Communication in ICU During COVID-19

May 9, 2021 updated by: Prashant Nasa, NMC Specialty Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

296

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ICU communication teams across South Asian and Middle East Region

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Paediatric ICU
  2. Neonatal ICU

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months
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)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NMC Specialty Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2021

Primary Completion (Actual)

April 7, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

October 21, 2020

First Submitted That Met QC Criteria

October 23, 2020

First Posted (Actual)

October 26, 2020

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 9, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ComICU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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