Description of research design
The research design used is the classical experimental design. In the study, a post-test-only design will be used to compare the standard policy of turning patients every one hour to turning them every two hours by measuring the effects that these interval repositioning of patients have on the patient outcome.
The experimental group (n=119) is going to be repositioned every one hour while the control group (n=118) will be turned every two hours. Both groups are going to be propped up using pillows at a 30-degree lateral position.
The protocol of sitting for both groups will be identical and the pressure areas will be under observation daily and classified according to the grades of the American Pressure Ulcer Advisory Panel. If there is an appearance or any pink areas on the patients’ bodies, the frequency of repositioning will be increased. The pillows will be placed between the knees and ankles to prevent prolonged pressure from accumulating on the patients’ bones. This type of research design is the type that uses controlled observation of various variables. There are several independent variables whose values are altered to assess their causal effect on other dependent variables (Carpenito-Moyet, 2008). This kind of experiment has time variables, there are relationships between variables, a control group is used and random sampling is used in addition to random assignments. The variables are pre-tested and post-tested. There will be a post-test done at the end of the experiment for both the experimental and comparison groups. There are several extraneous variables in this experiment such as the level of pressure ulcers the patients in the ICU are suffering from, the different skin types they have among other characteristics. To try and control the effects of these extraneous variables, randomization was used in the selection and assignment of the experimental and comparison group/control group.
At the beginning of the experiment, randomization would statically equalize the groups in all ways. The probability of them being equal is higher than the probability of them not being equal though not certain. By randomization, the extraneous variables in the population might be distributed equally (Clay 2008). The downside of this experimental design is that it is difficult to determine if the difference in patient outcomes at the end of the experiment is due to the kind of treatment given to the patients from the beginning of the experiment or other factors that influenced this outcome. The act of randomization does not specifically assure us that the two groups chosen are of similar characteristics to the latter.
The advantages of using this kind of research design are that it controls the study variables. It also is capable of using random assignment manipulation of the independent variables. The other advantage is that the impact of the experimental variable is visible over time. It also requires little time and money to finish.
Identification of the population
The t-test will be used to test the dependent variables in the experiment. The population that will participate in the experiment will be from the ICU department of the hospital. These will be the patients suffering from pressure ulcers that were admitted to the medical-surgical ICU who require to be changed from time to time. Pressure ulcers can develop in any patient as long as their critically ill and are on a hospital bed. This is because they are normally immobile and therefore cannot change their positions in response to pain (Morison, 2001). This is the characteristic of most patients in the ICU. In addition to this, most of them have reduced sensory perceptions making it even more difficult to prevent the development of pressure ulcers which are caused when pressure from their sleeping position causes sores on their skin. Movement helps to relieve pressure thus reducing significantly the occurrence of pressure ulcers. This has lately become an important therapeutic and preventive measure in cases of pressure ulcers. Some of the factors that can affect the development of these pressure ulcers are the age of the patient since aged patients generally have sensitive skin and their bones tend to stick out. The other factor is the length of the patient’s stay in the ICU. Those that have been there for long are more susceptible to skin infection than those who have not. These patients should be the ones on mattresses that have similar air pressure levels. Equally, these patients should be able to participate in the study independently and out of their consent. This means that they will have to sign the consent forms or have some other legal representatives sign them on their behalf.
The patients should be above the age of eighteen years but below the age of forty-five years and should weigh between fifty to eighty kilograms. Patients who are pregnant or who are not able to sign the consent forms will not be eligible for the experiment. The consent forms will be issued by the nurses in the hospital and will contain the participant’s contact information. The population size of the study is 186-88. The patients will be randomly assigned a group either in the experimental or the control group. The disadvantage of the random selection of the population is that their qualities might not adequately represent many population qualities or the characteristics of the general population. To be able to avoid this problem, the population sample should be bigger as this would ensure that the many characteristics of the general population are at least represented. But this is not possible in this experiment since careful observation and measurement of the outcome is vital if the results of the experiment are to be valid.
The process is however less time-consuming and limits bias in the assignment of groups. The number of males and females taking part in the experiment was equal.
