Post-ACS Glycemic Control 1 Running head: POST-ACS GLYCEMIC CONTROL Reducing Rehospitalization Rates by Improving Glycemic Control among Post-Acute Coronary Syndrome Patients Jennifer Brumfield, Vernon Kubiak, and Diana Stone Idaho State University Post-ACS Glycemic Control 2 Reducing Rehospitalization Rates by Improving Glycemic Control among Post-Acute Coronary Syndrome Patients The basis of this proposal is professional nursing experience with Type 2 diabetes mellitus (DM) patients hospitalized for Acute Coronary Syndrome (ACS) and the elevated readmission rates for these same patients with further cardiovascular difficulties despite facility interventions and standard discharge planning. Expectations are that the successful completion of this proposal will generate evidence to support the application of improved glycemic control measures for DM patients who have recently experienced an ACS, with the anticipation that these improved controls will reduce the readmission rates through enhanced cardiovascular recovery. This will also then reduce overall hospitalization and secondary care costs. Introduction Background Type 2 DM is a common disease process affecting 3% to 5% of people living in the Western hemisphere. Subsequent cardiovascular changes, including cardiovascular disease, coronary heart disease, stroke, and peripheral vascular disease are major causes of mortality and morbidity among patients with DM (Peter, Cox, & Evans, 2008). Patients with DM have been found to have up to a fourfold increased risk of acquiring cardiovascular disease and almost twice the risk of early mortality following an acute myocardial infarction (AMI) when compared to nondiabetics (Zarich, 2005). Although the control of DM has received significant attention in guidelines for the prevention and treatment of cardiovascular diseases, including ACS, many DM patient surveys identify poor adherence to recommended glycemic control levels (Steinberg, 2008). Moreover, despite this significant attention, According to Green Conway et al (2006), only two-thirds of diabetic patients with ACS have an HbA1c Post-ACS Glycemic Control 3 (glycosylated hemoglobin) assessment to evaluate glycemic control on discharge. Despite known inadequate short and long-term glycemic control, many of these patients also do not have adjustments made to their diabetic therapy to improve their glycemic levels and reduce their risks of further cardiovascular disease progression. Problem Identification The following problem requires further study: Do male patients between the ages of 40 to 66 years old with a pre-existing history of Type 2 DM hospitalized for an ACS present with improved clinical outcomes as evidenced by reduced re-admission rates if a tight glycemic control regime is implemented for the first three months following initial discharge. Individual components of the research problem are identified in Table 1 below. Table 1: Research Problem Identification Population Male patients between the ages of 40 to 66 years old with a pre-existing history of Type 2 DM hospitalized for an ACS Intervention Implementation of a tight glycemic control regime for the first three months following initial discharge Comparison Standard glycemic controls [based on American Diabetes Association (ADA) protocols] Outcome Present with a better clinical outcome as evidenced by reduced rehospitalization rates The specific population chosen for this proposal is based on the following criteria: males have a roughly 50% risk of developing coronary artery disease after the age of 40; between 70% to 89% of sudden cardiac events occur in males; the average age of a first heart attack for men is Post-ACS Glycemic Control 4 66 years (CDC, 2008); and DM is associated with an increased risk for cardiovascular disease and its complications (McGuire et al, 2004). The specific intervention chosen for examination in this proposal is based on the presumption that the assessment and thorough control of DM will improve the cardiovascular outcomes of patients with ACS (Green Conaway et al, 2006). The comparison chosen for this proposal is based on a patient following a standard glycemic control regime following initial discharge vs. a patient following an improved, tighter glycemic control regime following discharge. The outcome is based on the frequency of readmission required for DM patients experiencing their first ACS event. Proposal Significance Type 2 diabetes mellitus (DM) is a common disease process. Subsequent cardiovascular changes are major causes of mortality and morbidity among patients with DM (Peter, Cox, & Evans, 2008). Evidence from several trials, including the Diabetes Control and Complications Trial and the United Kingdom Prospective Diabetes Study, show that tight glycemic control levels can significantly reduce chronic diabetic complications (Fisher & Kapustin, 2007). With the increase in obesity and insulin resistance, the prevalence of DM is expected to double by the year 2030, and will increase the hospitalization and care of patients with cardiovascular disease attributable to DM (Donahoe et al., 2007). The total estimated cost of DM in 2007 is $174 billion, including $116 billion in total medical expenditures and $58 billion from reduced national productivity. The medical costs include $27 billion for direct care, $58 billion for chronic diabetic complications, and $31 billon in general medical costs. The largest components of diabetic medical expenditures are inpatient Post-ACS Glycemic Control 5 care (50% of total cost). People with DM incur average costs of $11,744 per year, of which $6,649 is directly attributed to diabetes. People with DM have, on average, medical costs about 2.3 times