Measurement and Validation of the Comprehensive Score for Financial Toxicity (COST) in a Population With Diabetes.

OBJECTIVE: The Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) is a validated instrument measuring financial distress among people with cancer. The reliability and construct validity of the 11-item COST-FACIT were examined in adults with diabetes and high A1C. RESEARCH DESIGN AND METHODS: We examined the factor structure (exploratory factor analysis), internal consistency reliability (Cronbach α), floor/ceiling effects, known-groups validity, and predictive validity among a sample of 600 adults with diabetes and high A1C. RESULTS: COST-FACIT demonstrated a two-factor structure with high internal consistency: general financial situation (7-items, α = 0.86) and impact of illness on financial situation (4-items, α = 0.73). The measure demonstrated a ceiling effect for 2% of participants and floor effects for 7%. Worse financial toxicity scores were observed among adults who were women, were below the poverty line, had government-sponsored health insurance, were middle-aged, were not in the workforce, and had less educational attainment (P < 0.01). Worse financial toxicity was observed for those engaging in cost coping behaviors, such as taking less or skipping medicines, delaying care, borrowing money, "maxing out" the limit on credit cards, and not paying bills (P < 0.01). In regression models for the full measure and its two factors, worse financial toxicity was correlated with higher A1C (P < 0.01), higher levels of diabetes distress (P < 0.01), more chronic conditions (P < 0.01), and more depressive symptoms (P < 0.01). CONCLUSIONS: Findings support both the reliability and validity of the COST-FACIT tool among adults with diabetes and high A1C levels. More research is needed to support the use of the COST-FACIT tool as a clinically relevant patient-centered instrument for diabetes care.

Effects of COVID-19 shelter-in-place confinement on diabetes prevention health behaviors among US adults with prediabetes: A cross-sectional survey.

The coronavirus disease 2019 (COVID-19) pandemic has resulted in significant lifestyle changes due to shelter-in-place confinement orders. The study's purpose was to assess if the COVID-19 pandemic affected self-reported diabetes prevention behaviors among American adults with prediabetes. As part of a randomized clinical trial among adults with prediabetes and overweight/obesity, questions were added to existing study surveys to assess the effect of the COVID-19 pandemic on diabetes prevention behaviors and stress. Survey responses were summarized using frequencies. 259 study participants completed seven COVID-19 survey questions from June 2020 to June 2021. Participants were 62.9% female, 42.5% White, 31.3% Black, 11.6% Asian, 8.1% Hispanic, and 6.6% Other. Over 75% of participants reported that the COVID-19 pandemic affected physical activity levels, with 82.1% of those affected reporting decreased physical activity; 70.3% reported that the pandemic affected their eating habits, with 61.7% of those affected reporting their eating habits became less healthy; 73.7% reported that the pandemic affected their level of stress, with 97.4% of those affected reporting that their level of stress had increased; 60% reported that the pandemic affected their motivation to adopt/maintain healthy habits, with 72.9% of those affected reporting their motivation decreased. A high percentage of study participants with prediabetes reported decreases in health promotion behaviors and increases in stress due to the COVID-19 pandemic. Consequently, the pandemic could lead to increased diabetes incidence. Strategies to improve diabetes prevention behaviors and address mental health concerns among those at-risk for diabetes are critical during and after the COVID-19 pandemic.

Comparing the effectiveness of Family Support for Health Action (FAM-ACT) with traditional community health worker-led interventions to improve adult diabetes management and outcomes: study protocol for a randomized controlled trial.

