Clinical trial facilitators: A novel approach to support the execution of clinical research at the study site level.

In the summer of 2020, multiple efforts were undertaken to establish safe and effective vaccines to combat the spread of the coronavirus disease (COVID-19). In the United States (U.S.), Operation Warp Speed (OWS) was the program designated to coordinate such efforts. OWS was a partnership between the Department of Health and Human Services (HHS), the Department of Defense (DOD), and the private sector, that aimed to help accelerate control of the COVID-19 pandemic by advancing development, manufacturing, and distribution of vaccines, therapeutics, and diagnostics. The U.S. Department of Veterans Affairs' (VA) was identified as a potential collaborator in several large-scale OWS Phase III clinical trial efforts designed to evaluate the safety and efficacy of various vaccines that were in development. Given the global importance of these trials, it was recognized that there would be a need for a coordinated, centralized effort within VA to ensure that its medical centers (sites) would be ready and able to efficiently initiate, recruit, and enroll into these trials. The manuscript outlines the partnership and start-up activities led by two key divisions of the VA's Office of Research and Development's clinical research enterprise. These efforts focused on site and enterprise-level requirements for multiple trials, with one trial serving as the most prominently featured of these studies within the VA. As a result, several best practices arose that included designating clinical trial facilitators to study sites to support study initiation activities and successful study enrollment at these locations in an efficient and timely fashion.

A natural language processing system for national COVID-19 surveillance in the US Department of Veterans Affairs

Timely and accurate accounting of positive cases has been an important part of the response to the COVID-19 pandemic. While most positive cases within Veterans Affairs (VA) are identified through structured laboratory results, some patients are tested or diagnosed outside VA so their clinical status is documented only in free-text narratives. We developed a Natural Language Processing pipeline for identifying positively diagnosed COVID-19 patients and deployed this system to accelerate chart review. As part of the VA national response to COVID-19, this process identified 6,360 positive cases which did not have corresponding laboratory data. These cases accounted for 36.1% of total confirmed positive cases in VA to date. With available data, performance of the system is estimated as 82.4% precision and 94.2% recall. A public-facing implementation is released as open source and available to the community. © ACL 2020.All right reserved.

Barriers and facilitators to the implementation of intensive treatments for PTSD: early lessons learned from the field

  This article addresses the barriers and facilitators associated with the implementation of PTSD Intensive Outpatient Programs (IOP) across three VHA Medical Centers. Each site developed programs that delivered EBPs in a massed or condensed format and relied on implementation science and the i-PARIHS model to help direct the innovation. Face-to-face, virtual, and combined platforms were used, demonstrating flexibility in design. While each site experienced unique challenges associated with local contextual factors, multiple themes emerged across sites that may help guide future IOP and massed EBP implementations. Common facilitators of the implementation process included: the availability or presence of a credible lead (i.e., champion) to guide the innovation, opportunities to consult with national or outside experts, strong team engagement, processes in place that allowed for ongoing review, clinic operations that are aligned with principles of PTSD specialty care (e.g., time-limited, evidence-based, utilization of measurement based care, willingness to treat complex cases), and leadership support. Alternately, shared barriers included limitations on available resources, options for provider coverage, early staff buy-in, and organizational factors. Solutions to address these barriers and recommendations for future direction are shared. [Author ]  

Comparing mental and physical health of U.S. veterans by VA healthcare use: implications for generalizability of research in the VA electronic health records.

OBJECTIVE: The Department of Veterans Affairs' (VA) electronic health records (EHR) offer a rich source of big data to study medical and health care questions, but patient eligibility and preferences may limit generalizability of findings. We therefore examined the representativeness of VA veterans by comparing veterans using VA healthcare services to those who do not. METHODS: We analyzed data on 3051 veteran participants age ≥ 18 years in the 2019 National Health Interview Survey. Weighted logistic regression was used to model participant characteristics, health conditions, pain, and self-reported health by past year VA healthcare use and generate predicted marginal prevalences, which were used to calculate Cohen's d of group differences in absolute risk by past-year VA healthcare use. RESULTS: Among veterans, 30.4% had past-year VA healthcare use. Veterans with lower income and members of racial/ethnic minority groups were more likely to report past-year VA healthcare use. Health conditions overrepresented in past-year VA healthcare users included chronic medical conditions (80.6% vs. 69.4%, d = 0.36), pain (78.9% vs. 65.9%; d = 0.35), mental distress (11.6% vs. 5.9%; d = 0.47), anxiety (10.8% vs. 4.1%; d = 0.67), and fair/poor self-reported health (27.9% vs. 18.0%; d = 0.40). CONCLUSIONS: Heterogeneity in veteran sociodemographic and health characteristics was observed by past-year VA healthcare use. Researchers working with VA EHR data should consider how the patient selection process may relate to the exposures and outcomes under study. Statistical reweighting may be needed to generalize risk estimates from the VA EHR data to the overall veteran population.

