THE EFFECT OF HEALTH LITERACY ON HEALTH OUTCOMES:
A Research Proposal

	Bader Alwadaany, MSN Student American University of Beirut
	Al-Qadsia, Block 6, St. 63, House 9 Kuwait, Zip Code: 35706 E-mail: wadani999@yahoo.com Phone: (+965) 9999-7656 Kuwait (+961) 7081-6369 Lebanon

ABSTRACT Due to the vast growth of knowledge in the medical and nursing fields and the increased demand on patients to comprehend communicated health information and effectively comply with treatment regimens, health literacy promotion has become the current trend in health care in the United States. Various studies around the world were able to identify a correlation between inadequate health literacy and poor health outcomes; unfortunately, there are few or no published studies regarding the subject in the Middle East. This research proposal examines the effect of the level of health literacy on the hospitalization rate and health-promoting behaviors among the chronically ill patients who live in Kuwait. In addition to the fact that this study corresponds to the research priorities of National Institute of Nursing Research (NINR), it has the potential to offer evidence that could improve nursing practice, enhance patient care, and reduce financial costs of care. As the findings of the study support the relationship between the variables, it would set the stage for further, extensive literature reviews and research to validate the study and develop interventions that would combat health literacy. Keywords: Health Literacy, Health Outcomes.

INTRODUCTION

The vast growth of knowledge in the nursing and medical fields about prevention and prognosis of diseases increase the demand on patients to adhere to certain regimens, which require high health literacy skills to cope with the complex health information. Since most patients have to deal with complex health related information at least on one occasion in their lifetime, they need to comprehend the communicated health information and be capable of evaluating and analyzing it for potential risks and benefits to arrive at an informed decision about certain treatment options. Furthermore, the current trend in health care is to promote health literacy in lay people, thus increasing their ability to make decisions about health issues; to take on healthy behaviors; to search for and use health information; and to communicate effectively with health providers. As health literacy improves in lay people, health care outcomes are expected to improve, which could translate into reduced health care cost.

Health literacy has been defined as a measure of an individuals' ability to perform basic reading and numerical tasks required to optimally function in the health care environment; it was also defined by the Department of Health and Human Services (2000, p.509) as: "The degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions". The Institute of Medicine (2004) mentioned in its report, "Health Literacy a Prescription to End the Confusion" that health literacy is not only about education, a person who has finished high school and knows how to read may still not be able to navigate the health system. Health literacy comes from a convergence of education, cultural and social factors, and health services. While reading, writing, and math skills make up part of the basis of health literacy, many other skills and abilities are also important, such as speaking, listening, having adequate background information, and being able to advocate for oneself in the health system. For patients, health literacy means being able to follow instructions, manage an illness, and take medications properly. For health care professionals, it means helping patients understand and act on health care information¹⁴.

Health literacy of patients could be an essential factor in preventing further deterioration of their health and achieving positive health outcomes. In 1999 the American Medical Association estimated that 90 million people or close to half of all adults in the United States have inadequate health literacy, leading to a higher rate of hospitalization and use of emergency services.

Moreover, poor health literacy is "a stronger predictor of a person's health than age, income, employment status, education level, and race" (Report on the Council of Scientific Affairs, Ad Hoc Committee on Health Literacy for the Council on Scientific Affairs, American Medical Association, 1999, p.554). Low health literacy is positively correlated with poor health outcomes; this statement is largely accepted in the United States because numerous studies have been conducted on that subject and revealed that a strong proportional relationship exists between health literacy and health outcomes.

Since there are few or no published reports addressing the relationship between health literacy and health outcomes in Middle East, studies are needed to support the existence of a relationship between health literacy and the rate of hospitalization and health-promoting behaviors among Patients who suffer from chronic illnesses. The purpose of this study is to measure health literacy in chronically ill patients with hypertension, diabetes or heart disease who live in Kuwait, and to examine the relationship between their health literacy and the rate of hospitalization and health-promoting behaviors.

SIGNIFICANCE

Health literacy and health outcomes correspond to the research priorities established by nursing research agencies, such as the National Institute of Nursing Research (NINR). Also there is a special interest in the study of adherence to treatment and health-promoting behaviors in chronically ill patients. Therefore, this study offers the potential to produce evidence that could improve nursing practice and patient care. Evidence of limited health literacy skills and how that affects patients' health is required to direct nursing team efforts toward identifying and improving health literacy skills and information comprehension in patients; and to enhance patients' education. These goals may be achieved through provision of easy-to-read educational materials, revising nurses' teaching methods, and communication skills.

