Systematic Review and Medication

Evidence-Based Project Proposal

Graduate Project in Nursing

The incidence of sexually transmitted diseases has been increasing among adolescents in countries around the world, but there remains a dearth of timely and relevant studies concerning salient differences in knowledge level and attitudes between different cultures and ethnic populations. One common factor that has been consistently demonstrated in improving the effectiveness of treatments for sexually transmitted diseases is promoting adherence to treatment regimens, most especially for medications since these are used in all treatments for sexually transmitted diseases. While there have been some studies concerning various strategies for promoting adherence levels to treatment regimens, there remains a lack of studies concerning evidence-based practices that incorporate technological solutions. To this end, the proposed study intends to conduct an experiment using innovative face recognition and motion detection smartphone app to evaluate its effectiveness in promoting adherence to medication regimens among a population of adolescents and young adults with a sexually transmitted disease.

EVIDENCE-BASED PROJECT PROPOSAL 3

Evidence-Based Project Proposal

Introduction

Practice Issue

There has been growing emphasis of the use of evidence-based practice (EBP) over the past 2 decades (Reed & Reed, 2012). This growing emphasis is attributed in large part to the notion that EBP is widely regarded as providing the framework needed for the cost-effective delivery of high quality care while taking the patients' interests and preferences into account. In this regard, the American Psychology Association defines EBP as "the integration of the best available research with clinical expertise in the context of patient characteristics, culture, and preferences" (as cited in Reed & Reed, 2012, p. 20). Although the increased calls from the helping professions for the use of EBP is fairly recent and, the use of EBP actually dates to Florence Nightingale's seminal work on the battlefields of the Crimean War in the 1850s (Rahman & Applebaum, 2012) While EBP has its share of critics, most practitioners agree that the approach represents the best available strategy for improving the quality of healthcare services in the face of scarce resources (Rahman & Applebaum, 2012).

Background Information

The incidence of sexually transmitted diseases among adolescents has experienced a steady increase in recent years (Kaptanglu & Suer, 2014). Because incidence rates of sexually transmitted diseases vary by country, it is possible that there are substantive cultural and ethnic differences in the respective levels of knowledge among adolescents in and their attitudes towards sex (Kaptanglu & Suer, 2014). In addition, individual perceptions of locus of control and the responsibility for their actions differ even among homogeneous populations, making the need to identify those factors that are most responsible for exacerbating sexually transmitted disease levels (Estrada & Dupoux, 2006). Although precise figures are unavailable and many authorities believe official reports seriously underestimate the extent of the problem, current projections indicate that more than 340 million people become infected with some type of sexually transmitted disease each year (Timiun, 2012).

While there are also differences in the prevalence rates for the various types of sexually transmitted diseases, these infections all share some serious and potentially fatal healthcare implications left untreated. In the United States, the U.S. Centers for Disease Control (CDC) report that there has been a 19% increase in global syphilis rates among men and women, but men are responsible for the vast majority (90%) of all primary and secondary cases of syphilis, which are the most infectious stages of the disease (Reported STDs in the United States, 2015). Moreover, the studies to date also indicate that syphilis can seriously increase the risk of acquiring even more deadly diseases such as the human immunodeficiency virus (HIV) (Reported STDs in the United States, 2015).

Aim of the Project

The primary aim of this project is to identify EBP-based strategies for improving adherence rates to medication and treatment regimens for adolescent patients with sexually transmitted diseases. This aim is congruent with the tenets of EBP which include improving patient healthcare outcomes, as well as the quality of care and overall health status (Grove, Burns, & Gray, 2013).

PICOT Question

A properly formulated PICOT question can serve to identify those studies that are most relevant for the specific purposes of an empirical analysis (Burnett, 2013). In this regard, Burnett (2013) advises that, "PICOT works like a filter, targeting efforts and narrowing the search for information as it applies to a specific patient care issue" (p. 37). In the proposed study, the specific patient care issue of interest concerns adherence levels to treatment regimens among adolescences being treated for sexually transmitted disease and identifying ways to improve these levels.

Significance

Poor patient adherence to treatment regimens is widely recognized as a significant problem, especially with certain population groups such as those with mental disorders and young people who lack the medical literacy to understand the significance of adherence to treatment regimens (Kalali & Richerson, 2016). According to the definition provided by Atibioke and Osinowo (2015), treatment adherence is "the extent to which a person's behavior coincides with medical or health advice, such as taking medication regularly, returning to a doctor's office for follow-up appointments, and observing preventive and healthful lifestyle changes" (p. 90). Because the treatment of sexually transmitted diseases always includes a medication intervention, adherence to treatment regimens should therefore include a focus on promoting patients' taking their medications precisely as they are instructed (Atibioke & Osinowo, 2015).

