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BACKGROUND: Studies show interdisciplinary treatment is highly effective for addressing chronic pain syndromes, including headache disorders. Increasingly, advanced practice pharmacists work collaboratively with physicians to apply their unique skills to enhance patient outcomes. OBJECTIVE: This qualitative study aimed to elucidate the potential in the Veterans Health Administration (VHA) for increased roles of clinical pharmacist practitioners (CPPs)-advanced practice pharmacists with a scope of practice-in collaborative, interdisciplinary headache care teams. Our research question was: How do CPPs integrate with interdisciplinary headache care teams in Headache Centers of Excellence (HCoE) and non-HCoE VHA facilities, and how can their roles be configured to optimize headache specialty care services? METHODS: This cross-sectional qualitative study used purposive sampling to recruit CPPs providing headache care within HCoEs and in non-HCoE VHA facilities for virtual, recorded, individual interviews. Multi-stage qualitative data analysis entailed: team discussions; immersion/crystallization for close reading of transcripts to identify emerging patterns of HCoE/non-HCoE comparison of CPPs' experiences; team data sorting using spreadsheets; and further immersion into sorted data for final identification of comparisons and interpretation of the data. RESULTS: A total of 15 CPPs involved in headache care were interviewed, with about half working in HCoEs and half in non-HCoE VHA facilities across the United States. CPPs' roles within and outside HCoEs have considerable overlap as both groups co-manage patients with headache with physicians. CPPs have independent and collaborative responsibilities as they extend headache specialists' services by providing direct patient care and referring to additional providers for headache treatment. When their roles differ within and outside HCoEs it is largely due to level of integration on interdisciplinary headache or pain teams. CPPs in HCoEs collaborate with headache neurologists and interdisciplinary teams; some outside HCoEs do as well, while others work with primary care. CPPs' weekly time dedicated specifically to headache tends to be greater in HCoEs. Nevertheless, most interviewees in both groups stated patient need exceeds CPP availability at their facilities for conducting detailed chart reviews, initial visits to understand the context of patients' headache, and scheduled follow-ups over time to monitor and adjust treatment. CPPs also consult with and educate physicians on headache pharmacy, particularly regarding appropriate use of non-formulary medications. CONCLUSION: Findings from this study suggest that CPPs' roles in headache care are valuable to clinical colleagues and their patients and should be leveraged and expanded within HCoEs and non-HCoE VHA facilities. When substantively integrated into interdisciplinary headache care teams, CPPs offer unique knowledge, headache management and patient behavior change skills, extend headache specialists' services, and provide both patient and physician education. These combined responsibilities contribute to enhancing patient outcomes and facilitating ongoing access to high quality, evidence-based headache care.
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OBJECTIVE: We examined the perspectives of expert headache psychologists to inform best practices for integrating headache psychologists into the care of children and adults with headache disorders within medical settings. BACKGROUND: Headache disorders are prevalent, chronic, and disabling neurological conditions. As clinical providers trained in evidence-based behavior change interventions with expertise in headache disorders, headache psychologists are uniquely positioned to provide behavioral headache treatment. METHODS: In 2020, we conducted semi-structured interviews with a purposive sample of expert headache psychologists working across the United States. Open-ended questions focused on their roles, clinical flow, and treatment content. Interviews were audio-recorded, transcribed, de-identified, and analyzed using a rapid qualitative analysis method. RESULTS: We interviewed seven expert headache psychologists who have worked for an average of 18 years in outpatient settings with pediatric (n = 4) and adult (n = 3) patients with headache. The themes that emerged across the clinical workflow related to key components of behavioral headache treatment, effective behavioral treatment referral practices, and barriers to patient engagement. The expert headache psychologists offered evidence-based behavioral headache interventions such as biofeedback, relaxation training, and cognitive behavioral therapy emphasizing lifestyle modification as standalone options or concurrently with pharmacological treatment and were of brief duration. Participants reported many of their patients appeared reluctant to seek behavioral treatment for headache. Participants believed referrals were most effective when the referring provider explained to the patient the rationale for behavioral treatment, treatment content, and positive impact on headache activity, functioning, and quality of life. Barriers cited by participants to integrating headache psychology into headache care included the paucity of psychologists with specialized headache training, lack of insurance reimbursement, limited patient time to seek behavioral treatment, and inadequate patient knowledge of what behavioral treatment entails. CONCLUSION: Headache psychologists are often core members of multidisciplinary headache teams offering short-term, evidence-based behavioral interventions, both as a standalone treatment or in conjunction with pharmacotherapy. However, barriers to care persist. Enhancing referring providers' familiarity with psychologists' role in headache care may aid successful referrals for behavioral interventions for headache.
