ABSTRACT
Methods: Target enrollment in the wHOPE (Whole Health Options in Pain Education) trial is 750 veterans with moderate to severe chronic pain from five geographically diverse VA facilities across the U.S. We are creating an inclusive and generalizable sample through few exclusion criteria, over-sampling and stratified randomization, prioritizing women veterans and those prescribed opioids, while closely monitoring racial and ethnic diversity. The primary aim of the trial is to determine whether a Whole Health Team (WHT) (interdisciplinary Whole Health/integrative pain team) is superior to Primary Care Group Education (PC-GE, abbreviated group Cognitive Behavioral Therapy for Chronic Pain), and whether both are superior to Usual Primary Care (UPC) in decreasing pain interference and secondarily, in improving quality of life and use of non-pharmacological modalities to manage chronic pain. An implementation evaluation and budget impact analysis will provide information about feasibility, maintenance, and sustainability. Descriptive statistics characterized wHOPE study participants including COVID-19-related impacts. Results: To date, of 248 randomized participants, mean age is 60.2 (SD+/-12.3) years;39% women;23% Black or African American and 9.2% Hispanic/Latinx;27% were prescribed opioids. Roughly half endorsed moderate to severe depression, moderate PTSD symptoms, and 58% reported sleep difficulties. Roughly 20% engaged in hazardous drinking and 10% problem drug use. At baseline, veterans reported high rates of non-pharmacological and CIH pain management, e.g., mindfulness (42%);spinal manipulation (32%). As a result of COVID, wHOPE participants reported worsening: mental and emotional health (73%);access to healthcare (59%);pain intensity (48%) and use of tobacco (44%) and cannabis products (36%). Background: To conduct a pragmatic trial to establish evidence for the VA Whole Health model for chronic pain care. Conclusion: This ongoing multi-site pragmatic trial in a diverse group of veterans with chronic pain and high rates of comorbidity indicates high baseline use of CIH and substantial negative COVID-related impacts.
ABSTRACT
Objective: This study investigated whether low vitamin D levels are independently associated with COVID-19-related hospitalization and mortality. Methods: A retrospective cohort of 5,634 COVID-19+ patients with recent Vitamin D labs receiving care at US Department of Veteran Affairs (VA) health care facilities from February 20, 2020 to November 8, 2020, was identified. Vitamin D level was ascertained using the 25-hydroxyvitamin D3 or D2+D3 test result within 90 days preceding the index positive COVID-19 test. Study outcomes were: (1) inpatient hospitalization requiring isolation and (2) 30-day mortality among those hospitalized. Poisson Generalized Linear Models with robust errors and adjusted for sociodemographics and comorbidities were used to estimate outcome probabilities conditional on the log of Vitamin D levels. Results: Of 5,634 veterans with a positive COVID-19 test, 707 (12.6%) were female, mean age was 62.5 (SD +/-15.1);1,920 (34.1%) identified as non-White, and 623 (11.1%) as Latinx. Low vitamin D levels (<20 ng/ml) were found in 794 (14.1%) and 1,162 (20.6%) were hospitalized for COVID-19 infection. After adjusting for all covariates, the probability of hospitalization was 23.7% for those with Vitamin D levels of 15ng/ml, but decreased to 19.8% for patients with higher vitamin D levels of 40 ng/ml, [Adjusted Relative Risk (ARR)=1.20 (1.06, 1.36, p=.004)]. Among 1,162 hospitalized patients, 186 (16.0%) died within 30 days. The adjusted mortality rate for patients with Vitamin D levels of 15 ng/ml was 22.3% and decreased to 14.4% for patients with higher vitamin D levels of 40 ng/ml, [ARR=1.55 (1.11,2.18, p=.011)]. Conclusion: Vitamin D level may have a role in predicting COVID-19-related hospitalization and mortality;larger trials are needed to determine if vitamin D supplementation improves COVID-19-related clinical outcomes.