Missed Healthcare Visits During the COVID-19 Pandemic: A Longitudinal Study.

INTRODUCTION: Missed visits have been estimated to cost the U.S. healthcare system $50 billion annually and have been linked to healthcare inefficiency, higher rates of emergency department visits, and worse outcomes. COVID-19 disrupted existing outpatient healthcare utilization patterns. In our study, we sought to examine the frequency of missed outpatient visits over the course of the COVID-19 pandemic and to examine patient-level characteristics associated with non-attendance. METHODS: This study utilized data from a longitudinal cohort study (the Chicago COVID-19 Comorbidities (C3) study). C3 participants were enrollees in 1 of 4 active, "parent" studies; they were rapidly enrolled in C3 at the onset of the pandemic. Multiple waves of telephone-based interviews were conducted to collect experiences with the pandemic, as well as socio-demographic and health characteristics, health literacy, patient activation, and depressive and anxiety symptoms. For the current analysis, data from waves 3 to 8 (05/01/20-05/19/22) were analyzed. Participants included 845 English or Spanish-speaking adults with 1 or more chronic conditions. RESULTS: The percentage of participants reporting missed visits due to COVID-19 across study waves ranged from 3.1 to 22.4%. Overall, there was a decline in missed visits over time. No participant sociodemographic or health characteristic was consistently associated with missed visits across the study waves. In bivariate and multivariate analysis, only patient-reported anxiety was significantly associated with missed visits across all study waves. CONCLUSION: Findings reveal that anxiety was consistently associated with missed visits during the COVID-19 pandemic, but not sociodemographic or health characteristics. Results can inform future public health initiatives to reduce absenteeism by considering patients' emotional state during times of uncertainty.

Longitudinal Associations Between Multimorbidities and Patient-Reported Quality of Life.

OBJECTIVES: The global prevalence of multimorbidity is increasing as the population ages. As individuals get older, they are likely to develop multiple chronic conditions, and nearly two-thirds of older adults in the United States are estimated to experience 2 or more chronic conditions. The present preregistered study examined whether multimorbidity was associated with longitudinal changes in health-related quality of life (i.e., anxiety, depression, and physical function) and whether these associations were moderated by sociodemographic factors (i.e., sex, race, marital status, income, insurance, and education). METHODS: Data come from the Health Literacy and Cognitive Function Among Older Adults Longitudinal Study (LitCog), a prospective cohort study of English-speaking older adults (N = 900). At each measurement occasion, participants reported anxiety, depression, and physical function using the Patient Reported Outcomes Information System, chronic conditions, and sociodemographic characteristics. We employed multilevel growth models to estimate changes in health-related quality of life, with multimorbidities as a predictor and sociodemographics as covariates. RESULTS: Results indicated that individuals with multiple chronic conditions reported persistently high levels of anxiety and depression, and worse physical function. We found evidence for racial health disparities, such that individuals who identified as non-White experienced worse health-related quality of life as multimorbidities increased, relative to White participants. DISCUSSION: These results contribute to the current conversation about the long-term impacts of structural and systemic barriers experienced by minoritized groups. We further discuss the public health implications of multimorbidity in older adulthood.

Characterizing Caregiver Roles and Conflict in Health Management Support to Older People With Multiple Chronic Conditions.

Caregivers provide critical support for older adults managing multiple chronic conditions (MCCs), but few studies describe the assistance caregivers provide or identify factors influencing their provision of support. We conducted qualitative interviews with 25 caregivers to older adults with MCCs to describe caregivers' roles and identify the factors that influence caregivers' ability to carry out these roles. Transcripts were analyzed using the Framework Method. Caregivers supported the management of MCCs in several ways, including monitoring conditions, communicating with clinicians, and tracking health information. Disagreement, or conflicted relationships, between caregivers and older adults over health and behaviors influenced the provision of support, resulting in less involved and less effective caregivers. Caregivers in conflicted relationships were more challenged by resistance from older adults. Greater agreement, or collaboration, between caregivers and older adults resulted in more involved and effective caregivers. Addressing health-related conflict may enhance caregivers' capacity to support older adults with MCCs.

