Abstract
Objective
The study was to assess the knowledge of warfarin in patients using the validated anticoagulation knowledge assessment questionnaire and to evaluate the predictors of the level of knowledge among outpatients receiving warfarin at the Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia.
Methods
It was a prospective cross-sectional study carried out from October 2019–January 2020. During the study period a total 401 of them were included in the study. Anticoagulation Knowledge Assessment questionnaire has 29 question items, a single patient should answer at least 21 of the question to be considered as knowledgeable about his/her medication. The data was exported into SPSS version 25 and a one way ANOVA and post hoc were conducted.
Results
The mean age of the study participants were 36 years old (SD ± 11.83), which was ranges from 18 to 82 and majority of the participants were females (69.6%). Almost in one-third of the participants (35.7%), the reasons for warfarin therapy were Chronic Rheumatic Valvular Heart Disease. The overall AKA mean ± SD score of the respondents was 7.4 (±2.6) that ranges from 2 to 22. From those only (4.2%) of the study participants had succeeds the passing score. Educational level and the duration of warfarin therapy were independent predictors towards patient’s warfarin knowledge.
Conclusion
The overall patient’s knowledge about warfarin treatment was poor when it was compared to most other studies. The longer duration of warfarin therapy and advanced educational level showed favored relationship towards better warfarin knowledge of the study participants.
Keywords: Assessment of patients’ knowledge, Anticoagulation, Ethiopia, Warfarin
Abbreviations
- AKA
Anticoagulation Knowledge Assessment
- INR
International Normalized Ratio
- TASH
Tikur Anbessa Specialized Hospital
1. Introduction
Given the recent launch of many direct-acting oral anticoagulants, warfarin, a vitamin K antagonist, is likely to remain the dominant medication for the prevention and treatment of thromboembolic, cardiac and hypercoagulable disorders in low-and middle-income countries in the years to come [1,2]. Warfarin has a narrow therapeutic index and possibly sever adverse effects, repeated laboratory testing is essential to maintain the International Normalized Ratio (INR) within the therapeutic range [[2], [3], [4]].
Warfarin, a coumarin derivative, prevents clotting by reducing the hepatic development of bioactive vitamin K-dependent clotting factors (activated factors II, VII, IX and X) [5,6]. Research indicates, however, that anticoagulant and antithrombotic effects can be completely separated and that the reduction of prothrombin and likely factor X is more essential than the reduction of antithrombotic factors VII and IX [7]. This has an unpredictable pharmacokinetics and dynamics and requires personalized dosing to achieve effective anticoagulation [8].
In most cases, the therapeutic INR range is 2.0–3.0. Exceptional cases can be when warfarin is being used for prevention following a myocardial infarction or in individuals with severe-risk mechanical prosthetic heart valves, in whose circumstance the range is 2.5–3.5 [2,5]. Follow up is necessary to prevent both low-intensity anticoagulation thromboembolic events and higher-intensity haemorrhagic events [9,10]. The rise in INR across the therapeutic range bestows a predisposition to bleeding, which would be a frequent cause of hospitalization(4).
In addition, a list of prescription medications has been considered as a highly interactive medication with food and other medicines [1,11]. In reality, it is understood that long-term consistency is difficult to achieve due to unpredictable changes in patients' INR values, which can be related to a wide variety of factors including dietary adjustment, poor medication compliance, alcohol intake, seasonal variability, and medication interactions [9].
The effectiveness of warfarin can be greatly determined by numerous factors, including concomitant drug treatment for patients, modifications in diet or alcohol consumption, and medical problem. Thus it is crucial for patients to be well advised and fully recognize the risks of anticoagulant therapy [[5], [6], [7],10]. Health care providers should also understand that many patients with warfarin will have major gaps in their warfarin-related information. In fact, patients may have unhealthy attitudes that could still be present after initial warfarin education and regular supervision by an anticoagulation clinic.
It is important to assess the level of awareness of warfarin therapy amongst these users as well as provide appropriate education and advice to patients. The aim of the study was to assess the knowledge of warfarin in patients using the validated Anticoagulation Knowledge Assessment (AKA) questionnaire and to evaluate the predictors of the level of knowledge among outpatients receiving warfarin at the Tikur Anbessa Specialized Hospital (TASH), Addis Ababa, Ethiopia.
2. Methods
2.1. Study setting
The study was done at TASH, one of the tertiary hospitals in Addis Ababa, Ethiopia. The hospital is affiliated with Addis Ababa University, it delivers the service divided as inpatient, outpatient and emergency departments [12]. In the Hospital there are 465 physicians, 76 pharmacists and 992 nurses are dedicated in providing health care service (College of health sciences, human resource management 2018). Around 600 beds are available in the hospital and more than half million patients served annually [13]. Mainly the cardiac and hematology clinics are the one most patients received a warfarin prescription in the hospital.
