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PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION Mrs. Lovera Suresh Mrs. Anju Malik Head of the Department 1st year M. Sc. Nursing Paediatriac Nursing Medical Surgical Nursing 2012-14 Sarvodaya College of Nursing, Oriental College of Nursing, Bangalore – 560 079 Bangalore – 560 010 1 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE, BANGALORE, KARNATAKA PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION 1 NAME OF THE CANDIDATE AND Mrs. ANJU MALIK 1st YEAR M.Sc NURSING, ADDRESS ORIENTAL COLLEGE OF NURSING, #43/52,2nd MAIN, INDUSTRIAL TOWN,WEST OF CHORD ROAD, RAJAJI NAGAR BANGALORE – 560010. 2 Oriental College Of Nursing NAME OF THE INSTITUTION Bangalore. 3 1st year M.Sc nursing COURSE OF THE STUDY AND Medical Surgical Nursing. SUBJECT 4 DATE OF ADMISSION OF COURSE 5 TITLE OF THE TOPIC 15.06.2012 “A study to evaluate the effectiveness of self instructional module on knowledge regarding care of patients on anticoagulant therapy among staff nurses in a selected hospital, Bangalore.” 6 BRIEF RESUME OF THE INTENDED WORK 7 6.0 Introduction Enclosed 6.1 Need for the study Enclosed 6.2 Review of literature Enclosed 6.2.1 Statement of the Problem Enclosed 6.3 Objectives of the study Enclosed 6.3.1 Operational definitions Enclosed 6.3.2 Assumptions Enclosed 6.3.3 Hypothesis Enclosed 6.3.4 Sampling Criteria Enclosed MATERIALS AND METHODS: 7.1 Sources of data – Data will be collected among staff nurses in a selected hospital, Bangalore 7.2 Method of data collection: Self administered questionnaire 7.3 Does the study require any investigation or interventions to be conducted on the patients or human beings or animals? Yes 7.4 Has ethical clearance being obtained your institution? Yes 8 LIST OF REFERENCES: Enclosed 2 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE, BANGALORE, KARNATAKA PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION 1 Mrs. ANJU MALIK NAME OF THE CANDIDATE 1st YEAR M.Sc NURSING, AND ADDRESS ORIENTAL COLLEGE OF NURSING, #43/52,2nd MAIN, INDUSTRIAL TOWN,WEST OF CHORD ROAD, RAJAJI NAGAR BANGALORE – 560010. 2 NAME OF THE INSTITUTION Oriental College Of Nursing Bangalore. 3 COURSE OF THE STUDY AND Medical Surgical Nursing. SUBJECT 4 DATE OF ADMISSION OF 15.06.2012 COURSE 5 1st year M.Sc nursing “A study to evaluate the effectiveness TITLE OF THE TOPIC of self instructional module on knowledge regarding care of patients on anticoagulant therapy among staff nurses in a selected hospital, Bangalore.” 3 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE, BANGALORE, KARNATAKA PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION 1. NAME OF THE Mrs. Anju Malik CANDIDATE & ADDRESS 1st Year M.Sc. Nursing Oriental College of Nursing, #43/52,2nd Main, Industrial Town,West of Chord Road, Rajaji Nagar Bangalore – 560010. 2. 3. 4. NAME OF THE Oriental College of Nursing, INSTITUTION Bangalore – 560010 COURSE OF STUDY AND 1st Year M.Sc. Nursing SUBJECT (Medical Surgical Nursing) DATE OF ADMISSION OF 15-06-2012 COURSE 5. “A TITLE OF THE STUDY study to evaluate the effectiveness of self instructional module on knowledge regarding care of patients on anticoagulant therapy among staff nurses in a selected hospital, Bangalore.” 4 6. BRIEF RESUME OF THE INTENDED WORK INTRODUCTION “Education is the most powerful weapon which you can use to change the world.” Nelson Mandela Systemic activities to prevent or cure health problems in humans are delivered by health care providers. The medicine man, the priest, the herbalist and magicians, all tried to bring relief to the sick in an almost complete absence of scientific medical knowledge. As the world becomes modernized, the advent of new technologies discovered many methods of treating diseases and illness.1 The global burden of disease study suggests that by the year 2020 India will have more individuals with Athero thrombotic Cardiovascular diseases than any other region.1 By 2020 Heart disease will become the leading cause of both death and disability worldwide. Compared to the year 2000, the number of years of productive life lost to Cardiovascular disease will be increasing in 2030 by 20% in USA, 30% in Portugal, 57% in china, 64% in Brazil and 95% in India. And by 2040, women in countries like Russia, Brazil, India, China and South Africa will represent higher proportion of deaths due to cardiovascular disease than men. The WHO predicts 