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Ethics clinical trials

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NCT ID: NCT06010836 Completed - Communication Clinical Trials

Anesthesia Counseling, Consent, & Professionalism

ACCP
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The anesthesia consent form has become a standard before surgery. However, verbal aspects of anesthesia consent and of the value of the preoperative anesthesia discussion has not been addressed. This study will use preoperative discussions and postoperative patient questionnaires to examine the degree of awareness that the patients and the patients families have regarding what general anesthesia is, the responsibilities of the anesthesiologist, and the specifics of what the participants are agreeing to by signing the consent form.

NCT ID: NCT05348564 Recruiting - Clinical trials for Familial Hypercholesterolemia

Comparing Direct vs Indirect Methods for Cascade Screening

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

An important aspect of successful genomic medicine implementation is developing effective approaches for screening at-risk family members after probands are identified, also known as cascade screening. Most cascade screening studies conducted to date have been conducted outside the US, and very few studies have used a rigorous approach involving a comparator group or randomized controlled design. A major question in the field is how to most effectively implement cascade screening, given commonly cited communication barriers, while respecting privacy among probands and family members. This study will conduct a randomized controlled trial to assess direct contact of relatives by study team members vs indirect, or proband-initiated, contact. We will assess efficacy of the cascade screening intervention, patient-centered outcomes regarding mental, physical, and psychosocial outcomes in probands and family members, and implementation evaluation outcomes. Individuals who are known to carry the KCNQ1 Met224Thr or APOB Arg3527Gln variant will be eligible to participate. After providing consent and being deemed eligible, individuals will be randomized in a 1:1 manner into the direct or indirect contact of family members arm of the study. The randomization will be stratified by variant to ensure equal representation of each variant in the study arms. Individuals in the indirect arm will be instructed to contact their first-degree family members about the opportunity to be screened. They will be provided with a disease-specific pamphlet and a family letter explaining the cascade screening. In the direct arm, probands will be advised that the study staff will be contacting their family members. They will be instructed to also contact their family members prior to the study team contacting them. Approximately two weeks after this meeting with the proband, the study staff will mail letters to eligible first-degree family members of the probands. If we do not hear back from individual family members, we will follow-up with another letter, telephone call, or home visit. The information contained in the letters will be the same information for both the direct and indirect arms of the study. All interested family members will receive pre-test counseling and free, in-home, saliva-based genetic testing, and post-test counseling.

NCT ID: NCT04586140 Completed - Covid19 Clinical Trials

Operation of the GHPSJ Clinical Ethical Reflection Assistance Group During the COVID-19 Period

ETHICOVID
Start date: November 9, 2020
Phase:
Study type: Observational

Between March and May 2020, Ile-de-France hospitals faced an influx of patients infected with the COVID 19 virus. Faced with the scale of the pandemic, the aggressiveness of this pathology, severe respiratory complications and the shortage of resuscitation beds , the teams had to make difficult decisions on the therapeutic strategy, the orientation of patients in the event of respiratory distress and their intensive care status. To do this, each establishment reflected in an emergency context on procedures for collegial deliberation and assistance in ethical reflection, based on the recommendations of the National Consultative Ethics Committee and learned societies such as the French Society. of Anesthesia and Resuscitation or the French Society of Support and Palliative Care. Some hospitals had already institutionalized the ethical approach upstream of the health crisis. For example, the Groupe d'Aide à la Réflexion Éthique Clinique (GAREC) was created in November 2005 within the Paris Saint-Joseph Hospital Group. GAREC is a collegial and multidisciplinary entity, made up of 8 members who intervene at the request of caregivers when a clinical situation turns out to be ethically complex. He gives an advisory opinion, the decision belonging to the referring physician. At the start of the COVID period, GAREC changed its structure, organization and operation in order to respond to the multiple issues posed by the complexity of the health situation. This study seeks to analyze the adaptation mechanisms put in place by this group during the epidemic period as well as the nature of the benefit provided to the caregivers who requested it, to the patients and to their relatives. - Adaptation mechanisms: during the COVID period, GAREC was extended to other paramedical professions (psychologists, nurses), thus increasing from 8 to 15 members. It has set up 2 weekly meetings, an on-call duty and on-call duty. The requests were made easier: they could be done by phone, by email, day or night. Several questions emerge: What were the motivations for enlarging the group? How were the members integrated into this group? What were its operating methods? How and by whom was it seized? For what purpose? Were the intervention teams multidisciplinary? - Nature of the benefit provided by GAREC: it will be approached by semi-structured interviews via a qualitative research method. This work is part of a broader reflective perspective: - What representation of ethics underlies this device? - Does the institutionalization of ethics help to enhance or make invisible what ethics owes to daily healthcare practices? - To what extent does the institutionalization of clinical ethics make health institutions more human and virtuous? - Under what conditions can a device like GAREC go beyond the role of ethical guarantor and transform the institution and nursing practices in the service of a collective reflective approach? This study will be carried out on patient data usually collected as part of their care and on data collected through semi-structured interviews with healthcare professionals. As such, it fits into the perspective of grounded theory.

