Ehete Bahiru, MD
Nominated From: University of Washington
Research Site: Kenya
Research Area: Cardiology
Primary Mentor: Mark Huffman
Research Project
Understanding and Improving Acute Coronary Syndrome in Kenya Using Mixed Methods
Sub-Saharan Africa (SSA) is increasingly facing a dual, and at times triple, disease burden of communicable diseases, HIV, and non-communicable, chronic diseases (NCDs), including ischemic heart disease, which is the leading cause of global deaths.[1] Although infectious diseases including HIV, tuberculosis, and malaria contribute to the top 5 disease burdens in SSA, the prevalence of NCDs is rapidly rising. The prevalence of ischemic heart disease is steadily rising in SSA due to population growth and aging as well as an unfavorable risk factor trends, particularly related to diabetes, obesity, hypertension, and dyslipidemia in the context of
urbanization and globalization.[2]
While the increasing burden of ischemic heart disease in SSA is recognized, few studies have evaluated the presentation, management and outcomes of acute manifestations of ischemic heart disease, such as acute coronary syndrome (ACS). For example, a 2012 prospective registry of 111 patients admitted for ACS at Aga Khan Hospital (2008-2010) demonstrated that approximately half of the patients were admitted with ST-segment elevation myocardial infarction, one-third of patients presented too late for reperfusion, and in-hospital mortality rates were approximately 8% for all patients.[3]. Further, a 2014 retrospective review of the management of ST-elevation myocardial infarction (STEMI) patients from Aga Khan Hospital in Nairobi included only 45 patients and showed that approximately 90% of patients received an electrocardiogram and were seen by a physician within 10 minutes of arrival, while 68% received fibrinolysis therapy. Less than half (43%) of patients undergoing percutaneous coronary intervention had a door-to-balloon time within 90 minutes of arrival, which is the recommended threshold by international professional organizations.[4]
ACS registries and quality improvement studies that began in high-income countries are being adapted to middle-income country settings, such as Brazil, China, and India. For example, the Acute Coronary Events – a Multinational Survey of Current Management Strategies (ACCESS) registry evaluated the presentation, management, and outcomes of patients with ACS from 19 countries and included one SSA country, South Africa.[5] The study included 12,068 adults hospitalized and found that 58% of patients with all types of ACS underwent coronary angiography, with 35% receiving PCI and only 39% of eligible patients with STEMI receiving fibrinolytic therapy. The study highlights the importance of identifying opportunities and acting upon those opportunities to improve rates of reperfusion therapy and reduce the risk of long-term morbidity and mortality in patients with ACS in developing countries.
The overall goal of this project is to create a pilot ACS registry in concert with the local cardiology community at Kenyatta National Hospital. This work will be supported by qualitative research to understand the local facilitators and barriers to optimal ACS care and quality improvement as well as a systematic review on the effects of quality improvement interventions on cardiovascular outcomes for patients with ACS using randomized and quasi-randomized trials. To achieve this goal, we propose the following aims.
Specific Aims:
SPECIFIC AIM 1A: Create an acute coronary syndrome (ACS) registry to evaluate presentation, management, and outcomes of ACS in Kenya.
HYPOTHESIS 1A. We hypothesize that it is feasible to create an ACS registry in Kenya.
The purpose of this registry is to evaluate current presentation, management, and outcomes of patients with acute coronary syndrome in Kenya. We will work with the Department of Cardiology at Kenyatta National Hospital (KNH) affiliated with the University of Nairobi to create the ACS registry. We will use the case report forms developed for the National Heart, Lung, and Blood Institute funded Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) trial based in India (PI: Huffman). We will report and evaluate differences across ACS subtype, namely ST-segment myocardial infarction, non-ST-segment myocardial infarction, and unstable angina to identify gaps in care and errors of commission that might be amenable to intervention to improve processes of care and outcomes.
We will use an electronic data capture system to collect in-hospital data (e.g., REDCap). We will report continuous variables as means with standard deviation or medians if the data skewed. We will report categorical variables as proportions. We will compare groups using analysis of variance, Kruskall Wallis, or Chi-square tests, as appropriate. We will compare in-hospital major adverse cardiovascular event rates (death, re-infarction, stroke, major bleeding, or cardiac arrest) by ACS sub-type using multivariable logistic regression. We will control for covariates from the validated Global Registry Acute Coronary Events (GRACE) risk model, namely age, heart rate, systolic blood pressure, serum creatinine, ST change, cardiac biomarker, or resuscitated cardiac arrest.[6] We will further perform hierarchical logistic regression using a random-effect model to account for within-hospital clustering.
SPECIFIC AIM 1B: Evaluate the association between optimal in-hospital medical therapy and in-hospital outcomes in ACS in Kenya.