higher than costs would be without DM (ADA, 2008). Although data is not available on specific costs for DM patients with an ACS, the typical mean length of stay for the initial hospitalization for ACS patients is 4.6 days, with costs averaging $22,921. The costs for ACS patients requiring rehospitalization for ischemic heart disease averaged $28,637 (Menzin, Wygant, Hauch, Jackel, & Friedman, 2008). Clarification of Terms Specific to Proposal Self-Blood Glucose Monitoring People with diabetes have an important role in their own medical care, and self-glucose monitoring is an opportunity for people with diabetes to take control of their health. Although diabetes is a chronic condition, it can usually be controlled with lifestyle changes and medication. The main goal of treatment is to keep glycemic levels in the normal or near-normal range. Monitoring blood glucose levels is one of the best ways of determining how well a diabetes treatment plan is working. Fine-tuning of blood glucose levels and treatment also requires that patients monitor their own blood glucose levels on a day-to-day basis. Self-blood glucose monitoring allows a person to know their blood glucose level at any time and helps prevent the immediate and potentially serious consequences of very high or very low blood glucose. Monitoring also enables tighter blood glucose control, which decreases the long-term risks of diabetic complications. Glycated Hemoglobin Glycated hemoglobin (HbA1c), also known as glycosylated hemoglobin or glycohemoglobin, is a series of stable minor hemoglobin components formed from hemoglobin Post-ACS Glycemic Control 6 and glucose. The rate of formation of HbA1ac is directly proportional to glucose concentration, and the level of HbA1c is in a sample of blood represents the glycemic history of the past 120 days (average erythrocyte lifespan) (Goldstein & Little, et al., 2004). Cardiovascular Disease Cardiovascular diseases include coronary heart disease, cerebrovascular disease, raised blood pressure (hypertension), peripheral artery disease, rheumatic heart disease, congenital heart disease, and heart failure. Diabetes Diabetes is a disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches and other food into energy needed for daily life. The cause of diabetes continues to be a mystery, although both genetics and environmental factors such as obesity and lack of exercise appear to play roles. According to the ADA, in order to determine whether or not a patient has pre-diabetes or diabetes, health care providers conduct a Fasting Plasma Glucose Test (FPG) or an Oral Glucose Tolerance Test (OGTT). Either test can be used to diagnose pre-diabetes or diabetes. The ADA recommends the FPG because it is easier, faster, and less expensive to perform. With the FPG test, a fasting blood glucose level between 100 and 125 mg/dl signals pre- diabetes. A person with a fasting blood glucose level of 126 mg/dl or higher has diabetes. In the OGTT test, a person's blood glucose level is measured after a fast and two hours after drinking a glucose-rich beverage. If the two-hour blood glucose level is between 140 and 199 mg/dl, the person tested has pre-diabetes. If the two-hour blood glucose level is at 200 mg/dl or higher, the person tested has diabetes. Post-ACS Glycemic Control 7 Heart Disease The heart is the organ that pumps blood, with its life-giving oxygen and nutrients, to all tissues of the body. If the pumping action of the heart becomes inefficient, vital organs like the brain and kidneys suffer. In addition, if the heart stops working altogether, death occurs within minutes. Life itself is completely dependent on the efficient operation of the heart. Heart disease includes conditions affecting the heart, such as coronary heart disease, heart attack, congestive heart failure, and congenital heart disease. Heart disease is the leading cause of death for men and women in the U.S. Keys to prevention include quitting smoking, lowering cholesterol, controlling high blood pressure, maintaining a healthy weight, and exercising. Acute Coronary Syndrome (ACS) This is an umbrella term used to cover any group of clinical symptoms compatible with acute myocardial ischemia. Acute myocardial ischemia is chest pain due to insufficient blood supply to the heart muscle that results from coronary artery disease (also called coronary heart disease). Acute coronary syndrome thus covers the spectrum of clinical conditions ranging from unstable angina to non-Q-wave myocardial infarction and Q-wave myocardial infarction. These life-threatening disorders are a major cause of emergency medical care and hospitalization in the United States. Coronary heart disease is the leading cause of death in the United States. Unstable angina and non-ST-segment elevation myocardial infarction are very common manifestations of this disease. Key Concepts Diabetes Mellitus and Cardiovascular Pathology The first key concept used in this proposal is that patients with DM will experience pathophysiologic changes and detrimental effects on cardiovascular health that will predispose Post-ACS Glycemic Control 8 the patient to both initial coronary syndromes and recurrence of coronary syndromes following initial hospitalization for coronary disease. This concept is identified in Figure 1. Figure 1: Type II DM and Pathophysiological Changes Adapted from Figure 4, Varughese, G., Tomson, J., & Lip, G. (2005, July). The macrovascular and microvascular disease process in DM is precipitated in part by the effects of DM on the renin–angiotensin–aldosterone system (RAAS). The combination of DM and the commorbitities of hypertension and dislipedemia are known to cause endothial dysfunction resulting in