Online KidClot education for patients and families initiating warfarin therapy: The eKITE study

Abstract

Anticoagulation with Vitamin K antagonists (VKA) has always posed challenges in terms of monitoring requirements. These challenges were further exacerbated in the setting of the COVID-19 pandemic, with limited access to and/or avoidance of laboratory testing. The importance of utilizing point of care (POC) health technology for individualized patient management is salient. The foundation of effective home INR monitoring is establishing patient knowledge about their therapy and INR testing proficiency. The eKITE series was developed to support patients in establishing foundational knowledge required for VKA (warfarin) management and INR monitoring. The primary objectives were to evaluate eKITE, a patient-oriented innovative online education program for warfarin therapy, participant learning stress, and patient preference for online learning. This multi-center prospective study provided patients access to warfarin online education. Participants were required to complete written quizzes assessing warfarin knowledge of key concepts proficiency and identifying knowledge deficits. Patient preference, evaluating calm (lack of anxiety) while learning, and an INR on a home meter was completed. Participants performed INR tests at home and reported INRs by telephone. The analysis included 144 children and caregivers enrolled at five US and CDN sites. Most indications for anticoagulation were cardiac (congenital or acquired heart disease) with varied INR target ranges. Mean knowledge scores for warfarin and INR self-testing modules were 97%, with low anxiety with TTR of 84%. Patient preferred online learning. eKITE is an effective teaching modality for warfarin/home INR monitoring with safe INR testing and warfarin management that is appropriate for pediatrics and adults alike.

Prologue

The whir in the hallways is deafening. Lights bright, alarms are ringing in a chorus of unsynchronized beeps and screeches. It has been more than a week since I have slept. Snuggled beside me is my precious child, whining and equally irritated with the asynchronous symphony, further compounded by anxiety, procedures, and pain. The sun has broken.

The staff smiles are welcoming and incessant, as one after one, they approach hurried, urgent, assiduous, their need to coach me for our upcoming departure to the warmth of home. Each provides essential information that I will require to keep my child, my treasure, safe and healthy. Yet, my eyes are heavy, blurred, and my brain foggy, trapped in a dark heavy cloud. How am I to follow? Comprehend? and retain anything? As they instruct, my precious child yearns for loving arms, compassion and love, whining, crying in disquiet. Overwhelmed does not adequately describe my ineffable exhaustion. Amidst this, how am I to learn about warfarin? Such a challenging medication, with so much to know. Concentrate, I tell myself, focus; now is my only opportunity to learn. I must be alert. It seems to be nonsensical.

1. Introduction

In today's fast-paced, busy environment, it is becoming increasingly difficult to engage patients in their health education, whether children, adolescents, adults, or caregivers. The COVID-19 pandemic has brought to light so many of the inadequacies of our health education construct and fractures in the delivery of care for both acute and chronic conditions across all ages. In the acute care, fast-paced hospital environment, it is difficult to engage patients and caregivers in the necessary health education necessary to transition to a safe discharge home. This is particularly true for patients on high-risk medications such as anticoagulation- namely vitamin K antagonists (VKA). VKAs like warfarin requires individualized dose titration based on International Normalized Ratio (INR) blood test with established therapeutic ranges for optimal drug safety and efficacy. Safety and efficacy of warfarin depend on keeping the INR within range [1], which is dependent on patient health literacy, sufficient patient knowledge of warfarin, self-care, avoidance of illness, adherence to medication protocols [2], and frequent INR testing. Coagulometers are an alternative to laboratory INR testing. They are demonstrated to be both accurate and precise [3], [4], [5] with home use, improving overall time in therapeutic range (TTR), a surrogate for warfarin safety and efficacy. Patients prefer CoaguChek INR testing over going to the laboratory [6], [7], [8].

The effect of Warfarin is most notably impacted by dietary vitamin K intake but is affected by various drugs, infectious/inflammatory states, and developmental changes in the hemostasis system. Given its complexity in management and risk of associated complications, be it bleeding or thrombosis, it's not surprising that effectual patient education improves patient knowledge (health literacy), patient engagement in their health, and long-term health outcomes [9], [10], [11], [12], [13], [14]. Health literacy is imperative to making informed health decisions and relies on the ability to obtain, process, and understand health information [15].

