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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background/Objectives Timely administration of antiischemic therapies improves outcomes in individuals with acute myocardial infarction ( AMI). Prior literature on delays in AMI care has largely focused on in-hospital delay ('door to balloon' time). Our objective was to identify factors associated with prehospital delay in a contemporary national cohort of older adults with AMI. Design Cross-sectional analysis of data from the Comprehen SIVe Evaluation of Risk Factors in Older Patients with Acute Myocardial Infarction ( SILVER- AMI) study, an observational study of older adults hospitalized for AMI. Setting U.S. academic and community hospitals (N = 94). Participants Individuals aged 75 and older hospitalized for AMI (N = 2,500). Measurements Prehospital delay was defined as symptom duration of 6 hours or longer before hospital presentation and was obtained according to participant or caregiver report during AMI hospitalization. Potential predictors of delay from demographic, clinical presentation, comorbid conditions, function, and social support domains were obtained through in-person assessment during the index hospitalization and medical record abstraction. Results Nonwhite race (adjusted odds ratio ( aOR) = 1.54, P = .002), atypical symptoms ( aOR = 1.41, P = .001), and heart failure ( HF) ( aOR = 1.35, P = .006 for HF) were significantly associated with delay. Conclusion In contrast with younger AMI populations, female sex and diabetes mellitus were not associated with delay in this older cohort, but factors from other domains (nonwhite race, atypical symptoms, and HF) were significantly associated with delay. These results can be used to customize future public health efforts to encourage early presentation for older adults with AMI. [ABSTRACT FROM AUTHOR]

Background While older adults (age 75 and over) represent a large and growing proportion of patients with acute myocardial infarction (AMI), they have traditionally been under-represented in cardiovascular studies. Although chronological age confers an increased risk for adverse outcomes, our current understanding of the heterogeneity of this risk is limited. The Comprehensive Evaluation of Risk Factors in Older Patients with AMI (SILVER-AMI) study was designed to address this gap in knowledge by evaluating risk factors (including geriatric impairments, such as muscle weakness and cognitive impairments) for hospital readmission, mortality, and health status decline among older adults hospitalized for AMI. Methods/Design SILVER-AMI is a prospective cohort study that is enrolling 3000 older adults hospitalized for AMI from a recruitment network of approximately 70 community and academic hospitals across the United States. Participants undergo a comprehensive in-hospital assessment that includes clinical characteristics, geriatric impairments, and health status measures. Detailed medical record abstraction complements the assessment with diagnostic study results, in-hospital procedures, and medications. Participants are subsequently followed for six months to determine hospital readmission, mortality, and health status decline. Multivariable regression will be used to develop risk models for these three outcomes. Discussion SILVER-AMI will fill critical gaps in our understanding of AMI in older patients. By incorporating geriatric impairments into our understanding of post-AMI outcomes, we aim to create a more personalized assessment of risk and identify potential targets for interventions. Trial registration Trial registration number: NCT01755052. [ABSTRACT FROM AUTHOR]

