Role of Preoperative Counselling With NSQIP Surgical Risk Calculator

NCT ID: NCT04757402

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-10-28

Brief Summary

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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

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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.

Conditions

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Satisfaction, Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Counselling with NSQIP Surgical risk calculator

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Counselling with NSQIP Surgical risk calculator

Intervention Type OTHER

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

Interventions

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Counselling with NSQIP Surgical risk calculator

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nepal Mediciti Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bikash Khadka

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Apurb Sharma, MD

Role: STUDY_CHAIR

Nepal Mediciti Hospital

Locations

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Bikash Khadka

Kathmandu, Bagmati, Nepal

Site Status

Countries

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Nepal

References

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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.

Reference Type BACKGROUND
PMID: 32118748 (View on PubMed)

Other Identifiers

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2077/0019

Identifier Type: -

Identifier Source: org_study_id

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