This pandemic has intensified the need for effective and accessible health literacy and has transformed technology uptake for patient management. Web-based interfaces are practical, functional, and now acceptable facilitating social distancing [16].

The cornerstone of decreasing adverse events and increasing health-related quality of life (HRQOL) for the family is empowering the patient and family to understand their health conditions and their management through knowledge and skills [16], [17], [18], [19], [20].

The KIDCLOT© program, Stollery Children's Hospital, is a leader in innovative strategies for patient education and management of anticoagulant therapy to improve health-related quality-of-life (QOL) [6], [7], [21] for children. Over the years, the KIDCLOT program has focused on improving, validating, and standardizing evidence-based warfarin management [8], [19], [22], [23] and has continually refined its program and patient education based on study results and patient feedback.

The eKITE (electronic KidClot Thrombophilia Education) study aimed to develop warfarin patient education and evaluate patient knowledge translation through the eKITE online learning series. Secondary outcomes were to review patient stress around learning, patient preference for learning style and safety and efficacy of warfarin therapy (TTR) in patients who participated in the eKITE learning program.

2. Materials and methods

2.1. Patient selection

Patients were enrolled between July 2019 and September 2021 at 6 Children's hospitals across Canada and the United States. All consecutive English-speaking participants (children and parents) were approached for consent and assent as appropriate. HREB and IRB approval were obtained for each participating site.

2.2. eKITE learning modules

The eKITE study consisted of 5 evidence-based modules developed to support patients in establishing foundational knowledge required for VKA (warfarin) management and INR monitoring. Experts developed these in consultation with experts in user experience and visual communication. Each module educates on warfarin and its management and engages viewers with storytelling [24]. Each module educated the patient/family on warfarin using story-telling [24], was accessible anytime at www.kidclot.com. The modules provided standardized and sequential patient learning about warfarin and were consistent with the ‘smart learning’ (Specific, Measurable, Attainable, Relevant, and Time-bound) framework. Modules varied in length (3–9 min each), with all five modules taking a minimum of 30 min in addition to quiz completion, without overlap of content and consecutively building knowledge. For ease and clarity, modules were grouped into chapters and were assigned as such. Modules included: 1. What is an anticoagulant? 2. Warfarin teaching, 3. INR testing, 4. Warfarin safety, and 5. Patient Self-Testing using a portable INR meter. CoaguChek XS and CoaguChek INRange (Roche Diagnostics, CA, and the USA, respectively) were assigned by the local anticoagulation provider. A short online quiz followed each module to assess patient knowledge and redirect the learning to appropriate content if there were incorrect responses. Once completed, INR meters were provided to patients who then performed an INR test using the INR meter to demonstrate proficiency, with a laboratory comparison to confirm the INR test result is within 15% of the laboratory INR when within the patient's target range.

Parents would complete modules for children 12 years and under with children viewing alongside their parents when feasible. Children ≥14 years and their parents completed their education independently. CoaguCheck XS (Canada) or CoaguChek INRange (US) meters and test strips were provided to patients for the duration of this study (Roche Diagnostics Inc. CA and USA).

Participants starting VKAs were provided passcode access to eKITE online modules accessible at www.kidclot.com for patient education, replacing existing patient education practices. All participants were given a point of care INR testing machine (Roche CoaguChek XS®) for the duration of the study so as to standardize approach to testing and INR management. Additionally, participants were evaluated on their ability to demonstrate proficiency utilizing a point of care INR testing machine. Patients and their families could view the modules at their convenience, as many times as they wish, and progress in a stepwise fashion through the modules when they felt ready. Embedded knowledge questions within each module emphasize essential concepts and incorrect responses redirect the learner to the appropriate content. Once the learner is comfortable with their knowledge and they have achieved a score of 100% online, a certificate of completion is issued to their appropriate hospital site, signalling patient completion.

Knowledge acquisition was assessed online, with participant completion of validated written quizzes 1–3 days following online module completion. Each consecutive module/quiz increased in complexity.

• •Module 1: Introduction to anticoagulants, primary principles
• •Module 2: Warfarin indications, monitoring, and therapeutic ranges
• •Module 3: Purpose and importance of INR testing
• •Modules 4: Safety principles surrounding anticoagulation
• •Module 5: Point of care INR testing using the CoaguChek meter principles.

As per the standard of care, INR were measured with warfarin dosing adjusted as per the recommendations of their health care provider. These INR results were also collected and used to calculate the time in the therapeutic range (TTR), a measure of warfarin effectiveness with high TTR associated with higher efficacy and safety. Participants performed INR tests at home, reported by telephone, allowing for remote warfarin dose adjustments.

HCP time required for supplemental teaching and verification of testing proficiency was tracked and compared to mean historical controls (pre-intervention).

2.3. Patient reported outcomes

Patient reported outcomes of stress and likeability/usability of the learning platform were evaluated. Stress around learning was assessed using the validated STAI-1 Self Evaluation Questionnaire-Short Form with worry (anxiety) and calm measures. This questionnaire consists of ten statements that evaluate how respondents' feelings of apprehension, tension, nervousness, and worry related to a particular situation or time, which in this study was learning about warfarin therapy. Participants were instructed to report the feelings they experienced at the time they were learning and tested. Each item is given a weighted score of 1 to 4, then translated to percent. A high score on the worry/anxiety quiz indicates a high level of anxiety, with the calm score indicating a high level of calm. The total possible minimum and the maximum score were 10 and 40 respectively then converted to a percentage. The State-Trait Anxiety Inventory (STAI) has been used extensively in research measure of stress in clinical practice and in the medical and social sciences.

Patient preference for online warfarin education was evaluated using a 5-question survey that is a 4-point validated Likert scale 4-point validated Likert scale questionnaire evaluating patient preferences with choices of ‘didn't like it’, ‘not sure’, ‘liked it’ and ‘loved it.’ The even number scale adds rigor to the patient responses. Finally, INR results were collected prospectively to assess the impact of this learning style on the safety and efficacy of warfarin management. Participants performed INR tests at home and reported their INR results by telephone to their local HCP, allowing for remote warfarin dose adjustments. INRs were collected once they achieved initial INR in the target range for calculation of TTR. Health care provider (HCP) (nursing for pharmacist) time required for warfarin teaching to ensure key concepts are understood was tracked by participating sites for each patient initiated on warfarin two months pre-intervention and per participant post-intervention. The eKITE knowledge quiz provided a tool to identify knowledge gaps to assist the HCP to expand on concepts that were not adequately understood by the participant.

Study data were collected and managed using a secure RedCap electronic data capture tools hosted at the University of Alberta.

2.4. Statistical analysis

The patients' and their families' baseline characteristics quiz scores and patient preference and mean provider pre-post teaching time are reported descriptively. STAI-1 scores were calculated as directed in the manual and reported descriptively. The TTR for each group and study phase was estimated using linear interpolation [25] between INR values. Stata/SE 13 (Stata Corp, College Station, TX) was used for the statistical analysis. All statistical analyses were performed using STATA/SE 16.

3. Results

One hundred forty-four (144) participants, aged mean 8.9 ± 6.0 years (range 2–19 years) were enrolled among five sites in Canada and the US and followed for three months from warfarin initiation. Indication for anticoagulation included: cardiac thromboprophylaxis or treatment in 88% (n = 128), VTE in 23% (n = 33) and inherited or acquired thrombophilia in 5% (n = 7). (Table 1 ) Target INRs ranges included: 1.5–2 for 14% (n = 20), 2–3 for 63% (n = 91), and 2.5–3.5 for 23% (n = 33).

Table 1.

Demographic inf.

Number of participants	144
Patient age (years)	8.9 SD = 6.0

Indication for anticoagulation	N (number)	Percentage %
Mechanical valve	41	25
Congenital heart disease (may include mechanical valves)	73	44
Acquired heart disease (may include mechanical valve)	13	8
VTE	33	20
Thrombophilia	7	4
Target INR (2) 1.5–2.5	20	14
Target INR 2.5 (2–3)	114	63
Target INR 3 (2.5–3.5)	33	23

The overall mean of all five knowledge quizzes (written) within one week of viewing modules was 97.4% ± 6.7%, indicating key concepts had been effectively learned and retained with limited knowledge gaps of critical concepts. Quiz scores specific to each quiz (1–5) are presented in Table 2 .

Table 2.

Written knowledge score.

