Northwestern Medicine
Chicago, Illinois, 60611, United States
NCT Number: NCT06945250
The informed consent process is an important part of any surgical and anesthetic intervention. It is also perhaps the most intellectually demanding portion of interacting with the healthcare system for patients. Competent patients have full autonomy over which treatments they receive, and making an informed choice about the decision to undergo a treatment requires at minimum a discussion of the proposed intervention, its risks and benefits, and alternatives to the proposed intervention.
The objective is to improve the anesthesia informed consent process for patients undergoing elective Caesarean delivery through the use of a pre-recorded audiovisual presentation that discusses the logistical aspects of perioperative care and the risks and benefits of anesthesia which is provided to patients prior to meeting their anesthesiologist.
The hypothesis is that the use of an audiovisual presentation which explains the purpose and nature of anesthesia for Caesarean delivery provided to the patient at least 24 hours prior to their procedure will result in a 10% increase in the effectiveness of risk communication and treatment decision making as measured by the Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE) tool.
This study is active but is not currently recruiting participants.
18 year and older
Female
Interventional
Not applicable
Chicago, Illinois, 60611, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in this group will receive the audiovisual presentation
Time frame: 1 Day after delivery of baby
COMRADE score for risk communication and treatment decision making on a 100-point scale, ranging from 0 (decision-making not informed at all (poor)) to 100 (most informed decision possible (good))
Time frame: 1 Day after delivery of baby
Demographic factors associated with increase in informed decision-making including age, education level, history of prior Caesarean delivery, history of other anesthetics (such as labor epidurals or general anesthetics)
Time frame: 1 Day after delivery of baby
Level of subjective anxiety associated with the proposed anesthetic based on a scale of 1-5 (1) strongly disagree, (2) disagree, (3) neither agree nor disagree, (4) agree, (5) strongly agree).
Time frame: 1 Day after delivery of baby
Level of subjective fear associated with the proposed anesthetic measured on a scale of 1-5 (1) strongly disagree, (2) disagree, (3) neither agree nor disagree, (4) agree, (5) strongly agree)
Time frame: 1 Day after delivery
Level of satisfaction with the anesthetic informed consent process based on a scale of 1-5 (1) strongly disagree, (2) disagree, (3) neither agree nor disagree, (4) agree, (5) strongly agree).
Northwestern University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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