Problem
Diabetes has become a major health concern throughout the world; Lewis et al. (2007) state that in the United States (U.S.), an estimated 20.8 million people (7% of the population) have diabetes mellitus, and 41 million more people have pre-diabetes. It has become the fifth leading cause of death in America. The major goals of diabetic management are the reduction of symptoms, promotion of well-being, prevention of acute complications of high glucose levels, and the prevention or delaying of onset and progression of long-term and lasting complications. These goals can only be reached with patient compliance to prescribed treatment regimens. Non-compliance to these regimens can have a devastating impact on the care and overall health of the patient. This study will attempt to isolate the problem of complex medication regimens in type II diabetics and how this contributes to noncompliance.
Review of Literature
Researchers found that improved patient compliance correlated with the use of prescribed regimens consisting of a reduced number of medications or fewer daily dosages. Noncompliance with antihyperglycemic therapy was found to be significant in the study conducted by Guillausseau (2005). The patients’ lack of compliance to prescribed treatment regimen decreases the effectiveness of treatments while increasing the risks for development of other disease related complications. “The effect of low compliance on metabolic control has been shown to represent an increase of up to 1.4% in glycosylated hemoglobin” (Guillausseau, 2005). Data collected showed an increase in patient compliance to prescribed treatment regimens when the daily administration frequency of medications was reduced. The study conducted by Martin, Williams, Haskard, and DiMatteo (2005) suggested patient compliance to prescribed treatment regimens impacted quality patient outcomes. Noncompliance can result in a decline to patient health and well-being. The researchers found that a strong physician and patient relationship was needed when discussing treatment regimens and assisted in maximizing patient compliance. The review concludes that patient compliance is greatly impacted be the prescribed treatment regimen.
The articles in this literature review address the relationship between complex drug therapies and medication noncompliance in the diabetic patient. Of special focus in numerous articles is the discussion of the fixed-dose combination (FDC). The FDC contains two or more medications within the same dosage. They greatly simplify treatment for patients and help patients better adhere to their medication. Bartels (2005) reports that not only do FDCs improve patient adherence, they actually motivate the patient toward improved chronic care management. Kocurek (2009) studied noncompliance by breaking it down into patient-related factors medication-related factors, and prescriber-related factors. Kocurek (2009) views the complexity of the medication regimen as a prescriber-related factor, and a greater barrier to compliancy than side effects or cost. Studies exploring simple versus complex dosing schedules have found that adherence falls off appreciably when regimens become more complicated and affect patients' lifestyles (Martin et al, 2005).
In this literature review, we find support for the theory that complex medication regimens can have a negative effect on patient health. Medication non-compliance among type II diabetics is associated with adverse clinical outcomes (Ho et al., 2006). Noncompliance affects the desired outcome of the medical treatment as well as clinical consequences. (Jin, Sklar, Oh, & Li, 2008). Jin, et al directly connects complex medication regimens to the failure of therapy. Implications for practice are the use of simpler medication dosing regimens to reduce the health risks and complications associated with noncompliance.
Framework
“The Health Belief Model (HBM) is by far the most commonly used theory in health education and health promotion” (Glantz et al., 2002). The underlying concept of HBM is that health behavior is determined by personal beliefs of a person about a disease and the strategies available to decrease its occurrence. The Theory of Reasoned Action (TRA) could explain why a patient's intentions could influence his reasons to follow or disobey treatment plans (Hale, Householder and Greene, 2002). When the diabetic patient is faced with complex medication regimens, the Health Belief Model and the Theory of Reasoned Action both begin to strongly influence the issue of compliance. The complexity of the medication regimen may have an impact on the individual’s health belief regarding the perceived benefit of trying to master the medication regimen, while the theory of reasoned action opens the situation to inhibit the intentions of the individual.
Question/Hypothesis
Research Design
The purpose of this study is to examine the effects of complex drug regimens on non-compliance in adults age 18 years and over with type II diabetes who utilize community health centers in Cuyahoga County, Ohio. A complex medication regimen will be administered to an experimental group, measuring patient resistance or compliance in adults with Type II Diabetes Mellitus, and compared to patients who are noncompliant to the regimen. Data on the physical effects of medication noncompliance will be collected and analyzed to discover whether or not a correlation can be found between complex medication regimens and noncompliance.
