Rajiv Gandhi University of Health Sciences s70

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 Name of the candidate and Ms. BETHIA.P.JAMES address SHREE DEVI COLLEGE OF (in block letters) NURSING MAINA TOWERS, BALLAL BAGH MANGALORE-575003. 2 Name of the institution SHREE DEVI COLLEGE OF NURSING MAINA TOWERS, BALLAL BAGH MANGALORE-575003. 3 Course of the study and subject M. Sc. NURSING (MEDICAL SURGICAL NURSING)

4 Date of admission to the course 13.10.2010

5 Title of the study

“A STUDY TO ASSESS THE EFFECTIVENESS OF SELF INSTRUCTIONAL MODULE ON IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AMONG STAFF NURSES IN A SELECTED HOSPITAL, MANGALORE.”

6 BRIEF RESUME OF THE INTENDED WORK

1 6.1 INTRODUCTION

BACKGROUND OF THE STUDY

Defibrillation is used in emergency situations as the treatment of choice for ventricular fibrillation and pulseless ventricular tachycardia. Defibrillation depolarizes critical mass of myocardial cells at once. When they repolarise the sinus nodes usually recaptures its role as the pacemaker. The electrical voltage required to defibrillate the heart is usually greater than that required for cardioversion1.

Michel Mirowski developed the implantable cardioverter defibrillator, and the first implantation was performed in the United States in 1980. Michel Mirowski and co-workers implanted an implantable cardioverter defibrillator (ICD) into their first patient. Later the implantable cardioverter defibrillator has become recognized as the therapy of first choice for managing patients at high risk of sudden cardiac ventricular tachyarrhythmias2.

An implantable cardioverter defibrillator is a device that detects and determinates life threatening episodes of ventricular tachycardia and ventricular fibrillation in high risk patients. An implantable cardioverter defibrillator consists of a generator and at least one lead that can sense intrinsic electric activity and deliver an electrical impulse. The device is implanted much like a pacemaker1.

Implantable cardioverter defibrillator has been increased to a preventive strategy in patients with arrhythmias. In the near future the number of implantations, due to primary prevention, can be expected to further increase which justifies more research to improve implantable cardioverter defibrillator care3. The nursing intervention for the patient with an implantable cardioverter defibrillator is provided throughout the pre-operative, peri-operative and post- operative phases. The nurses play a vital role in assisting the patient and their family by means of information, education, support, counselling and technical follow-up of the device. It is important for the nurses to acquire an in-depth understanding about the implantable cardioverter defibrillator and acute episodes of life threatening dysrrhythmias4.

6.2 NEED FOR THE STUDY Patients with implanted cardiac devices constitute a growing segment of the contemporary healthcare practice. According to the American Heart Association, more than 170,000 pacemakers and 30,000 implantable cardioverter- defibrillators (ICDs) are implanted in the United States each year5.

About 325,000 sudden cardiac arrest(SCA) occur annually in the United

2 States, of which 163,221 SCA take place out-of-hospitals. It was estimated that 75% of SCA had a previous heart attack. Roughly 330,000 coronary heart deaths (CHD) take place out-of-hospital annually.CHD is also the leading cause of death in women and bradyarrhythmias account for approximately 20-30% of all SCA6.

Cardiovascular disease is the leading cause of death, strikes Indians early and kills many in their productive mid-life years. Deaths due to cardiovascular disease, in the age group of 35 to 64 years, resulted in 9.2 million potentially productive years of life being lost in 2000 and are expected to rise to a loss of 17.9 million years in 20307.

Prevalence of Congestive Heart Failure in India was 18.8 million Indians (1.76% of population), the Incidence rate was 1.57 million per year (0.15%). More than 1 million patients with heart failure are now eligible to receive cardiac device therapy. Prevalence of Congestive Heart Failure in the US was 4.8 million Americans (1.76% of population). In which 2% of age 40-59, 5% of age 60-69, 10% of age over 70. The Incidence rate was 432 thousand per year (0.15%)8.