Another aspect of significance to this study is the potential for reduction of yearly expenditure on chronic patients who are prone to recurrent lengthy hospitalization, once their health literacy is improved.

This study would also have economical significance in the Middle East due to the rising cost of health care and the current economical status of some countries in the Middle East. The findings of this study may be used to estimate the magnitude and prevalence of low health literacy in Kuwait, to develop specific interventions to identify low health literacy patients, and develop educational materials to improve health literacy and subsequently health outcomes.

LITERATURE REVIEW

The National Adult Literacy Survey (NALS) examined literacy in more than 26,000 adults in the United States in 1992⁸. The survey was done in an effort to assess the population's ability to read, understand, and act on aspects encountered as a part of daily life. The findings of the survey were generalized to the United States population to estimate that 94 million people fall into the lowest two levels of five. There were no standard characteristics or a stereotype established by the survey that identifies people with low health literacy; however, most of the studies on literacy suggest that; old age, low socioeconomic status, and people having few years of education were characteristics found to be in most people with low health literacy⁵.

Roper (2002) did telephone interviews with a sample of 967 participants divided into: 150 physicians, 151 pharmacists and 666 patients who were taking prescription medication at the time of the study. The author found that 83 percent of patients simply are either unaware or unwilling to admit to having difficulty with health care information. Nonetheless, the study showed that even though individuals did not report that they had a problem themselves, they believed others did "Although most patients reject the notion that they personally have experienced difficulty with health information, 79 percent of those surveyed stated that they believe that many other people have difficulty"¹³.

In addition, one-third of all patients and two-thirds of physicians knew someone who had health problems because they did not understand how to take a prescription medication correctly¹³. These findings were supported by a report of the California Literacy, Inc. (2003), which stated that low health literacy is widely spread among the population; however, it is difficult to estimate the correct percentage of the health illiterate population due to a number of factors such as, people denying or hiding their illiteracy to prevent embarrassment, people not knowing they had a problem with literacy, or because of a faulty assumption by the assessor based on patients' appearances or carelessly asking patients if they understood the provided information.

Low health literacy is prevalent among chronically ill patients, since it is estimated that 75 percent of persons in the United States with chronic physical or mental health problems are in the lowest literacy category⁶. Kirsch et al. (2002) found in their study about "Adult Literacy in America" that inadequate literacy is especially prevalent among the elderly, the population with the largest burden of chronic disease, and consequently the greatest health-related reading demands. As the demand for learning about their health condition is high, low literacy places the elderly at risk of worsening of their health due to their inability to understand and obtain necessary information.

The previous statement is supported by Williams, Baker and Parker's (1998) study about the "Relationship of Functional Health Literacy to Patients' Knowledge of Their Chronic Disease". A cross-sectional survey was conducted on 402 hypertension patients and 114 diabetic patients from two public hospitals in the United States. Patients' health literacy was assessed while waiting in the clinic; health literacy was measured using the Test of Functional Health Literacy in Adults (TOFHLA), and knowledge of their disease was tested three days later via telephone interviews using two developed questionnaires with an adequate internal consistency, one assessing hypertension knowledge (Cronbach a =0.70) and the other assessing diabetes knowledge (Cronbach a =0.63).

The authors concluded that persons with inadequate literacy who suffer from chronic diseases (i.e., hypertension and diabetes) are less likely to know the basic elements on how to care for their medical problems (e.g., diet modification, warning symptoms, and normal ranges of basic tests), even if they have gone to special classes to learn how to manage their condition¹⁷.

To elaborate, patients' functional health literacy strongly correlated with knowledge of their disease (at P < .001), and patients with inadequate literacy were less likely to answer knowledge question correctly than literate patients (e.g., 60 percent of patients with poor literacy lack knowledge that exercise lowers blood pressure). Even though 73 percent of the diabetic patients attended diabetes education classes, 45% of them had inadequate knowledge about diabetes¹⁷.

This study points out that the problem is not just the lack of information, but also the inability to retain this information; this broadens the scope of the problem by suggesting that limited literacy might be related to poor compliance with recommended treatments. In a prospective study done by Baker et al. (2002), 3260 new Medicare managed care enrollees in four U.S. cities were selected to examine their health literacy level and related risk for hospitalization. The participants' level of health literacy was assessed using TOFHLA.