Primary care detection of cognitive impairment leveraging health and consumer technologies in underserved US communities: protocol for a pragmatic randomised controlled trial of the MyCog paradigm.

INTRODUCTION: Early identification of cognitive impairment (CI), including Alzheimer's disease and related dementias (ADRD), is a top public health priority. Yet, CI/ADRD is often undetected and underdiagnosed within primary care settings, and in health disparate populations. The MyCog paradigm is an iPad-based, self-administered, validated cognitive assessment based on the National Institutes of Health (NIH) Toolbox Cognition Battery and coupled with clinician decision-support tools that is specifically tailored for CI/ADRD detection within diverse, primary care settings. METHODS AND ANALYSIS: We will conduct a two-arm, primary care practice-randomised (N=24 practices; 45 257 active patients at the proposed practices), pragmatic trial among geographically diverse Oak Street Health sites to test the effectiveness of the MyCog paradigm to improve early detection CI/ADRD among low socioeconomic, black and Hispanic older adults compared with usual care. Participating practices randomised to the intervention arm will impart the MyCog paradigm as a new standard of care over a 3-year implementation period; as the cognitive component for Annual Wellness Visits and for any patient/informant-reported or healthcare provider-suspected cognitive concern. Rates of detected (cognitive test suggesting impairment) and/or diagnosed (relevant International Classification of Diseases-9/10 [ICD-9/10] code) cognitive deficits, impairments or dementias including ADRD will be our primary outcome of study compared between arms. Secondary outcomes will include ADRD severity (ie, mild or later stage), rates of cognitive-related referrals and rates of family member or caregiver involvement in ADRD care planning. We will use generalised linear mixed models to account for clustered study design. Secondary models will adjust for subject, clinic or visit-specific characteristics. We will use mixed-methods approaches to examine fidelity and cost-effectiveness of the MyCog paradigm. ETHICS AND DISSEMINATION: The Institutional Review Board at Advarra has approved the study protocol (Pro00064339). Results will be published in peer-reviewed journals and summaries will be provided to the funders of the study. TRIAL REGISTRATION NUMBER: NCT05607732.

Long-term impact of the COVID-19 pandemic on self-management of chronic conditions among high-risk adults in the USA: protocol for the C3 observational cohort study.

INTRODUCTION: COVID-19 is an unprecedented public health threat in modern times, especially for older adults or those with chronic illness. Beyond the threat of infection, the pandemic may also have longer-term impacts on mental and physical health. The COVID-19 & Chronic Conditions ('C3') study offers a unique opportunity to assess psychosocial and health/healthcare trajectories over 5 years among a diverse cohort of adults with comorbidities well-characterised from before the pandemic, at its onset, through multiple surges, vaccine rollouts and through the gradual easing of restrictions as society slowly returns to 'normal'. METHODS AND ANALYSIS: The C3 study is an extension of an ongoing longitudinal cohort study of 'high-risk' adults (aged 23-88 at baseline) with one or more chronic medical conditions during the COVID-19 pandemic. Five active studies with uniform data collection prior to COVID-19 were leveraged to establish the C3 cohort; 673 adults in Chicago were interviewed during the first week of the outbreak. The C3 cohort has since expanded to include 1044 participants across eight survey waves (T1-T8). Four additional survey waves (T9-T12) will be conducted via telephone interviews spaced 1 year apart and supplemented by electronic health record and pharmacy fill data, for a total of 5 years of data post pandemic onset. Measurement will include COVID-19-related attitudes/behaviours, mental health, social behaviour, lifestyle/health behaviours, healthcare use, chronic disease self-management and health outcomes. Mental health trajectories and associations with health behaviours/outcomes will be examined in a series of latent group and mixed effects modelling, while also examining mediating and moderating factors. ETHICS AND DISSEMINATION: This study was approved by Northwestern University's Feinberg School of Medicine Institutional Review Board (STU00215360). Results will be published in international peer-reviewed journals and summaries will be provided to the funders of the study.

