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CompletedNCT04602351Updated May 11, 2021

Communication in ICU During COVID-19

An observational study in COVID-19, Severe Acute Respiratory Syndrome Coronavirus 2 and Severe Acute Respiratory Syndrome, sponsored by NMC Specialty Hospital. Completed at 1 site in United Arab Emirates. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-05-11.

Sponsored by NMC Specialty Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
296
Ages
18 Years to 100 Years
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

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

Keywords

  • Communication in ICU
  • Doctor-family members communication
  • Informed consent
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 296 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

NMC Specialty Hospital is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

ICU communication teams across South Asian and Middle East Region

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Paediatric ICU
  2. Neonatal ICU
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
296 participants (actual)
Patient registry
No

Interventions

  • BehavioralCommunication

    policies on communication and informed consent in ICU

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 12 months

  2. 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)

    Time frame: 12 months

Secondary outcomes

  1. 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)

    Time frame: 12 months

07

Study locations

1 site
  • NMC Specialty Hospital
    Dubai, 7832, United Arab Emirates
08

References and documents

Publications

  • 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. PubMed 32240282 ↗
  • 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. PubMed 32380024 ↗
  • 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. PubMed 32451002 ↗
  • 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. PubMed 26792081 ↗
  • 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. PubMed 28716040 ↗

Individual participant data

Plan to share: No — No individual participant data will be shared to ensure confidentiality and privacy of participating Institution.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04602351
Lead sponsor
NMC Specialty Hospital
Responsible party
Prashant Nasa (Head Critical Care Medicine, NMC Specialty Hospital) — Principal investigator
First posted
Oct 26, 2020
Start date
Mar 22, 2021
Primary completion
Apr 7, 2021
Completion
May 1, 2021
Last update
May 11, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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