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NCT ID: NCT05165888 Recruiting - Critical Illness Clinical Trials

Targeting Bias to Reduce Disparities in End of Life Care

BRiDgE
Start date: February 3, 2022
Phase: N/A
Study type: Interventional

This study aims to determine the ways in which clinician implicit racial biases affect clinician communication with family members of patients near the end of life and to test a novel physician training intervention to reduce the effects of implicit racial bias on quality of communication. Phase 1: A sample of 50 physicians who care for seriously ill patients, including oncologists, critical care physicians and hospital-based internists will participated in a simulated clinical encounter with a Black standardized family member (actor) of a hypothetical case patient. Measures of implicit and explicit bias will be correlated with verbal and nonverbal communication behavior. Phase 2: This is a 2-arm randomized feasibility pilot of an intervention to mitigate the effects of clinician implicit bias on communication behavior. Physicians who treat patients with serious illness including oncologists, critical care physicians and hospital-based internists will be recruited to participate in a communication training session to reduce the effects of implicit bias or a control training session focusing only on communication skills. Their communication behavior will be videotaped during a simulated encounter with a Black standardized family member (actor) of a hypothetical patient with serious illness before and after the training sessions. The communication behavior before and after the training session will be compared between physicians that received the communication skills only intervention versus the physicians that received the communication skills and bias mitigation training. The primary hypothesis is that physicians who receive both the communication skills and the bias mitigation training will have greater improvements in communication skills with the Black standardized caregiver (actor) compared with those who receive only the communication skills training.

NCT ID: NCT05159791 Recruiting - Myocardial Ischemia Clinical Trials

New Patient-specific Functional Assessment of the Anomalous Aortic Origin of Coronary Arteries.

NECESSARY
Start date: November 23, 2021
Phase: N/A
Study type: Interventional

Anomalous Aortic Origin of the Coronary Arteries (AAOCA) is a rare congenital disease that may cause sudden death in young subjects. Frequently the first and only presentation is with an acute event (such as myocardial infarction or sudden cardiac deaths) during physical effort. Not only symptoms are often absent, but also provocative tests fail to induce ischemia or related signs, showing in most patients negative results. For these limitations, the decision to undergo corrective surgery is based on the morphologic characteristics without the support of a functional evaluation. The study focused on developing a personalized ischemic risk assessment with the aid of fluid dynamic simulations. The simulation system integrate clinical data from different diagnostic sources and integrate them with coronary blood flow evaluation at rest and during simulated physical effort.

NCT ID: NCT05140343 Recruiting - Clinical trials for Congenital Heart Disease

Mobile Electrocardiogram Monitoring for Detecting Arrhythmias in Children

Start date: April 7, 2021
Phase: N/A
Study type: Interventional

The objective of this project is to evaluate the capability of a specific mobile electrocardiogram monitoring of detecting arrhythmic events in children with history of palpitation and or syncope. We will compare this approach with the standard approach of clinical follow-up plus 24-hour Holter ECG monitoring in terms of acceptability and ability to identify significant arrhythmias.

NCT ID: NCT05089032 Recruiting - COVID-19 Pandemic Clinical Trials

The Practice of Providing Palliative Care in the Situation of the COVID-19 Pandemic

PEOpLeC19-EN
Start date: May 17, 2023
Phase:
Study type: Observational

The practice of providing palliative care in the situation of the COVID-19 pandemic in the perspective of physicians and nurses - survey study (PEOpLe-C19 study)

NCT ID: NCT05045040 Recruiting - Advanced Cancer Clinical Trials

Empathetic Communication Facilitation Program for Early Initiation of End-of-life Discussions