vasoconstriction, plaque rupture, and inflammation. Post-ACS Glycemic Control 9 In addition, the activation of platelets and thrombogenesis is central to cardiovascular disease and unstable coronary syndromes. The enhanced risk of atherosclerosis and the formation of thrombi in DM patients may be related to platelet hyperactivity, a fibrinolytic imbalance, dysfunction in the endothelial layer, dyslipidemia, or changes in blood flow (Varughese, Tomson, & Lip, 2005). Additional factors that precipitate cardiovascular disease in DM patients include alterations in endothelial tissue, abnormalities of extracellular matrix turnover, and arterial stiffness. DM patients also suffer from cardiomyopathy, including left ventricular wall enlargement, often referred to as diabetic cardiomyopathy. Cardiac autonomic neuropathy is also a common complication of DM, resulting in reduced cardiovascular autonomic function. Reduced heart rate variability and prolonged QT intervals are also associated with DM (Varughese, Tomson, & Lip, 2005). Not only are patients with DM predisposed to initial coronary syndromes, but these patients also have reduced viability following these initial events. Patients with DM who experienced coronary syndromes were found to have a higher mortality at 30 days and one year than patients with a coronary syndrome that did not have diabetes (JAMA, 2007). At 30 days patients with diabetes were more likely to possess coronary disease than patients without diabetes (62.0% vs. 48.1%). In addition, based on angiography results, patients without diabetes usually had no, or only single, vessel disease, where patients with diabetes had multi-vessel coronary disease. Mortality at 1 year was significantly higher among diabetes patients presenting with a UA/NSTEMI (7.2% vs. 3.1%) or STEMI (13.2% vs. 8.1%) (JAMA, 2007). Cardiac autonomic neuropathy is further related to poor outcomes of DM patients after acute myocardial infarctions (Varughese, Tomson, & Lip, 2005). Post-ACS Glycemic Control 10 Even traditional therapies, such as low-dose aspirin to mitigate cardiovascular damage after a myocardial infarction, are less effective in DM patients. The reduced response of platelets in patients with DM is related to higher levels of glycosylated hemoglobin (HbA1c). Glycemic Control The second concept used for this proposal is that maintenance of glycemic control can be performed by the patient in a discharged environment using current glucose determination technologies and educational preparation by the professional nurse. Maintenance of glycemic controls is typically based on maintenance of blood glucose levels consistent with the Standards of Medical Care in Diabetes (ADA, 2009). This includes recommendations for self-monitoring and a general HBA1c recommendation of 7%. Additional guidance is provided that reduced HBA1c levels may be appropriate to reduce microvascular complications such as cardiovascular disease, however, definitive guidance is not provided that states this is a consistent recommendation due to lack of research data (ADA, 2009). Maintenance of tight glycemic controls, sometimes called intensive glycemic controls, examines the maintenance of both daily glycemic levels as well as lower HBA1c goals than the general goal of 7% (following testing to determine patient susceptibility to hypoglycemic episodes). Tight glycemic controls will require additional testing and possible insulin administration for Type 2 DM patients to maintain proper body glucose levels. Current technologies available to the DM patient can be used to maintain both daily and HbA1c levels. Some studies have recommended the development of non-invasive measurement systems for blood glucose levels and automated insulin titration systems to improve patient outcomes following an ACS. These systems are currently available to patients, although costs typically restrict usage. Post-ACS Glycemic Control 11 Strict diabetes outpatient intensive management programs (DOIMPs) have shown that daily glycemic and glycosylated hemoglobin (HbA1c) levels can be managed through multidisciplinary diabetes education, complication monitoring, and telephone counseling (Song & Kim, 2009). Tight Glycemic Controls Following Discharge Individuals with DM and coronary syndromes experience an increased risk of death at 30 days and one year after the coronary syndrome (Donahoe et. al, 2007). Several studies have shown that glucose level is a strong, independent, factor in the long-term survivability of diabetic patients experiencing an acute myocardial infarction (Malmberg et al., 2005). Although these facts are known, there is evidence that glucose controls are inadequate in patients following an acute coronary syndrome. Several studies have identified that modifiable risk factors for cardiovascular disease, including glucose levels, are not well controlled (del Cañizo-Gómez, & Moreira-Andrés, 2004) and that physician and nurse counseling about patient lifestyle modification, including reducing risk from modifiable factors, such as poor glucose control, is less than optimal (Egede, 2002). Although results from randomized controlled trials demonstrate that the risk of vascular complications can be reduced by tight glycemic controls in patients with Type 2 diabetes (Skyler et al., 2009), there is room to evaluate whether patient re-admission rates can be reduced using tight glycemic controls. This is the basis of this proposal. Literature Review Key Words and Searches A comprehensive listing of articles reviewed and identified as applicable to this proposal is included in the reference section of this report. Key words used for the literature appraisal Post-ACS Glycemic Control 12 include blood