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2.
JAMA Netw Open ; 7(7): e2419640, 2024 Jul 01.
Article in English | MEDLINE | ID: mdl-38954414

ABSTRACT

Importance: Older adults who are hospitalized for COVID-19 are at risk of delirium. Little is known about the association of in-hospital delirium with functional and cognitive outcomes among older adults who have survived a COVID-19 hospitalization. Objective: To evaluate the association of delirium with functional disability and cognitive impairment over the 6 months after discharge among older adults hospitalized with COVID-19. Design, Setting, and Participants: This prospective cohort study involved patients aged 60 years or older who were hospitalized with COVID-19 between June 18, 2020, and June 30, 2021, at 5 hospitals in a major tertiary care system in the US. Follow-up occurred through January 11, 2022. Data analysis was performed from December 2022 to February 2024. Exposure: Delirium during the COVID-19 hospitalization was assessed using the Chart-based Delirium Identification Instrument (CHART-DEL) and CHART-DEL-ICU. Main Outcomes and Measures: Primary outcomes were disability in 15 functional activities and the presence of cognitive impairment (defined as Montreal Cognitive Assessment score <22) at 1, 3, and 6 months after hospital discharge. The associations of in-hospital delirium with functional disability and cognitive impairment were evaluated using zero-inflated negative binominal and logistic regression models, respectively, with adjustment for age, month of follow-up, and baseline (before COVID-19) measures of the respective outcome. Results: The cohort included 311 older adults (mean [SD] age, 71.3 [8.5] years; 163 female [52.4%]) who survived COVID-19 hospitalization. In the functional disability sample of 311 participants, 49 participants (15.8%) experienced in-hospital delirium. In the cognition sample of 271 participants, 31 (11.4%) experienced in-hospital delirium. In-hospital delirium was associated with both increased functional disability (rate ratio, 1.32; 95% CI, 1.05-1.66) and increased cognitive impairment (odds ratio, 2.48; 95% CI, 1.38-4.82) over the 6 months after discharge from the COVID-19 hospitalization. Conclusions and Relevance: In this cohort study of 311 hospitalized older adults with COVID-19, in-hospital delirium was associated with increased functional disability and cognitive impairment over the 6 months following discharge. Older survivors of a COVID-19 hospitalization who experience in-hospital delirium should be assessed for disability and cognitive impairment during postdischarge follow-up.


Subject(s)
COVID-19 , Cognitive Dysfunction , Delirium , Hospitalization , SARS-CoV-2 , Humans , COVID-19/complications , COVID-19/psychology , COVID-19/epidemiology , Delirium/epidemiology , Delirium/etiology , Female , Male , Aged , Cognitive Dysfunction/epidemiology , Cognitive Dysfunction/etiology , Prospective Studies , Hospitalization/statistics & numerical data , Aged, 80 and over , Middle Aged
3.
Article in English | MEDLINE | ID: mdl-38558166

ABSTRACT

BACKGROUND: Despite significant support system disruptions during the coronavirus 2019 (COVID-19) pandemic, little is known about the relationship between social support and symptom burden among older adults following COVID-19 hospitalization. METHODS: From a prospective cohort of 341 community-living persons aged ≥60 years hospitalized with COVID-19 between June 2020 and June 2021 who underwent follow-up at 1, 3, and 6 months after discharge, we identified 311 participants with ≥1 follow-up assessment. Social support prehospitalization was ascertained using a 5-item version of the Medical Outcomes Study Social Support Survey (range, 5-25), with low social support defined as a score ≤15. At hospitalization and each follow-up assessment, 14 physical symptoms were assessed using a modified Edmonton Symptom Assessment System inclusive of COVID-19-relevant symptoms. Mental health symptoms were assessed using Patient Health Questionnaire-4. Longitudinal associations between social support and physical and mental health symptoms, respectively, were evaluated through multivariable regression. RESULTS: Participants' mean age was 71.3 years (standard deviation, 8.5), 52.4% were female, and 34.2% were of Black race or Hispanic ethnicity. 11.8% reported low social support. Over the 6-month follow-up period, low social support was independently associated with higher burden of physical symptoms (adjusted rate ratio [aRR], 1.26; 95% confidence interval [CI], 1.05-1.52), but not mental health symptoms (aRR, 1.14; 95% CI, 0.85-1.53). CONCLUSIONS: Low social support is associated with greater physical, but not mental health, symptom burden among older survivors of COVID-19 hospitalization. Our findings suggest a potential need for social support screening and interventions to improve post-COVID-19 symptom management in this vulnerable group.


