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OBJECTIVES: To evaluate whether the effectiveness and safety of low (81 mg daily) versus high-dose (325 mg daily) aspirin is consistent across races among patients with established atherosclerotic cardiovascular disease (ASCVD). DESIGN: A secondary analysis of the randomised controlled trial ADAPTABLE was performed. SETTING: The study was conducted in 40 centres and one health plan participating in the National Patient-Centred Clinical Research Network (PCORnet) in the USA. PARTICIPANTS: Among 15 076 participants with established ASCVD, 14 096 had self-reported race available and were included in the analysis. Participants were divided according to self-reported race as Black (n=1311, 9.3%), White (n=11 990, 85.1%) or other race (n=795, 5.6%). INTERVENTIONS: Participants were randomised to open-label daily aspirin doses of 81 mg versus 325 mg in a 1:1 ratio for a median of 26.2 months. PRIMARY AND SECONDARY OUTCOMES MEASURES: The primary effectiveness endpoint was a composite of death from any cause, hospitalisation for myocardial infarction or hospitalisation for stroke. The primary safety endpoint was hospitalisation for bleeding requiring blood product transfusion. RESULTS: Estimated cumulative incidence of the primary effectiveness endpoint at median follow-up with the 81 mg and the 325 mg daily doses were 6.70% and 7.12% in White participants (adjusted HR: 1.00 [95% CI: 0.88 to 1.15]); 12.27% and 10.69% in Black participants (adjusted HR: 1.40 [95% CI: 1.02 to 1.93]); and 6.88% and 7.69% in other participants (adjusted HR: 0.86 [95% CI: 0.54 to 1.39]) (p-interaction=0.12), respectively. There was no significant interaction between self-reported race and assigned aspirin dose regarding the secondary effectiveness and the primary safety endpoints. CONCLUSION: Race is not an effect modifier on the impact of aspirin dosing on effectiveness and safety in patients with established ASCVD. In clinical practice, treatment decisions regarding aspirin dose in secondary prevention of ASCVD should not be influenced by race. TRIAL REGISTRATION NUMBER: NCT02697916.
Subject(s)
Aspirin , Atherosclerosis , Platelet Aggregation Inhibitors , Secondary Prevention , Aged , Female , Humans , Male , Middle Aged , Aspirin/administration & dosage , Aspirin/therapeutic use , Atherosclerosis/prevention & control , Cardiovascular Diseases/prevention & control , Dose-Response Relationship, Drug , Hemorrhage/chemically induced , Hospitalization/statistics & numerical data , Myocardial Infarction/prevention & control , Myocardial Infarction/ethnology , Myocardial Infarction/epidemiology , Platelet Aggregation Inhibitors/administration & dosage , Platelet Aggregation Inhibitors/therapeutic use , Secondary Prevention/methods , Stroke/prevention & control , Treatment Outcome , United States/epidemiology , White , Black or African AmericanABSTRACT
Importance: Atherosclerotic cardiovascular disease (ASCVD) remains the leading cause of morbidity and mortality in the US. Although aspirin is recommended for secondary prevention of ASCVD, there was no difference in safety and effectiveness of aspirin dosed daily at 81 mg or 325 mg in the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) randomized clinical trial. However, it is unknown whether differences by sex exist in the safety and effectiveness of the different aspirin doses. Objective: To evaluate sex-specific differences in the safety and effectiveness of 2 aspirin doses in the ADAPTAPLE trial. Design, Setting, and Participants: The ADAPTABLE study was an open-label, pragmatic, randomized clinical trial that randomly assigned participants with chronic, stable ASCVD to 81 mg vs 325 mg of aspirin daily. Using Cox proportional-hazard models, male and female participants were compared for outcomes. In addition, it was assessed whether sex was an effect modifier in the association between aspirin dose and outcomes. The ADAPTABLE trial was conducted at 40 medical centers and 1 health plan. Eligible patients were 18 years and older and had established ASCVD. Study data were analyzed from December 2021 to March 2024. Interventions: Patients received 81 mg or 325 mg of aspirin daily for the secondary prevention of ASCVD. Main Outcomes and Measures: The primary effectiveness outcomes included all-cause death and hospitalization for myocardial infarction (MI) or stroke. The primary safety outcome was hospitalization for major bleeding requiring transfusion. Results: A