glucose self-monitoring; glycemic control; cardiovascular disease; diabetes; heart disease; and acute coronary syndrome. Standard searches using the above key words were performed on a variety of national databases, including CINAHL, the Cochrane Library, and PubMed. International nursing guidelines, such as those published by the Royal College of Nursing in the United Kingdom, were also examined. Levels of Evidence Standard research evidence levels were used during the literature appraisal. Attempts were made to obtain documentation at the highest classification evidence level. Example documents are listed below in their respective levels. Level Ia Evidence Level Ia Evidence is obtained from meta-analysis of randomized controlled trials and accepted national guidelines. • Donahoe, S.M. Stewart, G.C. McCabe, C. H. Mohanavelu, S. Murphy, S.A. Cannon, C.P. Antman, E. M. (2007). Diabetes and mortality following Acute Coronary Syndromes. Journal of the American Medical Association, 298(7): 765- 775. • Stettler, C. Allemann, S. Juni, P. Cull, C.A. Holman, R. R. Egger, M. Krahenbuhl, S. Diem, P. (2006). Glycemic control and macrovascular disease in types 1 and 2 diabetes mellitus: Meta-analysis of randomized trials. American Heart Journal, 152(1): 27-38. Level Ib Evidence Level Ib evidence is obtained from at least one randomized controlled trial. Post-ACS Glycemic Control 13 • McGuire, D.K, Newby, L.K. Bhapkar, M.V. Moliterno, D.J. Hochman, et. al. (2004). Association of diabetes mellitus and glycemic control strategies with clinical outcomes after acute coronary syndromes. American Heart Journal, 147(2), 246-252. • Vanhorebeek, I., Langouche, L., & G, G. (2007, September 2). Tight blood glucose control: what is the evidence? Critical Care Medicine, 35(9), S496-502. Retrieved March 11, 2009, from CINAHL with Full Text database. Level IIa Evidence Level IIa Evidence obtained from at least one well-designed controlled study without randomization. • Green Conaway, D.L. Enriquez, J.R. Barberena, J.E. Jones, P.G. O'Keefe, J.H. Spertus, J.A. (2006). Assessment of and physician response to glycemic control in diabetic patients presenting with an acute coronary syndrome. American Heart Journal, 152(6), 1022-1027. Level IIb Evidence Level IIb evidence is obtained from at least one other type of well-designed quasi- experimental study (a situation in which implementation of an intervention is without the control of the investigators, but an opportunity exists to evaluate its effect). • Greenberg, B.H. Abraham, W. T. Albert, N.M. Chiswell, K. Clare, R. Gattis Stough, W. Gheorghiade, M. O’Connor, C.M. Sun, J.L. Yancy, C.W. Young, J.B. Fonarow, G.C. (2007). Influence of diabetes on characteristics and outcomes in patients hospitalized with heart failure: A report from the Organized Program to Post-ACS Glycemic Control 14 Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF). American Heart Journal, 154: 647-654. • Iribarren C, Karter AJ, Go AS, et al. (2001). Glycaemic control and heart failure among adult patients with diabetes. Circulation, 103:2668–2673. Level III Evidence Level III evidence is obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies and case studies. • McGuire, D.K, Newby, L.K. Bhapkar, M.V. Moliterno, D.J. Hochman, et. al. (2004). Association of diabetes mellitus and glycemic control strategies with clinical outcomes after acute coronary syndromes. American Heart Journal, 147(2), 246-252. • Peter, R., Cox, A., & Evans, M. (2008, March). Management of diabetes in cardiovascular patients: diabetic heart disease. Heart, 94(3), 369-375. Retrieved February 13, 2009, from CINAHL with Full Text database. Level IV Evidence Level IV evidence is obtained from expert committee reports or opinions and/or clinical experiences of respected authorities. • LeRoith, D., & Rayfield, E. (2007 2). The benefits of tight glycemic control in type 2 diabetes mellitus. Clinical Cornerstone, 8, S19-29. Retrieved March 11, 2009, from CINAHL with Full Text database. • Unger, J. (2007, December 2). Fine-tuning glycemic control using computerized downloading software: a case-based approach. Endocrinology & Metabolism Post-ACS Glycemic Control 15 Clinics of North America, 36, 27-45. Retrieved March 11, 2009, from CINAHL with Full Text database. Previous Research on Proposal The articles identified above provide significant quantitative, as well as qualitative, data associated with the research question posed for this proposal. The connection between DM and cardiovascular disease processes are clear, however, there is a less unified research view on the relationship between glycemic control regimes and the reduced progression of cardiovascular disease following an ACS. It is expected that completion of this proposal will provide a more cohesive view of this nursing problem. Clinical Practice Guidelines Referenced Clinical practice guidelines from the ADA and the American Heart Association are referenced in this proposal and provide a valuable tool for both identifying normal and tight glycemic controls and their effects on cardiovascular disease. These guidelines, however, fall short on providing definitive guidelines on glycemic controls following an ACS and promotion of reduced cardiac rehabilitation times. Literature Synthesis The literature can be synthesized into evidence that glycemic control can affect coronary rehabilitation following an ACS, however, there is a lack of information providing glycemic goals and evidence that can be translated into effective evidence based guidelines. Conceptual and Theoretical Framework Concept Linkage to Project This proposal will use the Orem’s Self Care Theory as a theoretical framework for study. This is based on the