2.2. Study design and period
It was a prospective cross-sectional study carried out from October 2019–January 2020. Information regarding the indications of warfarin, duration of therapy and current INR values were collected from medical records and the demographic characteristics and the question regarding patient’s warfarin knowledge were collected by interviewing the patients. After completion of the data collection procedure, to specific knowledge gaps on individual patients education and counseling was given by the principal investigator and trained data collectors to the patients about their warfarin treatment.
2.3. Source and study population
All the patients who visited a cardiac and hematology clinics at TASH was taken as source population and those patients who meet the eligibility criteria was considered as study population.
2.4. Inclusion and exclusion criteria
Patients who had an appointment while the study period, those who has a willingness to participate in the study and patients with a recent INR result (past three months) in their medical records were included. Patients with age less than 18 years old and patients who were on warfarin for less than six months were excluded from the study.
2.5. Sampling and sample size determination
During the study period a total of 447 patients and medical records were approached, form those 401 of them fulfill the eligibility criteria were included in the study.
2.6. Data collection instruments
In the current study a validated AKA questioner was implemented to collect the data [14]. An effort has been made to validate the contents of the AKA questioner regarding its readability and reliability by experts in the area. The data abstraction format has contained twenty nine multiple choice questions regarding different aspects of warfarin therapy. In this questioner the patient’s anticoagulation knowledge was assessed in ten major concerning areas. These areas were including the medication administration, interaction, physical activity, diet, pregnancy, procedure and basic laboratory monitoring.
The patients were categorized into three groups based on their scores points from AKA questioner. The first group composed of patients who had a score of less ten, group two assigned for respondents whose score was between eleven and twenty and the third group is the one who achieved the passing score of twenty one and above. Each correctly answered question was given a score of one point, whereas incorrectly answered questions were scored as zero. From all 29 question items, a single patient should answer at least 21 (72.4%) of the question to be considered as knowledgeable about his/her medication. Originally the questioner was presented in English, it was translated to local language Amharic and interviewed.
2.7. Data collectors recruitment and training
Five postgraduate pharmacy practice students were participate in the data collection process. Earlier to actual data collocation, a one day training was given about the AKA instrument and basic ethical principles by the principal investigator.
2.8. Data quality assurance and analysis
A pretest was conducted on 20 participants and slight adjacent was made in the instrument accordingly. The findings of the pretest were omitted from the final results. All over the data collection procedure a close supervision was made by the investigator. The data was checked for its completeness and consistency on regular base.
2.9. Data analysis and interpretation
The data was exported into SPSS version 25, after confirming its completeness. The descriptive statics has made to summarize the data by using mean , percentage and ranges. A one way ANOVA and post hoc analysis was demonstrated to check whether there is a significant association present between the socio-demographic characteristics and the overall mean score of warfarin knowledge of patients, a P-value < 0.05 was considered as statically significant association with warfarin knowledge score.
2.10. Ethical clearance
The study was approved by the ethical review board of Addis Ababa University, school of pharmacy (approval number: ERB/SOP/48/07/2019). A written permission was taken from both hematology and cardiac clinics. In addition to this an effort had been made by data collectors about explaining the aim of the study to the participants and an ethical consent was sought from each of the study participants before data collection.
3. Results
3.1. Socio-demographic and baseline clinical characteristics
The mean age of the study participants were 36 years old (SD ± 11.83), which was ranges from 18 to 82. From four hundred one study participants, majority of them were females 279 (69.6%). Around one-fourth of the respondents were single 102 (25.4%). Almost ten percent of the study were unable to read or write and a significantly huge number of participants were unemployed at a time of data collection 174 (43.4%). More than half of the study participants had taken warfarin for more than two years 226 (56.4%) (Table 1).
Table 1.
Socio-demographic and baseline clinical characteristics of study participants attending in cardiac and hematology clinics, Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia, 2019 (n = 401).