Variable	Mean %	SD	p50	P25	P75
Quiz 1-What is an anticoagulant	98.0	7.1	100	100	100
Quiz 2- Warfarin	96.8	7.0	100	100	100
Quiz 3- INR testing	96.4	6.6	100	90	100
Quiz 4-Safety on an anticoagulant	99.3	3.7	100	100	100
Quiz 5-INR Self Testing	96.8	9.0	100	100	100

For patient reported outcomes of anxiety, as evaluated utilizing the STAI, 86% of participants had low scores, consistent with “feeling calm when learning”, while 14% of participants scored slightly higher consistent with “low levels of anxiety or worry”. No patients scored high on STAI to equate to high levels of warfarin related worry or anxiety. Ninety-eight percent of patients prefer online learning over one-to-one teaching with an HCP (Table 3 ).

Table 3.

Patient preference.

Questions	Yes % of respondents	No % of respondents
Are the videos easy to understand	99	1
Are the videos interesting to watch	90	10
Did you need to watch the video a second time	10	88
Were you able to watch the videos at a time that was convenient for you	91	9
Do you prefer on-line learning over one-to-one patient education	98	2

A total of 1736 INRs were performed over three months. Median TTR over three months following enrolment once the patient first achieved the target range was 84 IQR 73–98, demonstrating INR control reflective of patient warfarin knowledge and understanding. INR testing occurred with a mean of 10.3 INRs per participant in 3 months. Indicating an INR every 1–2 weeks. Twenty-four INRs were >5 (<1%) reflecting warfarin-induced coagulopathy.

Prior to implementing eKITE median reported warfarin teaching time spent by HCP was 90 (range 60–180) min and 10 min (range 0–30) post-intervention as the HCP was quickly able to identify knowledge gaps through the written quiz responses and teach topics where there were incorrect responses and respond to patient questions.

4. Discussion

This is the first large pediatric study to develop and evaluate the effectiveness of translating knowledge to patients utilizing a remote warfarin educational program that is comprehensive and evidence-based. This study demonstrated that complex medical knowledge surrounding warfarin can be effectively disseminated to and retained by participants with concomitant reporting of reduced stress around learning.

The COVID-19 pandemic has significantly altered health care delivery, fostering, and necessitating the utilization of health technology to facilitate the delivery of health care remotely. Technology-based health education is an important step forward in teaching and learning [26], [27], [28], [29]. Children, adolescents, and adults use technology as a learning tool daily in schools or at workplaces. Updating current teaching styles for patient education to align with current learning styles is long overdue. Health education delivered remotely through technology provides a standardized, efficient, engaging, fun and readily accessible resource [27], [30], [31].

Warfarin remains the most widely used oral anticoagulant in children to treat and prevent thrombosis [13], [32], [33], [34], [35]. Although two pediatric studies have recently evaluated direct oral thrombin and Xa inhibitor; these anticoagulants are limited to specific indications or disease groups [36], [37], [38]. Anticoagulant therapies are high-risk medications associated with serious adverse events, including bleeding and stroke, if not managed correctly [39], [40], [41], [42]. Additionally, some patient populations (e.g. those with mechanical valves or antiphospholipid antibody syndrome) require anticoagulation long term, which negatively impacts health-related quality of life [18], [19], [42], [43].

Parent/patient education and knowledge are pivotal to staying safe on anticoagulant therapy at home and school. It also empowers them towards a healthier future and leads to improved HRQOL. Furthermore, early engagement in health management positively impacts adolescent transition to adult care [44]. Studies demonstrate that transition of adolescents with chronic disorders/on medications are currently associated with significant challenges, including a lack of consistent follow-up and hospital readmissions with catastrophic events [45].

Prior to this study, patient education was provided by a health care professional (HCP) (nurse, pharmacist, and physician) during hospital admission, emergency room stay or clinic visit. However, this approach to teaching has challenges limiting the assimilation of information. The family is assembled when an illness/health challenge is diagnosed or following major surgery at a stressful time, post-illness diagnosis or significant surgery.

