The Patient AS EDUcator in Anesthesia: Exploring the Patients' and Providers' Experience During Neuraxial Labour Analgesia (PAS-EDU-NLA)

The Patient AS EDUcator in Anesthesia: Exploring the Patients' and Providers' Experience During Neuraxial Labour Analgesia. A Prospective Patient-centered Multidisciplinary Quality Improvement Study. (PAS-EDU-NLA)

During the process of labour and delivery, patients may experience a wide range of events in a short time frame. This study focuses on exploring these experiences and aims to incorporate the improvements from these experiences so that in future, the expectations of patients delivering can be met as much as possible. Since every patient and encounter is unique, they might have a variety of experiences, be it during the labour epidural placement or during the delivery of the baby. Our study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience and to then use this information to enhance the quality of future anesthesia care during labour and delivery.

Patients who underwent labour and delivery and received labour epidural for pain management will be approached the day following the delivery, while their recollection of their experience is still fresh, and given the opportunity to participate in the study which will involve the completion of a questionnaire as well as an interview lasting approximately 20-25 minutes. In addition to interviewing the patients, the study will also involve several interviews of the obstetricians, anesthesiologists, and nurses with the goals of seeing how the patients' experiences compare to the providers' perspective of the care they are delivering. Following the gathering of this information and identification of potential improvements in current practice, a follow up study will be performed aiming to implement changes and improve the quality of anesthesia care during labour and delivery.

Study Overview

• Status: Not yet recruiting
• Conditions: Well-Being, Psychological
• Intervention / Treatment: Other: Interview

Detailed Description

About 85-90% of parturient receive labour epidural as a method of pain management for labour and delivery. Various factors play a role in requesting an epidural. Proper patient counseling and education before Labour Epidural Analgesia (LEA) alleviates patient's anxiety and also ensures safety. There are a limited number of studies that have explored the experience of the patient while undergoing LEA and labour and delivery, and even fewer that have focused on the patients' perspective that is used to educate health care professionals on how to improve the quality of anesthesia care during LEA. This study embraces the patient perspective to guide quality improvement in labour and delivery.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Sabine Nabecker, MD; Phone Number: 5270 416-586-4800; Email: sabine.nabecker@sinaihealth.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital
      • Sub-Investigator: Kristi Downey, MSc
      • Contact: Sabine Nabecker, MD; Phone Number: 5270 416-586-4800; Email: sabine.nabecker@sinaihealth.ca
      • Sub-Investigator: Ron George, MD
      • Sub-Investigator: Afsheen Nasir, MD
      • Sub-Investigator: Sunti Barahi, MD
      • Sub-Investigator: Ratesh Bassi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who deliver vaginally with neuraxial analgesia at Mount Sinai Hospital.

Description

Inclusion Criteria:

• aged 18 years and older
• ASA Physical Classification Score II or III
• Patients having vaginal delivery and LEA
• Singleton or Multiple pregnancy

Exclusion Criteria:

• under 18 years of age
• unwilling to provide written informed consent, or unable to follow the questions due to their mental state or language barriers.
• Patients who delivered via Cesarean section
• TOP/ IUFDs
• requiring instrumental deliveries- for example forceps or vacuum
• requiring to go to the OR postpartum for PPH or other reasons
• BMI at the time of delivery that falls in the super-morbidly obese category (BMI >55kg/m2)
• Preterm delivery (under 37 weeks of gestation)
• Patients who had inadvertent Dural Puncture during epidural placement
• Patients who had contraindicated or failed epidural anesthesia and required IV PCA for or during their delivery will also be excluded

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vaginal delivery with neuraxial analgesia; Patients who have a vaginal delivery with neuraxial analgesia.	Other: Interview; Patients will be interviewed by the research team to learn about their experience of vaginal delivery with neuraxial analgesia; Other Names: Interview questions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient interview	Patients will be interviewed in person by a member of the research team and asked open ended questions. Interviews will be recorded, transcribed and coded for themes. Responses are not reported on any scale. The interview will take approximately 30 minutes to complete.	Following scheduled c-section delivery, and prior to hospital discharge (at approximately 48 hours postpartum).
Patient questionnaire	Patients will be asked to rate their experience of having a vaginal delivery with neuraxial analgesia, in terms of satisfaction and their experience with any discomfort. Some questions are yes/no, some are on a scale from 1-10, where 1 = not at all and 10 = totally agree, and some are open-ended. The questionnaire will take approximately 10 minutes to complete.	Following scheduled c-section delivery, and prior to hospital discharge (at approximately 48 hours postpartum).

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Investigators: Principal Investigator: Sabine Nabecker, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: patient experience; labour epidural; neuraxial analgesia
• Other Study ID Numbers: 24-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No