Table of Contents
This occurs by identifying and shifting depressogenic thinking and generating alternative ways of thinking about the past (cognitive reconstruction). The recruiting and informed consent process will minimize the risks associated with the proposed study. Given the favorable risk: Benefit ratio, and the substantial mental health knowledge that will be gained by the proposed research, the minimal risks associated with the study are judged to be reasonable. Data safety monitoring plan. Study investigators (i.e., the student investigator and sponsor) will be responsible for all data and safety monitoring. The student investigator will seek guidance on collecting personal health information from Drs. Shellman, Starkweather, and Fortinsky. Participant confidentiality will be maintained by storing all non-electronic copies in a secured and double locked cabinet at the University of Connecticut. A master list linking patients ID numbers with their unique study ID numbers will be kept separate from participants’ data in a secure double-locked cabinet. This list will be destroyed after data collection, as indicated by federal and institutional guidelines. The participants’ responses will remain confidential.
In addition, any information provided by participants will be generic and confidential in nature and will not identify them personally. Any computer hosting such files will also have password protection to prevent access by unauthorized users. Research questionnaires will be labeled with a code and the code will be derived from a number that reflects how many people have enrolled in the study. All electronic files containing identifiable information will be password protected. The study will be free from harm, discomfort, and exploitation of patients. During data collection, any potentially negative event will be identified and rated on severity. Any such event meeting the definition of an adverse event by the Biomedical Research Ethics Committee at the UConn IRB will be filed for review in a timely manner. Any changes to the proposed study’s content or design will be made to prevent similar adverse events from occurring in the future. If a potentially negative event occurs, the student investigator or research team member conducting the session will assess the situation, take necessary remediator action and report the event to the other study researchers, including the sponsors (Table 2).
Table 2: Assessment of Adverse Event and Planned Course of Action Event Remediation Reporting Request for withdrawal from the study Participant can withdraw from the study at any time without incurring any penalty. If possible, the reason(s) for withdrawal will be obtained Discuss the event with the sponsor Verbalized discomfort with the group or questionnaire or intervention Study personnel will assist any participant to skip the problematic item or section. Occurrence will be noted Discussion of verbalized discomfort with sponsors and respective IRB representatives Verbalized or otherwise expressed psychological distress during the study. Study personnel will assist any participant to skip the problematic item or section, take a break from the session, or withdraw from the study as necessary. Discussion of the content of psychological distress with Sponsor and other researchers experienced with this study population. Adverse event report will be filed with respective IRBs. Significant distress associated with participation in the study Study personnel will withdraw the participant from the study and will determine the cause of the distress, if possible.
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Relevant resources will be offered. NIH will be notified should a severe event occur. There will be biweekly conference calls at which point all such problems will be thoroughly discussed. In addition, the student investigator will consult the respective IRB representative, and the School of Nursing department faculty member (Dr. Cong), who serves as the chair of the UConn IRB. Protection against risk. A set of safeguards will be put in in place to protect against the potential risks the first of which is the disclosure of depressive symptoms to other participants by virtue of participating in the group. Potential negative effects associated with this risk are minimized through our IRB-approval, HIPAA consent form, recruitment procedures, and informed consent that clearly conveys the conditions of disclosure to participants. Participants are informed of this risk, however, cannot be fully protected from it. Second of these safeguards include the potential for others in the same group to fail in maintaining participant’s privacy. We cannot guarantee that everyone will honor the pledge of confidentiality. To mitigate this risk, group facilitators will reinforce to participants the importance that they refrain from sharing anything they feel uncomfortable with others hearing. Participants will also be reminded that part of participating in groups is the agreement that information shared within the group is confidential and not to be spoken of outside the group.
Timeframe Training and recruitment are anticipated in month 1-3 of the study. Although the training materials for the research are not prepared, we do not expect any delays in initiating recruitment and enrollment within this period. Once a cohort of 10 begins the research protocol, additional participants will be enrolled to begin the research protocol as soon as the cohort reaches a maximum of 10 participants or at 3- month intervals to provide consistent orientation and progression of the reminiscence sessions. Completion of enrollment will occur with follow-up data collection time points completed in the final stage of the study, allowing for ample time to complete final data analyses and manuscript preparation. Potential Ethical Issues • Mention any risks or benefits associated with the use of mixed methods. The purpose of this pilot study is to describe the undergraduate nursing students’ experiences communicating with the psychiatric patients in mental health settings. Research Question: What is the essence of undergraduate nursing students’ experiences communicating with psychiatric patients in mental health settings? Interview Statement: Please describe experiences you have had during communicating with psychiatric patients in your clinical rotation. Share all the thoughts, perceptions, emotions, and feelings, you can recall until you have no more to say about your experiences. Specific examples of points you are making will be very valuable in helping to understand your experiences. Please describe for me your experiences communicating with psychiatric patients in mental health.
Describe all your thoughts, feelings, and perceptions that you wish to share. Specific examples of points that you are making will be very helpful. Please describe experiences you have had during communicating with psychiatric patients in your clinical rotation. Share all the thoughts, perceptions, emotions, and feelings, you can recall until you have no more to say about your experiences. Specific examples of points you are making will be very valuable in helping to understand your experiences.
Researchers’ Resources and Skills
- Include materials, software, and training required to gather, analyze, and integrate the quantitative and qualitative data. Timeline for Completing the Study
- Identify each major milestone (e.g., approvals, data collection, analysis, integration, interpretation, and writing).
