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NCT ID: NCT06071078 Not yet recruiting - End of Life Clinical Trials

Impact of a Protocol for Announcing Decision of Withholding and Withdrawing Life-sustaining Treatments on the Stress of the Relatives in the Emergency Departments

DISCUSS
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

Death is a daily reality in the emergency department. Deaths represent 0.3 to 0.5% of emergency admissions, i.e. approximately 26,000 per year for the whole of France. For 80% of these deceased patients, a decision of withholding and withdrawing life-sustaining treatments was made in the emergency departments. The announcement of death and decision of withholding and withdrawing life-sustaining treatments in this context is complex because of the lack of time and the inappropriate places for the announcement. In addition, the short delay in the occurrence of these events may increase the stress and anxiety of families who are unprepared for the announcement. However, there is little data in the literature on the impact on families in terms of their experience of announcements in the emergency context. It has been established that symptoms of anxiety and depression are correlated with the onset of posttraumatic stress disorder and that the latter is more important in the families of deceased patients and after a decision to undergo decision of withholding and withdrawing life-sustaining treatments in the intensive care unit. In order to identify it, several tools have been developed, including the Impact Event Scale (IES), which has been widely used to detect symptoms related to PTSD. It has also been shown that training nursing staff in communication skills or the use of written support in dealing with the families of patients who have died in intensive care reduces the appearance of post-traumatic stress symptoms. Human simulation is a pedagogical technique for learning interpersonal skills through role playing. It is used, among other things, in announcement situations in medicine. Nevertheless, its impact in emergency medicine has not been evaluated. Moreover, it has been shown that the involvement of the patient-partner in the care process must be improved and encouraged and that its impact has yet to be evaluated. Therefore, the objective is to evaluate the impact of a model protocol for announcing decision of withholding and withdrawing life-sustaining treatments, with human simulation and the intervention of partner families in a simulation center and in situ, on the reduction of family stress following the announcement of a decision of withholding and withdrawing life-sustaining treatments in the emergency departments. Hypothesis is that training all emergency department caregivers in the use of a model announcement protocol with the support of human simulation, combining training of pairs in a simulation center and in situ training, and the participation of partner families, would allow for a better understanding of announce of withholding and withdrawing life-sustaining treatments decision in the emergency department and reduce their impact on families in terms of the occurrence of acute stress and post-traumatic stress symptoms.

NCT ID: NCT06060249 Active, not recruiting - Sudden Infant Death Clinical Trials

Investigation of the Genetic Diseases in Infants With Unknown Cause of Death

SIDS
Start date: September 1, 2023
Phase:
Study type: Observational

Sudden infant death syndrome (SIDS) is a disease of an infant under one year of age, whose sudden death occurred unexpectedly, which the cause of death cannot be determined despite macro-autopsy, and toxicological, pathological and microbiological examinations. It is most common in babies aged 2-4 months. Although it cannot be attributed to a single cause, it is suggested that apnea/airway obstruction, abuse, developmental disorders, exposure to cigarette smoke, infections, toxic gases, metabolic diseases, and cardiac problems cause SIDS. It is known that genetic studies on SIDS are few and the literature reported so far is insufficient. On the other hand, as a result of rapid developments in genetic diagnosis methods, various genes associated with SIDS have been reported in recent studies. Most of the studies conducted include genetic studies aimed at investigating specific disease groups in SIDS. Although there are few studies on comprehensive investigation of genetic causes, potentially causative variants have been identified in 20% of cases where whole exome sequencing has been performed. In a study including perinatal deaths in which the reports of the Forensic Medicine Institute in our country were examined, 4% of the cases were reported as infant deaths of unknown cause. However, this study is only autopsy data and does not include metabolic and genetic examinations. For this reason, as far as we know, there is no information about the incidence of SIDS in our country. Based on this information, in our research, in the province of Ankara, the deaths of children under one year of age who died unexpectedly and suddenly were examined, autopsied, and toxicological examinations were performed on internal organ samples and body fluids taken during the autopsy by the Ankara Group Presidency of the Forensic Medicine Institute between 2018 and 2023. Genetic investigation of hereditary diseases that may lead to death of cases whose cause of death cannot be explained despite pathological and microbiological examinations will be carried out by the Whole Exome Sequencing (WES) method. The project will be carried out by researchers at Ankara University Faculty of Medicine and Forensic Medicine Institute Ankara Group Presidency. This research project was planned as a prospective, descriptive, open uncontrolled study. The duration of the project is foreseen as 12 months. Approval for our research was received from Ankara University

NCT ID: NCT06049212 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Sacituzumab Tirumotecan (MK-2870) as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-2870-008)

Start date: October 26, 2023
Phase: Phase 1
Study type: Interventional

This is a phase 1 trial of the safety, tolerability, and pharmacokinetics (PK) of sacituzumab tirumotecan monotherapy, and of sacituzumab tirumotecan in combination with pembrolizumab (MK-3475) or pembrolizumab + carboplatin, in Japanese participants with advanced solid tumors or treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC).

