Improving Guideline-Directed Medical Therapy for Patients With Heart Failure With Reduced Ejection Fraction: A Review of Implementation Strategies.

Despite recent advances in the use of guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF), achievement of target GDMT use and up-titration to goal dosages continue to be modest. In recent years, a number of interventional approaches to improve the usage of GDMT have been published, but many are limited by single-center experiences with small sample sizes. However, strategies including the use of multidisciplinary teams, dedicated GDMT titration algorithms and clinician audits with feedback have shown promise. There remains a critical need for large, rigorous trials to assess the utility of differing interventions to improve the use and titration of GDMT in HFrEF. Here, we review existing literature in GDMT implementation for those with HFrEF and discuss future directions and considerations in the field.

Factors Affecting Post-trial Sustainment or De-implementation of Study Interventions: A Narrative Review.

In contrast to traditional randomized controlled trials, embedded pragmatic clinical trials (ePCTs) are conducted within healthcare settings with real-world patient populations. ePCTs are intentionally designed to align with health system priorities leveraging existing healthcare system infrastructure and resources to ease intervention implementation and increase the likelihood that effective interventions translate into routine practice following the trial. The NIH Pragmatic Trials Collaboratory, funded by the National Institutes of Health (NIH), supports the conduct of large-scale ePCT Demonstration Projects that address major public health issues within healthcare systems. The Collaboratory has a unique opportunity to draw on the Demonstration Project experiences to generate lessons learned related to ePCTs and the dissemination and implementation of interventions tested in ePCTs. In this article, we use case studies from six completed Demonstration Projects to summarize the Collaboratory's experience with post-trial interpretation of results, and implications for sustainment (or de-implementation) of tested interventions. We highlight three key lessons learned. First, ineffective interventions (i.e., ePCT is null for the primary outcome) may be sustained if they have other measured benefits (e.g., secondary outcome or subgroup) or even perceived benefits (e.g., staff like the intervention). Second, effective interventions-even those solicited by the health system and/or designed with significant health system partner buy-in-may not be sustained if they require significant resources. Third, alignment with policy incentives is essential for achieving sustainment and scale-up of effective interventions. Our experiences point to several recommendations to aid in considering post-trial sustainment or de-implementation of interventions tested in ePCTs: (1) include secondary outcome measures that are salient to health system partners; (2) collect all appropriate data to allow for post hoc analysis of subgroups; (3) collect experience data from clinicians and staff; (4) engage policy-makers before starting the trial.

Defining and Improving Outcomes Measurement for Virtual Care: Report from the VHA State-of-the-Art Conference on Virtual Care.

Virtual care, including synchronous and asynchronous telehealth, remote patient monitoring, and the collection and interpretation of patient-generated health data (PGHD), has the potential to transform healthcare delivery and increase access to care. The Veterans Health Administration (VHA) Office of Health Services Research and Development (HSR&D) convened a State-of-the-Art (SOTA) Conference on Virtual Care to identify future virtual care research priorities. Participants were divided into three workgroups focused on virtual care access, engagement, and outcomes. In this article, we report the findings of the Outcomes Workgroup. The group identified virtual care outcome areas with sufficient evidence, areas in need of additional research, and areas that are particularly well-suited to be studied within VHA. Following a rigorous process of literature review and consensus, the group focused on four questions: (1) What outcomes of virtual care should we be measuring and how should we measure them?; (2) how do we choose the "right" care modality for the "right" patient?; (3) what are potential consequences of virtual care on patient safety?; and (4) how can PGHD be used to benefit provider decision-making and patient self-management?. The current article outlines key conclusions that emerged following discussion of these questions, including recommendations for future research.

Evaluating Factors Associated With Telehealth Appropriateness in Outpatient Rheumatoid Arthritis Encounters Using the Encounter Appropriateness Score for You (EASY).

