Impact of COVID-19 pandemic on nonpharmacological pain management trials in military and veteran healthcare settings: an evaluation informed by implementation science.

The coronavirus disease (COVID-19) pandemic disrupted healthcare and clinical research, including a suite of 11 pragmatic clinical trials (PCTs), across clinics within the Department of Veterans Affairs (VA) and the Department of Defense (DOD). These PCTs were designed to evaluate an array of nonpharmacological treatments and models of care for treatment of patients with pain and co-occurring conditions. The aims of the study are to (a) describe modifications to PCTs and interventions to address the evolving pandemic and (b) describe the application of implementation science methods for evaluation of those PCT modifications. The project used a two-phase, sequential, mixed-methods design. In Phase I, we captured PCT disruptions and modifications via a Research Electronic Data Capture questionnaire, using Periodic Reflections methods as a guide. In Phase II, we utilized the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) taxonomy to develop a focus group interview guide and checklist that would provide more in-depth data than Phase I. Data were analyzed using directed content analysis. Phase I revealed that all PCTs made between two and six trial modifications. Phase II, FRAME-guided analyses showed that the key goals for modifying interventions were increasing treatment feasibility and decreasing patient exposure to COVID-19, while preserving intervention core elements. Context (format) modifications led eight PCTs to modify parts of the interventions for virtual delivery. Content modifications added elements to enhance patient safety; tailored interventions for virtual delivery (counseling, exercise, mindfulness); and modified interventions involving manual therapies. Implementation science methods identified near-real-time disruptions and modifications to PCTs focused on pain management in veteran and military healthcare settings.

Active-duty personnel and veterans often report pain and seek treatment in military and veteran healthcare settings. Nondrug treatments, such as self-care, counseling, exercise, and manual therapy, are recommended for most patients with chronic pain. The COVID-19 pandemic has affected clinical trials of these nondrug treatments in military and veteran populations. In this study, we explored how 11 research teams adapted study trials on pain to address COVID-19. Team members completed online questions, brief checklists, and a one-time focus group about how they modified their trials. Each of the 11 trials made 2 to 6 changes to their studies. Most paused or delayed recruitment efforts. Many shifted parts of the study to a virtual format. Goals for adapting treatments included improved feasibility and decreased patient exposure to COVID-19. Context or format changes increased virtual delivery of study treatments. Content changes focused on patient safety, tailoring treatments for virtual delivery, and offering varied manual therapies. Provider concerns about technology and patient willingness to seek in-person care during the pandemic also were factors driving changes. These findings may support the increased use of virtual care for pain management in military and veteran health settings.

Antecedents to COVID-19 vaccine uptake among patients and employees in the Veterans Health Administration.

The present study sought to understand the antecedents to COVID-19 vaccination among those reporting a change in vaccine intention in order to improve COVID-19 vaccine uptake in the United States. We employed semi-structured interviews and one focus group discussion with vaccinated and unvaccinated Veterans Health Administration (VHA) employees and Veterans at three Veterans' Affairs medical centers between January and June 2021. A subset of these participants (n=21) self-reported a change in COVID-19 vaccine intention and were selected for additional analysis. We combined thematic analysis using the 5C scale (confidence, collective responsibility, complacency, calculation, constraints) as our theoretical framework with a constant comparative method from codes based on the SAGE Working Group on Vaccine Hesitancy. We generated 13 themes distributed across the 5C constructs that appeared to be associated with a change in COVID-19 vaccine intention. Themes included a trusted family member, friend or colleague in a healthcare field, a trusted healthcare professional, distrust of government or politics (confidence); duty to family and protection of others (collective responsibility); perceived health status and normative beliefs (complacency); perceived vaccine safety, perceived risk-benefit, and orientation towards deliberation (calculation); and ease of process (constraints). Key factors in promoting vaccine uptake included a desire to protect family; and conversations with as key factors in promoting vaccine uptake. Constructs from the 5C scale are useful in understanding intrapersonal changes in vaccine intentions over time, which may help public health practitioners improve future vaccine uptake.

In this study of the Veteran and VA employee population, we aimed to understand what factors led to a decision to receive a COVID-19 vaccine. As part of a quality improvement project, we interviewed individuals at three Veterans' Affairs sites in the first six months of 2021. We then used a smaller sample of 21 participants who reported a change in their intentions to receive a COVID-19 vaccine to analyze for this study. This analysis utilizes constructs from the 5C scale, which was developed to understand the conditions required for an individual to decide to receive a vaccine (confidence, collective responsibility, complacency, calculation, constraints). The coding process revealed a number of recurring themes across the interviews falling under each of the five constructs, but concepts relating to vaccine confidence (i.e., level of trust in those developing and disseminating the vaccine) were most common, and constraints (i.e., psychological and structural barriers that stand in the way of vaccination) appeared least frequently in our interviews. We found that significant motivators to receive the vaccine included a desire to protect family and conversations with trusted clinicians, particularly mental healthcare providers. Our study was unique in using the 5Cs to understand changes in vaccine changes over time. Findings show that change in vaccine attitudes is possible even in the presence of concerns and shed light on approaches that public health providers could use to improve vaccine and booster rates.