Subject(s)
COVID-19 , Hospitalization , Social Support , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , COVID-19/psychology , COVID-19/epidemiology , Hospitalization/statistics & numerical data , Mental Health , Prospective Studies , Symptom Burden
4.
J Am Geriatr Soc ; 71(3): 832-844, 2023 03.
Article in English | MEDLINE | ID: mdl-36544250

ABSTRACT

BACKGROUND: Most older adults hospitalized with COVID-19 survive their acute illness. The impact of COVID-19 hospitalization on patient-centered outcomes, including physical function, cognition, and symptoms, is not well understood. To address this knowledge gap, we collected longitudinal data about these issues from a cohort of older survivors of COVID-19 hospitalization. METHODS: We undertook a prospective study of community-living persons age ≥ 60 years who were hospitalized with COVID-19 from June 2020-June 2021. A baseline interview was conducted during or up to 2 weeks after hospitalization. Follow-up interviews occurred at one, three, and six months post-discharge. Participants completed comprehensive assessments of physical and cognitive function, symptoms, and psychosocial factors. An abbreviated assessment could be performed with a proxy. Additional information was collected from the electronic health record. RESULTS: Among 341 participants, the mean age was 71.4 (SD 8.4) years, 51% were women, and 37% were of Black race or Hispanic ethnicity. Median length of hospitalization was 8 (IQR 6-12) days. All but 4% of participants required supplemental oxygen, and 20% required care in an intensive care unit or stepdown unit. At enrollment, nearly half (47%) reported at least one preexisting disability in physical function, 45% demonstrated cognitive impairment, and 67% were pre-frail or frail. Participants reported a mean of 9 of 14 (SD 3) COVID-19-related symptoms. At the six-month follow-up interview, more than a third of participants experienced a decline from their pre-hospitalization function, nearly 20% had cognitive impairment, and burdensome symptoms remained highly prevalent. CONCLUSIONS: We enrolled a diverse cohort of older adults hospitalized with COVID-19 and followed them after discharge. Functional decline was common, and there were high rates of persistent cognitive impairment and symptoms. Future analyses of these data will advance our understanding of patient-centered outcomes among older COVID-19 survivors.


Subject(s)
COVID-19 , Humans , Female , Aged , Male , COVID-19/epidemiology , Patient Discharge , Prospective Studies , Aftercare , Hospitalization
6.
J Cardiopulm Rehabil Prev ; 42(2): 109-114, 2022 03 01.
Article in English | MEDLINE | ID: mdl-34799530

ABSTRACT

PURPOSE: Cardiac rehabilitation (CR) is a key aspect of secondary prevention following acute myocardial infarction (AMI). While there is growing evidence of unique benefits of CR in older adults, it remains underutilized. We aimed to examine specific demographic, clinical, and functional factors associated with utilization of CR among older adults hospitalized with AMI. METHODS: Our project used data from the SILVER-AMI study, a nationwide prospective cohort study of patients age ≥75 yr hospitalized with AMI and followed them up for 6 mo after discharge. Extensive baseline data were collected on demographics, clinical and psychosocial factors, and functional and sensory impairments. The utilization of CR was collected by a survey at 6 mo. Backward selection was employed in a multivariable-adjusted logistic regression model to identify independent predictors of CR use. RESULTS: Of the 2003 participants included in this analysis, 779 (39%) reported participating in CR within 6 mo of discharge. Older age, longer length of hospitalization, having ≤12 yr of education, visual impairment, cognitive impairment, and living alone were associated with decreased likelihood of CR participation; receipt of diagnostic and interventional procedures (ie, cardiac catheterization, percutaneous coronary intervention, and coronary artery bypass graft) was associated with increased likelihood of CR participation. CONCLUSIONS: Demographic and clinical factors, as well as select functional and sensory impairments common in aging, were associated with CR participation at 6 mo post-discharge in older AMI patients. These results highlight opportunities to increase CR usage among older adults and identify those at risk for not participating.


