Communication in ICU During COVID-19

• Sponsor: NMC Specialty Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04602351
• Collaborator: (none)
• Enrollment: 296
• Location: 1
• Actual Duration (Months): 1.3
• Patients Per Site Per Month: 225.2

Study Details

Study Description

Brief Summary

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.

Primary objective of this study are as follows:

1. Explore the changes in communication pattern with limited contact during the COVID-19 pandemic.

2. Assess the methods of informed consent in Intensive care units (ICUs) during the same period

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Severe Acute Respiratory Syndrome Coronavirus 2; Severe Acute Respiratory Syndrome	Behavioral: Communication

Detailed Description

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.

In 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.

Data 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 296 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Communication in ICU During COVID-19: Multinational, Multicentric Cross-sectional Survey (ComICU)
• Actual Study Start Date: Mar 22, 2021
• Actual Primary Completion Date: Apr 7, 2021
• Actual Study Completion Date: May 1, 2021

Outcome Measures

Primary Outcome Measures

1. Changes in the pattern of family members visiting process [12 months]

   Using a questionnaire the changes in visiting policy for family members or friends will be recorded from last year (before COVID-19 pandemic). This will include, visiting policy, visiting hours and their change after pandemic at the time of study (November 2020).

2. Changes in process of communication between health care workers(HCWs) and family members [12 months]

   Through a questionnaire, the process of communication between HCWs and family members or friends before pandemic (November 2019) and November 2020 will be recorded. This will include the responsible HCW for communication, place of communication and method of communication (in person versus electronic)

Secondary Outcome Measures

1. Changes in process of informed consent in ICU [12 months]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Adult ICUs,

2. New created COVID-19 ICUs during the pandemic

Exclusion Criteria:

1. Paediatric ICU

2. Neonatal ICU

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NMC Specialty Hospital	Dubai		United Arab Emirates	7832

Sponsors and Collaborators

• NMC Specialty Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Prashant Nasa, Head Critical Care Medicine, NMC Specialty Hospital
• ClinicalTrials.gov Identifier: NCT04602351
• Other Study ID Numbers: ComICU
• First Posted: Oct 26, 2020
• Last Update Posted: May 11, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prashant Nasa, Head Critical Care Medicine, NMC Specialty Hospital: Communication in ICU; Doctor-family members communication; Informed consent
• Additional relevant MeSH terms: COVID-19; Severe Acute Respiratory Syndrome; Syndrome

Study Results

No Results Posted as of May 11, 2021