Educational intervention and warfarin knowledge in atrial fibrillation patients

Educational Intervention for Patients Taking Warfarin at the Anticoagulation Clinic

Patients with a trial fibrillation (Afib or AF) and high stroke risks are often administered the anticoagulant, warfarin. Warfarin's benefit, however, hinges on the time that is spent in their INR's (international normalized ratio, which is 2.0-3.0) target therapeutic range (TTR). Patients with AF don't have adequate knowledge regarding their condition and treatment by warfarin; this may influence their INR control. Educating patients with regard to their illness and therapy will lead to improved patient grasp of warfarin medication and factors contributing to INR control.

Methods/Design: RCT (randomized controlled clinical trial) of a rigorous educational intervention comprises group sessions (involving 2 to 8 AF patients) wherein enrolled patients will acquire standardized information concerning the advantages and risks linked to oral anticoagulant (OAC) treatment, significance of INR monitoring and management, and lifestyle interactions. Patients will be provided this information via a specialist-patient-centered DVD, patient worksheets and an updated educational handbook. Study sample will comprise 200 patients unaware of warfarin effects (and eligible for being administered the drug), who will be randomly assigned to usual care or intervention groups. AF guidelines laid down by the National Institute for Health and Care Excellence (NICE) will dictate which patients are eligible to be administered the medication; also, participants chosen for the study's purpose should have electrocardiogram-documented AF. Criteria for exclusion from the study are: patients below 18 years of age; warfarin contraindication(s); valvular heart problems; warfarin usage history; those who can't read or talk English; impaired cognition; and likelihood of death within a year due to a disease. The time a patient spends in TTR represents primary endpoint, whereas secondary endpoints are quality of life measures (AF-QoL-18), depression and anxiety (HADS), medication-related beliefs (BMQ), awareness of anticoagulation and AF, and disease representations (IPQ-R). The study will entail recording of clinical outcomes, such as bleeding, anticoagulation interruptions, and stroke. Each measure of outcome will be evaluated 5 times: at baseline, at 30 days, 60 days, half a year, and one year after completion of intervention.

1. Introduction

The most widespread form of arrhythmia observed by clinicians is AF or atrial fibrillation; for individuals over 40 years of age, there is a roughly 25% chance of developing the disease throughout their lifetime. AF constitutes a standalone risk element for stroke, presenting five times greater risks among AF patients than among people with normal rhythm. It is responsible for nearly 10% to 15% of total ischemic strokes; nearly 25% of strokes occur among the elderly individuals aged 80+ (Lip & Edwards, 2006). Moreover, in case of AF-related strokes, the patient will typically have considerably larger rates of morbidity and mortality, increased risks of disability and prolonged hospitalization (Smith, Xuere, Pattison, Lip & Lane, 2010).

Educational interventions informing families of ways to lower possibilities of bleeding prove extremely valuable. Warfarin-linked bleeding risks are intimately associated withwarfarin control adequacy. Better warfarin control has been noted among patients who are educated regarding warfarin -- through both verbal and written modes. Warfarin is associated with more drug and food interactions than all other prescription drugs; knowledge of these interactions will facilitate warfarin control among patients (Newall, Monagle & Johnston, 2005).

1.1. Statement of the Problem

There are several reasons behind non-compliance of OAT prescriptions by AF patients (Engelke, 2012; Deck, 2015). Numerous factors may be ascribed to INR failing to be within therapeutic range. AF patients might exhibit (a) poor knowledge regarding OAT, (b) low educational level, (c) no education in regard to OAT, and (d) non-adherence to therapy. One obstacle is OAT-connected health beliefs. OAT-prescribed patients do not completely grasp the concept of self-regulation theory that involves consistent medication, and food-and-drink intake; their problems are further aggravated by poor communication between physician and patient (Hu, Chow, Dao, Errett & Keith, 2006). Other factors that heighten patients' bleeding risks include: aging effects and multiple comorbidities (Hu et al., 2006; Deck, 2015).

1.2. Significance of the Study

In the U.S., one among the five medication categories posing greatest risk for patients is - anticoagulants (Engelke, 2012). In over 2% of OAT-consuming patients, cases of major bleeding are reported. OAT-related cerebral hemorrhage shows 22% recurrence rate, following resumption of OAT intake (Engelke, 2012; Kirsch, 2011). Among the elderly patients (aged 80+), risk elements in regard to major bleeding expand to include poly-pharmacy and inadequate patient education (Engelke, 2012). Not even half of OAT-consuming patients can maintain target INR's stability (Kirsch, 2011). Departure from therapeutic range places warfarin users at risks, either for embolism or for bleeding (Deck, 2015).

1.3. Study Objective

This study is aimed at assessing the success of an educational intervention (created in relation to warfarin) on knowledge of warfarin-consuming patients and side-effect frequency (Abd El-Naby, Hashem & Ismail, 2014).