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BACKGROUND AND OBJECTIVE: Comprehensive headache care involves numerous specialties and components that have not been well documented or standardized. This study aimed to elicit best practices and characterize important elements of care to be provided in multidisciplinary headache centers. METHODS: Qualitative, semi-structured telephone interviews with a purposive sample of headache neurology specialists from across the US, using open-ended questions. Interviews were recorded, transcribed, and coded. Coded data were further analyzed using immersion/crystallization techniques for final interpretation. RESULTS: Mean years providing headache care was 17.7 (SD = 10.6). Twelve of the 13 participants held United Council for Neurologic Subspecialties headache certification. Six described their practice site as providing multidisciplinary headache care. Participants explained most of their patients had seen multiple doctors over many years, and had tried numerous unsuccessful treatments. They noted patients with chronic headache frequently present with comorbidities and become stigmatized. All participants asserted successful care depends on taking time to talk with and listen to patients, gain understanding, and earn trust. All participants believed multidisciplinary care is essential within a comprehensive headache center, along with staffing enough headache specialists, implementing detailed headache intake and follow-up protocols, and providing the newest medications, neuromodulation devices, botulinum toxin injections, monoclonal antibodies, nerve blocks and infusions, and treatment from a health psychologist. Other essential services for a headache center are other behavioral health practitioners providing cognitive behavioral therapy, mindfulness, biofeedback and pain management; and autonomic neurology, neuropsychology, vestibular audiology, sleep medicine, physical therapy, occupational therapy, exercise physiology, speech therapy, nutrition, complementary integrative health modalities, and highly trained support staff. CONCLUSION: While headache neurology specialists form the backbone of headache care, experts interviewed for this study maintained their specialty is just one of many types of care needed to adequately treat patients with chronic headache, and this is best provided in a comprehensive, multidisciplinary center.
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Transtornos da Cefaleia , Neurologia , Cefaleia/terapia , Humanos , Manejo da Dor , EspecializaçãoRESUMO
OBJECTIVE: The objective of this study was to evaluate the utilization of telehealth for headache services within the Veterans Health Administration's facilities housing a Headache Centers of Excellence and multiple stakeholder's perspectives to inform future telehealth delivery. BACKGROUND: Telehealth delivery of headache treatment may enhance patient access to headache care, yet little is known about the utilization or patient and provider perceptions of telehealth for veterans with headache. METHODS: This mixed-methods study analyzed multiple data sources: (1) administrative data, which included 58,798 patients with medically diagnosed headache disorders, documented in at least one outpatient visit, from August 2019 through September 2020 from the 12 Veterans Health Administration's facilities with a Headache Center of Excellence and (2) qualitative semistructured interviews with 20 patients and 43 providers 6 months before the coronavirus disease 2019 (COVID-19) pandemic, and 10 patients and 20 providers 6 months during the beginning of the pandemic. RESULTS: During the pandemic, in-person visits declined from 12,794 to 6099 (52.0%), whereas video (incidence rate ratio [IRR] = 2.05, 95% confidence interval [CI] = 1.66, 2.52), and telephone visits (IRR = 15.2, 95% CI = 10.7, 21.6) significantly increased. Utilization differed based on patient age, race/ethnicity, and rurality. Patients and providers perceived value in using telehealth, yet had limited experience with this modality pre-pandemic. Providers preferred in-person appointments for initial encounters and telehealth for follow-up visits. Providers and patients identified benefits and challenges of telehealth delivery, often relying on multiple delivery methods for telehealth to enhance patient engagement. CONCLUSIONS: The uptake of telehealth delivery of headache-related care rapidly expanded in response to the pandemic. Patients and providers were amenable to utilizing telehealth, yet also experienced technological barriers. To encourage equitable access to telehealth and direct resources to those in need, it is crucial to understand patient preferences regarding in-person versus telehealth visits and identify patient groups who face barriers to access.