Variables | Number (%) |
---|---|
Age | |
18–35 | 62 (15.5%) |
36–59 | 320 (79.8%) |
>60 | 19 (4.7%) |
Gender | |
Male | 122 (30.4%) |
Female | 279 (69.6%) |
Marital status | |
Single | 117 (29.2%) |
Married | 250 (62.3%) |
Widowed/divorce | 34 (8.5%) |
Educational level | |
Unable to read and write | 39 (9.7%) |
Completed primary school | 137 (34.2%) |
Completed secondary school | 102 (25.4%) |
Diploma | 69 (17.2%) |
Degree | 38 (9.5%) |
Masters and above | 16 (4.0%) |
Occupation | |
Unemployed | 174 (43.4%) |
Labor | 81 (20.0%) |
Governmental employer | 47 (11.7%) |
Private employer | 99 (24.7%) |
Duration of warfarin | |
3 months–1 year | 65 (16.2%) |
1 year–2 years | 110 (27.4%) |
>2years | 226 (56.4%) |
3.2. Indications for warfarin therapy
Almost in one-third of the study participants 143 (35.7%), the reason for warfarin therapy were Chronic Rheumatic Valvular Heart Disease (CRVHD). Atrial Fibrillation (AF) and heart valve replacement also significantly encountered for the indication of warfarin 106 (26.4%) and 64 (16.0%) respectively (Fig. 1).
Fig. 1.
Indications for warfarin therapy among study participants attending in cardiac and hematology clinics, Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia, 2019 (n = 401).
3.3. Warfarin knowledge of study participants
The overall AKA mean ± SD score of the respondents was 7.4 (±2.6) that ranges from 2 to 22. From those only seventeen (4.2%) of the study participants had succeeds the passing score. Majority of the patients correctly answered less than ten questions 233 (58.1%). More than one-third of the study participants were identified 11–20 of the AKA questions151 (37.7%). In the current study there was no single patient answered all twenty nine questions. The two most correctly answered questions by the study participants were (the best time of day for me to take my warfarin?) and (while in your pharmacy, you notice multivitamins are on sale. After some thought, you decide that you may need a multivitamin?) 381 (95.0%) and 365 (91.0%) respectively. On the other hand, the question about the duration of warfarin (Once your warfarin is stopped, how long does it take to get the medication to get out of your system?) was only answered by few respondents 4 (1%) (Table 2).
Table 2.
Warfarin knowledge of study participants attending in cardiac and hematology clinics, Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia, 2019 (n = 401).
Variables | Correctly answered (%) |
---|---|
Which one of these medications is recommended if you are taking Coumadin (warfarin) and want relief from a headache? | 13 (3.2%) |
| |
| |
| |
| |
Which of the following food items would interfere with your Coumadin (warfarin) medication? | 209 (52.1%) |
| |
| |
| |
| |
While on Coumadin (warfarin) medication, in which of the following would you go directly to the emergency room? | 184 (45.9%) |
| |
| |
| |
| |
You just remembered that you forgot to take your evening Coumadin (warfarin) medication dose last night. You would? | 122 (30.4%) |
| |
| |
| |
| |
While on Coumadin (warfarin) you? | 69 (17.2%) |
| |
| |
| |
| |
While out with friends for dinner, you have just finished your third glass of wine. This amount of alcohol consumed in a single evening will do? | 43 (10.7%) |
| |
| |
| |
| |
While in your pharmacy, you notice multivitamins are on sale. After some thought, you decide that you may need a multivitamin. You would do? | 365 (91.0%) |
| |
| |
| |
| |
If you ran out of your prescription for your Coumadin (warfarin) you would do? | 46 (11.5%) |
| |
| |
| |
| |
Which of the following is an effect of Coumadin (warfarin) medication that will most likely be experienced? | 297 (74.1%) |
| |
| |
| |
| |
You have a cold, which includes a runny nose and a cough. You do? | 205 (51.1%) |
| |
| |
| |
| |
When making a dental appointment while taking Coumadin (warfarin) medication, you need to remember you? | 131 (32.7%) |
| |
| |
| |
| |
When the need arises to take an antibiotic (to get rid of an infection) while taking Coumadin (warfarin), you need to? | 315 (78.6%) |
| |
| |
| |
| |
Coumadin (warfarin) works? | 196 (48.9%) |
| |
| |
| |
| |
The best time of day for me to take my Coumadin (warfarin) is? | 381 (95.0%) |
| |
| |
| |
| |
Which of the following is an effect of my Coumadin (warfarin) medication that I will most likely experience if my INR is too high? | 163 (40.6%) |
| |
| |
| |
| |
Which of the following drinks can decrease the effectiveness of your Coumadin (warfarin)? | 10 (2.5%) |
| |
| |
| |
| |
While taking Coumadin (warfarin), which of the following represents a situation when you should to go to the emergency room? | 164 (40.1%) |
| |
| |
| |
| |
Your neighbor brings over this great ‘‘all natural’’ herbal supplement she just bought from her chiropractor. She swears that this helps all her aches and pains and recommends that you take it when you ache. Your decision is to? | 67 (16.7%) |
