loneliness and sorrow stemming from isolation and disruptions to ordinary routines. These emotional impacts—sometimes combined with new constraints on care access and personal mobility—disrupted veterans’ health plans and sometimes deterred engagement in both routine and wellness care. Veterans already struggling with chronic mental and physical health conditions and those who experienced transitions or losses during the pandemic described the most severe impacts on their wellbeing. Virtual VA wellness services, especially health coaching and mind-body wellness groups, were a key source of support and connection for those who engaged in them. Conclusion We discuss the implications of our findings for care systems attempting to implement a Whole Health System of Care, including how they can address postpandemic barriers to engagement in healthcare and wellness programs, and how wellness programs can be leveraged to support those most at risk after the COVID-19 pandemic and in future crises.

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.

Assessing the impact of the COVID-19 pandemic on pragmatic clinical trial participants.

Characterizing the impacts of disruption attributable to the COVID-19 pandemic on clinical research is important, especially in pain research where psychological, social, and economic stressors attributable to the COVID-19 pandemic may greatly impact treatment effects. The National Institutes of Health - Department of Defense - Department of Veterans Affairs Pain Management Collaboratory (PMC) is a collective effort supporting 11 pragmatic clinical trials studying nonpharmacological approaches and innovative integrated care models for pain management in veteran and military health systems. The PMC rapidly developed a brief pandemic impacts measure for use across its pragmatic trials studying pain while remaining broadly applicable to other areas of clinical research. Through open discussion and consensus building by the PMC's Phenotypes and Outcomes Work Group, the PMC Coronavirus Pandemic (COVID-19) Measure was iteratively developed. The measure assesses the following domains (one item/domain): access to healthcare, social support, finances, ability to meet basic needs, and mental or emotional health. Two additional items assess infection status (personal and household) and hospitalization. The measure uses structured responses with a three-point scale for COVID-19 infection status and four-point ordinal rank response for all other domains. We recommend individualized adaptation as appropriate by clinical research teams using this measure to survey the effects of the COVID-19 pandemic on study participants. This can also help maintain utility of the measure beyond the COVID-19 pandemic to characterize impacts during future public health emergencies that may require mitigation strategies such as periods of quarantine and isolation.

"Then COVID happened ": Veterans' Health, Wellbeing, and Engagement in Whole Health Care During the COVID-19 Pandemic.

BACKGROUND: Little is known about the COVID-19 pandemic's impact on US military veterans' health, wellbeing, and care engagement. Healthcare systems like VA need additional information about the pandemic's biopsychosocial impacts and how a Whole Health approach may help to address them. OBJECTIVE: To examine how the pandemic has affected veterans' health, wellbeing, and engagement in the VA Whole Health System of Care. METHOD: We conducted qualitative interviews with 40 veterans at a large multicampus VA healthcare system during the pandemic. Informed by a Whole Health approach, interviews used open-ended questions to holistically explore pandemic impacts on mental and physical health, healthcare access and engagement, social support, coping strategies, and use of VA healthcare and wellness services. Interviews were conducted by telephone, audio-recorded, and analyzed using a matrix-based technique. Interviews were supplemented by an original survey assessing pandemic impacts; descriptive frequencies were calculated to describe and characterize the interviewed sample. INTERVIEW RESULTS: Nearly, all participating veterans described significant pandemic impacts on their wellbeing, especially loneliness and sorrow stemming from isolation and disruptions to ordinary routines. These emotional impacts-sometimes combined with new constraints on care access and personal mobility-disrupted veterans' health plans and sometimes deterred engagement in both routine and wellness care. Veterans already struggling with chronic mental and physical health conditions and those who experienced transitions or losses during the pandemic described the most severe impacts on their wellbeing. Virtual VA wellness services, especially health coaching and mind-body wellness groups, were a key source of support and connection for those who engaged in them. CONCLUSION: We discuss the implications of our findings for care systems attempting to implement a Whole Health System of Care, including how they can address postpandemic barriers to engagement in healthcare and wellness programs, and how wellness programs can be leveraged to support those most at risk after the COVID-19 pandemic and in future crises.