Escorts Heart Institute & Research Centre, New Delhi were the first to implant Implantable Cardioverter Defibrillators (ICD) in India. Current annual ICD implantation rates stand at 60 per year. The JIPMER institute at Madras implanted 14 automatic implantable cardioverter defibrillator which is the largest number in India9.

Treatment of the cardiac diseases depends on the severity of the symptoms which the patient have. Drug therapy such as beta blockers, diuretics, digoxin will be prescribed for commencing stage of heart disease. Devices are often used in patients with heart failure to prolong life. Sudden cardiac death is caused by an abrupt arrhythmia that results in lack of blood flow to the brain and can result in death. This condition can be treated with an implantable cardiac defibrillator that will deliver a shock to the heart when it recognizes such a rhythm and shock the heart back into normal rhythm10.

A retrospective population based study at Iceland shows that 62 patients received an ICD during the period of study. There was an increase in the number of implants by year and the number of new implants in 2004 and 2006 amounted to 38 per million, respectively. The mean age at implantation was 58 years. 40 patients (65%) had coronary artery disease. The most common indications for ICD implantation were cardiac arrest, 32 (52%) and another 26 (42%) had experienced ventricular tachycardia without cardiac arrest. Of the 13 patients deceased before or during the study period, no case of sudden arrhythmic death was observed11.

Division of Cardiology, Italy shows the implantable cardiac device implantation done for 4692 patients in 2005 (44.2%), 5938 patients in 2006

3 (52.2%), 7324 patients in 2007 (55.7%). Single-chamber ICDs were implanted in 28.5% of patients, dual chamber ICDs in 31.7%, and biventricular ICDs in 39.8%, respectively. The ICD implantation rate in Italy increased significantly in the period 2005-07. The study showed a significant increase in prophylactic and biventricular ICD use during the period of study12.

A recent study report of serious injury resulting from implanted cardiac defibrillators, Canada issued a Notice to Hospitals entitled "Important safety information regarding patients with implanted devices and implanted systems with leads". It warned about the risks of tissue overheating, serious injury and death in this group of patients. It suggested that all health professionals should be educated about care of patient with implanted cardiac devices13.

A recent study report of rising rate of cardiac device infection, US reveals the infection rates vary between 2% and 8%. Treatment typically involves the removal of all implanted hardware, in addition to long-term antibiotic therapy. The study concluded that beyond the highly specialized role of a pacemaker nurse, any nurse working in a primary health care setting should be familiar with at least some general aspects of the implanted cardiac device patients follow up care and provide counselling to this patient population14.

Staff nurses play a major role in hospital and long-term care and will ensure an uneventful procedure and a safe discharge as well as early detection of device malfunction and late complications. Education of the patient will prevent any self or environmental interactions which can adversely affect proper device function and will increase his or her adherence to the follow-up treatment. Finally, by providing psychosocial and emotional support the nursing staff can address the immediate concerns of the patient and help him or her cope successfully with the new life situation10.

All these above mentioned factors have urged the researcher to assess and educate the staff nurses knowledge about care of patient with implanted cardiac defibrillator, for patient wellbeing by using intervention based measures.

6.3 REVIEW OF LITERATURE The literature review will be presented under the following headings

1. Indication for implantable cardioverter defibrillator 2. Comparison of implantable cardioverter defibrillator with other treatment modalities 3. Nursing care of patients with implantable cardiac defibrillator 4. Self instructional module as an effective teaching aid Indication for implantable cardioverter defibrillator

4 An experimental study was conducted in USA, to know whether implan table cardioverter defibrillators (ICDs) improves the long-term prognosis of arrhythmogenic right ventricular cardiomyopathy(ARVC) patients at high risk of sudden death. Sixty patients with ARVC were treated with transvenous ICD systems. These ARVC patients compared with other entities. During follow-up after 43 months, event-free survival was 49% and 56% for potentially fatal VT after 3 years, respectively. These results strongly suggest an improvement in long-term prognosis by ICD therapy in high-risk patients with ARVC15.

