Faculty Bibliography

Background: In ED patients who present with acute drug overdose, severe QTc prolongation (>500 ms) has been shown to be a predictor of adverse cardiovascular events (ACVE). However, it is unclear what clinical factors are associated with delayed severe QTc prolongation (dsQTp), and it is unknown whether dsQTp can predict ACVE. This study aims to: (1) Define clinical factors associated with dsQTp, and (2) test whether dsQTp is an independent predictor for ACVE.
Method(s): This was a prospective cohort study at 2 urban tertiary care EDs. Data was collected by trained research assistants, and included demographics, drug exposure, medication administration, initial and repeat ECG data, lab data, and outcome measures. dsQTp was defined as presence of initial QTc 499. The primary study outcome was the composite of ACVE defined as in-hospital occurrence of any of the following: MI, shock, ventricular dysrhythmia, and cardiac arrest. Univariate statistics and multivariable logistic regression calculations were made using SPSS version 24. With a fixed sample size of 1670, we calculated that we would have 99% power to show a 3-fold increase in risk with 0.05 alpha.
Result(s): Out of 2311 patients screened, 641 were excluded (age 500) leaving 1670 patients for analysis. The dsQTp group (N = 27) was found to be older than the control group (N = 1643)(40.1 vs 51.6, P
Conclusion(s): This cohort study reveals a subset of ED patients who are at greater risk of overdose-related ACVE but not immediately apparent by the initial ECG. Further study is needed to identify which patients are at risk for dsQTp, as they may require prolonged observation and repeated ECGs. Limitations include missing repeat QTc measurements, and inability to control for overdose severity as a surrogate for repeat ECGs. Future study is warranted to further characterize patients at risk for dsQTp to evaluate other exposure-related factors as yet undiscovered

Persons living with human immunodeficiency virus (PLHIV) are at increased risk of atherosclerotic cardiovascular disease (ASCVD). In spite of this, uptake of evidence-based clinical interventions for ASCVD risk reduction in the HIV clinic setting is sub-optimal. METHODS: EXTRA-CVD is a 12-month randomized clinical effectiveness trial that will assess the efficacy of a multi-component nurse-led intervention in reducing ASCVD risk among PLHIV. Three hundred high ASCVD risk PLHIV across three sites will be randomized 1:1 to usual care with generic prevention education or the study intervention. The study intervention will consist of four evidence-based components: (1) nurse-led care coordination, (2) nurse-managed medication protocols and adherence support (3) home BP monitoring, and (4) electronic health records support tools. The primary outcome will be change in systolic blood pressure and secondary outcome will be change in non-HDL cholesterol over the course of the intervention. Tertiary outcomes will include change in the proportion of participants in the following extended cascade categories: (1) appropriately diagnosed with hypertension and hyperlipidemia (2) appropriately managed; (3) at treatment goal (systolic blood pressure <130 mm Hg and non-HDL cholesterol < National Lipid Association targets). CONCLUSIONS: The EXTRA-CVD trial will provide evidence appraising the potential impact of nurse-led interventions in reducing ASCVD risk among PLHIV, an essential extension of the HIV care continuum beyond HIV viral suppression.

BACKGROUND:Process evaluation is increasingly recognized as an important component of effective implementation research and yet, there has been surprisingly little work to understand what constitutes best practice. Researchers use different methodologies describing causal pathways and understanding barriers and facilitators to implementation of interventions in diverse contexts and settings. We report on challenges and lessons learned from undertaking process evaluation of seven hypertension intervention trials funded through the Global Alliance of Chronic Diseases (GACD). METHODS:Preliminary data collected from the GACD hypertension teams in 2015 were used to inform a template for data collection. Case study themes included: (1) description of the intervention, (2) objectives of the process evaluation, (3) methods including theoretical basis, (4) main findings of the study and the process evaluation, (5) implications for the project, policy and research practice and (6) lessons for future process evaluations. The information was summarized and reported descriptively and narratively and key lessons were identified. RESULTS:The case studies were from low- and middle-income countries and Indigenous communities in Canada. They were implementation research projects with intervention arm. Six theoretical approaches were used but most comprised of mixed-methods approaches. Each of the process evaluations generated findings on whether interventions were implemented with fidelity, the extent of capacity building, contextual factors and the extent to which relationships between researchers and community impacted on intervention implementation. The most important learning was that although process evaluation is time consuming, it enhances understanding of factors affecting implementation of complex interventions. The research highlighted the need to initiate process evaluations early on in the project, to help guide design of the intervention; and the importance of effective communication between researchers responsible for trial implementation, process evaluation and outcome evaluation. CONCLUSION/CONCLUSIONS:This research demonstrates the important role of process evaluation in understanding implementation process of complex interventions. This can help to highlight a broad range of system requirements such as new policies and capacity building to support implementation. Process evaluation is crucial in understanding contextual factors that may impact intervention implementation which is important in considering whether or not the intervention can be translated to other contexts.

BACKGROUND:Ineffective referral networks in low- and middle-income countries hinders access to evidence-based therapies by hypertensive patients, leading to high cardiovascular mortality and morbidity. The STRENGTHS (Strengthening Referral Networks for Management of Hypertension Across Health Systems) study evaluates strategies to improve referral processes utilizing the International Association of Public Participation framework to engage stakeholders. OBJECTIVES/OBJECTIVE:This study sought to identify and engage key stakeholders involved in referral of patients in the Ministry of Health, western Kenya. METHODS:Key stakeholders involved in policy formulation, provision, or consumption of public health care service were mapped out and contacted by phone, letters, and emissaries to schedule meetings, explain research objectives, and obtain feedback. RESULTS:Key stakeholders identified were the Ministry of Health, the Academic Model Providing Access to Healthcare, health professionals, communities and their leadership, and patients. Engaging them resulted in permission to contact research in their areas of jurisdiction and enabled collaboration in updating care protocols with emphasis on timely and appropriate referrals. CONCLUSIONS:Early stakeholder identification and engagement using the International Association of Public Participation model eased explanation of research objectives, building consensus, and shaping the interventions to improve the referral process.