glycemic control aspect of the study and the Orem model philosophy that all Post-ACS Glycemic Control 16 "patients wish to care for themselves". Self-care requisites are groups of needs or requirements that Orem identified. They are classified as either: universal self-care requisites, including those needs that all people have; or developmental self-care requisites, including those needs that relate to development of the individual; or health deviation requisites, including those needs that arise because of a patient's condition. Application of Framework to Project and Potential Impacts Dorothea E. Orem’s Theory of Self Care Deficit is predicated on the belief that each individual is conditioned through life experiences to engage in self-care. Orem describes both internal and external conditions that may influence an individual’s self-care. These experiences are influenced by development, socioeconomic background and cultural influences (Parker, 2006). Orem’s theory allows nurses to identify self-care deficits or potential for self-care deficits among individuals suffering from illness (Parker, 2006). According to Sousa et al (2005), an individual must possess self-care agency, the ability to perform specific behaviors, to be successful in glycemic control. An individual’s perception of self-efficacy is a vital component to success in self-care management of diabetes (Sousa et al, 2005). Ludlow and Gein (1995) noted a higher level of self-care among females than males, making the potential for self care deficits higher in males. Using Orem’s theory, care planning is generated through three operations: diagnosis, including establishing contact with the patient and developing a baseline that represents the patient’s sociocultural and environmental background; the prescriptive operation, that includes identifying self-care deficits and needs and planning care; and the regulatory state where the nurse designs the overall system for care (Chitty & Black, 2007). Post-ACS Glycemic Control 17 Applied to this proposal, the patient baseline is established as a Type 2 DM patient with an ACS. Self-care deficits include inability to maintain glycemic control levels within a structured range to facilitate cardiovascular recovery. The regulatory state will include the glycemic control regime that will maintain appropriate glycemic controls. There are several potential impacts based on the proposed framework. Individual sociocultural factors represent a potential impact given the difficulty in applying a general systematic approach to glycemic care that includes diet, medication, and similar sociocultural factors that can make a universal approach difficult to apply. Moreover, there is an assumption that sample selection will minimize bias through the presence of comorbities, although it may be difficult to identify self-care deficits in individuals who do not receive comprehensive health care. Figure 2: Proposal Framework Post-ACS Glycemic Control 18 Post-ACS Glycemic Control 19 Project Implementation Plan for Project Implementation The plan for project implementation will include obtaining the necessary approvals; instrument design; instrument validation; sampling plan implementation, collecting data; analyzing data; and determining the validity of the hypothesis. Barriers to Project Implementation Traditional barriers to evidence based application will be present for the results of this research. These will include barriers such as the implementer not seeing value in the change; implementer failure to see benefit for additional work and a perceived lack of ability to evaluate the quality of the research; lack of administration buy-in; lack of support from other healthcare professionals; and questions on the methodologies used, research statistics, and final conclusions. Specific barriers that may be unique to this research will include: obtaining sufficient viable data to evaluate both a traditional glycemic control and a tight glycemic control regime; difficulty in evaluating patient compliance with the glycemic control regime, especially in compliance to the daily glycemic control levels and variability; and the difficulty in establishing that other comorbities common to patients with cardiovascular disease do not play a significant role in clinical outcomes following an ACS. Required Resources for Project Implementation As this research is proposed as a nonexperimental quantitative research study, resources will include both researcher design and implementation needs; data collection needs; administrative needs; statistical needs; and peer review and assurance of results. Post-ACS Glycemic Control 20 Ethical Considerations Institutional Review Board Approval This nonexperimental quantitative study will include biomedical research involving human participants, and as such in order to protect the rights and welfare of the research subjects Institutional Review Board review and approval will be required. Physical Harm, Discomfort, or Psychological Distress Physical harm, discomfort, and psychological distress may be experienced by the participants in this study; however, this study should not cause any physical harm, discomfort, or psychological distress beyond that which would be normally experienced by a patient following the health care provider’s recommendations associated with glycemic control following an ACS. In some cases, the patient will be required to take oral and/or subcutaneous medication, as well as subject to frequent glucose monitoring which may include venous and capillary blood draws. There may also be dietary restrictions that may cause discomfort and psychological distress. The level of discomfort and stress is typical to patients