Role of Preoperative Counselling With NSQIP Surgical Risk Calculator

Satisfaction, Patient Clinical Trial

Official title:

Role of Preoperative Counselling With NSQIP Surgical Risk Calculator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757402
• Other study ID #: 2077/0019
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: October 28, 2023

Study information

• Verified date: October 2023
• Source: Nepal Mediciti Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Surgical patients undergo preoperative counseling which varies in quality and duration. Proper communication during the preoperative consultation can deliver relevant health information and guide improvement of perioperative health status. The methods, however, are non-standardized and the explanation of the postoperative course is generally vague or varies from person to person. We hypothesize that high-risk patients who receive pre-operative counseling with the help of the NSQIP surgical risk calculator compared to the current standard of care will have higher satisfaction concerning information on the perioperative journey.

Description:

The control arm will receive standard preoperative counselling and written consent will be taken. The NSQIP arm will receive standard preoperative counselling along with the details provided by NSQIP Surgical risk calculator and written consent will be taken. Anxiety among the patients will be accessed with the use of Preoperative anxiety measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire written in Nepali. Duration of counselling period will be noted from the start of counselling session till the consent is signed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 28, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA III or above and/or age above 65 high-risk surgical patients undergoing surgery at Nepal Mediciti Hospital

Exclusion Criteria:

• Adults who cannot consent Pregnant women Non-Nepali speakers Consent by surrogate

Related Conditions & MeSH terms

• Satisfaction, Patient

Intervention

Other:
• Counselling with NSQIP Surgical risk calculator
Use of NSQIP surgical risk calculator to check for patient satisfaction regarding pre operative counseling.

Locations

Country	Name	City	State
Nepal	Bikash Khadka	Kathmandu	Bagmati

Sponsors (1)

Lead Sponsor	Collaborator
Nepal Mediciti Hospital

Country where clinical trial is conducted

Nepal, 

References & Publications (1)

Sigdel S, Ozaki A, Basnet M, Kobashi Y, Pradhan B, Higuchi A, Uprety A. Anxiety evaluation in Nepalese adult patients awaiting cardiac surgery: A prospective observational study. Medicine (Baltimore). 2020 Feb;99(9):e19302. doi: 10.1097/MD.0000000000019302. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in patient satisfaction as assessed by a 7-point Likert scale	The study will compare patient satisfaction scores between the two arms of the study groups to determine if there is a difference in patient satisfaction. It will be based on a scale of 1 to 7, 7 being the most satisfied and 1 being the least.	5 MONTHS
Secondary	Preoperative anxiety measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire written in Nepalese	Anxiety evaluation during preoperative counselling will be done by APAIS using a five point scale,5 being the most anxious and 1 being the least.	5 months
Secondary	Duration of counseling	time taken to complete preoperative counseling which will be noted from start of counseling to the time when consent is signed.	5 months