Household Preparedness and Perceptions of Workforce Preparedness During Pandemics: A Health Care Employee Survey at the US Department of Veterans Affairs.

OBJECTIVE: To examine the effects of household preparedness on perceptions of workplace preparedness during a pandemic among all employees at the US Department of Veterans Affairs (VA) medical facilities. METHODS: The VA Preparedness Survey (October-December 2018, Los Angeles, CA) used a stratified simple random, web-based survey. Multivariate statistical analyses examined the effect of household preparedness on perceptions of workforce preparedness during a pandemic: institutional readiness; desire for additional training; and understanding their role and its importance. RESULTS: VA employees totaling 4026 participated. For a pandemic, 55% were confident in their VA medical facility's ability to respond, 63% would like additional training, 49% understood their role during a response, and 68% reported their role as important. Only 23% reported being "well prepared" at home during major disasters. After controlling for study-relevant factors, household preparedness was positively associated with perceptions of workforce preparedness during a pandemic. CONCLUSIONS: Efforts to increase household preparedness for health care employees could bolster workforce preparedness during pandemics. Organizations should consider robust policies and strategies, such as flexible work arrangements, in order to mitigate factors that may serve as barriers to household preparedness.

VA psychologists' professional practices and attitudes toward tele-neuropsychology among a tele-neuropsychology interest group within the Veterans Health Administration.

OBJECTIVE: To provide understanding of practices and attitudes toward tele-neuropsychology (teleNP) among Veterans Health Administration (VA) psychologists who have joined a related community of practice. METHODS: Several VA psychologists (the authors) developed this survey to better understand dissemination of teleNP and attitudes toward teleNP among those involved in a VA teleNP community of practice. We contacted VA psychologists within this group to complete the survey. The survey was open from July to August 2021, during which time a total of 62 VA psychologists participated. RESULTS: Response rate was estimated to be 41% of those receiving the survey (62 respondents). Approximately two thirds of those completing the survey reported current practice of teleNP (68%; n = 42). In contrast, only 25% of the entire sample (n = 15) conducted any teleNP pre-pandemic. Job satisfaction related to being able to perform teleNP is high. Support for continued and increased use of teleNP is high, with most respondents (84%) indicating they will be at least somewhat likely to practice teleNP post-pandemic. CONCLUSIONS: The survey provides increased support for the use of teleNP by VA psychologists who responded to the survey, with significantly increased adoption since the Covid-19 pandemic, and greater likelihood of intention to use teleNP post pandemic.

Implementation of Telehealth Services at the US Department of Veterans Affairs During the COVID-19 Pandemic: Mixed Methods Study.