Subject(s)
Cardiac Rehabilitation , Myocardial Infarction , Aftercare , Aged , Humans , Patient Discharge , Prospective Studies
7.
Mil Med ; 187(7-8): 179-185, 2022 07 01.
Article in English | MEDLINE | ID: mdl-34791412

ABSTRACT

Pragmatic clinical trials (PCTs) are well-suited to address unmet healthcare needs, such as those arising from the dual public health crises of chronic pain and opioid misuse, recently exacerbated by the COVID-19 pandemic. These overlapping epidemics have complex, multifactorial etiologies, and PCTs can be used to investigate the effectiveness of integrated therapies that are currently available but underused. Yet individual pragmatic studies can be limited in their reach because of existing structural and cultural barriers to dissemination and implementation. The National Institutes of Health, Department of Defense, and Department of Veterans Affairs formed an interagency research partnership, the Pain Management Collaboratory. The partnership combines pragmatic trial design with collaborative tools and relationship building within a large network to advance the science and impact of nonpharmacological approaches and integrated models of care for the management of pain and common co-occurring conditions. The Pain Management Collaboratory team supports 11 large-scale, multisite PCTs in veteran and military health systems with a focus on team science with the shared aim that the "whole is greater than the sum of the parts." Herein, we describe this integrated approach and lessons learned, including incentivizing all parties; proactively offering frequent opportunities for problem-solving; engaging stakeholders during all stages of research; and navigating competing research priorities. We also articulate several specific strategies and their practical implications for advancing pain management in active clinical, "real-world," settings.


Subject(s)
Military Personnel , Pragmatic Clinical Trials as Topic , Veterans , COVID-19 , Humans , Pain Management , Pandemics , Research Design
8.
Contemp Clin Trials ; 111: 106619, 2021 12.
Article in English | MEDLINE | ID: mdl-34775101

ABSTRACT

Characterizing the impacts of disruption attributable to the COVID-19 pandemic on clinical research is important, especially in pain research where psychological, social, and economic stressors attributable to the COVID-19 pandemic may greatly impact treatment effects. The National Institutes of Health - Department of Defense - Department of Veterans Affairs Pain Management Collaboratory (PMC) is a collective effort supporting 11 pragmatic clinical trials studying nonpharmacological approaches and innovative integrated care models for pain management in veteran and military health systems. The PMC rapidly developed a brief pandemic impacts measure for use across its pragmatic trials studying pain while remaining broadly applicable to other areas of clinical research. Through open discussion and consensus building by the PMC's Phenotypes and Outcomes Work Group, the PMC Coronavirus Pandemic (COVID-19) Measure was iteratively developed. The measure assesses the following domains (one item/domain): access to healthcare, social support, finances, ability to meet basic needs, and mental or emotional health. Two additional items assess infection status (personal and household) and hospitalization. The measure uses structured responses with a three-point scale for COVID-19 infection status and four-point ordinal rank response for all other domains. We recommend individualized adaptation as appropriate by clinical research teams using this measure to survey the effects of the COVID-19 pandemic on study participants. This can also help maintain utility of the measure beyond the COVID-19 pandemic to characterize impacts during future public health emergencies that may require mitigation strategies such as periods of quarantine and isolation.


Subject(s)
COVID-19 , Pragmatic Clinical Trials as Topic , Humans , Pandemics , Quarantine , Social Support , United States/epidemiology
9.
J Am Heart Assoc ; 10(18): e021047, 2021 09 21.
Article in English | MEDLINE | ID: mdl-34514837

ABSTRACT

Background Readmission over the first year following hospitalization for acute myocardial infarction (AMI) is common among younger adults (≤55 years). Our aim was to develop/validate a risk prediction model that considered a broad range of factors for readmission within 1 year. Methods and Results We used data from the VIRGO (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients) study, which enrolled young adults aged 18 to 55 years hospitalized with AMI across 103 US hospitals (N=2979). The primary outcome was ≥1 all-cause readmissions within 1 year of hospital discharge. Bayesian model averaging was used to select the risk model. The mean age of participants was 47.1 years, 67.4% were women, and 23.2% were Black. Within 1 year of discharge for AMI, 905 (30.4%) of participants were readmitted and were more likely to be female, Black, and nonmarried. The final risk model consisted of 10 predictors: depressive symptoms (odds ratio [OR], 1.03; 95% CI, 1.01-1.05), better physical health (OR, 0.98; 95% CI, 0.97-0.99), in-hospital complication of heart failure (OR, 1.44; 95% CI, 0.99-2.08), chronic obstructive pulmomary disease (OR, 1.29; 95% CI, 0.96-1.74), diabetes mellitus (OR, 1.23; 95% CI, 1.00-1.52), female sex (OR, 1.31; 95% CI, 1.05-1.65), low income (OR, 1.13; 95% CI, 0.89-1.42), prior AMI (OR, 1.47; 95% CI, 1.15-1.87), in-hospital length of stay (OR, 1.13; 95% CI, 1.04-1.23), and being employed (OR, 0.88; 95% CI, 0.69-1.12). The model had excellent calibration and modest discrimination (C statistic=0.67 in development/validation cohorts). Conclusions Women and those with a prior AMI, increased depressive symptoms, longer inpatient length of stay and diabetes may be more likely to be readmitted. Notably, several predictors of readmission were psychosocial characteristics rather than markers of AMI severity. This finding may inform the development of interventions to reduce readmissions in young patients with AMI.


