View clinical trials related to Consent.
Filter by:This study aims to understand how well app-based consent performs compared to paper-based consent when recruiting families for a clinical research project. The investigators aim to demonstrate that app-based consent is as effective as traditional methods; this will be measured by questionnaires assessing the family's comprehension and preference.
Previous research has shown that most parents would allow their child's leftover blood to be included in a de-identified biorepository using opt-out consent in an outpatient setting. In a pilot study to evaluate Pediatric Intensive Care Unit (PICU) parents' preferences and comprehension of a written opt-in consent to include their child's sample in a biorepository, the investigators showed 19% of parents did not agree to participate in the Biobank, more than the 8.7% reported in other settings. Parent comprehension varied. and the investigators also noted differential enrollment by sociodemographic factors. Critically ill children and their parents are vulnerable; seeking consent for non-therapeutic research in critical care requires special consideration. Therefore, the goal of this study is to evaluate whether the addition of a stakeholder influenced (parent, clinical research professionals) video aided consent will improve comprehension and rates of enrollment across diverse groups in this high intensity setting.
The Canadian Medical Protective Association (CMPA) defines informed consent (IC) as a voluntary process where important elements include details of the procedure, complications, and proposed alternatives. Laparoscopic cholecystectomy (LC) was the most common laparoscopic procedure cited in 423 medical-legal cases reported by CMPA in 2017, with 29% of cases citing issues in pre-operative care including inadequacy of the consent process. The investigators recently demonstrated that technology can help improve the IC process in an outpatient setting by conducting a prospective randomized controlled trial to examine the effects of adding a digital educational platform (DEP) module to a standard verbal consent (SVC) for an elective laparoscopic Roux-en-Y gastric bypass procedure. The investigators demonstrated a significant improvement in immediate post-consent knowledge of the risks, benefits and alternatives in patients who viewed the DEP module with equivalent patient satisfaction as compared to a SVC. With the proposed study the investigators plan to gather evidence to support implementing a digital education platform for emergent surgical procedures performed in an in-patient setting. The investigators propose to conduct a randomized controlled trial to explore the benefits of adding a DEP module to a SVC for patients presenting with acute cholecystitis requiring an emergent LC as an in-patient. Participants will be randomly allocated (1:1) to either a control group (SVC) or an intervention group (SVC + DEP). Primary outcome of interest will be immediate post-consent knowledge of the risks, benefits, alternatives and expected outcomes for a LC. Secondary outcomes will include satisfaction with the consent discussion and delayed retention of knowledge of the risks, benefits, alternatives and expected outcomes for a LC . The investigators hypothesize that completion of the DEP module in addition to SVC will result in superior immediate and delayed post-consent knowledge of risks and benefits of LC with equivalent patients satisfaction as compared to SVC alone. The results of this study will provide evidence supporting the addition of DEP to SVC for urgent and emergent surgical procedures.
There are no studies examining parents' attitudes towards day of surgery consent for research. The purpose of the study is to determine the attitudes parents of potential research participants have toward being approached for day of surgery consent. The primary objective is to determine parental attitudes regarding day of surgery consent for anesthesia research. The secondary objective is to determine the boundaries for day of surgery consent (e.g., study types, interventions, risk factors).
Multiloop audit of consenting practice in surgical procedures during the COVID-19 pandemic
The purpose of this study is to improve the lumbar puncture (LP) consent process for pediatric patients. Though a commonly performed and safe procedure, LP can be anxiety-provoking for parents. By using an educational video on a handheld device at the time of consent, we hope to improve parent understanding and comfort with the procedure.