total of 15â¯076 patients (median [IQR] age, 67.6 [60.7-73.6] years; 10â¯352 male [68.7%]) were followed up for a median (IQR) of 26.2 (19.0-34.9) months. Overall, 4724 (31.3%) were female, and 2307 of the female participants (48.8%) received aspirin 81 mg. Compared with males, female participants were younger (median [IQR] age, 66.3 [59.4-72.6] years vs 68.2 (61.4-73.9) years, less likely to self-report White race (3426 [72.5%] vs 8564 [82.7%]), more likely to smoke (564 [12.9%] vs 818 [8.4%]), and more likely to have a history of peripheral arterial disease (1179 [25.7%] vs 2314 [23.0%]). The primary effectiveness outcome of all-cause death and hospitalization for MI or stroke occurred in 379 female participants (8.1%) and 780 male participants (7.1%). There was no significant interaction by sex for the primary effectiveness end point between the 2 aspirin doses (female adjusted hazard ratio [aHR], 1.01; 95% CI, 0.82-1.26 and male aHR, 1.06; 95% CI, 0.91-1.23; P interaction term for sex = .74). During the trial, female participants had fewer revascularization procedures (237 [5.0%] vs 680 [6.6%]; aHR, 0.79; 95% CI, 0.68-0.92; P = .002) but had a higher risk of hospitalization for stroke (aHR, 1.72; 95% CI, 1.27-2.33; P < .001). Among female participants, there was a slightly higher rate of bleeding in the 81-mg aspirin cohort compared with the 325-mg cohort (20 [0.83%] vs 13 [0.52%]; aHR, 2.21; 95% CI, 1.04-4.70; P interaction term for sex = .07). There were no significant differences between female and male participants regarding aspirin dose adherence. Conclusions and Relevance: In this secondary analysis of the ADAPTABLE trial, there were no significant sex-specific differences in the effectiveness and safety of 2 aspirin doses for secondary prevention of ASCVD events. Trial Registration: ClinicalTrials.gov Identifier: NCT02697916.
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Importance: Pragmatic randomized clinical trials (RCTs) often use multiple data sources to examine clinical events, but the relative contribution of data sources to clinical end-point rates is understudied. Objective: To assess the contribution of data sources (electronic health records [EHRs], public/private insurance claims, and/or participant-reported data) to clinical end points among ADAPTABLE participants who had available data. Design, Setting, and Participants: The ADAPTABLE study was an open-label, pragmatic RCT from April 2016 through June 2019 conducted in research networks within clinical practice. Participants had existing atherosclerotic cardiovascular disease and available data to analyze. The characteristics of patients by combinations of data source availability were compared to examine the contribution of each of the data sources to end-point ascertainment. Data for this prespecified analysis were examined from January 2022 to June 2023. Exposures: Randomized exposure to 81 mg or 325 mg of aspirin daily. Main Outcomes and Measures: Number of events for the primary end point (composite of death, hospitalization for myocardial infarction, and hospitalization for stroke) that were contributed by EHR or claims data and then number of events contributed by each additional data source. Results: Of 15â¯006 participants randomized with at least 1 other source of data available beyond participant-reported data, there were 8756 (58.3%) with participant-reported and EHR data; 4291 (28.6%) with participant-reported, EHR, and claims data; 1412 (9.4%) with EHR-only data; 262 (1.7%) with participant-reported and claims data; 202 (1.3%) with EHR and claims data; and 83 (0.6%) with claims-only data. Participants with EHR-only data were younger (median age, 63.7 years; IQR, 55.8-71.4) compared with the other groups (range, 65.6-71.9 years). Among participants with both EHR and claims data, with or without participant-reported data (n = 4493), for each outcome, most events (92%-100%) were identified in the EHR or in claims data. For all clinical end points, participant-reported data contributed less than 10% of events not otherwise available from claims or EHR data. Conclusions and Relevance: In this analysis of a pragmatic RCT, claims and EHR data provided the most clinical end-point data when compared with participant-reported events. These findings provide a framework for collecting end points in pragmatic clinical trials. Further work is needed to understand the data source combinations that most effectively provide clinical end-point data in RCTs.