Hazardous drinking by older adults with chronic conditions during the COVID-19 pandemic: Evidence from a Chicago-based cohort.

BACKGROUND: It is unclear how older adults with chronic conditions, who have greater risk of alcohol-related adverse outcomes, used alcohol throughout the COVID-19 pandemic. We assess changes in hazardous drinking prevalence May 2020-December 2021 and factors associated with hazardous drinking. METHODS: Data are from structured phone interviews of older adults (age 60+) with chronic conditions (e.g., hypertension, diabetes, pulmonary disease, heart disease) in a Chicago-based longitudinal cohort (Chicago COVID-19 Comorbidities survey, Waves 3-7, n = 247). We tested differences in the prevalence of hazardous drinking (defined as AUDIT-C score of 3+ for women and 4+ for men) across waves for the full sample, by demographic group (sex, race, and ethnicity), and by chronic condition burden (<3 conditions, 3+ conditions). Generalized estimating equations investigated associations of hazardous drinking with sociodemographic and pandemic coping-related factors (stress, loneliness, outside contacts, depression, anxiety). RESULTS: Participants were 66.8% female; 27.9% non-Hispanic Black, 14.2% Hispanic, 4.9% other race. Hazardous drinking was reported by 44.9% of participants in May 2020, but declined to 23.1% by July-August 2020 and continued to slowly decline to 19.4% by September-December 2021. Differences from May 2020 were significant at the 0.05 level. Subgroups followed similar trajectories. Hazardous drinking prevalence was initially higher but declined more among men than women, consistently higher among non-Hispanic White respondents than among Hispanic and non-Hispanic Black respondents, and declined more rapidly among adults with 3+ chronic conditions. In adjusted models, race and ethnicity were associated with lower prevalence of hazardous drinking (non-Hispanic Black: adjusted prevalence ratio [aPR] = 0.50, 95% confidence interval [CI] = 0.33, 0.74; other race: aPR = 0.26, 95% CI = 0.09, 0.81, compared with non-Hispanic White). No coping-related factors were significantly associated with hazardous drinking. CONCLUSION: Among a cohort of older adults with chronic conditions, almost half engaged in hazardous drinking in early summer of the COVID-19 pandemic. While prevalence fell, these rates reinforce the need for alcohol screening and intervention in clinical settings among this population.

Pilot Testing of the MyCog Assessment: Rapid Detection of Cognitive Impairment in Everyday Clinical Settings.

Cognitive impairment (CI) and dementia can have profound social and emotional effects on older adults. Early detection of CI is imperative both to the identification of potentially treatable conditions and to provide services to minimize the effects of CI in cases of dementia. While primary care settings are ideal for identifying CI, it frequently goes undetected. We tailored a brief, iPad-based, cognitive assessment (MyCog) for primary care settings and piloted it in a sample of older adults. Eighty participants were recruited from an existing cohort study and completed a brief, in-person interview. CI was determined based on a diagnosis of dementia or CI in their medical record or based on a comprehensive cognitive battery performed within the past 18 months. MyCog had a sensitivity of 79% and specificity of 82%, offering a practical, scalable, primary care assessment for the routine case finding of cognitive impairment and dementia.

Impact of COVID-19 on the capacity to self-manage health and chronic conditions.