Start date: September 6, 2021
Phase: N/A
Study type: Interventional

Background: The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: palliative care recommends discussing advance care planning (ACP) when patients' estimated life expectancy is reduced from a year to months. Discussions about ACP focus on communication among patients, their caregivers, and healthcare providers to achieve cancer-related treatment and care consistent with the patient's preferences based on their values and goals. ACP can improve outcomes for patients and caregivers; however, provision of ACP to patients remain low. This may be because of the complexity of ACP in clinical practice. A Question Prompt List (QPL) is a structured question list encouraging patients to put forward their queries to physicians and promote discussion between patients and physicians during medical consultations. Our preliminary study found that for patients with advanced cancer after standard chemotherapy, face-to-face interventions by nurses or clinical psychologists using a QPL about treatment and care, which is consistent with the patient's preferences based on their values and goals promoted empathetic communication between patients and their physicians. In recent years, however, ensuring adequate time during outpatient visits has become difficult due to increased numbers of outpatients and shortages of corresponding medical personnel. Therefore, intervention methods not restricted by location or time are needed. Thus, the investigators develop a mobile-based empathetic communication support program, including a QPL, to facilitate discussions about patients' values and goals with their physicians. Purpose: This study examines whether a mobile-based empathetic communication support program, which intends to promote ACP discussions in earlier stages of advanced cancer treatment, improves such communication behaviors of patients with advanced cancer and their physicians. Main contents of the intervention: Patients in the intervention group are provided a mobile-based empathetic communication support program-a mobile application (app). The app comprises a QPL (46 questions in eight categories) and questions about the patient's preferred treatment and end-of-life care based on their values and goals. After registering on the app, patients are first given a program overview and instructions for using the app. Then, they proceed with the content themselves, at home or anywhere else, at any time. Between app registration and the next outpatient visit, the patient is interviewed (by phone or in person) by a nurse or a clinical psychologist, who helps them prepare for the discussion with the physician and asks questions based on the patient's app responses for 30 minutes to an hour. During the outpatient visit, patients and their physicians are provided feedback based on the interview. Study participants: Overall, 264 patients with advanced or recurrent cancer are recruited from four departments (respiratory medicine, gastroenterology, hepatobiliary medicine, and oncology) in the outpatient clinic of the National Cancer Center Hospital, Japan. Outcome measurement: The primary outcome of this trial is the Reassurance and Emotional support score of physician behavior measured using the SHARE model at the first visit after the intervention. SHARE is a conceptual communication skills model comprising 26 items and four subscales, categorized as S: Supportive environment, H: How to deliver bad news, A: Additional information, and RE: Reassurance and Emotional support. Reassurance and Emotional support assesses physicians' behavior in providing reassurance and addressing patients' emotions with empathetic responses (e.g., remaining silent out of concern for patient's feelings or accepting patient's expression of emotions). The conversation between patients and the physicians is audio-recorded, and a third person's impression of the physician's communication behavior during the outpatient consultation is scored on a 5-point scale from 0: not applicable at all to 4: strongly applicable. Scoring will be conducted by multiple raters blinded to the assignment. Raters are trained in conversation analysis with a manual, and inter- and intra-rater agreements will be checked in advance. Secondary outcomes are as follows: 1) the patient-physician behavioral assessment based on the conversation analysis manual, 2) number of conversations about ACP, 3) psychological distress, 4) quality of life, 5) medical care use, 6) app use, 7) feasibility of intervention program, 8) patients' satisfaction of the consultation, 9) care goals, and 10) preferred place for future care. The investigators chose these outcomes for their comparability with previous studies.

NCT ID: NCT04966260 Recruiting - Clinical trials for Psychological Distress

Virtual Reality Therapy to Improve Physical and Psychological Symptoms and Quality of Life for End-of-life Patients on a Palliative Care Unit

Start date: June 15, 2021
Phase: N/A
Study type: Interventional

People with advanced and life-threatening illnesses experience challenges across multiple domains of function including physical, psychological, social, and spiritual. The benefits of non-pharmacological interventions for palliative care patients are well recognized, but are relatively under-utilized. Virtual Reality (VR) therapy may help address these challenges and be a valuable addition to the current therapies used in palliative care. VR is a computer generated, three-dimensional environment that individuals can explore and interact with using specialized equipment such as a head-mounted display with internal sensors. VR has been increasingly adapted for applications in healthcare, as a simulation for medical training and an intervention tool to impact pain management, stress and anxiety. VR has the potential to improve both physical and psychological symptoms in patients with terminal illnesses. The current study is a small randomized controlled trial to understand the impact of VR on physical symptoms, psychological symptoms and quality of life in patients at the end of life. Participants will be randomized to a single comparator session, single session of standard VR, or single session of personalized VR. The comparator arm will consist of participants viewing an ordinary two-dimensional video on an iPad such as a peaceful nature scene. The standard VR arm will consist of participants viewing a "bucket list" experience self-selected from a VR library i.e. an experience the participant desires but has never experienced. The personalized VR arm will consist of participants viewing content that is personally meaningful to them. This content will be obtained through either a) family/friends creating a personalized video (e.g. video footage of their summer cottage) or b) the participant will select an experience from the VR library that is personally meaningful (e.g. visiting their honeymoon destination, exploring their childhood hometown, etc.) if option a) is not possible. Participants will complete self-report questionnaires about their physical and psychological symptoms and quality of life before and after the intervention (two days and seven days post intervention). Participants will also complete a feedback survey to evaluate their satisfaction with the intervention. Surveys will be administered by the research assistant.

