Caesarean Section, Pregnancy
Conditions
Keywords
Pregnancy, Cesarean Section, Consent Process, Surgical Procedure
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.
Interventions
OTHERExperimental Audio Visual
Participants in this group will receive the audiovisual presentation
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COMRADE survey score | 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)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographic factors associated with increase in informed decision-making | 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) |
| Level of subjective anxiety associated with the proposed anesthetic | 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). |
| Level of subjective fear associated with the proposed anesthetic | 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) |
| Level of satisfaction with the anesthetic informed consent process | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREleanor Kenny, MD
Northwestern Univesity
Outcome results
None listed