• Addressing Implementation Challenges to Digital Care Delivery for Adults With Multiple Chronic Conditions: Stakeholder Feedback in a Randomized Controlled Trial

      Williams, Kelly; Markwardt, Sarah; Kearney, Shannon M; Karp, Jordan F; Kraemer, Kevin L; Park, Margaret J; Freund, Paul; Watson, Andrew; Schuster, James; Beckjord, Ellen; et al. (JMIR Publications Inc., 2021-01-02)
      Background: Digital tools accessed via smartphones can promote chronic condition management, reduce disparities in health care and hospital readmissions, and improve quality of life. However, whether digital care strategies can be implemented successfully on a large scale with traditionally underserved populations remains uncertain. Objective: As part of a randomized trial comparing care delivery strategies for Medicaid and Medicare-Medicaid beneficiaries with multiple chronic conditions, our stakeholders identified implementation challenges, and we developed stakeholder-driven adaptions to improve a digitally delivered care management strategy (high-tech care). Methods: We used 4 mechanisms (study support log, Patient Partners Work Group log, case interview log, and implementation meeting minutes) to capture stakeholder feedback about technology-related challenges and solutions from 9 patient partners, 129 participants, and 32 care managers and used these data to develop and implement solutions. To assess the impact, we analyzed high-tech care exit surveys and intervention engagement outcomes (video visits and condition-specific text message check-ins sent at varying intervals) before and after each solution was implemented. Results: Challenges centered around 2 themes: difficulty using both smartphones and high-tech care components and difficulty using high-tech care components due to connectivity issues. To respond to the first theme's challenges, we devised 3 solutions: tech visits (eg, in-person technology support visits), tech packet (eg, participant-facing technology user guide), and tailored condition-specific text message check-ins. During the first 20 months of implementation, 73 participants received at least one tech visit. We observed a 15% increase in video call completion for participants with data before and after the tech visit (n=25) and a 7% increase in check-in completion for participants with data before and after the tech visit (n=59). Of the 379 participants given a tech packet, 179 completed care during this timeframe and were eligible for an exit survey. Of the survey respondents, 76% (73/96) found the tech packet helpful and 64% (62/96) actively used it during care. To support condition-specific text message check-in completion, we allowed for adaption of day and/or time of the text message with 31 participants changing the time they received check-ins and change in standard biometric settings with 13 physicians requesting personalized settings for participants. To respond to the second theme's challenges, tech visits or phone calls were made to demonstrate how to use a smartphone to connect or disconnect from the internet, to schedule video calls, or for condition-specific text message check-ins in a location with broadband/internet. Conclusions: Having structured stakeholder feedback mechanisms is key to identify challenges and solutions to digital care engagement. Creating flexible and scalable solutions to technology-related challenges will increase equity in accessing digital care and support more effective engagement of chronically ill populations in the use of these digital care tools.
    • COVID-19 infection, reinfection, and vaccine effectiveness in arizona frontline and essential workers: Protocol for a longitudinal cohort study

      Lutrick, K.; Ellingson, K.D.; Baccam, Z.; Rivers, P.; Beitel, S.; Parker, J.; Hollister, J.; Sun, X.; Gerald, J.K.; Komatsu, K.; et al. (JMIR Publications Inc., 2021)
      Background: COVID-19 has spread worldwide since late 2019, with an unprecedented case count and death toll globally. Health care personnel (HCP), first responders, and other essential and frontline workers (OEWs) are at increased risk of SARS-CoV-2 infection because of frequent close contact with others. Objective: The Arizona Healthcare, Emergency Response, and Other Essential Workers Study (AZ HEROES) aims to examine the epidemiology of SARS-CoV-2 infection and COVID-19 illness among adults with high occupational exposure risk. Study objectives include estimating the incidence of SARS-CoV-2 infection in essential workers by symptom presentation and demographic factors, determining independent effects of occupational and community exposures on incidence of SARS-CoV-2 infection, establishing molecular and immunologic characteristics of SARS-CoV-2 infection in essential workers, describing the duration and patterns of real-time reverse transcription-polymerase chain reaction (rRT-PCR) positivity, and examining postvaccine immunologic response. Methods: Eligible participants include Arizona residents aged 18 to 85 years who work at least 20 hours per week in an occupation involving regular direct contact (ie, within 3 feet) with others. Recruitment goals are stratified by demographic characteristics (50% aged 40 years or older, 50% women, and 50% Hispanic or American Indian), by occupation (40% HCP, 30% first responders, and 30% OEWs), and by prior SARS-CoV-2 infection (with up to 50% seropositive at baseline). Information on sociodemographics, health and medical history, vaccination status, exposures to individuals with suspected or confirmed SARS-CoV-2 infection, use of personal protective equipment, and perceived risks are collected at enrollment and updated through