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Completed

NCT Number: NCT04602351

Communication in ICU During COVID-19

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Severe Acute Respiratory Syndrome Coronavirus 2 Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NMC Specialty Hospital

Dubai, 7832, United Arab Emirates

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Paediatric ICU
  • Neonatal ICU

Treatment and study plan

Communication

Behavioral

policies on communication and informed consent in ICU

Primary outcomes

  1. Changes in the pattern of family members visiting process

    Time frame: 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

    Time frame: 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 outcomes

  1. Changes in process of informed consent in ICU

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

NMC Specialty Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 26, 2020
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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