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Role of Preoperative Counselling With NSQIP Surgical Risk Calculator

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ClinicalTrials.gov Identifier: NCT04757402
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : December 29, 2021
Sponsor:
Information provided by (Responsible Party):
Bikash Khadka, Nepal Mediciti Hospital

Study Description
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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
Satisfaction, Patient Other: Counselling with NSQIP Surgical risk calculator Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 1, 2021
Estimated Primary Completion Date : January 10, 2022
Estimated Study Completion Date : January 29, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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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
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Primary Outcome Measures :
  1. The difference in patient satisfaction as assessed by a 7-point Likert scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04757402


Contacts
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Contact: Bikash Khadka, MD +9779841411827 khadka.vkas@gmail.com

Locations
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Nepal
Bikash Khadka Recruiting
Kathmandu, Bagmati, Nepal, 44600
Contact: bikash khadka, MD    9841411827 ext 977    khadka.vkas@gmail.com   
Sponsors and Collaborators
Nepal Mediciti Hospital
Investigators
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Study Chair: Apurb Sharma, MD Nepal Mediciti Hospital
More Information
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Publications:

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Responsible Party: Bikash Khadka, Anesthesiologist, Nepal Mediciti Hospital
ClinicalTrials.gov Identifier: NCT04757402    
Other Study ID Numbers: 2077/0019
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: December 29, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: 10 months
Access Criteria: an email with explanations for the need of data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bikash Khadka, Nepal Mediciti Hospital:
NSQIP Surgical risk calculator
Preoperative counselling
Anxiety