OBJECTIVE: Telehealth has been proposed as a safe and effective alternative to in-person care for rheumatoid arthritis (RA). The purpose of this study was to evaluate factors associated with telehealth appropriateness in outpatient RA encounters. METHODS: A prospective cohort study (January 1, 2021, to August 31, 2021) was conducted using electronic health record data from outpatient RA encounters in a single academic rheumatology practice. Rheumatology providers rated the telehealth appropriateness of their own encounters using the Encounter Appropriateness Score for You (EASY) immediately following each encounter. Robust Poisson regression with generalized estimating equations modeling was used to evaluate the association of telehealth appropriateness with patient demographics, RA clinical characteristics, comorbid noninflammatory causes of joint pain, previous and current encounter characteristics, and provider characteristics. RESULTS: During the study period, 1823 outpatient encounters with 1177 unique patients with RA received an EASY score from 25 rheumatology providers. In the final multivariate model, factors associated with increased telehealth appropriateness included higher average provider preference for telehealth in prior encounters (relative risk [RR] 1.26, 95% CI 1.21-1.31), telehealth as the current encounter modality (RR 2.27, 95% CI 1.95-2.64), and increased patient age (RR 1.05, 95% CI 1.01-1.09). Factors associated with decreased telehealth appropriateness included moderate (RR 0.81, 95% CI 0.68-0.96) and high (RR 0.57, 95% CI 0.46-0.70) RA disease activity and if the previous encounters were conducted by telehealth (RR 0.83, 95% CI 0.73-0.95). CONCLUSION: In this study, telehealth appropriateness was most associated with provider preference, the current and previous encounter modality, and RA disease activity. Other factors like patient demographics, RA medications, and comorbid noninflammatory causes of joint pain were not associated with telehealth appropriateness.

Implementation of a Clinician-led Medication Adherence Intervention Among Patients With Systemic Lupus Erythematosus.

OBJECTIVE: Medication nonadherence in systemic lupus erythematosus (SLE) leads to poor clinical outcomes. We developed a clinician-led adherence intervention that involves reviewing real-time pharmacy refill data and using effective communication to address nonadherence. Prior pilot testing showed promising effects on medication adherence. Here, we describe further evaluation of how clinicians implemented the intervention and identify areas for improvement. METHODS: We audio recorded encounters of clinicians with patients who were nonadherent (90-day proportion of days covered [PDC] < 80% for SLE medications). We coded recordings for intervention components performed, communication quality, and time spent discussing adherence. We also conducted semistructured interviews with patients and clinicians on their experiences and suggestions for improving the intervention. We assessed change in 90-day PDC post intervention. RESULTS: We included 25 encounters with patients (median age 39, 100% female, 72% Black) delivered by 6 clinicians. Clinicians performed most intervention components consistently and exhibited excellent communication, as coded by objective coders. Adherence discussions took an average of 3.8 minutes, and 44% of patients had ≥ 20% increase in PDC post intervention. In structured interviews, many patients felt heard and valued and described being more honest about nonadherence and more motivated to take SLE medications. Patients emphasized patient-clinician communication and financial and logistical assistance as areas for improvement. Some clinicians wanted additional resources and training to improve adherence conversations. CONCLUSION: We provide further evidence to support the feasibility, acceptability, and fidelity of the adherence intervention. Future work will optimize clinician training and evaluate the intervention's effectiveness in a large, randomized trial.

A qualitative study of facilitators of medication adherence in systemic lupus erythematosus: Perspectives from rheumatology providers/staff and patients.

OBJECTIVE: Systemic lupus erythematosus (SLE) disproportionately affects patients from racial and ethnic minority groups. Medication adherence is lower among these patient populations, and nonadherence is associated with worse health outcomes. We aimed to identify factors that enable adherence to immunosuppressive medications among patients with SLE from racial and ethnic minority groups. METHODS: Using a qualitative descriptive study design, we conducted in-depth interviews with purposefully selected (1) patients with SLE from racial and ethnic minority groups who were taking immunosuppressants and (2) lupus providers and staff. We focused on adherence facilitators, asking patients to describe approaches supporting adherence and for overcoming common adherence challenges and providers and staff to describe actions they can take to foster patient adherence. We used applied thematic analysis and categorized themes using the Capability, Opportunity, Motivation, Behavior (COM-B) model. RESULTS: We interviewed 12 patients (4 adherent and 8 nonadherent based on medication possession ratio) and 12 providers and staff. Although each patient described a unique set of facilitators, patients most often described social support, physical well-being, reminders, and ability to acquire medications as facilitators. Providers also commonly mentioned reminders and easy medication access as facilitators as well as patient education/communication and empowerment. CONCLUSION: Using an established behavioral change model, we categorized a breadth of adherence facilitators within each domain of the COM-B model while highlighting patients' individual approaches. Our findings suggest that an optimal adherence intervention may require a multi-modal and individually tailored approach including components from each behavioral domain-ensuring medication access (Capability) and utilizing reminders and social support (Opportunity), while coupled with internal motivation through improved communication and empowerment (Motivation).

