Communication in ICU During COVID-19

COVID-19 Clinical Trial

Official title:

Communication in ICU During COVID-19: Multinational, Multicentric Cross-sectional Survey (ComICU)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602351
• Other study ID #: ComICU
• Status: Completed
• Start date: March 22, 2021
• Est. completion date: May 1, 2021

Study information

• Verified date: May 2021
• Source: NMC Specialty Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: May 1, 2021
• Est. primary completion date: April 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Adult ICUs,

2. New created COVID-19 ICUs during the pandemic

Exclusion Criteria:

1. Paediatric ICU

2. Neonatal ICU

Related Conditions & MeSH terms

• COVID-19
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2
• Syndrome

Intervention

Behavioral:
• Communication
policies on communication and informed consent in ICU

Locations

Country	Name	City	State
United Arab Emirates	NMC Specialty Hospital	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
NMC Specialty Hospital

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (5)

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. — View 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. — View 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/s — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the pattern of family members visiting process	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).	12 months
Primary	Changes in process of communication between health care workers(HCWs) and family members	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)	12 months
Secondary	Changes in process of informed consent in ICU	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)	12 months