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

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.

Completed

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Key information

Conditions

Informed Consent Patient and Caregiver Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Medicine, Maharajgunj

Kathmandu, Bagmati, 44600, Nepal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Patient and Caregiver Satisfaction with the Informed Consent Process

Time frame: Within 24 hours of the surgery

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.

Sponsors and collaborators

Lead sponsor

Maharajgunj Medical Campus

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Dec 24, 2024
Registry last updated: Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed