RECOVER-NEURO: study protocol for a multi-center, multi-arm, phase 2, randomized, active comparator trial evaluating three interventions for cognitive dysfunction in post-acute sequelae of SARS-CoV-2 infection (PASC).

BACKGROUND: Post-acute sequelae of SARS-CoV-2 infection (PASC) symptoms have broad impact, and may affect individuals regardless of COVID-19 severity, socioeconomic status, race, ethnicity, or age. A prominent PASC symptom is cognitive dysfunction, colloquially referred to as "brain fog" and characterized by declines in short-term memory, attention, and concentration. Cognitive dysfunction can severely impair quality of life by impairing daily functional skills and preventing timely return to work. METHODS: RECOVER-NEURO is a prospective, multi-center, multi-arm, phase 2, randomized, active-comparator design investigating 3 interventions: (1) BrainHQ is an interactive, online cognitive training program; (2) PASC-Cognitive Recovery is a cognitive rehabilitation program specifically designed to target frequently reported challenges among individuals with brain fog; (3) transcranial direct current stimulation (tDCS) is a noninvasive form of mild electrical brain stimulation. The interventions will be combined to establish 5 arms: (1) BrainHQ; (2) BrainHQ + PASC-Cognitive Recovery; (3) BrainHQ + tDCS-active; (4) BrainHQ + tDCS-sham; and (5) Active Comparator. The interventions will occur for 10 weeks. Assessments will be completed at baseline and at the end of intervention and will include cognitive testing and patient-reported surveys. All study activities can be delivered in Spanish and English. DISCUSSION: This study is designed to test whether cognitive dysfunction symptoms can be alleviated by the use of pragmatic and established interventions with different mechanisms of action and with prior evidence of improving cognitive function in patients with neurocognitive disorder. If successful, results will provide beneficial treatments for PASC-related cognitive dysfunction. TRIAL REGISTRATION: ClinicalTrials.gov NCT05965739. Registered on July 25, 2023.

Relationship Between Cognitive Impairment and Depression Among Middle Aged and Older Adults in Primary Care.

Objectives: To determine rates of previously undetected cognitive impairment among patients with depression in primary care. Methods: Patients ages 55 and older with no documented history of dementia or mild cognitive impairment were recruited from primary care practices in New York City, NY and Chicago, IL (n = 855). Cognitive function was assessed with the Montreal Cognitive Assessment (MoCA) and depression with the Patient Health Questionnaire-8. Results: The mean age was 66.8 (8.0) years, 45.3% were male, 32.7% Black, and 29.2% Latinx. Cognitive impairment increased with severity of depression: 22.9% in persons with mild depression, 27.4% in moderate depression and 41.8% in severe depression (p = .0002). Severe depression was significantly associated with cognitive impairment in multivariable analysis (standardized ß = -.11, SE = 0.33, p < .0001). Discussion: Depression was strongly associated with previously undetected cognitive impairment. Primary care clinicians should consider screening, or expand their screening, for both conditions.

Inflammatory markers in world trade center workers with asthma: Associations with post traumatic stress disorder.

BACKGROUND: Post-traumatic stress disorders (PTSD) is associated with worse asthma outcomes in individuals exposed to the World Trade Center (WTC) site. RESEARCH QUESTION: Do WTC workers with coexisting PTSD and asthma have a specific inflammatory pattern that underlies the relationship with increased asthma morbidity? STUDY DESIGN AND METHODS: We collected data on a cohort of WTC workers with asthma recruited from the WTC Health Program. Diagnosis of PTSD was ascertained with a Structured Clinical Interview for DSM-5 (Diagnostic and Statistical Manuel of Mental Disorders) and the severity of PTSD symptoms was assessed with the PTSD Checklist 5. We obtained blood and sputum samples to measure cytokines levels in study participants. RESULTS: Of the 232 WTC workers with diagnosis of asthma in the study, 75 (32%) had PTSD. PTSD was significantly associated with worse asthma control (p = 0.002) and increased resource utilization (p = 0.0002). There was no significant association (p>0.05) between most blood or sputum cytokines with PTSD diagnosis or PCL-5 scores both in unadjusted and adjusted analyses. INTERPRETATION: Our results suggest that PTSD is not associated with blood and sputum inflammatory markers in WTC workers with asthma. These findings suggest that other mechanisms likely explain the association between PTSD and asthma control in WTC exposed individuals.