They were also surveyed on several factors affecting health status and health practices, in addition to collecting demographic data, years of education and income. Hospital admissions were followed up for two years and determined based on claims from the managed care organization. In all statistical analysis a two-sided P< .05 was used to determine statistical significance. The authors suggested that inadequate health literacy could directly affect patients' health and the risk of hospital admission. "The number of chronic conditions was linearly related to the risk of admission and showed a stronger relation to admissions than did the Charlson Comorbidity Index"².

Patients with inadequate and marginal literacy (19.9% and 17.8%) had more than twice the risk of hospitalization than patients with adequate literacy (14.0%); they also tended to remain hospitalized nearly two days longer than those with higher literacy skills (P< .001)². Baker et al. (2002) also found that patients with inadequate functional health literacy are more likely to be unable to read, or to misread directions on prescription labels.

This can lead patients to mix medications or take either too much or too little of their prescribed medications. If patients lack knowledge of their medications or self-care techniques, they may be vulnerable to health problems or even have worsening health that would result in hospital admission.

Almost all of the studies, testing health literacy and health outcomes, found a relationship between low health literacy and deterioration in health status. Although causal relationships between limited health literacy and health outcomes are not yet established, cumulative and consistent findings suggest such a causal connection⁹. This means that health literacy may affect: patients' health, the ability of the health care system to provide effective high-quality health care and teaching, and costs of health care. Several experts have projected the costs of health illiteracy to be as high as 73 billion American dollars annually¹¹. Studies have shown that people with low health literacy understand health information less well, get less preventive health care, such as screenings for cancer, and use expensive health services such as emergency department care more frequently⁹. Furthermore, other recent studies have shown that people with low health literacy are less able to comply with prescribed treatments and self-care routines. They fail to seek preventive care, and they are at higher risk for hospitalization.

As a result, the annual health care costs are four times higher than for those with higher health literacy skills³. In summary, the literature suggests that chronically ill patients are at risk for low health literacy, especially the elderly and those with low education and socioeconomic status. This low literacy was found to be associated with use of health services and ineffective health-promoting behaviors.

RESEARCH QUESTION

Is there a relationship between health literacy in chronically ill patients with hypertension, diabetes or heart disease in Kuwait, and their risk for hospitalization and health-promoting behaviors?

Objectives

1. To determine the level of health literacy among persons with chronic illnesses in Kuwait.
   
2. To assess health-promoting behaviors and risk for hospitalization in Kuwaiti chronically ill patients.
   
3. To examine the existence and strength of a relationship between low health literacy and rates of hospitalization and health-promoting behaviors.
   

Theoretical Framework

The Chronic Care Model (CCM) developed by Wagner (1998) is the framework guiding the hypothesized relationship of the variables in this study. The model aims to improve health care systems at community, organization, practice and patient levels. The chronic care model was developed to correct deficiencies in managing chronic illnesses in the health care system through transformation of the health care system from reactive to proactive and focused on keeping a person as healthy as possible 15. One of the identified deficiencies in the management of chronic disease is that patients are inadequately trained and educated to manage their illness. The CCM emphasizes that chronically ill patients make decisions and engage in behaviors that affect their health, and that self-management support means acknowledging the patient's central role in achieving better outcomes¹⁵. Self-management support includes provision of health information, emotional support, and strategies for living with chronic illness. This study utilizes the chronic care model concept of empowering and preparing patients to manage their condition effectively in order to improve outcomes, as a mean to clarify the relationship between health knowledge and health outcomes, as evidenced by reduced risk for hospitalization and effective health- promoting behaviors.

Definition of variables
Health literacy is defined as the ability to perform basic reading and numerical tasks required to have the capacity to access, obtain, process, and understand basic health information and services needed to optimally function in a healthy manner and make appropriate health decisions.

Risk for hospitalization is defined as the number of times and duration of hospital admissions as a result for deterioration in health due to participants' chronic illness/es.
Health-promoting behaviors are defined as the behaviors and activities of participants that promote or maintain health.

RESEARCH DESIGN AND METHODS

Design

A non-experimental design was selected because the independent variable under study, health literacy, cannot be manipulated. This study utilizes a descriptive prospective (cohort) design that uses quantitative methodology to examine correlation between health literacy and risk for hospitalization and health-promoting behaviors. This type of design was selected because of the nature of the variables under study and the purpose of the study, which is to examine over time the potential effect of the independent variable on the dependant variables as it occurs naturally without intervention or manipulation. One advantage of this type of design is that it eliminates uncertainty about temporality between the studied variables.

