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Informed Consent clinical trials

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NCT ID: NCT06192511 Not yet recruiting - Clinical trials for Implementation Science

Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

MICI
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06104137 Not yet recruiting - Clinical trials for Bariatric Surgery Candidate

MOOC Applications Related to Shared Decision Making in Bariatric Surgery

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

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.

NCT ID: NCT05752318 Not yet recruiting - Informed Consent Clinical Trials

Analysis of the Persistence, Reservoir and HIV Latency

APRIL
Start date: February 27, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT04614688 Not yet recruiting - Informed Consent Clinical Trials

Assessing the Impact of a Patient Education Platform to Augment the Informed Consent Process for Obstetrics and Gynecology Procedures

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

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.