1.4. Study Hypothesis

H1: Patients engaging in a planned warfarin educational intervention will score more on warfarin-medication-related knowledge than those who aren't enrolled in it.

H2: Patients engaging in a planned warfarin educational intervention will show lower occurrence of side-effects of warfarin compared to those who aren't a part of the program (Abd El-Naby et al., 2014).

2. Review of the Literature

Existing literature reveals that compliance can be promoted and complications can be avoided among OAT-consuming patients through patient education. This education, however, is usually absent or insufficient. A 2009 study interviewed forty OAT-administered patients and their corresponding healthcare providers. The providers comprised one specialist and thirty five GPs (general practitioners) -- of these, 12 healthcare providers (i.e. around one-third) didn't know of the fact that their OAT-using patients suffered multiple issues, like non-compliance to treatment and depression (Lowthian el al., 2009).

There are great variations in published reports, concerning warfarin-anticoagulation patient education, in terms of strategy, patient testing and content. The key to improving warfarin anticoagulation will be: prioritization of educational domains; more effective educational material delivery; and standardization of educational material. For enhancing safety as well as effectiveness of OAT, numerous strategies, including educational programs, have been formulated. But the precise effect of an OAT-centered patient education intervention is still questionable (Abd El-Naby et al., 2014).

Literature has shown that OAT-related patient knowhow is different among patients of different ages. Older patients (aged more than 75 years) typically exhibit poorer OAT knowledge (Clarkesmith, Pattison, Lip and Lane, 2013). Altered eating habits, which include lesser appetite, may elicita drop of INR below therapeutic amounts because of the absorption pathways of the body. Time devoted to discussions with patients and gauging their extent of knowledge in the course of patient visits may assist in improving their beliefs, practices and knowledge (Deck, 2015).

2.1. Theoretical Framework

The adaptation model of Sister Callista Roy is the abstract framework utilized for driving this study. Roy's theory has its roots in the days of her pediatric nursing career (Phillips, 2010). Her job enabled her to observe children's resiliency and capability of adapting to physical and psychological changes, under hospitalization. Later on, while pursuing higher studies, Roy employed adaptation as groundwork for her theory (Phillips, 2010). The study also employs the following additional models, namely: Self-Regulation Theory Model, Health Belief Model, and Patient-Provider Communication Theory.

2.1.1 Self-Regulation Theory Model

In the medical education context, this model outlines clinical and academic performance's cyclical control via numerous key processes, including goal-directed action, employment of specific goal attainment strategies, and alterations and revisions to strategies/behaviors for performance and learning optimization. The theory offers powerful potential for enhancing clinical and academic performance in the medical education context (Sandars & Cleary, 2011). People continually govern personal behaviors. Thus, they represent a major locus in creating and successfully maintaining health promotional habits. Other motivational/guiding factors are not very likely to induce long-term behavioral modifications unless people cultivate ways to personally control their health-linked actions and motivation. Karoly and Maes (2005) document the increasing shift from prescriptive regimens-centered medical management approach and adherence to them, to a self-management one that is collaborative in nature. Their conceptualization of self-regulation is with regard to a triadic system whereby individuals' influence has a bearing on health-linked habits. According to the authors' goal-guidance theory, goal adoption causes self-directed modification; implementation plans transform goals into fruitful behavior; and maintenance plans assist with sustaining acquired behavioral modifications. Several health-connected cognitions were reviewed, which can influence all three general self-regulatory processes. The authors define measurement scales, of which many are designed in terms of traits, and assess their predictive empirical evidence. Self-regulation paradigms have a common meta-theory basis, that cognitive determinants significantly influence health behaviors (Sandars & Cleary, 2011).

2.1.2 Patient-Provider Communication Theory

Reviews and theoretical works contending that patient-healthcare provider interaction can improve compliance via various mechanisms, thoroughly scrutinize the relationship of patient-health provider interaction with patient adherence. Communication facilitates patients' grasp of their health issue and the advantages and risks of medication. Every aspect of the patient-physician relationship, right from initial procuring of medical history of the patient to describing a treatment strategy, depends on proper and successful communication, both non-verbal and verbal. While most patient-doctor communication essentially entails information-sharing regarding diagnosis and treatment alternatives, a majority of doctors will understand that they also entail the patient seeking a therapeutic relationship or psychosocial healing bond. Patient-physician interaction usually marks the foremost step in the direction of reconnection. Thus, it is vital that providers pay attention to their patients' concerns, offer emotional support and healing, as well as promote the relationship, on the whole. This particular element of a therapeutic bond is not easy to define, but may be found, without much doubt, at the core of truly therapeutic relations. Also, quality care delivery's foundation is this healing facet (Travaline, Ruchinskas&D'Alonzo, 2005).