11.1 million deaths will occur from Coronary heart disease (CHD) by 2020.2 In India, it is likely to have 100 million heart patients (60% of world’s heart patients by the year 2020).5 According to an observation made by president of Cardiological society of India, it has been predicted that these diseases will increase rapidly in India and this country will host more than half cases of heart disease in the world within next 15 years.3 5 Thrombosis is common in cardiovascular diseases such as Atrial Fibrillation (AF), Heart failure, Coronary artery syndromes, Stroke and even Cancers. As Thrombus consists of platelets and fibrins, optimum Antithrombotic prophylactic therapy can and should be directed towards both. Antithrombotic therapy refers to the use of medications which interfere with blood clot formation. The use of Antithrombotic drugs has become an important and vital part of treating Acute Myocardial Infarction (AMI), unstable angina pectoris, Coronary artery disease, Peripheral vascular disease and Stroke.4 A study was conducted on Thrombosis and Acute coronary lesions in sudden Cardiac Ischemic death. The sample comprised of 100 subjects who died of Ischemic Heart Disease in less than 6 hours, out of them 74% had Coronary thrombi, and 21% had Plaque fissuring. The study revealed that these findings have implications for the prevention of sudden cardiac deaths by Antithrombotic therapy.5 A study was conducted on Assessment of healthcare professional’s knowledge about Warfarin-Vitamin K drug-nutrient interactions. The study sample included 160 randomly selected healthcare providers (40 in each physicians, pharmacists, dietitians and nurses). A 98 item questionnaire was used in this study. It concluded that the healthcare professionals appear to have demonstrated some proficiency in their respective areas of expertise but they exhibited less knowledge than others. Therefore, additional training and integration of knowledge and expertise about drug-nutrient interactions among healthcare professionals are essential to provide appropriate patient counseling and optimal therapeutic outcomes.6 6.1 NEED FOR STUDY Medication errors are especially significant for nurses, since nurses are often at the sharp end of the medication administration process. Nurses perform an important role regarding patient safety in health care settings. Lack of drug knowledge and lack of important patient information causes medication errors. 6 Regardless of what is ordered, nurses need to be able to recognize when a prescribed dose of a medication is too high. In administering medications, nurses are accountable for knowing why the medication is being used, what possible side effects to monitor for and what a therapeutic dosage would be. Because the lack of knowledge of drugs can account for 15% of administration related medication errors, nurses must take the time needed to check dosing, they need to continually refresh their memory.7 Heart disease, stroke and chronic obstructive pulmonary disease are now adding a double burden on low and middle income countries with epidemics of diabetes (increase from 246 to 380 million between 2007 and 2025) and cancer (estimated number of new cases world wide will reach 16.8m with 65% occurring in developing countries in 2020). Of the 16.7 million deaths from cardiovascular disease every year (first leading cause of death), 7.2 million are due to ischemic heart disease, 5.5 million due to coronary artery disease, 3.9 million due to hypertensive and other heart conditions including artherothrombosis, peripheral arterial disease, thromboembolism which are predicted to be leading cause of death world wide by 2020 which comes under the cluster of vascular disease.8 Venous thromboembolism is the 3rd most common cardiovascular illness after acute myocardial infarction and stroke. Approximately one million cases of venous thromboembolism in United States each year, many of which represent recurrent disease which include pulmonary embolism and deep vein thrombosis. Incidence of venous thromboembolism is reported to be 28% in South Indian population. Pulmonary Embolism is the 3rd most common cause of hospital related death.9 Deep vein thrombosis occurs in about 1.79 per 1000 general population in India per year. It is estimated that approximately 350,000 to 600,000 Americans each year suffer from Deep Vein Thrombosis and pulmonary embolism and 