World Trade Center workers with asthma and post-traumatic stress disorder perceive airflow limitation more accurately.

BACKGROUND: Post-traumatic stress disorder (PTSD) is a major risk factor for increased asthma morbidity among World Trade Center (WTC) workers. OBJECTIVE: To investigate whether differences in perception of airflow limitation mediate the association of PTSD with worse asthma control in WTC workers. METHODS: We collected data from WTC workers on asthma control (Asthma Control Questionnaire and Asthma Quality of Life Questionnaire) and daily peak expiratory flow (PEF) measures over 6 weeks. Perception of airway limitation was assessed by comparing guessed vs actual PEF values. Post-traumatic stress disorder was diagnosed using the Structured Clinical Interview. We used unadjusted and adjusted models to compare PEF and perception measures in WTC workers with PTSD with those of workers without PTSD. RESULTS: Overall, 25% of 224 participants had PTSD. Post-traumatic stress disorder was associated with worse Asthma Control Questionnaire (2.2±0.8 vs 1.1±0.9, P < .001) and Asthma Quality of Life Questionnaire (3.9±1.1 vs 5.4±1.1, P < .001) scores. Adjusted analyses showed no significant differences in PEF between WTC workers with (351.9±143.3 L/min) and those without PTSD (364.6±131.6 L/min, P = .55). World Trade Center workers with PTSD vs those without PTSD had increased proportion of accurate perception (67.0±37.2% vs 53.5±38.1%, P = .01) and decreased underperception (23.3.0±32.1% vs 38.9±37.5%, P = .004) of airflow limitation during periods of limitation. Similar results were obtained in adjusted analyses. CONCLUSION: This study indicates that differences in perception of airflow limitation may mediate the relationship of PTSD and increased asthma symptoms, given WTC workers with PTSD have worse self-reported asthma control, an increased proportion of accurate perception, and decreased underperception, despite no differences in daily PEF measures.

Assessing the interrelationship between asthma and obesity self-management behaviors.

Asthma and obesity are common coexisting conditions with increasing prevalence and substantial morbidity. This study examines the inter-relationship between illness and treatment beliefs in asthma and obesity and how they influence self-management behaviors. Overweight and obese adults ≥ 18 years with asthma were recruited from primary care and pulmonary practices in New York, NY and Denver, CO (n = 219). Path analysis was used to examine the relationship between asthma, weight and exercise-related illness and medication beliefs and SMB. Necessity beliefs about asthma medications and diet were associated with better medication adherence and healthier dietary behaviors (ß = 0.276, p = < 0.001, ß = 0.148, p = 0.018 respectively) whereas concerns about these self-care activities were associated with poorer adherence and worse dietary behaviors (ß = - 0.282, p < 0.001, ß = - 0.188, p = 0.003 respectively). We found no statistically significant association of exercise behaviors with any other weight or asthma illness or treatment beliefs. Our study demonstrates that necessity and concerns about treatment are associated with adherence in asthma and obesity. The lack of association of exercise behaviors with any asthma or weight related beliefs may reflect limited awareness of the impact of weight on asthma and warrants additional research.

Feasibility Trial of a Comprehensive, Highly Patient-Centered COPD Self-Management Support Program.

