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COVID-19NCT04602351

Communication in ICU During COVID-19

An observational study of COVID-19 and Severe Acute Respiratory Syndrome Coronavirus 2, run by NMC Specialty Hospital at 1 site in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Communication
How many people
296 participants
Where
1 siteUnited Arab Emirates
Study dates
22 Mar 2021to 1 May 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: ICU communication teams across South Asian and Middle East Region

Who may be able to join

  • Adult ICUs,
  • New created COVID-19 ICUs during the pandemic

Who cannot join

  • Paediatric ICU
  • Neonatal ICU

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site

  • NMC Specialty Hospital

    Dubai, 7832

Other trials in United Arab Emirates

About this study

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

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.

Being tested
Communication
Keywords
Communication in ICU, Doctor-family members communication, Informed consent
Medical subject headings
COVID-19, Severe Acute Respiratory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CommunicationBehavioural

    policies on communication and informed consent in ICU

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

    Measured: 12 months

Secondary outcomes (1)

  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)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2020
  2. Study start22 Mar 2021
  3. Primary completion7 Apr 2021
  4. Study completion1 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
296 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04602351
Sponsor's protocol ID
ComICU
Status last verified
May 2021
First submitted
21 Oct 2020
Last updated
11 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data will be shared to ensure confidentiality and privacy of participating Institution.

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

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and Severe Acute Respiratory Syndrome Coronavirus 2, run by NMC Specialty Hospital at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the pattern of family members visiting process (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04602351, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.

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Communication in ICU During COVID-19 (NCT04602351) | AzTrials