Objective: To investigate well-being, lifestyle behaviors, self-management capacity and healthcare utilization among adults with chronic conditions at the outbreak of the COVID-19 pandemic. Methods: Data was collected from two interviewer-administered telephone surveys conducted between March 27 - May 22, 2020. Participants were patients at Chicago-area clinics. Self-report and validated measures were used for study-related outcomes. Results: A total of 553 participants (age range 23-88) completed data collection at both timepoints. One in five (20.7%) participants experienced stress due to the coronavirus most or all the time and rates of negative well-being were high (WHO-5 Index mean = 58.7%). Almost a quarter (22.3%) engaged in hazardous drinking and 79.7% reported insufficient physical activity. Nearly one in four participants (23.7%) avoided seeking medical care due to worry about COVID-19. In multivariable analyses, greater COVID-19 related stress was associated with less physical activity, lower self-efficacy, greater difficulty managing health and medications, and delays in seeking medical care due to the coronavirus. Conclusions: Mental well-being, lifestyle behaviors, self-management capacity, and healthcare utilization were impacted in the months following the COVID outbreak. Innovation: These findings suggest health systems should implement proactive measures for detecting and treating emotional and behavioral COVID-related concerns.

Early COVID-19 Attitudes and Behaviors and Their Associations With Later Infection: A Local Perspective From One U.S. City.

BACKGROUND: At the onset of the pandemic, there was poor public awareness and inaction in response to COVID-19; it is less known whether this translated to subsequent infections. OBJECTIVES: To explore whether adults who perceived COVID-19 as less of a threat and who were not taking early actions were more likely to become infected over the following year. RESEARCH DESIGN: Survey data from the ongoing (COVID-19 & Chronic Conditions (C3) anonymized for review) cohort study. PARTICIPANTS: Six hundred forty-two adults with a mean age of 63 and ≥1 chronic condition. MEASURES: Self-reported attitudes and behaviors regarding COVID-19 were assessed from March 13 to April 3, 2020, and COVID-19 infection status was captured between May 2020 and January 2021. Bivariate and multivariable analyses examined associations between early perceptions and behaviors with later infection. RESULTS: Approximately 7% reported infection with COVID-19 (N = 46). Adults who perceived the threat of COVID-19 less seriously at the initial outbreak were more likely to test positive over the following year [odds ratio (OR): 0.81, CI: 0.70-0.94; P = 0.006]. Those who were less likely to believe their actions would affect whether they would become infected were more likely to test positive (OR: 0.87, CI: 0.77-0.99; P = 0.03), as were adults who reported not changing their routines (OR: 0.45; CI: 0.24-0.85; P = 0.01). CONCLUSIONS: Adults with delayed responses in acknowledging the threat of COVID-19 and in changing behaviors were more likely to contract the virus. This investigation provides insight into the consequences of inadequate public understanding and response to COVID-19, and it highlights the importance of promoting early awareness among high-risk groups during public health crises.

Associations Between Cognitive Impairment Severity and Barriers to Healthcare Engagement Among Older Adults.

Objectives: To assess whether older adults with a cognitive impairment were more likely to report challenges interacting with medical providers, or to avoid needed medical care. Methods: Data for this exploratory, cross-sectional analysis were from older adults (N = 493) ages 60-82 participating in the "LitCog" cohort study. Multivariable generalized linear models compared cognitive impairment (none, mild, moderate, severe) with validated measures of healthcare engagement. Results: A moderate cognitive impairment was associated with delays in medical care due to embarrassment (RR 5.34.95% CI 1.30-22.0) and discomfort asking the doctor questions (RR 4.07, 95% CI 1.00-16.5). Conclusions: Intermediate cognitive deficits, such as with mild cognitive impairment (MCI) or mild dementias, may impact meaningful engagement with healthcare systems, potentially affecting timely detection and appropriate management of cognitive concerns and other chronic medical conditions. More research is needed to understand mechanisms underlying this relationship.

MidCog study: a prospective, observational cohort study investigating health literacy, self-management skills and cognitive function in middle-aged adults.

