Cardiopulmonary ArrestROUTINE-FNCT03807206
Resuscitation Outcomes in the Netherlands Flashmob Questionnaire
An observational study of Cardiopulmonary Arrest and DNR-orders, run by Erasmus Medical Center at 12 sites in Netherlands.
Trial summary
The aim of this study is to gain insight in patients' experiences regarding do not resuscitate conversations and decisions. A multicentre flash mob investigation will be conducted in which data will be obtained over the course of two weeks using electronic questionnaires that patients will fill out. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Arrest, DNR-orders
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,136 participants
- Where
- 12 sitesNetherlands
- Study dates
- 1 Jan 2019to 7 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The base population consists of all adult patients admitted to all the participating hospitals. These consist of one academic centre and 10 general hospitals. The sampling is based on non-probability as it does not represent the entire population (i.e. inhabitants of the Netherlands), however it is based on probability sampling when the population is solely patients admitted to hospital.
Who may be able to join
- All patients admitted to the participating hospitals with a planned admission >24 hours at the moment this study takes place.
Who cannot join
- • Refusal to participate
- <18 years of age
- Admitted in outpatient clinic and day treatment centres (e.g. haemodialysis)
- Admitted <24 hours, as defined by not sleeping overnight in hospital
- No reliable proxy in the following situations:
- Unable to answer questions (e.g. unconscious, cognitively impaired, delirious)
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- Language barrier (with no interpreter or family member)
- The following hospital departments are excluded:
- Intensive care unit
- Coronary/acute cardiac care unit
- Obstetrics
- Paediatrics
- Stroke unit
- Dialysis (outpatient dialysis)
- Day-care wards/short-stay (i.e. <1 day)
- Palliative care
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Netherlands12 sites
Jeroen Bosch ziekenhuis
's-Hertogenbosch
Rijnstate
Arnhem
Amphia
Breda
Reinier de Graaf gasthuis
Delft
Albert Schweitzer ziekenhuis
Dordrecht
Medisch Spectrum Twente
Enschede
Tergooi ziekenhuizen
Hilversum
Erasmus MC
Rotterdam, 3015CE
Franciscus Gasthuis & Vlietland
Rotterdam
Ikazia
Rotterdam
Maasstad
Rotterdam
Haaglanden Medisch Centrum
The Hague
About this study
Official title: Resucitation Outcomes in the Netherlands: Flash Mob Research on the Subject of Patient Experiences Regarding Do Not Resuscitate Orders.
The aim of this study is to gain insight in patients' experiences regarding do not resuscitate conversations and decisions. A multicentre flash mob investigation will be conducted in which data will be obtained over the course of two weeks using electronic questionnaires that patients will fill out. General demographic data and a brief quality of life assessment (EQ-5D) will be collected. Whether a DNR converstation has taken place will be noted, along with patients' experiences with this conversation. Lastly the patient will be asked about his/her expectations of survival after cardiopulmonary resuscitation.
Read the detailed description
Rationale: In-hospital cardiac arrest, associated with a survival to discharge of 15.0%, results in a good neurologic discharge in 9.1% - 30.0% of patients. Therefore it is recommended to engage in advanced care planning with patients, to discuss do-not-resuscitate (DNR) directives. In current knowledge, there are no published data about the prevalence of these DNR orders and associated factors in hospitalized patients in the Netherlands. Also, the conversation about DNR are sometimes perceived as awkward or untimely by patients.
Objective: The primary goal is to estimate prevalence DNR order in Dutch hospitals. A secondary goal is to assess what geographical, patient and disease factors are associated with DNR status. Furthermore patient experience in the conversation leading to DNR-orders is of interest.
Study design: A cross-sectional point prevalence study, in 10 participating hospitals of the ROUTiNE project.
Study population: Patients who plan to be admitted for more than 24 hours to the participating hospitals, aged 18 or older, who are responsive and conscious.
Main study parameters/endpoints: The prevalence of DNR orders, expressed as number per 1000 beds.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no risk. Only one ten-minute interview per participant. Therefore the benefit of this study (as described in the objectives) outweigh the potential risks.
- Conditions
- Cardiopulmonary Arrest, DNR-orders
- Being tested
- Questionnaire
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called structured interview
Patient questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Flashmob 2019 | Patients from the following hospitals will receive a questionnaire/structured intereview: Erasmus MC, Franciscus Gasthuis \& Vlietland, Ikazia, Haaglanden Medisch Centrum, Albert Schweitzer ziekenhuis, Jeroen Bosch ziekenhuis, Rijnstate ziekenhuis, Amphia ziekenhuis, Tergooi klinieken, Medisch Spectrum Twente, Reinier de Graaf gasthuis. Pending: Maasstad ziekenhuis Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of DNR-orders
Percentage of DNR-orders in the total cohort as noted in the electronic patient file
Measured: 1 day
Secondary outcomes (4)
DNR-order discussion prevalence
Number of patients who have had a DNR discussion with their physician
Measured: 1 day
DNR-order discussion experience
Patient experience with the DNR-order discussion; was it timely, was the explanation clear?