with DM who require various controls to maintain glycemic levels. Benefits vs. Harm The benefits associated with the completion of this study include improved health as evidenced by reduced rehospitalizations related to glycemic control and cardiovascular response. Harm is limited to increased frequency of medication administration and glycemic monitoring. Undue Influence or Deception There is no planned undue influence or deception in this analysis. Participation is voluntary, with right to refusal and right to terminate at any time in the study. Based on the Post-ACS Glycemic Control 21 anticipated analysis, there is no reasonable vector that would create a situation where undue influence would be probable or possible. Informed Consent Informed consent will be provided in this proposal. The informed consent will include all aspects of the proposed research and any expected or unexpected results with full disclosure during and after the study is completed. Privacy Privacy will be guaranteed under the methodology proposed for the study. The sampling plan and data collection plan will ensure specific patient information is protected in accordance with Federal laws and standards. Vulnerable Populations Although there are several definitions for what constitutes a vulnerable population, typical vulnerable populations are defined as: “Social groups who have an increased relative risk or susceptibility to adverse health outcomes. This differential vulnerability or risk is evidenced by increased comparative morbidity, premature mortality, and diminished quality of life. The fundamental causes of increased susceptibility to disease are attributed to low social and economic status and lack of environmental resources. Groups recognized as vulnerable are the poor; persons subjected to discrimination, intolerance, subordination and stigma; and those who are politically marginalized, disenfranchised, and denied human rights. Vulnerable groups typically include women and children, ethnic people of color, immigrants, gay men and lesbians, the homeless, and the elderly.” (Flaskerud & Winslow, 1998, pg. 1). Post-ACS Glycemic Control 22 Based on this definition, no vulnerable populations are expected to be included in this study. Exclusion Criteria No groups were omitted from this inquiry without valid scientific rationale. The selection of a specific age of males was based solely on frequency of ACS. The inclusion of only male participants was based strictly on frequency of ACS occurrence in that gender. Timeline The following timeline is proposed for the project. The timeline may change as data is collected and analyzed, so as such must be considered somewhat fluid to ensure proper research design is followed. Figure 3: Proposed Proposal Timeline Calendar 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Months Conceptual Phase Problem identification Literature review Clinical fieldwork Theoretical framework Hypothesis formulation Design/Planning Phase Research design Intervention protocols (NA) Population specification Sampling plan Data collection plan Ethics procedures Finalization of plans Empirical Phase Collection of data Data preparation Post-ACS Glycemic Control 23 Calendar 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Months Analytic Phase Data analysis Interpretation of results Dissemination Phase Presentations /reports Utilization of findings Calendar 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Months: Timeline Justification The following justifications are provided for the proposed timeline above. Figure 4: Timeline Justification Conceptual Phase 1. Problem identification Problem identification is required in the preliminary stages of the evidence based proposal process. For this proposal, a group consensus was obtained. 2. Literature review The literature review will require time to both find and analyze the numerous resources available in the field of both cardiology and diabetic nursing and management. These are two large fields, with numerous publications designed strictly around these topics alone. There is a well established relationship between diabetes and an increased risk for cardiovascular disease, however, although there have been several studies to both affirm this relationship and provide clinical recommendations to minimize comorbitities, there appears to be a lack of sufficient guidance to maintain glycemic levels within the needed parameters to prevent further cardiac damage following an initial acute coronary syndrome. 3. Clinical fieldwork Clinical fieldwork will include discussing the problem with healthcare professionals to evaluate both if the problem exists as identified and to see if modifications are needed to the research questions. Clinical fieldwork will also include obtaining the necessary data needed to both establish if the population is accurate and also to verify sufficient numbers of participants will be available. The research team will also have to establish specific glycemic parameters based on existing parameters in use in the field, those recommended by healthcare professionals, and those recommended for use by the results of the literature review. Post-ACS Glycemic Control 24 4. Theoretical framework Basing glycemic control on the patient’s ability or desire to monitor glucose levels we will implement Orem’s self-care theory. The Orem model is based upon the philosophy that all possess self care agency. 