NCT04602351

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. 1.Explore the changes in communication pattern with limited contact during the COVID-19 pandemic.
  2. 2.Assess the methods of informed consent in Intensive care units (ICUs) during the same period

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

March 22, 2021

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2021

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

16 days

First QC Date

October 21, 2020

Last Update Submit

May 9, 2021

Conditions

Keywords

Communication in ICUDoctor-family members communicationInformed consent

Outcome Measures

Primary Outcomes (2)

  • 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).

    12 months

  • 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)

    12 months

Secondary Outcomes (1)

  • Changes in process of informed consent in ICU

    12 months

Interventions

CommunicationBEHAVIORAL

policies on communication and informed consent in ICU

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU communication teams across South Asian and Middle East Region

You may qualify if:

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

You may not qualify if:

  • Paediatric ICU
  • Neonatal ICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NMC Specialty Hospital

Dubai, 7832, United Arab Emirates

Location

Related Publications (5)

  • 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.

    PMID: 32240282BACKGROUND
  • 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.

    PMID: 32380024BACKGROUND
  • 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.

    PMID: 32451002BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Critical Care Medicine

Study Record Dates

First Submitted

October 21, 2020

First Posted

October 26, 2020

Study Start

March 22, 2021

Primary Completion

April 7, 2021

Study Completion

May 1, 2021

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

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

Locations