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

Northwestern University

Status: Enrolling

Conditions: Caesarean Section; Pregnancy

Treatments: Other: Experimental Audio Visual

Study type: Interventional

Funder types: Other

Identifiers

NCT06945250

STU00222960

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Other: Experimental Audio Visual

Control Group

No Intervention group

Description:

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