Abstract
Introduction
While numerous therapeutic education programs exist in physical medicine and rehabilitation (PM&R), they rarely concern pharmacological treatments. Nevertheless, drugs prescribed during a hospital stay can have a significant risk of adverse events. Vitamin K antagonists (VKA) are among them.
Objective of the study
To assess patients’ knowledge on their oral anticoagulant treatment before their hospital discharge.
Methods
Fifty patients were enrolled in this prospective, monocenter study. Their level of knowledge was assessed by a semi-structured interview between the pharmacist and the patients and/or their caregivers.
Results
Seventy percent of patients were able to give the name of the drug they were taking, 82% could explain its effect and finally, 24% of patient knew their INR target values. Twenty-two percent of patients were able to describe the symptoms in case of overdose and what to do in that case. Forty percent of patients were aware of food interactions and 60% of self-medication risks. The patient’s knowledge and behavior acquired during their hospital stay are not enough to guarantee a safe treatment management upon discharge. Based on this study, therapeutic patient education sessions were implemented.
Conclusion
These results suggest that specific drug therapy management sessions should be developed as part of PM&R’s therapeutic education programs for patients.
Résumé
Introduction
Les démarches d’éducation thérapeutique sont nombreuses en médecine physique et réadaptation mais concernent peu le traitement pharmacologique. Pourtant, les patients hospitalisés bénéficient souvent d’un traitement médicamenteux avec risque iatrogène important. C’est le cas des antivitamine K (AVK).
Objectifs
Évaluer le niveau de connaissance des patients sur le traitement anticoagulant oral à l’issue de l’hospitalisation en service de médecine physique et réadaptation.
Patients et méthodes
Cinquante patients ont été inclus dans cette étude prospective monocentrique. Le recueil des informations auprès du patient et/ou de son aidant a été effectué par le pharmacien au cours d’un entretien semi-dirigé.
Résultats
Soixante-dix pour cent des patients connaissaient le nom de l’AVK, 82 % son rôle et 24 % les valeurs cibles de l’INR. Vingt-deux pour cent des patients savaient décrire les signes d’un surdosage et la conduite à tenir. Quarante pour cent connaissaient l’influence de l’alimentation et 60 % les risques de l’automédication. Durant l’hospitalisation, les connaissances acquises au contact de soignants étaient insuffisantes pour contribuer à une sécurité d’utilisation des AVK lors du retour au domicile. À l’issue de ce travail, des séances d’éducation thérapeutique ont été mises en place.
Conclusion
Ces résultats suggèrent l’intérêt d’intégrer des séances relatives aux traitements médicamenteux aux programmes éducatifs de médecine physique et réadaptation.
1
English version
1.1
Introduction
Vitamin K antagonists (VKA) are anticoagulant medicines aimed at preventing venous and arterial thromboembolic disorders. For some pathology (especially cardiovascular diseases at risk for pulmonary embolism), long-term treatments can be indicated. VKA are widely used as more than 1% of the French population takes them on a regular basis . These drugs can cause severe adverse side effects especially hemorrhages. Hemorrhaging complications due to VKA are the first cause of iatrogenic adverse drug reactions (ADR); in fact, 13% of hospital stays in France, due to adverse drug reactions, are attributed to VKA treatments, i.e. 17,000 hospital stays per year . The rate of severe hemorrhaging complications is close to 5% (out of 100 patients treated during 1 year) and it is even higher during the first 3 months of the treatment . For all these reasons, some evidence-based clinical practice guidelines directing the proper use of VKA drugs were instituted . In France, these guidelines are written and distributed by the French Agency for the Safety of Health Products ( Agence française de sécurité sanitaire des produits de santé ) that insists on the need for proper information and therapeutic education for patients taking VKA treatments .
According to the July 2009 “ Hôpital patient santé territoire (Hospital Patient Health Territory)” law , patients should have access to therapeutic education programs . In PM&R units or centers, this therapeutic patient education is also based on the April 2008 directive from the French Minister of Health . This directive is centered around the prevention of specific complications (pressure ulcers, urinary tract infections, joint stiffness) as well as maintaining the patient’s functional potential (autonomy, cardiorespiratory adaptation and training) . It does not focus as much on associated pharmaceutical treatments. However, VKA are often prescribed to patients hospitalized in PM&R units for pathologies of the locomotor system or central nervous system. The main indication for anticoagulant drugs is venous thromboembolic disease. Other indications include embolic cardiac events and cardiac dysrhythmia (continuous arrhythmia by atrial fibrillation CA/AF). Therapeutic information on VKA treatment is usually given by physicians and/or nurses during the patients’ hospital stay and upon discharge.