NCT ID: NCT06046261 Completed - Clinical trials for Chronic Kidney Disease

Exploring the Impact of " ACP Board Game for Life" on Death Preparation and Anxiety in Patients With Stage 4 and 5 Chronic Kidney Diseases: A Pilot Study

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

This study was to explore the impacts of participating in "ACP board game for life" on death preparation, death anxiety, end-of-life care preferences, and intervention perception in stage 4-5 CKD patients with advanced chronic kidney diseases in a medical center.

NCT ID: NCT06032091 Recruiting - Dementia Clinical Trials

Digital Phenotyping for Changes in Activity at the End of Life in People With Dementia

DIPHDEM
Start date: May 2, 2023
Phase:
Study type: Observational

Background: Almost 90% of people with dementia develop serious symptoms such as apathy, agitation, pain, and sleep disturbances. Movement and participation in daily activities also decrease dramatically over time. Traditional measures for these symptoms are usually in the form of a questionnaire and are not very accurate. Technology, such as a smartwatch, can be an effective tool for complementing traditional measures. Currently, there are few studies which look at activity and symptom measurements at the end-of-life. This makes results from this study extremely valuable for future care decisions, especially for people which may not be able to communicate their needs during the end-of-life period. Method/Design: DIgital PHenotyping in DEMentia (DIPH.DEM), a 3-year cross-sectional observational study (N=50), will look at activities, apathy, agitation, and sleep disturbances using sensing technologies to monitor participants at the end of life. The objective of the study is to use a smartwatch and wireless radar (bedside) device (Somnofy), in addition to validated assessment tools to describe the activity patterns for patients with dementia at the end of life (baseline and every 6.months). We hypothesize that this will enable better estimation of time of death, facilitating discussion surrounding improvement of end-of-life interventions and directives. Discussion: The use of sensors (smartwatch and wireless beside device) can provide valuable knowledge on living and dying with dementia, improve end-of-life directives, and provide guidance for timely, appropriate interventions, including referral to palliative services. Impact on society: DIPH.DEM has the potential to enable more timely, precise, and quality care for people with dementia living at home, in nursing homes, and hospitals.

NCT ID: NCT06026241 Recruiting - End-of-life Care Clinical Trials

Practice Analysis of Care, Paraclinical Exams and Treatments Received by Geriatric Patients Both During the Last Week and the Last 24 Hours of Their Lives.

Start date: March 1, 2024
Phase:
Study type: Observational

End-of-life care is a core topic for geriatricians. One of the key aspects of end-of-life management is deciding when to discontinue active care measures (for example blood pressure monitoring, blood tests and X-rays) in favor of exclusive comfort care. In this retrospective observational study, the investigators looked at the care measures, treatments and paraclinical exams received by geriatric patients both one week and 24 hours before their death.

NCT ID: NCT06008210 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease Severe

A Decision Aid on End-of-life Care for Patients With Advanced COPD and Their Family

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

This study aims to support EOL decision-making in patients with advanced COPD and their family members. A parallel two-arm single-blinded randomised controlled trial will be conducted to evaluate the effects of a specific decision support intervention. A total of 226 patients with advanced COPD and their designated family members will be recruited from hospital wards and outpatient clinics.