100,000 deaths may be directly or indirectly related to these disease. Various methods of treatment of vascular disorders include thrombectomy, embolectomy, venacava filter placement, thrombolytic therapy, and anticoagulant therapy. Among these, anticoagulant therapy are widely used and are available in the form 7 of Intravenous infusion of large volume of heparin, intermittent intravenous injection, unfractioned heparin, low molecular weight heparin or oral anticoagulant therapy.10 The prevalence of heart attack in Bangalore, which was 2% in 1960, has increased to 12% in 2008. Unfortunately heart attack and other heart related ailments are steadily increasing among the people.11Anticoagulants are effective and useful in the primary, secondary prevention of venous thromboembolism, prevention of acute myocardial infarction, prevention of systemic arterial embolism in patients with tissue or mechanical prosthetic heart valves and prevention of stroke. As the population continues to age and wider and variety of health problems and illness is treated more and more, people are being maintained on warfarin. Approximately 1% of the population or two million people in the United States receive oral anticoagulant therapy.5 Although the use of anticoagulant is effective, there are risks associated with it. The annual risk estimates range from 2-22% of bleeding and 2-9% for treatment failure. The cumulative risk of life threatening complication and oral anticoagulation related death was 1% at 6 month, 5% at 1 year, 7% at 2 and 3 years in an actuarial analysis of long term treatment. The risk of hemorrhagic complications was higher in elderly patients because of poor compliance or a relative dietary vitamin k deficiency. Other risk factors of anticoagulant related hemorrhage are well known such as active peptic ulcer, alcoholism, aspirin associated factors, coagulopathy, occult bleeding, severe hepatic or renal disease, severe hypertension, poor patient compliance and excessive anticoagulation.12 A descriptive study was conducted in 2012 on under use of Antithrombotic therapy which caused high incidence of Ischemic stroke (IS) in patients with Atrial fibrillation (AF). The incidence of ischemic stroke was 46.2% .The prescription rate was 53.3% in Antithrombotic therapy, which included 42.5% of Antiplatelet agents and 10.8% of Warfarin. The findings of the study reveals that it is important to give Anti thrombotic therapy to newly diagnosed patients with AF in order to prevent Ischemic stroke (IS). 13 8 An evaluative study was conducted on pharmacological Skills of Nurses and Nursing students, using the medication calculation and skill test. The maximum score was 24 points. The mean score for nurses was 18.6 and that for students was 16.3. Half (50%) of the students attained a score of 67% and 57% of nurses attained a score of 79%. It reveals that nurses and students had deficiencies in their pharmacological skills.14 The investigator came across ward, where a post Myocardial Infarction patient treated with Heparin was developing certain complications, where the nurses failed to recognize those complications. The above facts and studies created an insight in the investigator’s mind that by improving the knowledge regarding anticoagulant therapy among staff nurses who are taking care of clients on anticoagulants, will reduce the incidence of complications. It may enhance the changes in health care delivery system. 6.2 REVIEW OF LITERATURE A review of related literature is an essential component of any research study or research project. Literature review through light on the studies and their findings reported about the problem under study. It gives understanding and inspires insight into the problem. The review of literature in a research report is a summary of current knowledge about a particular practice problem and included what is known and not known about the problem.15 The literature for the present study is organized and presented under the following headings: 1. Literature related to incidence of using oral anticoagulation therapy. 2. Literature related to complications of anticoagulant therapy. 3. Literature related to knowledge regarding anticoagulant therapy among staff nurses. 