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BACKGROUND: Adults hospitalized for cardiovascular events are at high risk for postdischarge mortality. Screening of psychosocial risk is prioritized by the Joint Commission. We tested whether key patient-reported psychosocial and behavioral measures could predict posthospitalization mortality in a cohort of adults hospitalized for a cardiovascular event. METHODS: We conducted a prospective cohort study to test the prognostic utility of validated patient-reported measures, including health literacy, social support, health behaviors and disease management, and socioeconomic status. Cox survival analyses of mortality were conducted over a median of 3.5 years. RESULTS: Among 2977 adults hospitalized for either acute coronary syndrome or acute decompensated heart failure, the mean age was 53 years, and 60% were male. After adjusting for demographic, clinical, and other psychosocial factors, mortality risk was greatest among patients who reported being unemployed (hazard ratio [HR]: 1.99, 95% confidence interval [CI]): 1.30-3.06), retired (HR: 2.14, 95% CI: 1.60-2.87), or unable to work due to disability (HR: 2.36, 95% CI: 1.73-3.21), as compared to those who were employed. Patient-reported perceived health competence (PHCS-2) and exercise frequency were also associated with mortality risk after adjusting for all other variables (HR: 0.86, 95% CI: 0.73-1.00 per four-point increase in PHCS-2; HR: 0.86, 95% CI: 0.77-0.96 per 3-day increase in exercise frequency, respectively). CONCLUSIONS: Patient-reported measures of employment status, perceived health competence, and exercise frequency independently predict mortality after a cardiac hospitalization. Incorporating these brief, valid measures into hospital-based screening may help with prognostication and targeting patients for resources during post-discharge transitions of care.
Subject(s)
Hospitalization , Patient Discharge , Humans , Male , Female , Middle Aged , Prospective Studies , Acute Coronary Syndrome/mortality , Heart Failure/mortality , Patient Reported Outcome Measures , Aged , Adult , Risk Factors , Prognosis , Social Support , Health Literacy , Health BehaviorABSTRACT
Automated text messaging is a promising approach to monitor patients after hospital discharge and avert readmissions; however, it is not known to what extent patients would engage with this type of program and whether engagement may vary based on patients' characteristics. Using data from a 30-day postdischarge texting program at a large university hospital, we examined engagement over time (operationalized as response rate to text messages) and patient characteristics associated with engagement. Of the 1324 patients in the study sample, 838 (63%) stayed in the program for the full duration. Among those retained, the median response rate was 33% (interquartile range: 11%-77%) and decreased over time. Patients who were male (p < .05), were Black/African American (p < .001), had lower health literacy (p < .01), or had not recently logged into the patient portal (p < .001), all had lower response rates. Results support closer examinations of patient engagement in hospital-based texting programs and who is positioned to benefit.
Subject(s)
Patient Discharge , Patient Participation , Text Messaging , Humans , Male , Female , Middle Aged , Patient Readmission/statistics & numerical data , Aged , Health Literacy , Hospitals, University , AdultABSTRACT
BACKGROUND: Hospital readmission is common among patients with heart failure. Vulnerability to decline in physical function may increase the risk of noncardiovascular readmission for these patients, but the association between vulnerability and the cause of unplanned readmission is poorly understood, inhibiting the development of effective interventions. OBJECTIVES: We examined the association of vulnerability with the cause of readmission (cardiovascular vs. noncardiovascular) among hospitalized patients with acute decompensated heart failure. DESIGNS, SETTINGS, AND PARTICIPANTS: This prospective longitudinal study is part of the Vanderbilt Inpatient Cohort Study. MAIN OUTCOME AND MEASURES: The primary outcome was the cause of unplanned readmission (cardiovascular vs. noncardiovascular). The primary independent variable was vulnerability, measured using the Vulnerable Elders Survey (VES-13). RESULTS: Among 804 hospitalized patients with acute decompensated heart failure, 315 (39.2%) experienced an unplanned readmission within 90 days of discharge. In a multinomial logistic model with no readmission as the reference category, higher vulnerability was associated with readmission for noncardiovascular causes (relative risk ratio [RRR] = 1.36, 95% confidence interval [CI]: 1.06-1.75) in the first 90 days after discharge. The VES-13 score was not associated with readmission for cardiovascular causes (RRR = 0.94, 95% CI: 0.75-1.17). CONCLUSIONS: Vulnerability to functional decline predicted noncardiovascular readmission risk among hospitalized patients with heart failure. The VES-13 is a brief, validated, and freely available tool that should be considered in planning care transitions. Additional work is needed to examine the efficacy of interventions to monitor and mitigate noncardiovascular concerns among vulnerable patients with heart failure being discharged from the hospital.