Purpose: To test the feasibility of a novel self-management support intervention for people with chronic obstructive pulmonary disease (COPD). Methods: We conducted a feasibility randomized controlled trial involving patients ≥40 years with severe or very severe COPD in New York, New York (n=59). Community health workers screened patients and addressed barriers to COPD self-management. Patients were also offered home-based pulmonary rehabilitation (HBPR) and an antibiotic and steroid rescue pack. Control patients received general COPD education. Clinical outcomes for intervention and control were compared by difference-in-differences (DiD) at baseline and 6 months. The study was not powered for statistically significant differences for any measure. Feasibility measures were collected at 6 months. Results: There were high rates of completion of intervention activities, including 75% of patients undergoing evaluation for and participating in HBPR. Most (92%) intervention patients said the program was very or extremely helpful and 96% said they would participate again. Clinical outcomes generally favored the intervention: COPD assessment test, DiD -1.1 (95% confidence interval [CI] -5.9 to 3.6); 6-minute walk test distance, DiD 7.4 meters (95% CI -45.1 to 59.8); self-reported hospitalizations, DiD -9.8% (95% CI -42.3% to 22.8%); medication adherence, DiD 7.7% (-29.6%, 45.0%), and Physical Activity Adult Questionnaire, DiD 86 (95% CI -283 to 455). Intervention patients reported more emergency department visits, DiD 10.6% (95% CI 17.7% to 38.8%). Conclusions: A highly patient-centered, self-management support intervention for people with COPD was well received by patients and associated with potential improvements in clinical and self-management outcomes. A fully powered study of the intervention is warranted.

The relationships between Physical activity and asthma control and Body Mass Index (BMI) in patients with asthma.

OBJECTIVE: Asthma is one of the most common chronic conditions in developed countries. We examined whether physical activity (PA) is related to asthma control and body mass index (BMI) in asthma patients. METHODS: Cross-sectional data collected on PA (ActiGraph GT3X-BT), asthma control (the Asthma Control Questionnaire; ACQ), and BMI were examined in 206 adults (mean[sd] age 47.2[13.8] years; 49.5% had an obese BMI) with clinically diagnosed asthma. Relationships between PA and continuous BMI and asthma control were assessed using linear regression. Differences in PA across obesity (non-obese: <30 Kg/m2/obese: ≥30 Kg/m2) and asthma control categories (controlled: ≤0.75/uncontrolled: >0.75 ACQ score) were also examined. RESULTS: Median (p25, p75) steps counts and peak cadence were 6035 (4248, 8461) steps/day and 123 (115, 133) steps in a minute, respectively. There were nearly 2000 fewer steps/day among those with uncontrolled asthma versus controlled and among those with obese BMI versus nonobese, respectively (both p < 0.05). In regression models adjusted for relevant covariates each 1-unit increase in ACQ score was associated with -686 [95%CI -997, -13] (p ≤ 0.05) average steps/day. The statistical significance of these findings was attenuated (p ≥ 0.05) when BMI was added to the model. However, the point estimate was not reduced (-766 [95%CI -1060, 34]. CONCLUSIONS: Overall step counts were low in this population despite peak cadence values suggesting that most participants could perform moderate intensity activity. Increasing step counts should be considered an important lifestyle intervention goal in obese and non-obese asthma patients with low PA levels.

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.

Patterns of care in the management of high-risk COPD in the US (2011-2019): an observational study for the CONQUEST quality improvement program.