Improving acute myocardial infarction care in northern Tanzania: barrier identification and implementation strategy mapping.

BACKGROUND: Evidence-based care for acute myocardial infarction (AMI) reduces morbidity and mortality. Prior studies in Tanzania identified substantial gaps in the uptake of evidence-based AMI care. Implementation science has been used to improve uptake of evidence-based AMI care in high-income settings, but interventions to improve quality of AMI care have not been studied in sub-Saharan Africa. METHODS: Purposive sampling was used to recruit participants from key stakeholder groups (patients, providers, and healthcare administrators) in northern Tanzania. Semi-structured in-depth interviews were conducted using a guide informed by the Consolidated Framework for Implementation Research (CFIR). Interview transcripts were coded to identify barriers to AMI care, using the 39 CFIR constructs. Barriers relevant to emergency department (ED) AMI care were retained, and the Expert Recommendations for Implementing Change (ERIC) tool was used to match barriers with Level 1 recommendations for targeted implementation strategies. RESULTS: Thirty key stakeholders, including 10 patients, 10 providers, and 10 healthcare administrators were enrolled. Thematic analysis identified 11 barriers to ED-based AMI care: complexity of AMI care, cost of high-quality AMI care, local hospital culture, insufficient diagnostic and therapeutic resources, inadequate provider training, limited patient knowledge of AMI, need for formal implementation leaders, need for dedicated champions, failure to provide high-quality care, poor provider-patient communication, and inefficient ED systems. Seven of these barriers had 5 strong ERIC recommendations: access new funding, identify and prepare champions, conduct educational meetings, develop educational materials, and distribute educational materials. CONCLUSIONS: Multiple barriers across several domains limit the uptake of evidence-based AMI care in northern Tanzania. The CFIR-ERIC mapping approach identified several targeted implementation strategies for addressing these barriers. A multi-component intervention is planned to improve uptake of evidence-based AMI care in Tanzania.

Patient Characteristics Associated with Telemedicine Use for Diabetes Mellitus Care: Experience of a University Health System.

OBJECTIVES: The objective was to understand the characteristics of patients who used telemedicine for diabetes management to inform future implementation of telemedicine. METHODS: We examined patient characteristics associated with telemedicine use for diabetes mellitus (DM) care between March 1, 2020 and April 1, 2021 (the coronavirus disease 2019 pandemic period) in a large university health system when telemedicine visits increased rapidly. Logistic regression models assessed patient characteristics associated with telemedicine visits and delays in DM process measures (hemoglobin A1c checks, nephropathy, and retinopathy evaluations) during the pandemic period after adjusting for potential confounders and corresponding values before the pandemic period (March 1, 2019-February 29, 2020). RESULTS: A total of 45,159 patients were seen from 987,791 visits during the pandemic period. The number of visits averaged one visit less during the pandemic period than before the pandemic period. Approximately 5.4% of patients used telemedicine during the pandemic period from 42,750 visits. The mean (standard deviation) telemedicine visit was 1.28 (0.91). Men, Asian, Black, and other race (vs White), having Medicare or uninsured (vs private insurance), were less likely to use telemedicine. Patients with more visits before the pandemic period were more likely to use telemedicine and less likely to experience a delay in DM process measures during the pandemic period. Telemedicine users were 18% less likely to experience a delay in nephropathy visits than nonusers, but without difference for other process measures. CONCLUSIONS: Race, sex, insurance, and prepandemic in-person visits were associated with telemedicine use for DM management in a large health system. Telemedicine use was not associated with delays in hemoglobin A1c testing, nephropathy, and retinopathy assessments. Understanding reasons for not using telemedicine is important to be able to deliver equitable DM care.

Evaluating Therapeutic Inertia in Two Telehealth Interventions for Type 2 Diabetes: Secondary Analyses of a Randomized Trial.

