Clinical Research Directory

IMPULS-NRW: Telemedicine in Specialized Outpatient Palliative Care

This study examines the feasibility, user-friendliness, and impact of digital support in outpatient palliative care. Patients, relatives, and professional caregivers use the web-based ISPC platform (information system for Palliative Care) and an accompanying app to record symptom progression, vital signs, and care experiences. In addition, qualitative interviews, focus groups, and usability tests are conducted to analyze experiences, needs, and effects of digital innovations. The goal is to improve digital support in palliative care in a practical way, optimize patient care, and lay the foundation for sustainable integration into standard care.

Resilience-Building for Advance Care Planning

The aims of this study are to (1) assess the feasibility, acceptability, and usability of the ROCKS intervention among patients with advanced cancer and their family caregivers through a randomized controlled trial in a cancer center setting; (2) evaluate the preliminary efficacy of ROCKS, as compared to usual care, on changes in completion of advance directives; and (3) explore the dyadic effects of resilience on self-efficacy, optimism, dyadic communication and coping, anxiety, and depression using an actor-partner interdependence model.

Better Real-time Information on Documentation of Goals of Care for Engagement in Serious Illness Communication

The goal of this study is to test the accuracy of Large Language Model-generated serious illness communication (SIC) summaries, the feasibility of delivering the SIC summaries, and to collect perspectives on the SIC summaries from clinicians and participants with cancer. Large Language Models (LLMs) are artificial intelligence programs that can perform various natural language processing tasks.

Feasibility of the Comfort Measures Only Time Out (CMOT)

Nearly 25% of Americans die in intensive care units (ICUs). Most deaths in ICUs are expected and involve the removal of ventilator support, or palliative withdrawal of mechanical ventilation (WMV). Prior work by the Principal Investigator (PI) found that patient suffering can be common; with 30-59% of patients going through this process experiencing distress. Thus, experts and national organizations have called for evidence to inform guidelines for WMV. This research study will 1) develop and refine a Comfort Measures Only Time out (CMOT) intervention consisting of a structured time out with check-list protocol for the ICU team (nurse, physician, respiratory therapist) to improve the process of WMV. and 2) Pilot test the CMOT intervention in 4 ICUs (2 medical/2 surgical) among 40 WMV patients.

Eliciting Informed Goals of Care in Elderly Patients

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.

Identification of Obstacles and Levers to the Outpatient Care of Patients in Terminal Palliative Situations

80% of patients wish to die at home. The number of deaths will increase in the coming years due to the aging population. The general practitioner (GP) is at the center of this care. Despite national plans for the development of palliative care, dying at home remains complicated. The difficulties described and known are organizational (workload) and linked to the doctor's experience with the suffering of the patient and their family. Many studies have been conducted in hospital settings, and the solutions developed are often not very accessible to GP. Conducting a study on this subject will allow us to take stock of this outpatient care provided by general practitioners following numerous changes that have occurred in recent years, both in terms of palliative care teaching and in terms of modifications to the care offered.

Evaluation of the Acceptability, Appropriateness, and Feasibility/Usability of a Metastatic Breast-cancer Specific Prognostic Calculator Among Clinicians

I this qualitative study, Investigators will conduct semi-structured interviews with clinicians that are involved in the care of patients with breast cancer to evaluate the acceptability, appropriateness, and feasibility/usability of a metastatic breast cancer-specific prognostic tool. These interviews will be conducted by the UNC CHAI Core and will continue until thematic saturation (estimated 10 participants). The investigators will code the qualitative data using emerging themes, guided by a well-established implementation science theory, the Consolidated Framework for Implementation Research (CFIR). The information gained from these studies will inform an implementation approach to increase the usability and acceptability of a novel prognostic tool to assist oncologists in the prognosis of patients with metastatic breast cancer.

Study of Poetic Dignity Therapy for Sexual and Gender Minority Patients With Cancer

The purpose of this study is to find out if dignity therapy is practical and works well for sexual and gender minority (SGM) patients in MSK. SGM includes, but is not limited to, people who identify as lesbian, gay, bisexual, transgender, and/or queer/questioning (LGBTQ+). Dignity therapy is a type of psychotherapy where the clinician asks the patient questions to allow the patient to express their individual life story and ultimately be able to create a legacy document of their experiences that can be shared with their loved ones.

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

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.

Web-based Support for Family Caregivers of Patients With Advanced Cancer

For family caregivers of patients with advanced cancer, preparedness for caregiving is crucial for maintaining health and quality of life both during care and after the death of the patient. This project contributes to earlier research funded by the Swedish Cancer Society, about an intervention that was delivered by a multi-professional team and proved to be successful in promoting preparedness. However, such interventions are often costly and logistically challenging. In addition, the Covid-19 pandemic has further significantly raised the need for digital alternatives in healthcare. As a possible solution, an evidence-based intervention, narstaende.se, has been developed consisting of recorded videos of conversations between clinicians and family caregivers (actors), linked to informational texts and a moderated chat forum. The intervention was pilot tested during 2020 and 2021, exploring feasibility, content and family caregivers' experiences. As preliminary results are promising, the intervention is taken one step further and tested as a web-based intervention in a larger scale.

Wishes to Improve Support and Humanity at End-of-life in Safety-net Hospitals

Dignified and compassionate end-of-life (EOL) care is a cornerstone of high-quality, patient-centered care, but in safety-net hospitals EOL care is often overlooked, considered too late, or not at all. By eliciting and implementing final wishes for dying patients, the 3 Wishes Project (3WP) has demonstrated, in tertiary academic centers, that acts of compassion can improve the EOL experience and help families cope with loss. The investigators propose to implement the 3WP in safety-net hospitals where there are less resources and more diverse, disadvantaged patient populations, and hypothesize that there will be similar positive effects on the EOL experience for patients, families, and clinicians.

Embedded Palliative Care in the MICU

The goal of this study is to investigate whether embedding a hospice and palliative care practitioner within a medical intensive care unit will improve patient outcomes and healthcare usage. The practitioner will work solely within the medical intensive care units and offer timely as well as proactive consultations based on clinical criteria and estimated mortality risk. The study team will compare patients seen by the practitioner to patients in an adjacent ICU and historical patients to determine whether patient care is improved by this intervention.

Palliative Care Education in Assisted Living for Dementia Care Providers (PCEAL-DCP)

The palliative care education in assisted living for dementia care providers (PCEAL-DCP) is a 4-week intervention (once a week for 1.5 hours, a total of 6 hours) for licensed nurses, administrators and dementia care coordinators to improve quality of dementia care outcomes

Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer

This cluster-randomized comparative effectiveness trial compares a technology-based supportive cancer care (SCC) approach with a redesigned team-based supportive cancer care (SCC) approach.

A Mouth Education Program for Dry Mouth

The goal of this cluster based intervention trial is to evaluate the effect of a nurse-led patient education program on dry mouth in patients with a life-limiting condition or frailty. The Mouth Educational Program (MEP) is a nurse-led patient education program, in which trained nurses use current clinical, palliative dry mouth guidelines in a structured manner to discuss causes, consequences and interventions with the patients and to create an appropriate treatment plan. This intervention will be compared to a control group receiving care as usual. Therefore, the main question it aims to answer is: Does a nurse-led patient education program reduce dry mouth complaints in patients with a life-limiting condition or frailty? Participants will be asked to answer questionnaires and, when part of the intervention group, partake in the Mouth Educational Program (MEP).