Subject(s)
Diabetes Mellitus , Myocardial Infarction , Bayes Theorem , Female , Hospitalization , Humans , Male , Middle Aged , Myocardial Infarction/diagnosis , Myocardial Infarction/epidemiology , Myocardial Infarction/therapy , Patient Readmission , Risk Factors , Time Factors , United States/epidemiology , Young Adult
10.
J Am Geriatr Soc ; 69(12): 3476-3485, 2021 12.
Article in English | MEDLINE | ID: mdl-34383963

ABSTRACT

BACKGROUND: After hospitalization for acute myocardial infarction (AMI), older adults may be at increased risk for falls due to deconditioning, new medications, and worsening health status. Our primary objective was to identify risk factors for falls after AMI hospitalization among adults over age 75. METHODS: We used data from the Comprehensive Evaluation of Risk Factors in Older Patients with AMI (SILVER-AMI) study, a prospective cohort study of 3041 adults age 75 and older hospitalized with AMI at 94 community and academic medical centers across the United States. In-person interviews and physical assessments, as well as medical record review, were performed to collect demographic, clinical, functional, and psychosocial data. Falls were self-reported in telephone interviews and medically serious falls (those associated with emergency department use or hospitalization) were determined by medical record adjudication. Backward selection was used to identify predictors of fall risk in logistic regression analysis. RESULTS: A total of 554 (21.6%) participants reported a fall and 191 (6.4%) had a medically serious fall within 6 months of discharge. Factors independently associated with self-reported falls included impaired mobility, prior fall history, longer hospital stay, visual impairment, and weak grip. Factors independently associated with medically serious falls included older age, polypharmacy, impaired functional mobility, prior fall history, and living alone. CONCLUSIONS: Among older patients hospitalized for AMI, falls are common in the 6 months following discharge and associated with demographic, functional, and clinical factors that are readily identifiable. Fall risk should be considered in post-AMI clinical decision-making and interventions to prevent falls should be evaluated.


Subject(s)
Accidental Falls/statistics & numerical data , Hospitalization/statistics & numerical data , Myocardial Infarction/complications , Aged , Aged, 80 and over , Female , Health Status , Humans , Male , Prospective Studies , Risk Factors , United States
11.
Prev Med Rep ; 23: 101391, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34040930

ABSTRACT

Physical activity and social support are associated with better outcomes after surviving acute myocardial infarction (AMI), and greater walkability has been associated with activity and support. We used data from the SILVER-AMI study (November 2014-June 2017), a longitudinal cohort of community-living adults ≥ 75 years hospitalized for AMI to assess associations of neighborhood walkability with health outcomes, and to assess whether physical activity and social support mediate this relationship, if it exists. We included data from 1345 participants who were not bedbound, were discharged home, and for whom we successfully linked walkability scores (from Walk Score®) for their home census block. Our primary outcome was hospital-free survival time (HFST) at six months after discharge; secondary outcomes included physical and mental health at six months, assessed using SF-12. Physical activity and social support were measured at baseline. Covariates included cognition, functioning, comorbidities, participation in rehabilitation or physical therapy, and demographics. We employed survival analysis to examine associations between walkability and HFST, before and after adjustment for covariates; we repeated analyses using linear regression with physical and mental health as outcomes. In adjusted models, walkability was not associated with physical health (ß = 0.010; 95% CI: -0.027, 0.047), mental health (ß = -0.08; 95% CI: -0.175, -0.013), or HFST (ß = 0.008; 95% CI: -0.023, 0.009). Social support was associated with mental health in adjusted models. Neighborhood walkability was not predictive of outcomes among older adults with existing coronary disease, suggesting that among older adults, mobility limitations may supercede neighborhood walkability.