Introduction: Although therapeutic inertia is a known driver of suboptimal type 2 diabetes control, little is known about how to combat this phenomenon. We analyzed randomized trial data to determine whether a comprehensive telehealth intervention was more effective than a less structured telehealth approach (telemonitoring and care coordination) at promoting treatment intensification in poorly controlled diabetes. Methods: Patients with poorly controlled type 2 diabetes were randomized 1:1 to telemonitoring/care coordination or a comprehensive telehealth intervention, which included an active, study provider-guided medication management component. Prospectively collected medication lists were used to determine whether treatment intensification occurred for each patient during 3-month intervals throughout the study period. To examine between-arm differences in treatment intensification over time, we fit a generalized estimation equation model. In each arm, hemoglobin A1c levels at the beginning and end of each 3-month interval were used to distinguish between therapeutic inertia and potentially appropriate nonintensification of treatment. Results: The mean, model-estimated likelihood of treatment intensification during 3-month intervals was 61.3% in the comprehensive telehealth group versus 48.6% for telemonitoring/care coordination (odds ratio 1.7, 95% confidence interval 1.2-2.2; p = 0.0007), with no evidence that treatment effect varied over time (p = 0.54). Treatment intervals with observed therapeutic inertia were more common in the telemonitoring/care coordination arm than the comprehensive telehealth arm (116/300, 39% vs. 57/275, 21%). Conclusions: A comprehensive telehealth approach that integrated protocol-guided medication management increased treatment intensification and reduced therapeutic inertia compared with a less structured telehealth approach. The studied approaches may serve as examples of how systems might use telehealth to combat therapeutic inertia. Clinical Trial Registration: ClinicalTrials.gov NCT03520413.

Research Inclusion Across the Lifespan: A Good Start, but There Is More Work to Be Done.

While older adults account for a disproportionate amount of healthcare spending, they are often underrepresented in clinical research needed to guide clinical care. The purpose of this perspective is to make readers aware of new data on age at enrollment for participants included in National Institutes of Health (NIH)-funded clinical research. We highlight key findings of relevance to general internal medicine and suggest ways readers could support the inclusion of older adults in clinical research. Data from the NIH Research Inclusion Statistics Report show that there were 881,385 participants enrolled in all NIH-funded clinical research in 2021, of whom 170,110 (19%) were 65 years and older. However, on average, studies included a far lower percentage of older adults. Additionally, there were many conditions for which overall enrollment rates for older adults were lower than would be expected. For example, while 10% of participants in studies related to diabetes were ≥ 65 years old, older individuals represent 43% of all prevalent diabetes in the USA. Researchers should work with clinicians to advocate for older adults and ensure their participation in clinical research. Best practices and resources for overcoming common barriers to the inclusion of older adults in research could also be disseminated.

Incorporating TechQuity in Virtual Care Within the Veterans Health Administration: Identifying Future Research and Operations Priorities.

BACKGROUND: The Covid-19 pandemic dramatically changed healthcare delivery, driving rapid expansion of synchronous (i.e., real-time) audio-only and video telehealth, otherwise known as virtual care. Yet evidence describes significant inequities in virtual care utilization, with certain populations more dependent on audio-only virtual care than video-based care. Research is needed to inform virtual care policies and processes to counteract current inequities in access and health outcomes. OBJECTIVE: Given the importance of incorporating equity into virtual care within the Veterans Health Administration (VHA), we convened a Think Tank to identify priorities for future research and virtual care operations focused on achieving equitable implementation of virtual care within the VHA. METHODS: We used participatory activities to engage clinicians, researchers, and operational partners from across the VHA to develop priorities for equitable implementation of virtual care. We refined priorities through group discussion and force-ranked prioritization and outlined next steps for selected priorities. KEY RESULTS: Think Tank participants included 43 individuals from the VHA who represented diverse geographical regions, offices, and backgrounds. Attendees self-identified their associations primarily as operations (n = 9), research (n = 28), or both (n = 6). We identified an initial list of 63 potential priorities for future research and virtual care operations. Following discussion, we narrowed the list to four priority areas: (1) measure inequities in virtual care, (2) address emerging inequities in virtual care, (3) deploy virtual care equitably to accommodate differently abled veterans, and (4) measure and address potential adverse consequences of expanded virtual care. We discuss related information, data, key partners, and outline potential next steps. CONCLUSIONS: This Think Tank of research and operational partners from across the VHA identified promising opportunities to incorporate equity into the design and implementation of virtual care. Although much work remains, the priorities identified represent important steps toward achieving this vital goal.

Time to pain relief: A randomized controlled trial in the emergency department during vaso-occlusive episodes in sickle cell disease.