A study was conducted in United States on the effectiveness implantable cardioverter defibrillators on the management of serious ventricular dysrrhythmia. Population of this study involves 381 patients who received an implantable cardioverter defibrillator were followed for up to 9 years. The result showed that the device was effective in preventing sudden cardiac death with survival rates of 97% at 3 years and 94% at 5 years. Complication rates were low. They concluded that implantable cardioverter defibrillators are effective for management of serious ventricular dysrhythmias and also minimizing the mortality rates16.

An experimental study was conducted at Iceland, to detect whether the use of Implantable Cardioverter Defibrillator (ICD) improves survival in CABG patients with severe LV dysfunction. Study was conducted among 305 patients CABG patients. Of the entire group, 35 (11.5%) patients received an ICD with a median of 2 years after CABG. Indication for ICD implantation was clinical evidence of non sustained ventricular tachycardia. Survival at 5 years was 88% for the ICD group. The study concluded that implantation of ICD after CABG confers improved short and long term survival benefit to patients with severe LV dysfunction. Prophylactic ICD implantation in the setting of severe LV dysfunction and CABG surgery should be considered17.

Comparison of implantable cardioverter defibrillator with other treatment modalities

A retrospective study was conducted in UK, to analyze the effectiveness of ICD implantation as first-choice therapy versus the conventional therapeutic strategy of starting with drugs. Sixty consecutive survivors of cardiac arrest were randomly assigned early ICD implantation and the other group with normal medical treatment. Total mortality in the conventional group was 11 patients (35%).Comparison of the main outcome events in both strategies showed a significant difference in favour of early ICD implantation. These data suggest that ICD implantation as first choice is preferable to the conventional approach in survivors of cardiac arrest caused by old myocardial infarction18.

A prospective study was conducted in Spain, for the comparison of

5 implantable cardioverter defibrillator versus antiarrhythmic drug therapy in survivors of cardiac arrest secondary to documented ventricular arrhythmias. From 2005 eligible patients were randomized to an ICD, amiodarone, propafenone, or metoprolol. The study was terminated in March2010, when all patients had concluded a minimum 2-year follow-up. During long-term follow-up of cardiac arrest survivors, therapy with an ICD is associated with a 23% reduction of all mortality rates when compared with treatment with amiodarone or metoprolol19.

A retrospective study was conducted in Canada, about implantable cardioverter defibrillator (ICD) terminates VT or VF in patients compared with medical therapy with amiodarone. A total of 659 patients with resuscitated VF or VT were randomly assigned to treatment with the ICD or with amiodarone. A total of 328 patients were randomized to receive an ICD. A significant reduction in the risk of death was observed with the ICD, from 10.2% per year to 8.3% per year. The study suggests that there is 20% relative risk reduction occurred in all mortality20.

Nursing care of patients with implantable cardioverter defibrillator

A retrospective study was conducted at New Delhi on follow up care of patient with implanted cardiac devices by the nurses. Totally 341 patients were selected by random sampling method, in which 70% with implantable cardioverter defibrillator. They were followed retrospectively over a 3 year period by the health professionals. The result showed that less than 1% of them had inappropriate usage, rest all of them showed success rate. The study concluded that nurses should monitor the patient with a scientifical approach for the effective management and outcome21.

A descriptive study was conducted at Sweden, to explore how patients with an ICD experienced their life situation and how nurses described their experiences of delivering care to ICD patients. A questionnaire was used to describe the nurse’s experiences and a content analysis was used to describe the written educational information material provided to patients. The embodiment of the ICD reflects a merger of experiences about its presence and potential from both patients’ and nurses perspective. This research hopefully encourages nurses to carefully reflect on what their experiences in caring a patient with an ICD and to consider practice improvement for the patients’ and the next of kin22.

A experimental study was conducted at Sweden, to describe the clinical aspects of implantable cardioverter defibrillators care. Participants were recruited among physicians and nurses. Data was collected by a questionnaire. The nurses received specific implantable cardioverter defibrillators education. Holistic care of implantable cardioverter defibrillators patients can be achieved by means of a multidisciplinary implantable cardioverter defibrillators team and more patient- centred educational strategies23.