Background: In this study, we compare management of patients with high-risk chronic obstructive pulmonary disease (COPD) in the United States to national and international guidelines and quality standards, including the COllaboratioN on QUality improvement initiative for achieving Excellence in STandards of COPD care (CONQUEST). Methods: Patients were identified from the DARTNet Practice Performance Registry and categorized into three high-risk cohorts in each year from 2011 to 2019: newly diagnosed (≤12 months after diagnosis), already diagnosed, and patients with potential undiagnosed COPD. Patients were considered high-risk if they had a history of exacerbations or likely exacerbations (respiratory consult with prescribed medication). Descriptive statistics for 2019 are reported, along with annual trends. Findings: In 2019, 10% (n = 16,610/167,197) of patients met high-risk criteria. Evidence of spirometry for diagnosis was low; in 2019, 81% (n = 1228/1523) of patients newly diagnosed at high-risk had no record of spirometry/peak expiratory flow in the 12 months pre- or post-diagnosis and 43% (n = 651/1523) had no record of COPD symptom review. Among those newly and already diagnosed at high-risk, 52% (n = 4830/9350) had no evidence of COPD medication. Interpretation: Findings suggest inconsistent adherence to evidence-based guidelines, and opportunities to improve identification, documentation of services, assessment, therapeutic intervention, and follow-up of patients with COPD. Funding: This study was conducted by the Observational and Pragmatic Research Institute (OPRI) Pte Ltd and was partially funded by Optimum Patient Care Global and AstraZeneca Ltd. No funding was received by the Observational & Pragmatic Research Institute Pte Ltd (OPRI) for its contribution.

Barriers and facilitators of self-management behaviors among patients with chronic obstructive pulmonary disease and chronic comorbidities: A mixed-methods investigation.

OBJECTIVES: We investigated how individuals with chronic obstructive pulmonary disease (COPD) and multi-morbidity (MM) navigate barriers and facilitators to their health management. METHODS: We conducted a mixed-methods study using semi-structured interviews and survey assessments of adults with COPD, hypertension, and/or diabetes. We recruited 18 participants with an average age of 65, with 39% being male, 50% Black, and 22% Hispanic/Latino/a. Five investigators used an iterative, hybrid-coding process combining a priori and emergent codes to analyze transcripts and compare quantitative and qualitative data for themes. RESULTS: Participants reported a generalized approach to their health rather than managing MMs separately. Individuals with good or mixed adherence found daily routines facilitated regular medication use, while those with poor adherence experienced complex prescriptions and life stressors as barriers. Walking was viewed as beneficial but challenging due to limited mobility. Most participants viewed diet as important to their MMs, but only two reported high diet quality and many held inaccurate beliefs about healthy diet choices. DISCUSSION: Participants with MM were highly motivated to engage in self-management activities, but some individuals experienced barriers to maintaining them. Emphasizing an individualized clinical approach to assessing and solving patient barriers may improve self-management outcomes in this complex population.

Phenotypic characteristics of asthma and morbidity are associated with distinct longitudinal changes in L-arginine metabolism.

BACKGROUND: The L-arginine metabolome is dysregulated in asthma, though it is not understood how longitudinal changes in L-arginine metabolism differ among asthma phenotypes and relate to disease outcomes. OBJECTIVES: To determine the longitudinal associations between phenotypic characteristics with L-arginine metabolites and their relationships with asthma morbidity. METHODS: This is a prospective cohort study of 321 patients with asthma followed semiannually for over 18 months with assessments of plasma L-arginine metabolites, asthma control, spirometry, quality of life and exacerbations. Metabolite concentrations and ratios were transformed using the natural logarithm. RESULTS: There were many differences in L-arginine metabolism among asthma phenotypes in the adjusted models. Increasing body mass index was associated with increased asymmetric dimethylarginine (ADMA) and depleted L-citrulline. Latinx was associated with increased metabolism via arginase, with higher L-ornithine, proline and L-ornithine/L-citrulline levels, and was found to have higher L-arginine availability compared with white race. With respect to asthma outcomes, increasing L-citrulline was associated with improved asthma control and increasing L-arginine and L-arginine/ADMA were associated with improved quality of life. Increased variability in L-arginine, L-arginine/ADMA, L-arginine/L-ornithine and L-arginine availability index over 12 months were associated with increased exacerbations, OR 4.70 (95% CI 1.35 to 16.37), OR 8.69 (95% CI 1.98 to 38.08), OR 4.17 (95% CI 1.40 to 12.41) and OR 4.95 (95% CI 1.42 to 17.16), respectively. CONCLUSIONS: Our findings suggest that L-arginine metabolism is associated with multiple measures of asthma control and may explain, in part, the relationship between age, race/ethnicity and obesity with asthma outcomes.