BACKGROUND: Diabetes self-management education and support (DSMES) programs have struggled to deliver sustainable, effective support for adults with diabetes (AWDs) to improve self-management behaviors, achieve glycemic goals, and reduce risk for complications. One largely untapped resource for this support is AWDs' social networks. Fifty to 75% of AWDs have an unpaid family member or friend ("support person") who provides ongoing help with diabetes management. However, DSMES interventions to date lack structured and effective approaches to directly engage support persons in AWDs' diabetes management. METHODS: This parallel arm randomized trial is designed to determine the effectiveness of Family Support for Health Action (FAM-ACT), a novel community health worker (CHW)-delivered program focused on educating and supporting patients with type 2 diabetes (T2D) and their support persons (SPs), relative to an established, CHW-delivered, individual patient-focused DSMES and care management (I-DSMES) intervention. Both interventions were developed using a community-based participatory research (CBPR) approach. The study will be conducted in partnership with an urban Federally Qualified Health Center (FQHC) serving a low-income, Latino/a community, with target enrollment of 268 dyads consisting of an FQHC patient with T2D with high HbA1c and an SP. Patient-SP dyads will be randomized to receive FAM-ACT or I-DSMES over 6 months. The primary outcome is change in patient HbA1c from baseline to 6 months. Secondary patient outcomes include 12-month change in HbA1c, changes in patient blood pressure, diabetes self-management behaviors, diabetes distress, patient activation, diabetes self-efficacy, and perceptions of and satisfaction with SP support for diabetes. Secondary SP outcomes include self-efficacy for helping the patient with diabetes management and SP distress about the patient's diabetes. We also will assess the effect of the COVID-19 pandemic on patient's ability to manage diabetes. DISCUSSION: This study will inform scalable, evidence-based approaches that leverage family support to help AWDs improve and sustain self-management strategies that underpin optimal management of multiple diabetes complication risk factors. The protocol is designed for and evaluated with a low-income and predominantly Latino/a community, which may increase applicability to other similar communities. The COVID-19 pandemic presented several challenges to study protocol and intervention delivery; modifications made to address these challenges are described. TRIAL REGISTRATION: ClinicalTrials.gov NCT03812614. Registered on 18 January 2019.

Public Health Challenges and Barriers to Health Care Access for Asylum Seekers at the U.S.-Mexico Border in Matamoros, Mexico.

The Migrant Protection Protocols (MPP) and border closure to asylum seekers during the COVID-19 pandemic created a humanitarian crisis at the U.S.-Mexico border. This paper outlines the public health challenges and health care access barriers for asylum seekers living in a tent encampment in Matamoros, Mexico resulting from these policies. Thirty participants, including asylum seekers (n=20) and health care professionals (n=10) in the Matamoros asylum camp, were interviewed. Public health challenges included environmental exposures and inadequate infrastructure; poor sanitation and disease control; and limited safety, nutrition, education, and employment. Health care access barriers included lack of continuity of care and emergency services, resource insufficiencies, and interpersonal barriers. Policy responses to address these challenges include outlawing MPP and other immigration policies that infringe on human rights, collaborating with international partners, and implementing more creative and community-based approaches to asylum processing.

Risk factors for Veteran food insecurity: findings from a National US Department of Veterans Affairs Food Insecurity Screener.

OBJECTIVE: Food insecurity is associated with numerous adverse health outcomes. The US Veterans Health Administration (VHA) began universal food insecurity screening in 2017. This study examined prevalence and correlates of food insecurity among Veterans screened. DESIGN: Retrospective cross-sectional study using VHA administrative data. Multivariable logistic regression models were estimated to identify sociodemographic and medical characteristics associated with a positive food insecurity screen. SETTING: All US Veterans Administration (VA) medical centres (n 161). PARTICIPANTS: All Veterans were screened for food insecurity since screening initiation (July 2017-December 2018). RESULTS: Of 3 304 702 Veterans screened for food insecurity, 44 298 were positive on their initial screen (1·3 % of men; 2·0 % of women). Food insecurity was associated with identifying as non-Hispanic Black or Hispanic. Veterans who were non-married/partnered, low-income Veterans without VA disability-related compensation and those with housing instability had higher odds of food insecurity, as did Veterans with a BMI < 18·5, diabetes, depression and post-traumatic stress disorder. Prior military sexual trauma (MST) was associated with food insecurity among both men and women. Women screening positive, however, were eight times more likely than men to have experienced MST (48·9 % v. 5·9 %). CONCLUSIONS: Food insecurity was associated with medical and trauma-related comorbidities as well as unmet social needs including housing instability. Additionally, Veterans of colour and women were at higher risk for food insecurity. Findings can inform development of tailored interventions to address food insecurity such as more frequent screening among high-risk populations, onsite support applying for federal food assistance programs and formal partnerships with community-based resources.

