Role of Preoperative Counselling With NSQIP Surgical Risk Calculator

Sponsor
Nepal Mediciti Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04757402
Collaborator
(none)
66
1
2
17.6
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Counselling with NSQIP Surgical risk calculator
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Role of Preoperative Counselling With NSQIP Surgical Risk Calculator
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Aug 25, 2022
Anticipated Study Completion Date :
Sep 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control arm

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

Experimental: NSQIP Arm

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ASA III or above and 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bikash Khadka Kathmandu Bagmati Nepal 44600

Sponsors and Collaborators

  • Nepal Mediciti Hospital

Investigators

  • Study Chair: Apurb Sharma, MD, Nepal Mediciti Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bikash Khadka, Anesthesiologist, Nepal Mediciti Hospital
ClinicalTrials.gov Identifier:
NCT04757402
Other Study ID Numbers:
  • 2077/0019
First Posted:
Feb 17, 2021
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bikash Khadka, Anesthesiologist, Nepal Mediciti Hospital

Study Results

No Results Posted as of Jul 26, 2022