Under-perception of airflow limitation, self-efficacy, and beliefs in older adults with asthma.

OBJECTIVE: Under-perception of airflow limitation is more common in older adults with asthma and may lead to under-reporting of asthma symptoms. Asthma management self-efficacy is linked with better asthma control and quality of life (QoL). We sought to examine asthma and medication beliefs as a mediator in the relationship between both under-perception and self-efficacy with asthma outcomes. METHODS: This cross-sectional study recruited participants with asthma ≥60 years from hospital-affiliated practices in East Harlem and the Bronx, New York. Perception of airflow limitation was measured for 6 weeks by having participants enter peak expiratory flow (PEF) estimates into an electronic peak flow meter followed by PEF blows. We used validated instruments to assess asthma and medication beliefs, asthma management self-efficacy, asthma control, and QoL. Asthma self-management behaviors (SMB) were quantified by electronic and self-report measures of inhaled corticosteroid (ICS) adherence and observation of inhaler technique. RESULTS: The sample comprised 331 participants (51% Hispanic, 27% Black, 84% female). Beliefs mediated the relationship between greater under-perception and better self-reported asthma control (ß = -0.08, p = .02) and better asthma QoL (ß =0.12, p = .02). Higher self-efficacy was also associated with better reported asthma control (ß = -0.10, p = .006) and better asthma QoL (ß =0.13, p = .01) in this indirect effect through beliefs. Accurate perception of airflow limitation was associated with higher adherence to SMB (ß = 0.29, p = .003). CONCLUSIONS: Less threatening asthma beliefs may be maladaptive in under-perception of airflow limitation by contributing to under-reporting of asthma symptoms, but adaptive in the context of higher self-efficacy and better asthma control.

The relationship between social support, self-efficacy, and asthma outcomes in older adults.

OBJECTIVE: There has been a call for research examining factors that influence asthma outcomes in older adults because of the notable disparities observed in this age group. Social support and self-efficacy are resources that factor into asthma outcomes. The current study aimed to examine the relationship between these resources (independently and jointly) and asthma control and quality of life. METHODS: Older adults with moderate-severe asthma were recruited from NYC. Data were obtained during in-person interviews via validated measures of social support, asthma self-efficacy, asthma control, and asthma quality of life. Linear regression evaluated self-efficacy in the relationship between social support and asthma outcomes. RESULTS: In a sample of 359 older adults (M = 68.04, 47.9% Hispanic, 26.5% Black, and 25.6% other), social support had an inverse association with asthma control. As social support increased, asthma control decreased (ß = 0.95, t(356) = -3.13, p = .002). Self-efficacy significantly moderated this relationship (ß = 0.01, t(356) = 2.37, p = .018). For individuals with low or moderate asthma self-efficacy, more received social support was associated with worse asthma control (ß = -0.33, t(356) = -4.66, p < .0001; ß = -0.20, t(356) = -3.21, p = .0014, respectively). For individuals with high self-efficacy, no relationship was found between received social support and asthma control (ß = -0.10, t(356)= -1.20, p =.23). For asthma quality of life, higher levels of received social support were associated with worse quality of life (ß = -0.88, t(356) = -2.64, p = .009), but this association was not significantly moderated by self-efficacy (ß = 0.01, t(356) = 1.90, p = .0582). CONCLUSIONS: For older adults with asthma, receiving more social support is associated with worse asthma outcomes, especially for older adults with lower asthma self-efficacy.

Rates of Undiagnosed Cognitive Impairment and Performance on the Montreal Cognitive Assessment Among Older Adults in Primary Care.