quarterly surveys. Every week, participants complete active surveillance for COVID-like illness (CLI) and self-collect nasal swabs. Additional self-collected nasal swab and saliva specimens are collected in the event of CLI onset. Respiratory specimens are sent to Marshfield Laboratories and tested for SARS-CoV-2 by rRT-PCR assay. CLI symptoms and impact on work and productivity are followed through illness resolution. Serum specimens are collected every 3 months and additional sera are collected following incident rRT-PCR positivity and after each COVID-19 vaccine dose. Incidence of SARS-CoV-2 infections will be calculated by person-weeks at risk and compared by occupation and demographic characteristics as well as by seropositivity status and infection and vaccination history. Results: The AZ HEROES study was funded by the US Centers for Disease Control and Prevention. Enrollment began on July 27, 2020; as of May 1, 2021, a total of 3165 participants have been enrolled in the study. Enrollment is expected to continue through December 1, 2021, with data collection continuing through at least April 2022, contingent upon funding. Conclusions: AZ HEROES is unique in aiming to recruit a diverse sample of essential workers and to prospectively follow strata of SARS-CoV-2 seronegative and seropositive adults. Survey results combined with active surveillance data on exposure, CLI, weekly molecular diagnostic testing, and periodic serology will be used to estimate the incidence of symptomatic and asymptomatic SARS-CoV-2 infection, assess the intensity and durability of immune responses to natural infection and COVID-19 vaccination, and contribute to the evaluation of COVID-19 vaccine effectiveness. © 2021 JMIR Research Protocols.
    • Health impacts of perchlorate and pesticide exposure: Protocol for community-engaged research to evaluate environmental toxicants in a US border community

      Trotter, R.; Baldwin, J.; Buck, C.L.; Remiker, M.; Aguirre, A.; Milner, T.; Torres, E.; von Hippel, F.A.; Department of Community, Environment, and Policy, Mel & Enid Zuckerman College of Public Health, University of Arizona (JMIR Publications Inc., 2021)
      Background: The Northern Arizona University (NAU) Center for Health Equity Research (CHER) is conducting community-engaged health research involving “environmental scans” in Yuma County in collaboration with community health stakeholders, including the Yuma Regional Medical Center (YRMC), Regional Center for Border Health, Inc. (RCBH), Campesinos Sin Fronteras (CSF), Yuma County Public Health District, and government agencies and nongovernmental organizations (NGOs) working on border health issues. The purpose of these efforts is to address community-generated environmental health hazards identified through ongoing coalitions among NAU, and local health care and research institutions. Objective: We are undertaking joint community/university efforts to examine human exposures to perchlorate and agricultural pesticides. This project also includes the parallel development of a new animal model for investigating the mechanisms of toxicity following a “one health” approach. The ultimate goal of this community-engaged effort is to develop interventions to reduce exposures and health impacts of contaminants in Yuma populations. Methods: All participants completed the informed consent process, which included information on the purpose of the study, a request for access to health histories and medical records, and interviews. The interview included questions related to (1) demographics, (2) social determinants of health, (3) health screening, (4) occupational and environmental exposures to perchlorate and pesticides, and (5) access to health services. Each participant provided a hair sample for quantifying the metals used in pesticides, urine sample for perchlorate quantification, and blood sample for endocrine assays. Modeling will examine the relationships between the concentrations of contaminants and hormones, demographics and social determinants of health, and health status of the study population, including health markers known to be impacted by perchlorate and pesticides. Results: We recruited 323 adults residing in Yuma County during a 1-year pilot/feasibility study. Among these, 147 residents were patients from either YRMC or RCBH with a primary diagnosis of thyroid disease, including hyperthyroidism, hypothyroidism, thyroid cancer, or goiter. The remaining 176 participants were from the general population but with no history of thyroid disorder. The pilot study confirmed the feasibility of using the identified community-engaged protocol to recruit, consent, and collect data from a difficult-to-access, vulnerable population. The demographics of the pilot study population and positive feedback on the success of the community-engaged approach indicate that the project can be scaled up to a broader study with replicable population health findings. Conclusions: Using a community-engaged approach, the research protocol provided substantial evidence regarding the effectiveness of designing and implementing culturally relevant recruitment and dissemination processes that combine laboratory findings and public health information. Future findings will elucidate the mechanisms of toxicity and the population health effects of the contaminants of concern, as well as provide a new animal model to develop precision medicine capabilities for the population. International Registered Report Identifier (IRRID): DERR1-10.2196/15864. ©Robert Trotter II, Julie Baldwin, Charles Loren Buck, Mark Remiker, Amanda Aguirre, Trudie Milner, Emma Torres, Frank Arthur von Hippel.