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 postdischarge. 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: While older adults (age 75 and over) represent a large and growing proportion of patients with acute myocardial infarction (AMI), they have traditionally been under-represented in cardiovascular studies. Although chronological age confers an increased risk for adverse outcomes, our current understanding of the heterogeneity of this risk is limited. The Comprehensive Evaluation of Risk Factors in Older Patients with AMI (SILVER-AMI) study was designed to address this gap in knowledge by evaluating risk factors (including geriatric impairments, such as muscle weakness and cognitive impairments) for hospital readmission, mortality, and health status decline among older adults hospitalized for AMI.Methods/design: SILVER-AMI is a prospective cohort study that is enrolling 3000 older adults hospitalized for AMI from a recruitment network of approximately 70 community and academic hospitals across the United States. Participants undergo a comprehensive in-hospital assessment that includes clinical characteristics, geriatric impairments, and health status measures. Detailed medical record abstraction complements the assessment with diagnostic study results, in-hospital procedures, and medications. Participants are subsequently followed for six months to determine hospital readmission, mortality, and health status decline. Multivariable regression will be used to develop risk models for these three outcomes.Discussion: SILVER-AMI will fill critical gaps in our understanding of AMI in older patients. By incorporating geriatric impairments into our understanding of post-AMI outcomes, we aim to create a more personalized assessment of risk and identify potential targets for interventions.Trial Registration: Trial Registration Number: NCT01755052 . [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Among older adults (age ≥75 years) hospitalized for acute myocardial infarction, acute kidney injury after coronary angiography is common. Aging-related conditions may independently predict acute kidney injury, but have not yet been analyzed in large acute myocardial infarction cohorts.Methods: We analyzed data from 2212 participants age ≥75 years in the Comprehensive Evaluation of Risk Factors in Older Patients with Acute Myocardial Infarction (SILVER-AMI) study who underwent coronary angiography. Acute kidney injury was defined using Kidney Disease Improving Global Outcomes (KDIGO) criteria (serum Cr increase ≥0.3 mg/dL from baseline or ≥1.5 times baseline). We analyzed the associations of traditional acute kidney injury risk factors and aging-related conditions (activities of daily living impairment, prior falls, cachexia, low physical activity) with acute kidney injury, and then performed logistic regression to identify independent predictors.Results: Participants' mean age was 81.3 years, 45.2% were female, and 9.5% were nonwhite; 421 (19.0%) experienced acute kidney injury. Comorbid diseases and aging-related conditions were both more common among individuals experiencing acute kidney injury. However, after multivariable adjustment, no aging-related conditions were retained. There were 11 risk factors in the final model; the strongest were heart failure on presentation (odds ratio [OR] 1.91; 95% confidence interval [CI], 1.41-2.59), body mass index [BMI] >30 (vs BMI 18-25: OR 1.75; 95% CI, 1.27-2.42), and nonwhite race (OR 1.65; 95% CI, 1.16-2.33). The final model achieved an area under the receiver operating characteristic curve of 0.72 and was well calibrated (Hosmer-Lemeshow P = .50). Acute kidney injury was independently associated with 6-month mortality (OR 1.98; 95% CI, 1.36-2.88) but not readmission (OR 1.26; 95% CI, 0.98-1.61).Conclusions: Acute kidney injury is common among older adults with acute myocardial infarction undergoing coronary angiography. Predictors largely mirrored those in previous studies of younger individuals, which suggests that geriatric conditions mediate their influence through other risk factors. [ABSTRACT FROM AUTHOR]

Background: Among older adults hospitalized for acute myocardial infarction (AMI) undergoing cardiac catheterization, acute kidney injury (AKI) is common and associated with poor long-term outcomes. Our aim was to identify risk factors for AKI, using both traditional clinical variables and aging-related functional impairments unmeasured in prior studies. Methods: We analyzed data from the SILVER-AMI cohort, which enrolled patients age ≥75 with AMI across 94 U.S. hospitals. Our sample included the 2212 participants who underwent cardiac catheterization. AKI was defined based on KDIGO criteria (increase in serum Cr ≥0.3 mg/dL from baseline or ≥1.5 times baseline) and severity was divided into Stage 1 (1.5-1.9x baseline), Stage 2 (≥2.0-2.9x baseline), and stage 3 (≥3.0x baseline, or dialysis). We analyzed the association of both traditional AKI risk factors and functional impairments (Table) with AKI. We subsequently performed logistic regression with backwards selection to identify independent predictors of AKI. Results: Mean age was 81.3 years, 45.2% were female, 9.5% were nonwhite, and 77.2% underwent PCI. AKI occurred among 421 participants (19.0%); most AKI (88.4%) was Stage 1. After multivariable regression, 10 risk factors remained independent predictors of AKI (Table). The strongest predictors (adjusted) were history of heart failure (OR 1.63, 95% CI 1.23-2.17), nonwhite race (OR 1.53, 95% CI 1.08-2.16), and atrial fibrillation (OR 1.49, 95% CI 1.05-2.10). Among functional impairments analyzed, impaired mobility was the only factor independently associated with AKI (OR 1.39, 95% CI 1.24-1.56). At 6 months, AKI was associated with both mortality (14.5% vs. 5.4%, P<0.001) and hospital readmission (53.3% vs. 36.1%, P<0.001). Conclusions: AKI is common among older adults with AMI undergoing cardiac catheterization; most cases are mild. While traditional risk factors are strong predictors of AKI, mobility is also independently predictive, potentially due to its close association with the frailty syndrome. This suggests the potential utility of mobility in risk stratification among older adults. [ABSTRACT FROM AUTHOR]