Training Goals and Activities Planned Under this Award With support of the predoctoral fellowship, I will develop knowledge and research skills pertaining to reminiscence therapy for patients with dementia and comorbid depressive symptoms. To facilitate these activities, I propose the following goals for the grant period: Goal 1: I will acquire further knowledge and develop expertise in reminiscence therapy and dementia.
Goal 2: I will expand my research skills in data analytic strategies and dissemination. Goal 3: I will develop skills in multidisciplinary team science and scientific leadership.
Activities to achieve Goal 1 Didactic Components
I will tailor my coursework to supplement prior nursing training and experience to enable me to accomplish the proposed project. I I will receive leadership training to seek to support the educational development of nursing faculty. Career Goals I aim to become a nursing researcher in the field of psychiatric and mental health nursing whose research focuses on developing nonpharmacological treatments such as reminiscence therapy for early-onset dementia. The following career goals will facilitate this program of research and the applicant’s continued growth as a nurse researcher: First, obtain fellowships that focus on using reminiscence therapy to enhance psychological well-being in patients with dementia. Second, establish relationships with multidisciplinary collaborators to enhance the scientific rigor, dissemination, translation to clinical practice, and impact of this research. Third, advance the science of nursing by obtaining a faculty position at a research-intensive university.
Activities Planned Under this Award (Predoctoral Fellowship)
After careful consideration of time and feasibility, I will organize the following activities into a four-year plan to meet the training goals of the proposed study (Table 4). Year 1 (Coursework 70%, Research 30%) Including the Summer Semester The focus of the first year is to develop research instruments, complete IRB submissions for the proposed research, and complete all required coursework. During the first summer, I will complete an internship with Dr. Shellman focusing on refining the reminiscence intervention and submit a manuscript to the Journal of Geriatric Psychiatry and Neurology. Year 2 (Research 50%, Coursework 50%) Including the Summer Semester During Fall 2018, I will send a poster and abstract about the operational definition for reminiscence therapy to the International Reminiscence and Life Review Conference. In addition, a manuscript on the results of the study will be submitted for publication to the International Journal of Geriatric Psychiatry. Furthermore, I will regularly visit the UCA which hosts a range of lectures about reminiscence and dementia. During Spring 2019, I will conduct a pilot study to assess the study’s feasibility. Based on the results of the pilot study, a toolkit will be prepared to serve as a guide for the actual study. Year 3 (Research 100%) Intervention design will be refined and reviewed by expert collaborators prior to implementation. A final publication of the study intervention results will be submitted for publication. In Fall 2019, defense of the applicant’s dissertation proposal is projected to occur, including the completed full IRB application.
During this time, I will also provide informational sessions regarding the study purposes, processes, inclusion and exclusion criteria, and all basic protocols. After obtaining IRB approval, I will proceed with the research project. I will communicate study progress with my dissertation committee at least once a semester. In Spring 2020, recruitment, enrollment, and data collection will continue under the supervision of the dissertation committee. Year 4 (Research 100%) Subject recruitment, enrollment, and data collection are projected to be completed by Fall 2020. I will complete data entry, cleaning, and analysis and begin preparation of the study results manuscript. During Spring 2021, I will complete preparation of the study results manuscript and prepare to defend this dissertation. At this time, the applicant is projected to have met all the requirements for graduation. Institutions University of Connecticut (UConn) I chose the University of Connecticut as the institution for my graduate studies, as it offered the opportunity to work within the School of Nursing (SON). UConn SON faculty are well known for their statistical, methodological and applied contributions to nursing research (e.g., Drs. Shellman, Walsh, Starkweather, Cong, and McDonald). UConn/SON is specifically designed to prepare graduate students to become educators, researchers, and leaders in nursing, and will allow me to advance in nursing science. It is also a highly reputable university that would involve both academic and practical studies.
The curriculum of the PhD nursing program, with renown research, highly qualified nursing professors, student-centered approach, and opportunities for local field experience, will enrich my research and academic experiences. Within the School of Nursing, I will gain experience through teaching and networking with prominent nurse researchers in my field. All of this will strengthen my training and development of independent professional relationships. In addition, I will have support from the Center for Nursing Scholarship (CNS) in providing the most up to date data collection methodologies, and quantitative statistical software programs with PIs, faculty and IT professionals able to train me in their usage. Moreover, UConn offers a well-known Center on Aging Institute with over $70 million in the active US and international research grants. Through the The School of Nursing offers entry into the PhD program for students holding a Master’s and bachelor’s degree in Nursing. This option is designed for nurses who wish to focus their careers on research, public policy, administration, history, and/or nursing philosophy and theories.
The PhD program in nursing is offered within the framework of the School of Nursing and is consistent with the University and Graduate School requirements. The doctoral program in nursing prepares students to: i. Advance philosophical and theoretical bases of nursing through creative scholarship by: (a) analyzing knowledge development in past, present, and future contexts of the nursing profession, and (b) generating knowledge using empirical, ethical, aesthetic and existential methods to support the philosophical and theoretical bases of nursing. ii. Conduct an independent inquiry that advances nursing science by: (a) using quantitative and qualitative research methods to study nursing phenomena, (b) evaluating philosophical bases and assumptions of varied research methods, and (c) integrating knowledge and skills needed to secure competitive funding. iii. Provide distinguished leadership in the resolution of significant healthcare issues by: (a) demonstrating expertise in applying nursing knowledge to health care issues, and (b) using decision making and problem-solving processes to influence health care policy.
