View clinical trials related to Informed Consent.
Filter by:The purpose of this study is to implement an electronic consent education process for the retention and research use of residual dried bloodspots at four hospitals in Michigan and assess the impact of the new education, both on patients and hospital staff. The research team will recruit women who have just given birth to answer surveys about the Michigan BioTrust consent process. Surveys will be collected from participants in the hospital and again four weeks later. The research team will collect survey data from patient participants at each hospital prior to hospital staff implementation of the new education process and again after staff implementation.
To evaluate whether the use of augmented reality (AR) for visualizing 3D models can be a valuable addition to patient education regarding orthognathic procedures compared to using only 2D visualization (on a computer screen).
What is this trial ? A major aim in surgery is to consent patients appropriately for procedures. This is known as shared decision making. It is the clinician's duty to provide patients with the information they need to weigh up the risks and benefits of surgery and come to an informed decision. The investigators have created a patient information course on bariatric surgery on a platform known as a Massive Open Online Course (MOOC). This platform will host the course and will involve videos, written material and a number of questions to test the patient's understanding. The course will be undertaken after patients have completed Tier 3 and been discussed at the Tier 4 MDT (multidisciplinary team) and before the first consultant appointment to discuss surgical options. If patients choose to participate, they will be randomly allocated to either undertake the patient information course or not to undertake the course and just undergo the standard consenting process. The actual timeline of the bariatric journey will be unaffected by participation in the trial. The consultant will not know of patient participation and patients will be asked not to disclose it. What is involved? The patients will have been invited by one of the researchers, via a telephone call, and they will have sent the patient information for them to read. Their appointments and schedule will remain the same in spite of participation. If they choose to take part and are randomly allocated to the MOOC group, a member of research team will issue them with details of how to access the course. Three to six weeks later the research team will contact them to test their recall over the phone of some important information about bariatric surgery. At six week's after the procedure, the research team will send a copy of the SDM Q9 (shared decision making Q9) questionnaire to complete and send back. This is a questionnaire that asks about satisfaction with the shared decision making process. If a patient is randomly allocated to the non MOOC group, they will also receive a recall test and a questionnaire after the consultant appointment in order to compare the two groups. What is the purpose of the trial? The purpose of this study is to find out if using a patient information course on a massive open online course platform (MOOC) is useful to help the consent process by testing patient recall and also to test satisfaction with the shared decision making process compared to what current practice is.
The APRIL study aims at analyzing HIV reservoirs, latency and persistence on antiretroviral therapy. It enrolls HIV-infected adults providing blood samples of which peripheral blood mononuclear cells are stored. The frequency, phenotype and inducibility of HIV-infected cells are then analyzed. These parameters may vary across the different clinical and therapeutic settings.
Ethical research on detained persons remains limited, including research on informed consent. This study aimed to fill in this research gap and compared audio-visual and paper-based materials for a one-time general informed consent for research in prison, using a randomized design. The primary outcome was whether participants sign the inform consent. Secondary outcomes included understanding, evaluation, and time to read/watch the informed consent.
Informed consent form is a legal document that, ethically, should be obtained before any endoscopic procedure is performed. The main purpose of this research study is to assess the readability, comprehensibility and applicability of the new informed consent proposed by the Portuguese Society of Digestive Endoscopy as a way to standardize the information provided to patients prior to endoscopic exams.
Public deliberation is a novel method for engaging the public in collective decision-making. Its goal is to facilitate debate and discussion that: 1) fosters the formation of reasonable and informed opinions, 2) permits participants to revise their perspectives and positions in light of new information and dialogue with others, and 3) encourages participants to consider not only their own preferences but also the greater goal of a policy or resolution that is justifiable for all persons affected by the issue under debate. Public deliberation involves: in-depth education on the topic of interest, presentation of conflicting perspectives from expert witnesses and key stakeholders, facilitated public discussion of core issues, and development of resolutions that are acceptable to participants. Public deliberation requires significant commitment from deliberants who are actively engaged over the course of several sessions. Public deliberation can be successful when more traditional methods of stakeholder engagement fail, as it allows for in-depth discussion and demonstrated awareness of the moral difference in deciding for oneself and others. Minor consent to biomedical HIV prevention research highlights difficulties with consent, particularly for minors, and how key ethical principles may come into conflict. Typically, institutions and investigators rely upon parental permission to protect minors from research-related harm and coercion. However, the parent permission model may be harmful in stigmatizing health research such as HIV. The consent process creates potential for disclosure of the minor's sensitive behaviors and/or identities to their parents who were otherwise unaware of them. This risk is heightened for sexual and gender minority adolescents, who may face physical and social harm when their sexual or gender identities are disclosed. This risk of harm, and the ethical conflict it creates has contributed to delays in clinical trials and clinical use of HIV prevention methods in minors. This project will test public deliberation as a method for improving consent processes for engaging individuals from marginalized communities in clinical research on sensitive or stigmatizing health problems. The investigators use minor consent for biomedical HIV prevention research as an exemplar case. The primary hypothesis is that public deliberation will produce a resolution to ethical conflicts in minor consent that is better or different from the results of more traditional study approaches (e.g. surveys, in depth interviews).
Patient education is continuously becoming more important to enable patients to participate in making decisions regarding their medical treatment. Specifically, this is also the case for preoperative education on anesthesia. Worldwide, there are many initiatives to improve preoperative patient education and subsequent level of knowledge of anesthesia, for example by using digital aids. The demand for such aids has increased significantly since the start of the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic to facilitate remote preoperative anesthesiological screening. Although many videos to educate patients on anesthesia have been developed and circulate on the internet, there has been little effort to compare this method of educating patients with the traditional one-on-one conversation between the anesthesiologist and the patient. Objective: To compare short, mid-and long term retention of knowledge after education on anesthesia by watching a video to the traditional one-on-one explanation by the anaesthesiologist.
This is a prospective pilot study conducted within otolaryngology (ENT) clinics in a tertiary hospital between July and December 2016. 22 patients planned for common elective ENT operations were given a self-administered one-page survey on the same day after preoperative counselling. The investigators aim to identify if there are any associations between perceived and actual understanding of information given during pre-operative counselling and patient satisfaction with the process.
Over the past few decades, there has been a shift in the informed consent process, whereby the focus is centered on patient comprehension, preparedness and satisfaction. When comparing interactive informed consent processes, such as the use of educational pathways, videos, written communication, and the traditional conversational based process, the results are conflicting. Some studies report improved patient comprehension, satisfaction and preparedness with the informed consent interventions, while others found no difference. The purpose of this study is to determine whether the use of a preoperative interactive patient education pathway improves patient comprehension, preparedness and satisfaction prior to undergoing a hysteroscopic procedure.