INTRODUCTION: The lack of definitive means to prevent or treat cognitive impairment or dementia is driving intense efforts to identify causal mechanisms. Recent evidence suggests clinically meaningful declines in cognition might present as early as middle age. Studying cognitive changes in middle adulthood could elucidate modifiable factors affecting later cognitive and health outcomes, yet few cognitive ageing studies include this age group. The purpose of the MidCog study is to begin investigations of less-studied and potentially modifiable midlife determinants of later life cognitive outcomes. METHODS AND ANALYSIS: MidCog is a prospective cohort study of adults ages 35-64, with two in-person interviews 2.5 years apart. Data will be collected from interviews, electronic health records and pharmacy fill data. Measurements will include health literacy, self-management skills, cognitive function, lifestyle and health behaviours, healthcare use, health status and chronic disease outcomes. Associations of health literacy and self-management skills with health behaviours and cognitive/health outcomes will be examined in a series of regression models, and moderating effects of modifiable psychosocial factors.Finally, MidCog data will be linked to an ongoing, parallel cohort study of older adults recruited at ages 55-74 in 2008 ('LitCog'; ages 70-90 in 2023), to explore associations between age, health literacy, self-management skills, chronic diseases, health status and cognitive function among adults ages 35-90. ETHICS AND DISSEMINATION: The Institutional Review Board at Northwestern University has approved the MidCog study protocol (STU00214736). Results will be published in peer-reviewed journals and summaries will be provided to the funders of the study as well as patients.

Trajectories of Sleep Disturbance and Self-Management of Chronic Conditions during COVID-19 among Middle-aged and Older Adults.

Background: The COVID-19 pandemic has had a widespread impact on sleep quality, yet little is known about the prevalence of sleep disturbance and its impact on self-management of chronic conditions during the ongoing pandemic. Objective: To evaluate trajectories of sleep disturbance, and their associations with one's capacity to self-manage chronic conditions. Design: A longitudinal cohort study linked to 3 active clinical trials and 2 cohort studies with 5 time points of sleep data collection (July 15, 2020 - May 23, 2022). Participants: Adults living with chronic conditions who completed sleep questionnaires for two or more time points. Exposure: Trajectories of self-reported sleep disturbance across 5 time points. Main Outcomes: 3 self-reported measures of self-management capacity, including subjective cognitive decline, medication adherence, and self-efficacy for managing chronic disease. Results: 549 adults aged 23 to 91 years were included in the analysis. Two thirds had 3 or more chronic conditions; 42.4% of participants followed a trajectory of moderate or high likelihood of persistent sleep disturbance across the study period. Moderate or high likelihood of sleep disturbance was associated with older age (RR 1.57, 95% CI 1.09, 2.26, P<.05), persistent stress (RR 1.54, 95% CI 1.16, 2.06, P=.003), poorer physical function (RR 1.57, 95% CI 1.17, 2.13, P=.003), greater anxiety (RR 1.40, 95% CI 1.04, 1.87, P=.03) and depression (RR 1.63, 95% CI 1.20, 2.22, P=.002). Moderate or high likelihood of sleep disturbance was also independently associated with subjective cognitive decline, poorer medication adherence, and worse self-efficacy for managing chronic diseases (all P<.001). Conclusions: Persistent sleep disturbance during the pandemic may be an important risk factor for inadequate chronic disease self-management and potentially poor health outcomes in adults living with chronic conditions. Public health and health system strategies might consider monitoring sleep quality in adults with chronic conditions to optimize health outcomes.

Prediction of cognitive impairment using higher order item response theory and machine learning models.

Timely detection of cognitive impairment (CI) is critical for the wellbeing of elderly individuals. The MyCog assessment employs two validated iPad-based measures from the NIH Toolbox® for Assessment of Neurological and Behavioral Function (NIH Toolbox). These measures assess pivotal cognitive domains: Picture Sequence Memory (PSM) for episodic memory and Dimensional Change Card Sort Test (DCCS) for cognitive flexibility. The study involved 86 patients and explored diverse machine learning models to enhance CI prediction. This encompassed traditional classifiers and neural-network-based methods. After 100 bootstrap replications, the Random Forest model stood out, delivering compelling results: precision at 0.803, recall at 0.758, accuracy at 0.902, F1 at 0.742, and specificity at 0.951. Notably, the model incorporated a composite score derived from a 2-parameter higher order item response theory (HOIRT) model that integrated DCCS and PSM assessments. The study's pivotal finding underscores the inadequacy of relying solely on a fixed composite score cutoff point. Instead, it advocates for machine learning models that incorporate HOIRT-derived scores and encompass relevant features such as age. Such an approach promises more effective predictive models for CI, thus advancing early detection and intervention among the elderly.