In this context, nonadherence to treatment regimens for sexually transmitted diseases fall into two general categories: 1) not taking prescribed medication in the recommended dosage or frequency, or not taking prescribed medication at all; and 2) non-attendance or irregular attendance at appointments with healthcare providers (Kalali & Richerson, 2016). It has been well documented that nonadherence to treatment regimens can adversely affect clinical outcomes. For example, Kalali and Richerson (2016) emphasize that, "Nonadherence can result in an increased risk of relapse, hospitalization, poor therapeutic response, and delayed remission and recovery" (p. 25).

Moreover, nonadherence levels among adolescents suffering from sexually transmitted diseases may be significantly underestimated due to fears that their parents will discover their condition (Leichliter & Copen, 2017). Recent changes in the U.S. healthcare system have allowed dependent children to continue as beneficiaries of their parents' health insurance plans until they reach age 26 years, and the potential therefore exists for even young adults to avoid or delay seeking treatment or adhering to treatment regimens for their sexually transmitted disease due to these confidentiality issues (Leichliter & Copen, 2017). Therefore, taken together, it is reasonable to assert that improving treatment regimen adherence rates will have a correspondingly positive effect on improving healthcare outcomes for adolescents with sexually transmitted diseases.

Evidence Review and Synthesis

Database Search and Keeper Studies

The search for scholarly articles pertaining to this evidence-based project started with the university library. Search terms, medical subject headings and keywords used to search for relevant resources included "sexually transmitted diseases," "STDs," as well as chlamydia, gonorrhea, syphilis and HIV/AIDS. In addition, searches were also conducted using the terms "adherence rates [and/or] levels," "nonadherent patients," "treatment regimens" and "medication regimens." 'The scholarly articles were delimited to those published in juried journals in the English language within the past 5 years. The following academic databases were consulted for this purpose:

• EBSCOHost;

• Medline;

• CINAHL Plus; and,

• Questia.

In addition, reliable governmental resources such as the U.S. Centers for Disease Control were also consulted for current prevalence rates of sexually transmitted diseases as well as the vendor (www.aicure.com) of a technological solution to promote adherence to medication regimens. The results of those peer-reviewed studies that were deemed sufficiently relevant (e.g., "keeper studies") and which satisfied the inclusion criteria described above were incorporated into the evaluation and synthesis tables at the appendix.

Synthesis of Evidence

Synthesizing the evidence that emerged from the evaluation of the selected studies required more than one review and assessment, and rather followed the iterative process recommended by Noblit and Hare (1988) concerning the synthesis of multiple studies of different types wherein each study evaluated serves to inform the evaluation of the following studies. Following this series of assessments, the findings that emerged from the studies synthesized below were incorporated into the evaluation and synthesis tables provided at the appendix.

A retrospective study by Leichliter and Copen (2017) analyzed data from the 2013 -- 2015 National Survey of Family Growth and found that 12.7% of sexually experienced youths (adolescents aged 15 -- 17 years and those young adults aged 18 -- 25 years who were on a parent's insurance plan) refused to access sexual and reproductive healthcare services due to concerns their parents would discover their interests and needs, a concern that was especially pronounced among those aged 15 to 17 years (Leichliter & Copen, 2017). The 2013 -- 2015 survey included 10,205 respondents and had a valid (69.3%) response rate (Leichliter & Copen, 2017). Although the concern over the confidentiality of their seeking healthcare services for sexually related issues adversely affected all type of sexually transmitted diseases, the rates were highest for young people who were not allowed time alone with their healthcare provider (e.g., one or both parents were in the treatment room with them). These findings underscore the need to ensure that young people who acquire a sexually transmitted diseases are provided with the information they need to make an informed decision concerning the importance of seeking treatment and adhering to their treatment regimens (Leichliter & Copen, 2017). Therefore, the potential exists for enhancing the confidentiality of sexually transmitted disease services and corresponding adherence levels with treatment regimens through the use of various strategies as described further below.

A study by Cairns and Hill (2013) conducted a preliminary investigation of the effectiveness of using the Large Allen Cognitive Level Screen (LACLS) to improve adherence levels to treatment regimens among a convenience sample of 11 young adults. All participants had been prescribed oral medications and were requested to report if they used any medication aids (i.e., dosette/medication boxes, Webster/blister packs or phone or electronic reminders) (Cairns & Hill, 2013). The study's participants were requested to specify the medication support network that was in place that provided the best description of their circumstances as follows:

1. No one helps me with my medication;

2. Someone visits me regularly and checks my medication or reminds me to take it; and,

3. Someone calls me to check if I need scripts or refills (Cairns & Hill, 2013).

If none of the above descriptions were suitable, participants also had the option to describe their respective levels of support in their own words (Cairns & Hill, 2013). The findings that emerged from this preliminary investigation showed that "a strong positive association exists between the LACLS and medication adherence" (p. 139). These results were attributed to the screening process the LACLS provided clinicians in evaluating the participants' capacity to effectively manage their medication regimens. Based on these findings, Cairns and Hill (2013) concludes that "the LACLS is a time-efficient screen of a person's capacity to manage medication regimens [and the] successful use of the LACLS may prove a time-efficient tool for prioritizing comprehensive assessment and possible intervention to prevent medication non-adherence" (p. 139). While these findings may not be completely generalizable to a population of young adults suffering from sexually transmitted diseases, the results of this study do underscore the need for carefully assessing patients' capacity to adhere to mediation regimens (Cairns & Hill, 2013).

