Recommendations for monitoring adherence and fidelity in pragmatic trials based on experience in the Pain Management Collaboratory.

Objective: Most pragmatic trials follow the PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) criteria. The criteria specify unobtrusive measurement of participants' protocol adherence and practitioners' intervention fidelity but suggest no special monitoring strategies to assure trial integrity. We present experience with adherence/fidelity monitoring in the Pain Management Collaboratory (PMC) and provide recommendations for their monitoring in pragmatic trials to preserve inferences of treatment comparisons.

In-Hospital Delirium and Disability and Cognitive Impairment After COVID-19 Hospitalization.

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.

Associations of Social Support With Physical and Mental Health Symptom Burden After COVID-19 Hospitalization Among Older Adults.

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.

Rationale, Design, and Characteristics of the VALIANT (COVID-19 in Older Adults: A Longitudinal Assessment) Cohort.

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.

Factors Associated With Cardiac Rehabilitation Participation in Older Adults After Myocardial Infarction: THE SILVER-AMI STUDY.

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.

Optimizing the Impact of Pragmatic Clinical Trials for Veteran and Military Populations: Lessons From the Pain Management Collaboratory.

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.

Assessing the impact of the COVID-19 pandemic on pragmatic clinical trial participants.

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.

Development and Validation of a Risk Prediction Model for 1-Year Readmission Among Young Adults Hospitalized for Acute Myocardial Infarction.

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).

Falls in older adults after hospitalization for acute myocardial infarction.

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.

The association of neighborhood walkability with health outcomes in older adults after acute myocardial infarction: The SILVER-AMI study.

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.

Presentation, Treatment, and Outcomes of Older Adults Hospitalized for Acute Myocardial Infarction According to Cognitive Status: The SILVER-AMI Study.

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.

Development and Implementation of the Military Treatment Facility Engagement Committee (MTFEC) to Support Pragmatic Clinical Trials in the Military Health System.

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.

180-day readmission risk model for older adults with acute myocardial infarction: the SILVER-AMI study.

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.

Strategy for addressing research-site overlap in pragmatic clinical trials: lessons learned from the NIH-DOD-VA Pain Management Collaboratory (PMC).

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.

Risk Model for Decline in Activities of Daily Living Among Older Adults Hospitalized With Acute Myocardial Infarction: The SILVER-AMI Study.

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.

Comorbid vision and cognitive impairments in older adults hospitalized for acute myocardial infarction.

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.

Predicting 6-Month Mortality for Older Adults Hospitalized With Acute Myocardial Infarction: A Cohort Study.

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.

Sex-Based Differences in Presentation, Treatment, and Complications Among Older Adults Hospitalized for Acute Myocardial Infarction: The SILVER-AMI Study.

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.

Association Between Mobility Measured During Hospitalization and Functional Outcomes in Older Adults With Acute Myocardial Infarction in the SILVER-AMI Study.

Importance: Many older survivors of acute myocardial infarction (AMI) experience functional decline, an outcome of primary importance to older adults. Mobility impairment has been proposed as a risk factor for functional decline but has not been evaluated to date in older patients hospitalized for AMI.

Objective: To examine the association of mobility impairment, measured during hospitalization, as a risk marker for functional decline among older patients with AMI.

Association of Patient Priorities-Aligned Decision-Making With Patient Outcomes and Ambulatory Health Care Burden Among Older Adults With Multiple Chronic Conditions: A Nonrandomized Clinical Trial.

Importance: Health care may be burdensome and of uncertain benefit for older adults with multiple chronic conditions (MCCs). Aligning health care with an individual's health priorities may improve outcomes and reduce burden.

Objective: To evaluate whether patient priorities care (PPC) is associated with a perception of more goal-directed and less burdensome care compared with usual care (UC).