Engaging Operational Partners Is Critical for Successful Implementation of Research Products: a Coincidence Analysis of Access-Related Projects in the Veterans Affairs Healthcare System.

BACKGROUND/OBJECTIVE: The Veterans Health Administration (VHA) has prioritized timely access to care and has invested substantially in research aimed at optimizing veteran access. However, implementing research into practice remains challenging. Here, we assessed the implementation status of recent VHA access-related research projects and explored factors associated with successful implementation. DESIGN: We conducted a portfolio review of recent VHA-funded or supported projects (1/2015-7/2020) focused on healthcare access ("Access Portfolio"). We then identified projects with implementable research deliverables by excluding those that (1) were non-research/operational projects; (2) were only recently completed (i.e., completed on or after 1/1/2020, meaning that they were unlikely to have had time to be implemented); and (3) did not propose an implementable deliverable. An electronic survey assessed each project's implementation status and elicited barriers/facilitators to implementing deliverables. Results were analyzed using novel Coincidence Analysis (CNA) methods. PARTICIPANTS/KEY RESULTS: Among 286 Access Portfolio projects, 36 projects led by 32 investigators across 20 VHA facilities were included. Twenty-nine respondents completed the survey for 32 projects (response rate = 88.9%). Twenty-eight percent of projects reported fully implementing project deliverables, 34% reported partially implementing deliverables, and 37% reported not implementing any deliverables (i.e., resulting tool/intervention not implemented into practice). Of 14 possible barriers/facilitators assessed in the survey, two were identified through CNA as "difference-makers" to partial or full implementation of project deliverables: (1) engagement with national VHA operational leadership; (2) support and commitment from local site operational leadership. CONCLUSIONS: These findings empirically highlight the importance of operational leadership engagement for successful implementation of research deliverables. Efforts to strengthen communication and engagement between the research community and VHA local/national operational leaders should be expanded to ensure VHA's investment in research leads to meaningful improvements in veterans' care. The Veterans Health Administration (VHA) has prioritized timely access to care and has invested substantially in research aimed at optimizing veteran access. However, implementing research findings into clinical practice remains challenging, both within and outside VHA. Here, we assessed the implementation status of recent VHA access-related research projects and explored factors associated with successful implementation. Only two factors were identified as "difference-makers" to adoption of project findings into practice: (1) engagement with national VHA leadership or (2) support and commitment from local site leadership. These findings highlight the importance of leadership engagement for successful implementation of research findings. Efforts to strengthen communication and engagement between the research community and VHA local/national leaders should be expanded to ensure VHA's investment in research leads to meaningful improvements in veterans' care.

Use of oral anticoagulants in patients with valvular atrial fibrillation: findings from the NCDR PINNACLE Registry.

Recent data suggest direct oral anticoagulants are as safe and efficacious as warfarin among select patients with valvular heart disease and atrial fibrillation (AF). However, real-world treatment patterns of AF stroke prophylaxis in the setting of valvular AF are currently unknown. Accordingly, using the prospective, ambulatory National Cardiovascular Data Registry Practice Innovation and Clinical Excellence (PINNACLE) Registry, we sought to characterize overall use, temporal trends in use, and the extent of practice-level variation in the use of any direct oral anticoagulant and warfarin among patients with valvular AF from January 1, 2013, to March 31, 2019.

Efficacy of a centralized, blended electronic, and human intervention to improve direct oral anticoagulant adherence: Smartphones to improve rivaroxaban ADHEREnce in atrial fibrillation (SmartADHERE) a randomized clinical trial.

BACKGROUND: Improving adherence to direct oral anticoagulants (DOAC) is challenging, and simple text messaging reminders have not been effective. METHODS: SmartADHERE was a randomized trial that tested a personalized digital and human direct oral anticoagulant adherence intervention compared to usual care. Eligibility required age ≥ 18, newly-prescribed (≤90 days) rivaroxaban for atrial fibrillation (AF), 1 of 4 at-risk criteria for nonadherence, and a smartphone. The intervention consisted of combination of a medication management smartphone app, daily app-based reminders, adaptive text messaging, and phone-based counseling for severe nonadherence. The primary outcome was the proportion of days covered by rivaroxaban (PDC) at 6 months. There were 25 U.S. sites, all cardiology and electrophysiology outpatient practices, activated for a target sample size of 378, but the study was terminated by the sponsor prior to reaching target enrollment. RESULTS: There were 139 participants (age 65±9.6 years, 30% female, median CHA2DS2-VASc score 3 with IQR 2 to 4, mean total medication burden 7.7±4.4). DOAC adherence was high in both arms with no difference in the primary outcome (PDC 0.86±0.25 intervention vs 0.88±0.25 control, p=0.62) or in secondary outcomes including PDC ≥ 0.80 and medication persistence. Per protocol analyses had similar results. Because of the high overall PDC, the likelihood to answer the primary hypothesis was only 51% even if target enrollment were achieved. There were no study-related adverse events. CONCLUSIONS: The use of a centralized digital and human adherence intervention was feasible across multiple sites. Overall adherence was much higher than expected despite prescreening for at-risk individuals. SmartADHERE illustrates the challenges of trials of behavioral and technology interventions, where enrollment itself may lead to selection bias or treatment effects. Pragmatic study designs, such as cluster randomization or stepped-wedge implementation, should be considered to improve enrollment and generalizability.