Changes in Self-management During the COVID-19 Pandemic Among Adults with Type 2 Diabetes at a Federally Qualified Health Center.

The COVID-19 pandemic affected how adults with diabetes perform self-management, and impacts may be greater among vulnerable populations. We assessed the impact of the pandemic on diabetes self-management among adults with type 2 diabetes at a Federally Qualified Health Center. Participants were surveyed by phone in Spanish and English from July to October of 2020. Most respondents (74%) were Latino and preferred to speak Spanish, with mean age of 54 years and mean HbA1c of 9.2%. Fifty-three percent reported less physical activity during the pandemic. While 43% had more difficulty obtaining healthy food, 38% reported eating more healthfully. Sixty-one percent had increased difficulty accessing medical care. Many felt more socially isolated (49%) and stressed (51%). Changes in diabetes self-management were both positive and negative for majority Latino patients in this low-resource community, which may require tailored approaches to mitigate negative impacts of the pandemic on physical and mental health.

Clinicians' Perspectives on the Impacts of Post-2016 Immigration Enforcement on Immigrant Health and Health Care Use

Objective. To examine clinicians' perspectives on changes in health and health care utilization of immigrant patients, the presence of immigration enforcement in health facilities, and institutional responses to these changes in the post-2016 period in the United States. Methods. From a survey of clinician members of the Physicians for Human Rights Asylum Network (March–June 2020), we described responses and identified key themes. Results. Post-2016 anti-immigrant policies and rhetoric negatively affected mental health, physical health, and health care-seeking behaviors among immigrant patients. Although most clinicians reported rarely witnessing immigration enforcement activities, nearly half reported persistent fear among their immigrant patients. A higher percentage of clinicians in U.S. border states reported increased fears associated with adverse physical and mental health effects among immigrant patients than those in non-border states. Conclusion. Clinicians' perspectives on the impact of immigration enforcement on patient health is critical to informing multi-level interventions to improve immigrant health.

Impacts of the COVID-19 pandemic on unmet social needs, self-care, and outcomes among people with diabetes and poor glycemic control.

AIMS: The purpose of this study was to examine whether pandemic exposure impacted unmet social and diabetes needs, self-care behaviors, and diabetes outcomes in a sample with diabetes and poor glycemic control. METHODS: This was a cross-sectional analysis of participants with diabetes and poor glycemic control in an ongoing trial (n = 353). We compared the prevalence of unmet needs, self-care behaviors, and diabetes outcomes in successive cohorts of enrollees surveyed pre-pandemic (prior to March 11, 2020, n = 182), in the early stages of the pandemic (May-September, 2020, n = 75), and later (September 2020-January 2021, n = 96) stratified by income and gender. Adjusted multivariable regression models were used to examine trends. RESULTS: More participants with low income reported food insecurity (70% vs. 83%, p < 0.05) and needs related to access to blood glucose supplies (19% vs. 67%, p < 0.05) during the pandemic compared to pre-pandemic levels. In adjusted models among people with low incomes, the odds of housing insecurity increased among participants during the early pandemic months compared with participants pre-pandemic (OR 20.2 [95% CI 2.8-145.2], p < 0.01). A1c levels were better among participants later in the pandemic than those pre-pandemic (ß = -1.1 [95% CI -1.8 to -0.4], p < 0.01), but systolic blood pressure control was substantially worse (ß = 11.5 [95% CI 4.2-18.8, p < 0.001). CONCLUSION: Adults with low-incomes and diabetes were most impacted by the pandemic. A1c may not fully capture challenges that people with diabetes are facing to manage their condition; systolic blood pressures may have worsened and problems with self-care may forebode longer-term challenges in diabetes control.

