Evaluating Patient and Caregiver Satisfaction with the Informed Consent Process in Surgery

NCT06746207 | Completed

• 1 other identifier: 225-6-12
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate patient and caregiver satisfaction with the informed consent process in surgical practice at a tertiary care center in Nepal. The main questions it aims to answer are: How satisfied are patients and caregivers with the current informed consent process in surgery? How well do patients and caregivers understand the informed consent information provided? Are there differences in satisfaction and understanding based on factors such as education level or family involvement? Researchers will compare the perceptions of patients and caregivers to understand if there are gaps in communication and satisfaction. Participants will: Complete a structured questionnaire assessing their understanding and satisfaction with the informed consent process. Share their views on the type and quality of information provided during the consent process. Rate their satisfaction on a 10-point scale based on their experience with the informed consent procedure.

Conditions

Informed Consent; Patient and Caregiver Satisfaction

Outcome Measures

Primary Outcomes (1)

• Patient and Caregiver Satisfaction with the Informed Consent Process

  Satisfaction with the informed consent process will be evaluated using a structured questionnaire. Patients and caregivers will rate satisfaction on a 10-point Likert scale (1 = least satisfied, 10 = most satisfied) and respond to Yes/No questions assessing their understanding of the surgery's nature, risks, long-term effects, and anesthesia-related complications. Additional questions evaluate the clarity and completeness of the consent form, including whether essential components (e.g., patient name, diagnosis, procedure details, and risks) were documented. Responses aim to identify gaps in the consent process and assess whether it meets patient and caregiver expectations, as well as legal and ethical standards.

  Within 24 hours of the surgery

Study Arms (1)

Patients and Caregivers

This cohort includes two groups: patients undergoing major elective surgery and their caregivers. The patients are asked to provide feedback on their understanding and satisfaction with the informed consent process. The caregivers, who often provide the informed consent on behalf of the patients, are also surveyed to assess their perspectives on the consent process. There is no intervention in this study; the focus is on evaluating perceptions, satisfaction, and the communication process surrounding informed consent in a surgical setting.

Other: Informed Consent Process Evaluation

Interventions

Informed Consent Process Evaluation OTHER

This study does not involve a clinical intervention. Instead, it focuses on evaluating the existing process of informed consent in a surgical setting. Patients and caregivers will be surveyed to assess their understanding, satisfaction, and perceptions of the informed consent process. The study examines factors such as clarity of information provided, patient and caregiver involvement, and overall satisfaction with the process, without altering the current practices. The goal is to identify areas for improvement in communication and documentation, ensuring that patient rights and autonomy are respected.

Patients and Caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients undergoing major elective surgeries across various departments, including General Surgery, Neurosurgery, Plastic Surgery, Urology, ENT, Orthopedics, and Obstetrics \& Gynecology. Caregivers of these patients, typically responsible for providing informed consent, will also be included. The study aims to capture the perspectives of both groups regarding the informed consent process.

You may qualify if:

• Patients aged 18 years or older undergoing major elective surgical procedures requiring regional or general anesthesia.
• Caregivers of eligible patients who provide informed consent on behalf of the patient.
• Willingness to participate and provide consent for the study.

You may not qualify if:

• Patients undergoing emergency surgeries.
• Patients who are unable to participate due to language barriers or cognitive impairment.
• Patients or caregivers who refuse to participate in the study.

Sponsors & Collaborators

• Maharajgunj Medical Campus: lead

Study Sites (1)

Institute of Medicine, Maharajgunj

Kathmandu, Bagmati, 44600, Nepal

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 24, 2024
• Study Start: October 1, 2023
• Primary Completion: October 15, 2024
• Study Completion: December 9, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)