12.
Am J Med ; 134(7): 910-917, 2021 07.
Article in English | MEDLINE | ID: mdl-33737057

ABSTRACT

BACKGROUND: While survival after acute myocardial infarction has improved substantially, older adults remain at heightened risk for hospital readmissions and death. Evidence for the role of cognitive impairment in older myocardial infarction survivors' risk for these outcomes is limited. METHODS: 3041 patients aged ≥75 years hospitalized with acute myocardial infarction (mean age 82 ± 5 years, 56% male) recruited from 94 US hospitals. Cognition was assessed using the Telephone Interview for Cognitive Status; scores of <27 and <22 indicated mild and moderate/severe impairment, respectively. Readmissions and death at 6 months post-discharge were ascertained via participant report and medical record review. Associations between cognition and outcomes were evaluated with multivariable-adjusted logistic regression. RESULTS: Mild and moderate/severe cognitive impairment were present in 11% and 6% of the cohort, respectively. Readmission and death at 6 months occurred in 41% and 9% of participants, respectively. Mild and moderate/severe cognitive impairment were associated with increased risk of readmission (odds ratio [OR] 1.36; 95% confidence interval [CI], 1.08-1.72 and OR 1.58; 95% CI, 1.18-2.12, respectively) and death (OR 2.19; 95% CI, 1.54-3.11 and OR 3.82; 95% CI, 2.63-5.56, respectively) in unadjusted analyses. Significant associations between moderate/severe cognitive impairment and death (OR 1.69; 95% CI, 1.10-2.59) persisted after adjustment for demographics, myocardial infarction characteristics, comorbidity burden, functional status, and depression, but not for readmissions. CONCLUSIONS: Moderate-to-severe cognitive impairment is associated with heightened risk of death in older acute myocardial infarction patients in the months after hospitalization, but not with readmission. Routine cognitive screening may identify older myocardial infarction survivors at risk for poor outcomes who may benefit from closer oversight and support in the post-discharge period.


Subject(s)
Cognition/physiology , Myocardial Infarction/diagnosis , Myocardial Infarction/therapy , Outcome Assessment, Health Care/statistics & numerical data , Aged , Aged, 80 and over , Female , Hospitalization/statistics & numerical data , Humans , Logistic Models , Longitudinal Studies , Male , Myocardial Infarction/complications , Odds Ratio , Outcome Assessment, Health Care/methods , Prospective Studies , Risk Factors
13.
Mil Med ; 186(Suppl 1): 70-75, 2021 01 25.
Article in English | MEDLINE | ID: mdl-33499543

ABSTRACT

INTRODUCTION: Within the population of military service members and veterans, chronic pain is highly prevalent, often complex, and frequently related to traumatic experiences that are more likely to occur to members of this demographic, such as individuals with traumatic brain injury or limb loss. In September 2017, the National Institutes of Health (NIH), Department of Defense (DOD), and Department of Veterans Affairs (VA) Pain Management Collaboratory (PMC) was formed as a significant and innovative inter-government agency partnership to support a multicomponent research initiative focusing on nonpharmacological approaches for pain management addressing the needs of service members, their dependents, and veterans. METHODS: A Pain Management Collaboratory Coordinating Center (PMC3) was also established to facilitate collective learning across 11 individually funded pragmatic clinical trials (PCTs) designed to optimize the impact of the PMC as an integrated whole. Although the DOD and VA health care systems are ideal sites for the enactment of PCTs, executing these trials within the local context of DOD military treatment facilities (MTFs) can present unique challenges. The Military Treatment Facility Engagement Committee (MTFEC) was created to support the efforts of the PMC3 in its role as a national resource for development and refinement of innovative tools, best practices, and other resources in the conduct of high impact PCTs. RESULTS: The MTFEC is composed of experts from each service who bring experiences in executing clinical pain management trials that can enhance the planning and execution of the PCTs. It provides expertise and leadership in the execution of research studies at within MTFs and within the DOD health care system, with guidance from PMC3 Directors and in collaboration with NIH, DOD, and VA program and scientific officers. DISCUSSION/CONCLUSION: Considering the importance of enacting large-scale, pragmatic studies to implement effective strategies in clinical practice for chronic pain management, the MTFEC has begun to actualize its purpose by identifying potential barriers and challenges to study implementation and exploring how the PMC can support and aid in the execution of PCTs by applying similar approaches to stakeholder and subject matter engagement for their research.


