NCT04743232

Brief Summary

During the Corona Virus Pandemic health care resources have become scare, and the pandemic has brought forth the need for risk stratification of patients suffering from COVID19 in order to allocate resources appropriately. One of scarcest resources is Intensive Care treatment, mostly related to the need for invasive ventilation or for (post) cardiac arrest care. To identify patients for whom ICU-treatment is most successful and those for whom it would be futile, would allow for installing appropriate advanced care directives for escalation or limitation of treatment.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

7 active sites

Status
suspended

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

February 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

February 3, 2021

Last Update Submit

February 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • ICU-admissions

    number of ICU-admissions at baseline and after implementation of the intervention

    before and after the intervention; total duration is 12 weeks.

Secondary Outcomes (3)

  • Mortality

    before and after the intervention; patient follow-up at 30 days and 1 year

  • Health care professionals' satisfaction

    Measurements are repeated, before and after the intervention; total duration is 12 weeks.

  • Patient satisfaction

    Measurement is only done once. In one group of patients before and another group after the intervention; total duration is 12 weeks.

Study Arms (2)

Standard practice

NO INTERVENTION

Standard practice concerning advanced care directives; care as usual

Decision aid implementation

EXPERIMENTAL

Stepped-wedge implementation of the intervention

Other: Decision tool for clinicians

Interventions

Clinical decision aid, using a structured approach to advanced care directives and a comprehensive view of available risk scores.

Decision aid implementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults with COVID19 (proven by polymerase chain reaction, or with strong clinical suspicion based on clinical features and/or radiodiagnostics)

You may not qualify if:

  • minors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

OLVG

Amsterdam, North Holland, 1091AC, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, South Holland, 3079DZ, Netherlands

Location

Amsterdam UMC

Amsterdam, Netherlands

Location

Rijnstate

Arnhem, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Radboud UMC

Nijmegen, Netherlands

Location

Erasmus MC

Rotterdam, 3015CE, Netherlands

Location

MeSH Terms

Conditions

COVID-19Heart Arrest

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: stepped-wedge cluster randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist-intensivist

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 8, 2021

Study Start

March 1, 2021

Primary Completion

December 31, 2022

Study Completion

January 31, 2025

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations