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

NCT ID: NCT06945250

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-06
• Study Completion Date: 2027-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Experimental Audio Visual

Intervention Type: OTHER

Participants in this group will receive the audiovisual presentation

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Experimental Audio Visual

Participants in this group will receive the audiovisual presentation

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Eleanor Kenny

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eleanor Kenny, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Univesity

Locations

Northwestern Medicine

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Paul C Fitzgerald, RN,BSN,MS

Role: CONTACT

p-fitzgerald2@northwestern.edu

3126951064

Facility Contacts

Paul C Fitzgerald, RN,BSN,MS

Role: primary

p-fitzgerald2@northwestern.edu

312-695-1064

References

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.

Reference Type: BACKGROUND

PMID: 12900105 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9972735 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15078374 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36031429 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8909673 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23193502 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24898765 (View on PubMed)

Other Identifiers

STU00222960

Identifier Type: -

Identifier Source: org_study_id