The benefits of therapeutic education for patients treated by VKA drugs have been extensively proven in the literature . Tang et al. reported a positive correlation between the patient’s knowledge acquired during therapeutic education programs and reaching and maintaining the target INR level . Results also showed that patients who had therapeutic education have a lower risk of hemorrhaging accidents and/or thrombotic recurrences at 3 months post-discharge, this risk is four times lower than patients who did not benefit from therapeutic education . However, to our knowledge, no specific educational approaches have been developed for PM&R teams. The aim of this study was to assess the patients’ knowledge regarding their VKA treatment after their hospital stay in a PM&R unit before being discharged home.
1.2
Patients and methods
1.2.1
Studied population
This prospective, monocenter study was conducted at the Hospital Henry Gabrielle from January 1st, 2008 to December 31st, 2009 in two clinical care units. The study’s inclusion criteria were:
- •
to take the VKA treatment for a minimum of 3 months and continue at home;
- •
to return home after the hospital stay with or without the help of a caregiver;
- •
to have a level of oral comprehension compatible with a semi-structured interview for knowledge assessment;
- •
to obtain an oral agreement from the patient and/or their designated person.
The exclusion criteria were:
- •
psychiatric disorders that could interfere with the interview;
- •
severe comprehension and/or cognitive disorders that could impact the quality/reliability of the collected data.
The medical follow-up, organization of care, rehabilitation activities as well as drug prescription and dispensation were identical for all patients.
1.2.2
Methods
A questionnaire (16 items) was used during a semi-structured interview. This evaluation setup allows for a verbal exchange between the healthcare professional and interviewed patients who can then add details to their answers. The questionnaire is a guide for the interviewer but all questions are discussed between the patient and the health care professional conducting the interview.
The hospital pharmacist was in charge of the interviews (AJD) along with a medical or pharmacy student. The interview took place in the patient’s room in the presence or not of the caregiver. The implication of the caregiver was decided according to the patient’s cognitive and/or communication disorders. The questionnaire ( Appendix A ) was designed by the pharmacist in partnership with the PM&R medical team based on existing documents . It included some elements from the VKA notebook distributed by the French Cardiology Society . This written support helped for directing the interview and collecting the patients’ answers and remarks. The duration of this semi-structured evaluation interview lasted about 40 minutes.
It took place the week before the patient was to be discharged from the hospital. If the pharmacist felt that the patient had insufficient knowledge on his or her VKA treatment, additional information was provided during the interview .
The answers to the questionnaire were analyzed for all the patients included; they were also differentiated into two groups: “old treatments” (treatments started before the hospital stay) and “new treatments” (treatment implemented during the hospital stay). The correct response rate for each of the questionnaire’s item was calculated (ratio of the number of correct answers vs. number of total answers). We compared the rates of correct responses between both groups (Fisher’s exact test for statistical significance).
1.3
Results
1.3.1
Patients’ characteristics
Fifty-four patients were initially included. One patient ended up refusing the interview and three patients were transferred to another structure or hospital unit before the scheduled evaluation date. The 50 patients finally included in the study (29 men and 21 women) had a mean age of 58 years (±15.2). They were hospitalized in a PM&R setting for the following pathologies: hemiplegia secondary to ischemic stroke (18), paraplegia or quadriplegia (12), multiple trauma (14), acute inflammatory demyelinating polyneuropathy (three) and knee replacement (three). The indications for VKA treatment were mainly: venous thromboembolic disease (48%) and embolic cardiac events (36%). The VKA drugs prescribed were fluindione (88%) warfarin (6%) or acenocoumarol (6%). The caregiver was present during the semi-structured interview for 20 out of the 50 patients included.
1.3.2
Evaluation of vitamins K antagonists treatment knowledge
The results of the evaluation on VKA treatment knowledge are listed in Table 1 , we differentiated patients who were prescribed a treatment before their hospital stay (Group 1: n = 10) and those whose treatment was implemented during their hospital stay (Group 2: n = 40). Patients (in both groups) knew the name of their VKA (70%), the treatment start-up date (84%), indication (76%) and role of the medicine (82%). However, INR target levels were badly known (24%) even for patients who were prescribed the treatment before their hospital stay (50%), in fact, there was a statistical significance between both groups ( P = 0.04). Furthermore, 50% of patients in Group 1 said they never received any information and 60% were not aware of the existence of a VKA monitoring handbook. Most patients (22%) in both groups did not know much about drug toxicity, symptoms of overdose and what steps to take in that case. Finally, patients who started their treatment during their hospital stay had only partial notions on the following items: what to do when forgetting to take the medicine (43%), the need for close monitoring (35%), the importance of regularly taking the treatment (64%), risks incurred by taking too low a dosage (50%) and finally self-medication risks (53%).