A study by Levesque and Li (2012) used a custom questionnaire with demonstrated face validity to survey 298 patients in a Northern British Columbia city with a population of about 75,000. The study's guiding research questions were: 1) how often do patients adhere to prescribed medications?; 2) how often do patients adhere to recommended lifestyle changes?; 3) what is the nature of the relationship (linear or curvilinear) that links adherence to other determining factors?; and 4) what are the important factors in predicting adherence? (Levesque & Li, 2012).

The results of this study showed that: 1) adherence to lifestyle changes and participants' age presented a U-shape relationship; 2) those who perceived themselves to be in poor health were less likely than those in good health to adhere to lifestyle changes; 3) barriers such as the severe winter weather, lack of transportation, and cost of medications contributed negatively to adherence; and 4) adherence levels improved when doctors provided sufficient information on the benefits and use of the prescribed medications and the proposed lifestyle changes and patients reported trusting their doctors. Based on these findings, these researchers conclude that, "Physicians can play an important role in promoting adherence among patients. Community health workers should make efforts in reducing barriers that interfere with patient adherence" (Levesque & Li, 2012, p. 44).

A study by Atibioke and Osinowo (2015) used a cross-sectional survey research design to investigate the psychological determinants of treatment adherence to a rigorous medication regimen among 548 adults and children with HIV and AIDS undergoing active antiretroviral therapy treatments in a Nigerian program that involved ingesting at least 18 pills or capsules at the same time, with some regimens involving taking refrigerated medications at specific times, in some cases after eating and in others taking the medication on an empty stomach (Atibioke & Osinowo, 2015).

The results of this study showed that perceptions of stigmatization and discrimination did not affect treatment adherence levels, but those with adequate social support networks in place demonstrated significantly higher levels of adherence to their medication regimens. While there are likely some cross-cultural differences between this population and the population of interest to the study proposed herein, these findings underscore the need to actively involve patients' family and support network into the treatment protocols to the maximum extent possible (Atiobioke & Osinowogo, 2015).

Finally, a systematic review of the literature by Kalali and Richerson (2016) found that the most common reason for nonadherence to medication regimens is that patients simply forget to take their medication. Other reasons identified for nonadherence to treatment regimens included the following:

• Lack of insight;

• Negative emotional reaction to taking medication;

• Feeling better and no longer believing that the medication is needed;

• Distress associated with side effects;

• High cost of medication;

• Patient's perception that medication will not be effective;

• Concern about substance abuse;

• Fear of dependency;

• Complicated dosing regimen; and,

• General lack of motivation (Kalali & Richerson, 2016, p. 25).

Beyond the foregoing factors, there are some significant emotional barriers that are involved in medication adherence levels that have been largely ignored or minimized in the research to date. Emotional barriers may include 1) a sense of losing control, 2) self-stigmatization, 3) denial, 4) poor insight, and 5) beliefs about illness and medications (Kalali & Richerson, 2016). Additional patient variables that contribute to nonadherence include:

• Suboptimal health literacy;

• Stigma and shame about the need for treatment; and,

• Lack of patient involvement in treatment decision-making (Kalali & Richerson, 2016, p. 26).

It is important to note, though, that adherence to medication regimens is not the sole domain of patients, but is rather a combination of healthcare providers and the healthcare system in which they practice (Kalali & Richerson, 2016). Indeed, rather than being perceived as "hand-holding," active involvement on the part of healthcare providers can significantly enhance adherence levels to medication regimens. Many of the strategies that have been used to date, however (i.e., reminder telephone calls and additional clinic visits), can be expensive and untenable in view of already scarce organizational resources (Kalali & Richerson, 2016). Nevertheless, given the high costs that are associated with nonadherence to treatment regimens, even these alternatives may be viewed as cost effective over the long-term (Kalali & Richerson 2016). The positive outcomes that can be achieved through highly cost-effective innovative technological solutions to this problem, though, include improved adherence levels as well as reduced costs to healthcare providers.