Background: Readmissions among older adults hospitalized for acute myocardial infarction (AMI) are costly, disruptive, and difficult to predict. Aging-related functional impairments may improve risk prediction, but have not been measured in most studies. Our objective was therefore to develop a readmission risk model for older adults hospitalized for AMI that considered functional impairments. Methods: SILVER-AMI is a prospective cohort study of 3006 patients age ≥75 hospitalized with AMI at 96 U.S. hospitals. Participants underwent in-hospital assessment of functional impairments including cognition, vision, hearing, and mobility. Clinical variables traditionally associated with readmission risk, as well as patient reported health status, were also collected. The outcome was all-cause readmission at 30 days. We used backward selection and Bayesian model averaging to derive (N=2004) a risk model that was subsequently validated in a separate sample (N=1002). Model discrimination and calibration were respectively evaluated with the C-statistic and the Hosmer-Lemeshow test. Results: Mean age was 81.5 years, 44.4% were women, and 10.5% were nonwhite. Within 30 days, 547 participants (18.2%) experienced readmission (61.0% cardiac cause). Participants who were readmitted were older, had more comorbidities, and had a higher prevalence of functional impairments including activity of daily living disability (17.0% vs. 13.0%, P=0.01), weak grip strength (64.4% vs. 59.2%, P<0.01), and impaired mobility measured by Timed Up and Go (TUG) (72.5% vs. 53.6%, P<0.001). The final readmission risk model contained 8 variables; mobility was the only functional impairment retained, but was the strongest predictor (Figure). The model was well calibrated (P value >0.05 for Hosmer-Lemeshow statistic) and had moderate discrimination (C-statistic: 0.65 derivation cohort, 0.63 validation cohort) across all multiply imputed datasets. Conclusion: In our final risk model, functional mobility was the strongest predictor of 30-day readmission among older adults after AMI. The modest C-statistic indicates that much of the variability in readmission among this older adult population remains unexplained by patient-level factors. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Patient Health Priorities Identification (PHPI) is a values‐based process in which trained facilitators assist older adults with multiple chronic conditions identify their health priorities. The purpose of this study was to evaluate patients' perceptions of PHPI. DESIGN: Qualitative study using thematic analysis. SETTING: In‐depth semistructured telephone and in‐person interviews. PARTICIPANTS: Twenty‐two older adults who participated in the PHPI process. MEASUREMENTS: Open‐ended questions about patient perceptions of the PHPI process, perceived benefits of the process, enablers and barriers to PHPI, and recommendations for process enhancement. RESULTS: Patient interviews ranged from 9 to 63 minutes (median = 20 min; interquartile range = 15–26). The mean age was 80 years (standard deviation = 7.96), 64% were female, and all patients identified themselves as white. Of the sample, 73% reported no caregiver involvement in their healthcare; 36% lived alone. Most patients felt able to complete the PHPI process with ease. Perceived benefits included increased knowledge and insight into disease processes and treatment options, patient activation, and enhanced communication with family and clinicians. Patients identified several factors that were both enablers and barriers to PHPI including facilitator characteristics, patient demographic and clinical characteristics, social support, relationships between the patient and their primary care provider, and the changing health priorities of the patient. Recommendations for process enhancement included more frequent and flexible facilitator contacts, selection of patients for participation based on specific patient characteristics, clarification of process aims and expectations, involvement of family, written reminders of established health priorities, short duration between facilitation and primary care provider follow‐up, and the inclusion of health‐related tasks in facilitation visits. CONCLUSIONS: Patients found the PHPI process valuable in identifying actionable health priorities and healthcare goals leading to enhanced knowledge, activation, and communication regarding their treatment options and preferences. PHPI may be useful for aligning the healthcare that patients receive with their values‐based priorities. [ABSTRACT FROM AUTHOR]