BACKGROUND: The number of adults in the USA with cognitive impairment is increasing; however, few studies report prevalence rates of undiagnosed cognitive impairment among older adults in primary care. OBJECTIVE: To determine the prevalence of undiagnosed cognitive impairment among adults ages 55 years and older in primary care settings and provide normative data for the Montreal Cognitive Assessment in this context. DESIGN: Single interview, observational study. PARTICIPANTS: English-speaking adults ages 55 years and older without diagnoses of cognitive impairment recruited from primary care practices in New York City, NY, and Chicago, IL (n = 872). MAIN MEASURES: Montreal Cognitive Assessment (MoCA). Undiagnosed cognitive impairment was defined by age and education adjusted z-scores more than 1.0 and 1.5 standard deviations below published norms, corresponding to mild or moderate to severe cognitive impairment, respectively. KEY RESULTS: The mean age was 66.8 (8.0) years, 44.7% were male, 32.9% were Black or African-American, and 29.1% were Latinx. Undiagnosed cognitive impairment was identified in 20.8% of subjects (mild impairment, 10.5%; moderate-severe impairment, 10.3%). Impairment at any level of severity was associated in bivariate analyses with several patient characteristics, most notably for race and ethnicity (White, non-Latinx, 6.9% vs. Black, non-Latinx, 26.8%, Latinx, 28.2%, other race, 21.9%; p < 0.0001), place of birth (US 17.5% vs. non-US 30.7%, p < 0.0001), depression (33.1% vs. no depression, 18.1%; p < 0.0001), and impairment in activities of daily living (≥ 1 ADL impairment, 34.0% vs. no ADL impairment, 18.2%; p < 0.0001). CONCLUSIONS: Undiagnosed cognitive impairment is common among urban dwelling older adults attending primary care practices, and was associated with several patient characteristics, including non-White race and ethnicity and depression. Normative data for the MoCA from this study may serve as a useful resource for studies of similar patient populations.

The indirect influence of 'invisible' support on pulmonary function among adults with chronic obstructive pulmonary disease.

Individuals living with chronic obstructive pulmonary disease (COPD) often require support from family or friends. We examined whether invisible support - support that is provided but goes unnoticed - is related to pulmonary function, and whether this association is mediated by depressive symptoms and illness perceptions. Sixty-six dyads of individuals with COPD and their informal caregivers reported on receipt and provision of support, respectively. Those with COPD completed measures of depressive symptoms, illness perceptions and pulmonary function. Although invisible support was not directly related to pulmonary function, mediation analyses revealed a combined indirect effect through lower depressive symptoms and less negative illness perceptions. Interventions teaching skillful delivery of support to caregivers may reduce depressive symptoms and threatening illness cognitions, which may contribute to improvements in symptom burden among patients with COPD.

Care Disruptions and End-Of-Life Care Experiences Among Home-Based Primary Care Patients During the COVID-19 Pandemic in New York City: A Retrospective Chart Review.

Background: Research on deaths during COVID-19 has largely focused on hospitals and nursing homes. Less is known about medically complex patients receiving care in the community. We examined care disruptions and end-of-life experiences of homebound patients receiving home-based primary care (HBPC) in New York City during the initial 2020 COVID-19 surge. Methods: We conducted a retrospective chart review of patients enrolled in Mount Sinai Visiting Doctors who died between March 1-June 30, 2020. We collected patient sociodemographic and clinical data and analyzed care disruptions and end-of-life experiences using clinical notes, informed by thematic and narrative analysis. Results: Among 1300 homebound patients, 112 (9%) died during the study period. Patients who died were more likely to be older, non-Hispanic white, and have dementia than those who survived. Thirty percent of decedents had confirmed or probable COVID-19. Fifty-eight (52%) were referred to hospice and 50 enrolled. Seventy-three percent died at home. We identified multiple intersecting disruptions in family caregiving, paid caregiving, medical supplies and services, and hospice care, as well as hospital avoidance, complicating EOL experiences. The HBPC team responded by providing clinical, logistical and emotional support to patients and families. Conclusion: Despite substantial care disruptions, the majority of patients in our study died at home with support from their HBPC team as the practice worked to manage care disruptions. Our findings suggest HBPC's multi-disciplinary, team-based model may be uniquely suited to meet the needs of the most medically and socially vulnerable older adults at end of life during public health emergencies.