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COVID-19 , Telemedicina , Cefaleia/epidemiologia , Cefaleia/terapia , Humanos , Pandemias , SARS-CoV-2 , Telemedicina/métodosRESUMO
BACKGROUND: To evaluate quality improvement sustainment for Transient Ischemic Attack (TIA) and identify factors influencing sustainment, which is a challenge for Learning Healthcare Systems. METHODS: Mixed methods were used to assess changes in care quality across periods (baseline, implementation, sustainment) and identify factors promoting or hindering sustainment of care quality. PREVENT was a stepped-wedge trial at six US Department of Veterans Affairs implementation sites and 36 control sites (August 2015-September 2019). Quality of care was measured by the without-fail rate: proportion of TIA patients who received all of the care for which they were eligible among brain imaging, carotid artery imaging, neurology consultation, hypertension control, anticoagulation for atrial fibrillation, antithrombotics, and high/moderate potency statins. Key informant interviews were used to identify factors associated with sustainment. RESULTS: The without-fail rate at PREVENT sites improved from 36.7% (baseline, 58/158) to 54.0% (implementation, 95/176) and settled at 48.3% (sustainment, 56/116). At control sites, the without-fail rate improved from 38.6% (baseline, 345/893) to 41.8% (implementation, 363/869) and remained at 43.0% (sustainment, 293/681). After adjustment, no statistically significant difference in sustainment quality between intervention and control sites was identified. Among PREVENT facilities, the without-fail rate improved ≥2% at 3 sites, declined ≥2% at two sites, and remained unchanged at one site during sustainment. Factors promoting sustainment were planning, motivation to sustain, integration of processes into routine practice, leadership engagement, and establishing systems for reflecting and evaluating on performance data. The only factor that was sufficient for improving quality of care during sustainment was the presence of a champion with plans for sustainment. Challenges during sustainment included competing demands, low volume, and potential problems with medical coding impairing use of performance data. Four factors were sufficient for declining quality of care during sustainment: low motivation, champion inactivity, no reflecting and evaluating on performance data, and absence of leadership engagement. CONCLUSIONS: Although the intervention improved care quality during implementation; performance during sustainment was heterogeneous across intervention sites and not different from control sites. Learning Healthcare Systems seeking to sustain evidence-based practices should embed processes within routine care and establish systems for reviewing and reflecting upon performance. TRIAL REGISTRATION: Clinicaltrials.gov ( NCT02769338 ).
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Ataque Isquêmico Transitório , Medicina Baseada em Evidências , Prática Clínica Baseada em Evidências , Humanos , Ataque Isquêmico Transitório/terapia , Avaliação de Programas e Projetos de Saúde/métodos , Melhoria de QualidadeRESUMO
BACKGROUND: The Community of Practice (CoP) model represents one approach to address knowledge management to support effective implementation of best practices. OBJECTIVE: We sought to identify CoP developmental strategies within the context of a national quality improvement project focused on improving the quality for patients receiving acute transient ischemic attack (TIA) care. DESIGN: Stepped wedge trial. PARTICIPANTS: Multidisciplinary staff at six Veterans Affairs medical facilities. INTERVENTIONS: To encourage site implementation of a multi-component quality improvement intervention, the trial included strategies to improve the development of a CoP: site kickoff meetings, CoP conference calls, and an interactive website (the "Hub"). APPROACH: Mixed-methods evaluation included data collected through a CoP attendance log; semi-structured interviews with site participants at 6 months (n = 32) and 12 months (n = 30), and CoP call facilitators (n = 2); and 22 CoP call debriefings. KEY RESULTS: The critical seeding structures that supported the cultivation of the CoP were the kickoffs which fostered relationships (key to the community element of CoPs) and provided the evidence base relevant to TIA care (key to the domain element of CoPs). The Hub provided the forum for sharing quality improvement plans and other tools which were further highlighted during the CoP calls (key to the practice element of CoPs). CoP calls were curated to create a positive context around participants' work by recognizing team successes. In addition to improving care at their local facilities, the community created a shared set of tools which built on their collective knowledge and could be shared within and outside the group. CONCLUSIONS: The PREVENT CoP advanced the mission of the learning healthcare system by successfully providing a forum for shared learning. The CoP was grown through seeding structures that included kickoffs, CoP calls, and the Hub. A CoP expands upon the learning collaborative implementation strategy as an effective implementation practice.
