Clinical trial NCT06945250: A Multimedia Presentation to Augment the Informed Consent Process for Anesthesia for Patients Undergoing Scheduled Caesarian Delivery
Official title: A Multimedia Presentation to Augment the Informed Consent Process for Anesthesia for Patients Undergoing Scheduled Caesarian Delivery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy
Caesarean Section
Keywords: Pregnancy
Cesarean Section
Consent Process
Surgical Procedure
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age 18 or over on the day of the procedure
2. Able to provide verbal and written informed consent for participation in the study
3. Primarily English-speaking patients (the audiovisual presentation will be available only in English

Exclusion Criteria:

1. Refusal or inability to participate or provide informed consent
2. Primarily non-English speaking patients
3. At the discretion of the attending anesthesiologist of record due to medical complexity

Primary outcomes:
measure: COMRADE survey score
timeFrame: 1 Day after delivery of baby
Secondary outcomes:
measure: Demographic factors associated with increase in informed decision-making
timeFrame: 1 Day after delivery of baby
measure: Level of subjective anxiety associated with the proposed anesthetic
timeFrame: 1 Day after delivery of baby
measure: Level of subjective fear associated with the proposed anesthetic
timeFrame: 1 Day after delivery of baby
measure: Level of satisfaction with the anesthetic informed consent process
timeFrame: 1 Day after delivery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
affiliation: Northwestern Univesity
name: Eleanor Kenny, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edwards A, Elwyn G, Hood K, Robling M, Atwell C, Holmes-Rovner M, Kinnersley P, Houston H, Russell I. The development of COMRADE--a patient-based outcome measure to evaluate the effectiveness of risk communication and treatment decision making in consultations. Patient Educ Couns. 2003 Jul;50(3):311-22. doi: 10.1016/s0738-3991(03)00055-7.
citation: Cassady JF Jr, Wysocki TT, Miller KM, Cancel DD, Izenberg N. Use of a preanesthetic video for facilitation of parental education and anxiolysis before pediatric ambulatory surgery. Anesth Analg. 1999 Feb;88(2):246-50. doi: 10.1097/00000539-199902000-00004.
citation: Wisselo TL, Stuart C, Muris P. Providing parents with information before anaesthesia: what do they really want to know? Paediatr Anaesth. 2004 Apr;14(4):299-307. doi: 10.1046/j.1460-9592.2003.01222.x.
citation: Atsaidis Z, Antel R, Guadagno E, Wiseman J, Poenaru D. Understanding the effectiveness of consent processes and conversations in pediatric surgery: A systematic-scoping review. J Pediatr Surg. 2022 Dec;57(12):834-844. doi: 10.1016/j.jpedsurg.2022.08.004. Epub 2022 Aug 11.
citation: Garden AL, Merry AF, Holland RL, Petrie KJ. Anaesthesia information--what patients want to know. Anaesth Intensive Care. 1996 Oct;24(5):594-8. doi: 10.1177/0310057X9602400516.
citation: Jawaid M, Farhan M, Masood Z, Husnain S. Preoperative informed consent: is it truly informed? Iran J Public Health. 2012;41(9):25-30. Epub 2012 Sep 1.
citation: Tait AR, Teig MK, Voepel-Lewis T. Informed consent for anesthesia: a review of practice and strategies for optimizing the consent process. Can J Anaesth. 2014 Sep;61(9):832-42. doi: 10.1007/s12630-014-0188-8. Epub 2014 Jun 5.