| Old treatment n = 10, ( n [%]) | New treatment n = 40, ( n [%]) | Total n = 50, ( n [%]) | |
|---|---|---|---|
| Name of the anticoagulant | 9 (90) | 26 (65) | 35 (70) |
| Indication of the treatment | 8 (80) | 30 (75) | 38 (76) |
| Date the treatment started | 7 (70) | 35 (88) | 42 (84) |
| Information already received | 5 (50) | 13 (12) | 18 (36) |
| VKA handbook already received | 4 (40) | 2 (5) | 6 (12) |
| Therapeutic effect | 9 (90) | 32 (80) | 41 (82) |
| Taking the treatment at regular hours | 8 (80) | 24 (60) | 32 (64) |
| Need for monitoring | 8 (80) | 14 (35) a | 22 (44) |
| Target INR and WTD | 5 (50) | 7 (18) a | 12 (24) |
| Forgetting the medicine and WTD | 8 (80) | 17 (43) | 25 (50) |
| Signs/risks of over dosage and WTD | 4 (40) | 7 (18) | 11 (22) |
| Risks in case of under dosage and WTD | 4 (40) | 20 (50) | 24 (48) |
| Risks of self-medication and WTD | 9 (90) | 21 (53) a | 30 (60) |
| Scheduled therapeutic care and WTD | 6 (60) | 17 (43) | 23 (46) |
| Food interactions and WTD | 5 (50) | 15 (38) | 20 (40) |
These notions were globally better understood by patients from Group 2 who had a longer experience with their treatment, there was a statistical significance between the two groups for “need for monitoring” ( P = 0.01) and “self-medication risks” ( P = 0.03).
1.4
Discussion
During their hospital stay, patients become more knowledgeable about their treatment thanks to healthcare professional. However, these notions are not enough to guarantee a safe use of VKA treatments. If patients know the name and role of their VKA drugs (notions belonging to the “knowledge” field), very few of them were aware of what the overdose symptoms were and what to do in that case (notions belonging to the “know-how” field), even though patients should be understand these risks for their own safety. Some similar results were reported by other studies: in a study on 186 patients, 61% of the patients knew the role of their VKA drug but only 19% of them were aware of overdose risks . In another study conducted on 88 patients, 60 to 90% of patients knew what the indication was for their VKA treatment but only 11% were aware of hemorrhaging risks . These results highlight the need to improve the way information is given to the patient on this specific point. However, patients were more knowledgeable on the risks induced by taking too low a dose of their VKA. It seems that patients have an easier time understanding that they could get sick again if the treatment’s is not as effective . The knowledge of patients on the risks involved with self-medication was quite weak, especially when we know that more than two thirds of overdoses are caused by drug interactions increasing the effects of VKA treatments . Patients that had been treated for several years were not aware of the basic notions on VKA such as overdose risks and what to do in that case (60%) or even what their INR target level should be (50%). These data justify including these patients in a therapeutic patient education program on VKA treatment. Finally, in this study, patients were younger (58 ± 18 years), than in the other studies found in the literature .
The study was only conducted in two PM&R care units, corresponding to units where the medical and pharmaceutical cares and therapeutic procedures were identical, it could explain the small number of patients included in our study in light of other published works in spite of a 2-year inclusion period. However, the results concur with the ones reported in the literature.
Following this pilot study, some specific educational sessions were implemented (started in January 2010). Since these patients often have associated cognitive disorders, caregivers are very involved in this educational approach. Therapeutic education sessions are proposed to the patient and/or caregiver by a team including a physician and pharmacist. These sessions are preceded by a diagnosis on patients’ knowledge and they are designed to confront patients with practical situations to test their reactions and behaviors: e.g. hemorrhaging, forgetting to take their medicine, abnormally high or low INR levels, scheduled surgery. Educational tools were developed to illustrate the information given during these sessions: picture albums presenting commonly used medicines and images to explain the treatment, these tools facilitate the communication between patients and healthcare professionals.
To continue in this direction, we are planning to forward the patient’s therapeutic education file to our colleagues in private pharmacies in order to pursue this monitoring once the patients have returned home .
Finally, the results of this pilot study show the need to develop, in PM&R, specific therapeutic approaches for drug treatments in addition to other existing therapeutic approaches. In addition to anticoagulants, other pharmacological treatments should be concerned by these approaches: analgesics, psychotropic drugs, antispasticity treatment and finally cardiovascular prevention treatment (for ischemic stroke patients) .
The next step in our work is to design a complete and multidisciplinary educational program including treatment acceptance and compliance.
Disclosure of interest
The authors declare that they have no conflicts of interest concerning this article.