9 Section 1: Literature related to incidence of using oral anticoagulation therapy A study was conducted in USA on Trends in use of Anti Thrombotic agents (ATA) in patients with Non-ST Segment Elevation Myocardial Infarction [NSTEMI] managed with an invasive strategy. They analyzed Trends in use of ATA in 64,199 NSTEMI patients [n=100 sites] managed invasively with Cardiac catheterization from 2007-2010. ATA included Un-fractionated Heparin [UFH], Low Molecular Weight Heparin [LMWH], Glycoprotein IIb/IIIa inhibitors [GPI] and Bivalirudin [Biv]. From 2007-2010 a consistent increase in the use of Biv and decline in use of GPI was observed despite no change in the proportion of patients treated with Percutaneous Coronary Interventions(PCI) within 48 hrs of hospital arrival [50.0% VS 51.8% P=0.19]. Excess dosing of UFH [81.1% VS 58.9% P<0.0001] and GPI [8.4% VS 5.4%, P<0.0001] also declined significantly over this time period. Although in hospital mortality remained unchanged [2.2% VS 1.9% P=0.08], there was a significant decline in the rate of major bleeding [9 .1% VS 6.8%, P<0.0001]. In past 4 years NSTEMI patients managed invasively receiving less GPI and LMWH and more UFH and Biv, with better dosing accuracy as well. Mortality rate remained stable, but rates of major bleeding have improved.16 A study was conducted on global patterns of use of Antithrombotic and Antiplatelet therapies in patients with Acute coronary syndrome (ACS). Data from 12,665 patients with ACS were analyzed. Baseline characteristics, clinical presentation and medication use were compared. Regional differences of Antiplatelet and Antithrombotic therapies were analyzed. Overall Unfractionated Heparin (UFH) was used in 57% of patients and LMWH in 47% (P<0.0001). More than 90% of patients received aspirin, but approximately 13% were not discharged on Aspirin. Overall, 30% of patients received Thienopyridines (with PCI) in 79%. Of those who did not receive Aspirin, 31% received Thienopyridines. Intravenous Glycoprotein inhibitors were given to 17% patients. Among those treated with PCI, only 47% received Glycoprotein inhibitors and 21% of those given GPI inhibitors did not undergo PCI. The results revealed that significant geographic variation was apparent in the use of Un-fractionated Heparin, LMWH, Thienopyridines and Glycoprotein inhibitors.17 10 A prospective study conducted with an objective to determine the incidence of Deep Vein Thrombosis after abdominal, orthopaedic, neurosurgical procedures among 100 patients in Fr. Muller medical college, Karnataka from July 2004- June 2006 and the results revealed that 14 patients were having Deep Vein Thrombosis postoperatively, 7 from general surgery, 4 from neurosurgery, 3 from orthopaedic surgery and the author concluded that the incidence of Deep Vein Thrombosis in postoperative patients are significant enough to advocate prophylactic anticoagulant therapy to those who have to undergo major surgical procedures.18 A study conducted to identify the main indication of oral anticoagulant therapy and common drug used among 41 patients who are on long term anticoagulation with acenocumarol in hematology department, Spain over a period of 3 months and results revealed that indications of oral anticoagulation therapy were prosthetic valve (36.6%), Atrial Fibrillation (34.15%), Venous thromboembolism (21.95%) and others(7.31%) with target of 2-3 International Normalized Ratio units (63.4%) or 2.5-3.5(36.6%) and the most common drugs using are acenocumerol and the author concluded that oral anticoagulant therapy are mostly used by prosthetic valve patients.19 A retrospective study conducted with an objective to determine the incidence of Venous Thromboembolism among hospitalized patients and to increase the awareness of need for Venous Thromboembolism prophylaxis in medical college, Madhya Pradesh and the data collected from inpatient and outpatient record during the period of 1996- 2005 and the results revealed that Venous Thromboembolism was 17.6 per 10000 admissions, 5 per 10000 operations, 40.3% Deep Vein Thrombosis after general surgery, 20.1% after orthopaedic surgery and the author concluded that general surgery operations are the most common cause of Deep Vein Thrombosis, which is no longer a rarity in India, which require prophylaxis with anticoagulant therapy.20 A case report of 42 year old male patient with an old case of deep vein thrombosis on warfarin and other drugs like duetiapine, aspirin, diclofenac, sodium, fonofibrate, atrovastatin, propanolol and citalopram for concurrent illness 11 who presented with widespread mucocutaneous bleeding and epidural hematoma, presented in military hospital, Shilong, detected by MRI of the spine and the case report concluded that intraspinal hemorrhage is a rare but dangerous complication of anti coagulant therapy, that must be suspected in any patients in anti coagulant agents who complains of local or referred spinal pain so immediate intervention are essential to prevent complication from intraspinal hemorrhage due to drug interaction with warfarin which is common.21 2) Literature related to complications of anticoagulant therapy. A study was conducted on predictors and early outcomes of Hemorrhagic Transformation after Acute ischemic stroke (AIS) in particular in patients treated with Tissue Plasminogen Activator (tPA). 122 consecutive stroke patients (mean age 65.5 years, 41% women) who underwent T (2)-MRI within 6-60 hrs after stroke were included. 25.4% of patients were treated with tPA, the overall detection rate of Hypertension (HT) on T (2)-MRI was 20.5%. Potential predictors of HT such as age, sex, blood pressure, and stroke etiology, prior Antithrombotic medication, neurologic deficits on admission, tPA treatment, and specific MRI findings were analyzed. The main predictor for Hypertension(HT) was tPA treatment (48.4vs11.1% and odds ratio 7.50, 95% p<0.001).The results revealed that HT is a frequent finding on T(2)-MRI in patients with AIS associated with tPA treatment, territorial infarction and several neurological deficits on admission.22 A prospective multicenter observational study was conducted to determine the Incidence and severity of bleeding events in patients with Stroke and Cardiovascular disease who were taking Oral Antithrombotic agents in Japan. A sample of 4,009 patients were taken, who were taking Oral Antithrombotic agents for Cardiovascular Disease (CVD) and Stroke. They were classified into 4 groups, the single Antiplatelet agents group (47.2%), the dual Antiplatelet group (8.7%), the Warfarin group (32.4%) and the Warfarin plus Antiplatelet group (11.7%). During 19 months follow up there were 57 life threatening and 51 major bleeding events. The annual incidence of primary end point was 1.21% in single platelet group, 2.00 % in dual platelet group. After adjustment for baseline characteristics, 12 adding a platelet to Warfarin increased the risk of primary end point and adding another platelet to single platelet agent increased secondary end point bleeding. The study reveals that dual Antithrombotic therapy was related to increased risk of bleeding events.23 A study was conducted on the risk of Hemorrhagic complications of patients in hospital who fall while receiving Antithrombotic therapy. A 4 years old retrospective review of patients who fell during admissions in 500 bedded hospital, major hemorrhagic injuries including subdural hematoma, major bleedings, cuts, patients use of Antithrombotic medications (Warfarin, Aspirin, Clopidogrel and Heparin) and Anticoagulation status were recorded. A total of 1,861 patients were reviewed. 10% falls caused major hemorrhagic injury (Warfarin 6%, no therapy 11%. Logistic regression showed in hemorrhagic injury was with female gender (odds ratio 1.6), use of Aspirin (odds ratio 1.4) and use of Clopidogrel (odds ratio 2.2). The results revealed that person taking Antithrombotic therapy had more fall rates than Warfarin taking person. Their perception may contribute to the care gap between the number of patients who would theoretically derive over all benefit from Warfarin therapy and those who actually receive it.24 A population based observational cohort study was done to estimate the bleeding risks associated with combinations of Aspirin, Thienopyridine derivatives and Warfarin in elderly patients following Acute Myocardial Infarction (AMI). A total of 21,443 elderly survivors of AMI were studied. Patients were divided into five groups according to drug exposure. Hospitalization for bleeding was observed in 1,428 patients (7%). Compared with rates of patients receiving Aspirin alone (0.03% / patient year), rates of bleeding were higher among patients with Antiplatelet combination (0.07 % / patient year), Anticoagulation combination (0.08% / patient year) and 3 drug combination (0.09%/patient year). Compared with Aspirin alone, the ratio of bleeding was 1.65 for patients receiving Antiplatelet combination and 1.92 for patients receiving the Anticoagulant combination. Only 