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					                                                        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
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                         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
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(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
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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
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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
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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.
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       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
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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.
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       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).
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        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.
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       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
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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
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               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
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"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).
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        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
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                                      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.
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                                      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
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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).
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          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
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   specification
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   plan
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   plans
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   data
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      Calendar




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                                                                                                                            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


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