Subject(s)
Military Health Services , Chronic Pain , Humans , Pain Management , United States , United States Department of Veterans Affairs , Veterans
14.
Open Heart ; 8(1)2021 01.
Article in English | MEDLINE | ID: mdl-33452007

ABSTRACT

OBJECTIVE: To develop a 180-day readmission risk model for older adults with acute myocardial infarction (AMI) that considered a broad range of clinical, demographic and age-related functional domains. METHODS: We used data from ComprehenSIVe Evaluation of Risk in Older Adults with AMI (SILVER-AMI), a prospective cohort study that enrolled participants aged ≥75 years with AMI from 94 US hospitals. Participants underwent an in-hospital assessment of functional impairments, including cognition, vision, hearing and mobility. Clinical variables previously shown to be associated with readmission risk were also evaluated. The outcome was 180-day readmission. From an initial list of 72 variables, we used backward selection and Bayesian model averaging to derive a risk model (N=2004) that was subsequently internally validated (N=1002). RESULTS: Of the 3006 SILVER-AMI participants discharged alive, mean age was 81.5 years, 44.4% were women and 10.5% were non-white. Within 180 days, 1222 participants (40.7%) were readmitted. The final risk model included 10 variables: history of chronic obstructive pulmonary disease, history of heart failure, initial heart rate, first diastolic blood pressure, ischaemic ECG changes, initial haemoglobin, ejection fraction, length of stay, self-reported health status and functional mobility. Model discrimination was moderate (0.68 derivation cohort, 0.65 validation cohort), with good calibration. The predicted readmission rate (derivation cohort) was 23.0% in the lowest quintile and 65.4% in the highest quintile. CONCLUSIONS: Over 40% of participants in our sample experienced hospital readmission within 180 days of AMI. Our final readmission risk model included a broad range of characteristics, including functional mobility and self-reported health status, neither of which have been previously considered in 180-day risk models.


Subject(s)
Myocardial Infarction/therapy , Patient Readmission/trends , Risk Assessment/methods , Aged, 80 and over , Female , Follow-Up Studies , Humans , Incidence , Male , Myocardial Infarction/epidemiology , Prospective Studies , Risk Factors , Time Factors , United States/epidemiology
16.
Trials ; 21(1): 1021, 2020 Dec 11.
Article in English | MEDLINE | ID: mdl-33308289

ABSTRACT

BACKGROUND: The Pain Management Collaboratory (PMC) is a multi-site network of pragmatic clinical trials (PCTs) focused on nonpharmacological approaches to pain management, conducted in health care systems of the US Department of Defense (DoD) and Department of Veterans Affairs (VA) and co-funded by the National Institutes of Health (NIH). Concerns about potential research-site overlap prompted the PMC investigator community to consider strategies to avert this problem that could negatively affect recruitment and contaminate interventions and thus pose a threat to trial integrity. METHODS: We developed a two-step strategy to identify and remediate research-site overlap by obtaining detailed recruitment plans across all PMC PCTs that addressed eligibility criteria, recruitment methods, trial settings, and timeframes. The first, information-gathering phase consisted of a 2-month period for data collection from PIs, stakeholders, and ClinicalTrials.gov . The second, remediation phase consisted of a series of moderated conference calls over a 1-month time period to develop plans to address overlap. Remediation efforts focused on exclusion criteria and recruitment strategies, and they involved collaboration with sponsors and stakeholder groups such as the Military Treatment Facility Engagement Committee (MTFEC). The MTFEC is comprised of collaborating DoD and university-affiliated PIs, clinicians, and educators devoted to facilitating successful pragmatic trials in DoD settings. RESULTS: Of 61 recruitment sites for the 11 PMC PCTs, 17 (28%) overlapped. Four PCTs had five overlapping Military Treatment Facilities (MTFs), and eight PCTs had 12 overlapping VA Medical Centers (VAMCs). We developed three general strategies to avoid research-site overlap: (i) modify exclusion criteria, (ii) coordinate recruitment efforts, and/or (iii) replace or avoid any overlapping sites. Potential overlap from competing studies outside of the PMC was apparent at 26 sites, but we were not able to confirm them as true conflicts. CONCLUSION: Proactive strategies can be used to resolve the issue of overlapping research sites in the PMC. These strategies, combined with open and impartial mediation approaches that include researchers, sponsors, and stakeholders, provide lessons learned from this large and complex pragmatic research effort.