1 of 141 patients in 3 drug combination group had a bleeding event. The results revealed that in practice, Antiplatelet and 13 Anticoagulation combinations lead to modest increases in bleeding risk in elderly patients.25 Section III: Literature related to knowledge regarding anticoagulant therapy among staff nurses. A cross sectional study was conducted on Medication knowledge, certainty and risk of errors in health care. A sample of 203 RN’s aged 42.0(9.3) years with a working experience of 12.4(9.2) years were taken. Knowledge scores in pharmacology, drug management and drug calculations were 10.3, 7.5 and 11.2, respectively and certainty scores were 1.8, 1.9 and 2.0. 15% of the total answers showed a high risk of error, with 25% in drug management. Independent factors associated with high medication knowledge were working in hospitals, post graduation specialization (p=0.01) and completion of courses in drug management. The study revealed that Medication knowledge was found to be unsatisfactory among practicing nurses with significant risk for medication errors and need to improve nurses basic knowledge, especially in drug management is essential. 26 A study was conducted on Nurses knowledge of pharmacology behind drugs they commonly administer. The study included 42 nurses working in surgical wards of a foundation hospital in the North of England. Data were collected by structured knowledge interview and questionnaire methods. They were given a score of 10(100%) to determine their actual pharmacology knowledge. The sample comprised of 18(42.9%) junior nurses and 24(57.1%) senior nurses. They had a median experience of 10.87 years post registration. The results shows that mean knowledge score was six ranging between two and nine. Only 11(26.1%) nurses scored eight or above and the majority 24(57.2%) scored below seven, indicating inadequate knowledge. Knowledge of the mechanism of action and drug interactions was poor. There was a correlation between knowledge and experience. The study concludes and supports that the need for supplementary pharmacology education for nurses in clinical settings, focusing on common drugs they administer is necessary.27 14 A study was conducted on Assessment of healthcare professionals knowledge about Warfarin-vitamin K drug-nutrient interactions. The study sample included 160 randomly selected healthcare providers (40 in each- Physicians, Pharmacists, Dietitians and Nurses). A 98 item questionnaire was used in this study. It concluded that the healthcare professionals appear to have demonstrated some proficiency in their respective areas of expertise; they exhibited less knowledge in others. Therefore, additional training and integration of knowledge and expertise about drug-nutrient interactions among healthcare professionals are essential to provide appropriate patient counseling and optimal therapeutic outcomes.28 A study conducted to assess the knowledge on anti coagulant therapy among 120 patients in an outpatient clinic in Brazil over a one month period (2006), through a questionnaire with 10 questions with closed answers and correct answers to about 80% of the questions were considered satisfactory and results revealed that 64% showed satisfactory knowledge, 69.4% of the sample was beyond therapeutic range and 42.5% had hemorrhage in the last 6 months, so the author concluded that factors such as educational level, income, hemorrhagic event, anti coagulant time, gender, did not show satisfactory significant differences and obvious need for systematic follow up by health care professional using educational measure to detect the difficulties faced by patient and measuring optimal International Normalized Ratio.29 An article on the importance of organization of an education program by nurses for the assessment of patients satisfaction involved six districts of health authority “ASL 3 Genovese” (Genoe-Italy), where 3764 patients in oral anti coagulation therapy are followed for monitoring International Normalized Ratio after administration of a questionnaire to assess patients satisfaction with clarity of presentation, relevance of the contents, appropriateness of educational method and usefulness of booklet which was developed with the contribution of hospital cardiologist, laboratory services, risk managers and general practitioners and the results revealed that among 1074 patents who attended the 96 health education