Sample

The sample will include 300 participants from medical-surgical units reunited from two hospitals, one private hospital and one public hospital. Power Analysis estimates that to detect an effect size of 0.30 with power equal to 0.80 the sample size has to be 174 participants at a = 0.05. Although Power Analysis suggests a 174 sample size; however, a subgroup analysis for chronic illnesses (Hypertension, Diabetes and Heart disease) is going to be conducted and attrition and of participants is expected; therefore, a bigger sample size is recommended.

Patients' records in both hospitals will be used to draw the sample using a randomized systematic sampling approach; every Kth record-calculated according to the total number of eligible records- will be selected from a computerized list of records that has no order of any sort. The inclusion criteria for participants are a confirmed chronic illness diagnosis (hypertension, diabetes or heart disease), 50 years of age and older, living in Kuwait, and men and women who can read and write. Patients would be excluded if they were hospitalized at the time of the first and second interview, have a mental illness, cognitive impairment, or if they are blind or hearing-impaired. Patients who refuse to participate in the study or do not meet the inclusion criteria will be replaced by other patients using the same sampling technique until a sample of 300 participants is reached.

Procedure

After locating eligible patients, they will be approached via telephone to set up an appointment for interviews at their home. Trained personnel will explain to patients the significance of the study and the value of their participation for the study to succeed. Patients who agree to participate will receive a consent form confirming their agreement to participate and permission to examine files and records to determine date, duration and reason for hospital admission; trained personnel will also guarantee patients' anonymity and confidentiality of their information. During the interview, demographical data, educational level, and income data will be collected and followed by an assessment of the level of health literacy using an Arabic modified version of TOFHLA. Another interview will be scheduled to assess participants' health-promoting behaviors using a translated into Arabic version of Health-Promoting Lifestyle Profile II (HPLP II).

The second interview will be scheduled three days after the first one, so that participants will not lose interest or enthusiasm to be part of the study. At this point, the participants' part in the study has ended. The second outcome variable will be assessed by monitoring hospitalization of participants that are a result of deterioration of health due to their chronic illness/es for a period of two years, starting from the date of the first interview. Data concerning cause of admission, date of admission and duration of admission will be collected bi-annually by accessing participants' files and records from both hospitals. Participants will also be contacted to verify if they were admitted to other hospitals during the period of the study.

Instrument

The research data will be collected using participants' hospital files and questionnaires to measure health literacy and health-promoting behaviors. In addition, a patient information form will be used to collect demographical data, educational level, and income data. Participants will be contacted and their files and records will also be checked for a period of two years for data concerning admission; the data include admitting diagnosis, date and duration of admission.
Health literacy level will be determined using translated into Arabic and modified Test of Functional Health Literacy in Adults, TOFHLA. TOFHLA was developed by Parker and others in 1995. This health literacy tool measures the ability of patients to perform such tasks as reading labels on prescription bottles, instructions about how often to take medication, notices about when is the next doctor's appointment, informed consent forms, instructions about diagnostic tests, and how to complete insurance forms. It includes two sections: one section is on reading comprehension and the other is on numeracy and it takes about 22 minutes to administer¹².

Nurss, J., Parker, R., Williams, M., & Baker, D. (2001) calculated the internal consistency of TOFHLA and Cronbach's Alpha of TOFHLA was 0.98 and the content validity for the test was ensured by using actual hospital medical texts for both the reading comprehension and numeracy subtests. Since some of the items in the instrument are not applicable to the Kuwaiti population, these items will be modified and the instrument will be piloted to examine its validity and reliability. The instrument is not in the public domain, it is available for purchase from Peppercorn Books & Press, Inc.

Health-promoting behaviors will be measured using an Arabic language version of Walker's Health-Promoting Lifestyle Profile II (1995). It consists of six subscales addressing; health responsibility, physical activity, nutrition, spiritual growth, interpersonal growth, and stress management. HPLP II is a 52 items summated rating scale that employs 4-point response format ranging from 1= Never to 4= Routinely. Content validity was established by examining the literature and content experts' evaluation¹⁶. Construct validity was supported by factor analysis that identified a six-dimensional structure of health-promoting lifestyle, by convergence with the Personal Lifestyle Questionnaire (r = 0.678)¹⁶. Internal consistency for subscale alpha coefficients ranged from 0.793 to 0.861 and overall 0.943¹⁶. The author's written consent to permit use of this scale will be obtained from S.N. Walker, University of Nebraska Medical Center.