BACKGROUND: At the onset of the COVID-19 pandemic, there was a rapid increase in the use of telehealth services at the US Department of Veterans Affairs (VA), which was accelerated by state and local policies mandating stay-at-home orders and restricting nonurgent in-person appointments. Even though the VA was an early adopter of telehealth in the late 1990s, the vast majority of VA outpatient care continued to be face-to-face visits through February 2020. OBJECTIVE: We compared telehealth service use at a VA Medical Center, Greater Los Angeles across 3 clinics (primary care [PC], cardiology, and home-based primary care [HBPC]) 12 months before and 12 months after the onset of COVID-19 (March 2020). METHODS: We used a parallel mixed methods approach including simultaneous quantitative and qualitative approaches. The distribution of monthly outpatient and telehealth visits, as well as telephone and VA Video Connect encounters were examined for each clinic. Semistructured telephone interviews were conducted with 34 staff involved in telehealth services within PC, cardiology, and HBPC during COVID-19. All audiotaped interviews were transcribed and analyzed by identifying key themes. RESULTS: Prior to COVID-19, telehealth use was minimal at all 3 clinics, but at the onset of COVID-19, telehealth use increased substantially at all 3 clinics. Telephone was the main modality of patient choice. Compared with PC and cardiology, video-based care had the greatest increase in HBPC. Several important barriers (multiple steps for videoconferencing, creation of new scheduling grids, and limited access to the internet and internet-connected devices) and facilitators (flexibility in using different video-capable platforms, technical support for patients, identification of staff telehealth champions, and development of workflows to help incorporate telehealth into treatment plans) were noted. CONCLUSIONS: Technological issues must be addressed at the forefront of telehealth evolution to achieve access for all patient populations with different socioeconomic backgrounds, living situations and locations, and health conditions. The unprecedented expansion of telehealth during COVID-19 provides opportunities to create lasting telehealth solutions to improve access to care beyond the pandemic.

Robotic Process Automation

Robotic Process Automation (RPA) is a software solution used to perform mundane repetitive work previously done by people. RPAs emerged in the 2000s and grew as a subset of Business Process Management and the three technologies of screen scraping, workflow automation tools, and artificial intelligence. It was not until 2015 that RPAs began to enter the mainstream (Welsh, 2019, p. 2). Private industry reacted quickly and took advantage of the many benefits of RPA use, while reducing the burden of employee rote tasks.This research paper explores current Robotic Process Automation (RPA) use and identifies application areas of RPAs that could cross over from private industry to government or from one government agency to another. Additionally, this paper reports and analyzes efficiencies gained by automating mundane simple processes, which allow redirection of employees' efforts and a shift to more challenging work.A study of private industry and government entities revealed the business areas of finance and operations to be the top areas for RPA application. The benefits of an RPA application include cost savings, increased accuracy, increased productivity, increased scalability, and shift to high-level work. A secondary benefit of RPA use is employee job satisfaction.The Office and Management Budgets RPA directive should be implemented swiftly and with diligence, thus the paper strongly recommends that government entities look at their internal processes to assess, which of these might be improved by RPA application. Another recommendation is that government offices interested in RPAs contact the Federal RPA community of practice as a resource to planning and implementing a good RPA process. This would reduce the risk of duplicating RPA efforts that already exist and allow utilization of existing RPAs.

Optimizing Peripandemic Care for Veteran Major Non-Traumatic Lower Extremity Amputees: A Proposal Informed by a National Retrospective Descriptive Analysis of COVID-19 Risk Factor Prevalence

In response to the Coronavirus 2019 (COVID-19) pandemic, vascular surgeons in the Veteran Affairs Health Care System have been undertaking only essential cases, such as advanced critical limb ischemia. Surgical risk assessment in these patients is often complex, considers all factors known to impact short- and long-term outcomes, and the additional risk thatCOVID-19 infection could convey in this patient population is unknown. The European Centre for Disease Prevention and Control (ECDC) published risk factors (ECDC-RF) implicated in increased COVID-19 hospitalization and case-fatality which have been further evidenced by initial reports from the United States Centers for Disease Control and Prevention. CDC reports additionally indicate that African American (AA) patients have incurred disparate infection outcomes in the United States. We set forth to survey the Veterans Affairs Surgical Quality Improvement Program (VASQIP) database over a nearly 20 year span to inform ongoing risk assessment with an estimation of the prevalence of ECDC-RF in our veteran critical limb ischemia population and investigate whether an increased COVID-19 comorbidity burden exists for AA veterans presenting for major non-traumatic amputation.