6 Self instructional module as an effective teaching strategy A quasi-experimental study was conducted in USA, to assess the effectiveness of a computerized educational program among ICD patients. 30 patients with ICD participated in the study A computer assisted teaching was given to experimental group and usual care was provided to control group. Patient-assisted computerized education for recipients of ICDs resulted in comparable improvements in trait anxiety, quality of life, and device acceptance as the in-person treatment. The study showed that self instructional module as an effective teaching strategy24. A experimental study was conducted in Delhi on nursing care for patients with implantable defibrillators among nurses, Delhi. A teaching protocol given to 400 nurses by convenience sampling method, study period was one year. The result showed there is doubtless change among nurses in assisting patients to assume the role of being their own most important healthcare manager. They concluded that nurses should be educated for the effective management of patient with implantable cardiac devices25.

6.4 STATEMENT OF THE PROBLEM

A study to assess the effectiveness of self instructional module on implantable cardioverter defibrillator among staff nurses in selected hospital, Mangalore.

6.5 OBJECTIVES

 To assess the prior knowledge of staff nurses regarding the implantable cardiac defibrillator.

 To develop SIM on the implantable cardiac defibrillator.

 To find out the effectiveness of SIM in terms of gain in post test knowledge score.

 To associate the pre test knowledge score with selected demographic variables

6.6 OPERATIONAL DEFINITION

 Assess

In the present study, assess means valuing the quality of knowledge of staff nurses on implantable cardioverter defibrillator.

 Effectiveness

In the present study, effectiveness refers to the extent to which the self instructional module has achieved the desired objective that means improvement knowledge score on implantable cardioverter defibrillator.

7  Self instructional module(SIM)

In the present study, SIM is a planned module, which is a printed material in English language containing about implantable cardioverter defibrillator and is prepared based on pre test knowledge score of staff nurses working selected hospital.

 Implantable cardioverter defibrillator

In the present study, implantable cardioverter defibrillator refers to small electrical impulse generator implanted in patients with sudden cardiac death due to ventricular fibrillation and ventricular tachycardia.

 Staff nurses

In the present study, staff nurse is a person who is having a diploma or basic degree in nursing from a recognised university or board, registered under a state nursing council and is working at selected hospital, Mangalore.

 Selected hospital

In the present study, the selected hospital refers to that setting where researcher obtains permission and intends to conduct the study.

6.7 VARIABLES

 Independent variable: - self instructional module on implantable cardiac defibrillator.

 Dependent variable:- staff nurses knowledge on implantable cardioverter

Defibrillator

6.8 ASSUMPTIONS

The study assumes that:

 Staff nurses will have some knowledge regarding implantable cardiac defibrillator.

 Knowledge may vary from person to person

6.9 DELIMITATION

The study will be delimited to the staff nurses working in selected hospitals, Mangalore.

6.10 HYPOTHESES 7

8 All the hypothesis will be checked at 0.05 level of significance.

H1: The mean post-test knowledge score of staff nurses on implantable cardiac defibrillator will be significantly higher than the mean pre-test knowledge score

H2 : There will be significant association between pre-test knowledge score of the staff nurses with selected demographic variable

MATERIALS OF DATA COLLECTION

7.1.1 SOURCE OF DATA COLLECTION

The data will be collected from the staff nurses working at selected hospital, Mangalore.

7.1.2 RESEARCH DESIGN

The research design selected for the study is one group pre-test post-test design.

Pre-test Treatment Post-test

O1 X O2

E = O2 – O1 O1 - Pre-test on implantable cardioverter defibrillator

X - SIM on implantable cardioverter defibrillator

O2 - Post-test on implantable cardioverter defibrillator

E - effectiveness of SIM in terms of gain in post test knowledge score in implantable cardioverter defibrillator

7.1.3 SETTING

The study will be conducted at selected hospitals, Mangalore.

7.1.4 POPULATION

The population of this study will be staff nurses at selected hospitals, Mangalore.