Optimizing the Impact of Pragmatic Clinical Trials for Veteran and Military Populations: Lessons From the Pain Management Collaboratory.

Pragmatic clinical trials (PCTs) are well-suited to address unmet healthcare needs, such as those arising from the dual public health crises of chronic pain and opioid misuse, recently exacerbated by the COVID-19 pandemic. These overlapping epidemics have complex, multifactorial etiologies, and PCTs can be used to investigate the effectiveness of integrated therapies that are currently available but underused. Yet individual pragmatic studies can be limited in their reach because of existing structural and cultural barriers to dissemination and implementation. The National Institutes of Health, Department of Defense, and Department of Veterans Affairs formed an interagency research partnership, the Pain Management Collaboratory. The partnership combines pragmatic trial design with collaborative tools and relationship building within a large network to advance the science and impact of nonpharmacological approaches and integrated models of care for the management of pain and common co-occurring conditions. The Pain Management Collaboratory team supports 11 large-scale, multisite PCTs in veteran and military health systems with a focus on team science with the shared aim that the "whole is greater than the sum of the parts." Herein, we describe this integrated approach and lessons learned, including incentivizing all parties; proactively offering frequent opportunities for problem-solving; engaging stakeholders during all stages of research; and navigating competing research priorities. We also articulate several specific strategies and their practical implications for advancing pain management in active clinical, "real-world," settings.

Attitudes and Intentions of US Veterans Regarding COVID-19 Vaccination.

Importance: Compared with the general population, veterans are at high risk for COVID-19 and have a complex relationship with the government. This potentially affects their attitudes toward receiving COVID-19 vaccines. Objective: To assess veterans' attitudes toward and intentions to receive COVID-19 vaccines. Design, Setting, and Participants: This cross-sectional web-based survey study used data from the Department of Veterans Affairs (VA) Survey of Healthcare Experiences of Patients' Veterans Insight Panel, fielded between March 12 and 28, 2021. Of 3420 veterans who were sent a link to complete a 58-item web-based survey, 1178 veterans (34%) completed the survey. Data were analyzed from April 1 to August 25, 2021. Exposures: Veterans eligible for COVID-19 vaccines. Main Outcomes and Measures: The outcomes of interest were veterans' experiences with COVID-19, vaccination status and intention groups, reasons for receiving or not receiving a vaccine, self-reported health status, and trusted and preferred sources of information about COVID-19 vaccines. Reasons for not getting vaccinated were classified into categories of vaccine deliberation, dissent, distrust, indifference, skepticism, and policy and processes. Results: Among 1178 respondents, 974 (83%) were men, 130 (11%) were women, and 141 (12%) were transgender or nonbinary; 58 respondents (5%) were Black, 54 veterans (5%) were Hispanic or Latino, and 987 veterans (84%) were non-Hispanic White. The mean (SD) age of respondents was 66.7 (10.1) years. A total of 817 respondents (71%) self-reported being vaccinated against COVID-19. Of 339 respondents (29%) who were not vaccinated, those unsure of getting vaccinated were more likely to report fair or poor overall health (32 respondents [43%]) and mental health (33 respondents [44%]) than other nonvaccinated groups (overall health: range, 20%-32%; mental health: range, 18%-40%). Top reasons for not being vaccinated were skepticism (120 respondents [36%] were concerned about side effects; 65 respondents [20%] preferred using few medications; 63 respondents [19%] preferred gaining natural immunity), deliberation (74 respondents [22%] preferred to wait because vaccine is new), and distrust (61 respondents [18%] did not trust the health care system). Among respondents who were vaccinated, preventing oneself from getting sick (462 respondents [57%]) and contributing to the end of the COVID-19 pandemic (453 respondents [56%]) were top reasons for getting vaccinated. All veterans reported the VA as 1 of their top trusted sources of information. The proportion of respondents trusting their VA health care practitioner as a source of vaccine information was higher among those unsure about vaccination compared with those who indicated they would definitely not or probably not get vaccinated (18 respondents [26%] vs 15 respondents [15%]). There were no significant associations between vaccine intention groups and age (χ24 = 5.90; P = .21) or gender (χ22 = 3.99; P = .14). Conclusions and Relevance: These findings provide information needed to develop trusted messages used in conversations between VA health care practitioners and veterans addressing specific vaccine hesitancy reasons, as well as those in worse health. Conversations need to emphasize societal reasons for getting vaccinated and benefits to one's own health.