OBJECTIVE: Compare time to pain relief (minimum of a 13 mm and 30% reduction) during an Emergency Department (ED) visit among patients with sickle cell disease (SCD) experiencing severe pain associated with a vaso-occlusive episode who were randomized to receive either an individualized or weight-based pain protocol. METHODS: A randomized controlled trial in two EDs. Adults with sickle cell disease. Research staff recorded pain scores every 30 min during an ED visit (up to 6 h in the ED) using a 0-100 mm visual analogue scale. Analysis included 122 visits, representing 49 patients (individualized: 61 visits, 25 patients; standard: 61 visits, 24 patients). RESULTS: Pain reduction across 6-h was greater for the individualized compared to the standard protocol (protocol-by-time: p = .02; 6-h adjusted pain score comparison: Individualized: M = 29.2, SD = 38.8, standard: M = 45.3, SD = 35.6; p = .03, Cohen d = 0.43). Hazards models indicated a greater probability of 13 mm (HR = 1.54, 95% CI = 1.05, 2.27, p = .03) and 30% (HR = 1.71, 95% CI = 1.11, 2.63, p = .01) reduction in the individualized relative to the standard protocol. CONCLUSIONS: Patients who received treatment with an individualized protocol experienced a more rapid reduction in pain, including a 13 mm and 30% reduction in pain scores when compared to those that received weight-based dosing.

The Impact of COVID-19 on Hypertension and Hypertension Medication Adherence Among Underrepresented Racial and Ethnic Groups: A Scoping Review.

PURPOSE OF REVIEW: To conduct a scoping review of articles which examined the impact of COVID-19 on HTN and HTN medication adherence among underrepresented racial/ethnic minorities. RECENT FINDINGS: Seven studies were included in this review and impact of COVID-19 was examined at 4 levels: patient, provider, health system and society. The results indicated that patient level factors, such as high unemployment and inequitable access to telemedicine due to society factors- lack of access to high-speed Internet and variation in the offering of telehealth by health systems, were most impactful on adherence. Additionally, provider level clinical inertia may have further impacted adherence to HTN medication. Our review showed that the COVID-19 pandemic did not introduce new barriers but exacerbated preexisting barriers. Ongoing efforts are needed to change policies at the state and local levels to dismantle inequities in underrepresented communities to ensure access to health care with telemedicine to promote health equity.

The impact of COVID-19 on cardiovascular health behaviors in people living with HIV.

The COVID-19 pandemic's impact on cardiovascular health behaviors including diet, physical activity, medication adherence, and self-care among people living with HIV (PLWH) remains unknown. Using qualitative analyses, we examined the impact of the COVID-19 pandemic on cardiovascular health behaviors among PLWH. Twenty-four PLWH were enrolled in this multisite study from September to October 2020. Individuals participated in semi-structured telephone interviews that were recorded, transcribed, and coded by 4 independent coders. Codes were adjudicated and analyzed for common themes. Participants were, on average, 59.2 years old (+/-9.4), 75% African American (n = 18) and 71% male (n = 17). The pandemic altered cardiovascular disease health behaviors. PLWH changed diet based on stay-at-home orders and food access. Alterations in physical activity included transitioning from gym and group class exercise to home-based exercise. Antiretroviral adherence was maintained, even when other health behaviors wavered, suggesting resilience in PLWH that may be harnessed to maintain other health behaviors.

How Medication Adherence Affects Disease Management in Veterans with Glaucoma: Lessons Learned from a Clinical Trial.

INTRODUCTION: We conducted a secondary, real-world clinical assessment of a randomized controlled trial to determine how a glaucoma medication adherence intervention impacted the clinical outcomes of participants at 12 months post-randomization. Participants included veterans at a VA eye clinic with medically treated glaucoma who reported poor adherence and their companions, if applicable. METHODS: The treatment group received a glaucoma education session with drop administration instruction and virtual reminders from a "smart bottle" (AdhereTech) for their eye drops. The control group received a general eye health class and the smart bottle with the reminder function turned off. Medical chart extraction determined if participants in each group experienced visual field progression, additional glaucoma medications, or a recommendation for surgery or laser due to inadequate intraocular pressure control over the 12 months following randomization. The main outcome measure was disease progression, defined as visual field progression or escalation of glaucoma therapy, in the 12 months following randomization. RESULTS: Thirty-six versus 32% of the intervention (n = 100) versus control (n = 100) groups, respectively, experienced disease intensification. There was no difference between the intervention and control groups in terms of intensification (intervention vs. control group odds ratio: 1.20; 95% confidence interval: [0.67, 2.15]), including when age, race, and disease severity were accounted for in the logistic regression model. Those whose study dates included time during the COVID-19 pandemic were evenly distributed between groups. CONCLUSIONS: A multifaceted intervention that improved medication adherence for glaucoma for 6 months did not affect the clinical outcomes measured at 12 months post-randomization. Twelve months may not be long enough to see the clinical effect of this intervention or more than 6 months of intervention are needed.