Subject(s)
Heart Failure , Patient Readmission , Humans , Patient Readmission/statistics & numerical data , Male , Female , Aged , Prospective Studies , Longitudinal Studies , Aged, 80 and over , Risk Factors , Middle Aged , HospitalizationABSTRACT
BACKGROUND: In patients with atherosclerotic cardiovascular disease, increasing age is concurrently associated with higher risks of ischemic and bleeding events. The objectives are to determine the impact of aspirin dose on clinical outcomes according to age in atherosclerotic cardiovascular disease. METHODS AND RESULTS: In the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) trial, patients with atherosclerotic cardiovascular disease were randomized to daily aspirin doses of 81 mg or 325 mg. The primary effectiveness end point was death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke. The primary safety end point was hospitalization for bleeding requiring transfusion. A total of 15 076 participants were randomized to aspirin 81 mg (n=7540) or 325 mg (n=7536) daily (median follow-up: 26.2 months; interquartile range: 19.0-34.9 months). Median age was 67.6 years (interquartile range: 60.7-73.6 years). Among participants aged <65 years (n=5841 [38.7%]), a primary end point occurred in 226 (7.54%) in the 81 mg group, and in 191 (6.80%) in the 325 mg group (adjusted hazard ratio [HR], 1.23 [95% CI, 1.01-1.49]). Among participants aged ≥65 years (n=9235 [61.3%]), a primary end point occurred in 364 (7.12%) in the 81 mg group, and in 378 (7.96%) in the 325 mg group (adjusted HR, 0.95 [95% CI, 0.82-1.10]). The age-dose interaction was not significant (P=0.559). There was no significant interaction between age and the randomized aspirin dose for the secondary effectiveness and the primary safety bleeding end points (P>0.05 for all). CONCLUSIONS: Age does not modify the impact of aspirin dosing (81 mg or 325 mg daily) on clinical end points in secondary prevention of atherosclerotic cardiovascular disease.
Subject(s)
Atherosclerosis , Cardiovascular Diseases , Aged , Humans , Aspirin/therapeutic use , Atherosclerosis/complications , Atherosclerosis/diagnosis , Atherosclerosis/prevention & control , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/prevention & control , Cardiovascular Diseases/drug therapy , Hemorrhage/chemically induced , Platelet Aggregation Inhibitors/therapeutic use , Secondary Prevention , Middle AgedABSTRACT
OBJECTIVE: Patients with diabetes mellitus (DM) and concomitant atherosclerotic cardiovascular disease (ASCVD) must be on the most effective dose of aspirin to mitigate risk of future adverse cardiovascular events. RESEARCH DESIGN AND METHODS: ADAPTABLE, an open-label, pragmatic study, randomized patients with stable, chronic ASCVD to 81 mg or 325 mg of daily aspirin. The effects of aspirin dosing was assessed on the primary effectiveness outcome, a composite of all-cause death, hospitalization for myocardial infarction, or hospitalization for stroke, and the primary safety outcome of hospitalization for major bleeding. In this prespecified analysis, we used Cox proportional hazards models to compare aspirin dosing in patients with and without DM for the primary effectiveness and safety outcome. RESULTS: Of 15,076 patients, 5,676 (39%) had DM of whom 2,820 (49.7%) were assigned to 81 mg aspirin and 2,856 (50.3%) to 325 mg aspirin. Patients with versus without DM had higher rates of the composite cardiovascular outcome (9.6% vs. 5.9%; P < 0.001) and bleeding events (0.78% vs. 0.50%; P < 0.001). When comparing 81 mg vs. 325 mg of aspirin, patients with DM had no difference in the primary effectiveness outcome (9.3% vs. 10.0%; hazard ratio [HR] 0.98 [95% CI 0.83-1.16]; P = 0.265) or safety outcome (0.87% vs. 0.69%; subdistribution HR 1.25 [95% CI 0.72-2.16]; P = 0.772). CONCLUSIONS: This study confirms the inherently higher risk of patients with DM irrespective of aspirin dosing. Our findings suggest that a higher dose of aspirin yields no added clinical benefit, even in a more vulnerable population.