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Ataque Isquêmico Transitório , Serviços de Saúde Comunitária , Humanos , Ataque Isquêmico Transitório/terapia , Melhoria de QualidadeRESUMO
BACKGROUND: The Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurologic Symptoms (PREVENT) program was a complex quality improvement (QI) intervention targeting transient ischemic attack (TIA) evidence-based care. The aim of this study was to evaluate program acceptability among the QI teams and factors associated with degrees of acceptability. METHODS: QI teams from six Veterans Administration facilities participated in active implementation for a one-year period. We employed a mixed methods study to evaluate program acceptability. Multiple data sources were collected over implementation phases and triangulated for this evaluation. First, we conducted 30 onsite, semi-structured interviews during active implementation with 35 participants at 6 months; 27 interviews with 28 participants at 12 months; and 19 participants during program sustainment. Second, we conducted debriefing meetings after onsite visits and monthly virtual collaborative calls. All interviews and debriefings were audiotaped, transcribed, and de-identified. De-identified files were qualitatively coded and analyzed for common themes and acceptability patterns. We conducted mixed-methods matrix analyses comparing acceptability by satisfaction ratings and by the Theoretical Framework of Acceptability (TFA). RESULTS: Overall, the QI teams reported the PREVENT program was acceptable. The clinical champions reported high acceptability of the PREVENT program. At pre-implementation phase, reviewing quality data, team brainstorming solutions and development of action plans were rated as most useful during the team kickoff meetings. Program acceptability perceptions varied over time across active implementation and after teams accomplished actions plans and moved into sustainment. We observed team acceptability growth over a year of active implementation in concert with the QI team's self-efficacy to improve quality of care. Guided by the TFA, the QI teams' acceptability was represented by the respective seven components of the multifaceted acceptability construct. CONCLUSIONS: Program acceptability varied by time, by champion role on QI team, by team self-efficacy, and by perceived effectiveness to improve quality of care aligned with the TFA. A complex quality improvement program that fostered flexibility in local adaptation and supported users with access to data, resources, and implementation strategies was deemed acceptable and appropriate by front-line clinicians implementing practice changes in a large, national healthcare organization. TRIAL REGISTRATION: clinicaltrials.gov : NCT02769338 .
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Ataque Isquêmico Transitório , Veteranos , Humanos , Ataque Isquêmico Transitório/terapia , Equipe de Assistência ao Paciente , Melhoria de QualidadeRESUMO
BACKGROUND: Patient portals present the opportunity to expand patients' access to their clinicians and health information. Yet patients and clinicians have expressed the need for more guidance on portal and secure messaging procedures to avoid misuse. Little information is currently available concerning whether and how expectations of portal and messaging usage are communicated to patients. OBJECTIVE: To identify the information made available to patients about patient portal use, and to assess ease in accessing such information. DESIGN: A national survey of publicly available portal information from hospital websites. The study team followed up with phone calls to each hospital to request any additional patient-directed materials (e.g., pamphlets) not located in the web search. PARTICIPANTS: A random sample of 200 acute-care hospitals, 50 from each of four US Census regions, selected from the US Centers for Medicare & Medicaid Hospital Compare dataset. MAIN MEASURES: Availability of patient portals, secure messaging, and related functionality; the content and ease of access to patient-directed information about portals. KEY RESULTS: Of the hospitals sampled, 177 (89%) had a patient portal; 116 (66%) of these included secure messaging functionality. Most portals with secure messaging (N = 65, 58%) did not describe appropriate patient messaging conduct. Although many included disclaimers that the service is not for emergencies, 23 hospitals only included this within the fine prints of their "Terms and Conditions" section. Content analysis of additional patient-directed materials revealed a focus on logistical content, features of the portals, and parameters of use. Of the three categories, logistical content (e.g., creating an account) was the most thorough. CONCLUSIONS: Although most of the sampled hospitals had patient portals, many fail to educate patients fully and set expectations for secure messaging. To improve patient engagement and minimize harm, hospitals and clinicians need to provide more information and set clearer guidelines for patients.