Appendix A
Patients’ knowledge evaluation questionnaire.
Vitamins K antagonists treatment evaluation questionnaire.
| 1. What is the name of your prescribed VKA drug? | □ knows | □ doesn’t know |
| Previscan (fluindione), Sintrom/Minisintrom (acenocoumarol/coumarin), Coumadin (warfarin) | ||
| 2. What is the indication for your treatment? | □ knows | □ doesn’t know |
| Thrombosis, phlebitis, pulmonary embolism, arrhythmia, cardiac valvular disease, other… | ||
| 3. How long have you been taking this treatment? | □ knows | □ doesn’t know |
| Treatment started before the hospital stay (number of months or years taking the treatment). Treatment started during the hospital stay | ||
| 4. Did you already receive some information on this medicine? | □ yes | □ no |
| Who gave you the information: □ physician □ pharmacist □ nurse □ biologist □ dentist □ caregiver □ other? | ||
| What type of information:……………………………………… | ||
| 5. Do you own a VKA monitoring handbook? | □ yes | □ no |
| If yes, did you already read it? | □ yes | □ no |
| 6. What is the action of the medicine | □ knows | □ doesn’t know |
| A vitamin K antagonists (VKA) drug is an anticoagulant treatment: it acts as a blood thinner in order to prevent blood clots (phlebitis) or to dissolve pre-existing blood clots to prevent their migrating into blood vessels (embolism). VKA neutralizes the action of the vitamin K (vitamin promoting blood coagulation) | ||
| 7. When during the day do you take your medicine? | □ knows | □ doesn’t know |
| The drug must be taken daily at the same time(s). If there is one unique dose, it is better to take the medicine in the evening | ||
| 8. Do you know what to do if you forget to take your medicine? | □ knows | □ doesn’t know |
| If you forgot to take your medicine, take the missed dose within 8 hours of your usual medication time | ||
| After this time, it is preferable to “skip” this take and take the following one at the usual time the next day (do not double the dose). Inform your physician and/or biologist if this missed take happened just before having a blood test | ||
| 9. Why is it important to monitor this treatment? | □ knows | □ doesn’t know |
| It is necessary for the dose to be sufficient to prevent the formation of a blood clot or to dissolve it but the dose should not be too strong to avoid hemorrhage(s) | ||
| Do you know the modalities of this monitoring? | □ knows | □ doesn’t know |
| At the beginning of the treatment, frequent check-ups are done until the target INR is reached. Once this target INR is reached, the INR is monitored every 15 days (or every month). In case of additional associated treatments or having stopped taking associated treatment, additional INR check-ups will be necessary to adapt the dose | ||
| 10. What is the INR? | □ knows | □ doesn’t know |
| INR is a lab test evaluating the action of VKA on blood thinning. The dose is adjusted according to the INR results. This lab test is mandatory. The INR is done from a simple blood sample, taken in the morning when the VKA is taken at night | ||
| 11. Do you know what the clinical symptoms are in case of overdose? | □ knows | □ doesn’t know |
| Symptoms of external bleeding = blood in the urines, coughing up blood or bleeding from the gums and nose, hematoma, red eye, red blood in the stools | ||
| Symptoms of internal bleeding = unusual fatigue, abnormally out of breath, unusual paleness headache not alleviated by a treatment, unexplained fainting | ||
| 12. Do you know what to do in case of overdose? | □ knows | □ doesn’t know |
| 13. What are the risks of taking too low a dose? | □ knows | □ doesn’t know |
| 14. What are the authorized and forbidden medications? | □ knows | □ doesn’t know |
| What kind of treatment do you take for pain, headaches, a cold, etc.? | ||
| Remind the patient that he or she shouldn’t take any other type of medication or plants, even those not requiring a prescription (e.g. aspirin and other anti-inflammatory drugs). Ask which medications the patient has in his or her “first aid kit” | ||
| 15. Whack precautions do you have to take before any scheduled therapeutic gesture or procedure? | □ knows | □ doesn’t know |
| Inform them of your treatment; ask your physician before ANY injection, tooth extraction, pedicure… | ||
| 16. Are you aware of possible food interactions with your treatment and what to watch for? | □ knows | □ doesn’t know |
| No food is forbidden, but the patient should not eat too much of the following due to their high vitamin K contents: cabbage, cauliflower, Brussels sprouts, broccolis, lettuce and spinach | ||
| 17. What should you do if you would like to get pregnant? | □ knows | □ doesn’t know |
| (optional) | ||
| Tell your physician you would like to get pregnant. VKA treatments are not recommended during pregnancy, your physician will evaluate the relevance of continuing your treatment or opting for another anticoagulant treatment | ||
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