Subject(s)
National Institutes of Health (U.S.) , Pain Management , Delivery of Health Care , Humans , United States
17.
J Am Heart Assoc ; 9(19): e015555, 2020 10 20.
Article in English | MEDLINE | ID: mdl-33000681

ABSTRACT

Background Functional decline (ie, a decrement in ability to perform everyday activities necessary to live independently) is common after acute myocardial infarction (AMI) and associated with poor long-term outcomes; yet, we do not have a tool to identify older AMI survivors at risk for this important patient-centered outcome. Methods and Results We used data from the prospective SILVER-AMI (Comprehensive Evaluation of Risk Factors in Older Patients With Acute Myocardial Infarction) study of 3041 patients with AMI, aged ≥75 years, recruited from 94 US hospitals. Participants were assessed during hospitalization and at 6 months to collect data on demographics, geriatric impairments, psychosocial factors, and activities of daily living. Clinical variables were abstracted from the medical record. Functional decline was defined as a decrement in ability to independently perform essential activities of daily living (ie, bathing, dressing, transferring, and ambulation) from baseline to 6 months postdischarge. The mean age of the sample was 82±5 years; 57% were men, 90% were White, and 13% reported activity of daily living decline at 6 months postdischarge. The model identified older age, longer hospital stay, mobility impairment during hospitalization, preadmission physical activity, and depression as risk factors for decline. Revascularization during AMI hospitalization and ability to walk a quarter mile before AMI were associated with decreased risk. Model discrimination (c=0.78) and calibration were good. Conclusions We identified a parsimonious model that predicts risk of activity of daily living decline among older patients with AMI. This tool may aid in identifying older patients with AMI who may benefit from restorative therapies to optimize function after AMI.


Subject(s)
Activities of Daily Living , Myocardial Infarction/complications , Aged , Aged, 80 and over , Hospitalization , Humans , Male , Models, Statistical , Prospective Studies , Risk Assessment , Risk Factors
18.
J Comorb ; 10: 2235042X20940493, 2020.
Article in English | MEDLINE | ID: mdl-32728552

ABSTRACT

Older patients presenting with acute myocardial infarction (AMI) often have comorbidities. Our objective was to examine how outcomes differ by cognitive and vision status in older AMI patients. We use data from a prospective cohort study conducted at 94 hospitals in the United States between January 2013 and October 2016 that enrolled men and women aged ≥75 years with AMI. Cognitive impairment (CI) was defined as telephone interview for cognitive status (TICS) score <27; vision impairment (VI) and activities of daily living (ADLs) were assessed by questionnaire. Of 2988 senior AMI patients, 260 (8.7%) had CI but no VI, 858 (28.7%) had VI but no CI, and 251 (8.4%) had both CI/VI. Patients in the VI/CI group were most likely to exhibit geriatric syndromes. More severe VI was associated with lower (worse) scores on the TICS (ß -1.53, 95% confidence interval (CI) -1.87 to -1.18). In adjusted models, compared to participants with neither impairment, participants with VI/CI were more likely to die (hazard ratio 1.61, 95% CI 1.10-2.37) and experience ADL decline (odds ratio 2.11, 95% CI 1.39-3.21) at 180 days. Comorbid CIs and VIs were associated with high rates of death and worsening disability after discharge among seniors hospitalized for AMI. Future research should evaluate protocols to accommodate these impairments during AMI presentations and optimize decision-making and outcomes.

19.
Ann Intern Med ; 172(1): 12-21, 2020 01 07.
Article in English | MEDLINE | ID: mdl-31816630

ABSTRACT

Background: Older adults with acute myocardial infarction (AMI) have higher prevalence of functional impairments, including deficits in cognition, strength, and sensory domains, than their younger counterparts. Objective: To develop and evaluate the prognostic utility of a risk model for 6-month post-AMI mortality in older adults that incorporates information about functional impairments. Design: Prospective cohort study. (ClinicalTrials.gov: NCT01755052). Setting: 94 hospitals throughout the United States. Participants: 3006 persons aged 75 years or older who were hospitalized with AMI and discharged alive. Measurements: Functional impairments were assessed during hospitalization via direct measurement (cognition, mobility, muscle strength) or self-report (vision, hearing). Clinical variables associated with mortality in prior risk models were ascertained by chart review. Seventy-two candidate variables were selected for inclusion, and backward selection and Bayesian model averaging were used to derive (n = 2004 participants) and validate (n = 1002 participants) a model for 6-month mortality. Results: Participants' mean age was 81.5 years, 44.4% were women, and 10.5% were nonwhite. There were 266 deaths (8.8%) within 6 months. The final risk model included 15 variables, 4 of which were not included in prior risk models: hearing impairment, mobility impairment, weight loss, and lower patient-reported health status. The model was well calibrated (Hosmer-Lemeshow P > 0.05) and showed good discrimination (area under the curve for the validation cohort = 0.84). Adding functional impairments significantly improved model performance, as evidenced by category-free net reclassification improvement indices of 0.21 (P = 0.008) for hearing impairment and 0.26 (P < 0.001) for mobility impairment. Limitation: The model was not externally validated. Conclusion: A newly developed model for 6-month post-AMI mortality in older adults was well calibrated and had good discriminatory ability. This model may be useful in decision making at hospital discharge. Primary Funding Source: National Heart, Lung, and Blood Institute of the National Institutes of Health.