NCT ID: NCT04914039 Recruiting - Brain Death Clinical Trials

Evaluation of CTA on the Assessment of Brain Death

Start date: February 1, 2021
Phase:
Study type: Observational [Patient Registry]

At present, different countries have different standards for the diagnosis of brain death, but according to the classic brain death confirmation test, it needs to be combined with transcranial Doppler, EEG, evoked potential and apnea test in clinical practice. Some patients cannot undergo a complete clinical examination and apnea test due to certain factors, and the determination of brain death is limited. The American Academy of Neurology (AAN) guidelines regard cerebral angiography as an acceptable auxiliary examination and is widely regarded as the gold standard for cerebral blood flow evaluation. CT cerebrovascular angiography (CTA) is a noninvasive and widely used examination method that can identify missing or severely reduced cerebral blood flow. However, due to limited experience and lack of sufficient evidence to prove its reliability, it is not included in the AAN A recognized auxiliary examination; there are also a large number of domestic and foreign literature reports that CTA can be used as a new confirmation test for clinical judgment of brain death. This study aims to explore the value of CTA in the judgment of patients with brain death.

NCT ID: NCT04856267 Recruiting - Clinical trials for Sudden Cardiac Death

Exploration of Arrhythmia Burden in Cardiac Amyloidosis Using Implantable Loop Recorders

EXACLIBUR
Start date: May 27, 2021
Phase:
Study type: Observational

The overall aim of this study is to improve our understanding of the effects of the build-up of amyloid deposits in the heart, in particular, our understanding of the risk of abnormal heart beats, or rhythms, associated with people with cardiac (heart) amyloidosis. Symptoms such as palpitations (fast, strong or irregular heart beat) and blackouts are common in people with cardiac amyloidosis, but there is not enough information on what causes this. At present, there is also not enough information on when they occur, how often they happen, and which patients are at risk of having serious, life-threatening types of abnormal heart rhythms. Some of these abnormal heart rhythms can be treated with medicine; others need electronic devices (e.g. pacemakers) implanted or inserted in the heart to prevent serious harm. The information on when is the best time to implant these life-saving devices remains limited. In this study, a small device known as an implantable loop recorder (ILR) will be implanted under the skin on the chest wall to continuously monitor participants' heart rhythm. This will help us answer some of the questions about what causes the abnormal heart rhythms, when they happen, and which patients are particularly likely to have them. Furthermore, it may help us to identify earlier, rather than later, those who are at risk of developing abnormal heart rhythms. This may lead to improvements in the care of people with cardiac amyloidosis in the future. Participants may not directly benefit from taking part in this study; however, there is a chance that the ILR may reveal heart rhythm abnormalities in some participants which might not be picked up otherwise, and so may lead to a change in their treatment.

NCT ID: NCT04758455 Recruiting - Death Clinical Trials

The Use of Immunohistochemical Staining for the Prediction of Wilms Tumour Progression and Recurrence

Start date: February 14, 2021
Phase: N/A
Study type: Interventional

Wilms' tumour staging and grading are used to give an idea about the prognosis. Advanced staging, diffuse anaplasia, predominant blastemal elements and lymph node invasion are indicators of poor prognosis. In spite of using the previously mentioned parameters, some tumours which were considered of low risk did not respond to therapy and eventually resulted in mortality. In contrast, other tumours assumed to be of poor prognosis responded dramatically to treatment. In light of the above, it is crucial to search for predictors of Wilms' tumour prognosis other than tumour staging and grading. Many immunohistochemical (IHC) stains have been studied as prognostic markers for nephroblastoma in literature.

NCT ID: NCT04734574 Recruiting - Brain Death Clinical Trials

Methods of Confirmation of Brain Death

Start date: April 1, 2022
Phase:
Study type: Observational

The purpose of this study is to describe the use of methods confirming brain death in the real clinical practice of the transplant program in the Czech Republic.