| |
| |
| |
| |
Once you have reached a stable Coumadin (warfarin) dose, a PT/INR blood test? | 236 (58.9%) |
| |
| |
| |
| |
The results of your PT/INR test tell the pharmacist? | 109 (27.2%) |
| |
| |
| |
| |
While taking Coumadin (warfarin), you should call your Coumadin Clinic when you get? | 12 (3.0%) |
| |
| |
| |
| |
While on Coumadin (warfarin) you need to be routinely monitored for which of the following? | 353 (88.0%) |
| |
| |
| |
| |
Which of the following may have a significant effect on how well your Coumadin (warfarin) works? | 15 (3.7%) |
| |
| |
| |
| |
While taking Coumadin (warfarin), which of the following should lead you to the emergency room? | 188 (46.9%) |
| |
| |
| |
| |
Which of the following foods could affect how well your Coumadin (warfarin) works? | 227 (56.6%) |
| |
| |
| |
| |
You have generic and brand Coumadin (warfarin) tablets at home that are both the same dose. You should? | 363 (90.5%) |
| |
| |
| |
| |
Once your Coumadin (warfarin) is stopped, how long does it take to get the medication to get out of your system? | 4 (1%) |
| |
| |
| |
| |
After starting Coumadin (warfarin), how long (in months/years) would you expect to be taking Coumadin (warfarin)? | 193 (48.1%) |
| |
| |
| |
| |
Which of the following activities are more risky while taking Coumadin (warfarin)? | 141 (35.2%) |
| |
| |
| |
|
Correct answers.
3.4. Predictive factors associated with the patient’s warfarin knowledge
In this study educational level and the duration of warfarin therapy were independent predictors towards patient’s warfarin knowledge. The post hoc analysis revealed that patients with educational background of degree associated with a good knowledge of warfarin therapy than patients with other educational levels (P-value = 0.043*). Similarly patients who had been used warfarin for more than two years had relatively acquired more knowledge about their medication than other patients who were on warfarin for lesser duration (P-value = 0.000*) (Table 3).
Table 3.
Predictive factors towards warfarin knowledge of study participants attending in cardiac and hematology clinics, Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia, 2019 (n = 401).
Variables | Mean score (±SD) | F | P-value |
---|---|---|---|
Age | 0.263 | 0.697 | |
18-35 | 7.9 (±3.6) | ||
36-59 | 7.8 (±3.4) | ||
>60 | 7.4 (±3.1) | ||
Gender | 1.559 | 0.074 | |
Male | 8.1 (±3.8) | ||
Female | 7.5 (±3.4) | ||
Marital status | 0.394 | 0.091 | |
Single | 7.8 (±3.7) | ||
Married | 7.7 (±3.4) | ||
Widowed/divorce | 7.9 (±3.1) | ||
Educational level | 4.844 | 0.043a | |
Unable to read and write | 5.2 (±4.6) | ||
Completed primary school | 7.5 (±3.5) | ||
Completed secondary school | 7.4 (±3.8) | ||
Diploma | 7.8 (±3.7) | ||
Degree | 10.2 (±2.8) | ||
Masters and above | 8.9 (±3.3) | ||
Occupation | 0.972 | 0.688 | |
Unemployed | 7.1 (±3.5) | ||
Labor | 7.0 (±3.4) | ||
Governmental employer | 7.9 (±3.7) | ||
Private employer | 7.6 (±3.5) | ||
Private business | 7.6 (±3.6) | ||
Duration of warfarin | 3.548 | 0.000a | |
3 months–1 year | 6.8 (±4.2) | ||
1 year–2 years | 7.8 (±3.8) | ||
>2years | 9.1 (±2.7) |
Variables with statistically significant association.
4. Discussion
Lack of knowledge among patients who are receiving warfarin has been showed in which could be one of the important factors determining the degree of anticoagulation control and resulted in failure of achieving goal of treatment [1,15]. This makes it vital to evaluate the degree of knowledge of warfarin therapy among its user and provide necessary education and counseling regarding the medication to the patients [[16], [17], [18]].
The overall mean warfarin knowledge score of the study participants was 7.8 (±3.6) and only 4.2% of the respondents achieved the passing score. The finding was comparable with a study which had been done in this setup, Tamrat et el reported that the patients warfarin mean knowledge score was 11.8 (±2.6) [19]. However, this finding was much lower than most previous studies, for instance, in a Chinese study, the mean score of warfarin knowledge was 62.3% (±8.8%) and 44.4% of the study respondents had succeed the passing score(20). Similarly, in a Brazilin study, patients were classified into good, medium and poor knowledge based on their scores and exactly half of the study respondents had good knowledge about their medication [21]. Furthermore, a study from India revealed that, 18.5% of patients had high knowledge score towards their warfarin treatment [22]. The better warfarin knowledge in the above study might be explained by a better socio demographic characteristic of the study participants compared to patients in the current study.