NCT ID: NCT04234503 Completed - Ethics Clinical Trials

Ethical Activity Profile of Nurse Managers -Testing Ethics Quarter as an Intervention

Start date: March 2, 2020
Phase: N/A
Study type: Interventional

The aim of this study is: 1. to test a new ethics educational intervention for nurse mangers, Ethics Quarter (EQ) and 2. to measure the feasibility and the usability of the EQ The detailed research questions and hypothesis of this study are as follows: 1. Is EQ effective in increasing NMs' ethics knowledge? 2. Is EQ effective in increasing NMs' influencing ethics issues? 3. Is EQ effective in increasing NMs' ethics research implementing? 4. Is EQ effective in increasing NMs' ethics problem identifying? 5. Is EQ effective in increasing NMs' ethics problem solving? H 1-5: It is hypothesized that participating into EQ promotes NM's ethics knowledge, influencing ethics issues, ethics research implementing, ethics problem identifying and ethics problem solving compared to comparisons. 6. What are NM's perceptions of feasibility and usability of the EQ? The ultimate goal is to strengthen nurse managers' ethical activity profile and create a new, modern way to promote ethical management of nursing.

NCT ID: NCT03795077 Completed - Ethics Clinical Trials

Effect of a Programme Based on Professional Ethics in Physiotherapy Students

Start date: January 2, 2019
Phase: N/A
Study type: Interventional

The aim of this study was to assess the effect of a higher education programme based on professional ethics in physiotherapy students. A simple-blind clinical trial was performed. A three-months program based in professional ethics was carried out. The investigators compared a control group (traditonal lectures) with an intervention group (syllabus, activities, face to face techniques). Students´ attitudes, knowledge, professional values, and opinions towards professional ethics were evaluated before and after the programme, in both groups. All participants were informed about the study and procedures, and provided written informed consent.

NCT ID: NCT03405766 Completed - Critically Ill Clinical Trials

Barriers in the Process of Achieving Informed Consent From Critically Ill Patients

Start date: May 2, 2018
Phase:
Study type: Observational

The study will explore barriers in the process of achieving informed consent from critically ill patients

NCT ID: NCT03241693 Completed - Attitude Clinical Trials

Blended-learning in Physiotherapy: Professional Ethics

Start date: September 2010
Phase: N/A
Study type: Interventional

The aim of this study was to assess the effect of a blended-learning model on physiotherapy students´ attitude, knowledge and opinions towards learning professional ethics. A simple-blind clinical trial was performed. An eight-month blended learning program to teach professional ethics in clinical practices was worked out. An online syllabus and online activities were elaborated, whilst face to face active participation techniques were performed to discuss ethical issues detected among practices. Students´ attitudes, knowledge and opinions towards learning professional ethics were assessed. Non-parametric tests were carried out. All the participants were informed about the study and procedures, and provided written informed consent.