Translating a Stem Cell-Based Therapy for Epidermolysis Bullosa into the Clinic

This proposal is developing a stem-cell based therapy for recessive dystrophic epidermolysis bullosa (RDEB), which is one of the most severe forms of epidermolysis bullosa (EB), a group of rare inherited skin blistering diseases. To accomplish this goal, we are utilizing genetic correction of patient-specific induced pluripotent stem cells (iPSCs) followed by the differentiation of these corrected iPSCs into epidermal cells and fibroblasts for the generation of composite full thickness skin grafts for transplantation. During this funding period, we completed our studies on reproducibility of our simultaneous gene editing and reprogramming protocol for the generation of gene corrected RDEB iPSCs. We successfully generated gene corrected RDEB iPSCs from three patients and completed characterization of these iPSC lines on a molecule level. We initiated functional validation of keratinocytes derived from these genetically corrected RDEB iPSCs. In our preliminary analysis, keratinocytes derived from gene corrected RDEB iPSCs show the restoration of the expression of type VII collagen and the formation of a basement membrane in 3D skin equivalents. We also continue working with our cGMP-compliant facility to advance our protocols toward clinical manufacturing. As indicated in the previous report, the initiation of many in vivo studies was delayed due to the COVID-19 pandemic and the closure of research laboratories on the University of Colorado Anschutz Medical Campus. While the University allowed research activities to resume on July 1, research personnel are required to work on a staggered basis, with no more than 50% occupancy at any given time to maintain social distancing. These restrictions continue to impact our research progress. The potential delay caused by these restrictions will be mitigated by requesting a no cost extension before the completion of Year 3 of the project.

COVID-19: Missing Puzzle Pieces, Time, and Black Swans

The Veterans Affairs (VA) Health Care System cares for over 9.2 million Veterans. Between 8 February and 26 May, over 172,000 have been tested for SARS-CoV-2, with 11,300 testing positive, 8,700 reaching convalescence, and 3,600 hospitalized. The VA Office of Research and Development is embedded in the covered heath care entity and is developing several intramural efforts alongside other Federal agencies to overcome this pandemic.

Enhancing Quality of Orthotic Services with Process and Outcome Information

The objective of this proposed project is to develop data collection modules that can be used to improve the quality of services for users of ankle-foot orthoses (AFOs), the largest group of orthosis users. Three specific aims are: 1. Identify issues that are important to the quality of care for AFO users as well as items and instruments that can be used to assess these quality issues. 2. Evaluate and validate patient-reported outcome instruments using performance instruments. 3. Specify items required for quality measure development and design data collection modules that can be used in quality improvement efforts and to demonstrate accountability of health care delivery.

Comparative Approach to Human Auditory Synaptopathy

Exposure to noise can cause damage to structures in the inner ear, often resulting in a loss of hearing. Recent findings in noise-exposedanimals raise a new specter that even moderate noise exposures may result in damage specifically located in the synaptic region betweenthe sensory cells in the cochlea and primary auditory neurons. There is no way currently that scientists and clinicians can diagnose possibleauditory synaptic damage in humans, and diagnosis is critical for the development of innovative treatments. The objective of this project isto develop a statistical model that will accurately predict the likelihood of synaptopathy in humans who have had noise exposures in theirlives. The development of the statistical model will be supported by collecting non-invasive measurements in both humans and guinea pigs.Regulatory documents supporting human and animal testing have been approved both locally and through the relevant offices of theUSAMRMC. The animal laboratory was outfitted with a new sound booth for auditory testing, and data collection is on schedule to begin shortly. Research technicians have been hired to assist in both the human and animal facilities. However, overall progress has been significantly slowed by the seven months and ongoing international pandemic.

VA ACQUISITION MANAGEMENT: Actions Needed to Improve Management of Medical Surgical Prime Vendor Program and Inform Future Decisions

VA is developing the next iteration of its prime vendor program, MSPV 2.0, to meet the healthcare needs ofabout 9 million veterans. GAOs prior work found that VA medical centers use of the MSPV formularyfell below targets in VAs prior iteration of the program and that VA lacked an overarching medicalsupply program strategy.