2.1.3 Health Belief Model (HBM)

HBM, formulated during the 50s, is certainly the most prevalent model employed in health promotion and education. The purpose of this model was to explain the reason behind the poor success of American Public Health Service-offered medical screening initiatives, especially for tuberculosis. HBM's initial primary concept was that health activities are governed by people's views or beliefs regarding a disease, as well as strategies available for reducing its occurrence. Perceived seriousness, benefits, barriers, and susceptibility are the model's key constructs. All of these perceptions (combined or separately) can help account for health behavior. The HBM has had other constructs -- self-efficacy, indications to action, and motivating factors -- included more recently (Chapter 4 Health Belief Model, n.d.).

3. Methodology

3.2. Sampling

Primary endpoint power was computed on the basis of information, from a secondary study, of TTR time from ACTIVE-W trial. The assumption in power calculation is that routine care patients are characterized by 58% mean TTR (standard deviation=7.5). Sample size for the knowledge improvement (post-intervention) secondary endpoint was derived from Lowthian's 2009 research. The cardiac facility has approximately 365 patients with OAT-symptoms associated with their corresponding cardiovascular problems. A study with 100 participants (i.e. sample size=100, with 20% incomplete/non-submitted questionnaires) has minimum 80% power of detecting a knowledge increase of 18.5% in regard toAF and influencers of INR control, from baseline to follow-up after a year (Smith et al., 2010).

3.3. Data Collection

A- Form for procuring personal participant information. This information is categorized into 1) demographic information such as gender, age, education level, occupation, marital status, income, residential info, number of kids and b) specific medical variables such as diagnosis/operation, over-the-counter drugs used, debilitating ailments suffered, etc.

B- Questionnaire for assessing pre/post warfarin-related knowledge. This questionnaire is separated into two key divisions: the first evaluates the patients' warfarin-related knowledge and comprises questions pertaining to symptoms, side effects, action, patient and pharmacokinetic measures to be taken for side-effects prevention, and lab tests which must be regularly checked and evaluated. The second deals with symptoms and indications of warfarin's side effects (Abd El-Naby et al., 2014).

3.4 Measurement of Patient Satisfaction and Quality of Life

The amount of time a patient spends within INR's therapeutic range (i.e., 2.0-3.0) is used as a measure of patient satisfaction. All participants in the study (both usual care and intervention and groups) will have to undergo INR testing, at the outpatient section of the anticoagulant clinic, via capillary blood sample. INR visit frequency will be determined by the clinic. All INR outcomes right from baseline through the 1-year follow-up testing will be documented. Linear interpolation method will be applied for calculation of the amount of time all individual patients spend within therapeutic range of 2.0-3.0; information from 1 month through 12 months will be used (for enabling achievement of accurate warfarin dose in the first month) (Kirsch, 2011; Smith et al., 2010).

Indicators of QOL are; (1) patient awareness [knowledge decrease/increase/constancy will be assessed through score change], (2) medication-related attitudes (3) illness representations and (4) depression and anxiety. The association of frequency of major and minor bleeding, stroke, thromboembolism (assuming the trial can't identify such differences) and INR testing frequency with INR control will be examined by means of ancillary analyses. The amount of thromboembolic events, strokes, and bleeding will be ascertained from the hospital's computerized records of clinical information (Clarkesmith et al., 2013; Phillips, 2010).

3.5. Ethics Consideration

The relevant research committee was approached for obtaining permission to carry out this study. All potential participants were, during an initial interview, made aware of the study's nature, purpose and benefits. Participants were also informed of the voluntary nature of participation, as well as participant anonymity and confidentiality via data coding. All individuals who were willing to be a part of the research project were given a written form of consent, which was collected prior to study commencement (Abd El-Naby et al., 2014).

3.6. Analysis

Data analysis will be carried out bearing in mind that the purpose is to treat. Analyses stratification will be based on center. There will be comparisons made with secondary and primary outcome measures at each time-point for identifying long- and short-term intervention impacts. Weighted mean will be applied in case of continuous variables (like modifications in disease perception survey or alteration in duration spent in therapeutic INR range). Owing to the sample's randomized nature, baseline differences will not be anticipated among groups (Smith et al., 2010).

Self-Regulation Theory Model

The study hopes to observe improvements in patients taking warfarin and that more controlled INR can be achieved. In line with the underlying theory (The self-regulation theory), the studypostulates that adherence is associated with sturdier perceptions of obligation for treatment and lesser concerns regarding adverse consequences.Anticoagulation clinics as well as home INR monitoring tend to enhance anticoagulation outcomes and control. Patients who have their warfarin administration monitored within anticoagulation clinics show lower levels of hostile events and improved level of anticoagulation in range. Monitoring of home INR also seems to be beneficial. Moreover, adherence to warfarin clearly affects anticoagulation control levels and the possibility of maintaining patients taking warfarin. Even at the modest degree of poor compliance to warfarin significantly affected poor anticoagulation control within thestudy (Ha & Longnecker, 2010).