5. Hypothesis formulation The proposed project will consist of quantitative nonexperimental research. The hypothesis is proposed as follows: Placing diabetic patients who have experienced an ACS on tight glycemic controls for a three-month period following hospital discharge will show a reduction in rehospitalization rates. The independent variable (the presumed cause) is proposed to be tight glycemic controls. The dependent variable (the presumed effect) is proposed to be a reduction in readmission rates. Design/Planning Phase 6. Research design The overall plan for addressing the research question will need to be very detailed in order to provide a qualified study. Additionally, there will need to be significant collaboration to ensure the study’s integrity is valid. Initially a nonexperimental quantitative research design has been proposed. 7. Intervention protocols The specification of the interventions, as well as the alternative treatment considerations in a nonexperimental study will be considered only from the aspect that the variety of previously utilized treatments must be identified and matched to the criteria of the study. 8. Population specification The population specification was initially set in the hypothesis and the research question; however, the study must be flexible enough to consider changes based on available participants and the validity of the research. 9. Sampling plan The formal plan specifying a sampling method, the sample size, and the procedures for recruiting subjects will need to be established and modified as needed to ensure accurate statistical analysis can be performed. 10. Data collection plan The formal plan and procedures to guide the collection of data in a systematic and standardized fashion will need to be established early in the data collection phase. 11. Ethics procedures All formal ethics procedures to ensure the study adheres to professional, legal, and social obligations will need to be started at the initiation of the study and constantly revisited. Use of the Institutional Review Board will also be required. Post-ACS Glycemic Control 25 12. Finalization of plans All plans must be consolidated prior to initiation of data collection. Empirical Phase 13. Collection of data The data collection, performed in accordance with the data collection procedures, will be performed. As this study will require addressing considerable data, the period for performance of this phase will be likewise scheduled. 14. Data preparation The data will be organized following collection for analysis and determination. Analytic Phase 15. Data analysis The systematic organization and synthesis of the data collected during the previous phase will be conducted. 16. Interpretation of results The analyzed data will be reviewed against the hypothesis to determine if sufficient evidence exists to either support or deny the hypothesis. Dissemination Phase 17. Presentations/reports The results of the research study for will be readied for publication. 18. Utilization of findings Once the findings have been analyzed, if the hypothesis is proven, then standardized protocols based on the results will be developed, tested, and approved. Sampling Plan Basis The sampling plan is designed to specify how the study participants are selected for the study. The statistical conclusion validity will be based on the number of participants selected that will continue to the conclusion of the study. Post-ACS Glycemic Control 26 Population The population will be defined as male patients between the ages of 40 to 66 years old with a pre-existing history of DM hospitalized for an ACS. The basis for this population has been previously identified in the introductory section of this proposal. This population is expected to provide sufficient cases as a source population to allow for further refinement to a target population. Eligibility Eligibility in this study will include those male patients between the ages of 40 to 66 years old with a pre-existing history of Type II DM, controlled by diet, exercise, oral medications, or an insulin regime. The critical aspect of the study is dependent on the cardiovascular implications of the diabetes, and the post-ACS diabetic controls, as opposed to the pre-ACS type of glycemic control used by the participant. The post-ACS diabetic controls may also reflect a combination of therapies that are needed to maintain daily glycemic control and glycosated hemoglobin (HbA1c) level below 7%, or possibly below 6%, depending on the data analyzed. Participants with existing and known comorbidities or primary diagnoses that directly affect the life span, such as terminal cancer, will be excluded from the study to prevent bias. No participants will be excluded from this study due to cost constraints; practical constraints such as location and time issues; or medical constraints other than those previously identified. For the purposes of this study, the typical ACS patient was chosen. This will limit some participation, such as from female participants; however, it was determined to limit the selection to the typical ACS patient to provide a baseline for further studies, if needed. Post-ACS Glycemic Control 27 Sample Given the general parameters identified above, the proposed sampling method will be stratified random sampling. The two strata will be similar in that both strata will include hospitalized Type II diabetic patients who have experienced an ACS. The strata will be dissimilar in that the first strata will include those individuals who are discharged without receiving a specific glycemic monitoring and control regime. The second strata will include those individuals who are discharged with a specific glycemic control regime that maintains daily glucose levels within ideal ranges, as well as the glycosated hemoglobin (HbA1c) at below 7% for the three-month period following discharge. Since the glycosated hemoglobin level is determined as a three-month sample, the daily glycemic levels will