NCT ID: NCT02879565 Completed - Clinical trials for Disorders of Consciousness

Families Expectations and Hope Raised by an Evaluation of Consciousness in Patients in a Vegetative State

REVE
Start date: September 2011
Phase: N/A
Study type: Interventional

Progress in resuscitation has increased the chances of survival after anoxic or traumatic brain injury. More and more patients with severe cerebral damages are resuscitated but upon awakening from coma, some patients remain in a state which cannot be qualified as conscious and is now known as an unresponsive wakefulness syndrome (UWS; formerly known as vegetative state). This condition can be transitory and evolve towards recovery, or remain chronic and lasting for years. To improve the diagnosis of patients with disorders of consciousness, recent advances in brain imaging have led to the development of new methods of detecting awareness. In the absence of overt behavioral responses from these patients, imaging-based diagnostic methods have been first used to assess whether some cerebral areas were preserved in UWS patients and showed an activation of the primary sensory cortices in some UWS patients, whether it occurs at the auditory, visual or somatosensory level. Unavoidable technical and ethical issues are raised for clinicians before responding to such requests: 1. Is it technically possible to generalize neuroimaging protocols to all healthcare institutions? 2. Is it ethically acceptable to propose neuroimaging protocols without an accurate estimation of their psychological impact on families and caregivers? The present study aims to understand and anticipate the technical and ethical issues related to an evaluation of consciousness with functional neuroimaging. How the evaluation of awareness in a patient affects the caregivers and family members will be investigated. By using qualitative research hopes and expectations will be clarified through the experiences of families, clinicians and nurses faced to this situation. Will be included in this research professional caregivers and persons closely related to UWS patients: - Family members or close circle visiting the patients on a regular basis - Referring clinicians - Nurses in charge of the patients' care This prospective study uses qualitative, interview-based, research. Two key-moments are explored in succession to examine the impact of a neuroimaging evaluation of consciousness in institutionalized UWS patients: - interviews of professional caregivers and families about their hopes concerning the evaluation of consciousness of UWS patients, - interviews of professional caregivers and families about the impact of evaluating consciousness on their beliefs

NCT ID: NCT02841124 Completed - Advanced Cancer Clinical Trials

Decision to Limit or Withdraw Specific Therapies for Advanced Cancer and Hematological Malignancies.

WHATELSE
Start date: January 2011
Phase: N/A
Study type: Interventional

The decision to limit or withdraw specific therapies (DLWT) in patients with advanced cancer is a complex process that is always painful for patients, relatives and professionals. For more than 10 years, shared decision making has been more and more emphasized. However, few data in the literature rely on clinical research. In order to understand their difficulties and issues, this study explores the determinants and modalities of DLWT and analyses the feasibility of different methods for investigating this decision making process.

NCT ID: NCT00352573 Completed - Ethics Clinical Trials

Ethical Dilemmas in Clinical Practice: A Survey of European Physicians

Start date: September 1, 2002
Phase:
Study type: Observational

This study will survey a random sample of 2,100 general medicine physicians in Europe and in the U.S. about ethical difficulties they face in their practice of medicine. The participants will complete a questionnaire designed to meet the following study objectives: - Identify the types of ethical dilemmas physicians report that they face in their practice and approaches they find helpful in responding to these situations - Determine what ethical support physicians would find useful in dealing with ethically problematic situations - Explore physicians experience with 'bedside rationing', due to economic or societal constraints, what procedures they forgo as a result, and what criteria they use in their rationing decisions - Explore physicians perceptions of the equity of the health care system they work in - Determine what interventions directed at limiting health care costs physicians would find acceptable. Physicians in Italy, Norway, Switzerland and the United Kingdom who practice direct patient care for at least 20 percent of their time may enroll in this study. The practice of medicine sometimes involves situations where important values come into conflict. The refusal of life-saving treatment, the concern that telling the truth could have problematic consequences, acceptable ways of facing a request to die all are examples of dilemmas that can arise in the practice of medicine. The absence of clear-cut 'right answers' to questions raised by these situations have led to the development of support services, such as ethics consultations, to help in decision-making concerning ethical problems that arise in clinical settings. Information from this survey can provide input into the continuing development of ethics support services by establishing an evidence base regarding the ethical difficulties encountered by physicians and the type of support they would consider useful in resolving these dilemmas.