Prevalence and risk factors of sleep disturbance in adults with underlying health conditions during the ongoing COVID-19 pandemic.

To determine the prevalence of sleep disturbance during the coronavirus disease 2019 (COVID-19) pandemic among US adults who are more vulnerable to complications because of age and co-morbid conditions, and to identify associated sociodemographic and psychosocial factors. Cross-sectional survey linked to 3 active clinical trials and 2 cohort studies, conducted between 11/30/2020 and 3/3/2021. Five academic internal medicine practices and 2 federally qualified health centers. A total of 715 adults ages 23 to 91 years living with one or more chronic conditions. A fifth (20%) of participants reported poor sleep. Black adults were twice as likely to report poor sleep compared to Whites. Self-reported poor physical function (51%), stress (42%), depression (28%), and anxiety (36%) were also common and all significantly associated with poor sleep. Age ≥70 years and having been vaccinated for COVID-19 were protective against poor sleep. Sex, education, income, alcohol use, and employment status were not significantly associated with sleep quality. In this diverse sample of adults with chronic conditions, by race, ethnicity, and socioeconomic status, disparities in sleep health amid the ongoing pandemic were apparent. Worse physical function and mental health were associated with poor sleep and should be considered targets for health system interventions to prevent the many subsequent consequences of disturbed sleep on health outcomes. Measurements: self-reported sleep quality, physical function, stress, depression, and anxiety.

Trajectories of perceived susceptibility to COVID-19 over a year: The COVID-19 & chronic conditions (C3) cohort study.

ABSTRACT: The U.S. public health response to coronavirus disease 2019 (COVID-19) has been widely criticized as having downplayed the potential implications COVID-19 could have on one's personal health. Despite the unprecedented threat of COVID-19, many individuals still believed that it was not at all likely that they would become infected. We sought to investigate trends in adults' perceived susceptibility to COVID-19 over the first year of the pandemic, whether distinct trajectories emerged, and if these trajectories differed by participant socio-demographic characteristics.This was a longitudinal cohort study with 5 time points of data collection (March 13, 2020-March 3, 2021). Subjects included 627 adults living with ≥1 chronic conditions, who completed a baseline interview and at least one follow-up interview. In addition to collecting relevant socio-demographic characteristics, participants' perceived susceptibility to COVID-19 across time was assessed and classified into distinct trajectories.Nearly two-thirds (62.2%) of participants perceived themselves to be highly susceptible to COVID-19 from the onset of the pandemic ("early responders") and sustained this over a year, a third (29.0%) eventually perceived themselves to be highly susceptible ("late responders"), and 8.8% maintained a low likelihood of susceptibility throughout the pandemic ("non-responders"). In multivariable analyses, compared to White participants, Latinx participants were significantly more likely to be non-responders and report low likelihood of perceived susceptibility (Risk Ratio [RR]: 3.46; 95% confidence interval: 1.19, 10.1), as were Black participants (RR: 5.49; 95% confidence interval: 2.19, 13.8).A year into the COVID-19 pandemic, 1 out of 11 participants persistently did not think they might be susceptible and potentially infected. Future studies are needed to understand reasons why certain individuals, particularly those of racial/ethnic minorities, did not perceive themselves at risk for infection.

Prevalence of anxiety and depressive symptoms and impact on self-management among adults with chronic conditions in Chicago, Illinois, USA, during the COVID-19 pandemic: a cross-sectional survey.