Vaccine hesitancy as an opportunity for engagement: A rapid qualitative study of patients and employees in the U.S. Veterans Affairs healthcare system.

Although COVID-19 vaccines have been available to many U.S. Veterans Affairs (VA) healthcare system employees and Veteran patients since early 2021, vaccine receipt data indicates some groups are not receiving them. Our objective was to conduct a rapid qualitative assessment of Veterans' and VA employees' views on COVID-19 vaccination to inform clinical leaders' ongoing efforts to increase vaccine uptake across the VA. We employed semi-structured interviews and a focus group involving employees and Veterans as part of a quality improvement project between January and June 2021 at three VA medical centers. Thirty-one employees and 27 Veterans participated in semi-structured interviews; 5 Veterans from a national stakeholder organization participated in a focus group. Data were analyzed using directed content analysis, involving an a priori coding framework comprised of four domains with subcodes under each: contextual influences, barriers and facilitators, vaccine-specific issues, and VA/military experiences. We then classified initial codes into five categories of hesitancy: vaccine deliberation, dissent, distrust, indifference and skepticism. A subset of Veterans (n = 14) and employees (n = 8) identified as vaccine hesitant. Vaccine hesitancy categories were represented by subcodes of religion, culture, gender or socio-economic factors, perceptions of politics and policies, role of healthcare providers, and historical influences; (contextual influences); knowledge or awareness of vaccines, perceived susceptibility to COVID-19, and beliefs and attitudes about health and illness (barriers and facilitators); vaccine development process (vaccine-specific issues) and military experiences (VA/military factors). Facilitators involved talking with trusted others, ease of vaccine access, and perceptions of family and societal benefits of vaccines. Vaccine hesitancy is multi-faceted and likely requires multiple strategies for engaging in conversations to address Veteran and VA employee concerns. Messages should involve patient-centered communication strategies delivered by trusted healthcare providers and peers and should focus on addressing expected benefits for family, friends, and society.

Clinical leaders and providers' perspectives on delivering medications for the treatment of opioid use disorder in Veteran Affairs' facilities.

BACKGROUND: Improving access to medication treatment of opioid use disorder (MOUD) is a national priority, yet common modifiable barriers (e.g., limited provider knowledge, negative beliefs about MOUD) often challenge implementation of MOUD delivery. To address these barriers, the VA launched a multifaceted implementation intervention focused on planning and educational strategies to increase MOUD delivery in 18 medical facilities. The purpose of this investigation was to determine if a multifaceted intervention approach to increase MOUD delivery changed providers' perceptions about MOUD over the first year of implementation. METHODS: Cross-disciplinary teams of clinic providers and leadership from primary care, pain, and mental health clinics at 18 VA medical facilities received invitations to complete an anonymous, electronic survey prior to intervention launch (baseline) and at 12- month follow-up. Responses were summarized using descriptive statistics, and changes over time were compared using regression models adjusted for gender and prescriber status, and clustered on facility. Responses to open-ended questions were thematically analyzed using a template analysis approach. RESULTS: Survey response rates at baseline and follow-up were 57.1% (56/98) and 50.4% (61/121), respectively. At both time points, most respondents agreed that MOUD delivery is important (94.7 vs. 86.9%), lifesaving (92.8 vs. 88.5%) and evidence-based (85.2 vs. 89.5%). Over one-third (37.5%) viewed MOUD delivery as time-consuming, and only 53.7% affirmed that clinic providers wanted to prescribe MOUD at baseline; similar responses were seen at follow-up (34.5 and 52.4%, respectively). Respondents rated their knowledge about OUD, comfort discussing opioid use with patients, job satisfaction, ability to help patients with OUD, and support from colleagues favorably at both time points. Respondents' ratings of MOUD delivery filling a gap in care were high but declined significantly from baseline to follow-up (85.7 vs. 73.7%, p < 0.04). Open-ended responses identified implementation barriers including lack of support to diagnose and treat OUD and lack of time. CONCLUSIONS: Although perceptions about MOUD generally were positive, targeted education and planning strategies did not improve providers' and clinical leaders' perceptions of MOUD over time. Strategies that improve leaders' prioritization and support of MOUD and address time constraints related to delivering MOUD may increase access to MOUD in non-substance use treatment clinics.