also be required. The maintenance of the daily glycemic levels will occur through a variety of regimes. Based on the results of the literature review, it is expected that sufficient study participants will be identified in this strata – roughly one-third of DM patients with an ACS do receive a form of glycemic control on discharge (Green Conway et al, 2006), and this should translate to a sufficient strata for analysis. The sample plan for this proposal is graphically identified in Figure 5 below. Post-ACS Glycemic Control 28 Figure 5: Sample Methods to Reduce Bias In order to reduce bias, once the strata are identified, all further identification of study participants will be based on computer generated randomization without bias. Masking will also be used within each group to reduce bias. Post-ACS Glycemic Control 29 Data Collection Data Collection Plan This proposal will use secondary analyses of existing data that has been generated through the numerous research studies associated with DM and ACS. It is expected these previous studies will provide sufficient information that can be analyzed to identify specific items of interest for the proposal. Data collection will be limited to collection of biophysical data associated with glycemic control and rehospitalization rates. Given the nature of the research, the record-keeping requirements of the facilities (larger hospitals with longevity) that treat DM and ACS, and the recent emphasis on these disease processes, it is expected that the records will be current and comprehensive such that bias from selective deposit and selective survival will not be encountered. The overall data collection plan is summarized in Figure 6. The proposal assumes that a sufficient instrument to collect relevant data will be developed and pre-tested by the researchers. This pre-testing will also be used to verify the efficiency of all forms required by the proposal. It is anticipated that general data, such as participants' age, gender, race or ethnicity, educational background, marital status, and income level will be collected, in addition to the specific data required for analysis. Costs of data collection will include time costs, retrieval costs, and reproduction costs of appropriate objective evidence. Additional costs may be required for independent verification that data manipulation has not inadvertently occurred during collection. Post-ACS Glycemic Control 30 Figure 6: Data Collection Plan Summary Post-ACS Glycemic Control 31 Data Analyses The data analyses phase of this proposal will include a pre-analysis phase that will include ensuring traceability of data collected; general reviews for completeness and applicability; data codification; and selection of appropriate statistical software for data analyses. The preliminary assessment phase of this proposal will include assessing data quality and possible data biasing. This phase will also include restructuring of missing data or elimination of data considered incomplete. The preliminary action phase of this proposal will include data transformation and assignment of scales of data value. The principle analysis phase will include statistical analyses of the data. The interpretation phase will follow, where the data will be evaluated to determine if the hypothesis is proven correct, proven wrong, or indeterminate. Evaluation Plan Plan for Continued Evaluation It is expected that the results of this study will allow evidence based guidelines to be developed for post-ACS Type 2 DM patient glycemic controls that will enhance patient cardiovascular health and reduce readmissions and rehospitalization costs. It will be beneficial to continue to evaluate the health status of the study participants to determine long-term cardiovascular health status as well. Conclusion This proposal will hopefully result in sufficient evidence to support the application of improved glycemic control measures for Type 2 DM patients who have recently experienced an ACS, with the anticipation that these improved controls will reduce the readmission rates of Post-ACS Glycemic Control 32 these patients through enhanced cardiovascular recovery. This will also then reduce overall hospitalization and secondary care costs. An example guideline that may be generated from the research is included in Figure 7 below. Figure 7: Example Guideline Glycemic Control Recommendations for Post-Acute Coronary Syndrome Patients The key concepts of glycemic goals in the post-ACS setting are as follows: 1. Glycosated hemoglobin (HbA1c) is the primary target for glycemic control 2. Goals should be evaluated and designed specific to each patient. The above represents general goals. Goals should be individualized based on the following conditions: Duration of diabetes Ability of patient to maintain treatment guidelines Patient age Comorbidity status Patients who are prone to glycemic variability (such as diabetic patients with severe insulin deficiency, glycemic control must be based on a combination of HbA1c and capillary plasma glucose) Glycemic Recommendations for Post-ACS Patients Glycosated hemoglobin (HbA1c) 6.0 to 7.0%1 Preprandial capillary plasma glucose2 70–130 mg/dl (3.9–7.2 mmol/l) Peak postprandial capillary plasma glucose3 180 mg/dl (10.0 mmol/l) 1. Prior to maintenance of this glycemic range, the patient must be evaluated for susceptibility to hypoglycemic episodes 2. Preprandial glucose measurements should be taken within one hour of meals 3. Postprandial glucose measurements should be taken one to two hours after the start of meals Post-ACS Glycemic Control 33 References and Relevant Documents American Diabetes Association. (2009). 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