Objectives: While patients’ health priorities should inform healthcare, strategies for doing so are lacking for patients with multiple conditions. We describe challenges to, and strategies that support, patients’ priorities-aligned decision-making. Design: Participant observation qualitative study. Setting: Primary care and cardiology practices in Connecticut. Participants: Ten primary care clinicians, five cardiologists, and the Patient Priorities implementation team (four geriatricians, physician expert in clinician training, behavioral medicine expert). The patients discussed were ≥ 66 years with >3 chronic conditions and ≥10 medications or saw ≥ two specialists. Exposure: Following initial training and experience in providing Patient Priorities Care, the clinicians and Patient Priorities implementation team participated in 21 case-based, group discussions (10 face-to-face;11 telephonic). Using emergent learning (i.e. learning which arises from interactions among the participants), participants discussed challenges, posed solutions, and worked together to determine how to align care options with the health priorities of 35 patients participating in the Patient Priorities Care pilot. Main outcomes: Challenges to, and strategies for, aligning decision-making with patient’s health priorities. Results: Categories of challenges discussed among participants included uncertainty, complexity, and multiplicity of problems and treatments; difficulty switching to patients’ priorities as the focus of decision-making; and differing perspectives between patients and clinicians, and among clinicians. Strategies identified to support patient priorities-aligned decision-making included starting with one thing that matters most to each patient; conducting serial trials of starting, stopping, or continuing interventions; focusing on function (i.e. achieving patient’s desired activities) rather than eliminating symptoms; basing communications, decision-making, and effectiveness on patients’ priorities not solely on diseases; and negotiating shared decisions when there are differences in perspectives. Conclusions: The discrete set of challenges encountered and the implementable strategies identified suggest that patient priorities-aligned decision-making in the care of patients with multiple chronic conditions is feasible, albeit complicated. Findings require replication in additional settings and determination of their effect on patient outcomes. [ABSTRACT FROM AUTHOR]

Older adults with multiple chronic conditions (MCCs) receive care that is fragmented and burdensome, lacks evidence, and most importantly is not focused on what matters most to them. An implementation feasibility study of Patient Priorities Care (PPC), a new approach to care that is based on health outcome goals and healthcare preferences, was conducted. This study took place at 1 primary care and 1 cardiology practice in Connecticut and involved 9 primary care providers (PCPs), 5 cardiologists, and 119 older adults with MCCs. PPC was implemented using methods based on a practice change framework and continuous plan‐do‐study‐act (PDSA) cycles. Core elements included leadership support, clinical champions, priorities facilitators, training, electronic health record (EHR) support, workflow development and continuous modification, and collaborative learning. PPC processes for clinic workflow and decision‐making were developed, and clinicians were trained. After 10 months, 119 older adults enrolled and had priorities identified; 92 (77%) returned to their PCP after priorities identification. In 56 (46%) of these visits, clinicians documented patient priorities discussions. Workflow challenges identified and solved included patient enrollment lags, EHR documentation of priorities discussions, and interprofessional communication. Time for clinicians to provide PPC remains a challenge, as does decision‐making, including clinicians' perceptions that they are already doing so; clinicians' concerns about guidelines, metrics, and unrealistic priorities; and differences between PCPs and patients and between PCPs and cardiologists about treatment decisions. PDSA cycles and continuing collaborative learning with national experts and peers are taking place to address workflow and clinical decision‐making challenges. Translating disease‐based to priorities‐aligned decision‐making appears challenging but feasible to implement in a clinical setting. See related editorial by William B. Applegate et al. [ABSTRACT FROM AUTHOR]