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Comunicação , Portais do Paciente , Idoso , Registros Eletrônicos de Saúde , Hospitais , Humanos , Medicare , Participação do Paciente , Estados UnidosRESUMO
This paper explores the concept of "community-engaged research" (CEnR) within the context of Veteran health care delivery and reintegration programs. A multi-sector expert panel (msExP) was formed to evaluate and make recommendations on Veteran community reintegration research and programs. The panel consisted of Veterans, care partners, clinical providers, researchers, community stakeholders, and subject matter experts. The paper examines the composition and lifecycle of the panel, highlighting the characteristics and experiences of the participants. Shifts in the panel's purpose and engagement levels occurred in response to unanticipated disruptions, particularly the COVID-19 pandemic. The transformation of the panel emphasizes the importance of aligning individual and group needs and deepening intrapersonal relationships Findings based on observations, surveys, and interviews with panel members contribute to the field of community-engaged research by demonstrating the utility of catalytic validity that balances group and individual development. As part of a broader study on Veteran reintegration, the panel and its development over time allowed for various perspectives on Veteran experiences and reintegration within the community that shaped the overall project. Despite the challenges of developing and maintaining a panel alongside a research study, feedback from the panel members on their participation provides insight into the potential for future working alliances in community-engaged health research.
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Background Since headache specialists cannot treat all the patients with headache disorders, multidisciplinary teams that include health psychologists are becoming more prevalent. Health psychologists mainly use a form of cognitive-behavioral therapy (CBT), along with biofeedback on occasion, to effectively address patients' pain and headache disorders. The Veterans Health Administration (VHA) is one setting that routinely includes a health psychologist with advanced training in pain disorders in their pain care to its veterans. The VHA has established Headache Centers of Excellence (HCoE) around the country to provide multidisciplinary treatment for patients with headache disorders, which enables headache specialists to regularly interact with health psychologists. Objective The study's objective is to evaluate headache specialists' views of health psychologists in the treatment of patients with headache disorders. Method Semi-structured interviews were conducted with headache specialists in academic-based healthcare settings, the community, and VHA HCoE sites. The interviews were audio-recorded and de-identified so they could be transcribed and analyzed using content matrix analysis. Results Four themes emerged: headache specialists desired to work with health psychologists and included them as members of multidisciplinary teams; valued health psychologists because they provided non-pharmacological treatments, such as CBT and biofeedback; preferred in-person communication with health psychologists; and used multiple titles when referring to health psychologists. Conclusion Headache specialists valued health psychologists as providers of behavioral and non-pharmacological treatments and considered them essential members of multidisciplinary teams. Headache specialists should strive to work with a headache psychologist, not just a general health psychologist. By committing to this, headache specialists can foster changes in the quality of care, resource allocation, and training experiences related to health psychologists.
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AIM: To describe adults' health-related experiences with chronic cough. DESIGN: Survey and interviews. METHODS: Participants completed questionnaires and interviews, to explore chronic cough's impact and management. DATA SOURCES: Patients aged 18-85 years with at least three cough-related encounters within 56-120 days. RESULTS: Forty-one patients were surveyed. Mean cough severity was 4.5 (scale 0-9). Chronic cough-related problems included embarrassment (66%), fatigue (56%), and anxiety or depression (49%). Testing was judged insufficient by 44%. Only 28% were satisfied with treatment; 20% reported abandoning treatment due to ineffectiveness. Interview themes (N = 30) included frustration with diagnostic uncertainty, and feelings of therapeutic futility. Some reported psychological distress. Work and socializing were commonly disrupted. CONCLUSION: Diagnostic uncertainty, perceived limitations of testing, and treatment failures suggest needs for better approaches to evaluating and treating chronic cough. Special attention to identifying and addressing mental health issues appears warranted.
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Tosse , Projetos de Pesquisa , Humanos , Adulto , Tosse/terapia , Emoções , Ansiedade , Pesquisa EmpíricaRESUMO
Patients living with headache diseases often have difficulty accessing evidence-based care. Authors conducted a qualitative research study with 20 patients receiving headache care at seven Headache Centers of Excellence within the Veterans Health Administration to examine their experiences navigating headache care. This study employed thematic qualitative analysis and conducted cross-case comparisons. Several key findings emerged. 1) Most patients saw multiple healthcare providers over numerous years before reaching a headache specialist to manage chronic headaches. 2) Receipt of high-quality and comprehensive headache specialty care was associated with high satisfaction. 3) Patients with headache diseases reported oftentimes they experienced an arduous journey across multiple healthcare systems and between several healthcare providers before receiving evidence-based headache treatment that they found acceptable. Results demonstrate that most patients were satisfied with their current specialty headache care in the Veterans Health Administration. Authors discuss implications for future studies and highlight ways to improve patient satisfaction and timely access to appropriate headache care.