Subject(s)
Atherosclerosis , Cardiovascular Diseases , Diabetes Mellitus , Myocardial Infarction , Stroke , Humans , Aspirin/therapeutic use , Cardiovascular Diseases/drug therapy , Cardiovascular Diseases/prevention & control , Cardiovascular Diseases/chemically induced , Diabetes Mellitus/drug therapy , Diabetes Mellitus/chemically induced , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Myocardial Infarction/drug therapy , Myocardial Infarction/epidemiology , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/adverse effects , Stroke/epidemiologyABSTRACT
The growing recognition of differences in health outcomes across populations has led to a slow but increasing shift towards transparent reporting of patient outcomes. In addition, pay-for-equity initiatives, such as those proposed by the Centers for Medicare and Medicaid, will require the reporting of health outcomes across subgroups over time. Dashboards offer one means of visualising data in the health-care context that can highlight essential disparities in clinical outcomes, guide targeted quality-improvement efforts, and ultimately improve health equity. In this Viewpoint, we evaluate all studies that have reported the successful development of a disparity dashboard and share the data collected and unintended consequences reported. We propose a framework for systematic equality improvement through incentivisation of the collecting and reporting of health data and through implementation of reward systems to reduce health disparities.
Subject(s)
Health Equity , Aged , Humans , United States , Medicare , Delivery of Health Care , Quality Improvement , Health FacilitiesABSTRACT
Background: Adults hospitalized for cardiovascular events are at high risk for post-discharge mortality. Hospital-based screening of health-related psychosocial risk factors is now prioritized by the Joint Commission and the National Quality Forum to achieve equitable, high-quality care. We tested our hypothesis that key patient-reported psychosocial and behavioral measures could predict post-hospitalization mortality in a cohort of adults hospitalized for a cardiovascular event. Methods: This was a prospective cohort of adults hospitalized at Vanderbilt University Medical Center. Validated patient-reported measures of health literacy, social support, disease self-management, and socioeconomic status were used as predictors of interest. Cox survival analyses of mortality were conducted over a median 3.5-year follow-up (range: 1.25 - 5.5 years). Results: Among 2,977 adults, 1,874 (63%) were hospitalized for acute coronary syndrome and 1,103 (37%) were hospitalized for acute decompensated heart failure; 60% were male; and the mean age was 53 years. After adjusting for demographic, clinical, and other psychosocial factors, mortality risk was greatest among patients who reported being unable to work due to disability (Hazard Ratio (HR) 2.36, 95% Confidence Interval (CI): 1.73-3.21), who were retired (HR 2.14, 95% CI 1.60-2.87), and who reported unemployment (HR 1.99, 95% CI 1.30-3.06) as compared to those who were employed. Patient-reported measures of disease self-management, perceived health competence and exercise frequency, were also associated with mortality risk after full covariate adjustment (HR 0.86, 95% CI 0.73-1.00 per four-point increase), (HR 0.86, 95% CI 0.77-0.96 per three-day change), respectively. Conclusions: Patient-reported measures of employment status independently predict post-discharge mortality after a cardiac hospitalization. Measure of disease self-management also have prognostic modest utility. Hospital-based screening of psychosocial risk is increasingly prioritized in legislative policy. Incorporating brief, valid measures of employment status and disease self-management factors may help target patients for psychosocial, financial, and rehabilitative resources during post-discharge transitions of care.
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Background The ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) was a large, pragmatic, randomized controlled trial that found no difference between high- versus low-dose aspirin for secondary prevention of atherosclerotic cardiovascular disease. Whether concomitant P2Y12 inhibitor therapy modifies the effect of aspirin dose on clinical events remains unclear. Methods and Results Participants in ADAPTABLE were stratified according to baseline use of clopidogrel or prasugrel (P2Y12 group). The primary effectiveness end point was a composite of death, myocardial infarction, or stroke; and the primary safety end point was major bleeding requiring blood transfusions. We used multivariable Cox regression to compare the relative effectiveness and safety of aspirin dose within P2Y12 and non-P2Y12 groups. Of 13 815 (91.6%) participants with available data, 3051 (22.1%) were receiving clopidogrel (2849 [93.4%]) or prasugrel (203 [6.7%]) at baseline. P2Y12 inhibitor use was associated with higher risk of the primary effectiveness end point (10.86% versus 6.31%; adjusted hazard ratio [HR], 1.40 [95% CI, 1.22-1.62]) but was not associated with bleeding (0.95% versus 0.53%; adjusted HR, 1.42 [95% CI, 0.91-2.22]). We found no interaction in the relative effectiveness and safety of high- versus low-dose aspirin by P2Y12 inhibitor use. Overall, dose switching or discontinuation was more common in the high-dose compared with low-dose aspirin group, but the pattern was not modified by P2Y12 inhibitor use. Conclusions In this prespecified analysis of ADAPTABLE, we found that the relative effectiveness and safety of high- versus low-dose aspirin was not modified by baseline P2Y12 inhibitor use. Registration https://www.clinical.trials.gov. Unique identifier: NCT02697916.