Subject(s)
Myocardial Infarction/mortality , Activities of Daily Living , Acute Disease , Aged , Aged, 80 and over , Female , Hospitalization/statistics & numerical data , Humans , Male , Myocardial Infarction/diagnosis , Prognosis , Prospective Studies , Risk Factors , United States/epidemiology
20.
Circ Cardiovasc Qual Outcomes ; 12(10): e005691, 2019 10.
Article in English | MEDLINE | ID: mdl-31607145

ABSTRACT

BACKGROUND: Studies of sex-based differences in older adults with acute myocardial infarction (AMI) have yielded mixed results. We, therefore, sought to evaluate sex-based differences in presentation characteristics, treatments, functional impairments, and in-hospital complications in a large, well-characterized population of older adults (≥75 years) hospitalized with AMI. METHODS AND RESULTS: We analyzed data from participants enrolled in SILVER-AMI (Comprehensive Evaluation of Risk Factors in Older Patients With Acute Myocardial Infarction)-a prospective observational study consisting of 3041 older patients (44% women) hospitalized for AMI. Participants were stratified by AMI subtype (ST-segment-elevation myocardial infarction [STEMI] and non-STEMI [NSTEMI]) and subsequently evaluated for sex-based differences in clinical presentation, functional impairments, management, and in-hospital complications. Among the study sample, women were slightly older than men (NSTEMI: 82.1 versus 81.3, P<0.001; STEMI: 82.2 versus 80.6, P<0.001) and had lower rates of prior coronary disease. Women in the NSTEMI subgroup presented less frequently with chest pain as their primary symptom. Age-associated functional impairments at baseline were more common in women in both AMI subgroups (cognitive impairment, NSTEMI: 20.6% versus 14.3%, P<0.001; STEMI: 20.6% versus 12.4%, P=0.001; activities of daily living disability, NSTEMI: 19.7% versus 11.4%, P<0.001; STEMI: 14.8% versus 6.4%, P<0.001; impaired functional mobility, NSTEMI: 44.5% versus 30.7%, P<0.001; STEMI: 39.4% versus 22.0%, P<0.001). Women with AMI had lower rates of obstructive coronary disease (NSTEMI: P<0.001; STEMI: P=0.02), driven by lower rates of 3-vessel or left main disease than men (STEMI: 38.8% versus 58.7%; STEMI: 24.3% versus 32.1%), and underwent revascularization less commonly (NSTEMI: 55.6% versus 63.6%, P<0.001; STEMI: 87.3% versus 93.3%, P=0.01). Rates of bleeding were higher among women with STEMI (26.2% versus 15.6%, P<0.001) but not NSTEMI (17.8% versus 15.7%, P=0.21). Women had a higher frequency of bleeding following percutaneous coronary intervention with both NSTEMI (11.0% versus 7.8%, P=0.04) and STEMI (22.6% versus 14.8%, P=0.02). CONCLUSIONS: Among older adults hospitalized with AMI, women had a higher prevalence of age-related functional impairments and, among the STEMI subgroup, a higher incidence of overall bleeding events, which was driven by higher rates of nonmajor bleeding events and bleeding following percutaneous coronary intervention. These differences may have important implications for in-hospital and posthospitalization needs.


Subject(s)
Health Status Disparities , Healthcare Disparities , Myocardial Revascularization , Non-ST Elevated Myocardial Infarction/epidemiology , Non-ST Elevated Myocardial Infarction/therapy , Patient Admission , ST Elevation Myocardial Infarction/epidemiology , ST Elevation Myocardial Infarction/therapy , Age Factors , Aged , Aged, 80 and over , Comorbidity , Disability Evaluation , Female , Humans , Life Style , Male , Myocardial Revascularization/adverse effects , Non-ST Elevated Myocardial Infarction/diagnosis , Prevalence , Prospective Studies , Risk Assessment , Risk Factors , ST Elevation Myocardial Infarction/diagnosis , Sex Factors , Social Determinants of Health , Time Factors , Treatment Outcome , United States/epidemiology
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