A Multimedia Presentation to Augment the Informed Consent Process for Anesthesia for Patients Undergoing Scheduled Caesarian Delivery

NCT06945250 | Active Not Recruiting

• 1 other identifier: STU00222960
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Caesarean Section

Keywords

Pregnancy; Cesarean Section; Consent Process; Surgical Procedure

Outcome Measures

Primary Outcomes (1)

• COMRADE survey score

  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))

  1 Day after delivery of baby

Secondary Outcomes (4)

• Demographic factors associated with increase in informed decision-making

  1 Day after delivery of baby

• Level of subjective anxiety associated with the proposed anesthetic

  1 Day after delivery of baby

• Level of subjective fear associated with the proposed anesthetic

  1 Day after delivery of baby

• Level of satisfaction with the anesthetic informed consent process

  1 Day after delivery

Study Arms (2)

Intervention Group

EXPERIMENTAL

Intervention Group: Participants randomized to the intervention group will receive a link to the audiovisual presentation via e-mail to review prior to coming into the hospital for caesarean section.

Other: Experimental Audio Visual

Control Group

NO INTERVENTION

Control Group: Participants randomized to the control group will not receive the link to the audiovisual presentation

Interventions

Experimental Audio Visual OTHER

Participants in this group will receive the audiovisual presentation

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant females only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (7)

• 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.

  PMID: 12900105 BACKGROUND

• 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.

  PMID: 9972735 BACKGROUND

• 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.

  PMID: 15078374 BACKGROUND

• 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.

  PMID: 36031429 BACKGROUND

• 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.

  PMID: 8909673 BACKGROUND

• 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.

  PMID: 23193502 BACKGROUND

• 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.

  PMID: 24898765 BACKGROUND

Study Officials

• Eleanor Kenny, MD

  Northwestern Univesity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: June 6, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)