Role of Preoperative Counselling With NSQIP Surgical Risk Calculator

Not Applicable

Completed

• Conditions: Satisfaction, Patient
• Interventions: Other: Counselling with NSQIP Surgical risk calculator

• Registration Number: NCT04757402
• Lead Sponsor: Nepal Mediciti Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-17
• Study Start: 2021-04-01
• Primary Completion: 2023-09-20
• Status Verified: 2023-10
• Study Completion: 2023-10-28
• Last Update Submitted: 2023-10-28
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Counselling with NSQIP Surgical risk calculator	All eligible candidates will be receiving standard preoperative counselling as per the hospital standards and protocols. The patient will fill five-points Amsterdam Preoperative Anxiety and Information Scale (APAIS) form for anxiety evaluation and Seven-points Likert Scale form for satisfaction regarding the counselling.
NSQIP Arm	Counselling with NSQIP Surgical risk calculator	All eligible candidates will be receiving standard preoperative counselling as per the control arm PLUS the risk will be explained using the scores from the NSQIP surgical risk calculator. The anxiety and the satisfaction scores will be recorded as in the control arm.

Primary Outcome Measures

Name	Time	Method
The difference in patient satisfaction as assessed by a 7-point Likert scale	5 MONTHS	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.

Secondary Outcome Measures

Name	Time	Method
Preoperative anxiety measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire written in Nepalese	5 months	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.
Duration of counseling	5 months	time taken to complete preoperative counseling which will be noted from start of counseling to the time when consent is signed.

Trial Locations

Locations (1)

Bikash Khadka; 🇳🇵 Kathmandu, Bagmati, Nepal