Association of Healthcare Plan with atrial fibrillation prescription patterns.

BACKGROUND: Atrial fibrillation (AF) is treated by many types of physician specialists, including primary care physicians (PCPs). Health plans have different policies for how patients encounter these providers, and these may affect selection of AF treatment strategy. HYPOTHESIS: We hypothesized that healthcare plans with PCP-gatekeeping to specialist access may be associated with different pharmacologic treatments for AF. METHODS: We performed a retrospective cohort study using a commercial pharmaceutical claims database. We utilized logistic regression models to compare odds of prescription of oral anticoagulant (OAC), non-vitamin K-dependent oral anticoagulant (NOAC), rate control, and rhythm control medications used to treat AF between patients with PCP-gated healthcare plans (eg, HMO, EPO, POS) and patients with non-PCP-gated healthcare plans (eg, PPO, CHDP, HDHP, comprehensive) between 2007 and 2012. We also calculated median time to receipt of therapy within 90 days of index AF diagnosis. RESULTS: We found similar odds of OAC prescription at 90 days following new AF diagnosis in patients with PCP-gated plans compared to those with non-PCP-gated plans (OR: OAC 1.01, P = 0.84; warfarin 1.05, P = 0.08). Relative odds were similar for rate control (1.17, P < 0.01) and rhythm control agents (0.93, P = 0.03). However, PCP-gated plan patients had slightly lower likelihood of being prescribed NOACs (0.82, P = 0.001) than non-gated plan patients. Elapsed time until receipt of medication was similar between PCP-gated and non-gated groups across drug classes. CONCLUSIONS: Pharmaceutical claims data do not suggest that PCP-gatekeeping by healthcare plans is a structural barrier to AF therapy, although it was associated with lower use of NOACs.

Accessing Care Through the Veterans Choice Program: The Veteran Experience.

BACKGROUND: The Veterans Choice Program (VCP) was implemented to improve healthcare access by expanding healthcare options for Veterans Health Administration (VHA) enrollees. OBJECTIVES: To understand Veterans' experience accessing VCP care. DESIGN: Qualitative content analysis. SUBJECTS: Forty-seven veterans from three medical centers in three of the five VA geographical regions. APPROACH: We used semi-structured telephone interviews designed to elicit descriptions of Veterans' experiences. Data was analyzed using iterative, inductive, and deductive content analysis. Broad themes were identified based on representative interview responses. KEY RESULTS: We identified six themes: general impressions (concept and frustration); preferred source of care (institution, specialty, and individual provider); facilitators (VA staff facilitation and proactive Veterans); barriers (complexity, lack of responsiveness, lack of local providers, and poor coordination); perceived sources of VCP problems (learning curve, leadership and staff, and politics); and unintended negative impact (responsibility for costs of care and discontinued access to community care). DISCUSSION: Most Veterans who had received care through the VCP felt that it improved their access to care. However, accessing care through the VCP is a complex process that requires proactive Veterans and active support from the VA, third-party administrators, and availability of participating community providers. Veterans' abilities to navigate this process and the level of support provided varied widely. Even patients who did receive care through VCP found the process challenging. Greater support is needed for some Veterans to successfully access VCP care because Veterans who need care the most may be the least able to access it.

Coronary artery disease severity modifies associations between glycemic control and both mortality and myocardial infarction.

AIMS: This study examined whether the association between hemoglobin A1c (HbA1c) and short-term clinical outcomes is moderated by CAD severity. METHODS: We studied 17,394 US Veterans with type 2 diabetes who underwent elective cardiac catheterization between 2005 and 2013. CAD severity was categorized as obstructive, non-obstructive, or no CAD. Using multivariable Cox proportional hazards regression, we assessed associations between time-varying HbA1c and two-year all-cause mortality and non-fatal MI, with an interaction term between HbA1c and CAD severity. RESULTS: 61%, 22%, and 17% of participants had obstructive, non-obstructive, and no CAD, respectively. CAD severity modified the relationship between HbA1c and each outcome (interaction p-value 0.0005 for mortality and <0.0001 for MI). Low HbA1c (<42 mmol/mol) was associated with increased mortality, relative to HbA1c of 48-52 mmol/mol, in individuals with obstructive CAD (HR 1.52 [1.17, 1.97]) and non-obstructive CAD (HR 2.61 [1.61, 4.23]), but not in those with no CAD (HR 0.91 [0.46, 1.79]). In contrast, higher HbA1c levels (≥53 mmol/mol) were associated with increased MI risk only in individuals with obstructive CAD. CONCLUSIONS: The associations between HbA1c and mortality and MI were moderated by CAD severity. Measures of cardiovascular disease severity may inform optimal individualized diabetes management.

Recent Approaches to Improve Medication Adherence in Patients with Coronary Heart Disease: Progress Towards a Learning Healthcare System.