Selection of a setting
The patients that will be selected for the experiment are from the ICU. These are the patients who have been admitted to the medical-surgical ICU due to the critical nature of their illnesses and have developed pressure ulcers. The patients should not be pregnant or below the age of eighteen but should also not exceed the age of forty-five years. The experiment will take place in the same ICU but a different wing of the ICU department. Separating them from the rest of the ICU patients will allow for the control of the study environment. This is to say that there will be no possibility of anyone else changing the patients’ positions without the knowledge of the researchers or the nurses that are assigned to the room. The air pressures of their beds will also be the same so that only the independent variable is altered in this case being the number of times a patient is repositioned. Only the nurses that are helping out with the experiment will be allowed into the wing of the ICU where the experiment will take place. The supporting nurses will be monitoring the conditions of the patients taking part in the experiment. They will be responsible for repositioning the patients and changing the pillows that are used to prop up the patients daily. For those participating patients who develop pink patches on their skin fast, the frequency of their turning will be increased and the outcome recorded by the nurses. The nurses helping with the experiment will be issued with information forms that they will be required to fill at the end of every day until the study is over.
Presentation of ethical considerations
The study will be presented to the Institutional Review Board for approval and also ensure that the rights of the human subjects are adhered to with a lot of precision. Any changes that the board might recommend will be made appropriately and with immediate effect. This is because all humans participating in any clinical trial are entitled to some rights and protections established by the United States law. The university administrative board has approved the study and the matters about management and insurance of liabilities were properly addressed in this study. Some of the activities that will be done during the experiment will be harmful to the patients and might cause them pain. This is like the fact that the participants will be changed constantly and this might inflict some pain on their pressure ulcers since even during repositioning some pressure is asserted to the ulcers. The frequency of the repositioning activities will also be increased as soon as the patients show signs of pink patches on their skin. This might cause them some pain though it is intended to reduce the severity of the pressure ulcers. Safety guidelines from the hospital manual will be followed carefully during the experiment so as not to put too much pressure on the patients. Every patient has the right to privacy and this right will be respected by both the researchers and the support nurses. These are laws created in the Health Insurance Portability Act and all the regulations must be adhered to carefully.
All the participating patients will be informed of the benefits of the study and will know how they will have helped the field of medical research. This experiment will help determine if the patients suffering from pressure ulcers could benefit from the frequent repositioning of their sleeping positions. The study will be funded by the university board and partner hospitals that also have a stake in the outcome of the study. The proposal has to go through the hands of the academic committee of the university who shall oversee the conduct of the student carrying out this study. The IRB and the human rights committee will also evaluate the proposal to ensure that the experiment violates no rights of citizens in the law.
Selection of measurement methods
The main outcome was measured using wound survival rates, healing rates of the wound surfaces, and the changes considered to be clinometric observed over twelve weeks were measured using a clinical rating scale. The clinical rating scale measures the rate of the growth of pressure ulcers in the patients and this measurement is converted to a percentage. It works by measuring the surface of the pressure ulcer to determine how big the ulcer is. The size of the ulcer implies the severity of the pressure ulcer caused by the frequency or lack of frequency in the repositioning of the patients taking part in the experiment. The percentage that is obtained is the rate of development of pressure ulcers in the subjects of the experiment. The clinical rating scale is relatively accurate but might not give the exact percentage rate of pressure ulcer development. This is the only threat to its reliability.
Plan for data collection definitely
The data collection process will be carefully planned to ensure that the data collection methods are accurate and precise and depict the real situation that took place during the experiment. There will be seven support nurses who will be helping out with the experiment.
These nurses will be from the hospital and will be familiar with the patients taking part in the experiment. They will receive formal training for about a week before the commencement of the study on the various methods of data collection and recording that will be in use during the experiment. The number of support nurses will be given considering the number of patients taking part in the experiment. They will each be assigned a certain number of patients that they will keep vigil over and be responsible for changing at the intervals indicated in the study proposal. They will be assigned to either the control group or the experimental group equally.
The nurses will be made aware of the rights of the patients participating in the clinical trial and will ensure that the patients have fully consented to the experiment that will be done on them. The support nurses will ensure this by overseeing the signing of the consent forms and collecting them and keeping them well should there be a future need to retrieve them. The patients will also be alerted on the data collection methods that will be used to ensure their full cooperation. This process is to be done on the first day of the study to ensure that there is a mutual agreement between the researcher, the support nurses, and the participating patients. The progress rates of the patients will be recorded daily until the end of the twelve weeks the study is supposed to take. The number of times a patient is repositioned will also be recorded in a database that will be created by the researcher with each patient having a special patient number assigned to them by the hospital nurse. At the end of the study, the level of surface growth of the pressure ulcer will be recorded after being measured using the clinical rating scale. The data will be saved in both a soft copy and a hard copy. All these activities will be done for both groups as in the experimental group and the control group separately. At the end of every week, the researcher and the support nurses will analyze the data collected and arrange them in order before the next week’s observations begin. Each patient file will contain the consent form and the progress reports of their pressure ulcers including the intervals at which they were repositioned. All the soft copies will be kept by the researcher on her laptop that will have a password for security purposes.