Subject(s)
Acute Coronary Syndrome , Atherosclerosis , Cardiovascular Diseases , Humans , Clopidogrel/adverse effects , Platelet Aggregation Inhibitors/therapeutic use , Prasugrel Hydrochloride/adverse effects , Ticlopidine/therapeutic use , Secondary Prevention , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/prevention & control , Cardiovascular Diseases/chemically induced , Purinergic P2Y Receptor Antagonists/therapeutic use , Acute Coronary Syndrome/drug therapy , Aspirin/therapeutic use , Hemorrhage/chemically induced , Atherosclerosis/diagnosis , Atherosclerosis/drug therapy , Atherosclerosis/prevention & controlABSTRACT
BACKGROUND: Access to programs for high-needs patients depending on single-institution electronic health record data (EHR) carries risks of biased sampling. We investigate a statewide admission, discharge, and transfer feed (ADT) in assessing equity in access to these programs. METHODS: This is a retrospective cross-sectional study. We included high-need patients at Vanderbilt University Medical Center (VUMC) 18 years or older, with at least three emergency visits (ED) or hospitalizations in Tennessee from January 1 to June 30, 2021, including at least one at VUMC. We used the Tennessee ADT database to identify high-need patients with at least one VUMC ED/hospitalization. Then, we compared this population with high-need patients identified using VUMC's Epic® EHR database. The primary outcome was the sensitivity of VUMC-only criteria for identifying high-need patients compared to the statewide ADT reference standard. RESULTS: We identified 2549 patients with at least one ED/hospitalization and assessed them as high-need based on the statewide ADT. Of those, 2100 had VUMC-only visits, and 449 had VUMC and non-VUMC visits. VUMC-only visit screening criteria showed high sensitivity (99.1%, 95% CI: 98.7 - 99.5%), showing that the high-needs patients admitted to VUMC infrequently access alternative systems. Results showed no meaningful difference in sensitivity when stratified by patient's race or insurance. CONCLUSIONS: ADT allows examination for potential selection bias when relying upon single-institution utilization. In VUMC's high-need patients, there's minimal selection bias when depending on same-site utilization. Further research must understand how biases vary by site and durability over time.
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Hospitalization , Patient Discharge , Humans , Retrospective Studies , Cross-Sectional Studies , Tennessee , Emergency Service, HospitalABSTRACT
Introduction: To assess healthcare professionals' perceptions of rural barriers and facilitators of lung cancer screening program implementation in a Veterans Health Administration (VHA) setting through a series of one-on-one interviews with healthcare team members. Methods: Based on measures developed using Reach Effectiveness Adoption Implementation Maintenance (RE-AIM), we conducted a cross-sectional qualitative study consisting of one-on-one semi-structured telephone interviews with VHA healthcare team members at 10 Veterans Affairs medical centers (VAMCs) between December 2020 and September 2021. An iterative inductive and deductive approach was used for qualitative analysis of interview data, resulting in the development of a conceptual model to depict rural barriers and facilitators of lung cancer screening program implementation. Results: A total of 30 interviews were completed among staff, providers, and lung cancer screening program directors and a conceptual model of rural barriers and facilitators of lung cancer screening program implementation was developed. Major themes were categorized within institutional and patient environments. Within the institutional environment, participants identified systems-level (patient communication, resource availability, workload), provider-level (attitudes and beliefs, knowledge, skills and capabilities), and external (regional and national networks, incentives) barriers to and facilitators of lung cancer screening program implementation. Within the patient environment, participants revealed patient-level (modifiable vulnerabilities) barriers and facilitators as well as ecological modifiers (community) that influence screening behavior. Discussion: Understanding rural barriers to and facilitators of lung cancer screening program implementation as perceived by healthcare team members points to opportunities and approaches for improving lung cancer screening reach, implementation and effectiveness in VHA rural settings.
