Clinical trial NCT04602351: Communication in ICU During COVID-19
Official title: Communication in ICU During COVID-19: Multinational, Multicentric Cross-sectional Survey (ComICU)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Severe Acute Respiratory Syndrome Coronavirus 2
Severe Acute Respiratory Syndrome
Keywords: Communication in ICU
Doctor-family members communication
Informed consent
Lead sponsor: NMC Specialty Hospital
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU communication teams across South Asian and Middle East Region

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

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.

Eligibility criteria: Inclusion Criteria:

1. Adult ICUs,
2. New created COVID-19 ICUs during the pandemic

Exclusion Criteria:

1. Paediatric ICU
2. Neonatal ICU

Primary outcomes:
measure: Changes in the pattern of family members visiting process
timeFrame: 12 months
measure: Changes in process of communication between health care workers(HCWs) and family members
timeFrame: 12 months
Secondary outcomes:
measure: Changes in process of informed consent in ICU
timeFrame: 12 months
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: NMC Specialty Hospital
Study officials:
References:
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.
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.
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.
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.
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.