HYPOTHESIS 1B: We hypothesize that patients who receive optimal in-hospital medical therapy, defined by the use of dual antiplatelet therapy, heparin, beta blockade, statin, and reperfusion therapy (STEMI only), will have lower in-hospital rates of major adverse cardiovascular events compared with patients who receive non-optimal therapy.
International guidelines for optimal treatment of ACS recommend dual antiplatelet therapy (aspirin + thienopyridine), anticoagulants, beta-blockers, high intensity statins, and reperfusion therapy for patients with ST-segment elevation myocardial infarction.[6] Using the registry created per specific aim 1a, we plan to assess this potential association as well as the potential predictors of optimal in-hospital therapy using multivariable logistic regression as outlined in Specific Aim 1a. The goal of this aim is to define the potential gains from achieving optimal ACS and identifying potentially modifiable factors that would lead to increasing optimal ACS care processes and outcomes.
EXPLORATORY AIM 2: Identify facilitators and barriers to optimal in-hospital ACS care and identify knowledge, attitudes, and behaviors about health care quality improvement interventions through focus group discussions and in-depth interviews with physicians, nurses, and patients.
Because we do not know of similar research in Kenya, we have not provided a corresponding hypothesis for this exploratory aim.
We will lead 6 to 8 focus group discussions and in-depth interviews with groups of physicians, nurses, and patients to understand facilitators and barriers to optimal in-hospital ACS care and knowledge, attitudes, and behaviors about quality improvement interventions. Participants will be asked to complete brief surveys to complement the qualitative data collection. We will begin sampling using a convenience sample of key informants and then use a snowballing technique to recruit additional participants as needed. We will continue recruitment until we reach saturation of key concepts related to quality improvement knowledge, attitudes, and behaviors. Discussions and interviews will be recorded, transcribed, coded, and analyzed using qualitative research software. We will identify themes using a framework analysis and will build off the theoretical model and findings from similar research activities in Kerala, India.
Our team’s prior research in India has led to the development of a model that includes facilitators and barriers prior to first medical contact, at the point of first medical contact, early hospitalization, mid-to-late hospitalization, and at the point of discharge. We have also identified the decision to pursue reperfusion (thrombolysis percutaneous coronary intervention) as an important area of delay in which rates of decisional conflict appear high. It is uncertain whether similar or different themes will emerge in Kenya. The goal of this research aim is to be able to contextualize a future quality improvement intervention to the Kenyan context.
SPECIFIC AIM 3: Perform a systematic review evaluating the effects of quality improvement interventions for patients with acute coronary syndromes.
HYPOTHESIS 3: We hypothesize that we will identify, synthesize, and estimate the effect size and quality of evidence for acute coronary syndrome quality improvement interventions.
The majority of quality improvement programs in the US have been based on non-randomized studies, which have demonstrated powerful associations between improved processes of care and outcomes. However, the primary question remains as to whether or not these interventions are causal and effective and should be scaled. To date, we know of only a limited number of randomized or quasi-randomized trials evaluating the effect of quality improvement interventions for patients with ACS, including: Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes (BRIDGE ACS, Brazil [7]); Clinical Pathways in Acute Coronary Syndrome (CPACS-2 and -3, China [8]); and Acute Coronary Syndrome in Kerala (India; NCT02256657). The first two trials have demonstrated improvements in processes of care but not outcomes, and the second two trials are ongoing. As cardiovascular quality improvement programs increase, it is important to synthesize the state of the science, particularly as our team looks to ultimately develop, implement, and evaluate an ACS quality improvement intervention in Kenya.
Using the infrastructure of the Cochrane Heart Group US Satellite, we will develop and publish a protocol for our systematic review that would include randomized and quasi-randomized trials (e.g., interrupted time series design). We will evaluate outcomes relevant to stakeholders, including in-hospital mortality, major adverse cardiovascular events, health-related quality of life, and costs. We will work with the Cochrane Heart Group US Satellite Trials Search Coordinator to develop and execute our search in multiple databases. We will perform duplicate title screening and full-text review, duplicate data extraction, and data synthesis, where possible. We will evaluate the risk of bias using the Cochrane Risk of Bias Tool (handbook.Cochrane.org) and will rate the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework.[9]
Research Significance
This project proposes to increase understanding of acute coronary syndrome in Kenya through multiple methodologies. Our intent is to identify and promote novel approaches to improve acute coronary care through a collaborative effort across multiple institutions. We plan to work with national and multinational cardiac societies such as the Kenya Cardiac Society and the Pan-African Society of Cardiology with the long-term goal to promote multinational collaboration such as quality improvement trials to increase understanding and improve ACS care in SSA.
Mentors
- Mark Huffman, Northwestern University
- Frederick Bukachi, Kenyatta National Hospital
- Carey Farquhar, University of Washington
- Tecla Temu, Brown School of Public Health
Read more about her project and her mentors: here
Publications