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Background Internet-based participation has the potential to enhance pragmatic and decentralized trials, where representative study populations and generalizability to clinical practice are key. We aimed to study the differences between internet and noninternet/telephone participants in a large remote, pragmatic trial. Methods and Results In a subanalysis of the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) study, we compared internet participants with those who opted for noninternet participation. Study process measures examined included participant characteristics at consent, study medication adherence, and study retention. The clinical outcome examined was a composite of all-cause mortality, hospitalization for myocardial infarction, or hospitalization for stroke. Noninternet participants were older (mean 69.4 versus 67.4 years), more likely to be female (38.9% versus 30.2%), more likely to be Black (27.3% versus 6.0%) or Hispanic (11.1% versus 2.0%), and had a higher number of comorbid conditions. The composite clinical outcome was more than twice as high in noninternet participants. The hazard of nonadherence to the assigned aspirin dosage was 46% higher in noninternet participants than internet participants. Conclusions Noninternet participants differed from internet participants in notable demographic characteristics while having poorer baseline health. Over the course of ADAPTABLE, they also had worse clinical outcomes and greater likelihood of study drug nonadherence. These results suggest that trials focused on internet participation select for younger, healthier participants with a higher proportion of traditionally overrepresented patients. Allowing noninternet participation enhances diversity; however, additional steps may be needed to promote study retention and study medication adherence. Registration Information clinicaltrials.gov. Identifier: NCT02697916.
Subject(s)
Myocardial Infarction , Stroke , Female , Humans , Male , Aspirin/therapeutic use , Internet , Myocardial Infarction/drug therapy , Stroke/epidemiology , Stroke/drug therapy , AgedABSTRACT
INTRODUCTION: Lung cancer screening is widely underutilized. Organizational factors, such as readiness for change and belief in the value of change (change valence), may contribute to underutilization. The aim of this study was to evaluate the association between healthcare organizations' preparedness and lung cancer screening utilization. METHODS: Investigators cross-sectionally surveyed clinicians, staff, and leaders at10 Veterans Affairs from November 2018 to February 2021 to assess organizational readiness to implement change. In 2022, investigators used simple and multivariable linear regression to evaluate the associations between facility-level organizational readiness to implement change and change valence with lung cancer screening utilization. Organizational readiness to implement change and change valence were calculated from individual surveys. The primary outcome was the proportion of eligible Veterans screened using low-dose computed tomography. Secondary analyses assessed scores by healthcare role. RESULTS: The overall response rate was 27.4% (n=1,049), with 956 complete surveys analyzed: median age of 49 years, 70.3% female, 67.6% White, 34.6% clinicians, 61.1% staff, and 4.3% leaders. For each 1-point increase in median organizational readiness to implement change and change valence, there was an associated 8.4-percentage point (95% CI=0.2, 16.6) and a 6.3-percentage point increase in utilization (95% CI= -3.9, 16.5), respectively. Higher clinician and staff median scores were associated with increased utilization, whereas leader scores were associated with decreased utilization after adjusting for other roles. CONCLUSIONS: Healthcare organizations with higher readiness and change valence utilized more lung cancer screening. These results are hypothesis generating. Future interventions to increase organizations' preparedness, especially among clinicians and staff, may increase lung cancer screening utilization.
Subject(s)
Early Detection of Cancer , Lung Neoplasms , Humans , Female , Middle Aged , Male , Organizational Innovation , Lung Neoplasms/diagnosis , Delivery of Health Care , Linear ModelsABSTRACT
Health outcomes are markedly influenced by health-related social needs (HRSN) such as food insecurity and housing instability. Under new Joint Commission requirements, hospitals have recently increased attention to HRSN to reduce health disparities. To evaluate prevailing attitudes and guide hospital efforts, the authors conducted a systematic review to describe patients' and health care providers' perceptions related to screening for and addressing patients' HRSN in US hospitals. Articles were identified through PubMed and by expert recommendations, and synthesized by relevance of findings and basic study characteristics. The review included 22 articles, which showed that most health care providers believed that unmet social needs impact health and that screening for HRSN should be a standard part of hospital care. Notable differences existed between perceived importance of HRSN and actual screening rates, however. Patients reported high receptiveness to screening in hospital encounters, but cautioned to avoid stigmatization and protect privacy when screening. Limited knowledge of resources available, lack of time, and lack of actual resources were the most frequently reported barriers to screening for HRSN. Hospital efforts to screen and address HRSN will likely be facilitated by stakeholders' positive perceptions, but common barriers to screening and referral will need to be addressed to effectively scale up efforts and impact health disparities.