Impact of COVID-19 on Diabetes Self-Management and Care

Stay at home orders, changes in business and clinic operations, and financial concerns related to the COVID-19 pandemic may have affected how adults with diabetes obtained food, medications, medical care, and performed diabetes self-management. These impacts may be most pronounced among people in low-resource urban communities. We assessed the experiences of adults with type 2 diabetes participating in a federally-qualified health center diabetes management program. Of 72 patients called, 61 completed telephone surveys from July to October 2020 in Spanish and English. 74% of respondents were Latino with Spanish as their preferred language. Respondents' mean age was 54 years, 62% were female, and 57% had less than a high school degree. Five patients reported testing positive for COVID-19, and 7 lived with someone who tested positive. Of 33 respondents who worked outside the home before COVID-19, 61% had lost their jobs or now worked fewer hours. When asked how diabetes management behaviors changed during the pandemic, 53% of respondents reported less physical activity, while 25% reported more. 18% reported eating less healthfully, while 38% reported eating more healthfully. 43% found it more difficult to obtain healthy food. 15% reported taking their medications more regularly, while 5% reported less. 61% reported increased difficulty accessing medical care. 41% felt more worried about being able to manage their diabetes during the pandemic and 49% felt more socially isolated. Changes in diabetes self-management behaviors related to COVID-19 were both positive and negative for patients in this low-resource urban setting. Programs supporting patients with diabetes could help patients adapt to pandemic changes by facilitating access to medications and health care, providing virtual support for self-management and other health habits, connecting patients with financial and food security concerns to community resources, and addressing stress and social isolation through virtual diabetes support groups.

Challenges and Effects of the COVID-19 Pandemic on Asylum Seeker Health at the U.S.-Mexico Border.

Purpose: The coronavirus disease 2019 (COVID-19) pandemic presents health care challenges to asylum seekers living in congregate encampments, including those along the U.S.-Mexico border. It is necessary to understand the impact of the pandemic among this population to address health care needs, reduce transmission, and diminish COVID-19-related morbidity. Methods: Thirty interviews were conducted with asylum seekers and health care professionals in a temporary camp in Matamoros, Mexico to determine challenges, perceptions, and effects of the COVID-19 pandemic. Interviews were coded in NVivo12 by using a team-based approach. Results: The pandemic caused significant mental health burdens but no perceived adverse physical effects, with the U.S. border closure and health care access barriers as more pressing concerns. Participants reported access to information about COVID-19 but had varied levels of knowledge and adherence to disease reduction strategies due to camp conditions. Most participants believed that they had special protection from COVID-19, including strong immune systems or from God. The nongovernmental organizations providing health care and sanitation faced multiple challenges to implement new policies to manage COVID-19. The institution of required temperature checks and quarantine of COVID-19 positive patients led to distrust, decreased seeking of health care services among asylum seekers, and possible underreporting of COVID-19 cases. Conclusion: Our findings among asylum seekers in a Matamoros camp highlight the challenges to implementing disease reduction policies in low-resource congregate camps. Policies to address disease outbreaks focusing on the social determinants of health, health care access barriers, and community engagement may be more acceptable to asylum seekers, suggesting the need for effective strategies to provide prevention information that complements such measures.

Protecting providers and patients: results of an Internet survey of health care workers' risk perceptions and ethical concerns during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic has generated worldwide scarcity of critical resources to protect against and treat disease. Shortages of face masks and other protective equipment place health workers, already on the frontline of the disease, at higher risk. Moral distress from making difficult decisions about allocating scarce resources and care to patients ill with COVID-19 can further add to burdens health workers face. This study investigates clinical health workers' risk perceptions and concerns about the ethics of their clinical decision-making, the actions of their institutions to address resource scarcity concerns during the COVID-19 pandemic, and their ability to voice safety concerns, as well as their own views on how scarce resources should be allocated. METHODS: An online survey was open to health care workers who provide clinical care to patients, with no specialty training or geographic location requirements, from May 19 to June 30, 2020. Participants were recruited through purposive sampling using medical association and institutional email lists, and by snowball sampling. RESULTS: Of 839 participants, a majority were physicians (540, 69.4%) working in academic medical centers (270, 35.2%) or private health systems in the community (234, 30.5%) in the USA (760, 90.7%). Most reported being concerned about their own health (494, 73.6%) and about the possibility of spreading COVID-19 to family and friends (534, 85.9%) during the pandemic. All respondents reported shortages or rationing of at least one type of medical resource (e.g., sanitizing supplies and personal protective equipment). More than half of respondents (351, 53.9%) did not feel they received sufficient training in how to allocate scarce resources in the pandemic. Many felt moral distress related to conflicts between institutional constraints and what they believed was right (459, 66.5%). Though a majority (459, 67.7%) reported feeling "comfortable" internally communicating with their administration about safety issues, far fewer reported feeling "confident" speaking publicly about safety issues without retaliation from their institution (255, 37.3%). CONCLUSIONS: In the face of limited resources, surveyed health care workers reported concern about their own and their families' health from exposure. Securing adequate protective equipment must be a high priority for pandemic management. In addition, more governmental and facility-level ethical guidance is required for allocation of resources given ongoing scarcity, and facilities must create conditions so health care workers can speak openly about safety issues without fear of retaliation.

