Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-11 @ 3:10 AM
Study NCT ID:
NCT04757402
Status:
COMPLETED
Last Update Posted:
2023-10-31
First Post:
2021-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Preoperative Counselling With NSQIP Surgical Risk Calculator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-28', 'studyFirstSubmitDate': '2021-02-12', 'studyFirstSubmitQcDate': '2021-02-12', 'lastUpdatePostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference in patient satisfaction as assessed by a 7-point Likert scale', 'timeFrame': '5 MONTHS', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Preoperative anxiety measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire written in Nepalese', 'timeFrame': '5 months', 'description': '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.'}, {'measure': 'Duration of counseling', 'timeFrame': '5 months', 'description': 'time taken to complete preoperative counseling which will be noted from start of counseling to the time when consent is signed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSQIP Surgical risk calculator', 'Preoperative counselling', 'Anxiety'], 'conditions': ['Satisfaction, Patient']}, 'referencesModule': {'references': [{'pmid': '32118748', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The control arm will receive standard preoperative counselling and written consent will be taken.\n\nThe NSQIP arm will receive standard preoperative counselling along with the details provided by NSQIP Surgical risk calculator and written consent will be taken.\n\nAnxiety 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.\n\nDuration of counselling period will be noted from the start of counselling session till the consent is signed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA III or above and/or age above 65 high-risk surgical patients undergoing surgery at Nepal Mediciti Hospital\n\nExclusion Criteria:\n\n* Adults who cannot consent Pregnant women Non-Nepali speakers Consent by surrogate'}, 'identificationModule': {'nctId': 'NCT04757402', 'briefTitle': 'Role of Preoperative Counselling With NSQIP Surgical Risk Calculator', 'organization': {'class': 'OTHER', 'fullName': 'Nepal Mediciti Hospital'}, 'officialTitle': 'Role of Preoperative Counselling With NSQIP Surgical Risk Calculator', 'orgStudyIdInfo': {'id': '2077/0019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'description': '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.', 'interventionNames': ['Other: Counselling with NSQIP Surgical risk calculator']}, {'type': 'EXPERIMENTAL', 'label': 'NSQIP Arm', 'description': '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.', 'interventionNames': ['Other: Counselling with NSQIP Surgical risk calculator']}], 'interventions': [{'name': 'Counselling with NSQIP Surgical risk calculator', 'type': 'OTHER', 'description': 'Use of NSQIP surgical risk calculator to check for patient satisfaction regarding pre operative counseling.', 'armGroupLabels': ['Control arm', 'NSQIP Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44600', 'city': 'Kathmandu', 'state': 'Bagmati', 'country': 'Nepal', 'facility': 'Bikash Khadka', 'geoPoint': {'lat': 27.70169, 'lon': 85.3206}}], 'overallOfficials': [{'name': 'Apurb Sharma, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nepal Mediciti Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '10 months', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication', 'accessCriteria': 'an email with explanations for the need of data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nepal Mediciti Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Bikash Khadka', 'investigatorAffiliation': 'Nepal Mediciti Hospital'}}}}