OBJECTIVES: To examine the prevalence of mental health symptoms during the first surge of COVID-19 in the USA, and their associations with COVID-19-related emotional distress, health self-management and healthcare utilisation. DESIGN: Cross-sectional analysis of wave 3 (1-22 May 2020) survey data from the ongoing Chicago COVID-19 Comorbidities (C3) study. SETTING: Seven academic and community health centres in Chicago, Illinois. PARTICIPANTS: 565 adults aged 23-88 with one or more chronic conditions completing at least one prior C3 study wave. PRIMARY AND SECONDARY OUTCOME MEASURES: Clinically relevant anxiety and depressive symptoms as measured using Patient-Reported Outcomes Measurement Information System short forms. Self-reported emotional and health-related responses to COVID-19 were measured through a combination of single-item questions and validated measures. RESULTS: Rates of anxiety and depressive symptoms were 14% (81/563) and 15% (84/563), respectively. Anxiety and depressive symptoms were then each separately associated with greater worry about contracting COVID-19 (relative risk (RR) 2.32, 95% CI 1.52 to 3.53; RR 1.67, 95% CI 1.10 to 2.54), greater stress (RR 4.93, 95% CI 3.20 to 7.59; RR 3.01, 95% CI 1.96 to 4.61) and loneliness (RR 3.82, 95% CI 2.21 to 6.60; RR 5.37, 95% CI 3.21 to 8.98), greater avoidance of the doctor (RR 1.62, 95% CI 1.06 to 2.49; RR 1.54, 95% CI 1.00 to 2.36) and difficulty managing health (least square means (LS Means) 6.09, 95% CI 5.25 to 6.92 vs 4.23, 95% CI 3.70 to 4.75; LS Means 5.85, 95% CI 5.04 to 6.65 vs 4.22, 95% CI 3.70 to 4.75) and medications (LS Means 3.71, 95% CI 2.98 to 4.43 vs 2.47, 95% CI 2.02 to 2.92) due to the pandemic. CONCLUSIONS: Identifying and addressing mental health concerns may be an important factor to consider in COVID-19 prevention and management among high-risk medical populations.

The Relationship Between COVID-19 Related Stress and Medication Adherence Among High-Risk Adults During the Acceleration Phase of the US Outbreak.

PURPOSE: To assess the relationship between stress regarding COVID-19 and medication adherence. PATIENTS AND METHODS: Older adults with ≥1 chronic condition(s) were recruited from 4 active, federally funded studies in Chicago to participate in a longitudinal telephone survey. Participants self-reported stress regarding COVID-19 in the last week. Adherence was measured via the ASK-12 survey. RESULTS: Most participants reported feeling stressed "some of the time" (54.0%), while 18.2% felt stressed "most" or "all of the time" and 27.8% "never" felt stressed. In bivariate analyses, participants who reported being stressed "most" or "all of the time" had worse medication adherence than participants who reported being stressed "some of the time" or "never" (p < 0.001). In multivariable analyses, participants who reported feeling stressed "most" or "all of the time" had worse adherence than those who "never" felt stressed (Adjusted Least Square Mean (Standard Error): 21.3 (0.6) vs 19.7 (0.6), p=0.01). CONCLUSION: Stress due to COVID-19 has significantly impacted medication adherence, which has negative implications for the course of both COVID-19 and comorbid conditions. Healthcare providers should be aware of the potential impact of COVID-19 on patients' mental and physical well-being and consider ways to routinely assess patient experiences.

Perceived Adequacy of Tangible Support during Stay-at-Home Orders in Chicago and New York.

