COVID-19 Resuscitation Plans and Decisions on Escalation and Limitation of Treatment (CORDEAL)
Primary Purpose
Covid19, Cardiac Arrest
Status
Suspended
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Decision tool for clinicians
Sponsored by
About this trial
This is an interventional screening trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- adults with COVID19 (proven by polymerase chain reaction, or with strong clinical suspicion based on clinical features and/or radiodiagnostics)
Exclusion Criteria:
- minors
Sites / Locations
- OLVG
- Maasstad Ziekenhuis
- Amsterdam UMC
- Rijnstate
- Medisch Spectrum Twente
- Radboud UMC
- Erasmus MC
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard practice
Decision aid implementation
Arm Description
Standard practice concerning advanced care directives; care as usual
Stepped-wedge implementation of the intervention
Outcomes
Primary Outcome Measures
ICU-admissions
number of ICU-admissions at baseline and after implementation of the intervention
Secondary Outcome Measures
Mortality
COVID mortality rates for hospital, ICU-mortality, 30-day and 1-year mortality.
Health care professionals' satisfaction
Health care professionals' satisfaction with the implemented decision tool and with the decision process as a whole. This will be measured via a structured questionnaire, using visual analogue scales (VAS, range 1-10) and Likert-scales for satisfaction scores.
Patient satisfaction
Patient satisfaction with the the communication in the hospital. This will be measured via a structured questionnaire, using visual analogue scales (VAS, range 1-10) and Likert-scales for satisfaction scores.
Full Information
NCT ID
NCT04743232
First Posted
February 3, 2021
Last Updated
February 13, 2023
Sponsor
Erasmus Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04743232
Brief Title
COVID-19 Resuscitation Plans and Decisions on Escalation and Limitation of Treatment
Acronym
CORDEAL
Official Title
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) or COVID-19 Pandemic Resuscitation Plans and Decisions on Escalation and Limitation of Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Why Stopped
Because the COVID pandemic became less severe (omikron)
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Disease resulting from infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has a high mortality rate with deaths predominantly caused by respiratory failure. As of 1 September 2020, over 25 million people had confirmed coronavirus disease 2019 (COVID-19) worldwide and at least 850 000 people had died from the disease. As hospitals around the world are faced with an influx of patients with COVID-19, there is an urgent need for a pragmatic risk stratification tool that will allow the early identification of patients infected with SARS-CoV-2 who are at the highest risk of death to guide management and optimise resource allocation.
As is apparent not only from medical literature, but also from popular media, there is a need for risk stratification and decision aid. The problem with our current health care capacity mainly pertains to ICU-admissions. Ideally, clinicians would be able to predict who benefits from invasive ICU-treatment, and who does not. Subsequently, patients for whom ICU-admission is futile,doctors can install advanced care directives to refrain from escalation and limit the curative treatment they receive, and rather focus on palliation. As the investigators of this study previously discovered, patients are not unwilling to discuss these matters. In COVID-19 patients, three interventions seem logical to warrant special attention: ICU-admission, invasive ventilatory support and cardiopulmonary resuscitation. The latter because mortality in cardiac arrest patients with concurrent COVID appears higher than in non-COVID patients and performing CPR in patients with contagious diseases can potentially bring harm to health care providers.
Prognostic scores attempt to transform complex clinical pictures into tangible numerical values.
Dutch clinicians in general have been particularly busy identifying and providing prognostic scores for mortality and ICU-admission. Recent reviews listed many prognostic scores used for COVID-19, which varied in their setting, predicted outcome measure, and the clinical parameters included. It also highlights the importance of age, something that has been a subject to political debate. Therefore, in the past months, two Dutch research groups and one British group have developed two prognostic scores:
COVID Outcome Prediction in the Emergency department:
COPE (ErasmusMC, NL)
Risk Stratification in the Emergency Department in Acutely Ill Older Patient:
RISE-UP (MUMC+, NL) 3. The International Severe Acute Respiratory and emerging Infections Consortium Coronavirus Clinical Characterisation Consortium of the World Health Organisation: 4C-score (UK)
In non-COVID patients, the Good Outcome for Attempted Resuscitation (GO-FAR) score serves as an acceptable prognostic tool for the prognosis of Cardiopulmonary Resuscitation (CPR). To date, no prognostic tool has been developed for CPR in COVID-patients. Last April, the Dutch board of intensive care medicine (NVIC) wrote a handbook to guide clinicians during the phase of the pandemic where resources would be limited to none (Code Black). In this handbook they summed up criteria in patients for whom ICU-admission would be futile or not-recommendable. Among these criteria was cardiac arrest. These criteria have however never been researched. Furthermore, although this handbook is necessary, there is no guidance for installing advanced care directives in the current stage of the pandemic, i.e. situations which are not Code Black - situations.
The aim of this study is to implement a clinical decision tool to aid clinicians in establishing advanced care directives about escalation and limitation of treatment in COVID-patients. The decision tool will provide two novelties: 1) A structured approach to discussing advanced care directives with patients who need to be admitted to hospital, and 2) A comprehensive oversight of available risk scores. The decision tool will not provide cut-off values or dichotomous decisions, this will be left to the discretion of the responsible physician. The secondary goal is to evaluate the use of this decision tool in terms of ICU-admissions, mortality and health care professionals' satisfaction with the implemented decision tool.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Cardiac Arrest
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
stepped-wedge cluster randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard practice
Arm Type
No Intervention
Arm Description
Standard practice concerning advanced care directives; care as usual
Arm Title
Decision aid implementation
Arm Type
Experimental
Arm Description
Stepped-wedge implementation of the intervention
Intervention Type
Other
Intervention Name(s)
Decision tool for clinicians
Intervention Description
Clinical decision aid, using a structured approach to advanced care directives and a comprehensive view of available risk scores.
Primary Outcome Measure Information:
Title
ICU-admissions
Description
number of ICU-admissions at baseline and after implementation of the intervention
Time Frame
before and after the intervention; total duration is 12 weeks.
Secondary Outcome Measure Information:
Title
Mortality
Description
COVID mortality rates for hospital, ICU-mortality, 30-day and 1-year mortality.
Time Frame
before and after the intervention; patient follow-up at 30 days and 1 year
Title
Health care professionals' satisfaction
Description
Health care professionals' satisfaction with the implemented decision tool and with the decision process as a whole. This will be measured via a structured questionnaire, using visual analogue scales (VAS, range 1-10) and Likert-scales for satisfaction scores.
Time Frame
Measurements are repeated, before and after the intervention; total duration is 12 weeks.
Title
Patient satisfaction
Description
Patient satisfaction with the the communication in the hospital. This will be measured via a structured questionnaire, using visual analogue scales (VAS, range 1-10) and Likert-scales for satisfaction scores.
Time Frame
Measurement is only done once. In one group of patients before and another group after the intervention; total duration is 12 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults with COVID19 (proven by polymerase chain reaction, or with strong clinical suspicion based on clinical features and/or radiodiagnostics)
Exclusion Criteria:
minors
Facility Information:
Facility Name
OLVG
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1091AC
Country
Netherlands
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3079DZ
Country
Netherlands
Facility Name
Amsterdam UMC
City
Amsterdam
Country
Netherlands
Facility Name
Rijnstate
City
Arnhem
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Name
Radboud UMC
City
Nijmegen
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015CE
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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COVID-19 Resuscitation Plans and Decisions on Escalation and Limitation of Treatment
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