BACKGROUND:Elevated blood pressure is the leading risk for mortality in the world. Task redistribution has been shown to be efficacious for hypertension management in low- and middle-income countries. However, the workforce requirements for such a task redistribution strategy are largely unknown. Therefore, we developed a needs-based workforce estimation model for hypertension management in western Kenya, using need and capacity as inputs. METHODS:Key informant interviews, focus group discussions, a Delphi exercise, and time-motion studies were conducted among administrative leadership, clinicians, patients, community leaders, and experts in hypertension management. These results were triangulated to generate the best estimates for the inputs into the health workforce model. The local hypertension clinical protocol was used to derive a schedule of encounters with different levels of clinician and health facility staff. A Microsoft Excel-based spreadsheet was developed to enter the inputs and generate the full-time equivalent workforce requirement estimates over 3 years. RESULTS:Two different scenarios were modeled: (1) "ramp-up" (increasing growth of patients each year) and (2) "steady state" (constant rate of patient enrollment each month). The ramp-up scenario estimated cumulative enrollment of 7000 patients by year 3, and an average clinical encounter time of 8.9 min, yielding nurse full-time equivalent requirements of 4.8, 13.5, and 30.2 in years 1, 2, and 3, respectively. In contrast, the steady-state scenario assumed a constant monthly enrollment of 100 patients and yielded nurse full-time equivalent requirements of 5.8, 10.5, and 14.3 over the same time period. CONCLUSIONS:A needs-based workforce estimation model yielded health worker full-time equivalent estimates required for hypertension management in western Kenya. The model is able to provide workforce projections that are useful for program planning, human resource allocation, and policy formulation. This approach can serve as a benchmark for chronic disease management programs in low-resource settings worldwide.

Objective: Sodium bicarbonate therapy (SBT) is provided in the emergency department (ED) for a variety of indications but its use is controversial. Some authors recommend SBT for overdoses of salicylates and sodium channel antagonists (e.g. tricyclic antidepressants [TCAs]). Due to its effect in lowering serum potassium, however, SBT administration may prolong the QTc interval and potentially cause increased rates of adverse cardiovascular events (ACVE), such as ventricular dysrhythmias. To quantify this risk, we evaluated an emergency department (ED) overdose patient population for the association between SBT and ACVE.
Method(s): We prospectively analyzed consecutive ED patients with acute drug overdose who were given SBT at two urban teaching hospitals from 2015-present. Data included SBT indication, dose, duration, and QTc (initial/peak from computer generated Bazett correction) during hospital stay. We used median values to dichotomize total dose (high/low) and total duration (long/short) of SBT. Patients were prospectively followed to hospital discharge for the occurrence of the primary outcome: ACVE and/or mortality. The previously validated definition of ACVE was used for in-hospital occurrence of any of the following: ventricular dysrhythmia, myocardial infarction, shock requiring vasopressors, and cardiac arrest [1]. Severe QTc prolongation was defined as previously validated using the cut off >=500ms. Occurrence of ventricular dysrhythmia was adjudicated by a blinded cardiologist.
Result(s): Indications for SBT in 30 patients analyzed were: salicylism (n= 5), sodium channel antagonist (6 TCA, 5 other), wide QRS in absence of known drug (n= 9), acidosis or cardiac arrest (n= 3), and unknown (n= 2). After SBT, severe QTc prolongation occurred in 6 (20%), ACVE in 17 (57%), and 6 patients (20%) died. There was a significant association between severe QTc prolongation in-hospital for both high dose and long duration groups (p < 0.05 for both). There was a significant correlation between both SBT dose (83% high, 38% low, p < 0.05) and SBT duration (100% long, 25% short, p < 0.05) with the primary outcome.
Conclusion(s): ED patients with acute drug overdose receiving SBT had very high rates of mortality and ACVE, which were strongly associated with higher dose and longer duration of SBT. Severity of overdose may represent a limitation to interpretation as a potential confounder. Overall, these results are consistent with the hypothesis that SBT may cause unintended ACVE, and validates previous safety concerns regarding the administration of SBT to overdose patients

The American Association of Clinical Endocrinologists (AACE) has created a transculturalized diabetes chronic disease care model that is adapted for patients across a spectrum of ethnicities and cultures. AACE has conducted several transcultural activities on global issues in clinical endocrinology, and completed a 3-city series of conferences in December 2017 that focused on diabetes care for ethnic minorities in the U.S. Proceedings from the "Diabetes Care Across America" series of transcultural summits are presented here. Information from community leaders, practicing health care professionals, and other stakeholders in diabetes care is analyzed according to biological and environmental factors. Four specific U.S. ethnicities are detailed: African Americans, Latino/Hispanics, Asian Americans, and Native Americans. A core set of recommendations to culturally adapt diabetes care is presented that emphasizes culturally appropriate terminology, transculturalization of white papers, culturally adapting clinic infrastructure, flexible office hours, behavioral medicine especially motivational interviewing and building trust, culturally competent nutritional messaging and health literacy, community partnerships for care delivery, technology innovation, clinical trial recruitment and retention of ethnic minorities, and more funding for scientific studies on epigenetic mechanisms of cultural impact on disease expression. It is hoped that through education, research, and clinical practice enhancements, diabetes care can be optimized in terms of precision and clinical outcomes for the individual and U.S. population as a whole.