Patient and provider perspectives of a new prenatal care model introduced in response to the coronavirus disease 2019 pandemic.

BACKGROUND: Randomized controlled trials document the safety and efficacy of reduced frequency prenatal visit schedules and virtual visits, but real-world data are lacking. Our institution created a prenatal care delivery model incorporating these alternative approaches to continue safely providing prenatal care during the coronavirus disease 2019 pandemic. OBJECTIVE: To evaluate institutional-level adoption and patient and provider experiences with the coronavirus disease 2019 prenatal care model. STUDY DESIGN: We conducted a single-site evaluation of a coronavirus disease 2019 prenatal care model incorporating a reduced frequency visit schedule and virtual visits deployed at a suburban academic institution on March 20, 2020. We used electronic health record data to evaluate institution-level model adoption, defined as changes in overall visit frequency and proportion of virtual visits in the 3 months before and after implementation. To evaluate the patient and provider experience with the coronavirus disease 2019 model, we conducted an online survey of all pregnant patients (>20 weeks' gestation) and providers in May 2020. Of note, 3 domains of care experience were evaluated: (1) access, (2) quality and safety, and (3) satisfaction. Quantitative data were analyzed with basic descriptive statistics. Free-text responses coded by the 3 survey domains elucidated drivers of positive and negative care experiences. RESULTS: After the coronavirus disease 2019 model adoption, average weekly prenatal visit volume fell by 16.1%, from 898 to 761 weekly visits; the average weekly proportion of prenatal visits conducted virtually increased from 10.8% (97 of 898) to 43.3% (330 of 761); and the average visit no-show rate remained stable (preimplementation, 4.3%; postimplementation, 4.2%). Of those eligible, 74.8% of providers (77 of 103) and 15.0% of patients (253 of 1690) participated in the surveys. Patient respondents were largely white (180 of 253; 71.1%) and privately insured (199 of 253; 78.7%), reflecting the study site population. The rates of chronic conditions and pregnancy complications also differed from national prevalence. Provider respondents were predominantly white (44 of 66; 66.7%) and female (50 of 66; 75.8%). Most patients and almost all providers reported that virtual visits improved access to care (patients, 174 of 253 [68.8%]; providers, 74 of 77 [96.1%]). More than half of respondents (patients, 124 of 253 [53.3%]; providers, 41 of 77 [62.1%]) believed that virtual visits were safe. Nearly all believed that home blood pressure cuffs were important for virtual visits (patients, 213 of 231 [92.2%]; providers, 63 of 66 [95.5%]). Most reported satisfaction with the coronavirus disease 2019 model (patients, 196 of 253 [77.5%]; providers, 64 of 77 [83.1%]). In free-text responses, drivers of positive care experiences were similar for patients and providers and included perceived improved access to care through decreased barriers (eg, transportation, childcare), perceived high quality of virtual visits for low-risk patients and increased safety during the pandemic, and improved satisfaction through better patient counseling. Perceived drivers of negative care experience were also similar for patients and providers, but less common. These included concerns that unequal access to virtual visits could deepen existing maternity care inequities, concerns that the lack of home devices (eg, blood pressure cuffs) would affect care quality and safety, and dissatisfaction with poor patient-provider continuity and inadequate expectation setting for the virtual visit experience. CONCLUSION: Reduced visit schedules and virtual visits were rapidly integrated into real-world care, with positive experiences for many patients and providers. Future research is needed to understand the health outcomes and care experience associated with alternative approaches to prenatal care delivery across more diverse patient populations outside of the coronavirus disease 2019 pandemic to inform broader health policy decisions.