OBJECTIVES: Physical distancing precautions during the COVID-19 pandemic may challenge the provision of tangible support many middle age and older adults receive in managing their health. We examined the association between unmet tangible support needs and self-management behaviors and mental health status during the stay-at-home orders in Chicago and New York. METHODS: We used data from the COVID-19 & Chronic Conditions study collected between May 1st and May 22nd, 2020. A total of 801 middle age and older adults with ≥1 chronic condition in Chicago and New York City completed the telephone interview. Adequacy of tangible social support was measured using a brief, validated scale that determined whether an individual needed assistance managing his or her health, and if yes, whether this need was met. Participants reported their level of difficulty engaging in self-management behaviors using 2 discrete items; they also self-reported medication adherence using the ASK-12 medication adherence scale. Mental health status was measured using the depression and anxiety PROMIS short-form instruments. RESULTS: Participants' mean age was 63 years; 30% identified as Black, 26% identified as Latino, and 12% identified unmet support needs. Inadequacy of tangible support was associated with greater difficulty managing one's health and accessing medications due to COVID-19, as well as poorer medication adherence, increased anxiety and depressive symptoms, and poorer overall well-being (P's < .05). CONCLUSIONS: Perceived unmet support needs during stay-at-home orders were associated with greater difficulty engaging in self-management behaviors and poorer overall well-being. Two brief items quickly identified individuals with unmet support needs.

Cognitive impairment no dementia and associations with health literacy, self-management skills, and functional health status.

OBJECTIVES: To determine the prevalence of cognitive impairment no dementia (CIND) among a diverse, community-based population, and establish associations between CIND and health literacy, chronic disease self-management and functional health status. METHODS: 863 primary care adults without dementia aged 55-74. Adjusted logistic and linear regressions were used to assess associations between CIND (None, Mild, Moderate/Severe) and outcomes. RESULTS: 36 % participants exhibited CIND. It was strongly associated with limited health literacy (Newest Vital Signs: Mild [OR 3.25; 95 % CI 1.93, 5.49], Moderate/Severe [OR 6.45; 95 % CI 3.16, 13.2]; Test of Functional Health Literacy in Adults: Mild [OR 3.46; 95 % CI 2.08, 5.75], Moderate/Severe [OR 8.82; 95 % CI 4.87, 16.0]; all p's < 0.001) and poor chronic disease self-management (Mild [B = -11.2; 95 % CI -13.5, -8.90], Moderate/Severe CI [B = -21.0; 95 % CI -23.6, -18.4]; both p's < 0.001). Associations between CIND and functional health status were non-significant. CONCLUSIONS: CIND was prevalent in this cohort, and strongly associated with requisite skills for managing everyday health needs. PRACTICE IMPLICATIONS: Attention to subtle declines in chronic disease self-care may assist with CIND identification and care management within this population. When CIND is observed, clinicians should also expect and address difficulties with self-management.

Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review.

INTRODUCTION: Risk minimization programs are interventions mandated by regulatory agencies to ensure that benefits of pharmaceutical products outweigh risks. Many regulatory agencies require programs be evaluated for effectiveness; however, the quality of evidence has limited the ability to definitively determine if programs improve drug safety. OBJECTIVE: The aim of this systematic review was to assess and describe the current status of reporting on the effectiveness of pharmaceutical risk management programs. METHODS: Peer-reviewed articles published between January 2012 and December 2018 were selected from three online databases (MEDLINE, PubMed, Embase). Eligible studies reported on effectiveness evaluations of mandated risk minimization measures (beyond labeling) and were written in English. Two reviewers independently examined 2744 titles of articles and 52 full articles were included. Forty-eight sources of gray literature from conference abstract presentations and publicly available regulatory documents were also included. RESULTS: Key opportunities for improvement in reporting included the provision of information regarding (1) selection, design, and testing of risk minimization measures, (2) implementation of programs, (3) process and outcome metrics, including the extent to which programs reached the intended audience, were integrated into the target healthcare settings, or were sustained over time, and (4) burden of the program on the healthcare system and implications for patient access. CONCLUSIONS: Gaps in reporting of risk minimization program evaluation studies were identified. Addressing gaps will help build the evidence base regarding risk minimization initiatives, as well as ensure that programs are maximally effective and minimally burdensome on the healthcare system, and do not unduly interfere with patient access to the medicine.