Plan for data analysis
The data will be analyzed using quantitative analysis methods. This will be done by obtaining the percentages of the rate of pressure ulcer development in the patients in the experimental group who were repositioned after every one hour and it will be compared to the percentage rate of pressure ulcers development of the control group that was repositioned after every two hours. The deviation in the two groups will be obtained using the data that will have been collected at the end of the study. The rate of pressure ulcer development will be shown in a curve that will represent the two groups using differently colored curves. The support nurses will be analyzing the data every week to ensure that the analysis of the same data at the end of the experiment will give accurate results. The results obtained from the data collection will be analyzed by the researcher herself.
Identification of limitations
One of the limitations of the study will be that the results may not be so conclusive since there might be other factors that accelerated the rate of pressure ulcer development in the patients like their skin type and the differences in their ages.
The effects vary when the patient lies on one side or a position in which the femoral trochanter bears weight and also when the patient lies on the position where the sacrum and the heels bear weight, also known as supine influences the advancement rate of the pressure ulcers.
Other factors that can falter the results would be the body temperatures of the patients which might differ from one patient to another causing the difference in the results obtained.
The other issue is the fact that the population sample that is being used is from the hospital and might not contain all of the characteristics of other patients in other hospitals. The study results might not be so applicable to other cases of pressure ulcer patients in other hospitals. The age of the patients also determines the development of the pressure ulcers and this is not so easy to control during the experiment. These factors generalize these study findings a problem and make the results disputable and debatable.
Discussion of communications of findings
The result findings will be presented to the journal of Multicultural Nursing and Health for consideration of publication. This is a journal that publishes articles that relate to the provision of healthcare to minorities, immigrants, and other ethnic communities and societies. A copy of it will also be sent to the American Journal of Nursing for publication. An application of it will be converted into a PowerPoint presentation that will be published on the university website for public viewing. The study results will be presented as a presentation at the upcoming dermatology for the non-dermatologist conference in Sarasota. Its success in this conference will determine if it will be presented at the Shanghai International Nursing Conference in Shanghai, China.
Presentation of a study budget and timetable
The funding proposals will be made available to the National Institute of Nursing Research as well as the University Board. The budget will feature the following aspects:
- Allowances for the support nurses
- Compensation for the participating patients
- Printing costs for the hardcopy of results and records and the designing and printing of the consent forms
- Purchase of computer software and laptop for the researcher.
- Funding for the publication of the findings of the study in the various journals
- Hire of the private wing of the hospital ICU
- Purchase of logbooks where the results of the experiment will be recorded
After the funding is secured, the support nurses will be recruited and trained for four weeks on the study method and design as well as data collection methods and analysis. In the following week, the selection of patients to participate in the study will be done and this will take around one week to get the well-qualified subjects.
After this, the private wing of the hospital ICU department will be hired and prepared to fit the situation and conditions favorable for experimenting. The patients will then be moved to the wing of the ICU in readiness for the study. Meanwhile, the database for each patient will be designed and the consent forms will have been signed and stored by the support nurses according to each file. The researcher will then purchase a laptop and install the necessary software for the recording and analysis of data. Once all these preparations have taken place, then the study can begin and the patients will be put on twenty-four-hour surveillance and constant repositioning at the various intervals indicated in the experiment guide. Once the study is complete and the findings have been analyzed, it will take another two months to come up with the appropriate documentation of the study findings and procedures.
Carpenito-Moyet, L. (2008). Nursing Care Plans and Documentation: Nursing Diagnosis and Collaborative Problems. Baltimore: Lippincott Williams & Wilkins.
Clay, K. (2008). Evidence-Based Pressure Ulcer Prevention. Boston: Hcpro Inc.
Morison, M. (2001). The Prevention and Treatment of Pressure Ulcers. Colorado: Elsevier Health Sciences.