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

Evaluating Patient and Caregiver Satisfaction on the Informed Consent Process in Surgical Practice in a Tertiary Care Centre: a Cross-Sectional Study

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.

Study Overview

• Status: Completed
• Conditions: Informed Consent; Patient and Caregiver Satisfaction
• Intervention / Treatment: Other: Informed Consent Process Evaluation

• Study Type: Observational
• Enrollment (Actual): 384

Contacts and Locations

Study Locations

• Nepal
  • Bagmati
    • Kathmandu, Bagmati, Nepal, 44600
      • Institute of Medicine, Maharajgunj

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Maharajgunj Medical Campus

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): December 9, 2024

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 225-6-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Since this is an observational study focused on evaluating the informed consent process, Individual Participant Data (IPD) will not be shared as part of the study's results. However, the aggregated findings, such as overall satisfaction scores and analysis of demographic factors influencing consent understanding, will be presented in the final study report.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No