sessions, 1039 participants completed the questionnaires and the rate of attendance varied greatly in the 6 districts ranging from 26%-68%, mean age was 15 74 and author concluded that educational services with the involvement of all the professionals that contribute the patents care were very appreciated.30 A study conducted to evaluate patients knowledge regarding oral anticoagulation among 150 patients attending anticoagulation clinic in Dublin teaching Hospital, over a 1 month period, 2003, Ireland and revealed the following as 125(83%) perceived that they had received education about therapy, concomitant aspirin was avoided by 125(83%) patients but 25(12%) thought it is safe in combination with warfarin, 33 (22%) believed that alcohol was safe in combinations with warfarin, 125 (83%) patients identified the 1mg correctly, 105 (70%) identified 3mg tab and 98 (65%) the 5 mg tab correctly . 42 (28%) patients couldn’t describe their current therapy, potential complication from over and under dosage with warfarin were unknown 89 (59%) and 90(68%) patients respectively and the author suggest improving staff nurse knowledge and educate patients may improve control, reduce complication and therefore reduce burden on the health science.31 6.2.1 STATEMENT OF THE PROBLEM “A study to evaluate the effectiveness of self instructional module on knowledge regarding care of patients on anticoagulant therapy among staff nurses in a selected hospital, Bangalore.” 6.3 OBJECTIVES OF THE STUDY 1. To assess the knowledge of staff nurses regarding care of patients on selected anticoagulant drugs by conducting pre test. 2. To evaluate the effectiveness of Self instructional Module regarding care of patients on selected anticoagulant drugs among staff nurses by comparing mean pretest and post test knowledge scores. 16 3. To find the association between pretest knowledge scores of the staff nurses regarding care of patients on selected anticoagulant drugs with selected socio demographic variables. 6.3.1 OPERATIONAL DEFINITIONS 1. Effectiveness: In this study, it refers to the extent to which the self instructional module has achieved the desired result in enhancing the level of knowledge of staff nurses on care of patients on selected anticoagulant drugs in terms of difference in mean pre test and post test knowledge scores. 2. Self instructional module: In this study, it is a self contained written material prepared by the researcher to promote self learning of staff nurses about care of patients on selected anticoagulant drugs. 3. Knowledge: In this study, it refers to the information obtained from the staff nurses regarding care of patients on selected anticoagulant drugs as measured by the number of correct responses given to the items in the structured knowledge questionnaire. 4. Anti coagulant therapy: In this study, it refers to the drugs which reduce chance of clot formation like Heparin,Warfarin, ,Danaparoid,Urokinase etc. 5. Staff nurses: It refers to a Registered nurse who holds Diploma, Bachelor’s degree or Masters Degree in nursing and those who are working in a selected hospital, Bangalore. 6.3.2 ASSUMPTIONS 1. Staff nurses may have inadequate knowledge regarding care of patients on selected anticoagulant drugs. 2. Self Instructional Module may improve the level of knowledge of staff nurses regarding care of patients on selected anticoagulant drugs. 17 6.3.3. HYPOTHESIS:H1: There will be significant improvement in the post test knowledge scores among staff nurses regarding care of patients on selected anticoagulant drugs. H2: There will be significant association between the pretest knowledge scores among staff nurses regarding care of patients on selected anticoagulant drugs with selected socio demographic variables. 6.3.4 SAMPLING CRITERIA A. INCLUSION CRITERIA: The study includes staff nurses who are:1. available at the time of data collection. 2. working in ICU, Medical and surgical wards. B. EXCLUSION CRITERIA: The study excludes staff nurses who are: 1. not willing to participate and not available during data collection. 6.3.5 DELIMITATIONS 1. The study is limited to selected staff nurses in a selected Hospital, Bangalore. 2. The study is limited to 50 staff nurses. 3. The duration of data collection is limited to 4 weeks. 7. MATERIALS AND METHODS 7.1 SOURCES OF DATA Staff nurses in a selected Hospital, Bangalore. 