Measured: 1 day
DNR-order discrepancy
DNR-order reported by the patient, compared to DNR-order from the electronic patient file
Measured: 1 day
Quality of life
EQ-5D (Euroqol): EQ-5D-5L is a standardized, participant-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the visual analogue scale (VAS). The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to choose one of 5 levels that best describes their health on that day: "no problem" (1), "slight" (2), "moderate" (3), "severe" (4), or "unable/extreme" (5). The VAS is the participant's rating of their health on a scale of 0 "worst health you can imagine" to 100 "best health you can imagine".
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Jan 2019
- Primary completion7 Feb 2019
- Study completion7 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary ArrestStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Anaesthesiology
- Responsible party
- Principal investigator, Marc Schluep, Erasmus Medical Center
- Investigators
- Robert Jan Stolker, MD PhD, Principal investigator, Erasmus Medical CenterMonique van Dijk, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807206
- Sponsor's protocol ID
- ROUTINE-F
- Acronym
- ROUTINE-F
- Status last verified
- Jul 2019
- First submitted
- 7 Jan 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because of the personal nature of data (reg. age, sex, religion, eductional level) we will not make it available.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resucitation Outcomes in the Netherlands: Flash Mob Research on the Subject of Patient Experiences Regarding Do Not Resuscitate Orders.
- ClinicalTrials.gov ID
- NCT03807206
- Acronym / sponsor ID
- ROUTINE-F / ROUTINE-F
- Conditions
- Cardiopulmonary Arrest, DNR-orders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,136 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- European Society of Anaesthesiology
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to gain insight in patients' experiences regarding do not resuscitate conversations and decisions. A multicentre flash mob investigation will be conducted in which data will be obtained over the course of two weeks using electronic questionnaires that patients will fill out. General demographic data and a brief quality of life assessment (EQ-5D) will be collected. Whether a DNR converstation has taken place will be noted, along with patients' experiences with this conversation. Lastly the patient will be asked about his/her expectations of survival after cardiopulmonary resuscitation.
Detailed description
Rationale: In-hospital cardiac arrest, associated with a survival to discharge of 15.0%, results in a good neurologic discharge in 9.1% - 30.0% of patients. Therefore it is recommended to engage in advanced care planning with patients, to discuss do-not-resuscitate (DNR) directives. In current knowledge, there are no published data about the prevalence of these DNR orders and associated factors in hospitalized patients in the Netherlands. Also, the conversation about DNR are sometimes perceived as awkward or untimely by patients.
Objective: The primary goal is to estimate prevalence DNR order in Dutch hospitals. A secondary goal is to assess what geographical, patient and disease factors are associated with DNR status. Furthermore patient experience in the conversation leading to DNR-orders is of interest.
Study design: A cross-sectional point prevalence study, in 10 participating hospitals of the ROUTiNE project.
Study population: Patients who plan to be admitted for more than 24 hours to the participating hospitals, aged 18 or older, who are responsive and conscious.
Main study parameters/endpoints: The prevalence of DNR orders, expressed as number per 1000 beds.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no risk. Only one ten-minute interview per participant. Therefore the benefit of this study (as described in the objectives) outweigh the potential risks.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flashmob 2019 | – | Behavioral: QuestionnairePatients from the following hospitals will receive a questionnaire/structured intereview: Erasmus MC, Franciscus Gasthuis \& Vlietland, Ikazia, Haaglanden Medisch Centrum, Albert Schweitzer ziekenhuis, Jeroen Bosch ziekenhuis, Rijnstate ziekenhuis, Amphia ziekenhuis, Tergooi klinieken, Medisch Spectrum Twente, Reinier de Graaf gasthuis. Pending: Maasstad ziekenhuis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The base population consists of all adult patients admitted to all the participating hospitals. These consist of one academic centre and 10 general hospitals. The sampling is based on non-probability as it does not represent the entire population (i.e. inhabitants of the Netherlands), however it is based on probability sampling when the population is solely patients admitted to hospital.
Key inclusion criteria (1 listed)
- All patients admitted to the participating hospitals with a planned admission >24 hours at the moment this study takes place.
Key exclusion criteria (16 listed)
- • Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: structured interviewPatient questionnaire | Behavioural | Flashmob 2019 |
Primary outcome
Prevalence of DNR-orders
Time frame: 1 day
Percentage of DNR-orders in the total cohort as noted in the electronic patient file
4 secondary outcomes
DNR-order discussion prevalence
Time frame: 1 day
DNR-order discussion experience
Time frame: 1 day
DNR-order discrepancy
Time frame: 1 day
Quality of life
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Individual participant dataSharing planned: No. Because of the personal nature of data (reg. age, sex, religion, eductional level) we will not make it available.
Related trials for Cardiopulmonary Arrest
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
Not yet recruiting
Generative AI and Gamified Simulation-Based Train-the-Trainer Basic Life Support Training for High School Teachers in Vietnam
Cardiac Arrest, Cardiopulmonary Resuscitation
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Jan Stolker, MD PhD principal investigator
Erasmus Medical Center
Monique van Dijk, MD PhD principal investigator
Erasmus Medical Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Arrest and DNR-orders, run by Erasmus Medical Center at 12 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of DNR-orders (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.