Development and Implementation of Work Engagement Strategies in a Clinical Research Consortium During the Coronavirus Disease 2019 (COVID-19) Pandemic: A Reflective Inquiry

Work engagement is defined as a positive work-related state of mind that is characterized by vigor, dedication, and absorption. The engagement of staff has been associated with their performance and efficiency, productivity, safety, attendance and retention, customer service and satisfaction, and several other organizational success factors. The Coronavirus Disease 2019 (COVID-19) is an infectious disease caused by the most recently discovered coronavirus and is now a pandemic that is affecting many countries globally. The literature surrounding the employment of measures and strategies to increase work engagement amongst clinical research staff during pandemics is scarce, and to date, focuses primarily on health care and community health workers. The Cooperative Studies Program (CSP) Network of Dedicated Enrollment Sites (NODES) is a clinical research consortium of ten medical centers that are embedded within the Department of Veterans Affairs (VA) Health Care System. The consortium developed and implemented strategies during the pandemic that were intended to maintain work engagement amongst clinical research staff at each of the sites within the consortium. In this manuscript, we describe the development and deployment of these strategies to clinical research study teams in our clinical research consortium. It is our hope that the opportunities, successes, and challenges described here will serve as a useful resource for other clinical research consortia that are working to identify approaches to keep their staff members engaged during the current pandemic, as well as in other potential future situations in which their primary operations may be altered during other times of crises.

Sexual orientation-related disparities in health conditions that elevate COVID-19 severity.

PURPOSE: The Veterans Health Administration (VA) is the largest single integrated healthcare system in the US and is likely the largest healthcare provider for people with minoritized sexual orientations (e.g., gay, lesbian, bisexual). The purpose of this study was to use electronic health record (EHR) data to replicate self-reported survey findings from the general US population and assess whether sexual orientation is associated with diagnosed physical health conditions that may elevate risk of COVID-19 severity among veterans who utilize the VA. METHODS: A retrospective analysis of VA EHR data from January 10, 1999-January 07, 2019 analyzed in 2021. Veterans with minoritized sexual orientations were included if they had documentation of a minoritized sexual orientation within clinical notes identified via natural language processing. Veterans without minoritized sexual orientation documentation comprised the comparison group. Adjusted prevalence and prevalence ratios (aPR) were calculated overall and by race/ethnicity while accounting for differences in distributions of sex assigned at birth, age, calendar year of first VA visit, volumes of healthcare utilization, and VA priority group. RESULTS: Data from 108,401 veterans with minoritized sexual orientation and 6,511,698 controls were analyzed. After adjustment, veterans with minoritized sexual orientations had a statistically significant elevated prevalence of 10 of the 11 conditions. Amongst the highest disparities observed were COPD (aPR:1.24 [95% confidence interval:1.23-1.26]), asthma (1.22 [1.20-1.24]), and stroke (1.26 [1.24-1.28]). CONCLUSIONS: Findings largely corroborated patterns among the general US population. Further research is needed to determine if these disparities translate to poorer COVID-19 outcomes for individuals with minoritized sexual orientation.

Organizational and External Factors Associated with Video Telehealth Use in the Veterans Health Administration Before and During the COVID-19 Pandemic.

Objectives: To identify organizational and external factors associated with medical center video telehealth uptake (i.e., the proportion of patients using telemedicine) before and early in the coronavirus disease 2019 (COVID-19) pandemic. Materials and Methods: We conducted a retrospective, observational study using cross-sectional data for all 139 U.S. Veterans Affairs Medical Centers (VAMCs). We used logistic regression analyses to identify factors that predicted whether a VAMC was in the top quartile of VA Video Connect (VVC) telehealth uptake for primary care and mental health care. Results: All 139 VAMCs increased their VVC uptake at least 2-fold early in the pandemic, with most increasing uptake between 5- and 10-fold. Pre-COVID-19, higher VVC uptake in primary care was weakly and positively associated with having more high-risk patients, negatively associated with having more long-distance patients, and positively associated with the prior fiscal year's VVC uptake. During COVID-19, the positive association with high-risk patients and the negative association with long-distance patients strengthened, while weaker broadband coverage was negatively associated with VVC uptake. For mental health care, having more long-distance patients was positively associated with higher VVC uptake pre-COVID-19, but this relationship reversed during COVID-19. Discussion: Despite the marked increase in VVC uptake early in the COVID-19 pandemic, significant VAMC-level variation indicates that VVC adoption was more difficult for some medical centers, particularly those with poorer broadband coverage and less prior VVC experience. Conclusions and Relevance: These findings highlight opportunities for medical centers, VA Central Office, and other federal entities to ensure equitable access to video telehealth.