Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT04602351
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2020-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Communication in ICU During COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-09', 'studyFirstSubmitDate': '2020-10-21', 'studyFirstSubmitQcDate': '2020-10-23', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the pattern of family members visiting process', 'timeFrame': '12 months', 'description': 'Using a questionnaire the changes in visiting policy for family members or friends will be recorded from last year (before COVID-19 pandemic).\n\nThis will include, visiting policy, visiting hours and their change after pandemic at the time of study (November 2020).'}, {'measure': 'Changes in process of communication between health care workers(HCWs) and family members', 'timeFrame': '12 months', 'description': 'Through a questionnaire, the process of communication between HCWs and family members or friends before pandemic (November 2019) and November 2020 will be recorded.\n\nThis will include the responsible HCW for communication, place of communication and method of communication (in person versus electronic)'}], 'secondaryOutcomes': [{'measure': 'Changes in process of informed consent in ICU', 'timeFrame': '12 months', 'description': 'Through a questionnaire, the process of informed consent for procedures and end of life (EOL) or do not attempt to resuscitation (DNAR) in ICU will be collected and its change in last 12 months (from November 2019 to November 2020)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Communication in ICU', 'Doctor-family members communication', 'Informed consent'], 'conditions': ['COVID-19', 'Severe Acute Respiratory Syndrome Coronavirus 2', 'Severe Acute Respiratory Syndrome']}, 'referencesModule': {'references': [{'pmid': '32240282', 'type': 'BACKGROUND', 'citation': 'Back A, Tulsky JA, Arnold RM. Communication Skills in the Age of COVID-19. Ann Intern Med. 2020 Jun 2;172(11):759-760. doi: 10.7326/M20-1376. Epub 2020 Apr 2.'}, {'pmid': '32380024', 'type': 'BACKGROUND', 'citation': 'Azoulay E, Kentish-Barnes N. A 5-point strategy for improved connection with relatives of critically ill patients with COVID-19. Lancet Respir Med. 2020 Jun;8(6):e52. doi: 10.1016/S2213-2600(20)30223-X. Epub 2020 May 4. No abstract available.'}, {'pmid': '32451002', 'type': 'BACKGROUND', 'citation': 'Rubinelli S, Myers K, Rosenbaum M, Davis D. Implications of the current COVID-19 pandemic for communication in healthcare. Patient Educ Couns. 2020 Jun;103(6):1067-1069. doi: 10.1016/j.pec.2020.04.021. No abstract available.'}, {'pmid': '26792081', 'type': 'RESULT', 'citation': 'van Beusekom I, Bakhshi-Raiez F, de Keizer NF, Dongelmans DA, van der Schaaf M. Reported burden on informal caregivers of ICU survivors: a literature review. Crit Care. 2016 Jan 21;20:16. doi: 10.1186/s13054-016-1185-9.'}, {'pmid': '28716040', 'type': 'RESULT', 'citation': 'Cicekci F, Duran N, Ayhan B, Arican S, Ilban O, Kara I, Turkoglu M, Yildirim F, Hasirci I, Karaibrahimoglu A, Kara I. The communication between patient relatives and physicians in intensive care units. BMC Anesthesiol. 2017 Jul 17;17(1):97. doi: 10.1186/s12871-017-0388-1.'}]}, 'descriptionModule': {'briefSummary': 'This study explores the actual situation of communication during the Coronavirus disease 2019 (COVID-19) pandemic in the South Asia and Middle East region. The purpose is to assess the effect of the limited visitor policy during the COVID-19 pandemic, on the pattern of interaction of critically ill patients to their kin/ guardian and doctor-family members communication.\n\nPrimary objective of this study are as follows:\n\n1. Explore the changes in communication pattern with limited contact during the COVID-19 pandemic.\n2. Assess the methods of informed consent in Intensive care units (ICUs) during the same period', 'detailedDescription': 'An observational, cross-sectional, web-based questionnaire survey, with multi-centre involvement across hospitals in the South Asia and middle-east region. The questionnaire consists of two sections. Section one obtains information from participants regarding communication and visiting practices in ICU during pre-COVID-19 era, and the Section two obtains information regarding the policy changes if any during the COVID-19 pandemic in regards to safety of healthcare workers (HCWs) and public.\n\nIn order to obtain the largest representation of South Asia and Middle East ICUs, a network of research doctors as facilitators from each country is created. The role of the facilitators is to contact and recruit adult ICUs within their country. Each facilitator contacts the hospitals (public and private), creating a network of collaborating doctors/nurses (participants) from those hospitals who expressed their willingness to participate.\n\nData collection: a web based Google Forms with online access will be used Only one entry per ICU will be collected during the study. Statistic analysis: a descriptive analysis is planned for the general characteristics of the participating units and the study population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ICU communication teams across South Asian and Middle East Region', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult ICUs,\n2. New created COVID-19 ICUs during the pandemic\n\nExclusion Criteria:\n\n1. Paediatric ICU\n2. Neonatal ICU'}, 'identificationModule': {'nctId': 'NCT04602351', 'briefTitle': 'Communication in ICU During COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'NMC Specialty Hospital'}, 'officialTitle': 'Communication in ICU During COVID-19: Multinational, Multicentric Cross-sectional Survey (ComICU)', 'orgStudyIdInfo': {'id': 'ComICU'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Communication', 'type': 'BEHAVIORAL', 'description': 'policies on communication and informed consent in ICU'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7832', 'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': 'NMC Specialty Hospital', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data will be shared to ensure confidentiality and privacy of participating Institution.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NMC Specialty Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Critical Care Medicine', 'investigatorFullName': 'Prashant Nasa', 'investigatorAffiliation': 'NMC Specialty Hospital'}}}}