18 7.2 METHOD OF DATA COLLECTION i. Research approach : Evaluative approach. ii. Research design : Quasi-experimental, pretest-post test design. iii. Setting of the study : Selected Hospital, Bangalore. iv. Population : All staff nurses in a selected hospital, Bangalore. v. Sample : Staff nurses in a selected hospitals who fulfill the inclusion criteria, Bangalore. vi. Sample size vii. Sampling technique : 50 staff nurses. : Non-probability, Convenient sampling technique. viii. Method of data collection: Self administered Questionnaire. ix. Tool for data collection : Structured knowledge Questionnaire. x.Method of data analysis : The researcher will use appropriate statistical technique for data analysis and will present in the form of tables and diagrams. 1. Demographic variables will be analyzed by frequency, percentage distribution. 2. Knowledge will be analyzed by Mean, Median, Standard Deviation. 3. Effectiveness of self instructional module will be analyzed by paired T-test 4. Association between pre test level of knowledge regarding care of patients with anticoagulant therapy and selected demographic variables will be analyzed by chi-square test. xi. Duration of study : 4 weeks xii. Variables Independent variable In this study the independent variable refers to SIM on care of patients on selected anticoagulant drugs. Dependent variable In this study the dependent variable is knowledge of staff nurses regarding on care of patients on selected anticoagulant drugs. Demographic variables Demographic variables such as age, gender, marital status, occupation, educational qualification, types of family, previous information. 19 xiii. Projected Outcome: The study may be beneficial in improving the level of knowledge among staff nurses regarding the care of patients on anticoagulant therapy and help them to take precautionary measures to prevent further complications. 7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? Yes 7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM INSTITUTIONS? Yes. Ethical clearance report is here with enclosed. 20 8.0 REFERENCE 1. Health- EU. The Public Health Portal of the European union [Online] 2008. [cited. 2010 Oct 25]. Available from: URL:http:ec-europa.eu/health eu/health-problems/other non communicable disease. 2. Crow R, Chapman R. Prevention and control of non communicable disease in twelve Pacific Rim cities. AWL Public health research group 2008; 40(5):22-6. 3. Sorbo J, Erickson H. Arch Internal medicine. Vascular disorders 2000; 160(6):769-74. 4. Wedgo BC. Deep vein thrombosis. 2008 [cited 2010 nov 22]. Available from: URL:http://www.medicine net /deep-vein-thrombosis/article.htm. 5. Kim E, Barthlomai J. venous thromboembolism, American Heart Association 2001; 103: 22-34. 6. Subramanyam P, Ranganayakulu D. The management of anticoagulant therapy in patient point of view. International Journal of Pharmacy science and Biotechnology 2010; 1(3):169-73. 7. Spath PL. Home study program: using failure mode and effects analysis to improve patient safety. AORN J 2003; 78(1):16-37. 8. International cardiovascular statistics update. American Heart Association [online] 2009 (cited on 2010 Dec 2) Available from: URL:http://www.american heart org. 9. Lee A D, Stephen E, Agarwal S, Premkumar P. Venous thromboembolism. Vascular disease 2009; 37(4): 482-5. 21 10. Wedgo BC. Deep vein thrombosis [online] 2008 [cited 2010 nov 22]. Available from: URL:http://www.medicine net /deep-vein- thrombosis/article.htm. 11. Prevalence of heart disease. 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Assessment of health care professionals knowledge about Warfarin- Vitamin k nutrient interactions. Journal of American college of nutrition 2000; 19(4):439-45. 29. Henn C, Rabelo E R, Boaz M, Souza E N. Knowledge on chronic anticoagulation of patients followed in outpatient clinic. Journal of cardiology 2008 Jun;29(2):207-13. 30. Sawidea P, Oltarzewska A. Knowledge of patient undergoing long term acenocumerol about safety of oral anticoagulant therapy. Journal of cardiology 2007 Jan; 22(127): 36-40. 31. Roche N G, Chambers F, Nanra J, Boucher H. Evaluation of patient knowledge regarding anticoagulation. Indian Journal of cardiology 2003 Aug; 96(7): 211-3. 24 9. SIGNATURE OF THE CANDIDATE 10. REMARKS OF THE GUIDE 11. NAME AND DESIGNATION 11.1 GUIDE 11.2 SIGNATURE 11.3 CO-GUIDE 11.4 SIGNATURE 11.5 HEAD OF THE DEPARTMENT 11.6 SIGNATURE 12. 12.1 REMARK OF THE PRINCIPAL 12.2 SIGNATURE 25 26