Objectives: To develop a values‐based, clinically feasible process to help older adults identify health priorities that can guide clinical decision‐making. Design: Prospective development and feasibility study. Setting: Primary care practice in Connecticut. Participants: Older adults with 3 or more conditions or taking 10 or more medications (N=64). Intervention: The development team of patients, caregivers, and clinicians used a user‐centered design framework—ideate → prototype → test →redesign—to develop and refine the value‐based patient priorities care process and medical record template with trained clinician facilitators. Measurements: We used descriptive statistics of quantitative measures (percentage accepted invitation and completed template, duration of process) and qualitative analysis of barriers and enablers (challenges and solutions identified, facilitator perceptions). Results: We developed and refined a process for identifying patient health priorities that was typically completed in 35 to 45 minutes over 2 sessions; 64 patients completed the process. Qualitative analyses were used to elucidate the characteristics and training needed for the patient priorities facilitators, as well as perceived benefits and challenges of the process. Refinements based on our experience and feedback include streamlining the process for greater feasibility, balancing fidelity to the process while customizing to individuals, encouraging patients to share their priorities with their clinicians, and simplifying the template transmitted to clinicians. Conclusion: Trained facilitators conducted this process in a busy primary care practice, suggesting that patient priorities identification is feasible and acceptable, although testing in additional settings is necessary. We hope to show that clinicians can align care with patients' health priorities. See related editorial by William B. Applegate et al [ABSTRACT FROM AUTHOR]

The authors report on the use of a Patient Priorities Care (PPC) approach to medical care for older patients with multiple chronic conditions. They discuss the use of PPC in clinical care, the perceived benefits and difficulties of discussing priorities with the patient, and how the clinicians felt about the process.

Background: Differences between sexes in cardiac risk factors, perceptions of cardiac risk, and health care provider discussions about risk among young patients with acute myocardial infarction (AMI) are not well studied.Objectives: This study compared cardiac risk factor prevalence, risk perceptions, and health care provider feedback on heart disease and risk modification between young women and men hospitalized with AMI.Methods: We studied 3,501 AMI patients age 18 to 55 years enrolled in the VIRGO (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients) study in U.S. and Spanish hospitals between August 2008 and January 2012, comparing the prevalence of 5 cardiac risk factors by sex. Modified Poisson regression was used to assess sex differences in self-perceived heart disease risk and self-reported provider discussions of risk and modification.Results: Nearly all patients (98%) had ≥1 risk factor, and 64% had ≥3. Only 53% of patients considered themselves at risk for heart disease, and even fewer reported being told they were at risk (46%) or that their health care provider had discussed heart disease and risk modification (49%). Women were less likely than men to be told they were at risk (relative risk: 0.89; 95% confidence interval: 0.84 to 0.96) or to have a provider discuss risk modification (relative risk: 0.84; 95% confidence interval: 0.79 to 0.89). There was no difference between women and men for self-perceived risk.Conclusions: Despite having significant cardiac risk factors, only one-half of young AMI patients believed they were at risk for heart disease before their event. Even fewer discussed their risks or risk modification with their health care providers; this issue was more pronounced among women. [ABSTRACT FROM AUTHOR]