PURPOSE OF REVIEW: Non-adherence to medications for the secondary prevention of myocardial infarction (MI) is a major contributor to morbidity and mortality in these patients. This review describes recent advances in promoting adherence to therapies for coronary artery disease (CAD). RECENT FINDINGS: Two large randomized controlled trials to "incentivize" adherence were somewhat disappointing; neither financial incentives nor "peer pressure" successfully increased rates of adherence in the post-MI population. Patient education and provider engagement appear to be critical aspects of improving adherence to CAD therapies, where the provider is a physician, pharmacist, or nurse and follow-up is performed in person or by telephone. Fixed-dose combinations of CAD medications, formulated as a so-called "polypill," have shown some early efficacy in increasing adherence. Technological advances that automate monitoring and/or encouragement of adherence are promising but seem universally dependent on patient engagement. For example, medication reminders via text message perform better if patients are required to respond. Multifaceted interventions, in which these and other interventions are combined together, appear to be most effective. There are several available types of proven interventions through which providers, and the health system at large, can advance patient adherence to CAD therapies. No single intervention to promote adherence will be successful in all patients. Further study of multifaceted interventions and the interactions between different interventions will be important to advancing the field. The goal is a learning healthcare system in which a network of interventions responds and adapts to patients' needs over time.

Implications for Ezetimibe Therapy Use Based on IMPROVE-IT Criteria.

PURPOSE: In the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), simvastatin/ezetimibe combination was associated with a 6% relative risk reduction in the combined cardiovascular outcome compared with simvastatin alone in patients with acute coronary syndrome. Given strict inclusion criteria (low-density lipoprotein cholesterol 50-125 mg/dL and no use of statins more potent than simvastatin 40 mg), the implications of this important trial in routine acute coronary syndrome care are unknown. METHODS: We identified patients with acute coronary syndrome from the Veterans Affairs health care system over a 5-year period and determined what proportion would be candidates for ezetimibe on the basis of IMPROVE-IT criteria. We then evaluated what proportion could potentially see an increase in ezetimibe use if IMPROVE-IT criteria are not strictly followed. RESULTS: Of 219,625 patients with acute coronary syndrome, 69,508 (31.6%) would qualify for ezetimibe on the basis of strict criteria. Among those who did not meet IMPROVE-IT criteria (n = 150,117), ezetimibe could potentially be prescribed by clinicians in a further 28% of patients (n = 61,635) using statins more potent than simvastatin 40 mg, 7.1% of patients (15,527) with a documented statin intolerance, and 10.4% of patients (22,758) with low-density lipoprotein cholesterol >125 mg/dL. CONCLUSIONS: Our results provide a first look at the implications of this trial in a large health care system. Although 31.6% of patients would qualify for ezetimibe, there is a large potential for an increase in ezetimibe use in acute coronary syndrome outside of the strict trial inclusions. These findings call for a discussion on ezetimibe's role in patients with acute coronary syndrome already taking high-intensity statins or those with statin intolerance.

Quality of care for acute myocardial infarction in 58 U.S. emergency departments.

OBJECTIVES: The objectives of this study were to determine concordance of emergency department (ED) management of acute myocardial infarction (AMI) with guideline recommendations and to identify ED and patient characteristics predictive of higher guideline concordance. METHODS: The authors conducted a chart review study of ED AMI care as part of the National Emergency Department Safety Study (NEDSS). Using a primary hospital discharge diagnosis of AMI (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM], codes 410.XX), a random sample of ED visits for AMI in 58 urban EDs across 20 U.S. states between 2003 and 2006 were identified. Concordance with American College of Cardiology/American Heart Association (ACC/AHA) guideline recommendations was evaluated using five individual quality measures and a composite concordance score. Concordance scores were calculated as the percentage of eligible patients who received guidelines-recommended care. These percentage scores were rescaled from 0 to 100, with 100 indicating perfect concordance. RESULTS: The cohort consisted of 3,819 subjects; their median age was 65 years, and 62% were men. The mean (± standard deviation [SD]) ED composite concordance score was 61 ± 8), with a broad range of values (42 to 84). Except for aspirin use (mean concordance, 82), ED concordance scores were low (beta-blocker use, 56; timely electrocardiogram [ECG], 41; timely fibrinolytic therapy, 26; timely ED disposition for primary percutaneous coronary intervention [PCI] candidates, 43). In multivariable analyses, older age (beta-coefficient per 10-year increase, -1.5; 95% confidence interval [CI] = -2.4 to -0.5) and southern EDs (beta-coefficient, -5.2; 95% CI = -9.6 to -0.9) were associated with lower guideline concordance, whereas ST-segment elevation on initial ED ECG was associated with higher guideline concordance (beta-coefficient, 3.6; 95% CI = 1.5 to 5.7). CONCLUSIONS: Overall ED concordance with guideline-recommended processes of care was low to moderate. Emergency physicians should continue to work with other stakeholders in AMI care, such as emergency medical services (EMS) and cardiologists, to develop strategies to improve care processes.