There are several conventional approaches to evaluating adherence levels to medication regimens, but none of them are perfect. The easiest and most cost effective approach -- simply asking patients if they are taking their medication as directed -- is the most commonly used but it is also the least effective because patients tend to overestimate their adherence levels (Kalali & Richerson, 2016). In the alternative, direct measures can be used to evaluate adherence levels. These alternatives include actually watching patients take their medications and, because even this step can be faked, testing their blood or urine to assess medication concentration levels (Kalali & Richerson, 2016). This approach is regarded as effective but overly invasive and expensive.

Indirect methods for evaluating adherence levels to medication regimens include 1) pill counts, 2) medication diaries, 3) self-reports, 4) clinician ratings, 5) pharmacy chart review, and 5) various electronic devices that monitor the opening of a lid or tablet strip or otherwise indicate medication consumption; the research to date concerning the effectiveness of these alternatives has been mixed, but many studies have identified suboptimal outcomes for each of these solutions due to inherent constraints in their design and application in real-world settings (Kalali & Richerson, 2016). For instance, electronic devices that monitor lid openings do not guarantee that patients actually took their medications.

The foregoing constraints can be addressed by using so-called "event marker-signaling devices" that contain "ingestible event markers" that signal a patch worn on the skin when patients take their medications (Kalali & Richerson, 2016). The patch then transmits the data to a cell phone recording when the medication was taken and what type. A preliminary study of the efficacy of this alternative with 28 patients found that the vast majority (96%) regarded it as acceptable and easily tolerated (Kalali & Richerson, 2016).

There is also breath-based technologies that are available that can evaluate patient adherence to medication regimens. One such handheld device produces a reminder for patient to take their medications, and then detects where the medication was actually taken or not by having patients blow into the device (Kalali & Richerson, 2016). According to Kalali and Richerson, "The medication has breath-detectable adherence markers already incorporated. The adherence marker then is released into the stomach and small intestine, where the adherence marker metabolite is transported through the bloodstream into the lungs and exhaled" (2016, p. 26). Although the research to date indicates that the adherence markers do not produce any adverse effect, there are no clinical data currently available concerning the effectiveness of these devices in promoting adherence levels to medication regimens (Kalali & Richerson, 2016).

Finally, one technological solution that has significant promise for improving adherence levels is a facial recognition-based technology developed by AiCure (www.aicure.com) that functions on any type of smartphone. This innovative app uses artificial intelligence and motion-sensing technologies to determine if patients are taking their medications as directed in real time. In this regard, Kalali and Richerson (2016) report that, "Patients who take an incorrect dose, or who do not use the software, are automatically flagged for immediate follow-up enabling real-time intervention by a provider with the nonadherent patient (p. 26). The vendor reports adherence levels ranging from 91% to 100% with the use of the AiCure technology (Why AiCure?, 2017). The AiCure platform is depicted in Figure 1 below.

Figure 1. AiCure smartphone platform

Source: https://aicure.com/wp-content/themes/theme-with-animations/images/phone_image.png

Unless an immediate flag is generated, the monitoring data is automatically aggregated, trended and communicated to patients' healthcare providers thereby allowing for the straightforward analysis of the patients' adherence levels to their mediation regimens. This technology allows healthcare practitioners to factor in adherence assumptions based on actual clinical evidence which is the foundation of evidence-based practice (Rahman & Applebaum, 2012).

Purpose of the Project

The overarching purpose of this project was to identify salient EBPs for improving adherence rates for medication regimens for sexually transmitted disease interventions using innovative technological solutions such as the AiCure smartphone app based on the theoretical framework described below.

Theoretical Framework

The theoretical framework that will be used in the proposed study is Rotter's (1954) social learning theory which conceptualizes human behavior in terms of behavior potential, expectancy, reinforcement value, and the operative psychological situation. Social learning theory also includes the personality construct of locus of control, wherein differences in the perception of the effects of sexual behaviors can affect the respective tendencies of individuals to engage in unsafe sexual practices (Estrada & Dupoux, 2006). In this regard, Estrada and Dupous (2006) report that, "People who are prototypical externals do not perceive a reliable contingency between their behaviors and their outcomes. People who are prototypical internals perceive a reliable contingency between their behaviors and their outcomes" (p. 44). Therefore, gaining a better understanding concerning the antecedent variables that exacerbate nonadherence to treatment regimens can provide practitioners with insights concerning how to improve these rates and the clinical outcomes that result.

Because a number of different factors can predict poor adherence levels with treatment regimens, however, it is reasonable to posit that no single strategy will be the most efficacious in improving adherence levels, thereby creating the need to identify optimal approaches that may involve two or more strategies. In many cases, the most effective interventions include information and technology communications (ICT) elements to promote adherence levels with treatment regimens (Kalali & Richerson, 2016). Because most young people today are experts with ICT and readily embrace apps for their smartphones, it is also reasonable to posit that interventions that incorporate these types of ICT elements will be more effective than those that do not.