Good Research Proposal About The Ethical Considerations For The Study Are As Follows

Published: 2021-06-21 23:51:23
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- Methodology
This study will employ Randomized Control Trial (RCT) design in determining the effectiveness of post discharge calls intervention in reducing readmission of patients with heart failure. It will be used on patients attending Singapore General Hospital. This study is a clinical study. Randomized Control Trial design is considered the gold standard of epidemiological and clinical studies (Evans, 1998). Therefore, this study design is the most suitable for the study. Besides, the design has several advantages: studies done using this design are easier to blind than observational studies; the design eliminates population bias; and it makes it possible to identify populations of individuals intended to participate in a study. The study will compare two variables: post discharge calls and readmission of study subjects. The study will take place for a period of five months. Qualitative method that will be employed is interview that will be done through phone calls.
Implementation process will begin with recruitment of participants. The recruitment process will be conducted after every one month for a period of five months. First, potential participants scheduled for discharge will be identified and their consent to participate in the study will be sought. Next, two study groups, which are control group and intervention group, will be pre-randomized. The potential participants who will agree to participate in the study will be randomly assigned in either control or intervention group. Nurses who will participate in the study will be selected from the cardiovascular ward. They will help with making calls, identifying potential participants during recruitment, and documentation of data. Then phone numbers of the participant and those of three other people who are relatives of potential participants and can be reached by the study team on phones will be collected. The three individuals must be in contact with the participant or must be able to tell the condition of the participant whenever contacted. These individuals will include but not limited to; daughter, son, wife, and daughter-in-law. Calls will be made after discharge starting form day two. Successive calls will be made on day seven, day fourteen, day twenty first, and day twenty eighth respectively. Calls will be manipulated such that only the intervention group will be called while the other group (control group) will not receive post discharge calls intervention as mentioned above.
Participants in the study will be people with certain characteristic suitable for the study. First, they will have to be patients aged sixty five years and older. This age category is selected because it exhibits high prevalence of heart failure. Consequently, incorporating them in the study will enable the researchers to obtain a wide range of subjects for the study. The participants will also be patients who are admitted for heart failure as the primary diagnosis. This characteristic is important since it increases chances that if a patient is readmitted, it would be due to heart failure. Besides, since the study only deals with patient with heart failure disease, it is important to limit the study on patient with the condition.
Another determinant of inclusion in the study is the language a participant is proficient in. The study will involve patients who can speak English, Mandarin, Tamil, and Malay fluently. This is very important given that calls will be made to the participants in the intervention group and this will require communication. The requirement also takes care of the fact that some of the nurses who will conduct the study may not be proficient in all the languages but fluent in one. Therefore, participants will be required to be able to communicate in all the above-mentioned languages so that they will be able to answer calls from various nurses who can only speak one language. It is also important to note that Singapore is a highly cosmopolitan Country inhabited by diverse ethnic groups. The work force also consists mainly of foreigners who may only be fluent in one language.
Another criterion for inclusion of participants in the study is having no primary care giver. This is important for the study since the study assumes that participants will only seek health services from health facilities whenever their condition gets worse. Patients will also be eligible to participate in the study if they are accessible via telephone calls. This is especially crucial for participants in intervention group since calls intervention forms an integral part of the study. Lastly, eligible patients will be those discharged from the facility. The discharged participants will then be followed up based on groups to which they are assigned.
Participants will also be excluded from the study if they meet the following conditions: having coronary artery disease or valvular heart disease; having concurrent medical conditions such as severe pulmonary disease, untreated renal failure, cognitive impairment, and advanced malignancy; having hearing or visual impairment or both; and being discharged to either community hospital or nursing home.
The sample size will be calculated using sample size calculator (RAOSOFT). The acceptable margin of error for this study is 4.98% and the desirable confidence level is 95%. Population size of potential participants is 1000 according to data released by the Ministry of Health. Using the above information: margin of error of 4.98%, confidence level of 95%, and population size of 1000 the researchers will obtain 280 as the sample population size.
The various tools that will be needed in the study are phones, computer software, and computers. The phones will be used to contact the study subjects during the study. Computer software will be used in analysis, interpretation, and presentation of data. Computers will provide programs for storing data obtained from the study and findings obtained from data analysis.
Qualitative data pertaining to the proportion of participants who will be readmitted within 30 days after discharge and the proportion of those that will not be readmitted in both control and intervention group will be collected through follow up survey. Participants in the intervention group will be called twice per day on the following days after discharge: day2, day7, day14, day 21, and day 28. On the other hand, participants in the control group will be contacted at the end of the 30 days to determine whether they were readmitted for heart failure condition or not. The data collected will be stored, analyzed, interpreted, and presented.
Construct validity test will be used to test the validity and reliability of data collected. The content of phone interview will also be shared with review panel of experts who will test them further.
- Proposal for the proposed study will be submitted to Singapore General Hospital, Campus, and head of department of cardiovascular medicine to seek permission.
- The proposed study proposal will also be submitted to IRB to seek permission.
- Consent of the potential participants will be sought and they will be informed of the study. However, the group they are assigned will not be disclosed to them.
- Participants will also be asked to choose the time they find convenient to be contacted on phone.
- Data analysis
T-test will be used in the analysis of data obtained from the study. T –test is used to determine whether means or proportions of two samples are equal. In this study, it will be used to determine whether there is statistically significant difference between the proportions of readmitted patients within thirty days after discharge in control group and the proportion of readmitted patients in intervention group. Therefore, the test is appropriate for the study. Based on the T-value obtained, it will be possible to either approve or disapprove the hypothesis. Qualitative analysis will be based on the level of patients’ perception of people’s concern in their conditions. Patients who receive many calls after discharge are likely to perceive that people are concerned in there conditions hence their confidence improves and this helps reduce chances of readmission.
- Evaluation
Nursing care bears significant implications on likelihood of patients’ conditions to improve. This explains why prolonged contact of a patient with a nurse helps improve the patient’s condition. Nurses spend longer hours with patients than any other health practitioner. They have greater influence on patients hence it is important to incorporate them in the study.
The various limitations likely to be encountered in the study are following:
- Some patients when contacted may present complains that have nothing to do with purpose of the study. This may be disruptive. The research team can overcome this by remaining focused.
- Some patients may only be reachable through next of keen who may at times be unavailable on phone. This is overcome by obtaining contacts of at least three relatives of the participants.
In conclusion, the study will employ longitudinal design and Randomized Control Trial design to compare whether post discharge calls reduce chances of readmission of a patient with heart failure or not. Data collection method chosen is appropriate since it is cost effective. The results obtained will form basis for fostering follow-up process of patients with other conditions.
Evans, J. (1998). Epidemiology in Practice: Randomised Controlled Trials. Community Eye Health, 11(26), 26.

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