Patient-Provider Communication Theory

Educating patients about both risks and benefits of anticoagulation is essential and ensures that patients are aware of: the way to take warfarin, warfarin can affect other medications, and appreciate the significance of consistent monitoring. Moreover, evidence indicates that even when patients comply with therapy, both dose and schedule of what patients actually take mayvary from the approved regimen; this "discordant care" canarise from lapses in communication between patient and physician. Patients who have limited health awareness did not show significant differences from those who had adequate health literacy with regard to the time in therapeutic INR range. Confining the analyses to the group of patients with INRs drawn did not considerably change the results (Fang, Machtinger, Wang & Schillinger, 2006).

Health Belief Model (HBM)

Patients learn through the health-belief model that deals with the patients' concerns such assymptoms and experience. The interdisciplinary approach developed through participation including patients' feedback using culturally suitable material aimed at improving outcomes, reducing barriers and health costs, and increasing compliance (Hui, 2010). The model showed the impact of patients'beliefs in their health behaviors.

3.7. Discussion

Roy's adaptation model, applied in the study, has the following strengths: assessment convenience in relevant and significant nursing programs that assisted patient flow via contextual, residual, and focal stimuli. Further, patient adaptation could be clearly seen through teaching by means of video and booklet; some of the patients preferred learning by watching a video, while others favoured booklet over video. Coping skills of patients were studied via their favoured learning mode (Abd El-Naby et al., 2014).

The adaptation model displays the following weaknesses: the four adaptation modes, all of which were regarded as processes; therefore, when speedy decision-making is necessitated, they may prove weak. Another shortcoming was development of patient problem-solving abilities as they learned what they were taught. Yet another shortcoming was implied as nursing intervention or assessment, which, in fact, is regarded as an advantage (Phillips, 2010), since nursing intervention and assessment was pursued actively with all patients (Smith et al., 2010; Clarkesmith et al., 2013).

Self-Regulation Theory Model

Availability of INR (International normalized ratio) monitoring has permitted consumers of warfarin to directly screen their INR results. There are several important benefits associated with self-motoring such as INR optimized control, superior patient motivation and enablement as well as enhanced knowledge with regard to warfarin. Community clinicians are at a unique position to assume the role of training and identified individuals who seem to be suitable for patient self-monitoring and offering them ongoing support. Self-monitoring seems to be a viable alternative for patients capable of coping with the testing procedure. Caution is needed when generalizing the results of this model since the results in the study reflect the experiences of the patients in the study. Moreover, the general population of individuals on warfarin can possibly vary considerably in their responses and attitudes to training (Bereznicki, 2010).

Patient-Provider Communication Theory

Patients in anticoagulation clinics and narrow health literacy were likely than patients with adequate health knowledge to offer incorrect answers regarding their warfarin therapy. Nevertheless, narrow health literacy did not considerably associate with self-reported compliance with warfarin or even INR control. It was a concern that majority of the subjects on chronic warfarin therapy were unable to answer general questions regarding warfarin, particularly given the possibly high-risk associated with anticoagulation treatment. It seems limited health literacy is an indicator of factors associated with if a patientunderstands or receives warfarin teaching, like quality of verbal communication, specifically in domains of participatory and explanatory communication.Nevertheless, this model has a number of limitations. For instance, since the study was observational, the study was unable to establish if there was a link connecting limited health literacy to lack of anticoagulation knowledge. In addition, the model did not have direct measures on clinician-patient communication as well as the value of shared decision making the subject experienced (Fang, Machtinger, Wang & Schillinger, 2006).

Health Belief Model (HBM)

The model suggests that a patient's readiness to alter his/her behavior relies on a number of factors. First the patient's belief regarding the way the patient is susceptible to developing severe symptoms or even the condition becoming worse. Second the patient's belief regarding the severity of the condition when left untreated. Third, the patient's belief that values taking medicines when decreasing the likelihood of developing severe or even worse condition. As well, the patients' insights on the treatment and the way it impacts their condition can affect the likelihood of adhering to it. Although health belief model underscore some essential areas that are worthy considering in a clinical encounter, lack of robust research evidence in support of the model is one of the problem with this model. Nevertheless, the model shows the subjective understanding of the health condition as well as its significance in managing treatment and disease (Aslani, Krass, Bajorek, Thistlethwaite & Tofler, 2011). Patients' beliefs as well as other circumstantial factors that affected their behavior with regard to taking medications are consistent with other models that explain patient behavior like the Health Belief Model.