7.2 METHOD OF DATA COLLECTION

9 7.2.1 SAMPLING PROCEDURE

Purposive sampling technique will be adopted for this study.

7.2.2 SAMPLE SIZE

The sample size for the present study will be approximately 50 staff nurses working at selected hospitals, Mangalore.

7.2.3 INCLUSION CRITERIA FOR SAMPLING

Staff nurses who are:

 Working at selected hospital, Mangalore

 able to speak and understand English

 willing to participate in the study

 available at the time of data collection

7.2.4 EXCLUSION CRITERIA FOR SAMPLING

Students who are not:

 available during the period of data collection

 willing to participate in the study

7.2.5 DEVELOPMENT OF TOOL Instrument Used 1. Closed ended questionnaire related to implantable cardioverter defibrillator 2. SIM on implantable cardioverter defibrillator Description Of The Tools Closed ended questionnaire will be prepared to assess the knowledge of staff nurses regarding implantable cardioverter defibrillator . The closed ended questionnaire will have two parts. Part A- Demographic characteristics. Part B- Items on implantable cardioverter defibrillator SIM will be prepared on the basis of objectives, literature reviews, pretest knowledge score and expert’s opinion.

7.2.6 DATA COLLECTION METHOD

1. Prior to the data collection permission will be obtained from the concerned

10 authority of the selected college for a period of one month.

2. Data will be collected from approximately 50 staff nurses

3. The objectives of the study will be explained to the participants and a formal written consent will be taken from the subjects.

4. Pre-test will be conducted using a structured knowledge questionnaire and the planned teaching programme will be provided to the staff nurses on the same day. Post-test will be conducted using the same knowledge questionnaire on the seventh day.

7.2.7 DATA ANALYSIS PLAN The data will be planned and analyzed by differential and inferential statistics.

 Demographic data will be analysed by differential statistics by using mean, median, standard deviation and mean percentage etc.

 Data will be tested at 0.05 level of significance.

 Paired‘t’ test will be used to find the promotion of knowledge through the planned teaching programme.

 Association between pre-test knowledge scores and selected demographic variables will be found using chi-square test.

8 7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS?

Yes, a self instructional module on implantable cardioverter defibrillator will be required to assess the knowledge of staff nurses.

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3?

 Yes, ethical clearance will be obtained from the concerned authority.

REFERENCE

1. Brunner, Suddarths. Text book of Medical surgical nursing. 12th ed. New Delhi: Lippincott Williams & Wilkims; 2010

11 2. Ector H, Vardas P. European Society of Cardiology. Current use of pacemakers, implantable cardioverter defibrillators and resynchronization therapy. European Heart J. [citedMarch2007]; 9:144-149. Available from URL: http:// lib.bioinfo .pl/ pm :11 87 2977

3. Bradley D, Bradley E, Baughman K, et al. Cardiac resynchronization and death from progressive heart failure. JAMA 2008; 289:730-740

4. Counseling Patients with Implanted Cardiac Devices: the Nurse’s Role. [cited2010April];Availablefrom:URL:http://www.hospitalchronicles.gr/inde x .php/hchr/article/view/104/93

5. American Heart Association: Statistics. Heart disease and stroke Statistics update. 2004 [cited 2010 march 31]; Available from: URL:http://www.hospitalchronicles .gr/index.php/hchr/article/view/104/93

6. Cardiovascular disease leading to congestive heart failure [cited 2010 April 21]; Available from: URL:http://www.medscape.com/viewarticle/581618

7. India Wakes Up to the Threat of Cardiovascular Diseases [cited 2010 April 11]; Available from: URL: http://content.onlinejacc.org/cgi/content/full/j.jacc.2007

8. Cardiovascular disease leading to congestive heart failure. [cited 2010 April 21]; Available from URL:http://www.medscape.com/viewarticle/581618_6

9. Chennai gets India’s first heart implant training centre [cited 2010 April 5]; Available from: URL:http://www.thaindian.com/ newsportal /health/ chennai-gets-indias-first-heart-implant-training-centre_10073555.html.