Specialty preference for cardiovascular prevention practice in the Southeast US and role of a preventive cardiologist.

INTRODUCTION: Cardiovascular disease (CVD) prevention is practiced concurrently by providers from several specialties. Our goal was to understand providers' preference of specialties in CVD prevention practice and the role of preventive cardiologists. MATERIALS AND METHODS: Between 11 October 2021 and 1 March 2022, we surveyed providers from internal medicine, family medicine, endocrinology, and cardiology specialties to examine their preference of specialties in managing various domains of CVD prevention. We examined categorical variables using Chi square test and continuous variables using t or analysis of variance test. RESULTS: Of 956 invitees, 263 from 21 health systems and 9 states responded. Majority of respondents were women (54.5%), practicing physicians (72.5%), specializing in cardiology (43.6%), and working at academic centers (51.3%). Respondents favored all specialties to prescribe statins (43.2%), ezetimibe (37.8%), sodium-glucose cotransporter-2 (SGLT2) inhibitors (30.5%), and aspirin in primary prevention (36.3%). Only 7.9% and 9.5% selected cardiologists and preventive cardiologists, respectively, to prescribe SGLT2 inhibitors. Most preferred specialists (i.e. cardiology and endocrinology) to manage advanced lipid disorders, refractory hypertension, and premature coronary heart disease. The most common conditions selected for preventive cardiologists to manage were genetic lipid disorders (17%), cardiovascular risk assessment (15%), dyslipidemia (13%), and refractory/resistant hypertension (12%). CONCLUSIONS: For CVD prevention practice, providers favored all specialties to manage common conditions, specialists to manage complex conditions, and preventive cardiologists to manage advanced lipid disorders. Cardiologists were least preferred to prescribe SGLT2 inhibitor. Future research should explore reasons for selected CVD prevention practice preferences to optimize care coordination and for effective use of limited expertise.

Provider Interaction With an Electronic Health Record Notification to Identify Eligible Patients for a Cluster Randomized Trial of Advance Care Planning in Primary Care: Secondary Analysis.

BACKGROUND: Advance care planning (ACP) improves patient-provider communication and aligns care to patient values, preferences, and goals. Within a multisite Meta-network Learning and Research Center ACP study, one health system deployed an electronic health record (EHR) notification and algorithm to alert providers about patients potentially appropriate for ACP and the clinical study. OBJECTIVE: The aim of the study is to describe the implementation and usage of an EHR notification for referring patients to an ACP study, evaluate the association of notifications with study referrals and engagement in ACP, and assess provider interactions with and perspectives on the notifications. METHODS: A secondary analysis assessed provider usage and their response to the notification (eg, acknowledge, dismiss, or engage patient in ACP conversation and refer patient to the clinical study). We evaluated all patients identified by the EHR algorithm during the Meta-network Learning and Research Center ACP study. Descriptive statistics compared patients referred to the study to those who were not referred to the study. Health care utilization, hospice referrals, and mortality as well as documentation and billing for ACP and related legal documents are reported. We evaluated associations between notifications with provider actions (ie, referral to study, ACP not documentation, and ACP billing). Provider free-text comments in the notifications were summarized qualitatively. Providers were surveyed on their satisfaction with the notification. RESULTS: Among the 2877 patients identified by the EHR algorithm over 20 months, 17,047 unique notifications were presented to 45 providers in 6 clinics, who then referred 290 (10%) patients. Providers had a median of 269 (IQR 65-552) total notifications, and patients had a median of 4 (IQR 2-8). Patients with more (over 5) notifications were less likely to be referred to the study than those with fewer notifications (57/1092, 5.2% vs 233/1785, 13.1%; P<.001). The most common free-text comment on the notification was lack of time. Providers who referred patients to the study were more likely to document ACP and submit ACP billing codes (P<.001). In the survey, 11 providers would recommend the notification (n=7, 64%); however, the notification impacted clinical workflow (n=9, 82%) and was difficult to navigate (n=6, 55%). CONCLUSIONS: An EHR notification can be implemented to remind providers to both perform ACP conversations and refer patients to a clinical study. There were diminishing returns after the fifth EHR notification where additional notifications did not lead to more trial referrals, ACP documentation, or ACP billing. Creation and optimization of EHR notifications for study referrals and ACP should consider the provider user, their workflow, and alert fatigue to improve implementation and adoption. TRIAL REGISTRATION: ClinicalTrials.gov NCT03577002; https://clinicaltrials.gov/ct2/show/NCT03577002.