COVID-19 precautions have limited the number of family members at the bedside or outpatient clinic, limiting who can participate and support the patient. In addition, current teaching styles are non-engaging, laborious, and time-consuming, which can be costly. All of which pose challenges to patient education and limit patient understanding and retention of information. Thus, it is necessary to evaluate new educational methods and to determine their effectiveness in translating knowledge to the patient.

eKITE are infographic visual representations that present information quickly and clearly, integrating words and graphics that tell a story to reveal information. These facilitate self-directed learning with easy-to-understand information presented in an engaging way to enhance learning for children and their families. Patients can learn at a pace consistent with their learning style to facilitate knowledge development and health literacy. Infographic presentations have numerous advantages over current teaching tools, including multi-modal presentation, focused content, ease of use, interactive, and adaptability. More importantly, the online platform allows the patients to revisit modules as many times as needed, facilitating cumulative learning where reasoning is necessary to progress in the module [46], [47]. Learning is optimized when the learner can revisit the education/resources to grow knowledge and develop practice skills related to health [27], [48]. In addition, the modules present standardized, evidence-based information, which decreases the challenges associated with current educational models in health care, which are educator dependent, time-consuming and thus costly, and do not approach the learner in a manner conducive to effective integration of knowledge [27], [30], [48].

eKITE warfarin modules provide a self-directed learning approach, promote patient interaction, and develop knowledge over a continuum of time. Each module builds on the previous, exploring core elements, progressively building knowledge [47] leading to better patient engagement and effective knowledge translation, which is essential to safe anticoagulation therapy and health management. eKITE provides opportunities and resources for patients to engage in health education at a suitable pace for their learning needs and at times that will optimize their learning readiness. This is in contrast to current educational initiatives where education is presented during highly stressful times such as hospital admissions associated with recent surgery, new treatments, or diagnoses. The user can progress through learning with eKITE at a pace suitable to their learning needs and not disadvantaged by HCP time constraints. In addition, current methods require significant HCP time, which can be costly. All of these pose challenges to patient education and limit patient comprehension and retention of information. Thus, it is necessary to evaluate new educational methods and determine their effectiveness in translating knowledge to the patient. In addition, current methods require significant HCP time without a positive correlative impact on the internalization of knowledge concepts by the patient.

TTR was used in this study as a recognized measure of safety and efficacy of warfarin and was outstanding at 84%, which is comparable to or better than what is reported in previous studies [8], [49].

The reduction in HCP time engaged in warfarin teaching decreased from 93 (range 60–180) to 10 (range 0–30) min, potentially translating to cost savings, although this was not formally evaluated in this study. Formal cost analysis evaluating hospital readmissions and HCP follow up time would be required in future studies.

This prospective study collected data on various aspects of warfarin education and understanding, and utilized time in the therapeutic range (TTR) as a surrogate for efficacy and safety of this intervention on anticoagulation therapy. Many studies have demonstrated the association of higher TTR with lower rates of bleeding and thrombotic complications. However, we did not collect data on hospital readmission, bleeding/thrombosis adverse events and/or thrombosis prevention/resolution that may be directly impacted by these interventions. As such, we are limited in our ability to draw conclusion on the overall clinical impact of these modules of cost effectiveness, resource utilization and safety as it relates to hospital readmissions, adverse events and other clinical outcomes. The long-term retention of knowledge also requires further evaluation.

An additional limitation of this study was that these modules were created in English, and were primarily focused on warfarin/Coumadin as the vitamin K antagonist of interest. These agents are utilized most commonly in North America, with other vitamin K antagonists such as phenprocoumon utilized more in Europe. While the general principles of vitamin K antagonists as it related to INR and factors that impact INR are universal across various agents, there are certain aspects such as target INRs that are not generalizable across various VKAs. As such, we hope to expand modules to incorporate specific information regarding different VKAs, and have them accessible in various languages for future iterations.

5. Conclusions

eKITE is an online (www.kidclot.com) teaching modality and demonstrated effective warfarin education and participant internalization of knowledge. It teaches essential concepts to the patient, facilitates knowledge transfer, reduces stress associated with learning, actively engages patients, and reduces the time required by the HCP to provide patient education. Home INR monitoring facilitated social distancing for both healthcare providers and patients. TTR demonstrated in this study supports participant learning as knowledge is required to understand and better manage warfarin at home effectively. eKITE provides a sustainable educational resource to warfarinized patients and will be cost-effective in the long term, saving healthcare dollars.

Declaration of competing interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.