10. Heart disease [Online]. 2004 [cited 2010 April 05]; Available from: URL:http:// www.netwellness.org/healthtopics/heart/heartfailure.cfm

11. Margret. L, Gurdrun.R , et al. Use of implantable cardioverter defibrillator. BMC Cardiovascular disorder 2008;6:10;1471-1474

12. Counseling Patients with Implanted Cardiac Devices: the Nurse’s Role [Online]. 2008 [cited 2010 April 5]; Available from URL: http://www.hospital chronicles.gr /index.php/hchr/article/view/104/93

13. Cardiac disease doubles in India. [cited 2010 April 11]; Available from: URL: http://economictimes.indiatimes.com/news/news-by- industry/healthcare/biotech /healthcare/Cardiac-disease-doubles-in- India/articleshow/2018779.cms

14. Prevalence of heart disease [cited 2010 April 20]; Available from: URL: http://www. dawn.com/2008/04/25/int12.htm

15. Thomas W, Medizinische K, et al. Implantable Cardioverter/Defibrillator

12 Therapy in Arrhythmogenic Right Ventricular Cardiomyopathy. Circulation. 2004; 109: 1503-1508.

16. Quality of life of patient with ICD [Online]. 2008 April [cited 2010 April 11]; Available from: URL: www.pubmed.com

17. Ashraf S, Rochus K, Paymon R, et al. Implantable cardioverter-defibrillators improve survival after coronary artery bypass grafting in patients with severely impaired left ventricular function. J of cardiothoracic surgery. [cited March 2010]. Available from: URL: http://www.asianheartinstitute.org/html/ medical_services/ medical_services.htm.

18. Eric F.D, Richard N.W, Frans J.L. Randomized Study of Implantable Defibrillator as First-Choice Therapy Versus Conventional Strategy in Postinfarct Sudden Death Survivors .JAMA. 2009; 201: 456-458

19. Karl. H, Riccardo C, Jurgen S.et al. Randomized Comparison of Antiarrhythmic Drug Therapy With Implantable Defibrillators in Patients Resuscitated From Cardiac Arrest. European Heart J. [cited June 2010]. Available from:URL http://ejcts. ctsnetjournals.org/cgi/constent/abstract/37/4/875.

20. Stuart. J, Michael .G, Robin .S. A Randomized Trial of the Implantable Cardioverter Defibrillator Against Amiodarone . [cited April 2009]. Available from:URL: http://www.expresspharmaonline.com/20090131/research01.shtml

21. Patients with an implanted cardioverter defibrillator: a new challenge [Online]. 2008 [cited 2010 April 21]; Available from: URL:http:// www.ncbi. nlm.nih.gov/ pubmed/2370727.

22. Can nurses in cardiology areas prepare patients for implantable cardioverter defibrillator implant and life at home [cited 2010 April 5]; Available from: URL: http://lib.bioinfo.pl/pmid:11872977.

23. Nursing management and rehabilitation of chronic ventricular assist device (VAD) [cited 2010 march 31]; Available from: URL:http:// www .ncbi.nlm.nih.gov/pubmed/1301565

24. American Heart Association: implantable cardioverter defibrillator planning care [cited 2010 march 31]; Available from:URL:http://www.hospital chronicles. gr/index.php/hchr/article/view/104/93

25. Malfunctions in implantable cardiac devices [Online]. 2008 [cited 2010 April 21]; Available from: URL: http://www.ccjm.org/content/72/9/736.full.pdf.

13 9. Signature of the candidate

10. Remarks of the guide This copy is recommended for registration.

11. Name and designation of (in block letters) MR. GIREESH. G.R 11.1Guide HOD,MEDICAL SURGICAL NURSING SHREE DEVI JURSING COLLEGE MANGALORE-575003

11.2Signature

11.3Co-guide (if any)

11.4Signature

MR. GIREESH .G. R 11.5 Head of the department HOD,MEDICAL SURGICAL NURSING SHREEDEVI NURSING COLLEGE MANGALORE-575003

11.6Signature

12. 12.1 Remarks of the Chairman and Principal Recommended for approval.

12.2 Signature