In the current study less than half of patients 48.9%, aware of how warfarin works. This value was lower than both studies which were conducted in Malaysia 71.2% and 66.5% respectively [15,18]. Furthermore, in a multi centered European study on patients with atrial fibrillation, 90% of the respondents identified that warfarin is a medicine with the purpose of thinning their blood [23]. In Indian study, almost the same number of study respondents (90%) knew the reason for prescribing warfarin was to prevent blood clotting [22].
Several study participants 88%, knew about their routine laboratory monitoring’s which are vital to monitor their warfarin treatment. This finding was in line with the European study on atrial fibrillation patients, in that study 76% of the respondents recognized the specific laboratory monitoring and the frequency that tests should be conducted [23]. In the contrary more than two-third of the study participants (67.9%) don’t have the basic knowledge about laboratory monitoring of warfarin therapy in the Indian study [22].
Another interesting concern about patients on warfarin is the interaction profile of the drug, since it’s one of the medications with the narrow therapeutic index. In the present study patients were asked about to identify the safest medication that can help them of relief from a headache. Only a few number of the respondents (3.2%) identified the correct answer towards selecting the appropriate medication which can be taken with warfarin. This was much lower than the Malaysian study, the study reported that 42.9% of the respondents had good knowledge about the interaction between warfarin and other medications [18]. A multi-centered Africans study also revealed that more than half (55%) of the study participants had taken a potentially interacting medication alongside with their warfarin treatment [24].
In the AKA questioner there are four questions that are intended to assess the patients knowledge about the situation in which they needs to visit the emergency room right away. The average means score of those four questions were 34.0% and it was lower than most other similar studies. For instance in a cohort of Australian patients taking warfarin, beyond two-third (67.6%) of the respondents identified when to seek urgent medical attention [17]. In the Indian study 78% of the study participants aware of that the major signs or symptoms which they need to come to emergency room [22].
Educational level and the duration of warfarin therapy had a positive significant association with the patient’s knowledge about warfarin and it was consistence with prior studies [3,15,20,25]. Besides in Malaysians study age and income were also had a significant association with patients knowledge of warfarin [15], however, those variables had no role in predicting the patients warfarin knowledge score the current study.
The limitation of the study was it’s a single centered study and it was conducted in urban city of the country perhaps, this may not represent that the patients’ warfarin knowledge found in rural area of the country. It was also difficult to reach on conclusion by one-time assessment of knowledge of patients. Another limitation of the study was that, it was difficult to assess post education and counseling knowledge level because patients appointment was varied that makes difficult to meet the same patients in the following appointment.
As a conclusion the overall patient’s knowledge about warfarin treatment was poor when it was compared to most other studies [1,18,20,22]. The longer duration of warfarin therapy and advanced educational level showed favored relationship towards better warfarin knowledge of the study participants.
Ethics approval and consent to participate
The study was approved by the ethics review board of the school of pharmacy, Addis Ababa University and written consent was taken from each of the study participants before starting the data collection.
Consent for publication
Not applicable.
Availability of data and material
The datasets analyzed during the current study are available from the corresponding author on request.
Funding
No financial support was gained to conduct the study.
CRediT authorship contribution statement
Abdella Birhan Yabeyu: Writing – original draft, Formal analysis, Supervision, contributed to designing the study, manuscript preparation, and finalization, contributed to data analysis, and data interpretation, participated in the supervision of the study. Meaza Adugna Ayanaw: Formal analysis, contributed to data analysis, and data interpretationand, and. Kaleab Taye Haile: Formal analysis, Supervision, contributed to data analysis, and data interpretation, participated in the supervision of the study, All authors read and approved the final manuscript. Zemene Demelash Kifle: Formal analysis, contributed to data analysis, and data interpretation.
Declaration of competing interest
The authors declare that they have no competing interest.
Acknowledgment
The authors would like to acknowledge the support of the school of pharmacy, Addis Ababa University, in facilitating the data collection process and would also like to thank all volunteer participants of the study.
Contributor Information
Abdella Birhan Yabeyu, Email: birhanabdella@gmail.com.
Meaza Adugna Ayanaw, Email: meazaadugna23@gmail.com.
Kaleab Taye Haile, Email: teezysam@gmail.com.
Zemene Demelash Kifle, Email: zeme2010@gmail.com.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets analyzed during the current study are available from the corresponding author on request.