Protection of Human Rights

The research will be conducted by qualified nurses and trained data collectors to ensure protection of participants' rights. Autonomy and right to self-determination will be maintained throughout the study, by informing participants that they are free to voluntarily participate or withdraw at any time. Confidentiality and anonymity of participants will be preserved by keeping measures to safe-guard their identities and information. Data will be collected from participants information form, two questionnaires and the participants' files. As a measure to maintain comfort and reduce anxiety, questionnaires will be administered on two short and separate meetings in the homes of the participants. Collected data from the questionnaires and records will be securely locked in cabinets with limited access. The names of participants will be coded so that identities remain anonymous. All of the collected data are strictly used for the benefit of this study, and will be destroyed as soon as the study is over. The study carries no apparent risks to participants since it is a correlation study and no interventions or treatments are involved in the design of the study; however, the Institutional Review Board (IRB) will evaluate the ethical aspect of the study's design and methodology to ensure protection of participants' rights.

Data Analysis

Health literacy is the independent variable; it will be divided into three categories; adequate, marginal and inadequate. In order to determine level of health literacy, participants will be assigned to one of the three categories if their score on TOFHLA was: 0-55, 56-76 and 77-100, respectively. The data will be described using percentages for each level; first for participants of both hospitals combined, and then separate percentages for participants from each hospital (objective #1). The first outcome variable is risk for hospitalization: collected data will be the number of times each participant is hospitalized and the length of stay for each hospitalization, measured in number of days. The describing statistics used to assess the first outcome will be the mean and standard deviation (objective #2). Furthermore, comparisons between the groups' length of stay will be described by calculating the percentages for each group. The second outcome is health-promoting behavior, and the describing statistics will be the mean and standard deviation. On each subscale and on the overall scale, participants will be assigned to one of four groups: ineffective, sometimes effective, often effective and effective, if they had a mean score of 0- 1, 1.1- 2, 2.1- 3 and 3.1- 4, respectively (objective #2). The stratifying variables; gender, education level and income will be grouped. Gender will be either male or female. Education level will have four groups ranging from elementary education or lower to college education and higher. Income will also have four groups. The first group contains participants with yearly income of $10,000 and lower, and the fourth group contains participants with higher than $50,000 yearly income. Finally, age will be described using the mean and standard deviation.

The means of number of hospitalizations, the length of stay and the means of health-promoting behaviors instrument for the three health literacy levels of participants, will be tested separately for differences using ANOVA. A multifactor ANOVA will also be used to test the relationship between the stratifying factors and the outcome variables. The correlation between health literacy and the outcome variables will be tested using Pearson r coefficient, to examine the existence and strength of the relationship (research question). A correlation matrix will summarize correlations among the three levels of health literacy, and participants' characteristics (age, gender, education level, and income) as predictors of the two outcomes (number of hospitalizations and scores of health-promoting behaviors instruments), another correlation matrix will be used to identify which chronic condition (Hypertension, Diabetes and Heart disease) has the highest risk for low health literacy and which one is the strongest predictor of the dependant variables. The chi-square test will be used to illustrate the proportion of participants, with specified health literacy level, that fall into a yes or no for hospitalization groups.

In all tests, the significance level (Alpha a) is set at 0.05, and the Confidence Interval will be set at 95%.

CONCLUSION AND LIMITATIONS

If the results of this study fail to support the research hypothesis, a revision of the study's methods and procedures is recommended, and to widen the study's investigation of other variables that may have confounded the results.

The expected limitations of the study may be the effect of attrition of selected participants on the sample to be representative of the population. Since hospitalization or ineffective health-promoting behaviors could be a result of many causes; therefore, the findings are subject to many confounding variables that were not included or in the study; however, the most important variables that would account for other variables were included in the study. For example, income was included in the study and it would account for other variables such as; access to health care and medications, clean and safe households.

As the findings of this study support that health literacy is related to the rate of hospitalization and health-promoting behaviors in chronically ill patients, an effort is required to conduct literature reviews and further research to determine effective methods to combat low health literacy such as; comprehendible and specially-designed materials, that improves processing and retention of information. Utilization of these study findings in nursing practice is necessary to revise and modify nursing assessment of learning needs of patients, nurses' communication skills and health care information delivery. Additionally, nursing administrations are needed to adopt and sponsor researches targeting solutions and interventions to either identify or promote health literacy in patients.

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