Role of Preoperative Counselling With NSQIP Surgical Risk Calculator

NCT04757402 | Completed

• 1 other identifier: 2077/0019
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Satisfaction, Patient

Keywords

NSQIP Surgical risk calculator; Preoperative counselling; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Preoperative anxiety measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire written in Nepalese

  5 months

• Duration of counseling

  5 months

Study Arms (2)

Control arm

ACTIVE COMPARATOR

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.

Other: Counselling with NSQIP Surgical risk calculator

NSQIP Arm

EXPERIMENTAL

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.

Other: Counselling with NSQIP Surgical risk calculator

Interventions

Counselling with NSQIP Surgical risk calculator OTHER

Use of NSQIP surgical risk calculator to check for patient satisfaction regarding pre operative counseling.

Control arm; NSQIP Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nepal Mediciti Hospital: lead

Study Sites (1)

Bikash Khadka

Kathmandu, Bagmati, 44600, Nepal

Location

Related 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.

  PMID: 32118748 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction; Anxiety Disorders

Interventions

Counseling

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Apurb Sharma, MD

  Nepal Mediciti Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 17, 2021
• Study Start: April 1, 2021
• Primary Completion: September 20, 2023
• Study Completion: October 28, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 10 months
• Access Criteria: an email with explanations for the need of data

Locations

NE (1)