Outcomes of home-based primary care for homebound older adults: A randomized clinical trial.

BACKGROUND: Homebound older adults are medically complex and often have difficulty accessing outpatient medical care. Home-based primary care (HBPC) may improve care and outcomes for this population but data from randomized trials of HBPC in the United States are limited. METHODS: We conducted a randomized controlled trial of HBPC versus office-based primary care for adults ages ≥65 years who reported ≥1 hospitalization in the prior 12 months and met the Medicare definition of homebound. HBPC was provided by teams consisting of a physician, nurse practitioner, nurse, and social worker. Data were collected at baseline, 6- and 12-months. Outcomes were quality of life, symptoms, satisfaction with care, hospitalizations, and emergency department (ED) visits. Recruitment was terminated early because more deaths were observed for intervention patients. RESULTS: The study enrolled 229 patients, 65.4% of planned recruitment. The mean age was 82 (9.0) years and 72.3% had dementia. Of those assigned to HBPC, 34.2% never received it. Intervention patients had greater satisfaction with care than controls (2.26, 95% CI 1.46-3.06, p < 0.0001; effect size 0.74) and lower hospitalization rates (-17.9%, 95% CI -31.0% to -1.0%; p = 0.001; number needed to treat 6, 95% CI 3-100). There were no significant differences in quality of life (1.25, 95% CI -0.39-2.89, p = 0.13), symptom burden (-1.92, 95% CI -5.22-1.37, p = 0.25) or ED visits (1.2%, 95% CI -10.5%-12.4%; p = 0.87). There were 24 (21.1%) deaths among intervention patients and 12 (10.7%) among controls (p < 0.0001). CONCLUSION: HBPC was associated with greater satisfaction with care and lower hospitalization rates but also more deaths compared to office-based primary care. Additional research is needed to understand the nature of the higher death rate for HBPC patients, as well as to determine the effects of HBPC on quality of life and symptom burden given the trial's early termination.

A national qualitative study of Hospital-at-Home implementation under the CMS Acute Hospital Care at Home waiver.

BACKGROUND: The Centers for Medicare & Medicaid Services (CMS) announced the Acute Hospital Care at Home (AHCaH) waiver program in November 2020 to help expand hospital capacity to cope with the COVID-19 pandemic. The AHCaH waived the 24/7 on-site nursing requirement and enabled hospitals to obtain full hospital-level diagnosis-related group (DRG) reimbursement for providing Hospital-at-Home (HaH) care. This study sought to describe AHCaH implementation processes and strategies at the national level and identify challenges and facilitators to launching or adapting a HaH to meet waiver requirements. METHODS: We conducted semi-structured interviews to explore barriers and facilitators of HaH implementation. The analysis was informed by the Exploration, Preparation, Implementation, and Sustainment (EPIS) implementation framework. Interviews were audio recorded for transcription and thematic coding. PRINCIPAL FINDINGS: We interviewed a sample of clinical leaders (N = 18; clinical/medical directors, operational and program managers) from 14 new and pre-existing U.S. HaH programs diverse by size, urbanicity, and geography. Participants were enthusiastic about the AHCaH waiver. Participants described barriers and facilitators at planning and implementation stages within three overarching themes influencing waiver program implementation: 1) institutional value and assets; 2) program components, such as electronic health records, vendors, pharmacy, and patient monitoring; and 3) patient enrollment, including eligibility and geographic limits. CONCLUSIONS: Implementation of AHCaH waiver is a complex process that requires building components in compliance with the requirements to extend the hospital into the home, in coordination with internal and external partners. The study identified barriers that potential adopters and proponents should consider alongside the strategies that some organizations have found useful. Clarity regarding the waiver's future may expedite HaH model dissemination and ensure longevity of this valuable model of care delivery.