Excess dosing of anticoagulant agents has been linked to increased risk of bleeding after percutaneous coronary intervention (PCI) for women compared with men, but these studies have largely included older patients. We sought to determine the prevalence and gender-based differences of excess dosing of anticoagulants including glycoprotein IIb/IIIa inhibitors, bivalirudin, and unfractionated heparin in young patients with acute myocardial infarction who underwent PCI and to examine its association with bleeding. Of 2,076 patients enrolled in the Variation in Recovery: Role of Gender on Outcomes of Young Acute Myocardial Infarction Patients study who underwent PCI, we abstracted doses of unfractionated heparin, bivalirudin, and glycoprotein IIb/IIIa inhibitors administered during PCI from the medical records. At least 47.2% received at least 1 excess dose of an anticoagulant, which did not differ by gender. We used logistic regression to determine the predictors of excess dosing and the association of excess dosing with bleeding. In multivariable analysis, only lower body weight and younger age were significant predictors of excess dosing. Bleeding was higher in young women who received excess dosing versus those who did not (9.3% vs 6.0%, p = 0.03) but was comparable among men (5.2% vs 5.9%, p = 0.69) in univariate analysis. In multivariable analysis, there was a trend to an association between excess dosing and bleeding (odds ratio 1.33, 95% confidence interval 0.92 to 1.91) although not statistically significant. In conclusion, approximately half of the patients received excess dosing of anticoagulant drugs during PCI, which did not vary based on gender. There was a trend toward an association between excess dosing and increased bleeding, although not statistically significant. [ABSTRACT FROM AUTHOR]

Background: Sex disparities in reperfusion therapy for patients with acute ST-segment-elevation myocardial infarction have been documented. However, little is known about whether these patterns exist in the comparison of young women with men.Methods and Results: We examined sex differences in rates, types of reperfusion therapy, and proportion of patients exceeding American Heart Association reperfusion time guidelines for ST-segment-elevation myocardial infarction in a prospective observational cohort study (2008-2012) of 1465 patients 18 to 55 years of age, as part of the US Variations in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study at 103 hospitals enrolling in a 2:1 ratio of women to men. Of the 1238 patients eligible for reperfusion, women were more likely to be untreated than men (9% versus 4%, P=0.002). There was no difference in reperfusion strategy for the 695 women and 458 men treated. Women were more likely to exceed in-hospital and transfer time guidelines for percutaneous coronary intervention than men (41% versus 29%; odds ratio, 1.65; 95% confidence interval, 1.27-2.16), more so when transferred (67% versus 44%; odds ratio, 2.63; 95% confidence interval, 1.17-4.07); and more likely to exceed door-to-needle times (67% versus 37%; odds ratio, 2.62; 95% confidence interval, 1.23-2.18). After adjustment for sociodemographic, clinical, and organizational factors, sex remained an important factor in exceeding reperfusion guidelines (odds ratio, 1.72; 95% confidence interval, 1.28-2.33).Conclusions: Young women with ST-segment-elevation myocardial infarction are less likely to receive reperfusion therapy and more likely to have reperfusion delays than similarly aged men. Sex disparities are more pronounced among patients transferred to percutaneous coronary intervention institutions or who received fibrinolytic therapy. [ABSTRACT FROM AUTHOR]

Background—Sex disparities in reperfusion therapy for patients with acute ST-segment-elevation myocardial infarction have been documented. However, little is known about whether these patterns exist in the comparison of young women with men. Methods and Results—We examined sex differences in rates, types of reperfusion therapy, and proportion of patients exceeding American Heart Association reperfusion time guidelines for ST-segment-elevation myocardial infarction in a prospective observational cohort study (2008-2012) of 1465 patients 18 to 55 years of age, as part of the US Variations in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study at 103 hospitals enrolling in a 2:1 ratio of women to men. Of the 1238 patients eligible for reperfusion, women were more likely to be untreated than men (9% versus 4%, P=0.002). There was no difference in reperfusion strategy for the 695 women and 458 men treated. Women were more likely to exceed in-hospital and transfer time guidelines for percutaneous coronary intervention than men (41% versus 29%; odds ratio, 1.65; 95% confidence interval, 1.27-2.16), more so when transferred (67% versus 44%; odds ratio, 2.63; 95% confidence interval, 1.17-4.07); and more likely to exceed door-to-needle times (67% versus 37%; odds ratio, 2.62; 95% confidence interval, 1.23-2.18). After adjustment for sociodemographic, clinical, and organizational factors, sex remained an important factor in exceeding reperfusion guidelines (odds ratio, 1.72; 95% confidence interval, 1.28-2.33). Conclusions—Young women with ST-segment-elevation myocardial infarction are less likely to receive reperfusion therapy and more likely to have reperfusion delays than similarly aged men. Sex disparities are more pronounced among patients transferred to percutaneous coronary intervention institutions or who received fibrinolytic therapy. [ABSTRACT FROM AUTHOR]