Availability of Specialty Services for Cardiovascular Prevention Practice in the Southeastern United States.

OBJECTIVES: A comprehensive cardiovascular disease (CVD) prevention approach should address patients' medical, behavioral, and psychological issues. The aim of this study was to understand the clinician-reported availability of a pertinent CVD preventive workforce across various specialties using a survey study in the southeastern United States, an area with a disproportionate burden of CVD and commonly known as the Stroke Belt. METHODS: We surveyed physicians, advanced practice providers (APPs), and pharmacists in internal medicine, family medicine, endocrinology, and cardiology regarding available specialists in CVD preventive practice. We examined categorical variables using the χ2 test and continuous variables using the t test/analysis of variance. RESULTS: A total of 263 clinicians from 21 health systems participated (27.6% response rate, 91.5% from North Carolina). Most were women (54.5%) and physicians (72.5%) specializing in cardiology (43.6%) and working at academic centers (51.3%). Overall, most clinicians stated having adequate specialist services to manage hypertension (86.6%), diabetes mellitus (90.1%), and dyslipidemia (84%), with >50% stating having adequate specialist services for obesity, smoking cessation, diet/nutrition, and exercise counseling. Many reported working with an APP (69%) or a pharmacist (56.5%). Specialist services for exercise therapy, psychology, behavioral counseling, and preventive cardiology were less available. When examined across the four specialties, the majority reported having adequate specialist services for hypertension, diabetes mellitus, obesity, dyslipidemia, and diet/nutrition counseling. Providers from all four specialties were less likely to work with exercise therapists, psychologists, behavioral counselors, and preventive cardiologists. CONCLUSIONS: A majority of providers expressed having adequate specialists for hypertension, diabetes mellitus, dyslipidemia, obesity, smoking cessation, diet/nutrition, and exercise counseling. Most worked together with APPs and pharmacists but less frequently with exercise therapists, psychologists, behavioral counselors, and preventive cardiologists. Further research should explore approaches to use and expand less commonly available specialists for optimal CVD preventive care.

Team-Based Qualitative Rapid Analysis: Approach and Considerations for Conducting Developmental Formative Evaluation for Intervention Design.

Qualitative rapid analysis is one of many rapid research approaches that offer a solution to the problem of time constrained health services evaluations and avoids sacrificing the richness of qualitative data that is needed for intervention design. We describe modifications to an established team-based, rapid analysis approach that we used to rapidly collect and analyze semi-structured interview data for a developmental formative evaluation of a cardiovascular disease prevention intervention. Over 18 weeks, we conducted and analyzed 35 semi-structured interviews that were conducted with patients and health care providers in the Veterans Health Administration to identify targets for adapting the intervention in preparation for a clinical trial. We identified 12 key themes describing actionable targets for intervention modification. We highlight important methodological decisions that allowed us to maintain rigor when using qualitative rapid analysis for intervention adaptation and we provide practical guidance on the resources needed to execute similar qualitative studies. We additionally reflect on the benefits and challenges of the described approach when working within a remote research team environment.ClinicalTrials.gov: NCT04545489.

Moving from the Trial to the Real World: Improving Medication Adherence Using Insights of Implementation Science.

Medication nonadherence is a serious public health concern. Although there are promising interventions that improve medication adherence, most interventions are developed and tested in tightly controlled research environments that are dissimilar from the real-world settings where the majority of patients receive health care. Implementation science methods have the potential to facilitate and accelerate the translation shift from the trial world to the real world. We demonstrate their potential by reviewing published, high-quality medication adherence studies that could potentially be translated into clinical practice yet lack essential implementation science building blocks. We further illustrate this point by describing an adherence study that demonstrates how implementation science creates a junction between research and real-world settings. This article is a call to action for researchers, clinicians, policy makers, pharmaceutical companies, and others involved in the delivery of care to adopt the implementation science paradigm in the scale-up of adherence (research) programs.