    • Modeling risk factors for sleep- And adiposity-related cardiometabolic disease: Protocol for the short sleep undermines cardiometabolic health (slumbrx) observational study

      Knowlden, A.P.; Higginbotham, J.C.; Grandner, M.A.; Allegrante, J.P.; Department of Psychiatry, College of Medicine, University of Arizona (JMIR Publications Inc., 2021)
      Background: Obesity and short sleep duration are significant public health issues. Current evidence suggests that these conditions are associated with cardiovascular disease, metabolic syndrome, inflammation, and premature mortality. Increased interest in the potential link between obesity and short sleep duration, and its health consequences, has been driven by the apparent parallel increase in the prevalence of both conditions in recent decades, their overlapping association with cardiometabolic outcomes, and the potential causal connection between the two health issues. The SLUMBRx (Short Sleep Undermines Cardiometabolic Health) study seeks to contribute to the development of a comprehensive adiposity-sleep model while laying the groundwork for a future research program that will be designed to prevent and treat adiposity- and sleep-related cardiometabolic disease risk factors. Objective: This SLUMBRx study aims to address 4 topics pertinent to the adiposity-sleep hypothesis: The relationship between adiposity and sleep duration; sex-based differences in the relationship between adiposity and sleep duration; the influence of adiposity indices and sleep duration on cardiometabolic outcomes; and the role of socioecological factors as effect modifiers in the relationship between adiposity indices, sleep, and cardiometabolic outcomes. Methods: SLUMBRx will employ a large-scale survey (n=1000), recruiting 159 participants (53 normal weight, 53 overweight, and 53 obese) to be assessed in 2 phases. Results: SLUMBRx was funded by the National Institutes of Health, Heart, Lung, and Blood Institute through a K01 grant award mechanism (1K01HL145128-01A1) on July 23, 2019. Institutional Review Board (IRB) approval for the research project was sought and obtained on July 10, 2019. Phase 1 of SLUMBRx, the laboratory-based component of the study, will gather objective adiposity indices (air displacement plethysmography and anthropometrics) and cardiometabolic data (blood pressure, pulse wave velocity and pulse wave analysis, and a blood-based biomarker). Phase 2 of SLUMBRx, a 1-week, home-based component of the study, will gather sleep-related data (home sleep testing or sleep apnea, actigraphy, and sleep diaries). During phase 2, detailed demographic and socioecological data will be collected to contextualize hypothesized adiposity and sleep-associated cardiometabolic disease risk factors. Collection and analyses of these data will yield information necessary to customize future observational and intervention research. Conclusions: Precise implementation of the SLUMBRx protocol promises to provide objective and empirical data on the interaction between body composition and sleep duration. The hypotheses that will be tested by SLUMBRx are important for understanding the pathogenesis of cardiometabolic disease and for developing future public health interventions to prevent its conception and treat its consequences. © 2021 JMIR Publications Inc.. All right reserved.