Subject(s)
Health Personnel , Hospitals , Humans , Attitude of Health Personnel , Mass ScreeningABSTRACT
BACKGROUND: The second Multicenter Medication Reconciliation Quality Improvement Study demonstrated a marked reduction in medication discrepancies per patient. The aim of the current analysis was to determine the association of patient exposure to each system-level intervention and receipt of each patient-level intervention on these results. METHODS: This study was conducted at 17 North American Hospitals, the study period was 18 months per site, and sites typically adopted interventions after 2-5 months of preintervention data collection. We conducted an on-treatment analysis (ie, an evaluation of outcomes based on patient exposure) of system-level interventions, both at the category level and at the individual component level, based on monthly surveys of implementation site leads at each site (response rate 65%). We then conducted a similar analysis of patient-level interventions, as determined by study pharmacist review of documented activities in the medical record. We analysed the association of each intervention on the adjusted number of medication discrepancies per patient in admission and discharge orders, based on a random sample of up to 22 patients per month per site, using mixed-effects Poisson regression with hospital site as a random effect. We then used a generalised linear mixed-effects model (GLMM) decision tree to determine which patient-level interventions explained the most variance in discrepancy rates. RESULTS: Among 4947 patients, patient exposure to seven of the eight system-level component categories was associated with modest but significant reductions in discrepancy rates (adjusted rate ratios (ARR) 0.75-0.97), as were 15 of the 17 individual system-level intervention components, including hiring, reallocating and training personnel to take a best possible medication history (BPMH) and training personnel to perform discharge medication reconciliation and patient counselling. Receipt of five of seven patient-level interventions was independently associated with large reductions in discrepancy rates, including receipt of a BPMH in the emergency department (ED) by a trained clinician (ARR 0.40, 95% CI 0.37 to 0.43), admission medication reconciliation by a trained clinician (ARR 0.57, 95% CI 0.50 to 0.64) and discharge medication reconciliation by a trained clinician (ARR 0.64, 95% CI 0.57 to 0.73). In GLMM decision tree analyses, patients who received both a BPMH in the ED and discharge medication reconciliation by a trained clinician experienced the lowest discrepancy rates (0.08 per medication per patient). CONCLUSION AND RELEVANCE: Patient-level interventions most associated with reductions in discrepancies were receipt of a BPMH of admitted patients in the ED and admission and discharge medication reconciliation by a trained clinician. System-level interventions were associated with modest reduction in discrepancies for the average patient but are likely important to support patient-level interventions and may reach more patients. These findings can be used to help hospitals and health systems prioritise interventions to improve medication safety during care transitions.
Subject(s)
Hospitalization , Medication Reconciliation , Humans , Patient Discharge , Patient Transfer , Hospitals , PharmacistsABSTRACT
Background: Access to programs for high-needs patients depending on single-institution electronic health record data (EHR) carries risks of biased sampling. We investigate a statewide admissions, discharge, transfer feed (ADT), in assessing equity in access to these programs. Methods: This is a retrospective cross-sectional study. We included high-need patients at Vanderbilt University Medical Center (VUMC), who were 18 years or older, with minimum three emergency visits (ED) or hospitalizations in Tennessee from January 1 to June 30, 2021, including at least one at VUMC. We used the Tennessee ADT database to identify high-need patients with at least one VUMC ED/hospitalization, then compared this population with high-need patients identified using VUMC's Epic® EHR database. The primary outcome was the sensitivity of VUMC-only criteria for identifying high-need patient when compared to statewide ADT reference standard. Results: We identified 2549 patients that had at least one ED/hospitalization and were assessed to be high-need based on the statewide ADT. Of those, 2100 had VUMC-only visits, and 449 had VUMC and non-VUMC visits. VUMC-only visit screening criteria showed high sensitivity (99.1%, 95% CI: 98.7% - 99.5%), indicating that the high-needs patients admitted to VUMC infrequently access alternative systems. Results demonstrated no meaningful difference in sensitivity when stratified by patient's race or insurance. Conclusions: ADT allows examination for potential selection bias when relying upon single-institution utilization. In VUMC's high-need patients, there's minimal selection bias when relying upon same-site utilization. Further research needs to understand how biases may vary by site, and durability over time.