NCT ID: NCT06005272 Recruiting - Perinatal Death Clinical Trials

Mothers Working to Prevent Early Stillbirth Study 20-28

MiNESS20-28
Start date: September 1, 2023
Phase:
Study type: Observational

This project aims to identify factors linked to pregnancy losses occurring between 20 and 28 weeks of pregnancy that can be modified by changing mother's behaviour or healthcare provision. The death of a child before birth (also called stillbirth or miscarriage) has enduring psychological, social and economic effects for women, their families and wider society. In 2015, the stillbirth rate in the UK was higher than comparable countries. The UK government has committed to reduce stillbirths by 50% by 2025. Presently, stillbirths after 28 weeks of pregnancy have reduced by 16% but there has been no change in losses between 20 and 28 weeks of pregnancy with 1,600 losses estimated to occur at this stage of pregnancy each year. Identification of modifiable causes of stillbirth was identified as a research priority by the Stillbirth Priority Setting Partnership which involved over 1,000 participants, one third of whom were bereaved parents. The investigators previously completed a study of 291 women who had a late stillbirth (after 28 weeks of pregnancy) and 733 women who had a live baby in 41 maternity units in the UK. This study identified factors linked to stillbirth which can be changed including the position women go to sleep in, cigarette smoking and caffeine consumption. In addition, the investigators previously found changes in mother's perception of baby's movements, whether women had tests for diabetes or whether women were exposed to domestic violence or stressful situations. These factors can be addressed by different care in pregnancy. Information from this study has been included in national and international guidelines that aim to reduce stillbirth. The investigators will use the same study type to identify factors associated with pregnancy loss between 20 and 28 weeks of pregnancy (early stillbirth). The investigators have asked parents who have experienced the death of a baby at these stages of pregnancy about the design of the study, the questions that would be asked and how best to approach bereaved parents. This led us to include miscarriages from 20-22 weeks of pregnancy that are not usually "counted" in UK stillbirth statistics. The investigators will need 316 women with stillbirth between 20 and 28 weeks of pregnancy and 632 women with an ongoing live pregnancy to participate in the study. All women will complete a questionnaire about themselves, their diet, behaviours and sleep, their baby's movements and pregnancy care. The investigators will compare information between women who have early stillbirth and those who have a live birth to identify factors associated with stillbirth at less than 28 weeks of pregnancy. The study findings will be disseminated in collaboration with patient organisations using effective ways to reach pregnant women. The investigators anticipate the findings from this study will be included in clinical practice guidelines and rapidly translated into antenatal care.

NCT ID: NCT06002113 Not yet recruiting - End of Life Clinical Trials

Eliciting Informed Goals of Care in Elderly Patients

ASKMEGOC
Start date: September 15, 2023
Phase: N/A
Study type: Interventional

Patient-centered medical care considers a patient's values and goals for their health and well-being. Healthcare providers use this information to formulate a medical care plan that is aligned with these expectations. This shared-decision making process should occur with every medical decision, but it is especially important whenever decisions about end-of-life care are being considered. Eliciting patient preferences about resuscitation and life-support treatments in the event of life-threatening illnesses are considered to be a standard of excellent and appropriate medical care. Unfortunately, these discussions don't happen consistently and even when they do occur, are rarely ideal. The consequences can be devastating, often resulting in the delivery of unwanted medical care that can be associated with significant physical and mental suffering among patients and their families. In response to this problem, the investigators developed a novel tool to help guide these difficult conversations between healthcare providers and patients. The investigators previously tested this tool in a small group of hospitalized patients who found it acceptable and helpful. In this larger study, the investigators will compare how effective this tool is compared to usual care in ensuring hospitalized patients have their treatment preferences identified, documented and result in end-of-life care that is consistent with their preferences.

NCT ID: NCT05994430 Active, not recruiting - End-of-life Care Clinical Trials

The Effect of End-of-Life Care Awareness Education on Knowledge, Attitudes, and Behaviors of Intensive Care Nurses: A Randomized Controlled Study

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

This study was designed as a prospective randomized controlled study in order to evaluate the effect of end-of-life care awareness training to be given to intensive care nurses on the knowledge levels, attitudes, and behaviors of nurses. The study was conducted between May and July 2023 with 76 nurses working in the Anesthesia and Reanimation Intensive Care Unit, General Intensive Care Unit, and Cardiovascular Surgery Intensive Care Unit of Van Training and Research Hospital, who met the inclusion criteria. The hypotheses of this research: H1: End-of-life care awareness training increases the knowledge level of intensive care nurses about end-of-life care. H2: End-of-life care awareness training positively affects intensive care nurses' attitudes toward end-of-life care. H3: End-of-life care awareness training positively affects the behaviors of intensive care nurses towards end-of-life care. Nurses who completed their undergraduate education worked in intensive care for at least one year, actively continued their profession (no annual leave, report, etc.), and were willing and voluntary to participate in the study were included in the study. Nurses who had a palliative care nursing certificate, had received training on end-of-life care by participating in a training program such as ELNEC, and had not participated in the training program of the study for more than two sessions were not included in the study. At the beginning of the research, the pre-test forms/scales "Nurse Information Form", "End-of-Life Care Knowledge Test" and "Intensive Care Nurses' Attitudes and Behaviors Towards End-of-Life Care Scale" were administered to all nurses. After the pre-test application, the nurses were randomly included in the training and control groups. A randomization list generated by a computer-based random number sequence was used to determine which group the intensive care nurses would be in. - The "End-of-Life Care Education Program in Intensive Care" prepared by the researchers in line with the End-of-Life Nursing Education-Intensive Care program was applied to the intensive care nurses in the training group. The training program was implemented online for 45-60 minutes one day a week for 4 weeks. The same forms/scales were repeated 4 weeks after the training. - Intensive care nurses in the control group did not receive any intervention during the study. Similar to the training group, the same forms/scales were repeated 4 weeks after the training. After the study is completed, the same training program will be applied to the nurses in the control group.