Background--Younger age and female sex are both associated with greater mental stress in the general population, but limited data exist on the status of perceived stress in young and middle-aged patients presenting with acute myocardial infarction. Methods and Results--We examined sex difference in stress, contributing factors to this difference, and whether this difference helps explain sex-based disparities in 1-month recovery using data from 3572 patients with acute myocardial infarction (2397 women and 1175 men) 18 to 55 years of age. The average score of the 14-item Perceived Stress Scale at baseline was 23.4 for men and 27.0 for women (P<0.001). Higher stress in women was explained largely by sex differences in comorbidities, physical and mental health status, intrafamily conflict, caregiving demands, and financial hardship. After adjustment for demographic and clinical characteristics, women had worse recovery than men at 1 month after acute myocardial infarction, with mean differences in improvement score between women and men ranging from -0.04 for EuroQol utility index to -3.96 for angina-related quality of life (P<0.05 for all). Further adjustment for baseline stress reduced these sex-based differences in recovery to -0.03 to -3.63, which, however, remained statistically significant (P<0.05 for all). High stress at baseline was associated with significantly worse recovery in angina-specific and overall quality of life, as well as mental health status. The effect of baseline stress on recovery did not vary between men and women. Conclusions--Among young and middle-aged patients, higher stress at baseline is associated with worse recovery in multiple health outcomes after acute myocardial infarction. Women perceive greater psychological stress than men at baseline, which partially explains women's worse recovery. [ABSTRACT FROM AUTHOR]

The article discusses the depression treatment and health status outcomes in young patients with acute myocardial infarction (AMI) and presents study on same. Topics include continued antidepressant medications and depression counseling received by patients; measuring treatment effects with random effects for marital status, diabetes mellitus, and heart failure; and higher depression rates in women among AMI survivors.

Background: Various national campaigns launched in recent years have focused on young women with acute myocardial infarctions (AMIs). Contemporary longitudinal data about sex differences in clinical characteristics, hospitalization rates, length of stay (LOS), and mortality have not been examined. Objectives: This study sought to determine sex differences in clinical characteristics, hospitalization rates, LOS, and in-hospital mortality by age group and race among young patients with AMIs using a large national dataset of  U.S. hospital discharges. Methods: Using the National Inpatient Sample, clinical characteristics, AMI hospitalization rates, LOS, and in-hospital mortality were compared for patients with AMI across ages 30 to 54 years, dividing them into 5-year subgroups from 2001 to 2010, using survey data analysis techniques. Results: A total of 230,684 hospitalizations were identified with principal discharge diagnoses of AMI in 30- to 54-year-old patients from Nationwide Inpatient Sample data, representing an estimated 1,129,949 hospitalizations in the United States from 2001 to 2010. No statistically significant declines in AMI hospitalization rates were observed in the age groups >55 years or stratified by sex. Prevalence of comorbidities was higher in women and increased among both sexes through the study period. Women had longer LOS and higher in-hospital mortality than men across all age groups. However, observed in-hospital mortality declined significantly for women from 2001 to 2010 (from 3.3% to 2.3%, relative change 30.5%; p for trend < 0.0001) but not for men (from 2% to 1.8%, relative change 8.6%; p for trend = 0.60). Conclusions: AMI hospitalization rates for young people have not declined over the past decade. Young women with AMIs have more comorbidity, longer LOS, and higher in-hospital mortality than young men, although their mortality rates are decreasing. [ABSTRACT FROM AUTHOR]