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OBJECTIVE: To evaluate veteran patient and provider perceptions and preferences on complementary and integrative medicine (CIM) for headache management. BACKGROUND: The Veterans Health Administration (VHA) has spearheaded a Whole Health system of care focusing on CIM-based care for veteran patients. Less is known about patients' and providers' CIM perceptions and preferences for chronic headache management. METHODS: We conducted semi-structured interviews with 20 veteran patients diagnosed with headache and 43 clinical providers, across 12 VHA Headache Centers of Excellence (HCoE), from January 2019 to March 2020. We conducted thematic and case comparative analyses. RESULTS: Veteran patients and VHA clinical providers viewed CIM favorably for the treatment of chronic headache. Specific barriers to CIM approaches included: (1) A lack of personnel specialized in specific CIM approaches for timely access, and (2) variation in patient perceptions and responses to CIM treatment efficacy for headache management. CONCLUSION: Veteran patients and VHA clinical providers in this study viewed CIM favorably as a safe addition to mainstream headache treatments. Advantages to CIM include favorable adverse effect profiles and patient autonomy over the treatment. By adding more CIM providers and resources throughout the VHA, CIM modalities may be recommended more routinely in the management of veterans with headache.
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Transtornos da Cefaleia/terapia , Equipe de Assistência ao Paciente , Padrões de Prática Médica , Veteranos , Terapias Complementares , Estudos Transversais , Registros Eletrônicos de Saúde , Feminino , Humanos , Medicina Integrativa , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Estados Unidos , Serviços de Saúde para Veteranos MilitaresRESUMO
BACKGROUND: Facilitation is a complex, relational implementation strategy that guides change processes. Facilitators engage in multiple activities and tailor efforts to local contexts. How this work is coordinated and shared among multiple, external actors and the contextual factors that prompt and moderate facilitators to tailor activities have not been well-described. METHODS: We conducted a mixed methods evaluation of a trial to improve the quality of transient ischemic attack care. Six sites in the Veterans Health Administration received external facilitation (EF) before and during a 1-year active implementation period. We examined how EF was employed and activated. Data analysis included prospective logs of facilitator correspondence with sites (160 site-directed episodes), stakeholder interviews (a total of 78 interviews, involving 42 unique individuals), and collaborative call debriefs (n=22) spanning implementation stages. Logs were descriptively analyzed across facilitators, sites, time periods, and activity types. Interview transcripts were coded for content related to EF and themes were identified. Debriefs were reviewed to identify instances of and utilization of EF during site critical junctures. RESULTS: Multi-tiered EF was supported by two groups (site-facing quality improvement [QI] facilitators and the implementation support team) that were connected by feedback loops. Each site received an average of 24 episodes of site-directed EF; most of the EF was delivered by the QI nurse. For each site, site-directed EF frequently involved networking (45%), preparation and planning (44%), process monitoring (44%), and/or education (36%). EF less commonly involved audit and feedback (20%), brainstorming solutions (16%), and/or stakeholder engagement (5%). However, site-directed EF varied widely across sites and time periods in terms of these facilitation types. Site participants recognized the responsiveness of the QI nurse and valued her problem-solving, feedback, and accountability support. External facilitators used monitoring and dialogue to intervene by facilitating redirection during challenging periods of uncertainty about project direction and feasibility for sites. External facilitators, in collaboration with the implementation support team, successfully used strategies tailored to diverse local contexts, including networking, providing data, and brainstorming solutions. CONCLUSIONS: Multi-tiered facilitation capitalizing on emergent feedback loops allowed for tailored, site-directed facilitation. Critical juncture cases illustrate the complexity of EF and the need to often try multiple strategies in combination to facilitate implementation progress. TRIAL REGISTRATION: The Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) is a registered trial ( NCT02769338 ), May 11, 2016-prospectively registered.