Clinical trial NCT03807206: Resuscitation Outcomes in the Netherlands Flashmob Questionnaire
Official title: Resucitation Outcomes in the Netherlands: Flash Mob Research on the Subject of Patient Experiences Regarding Do Not Resuscitate Orders.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiopulmonary Arrest
DNR-orders
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: European Society of Anaesthesiology
First posted: 2019-01-16
Enrollment: 1136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* All patients admitted to the participating hospitals with a planned admission \>24 hours at the moment this study takes place.

Exclusion Criteria:

* • 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)
    * 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

Primary outcomes:
measure: Prevalence of DNR-orders
timeFrame: 1 day
Secondary outcomes:
measure: DNR-order discussion prevalence
timeFrame: 1 day
measure: DNR-order discussion experience
timeFrame: 1 day
measure: DNR-order discrepancy
timeFrame: 1 day
measure: Quality of life
timeFrame: 1 day
Other outcomes:
measure: General demographic data
timeFrame: 1 day
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Breda
country: Netherlands
facility: Amphia
city: Delft
country: Netherlands
facility: Reinier de Graaf gasthuis
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch ziekenhuis
city: Den Haag
country: Netherlands
facility: Haaglanden Medisch Centrum
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer ziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Hilversum
country: Netherlands
facility: Tergooi ziekenhuizen
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
city: Rotterdam
country: Netherlands
facility: Ikazia
city: Rotterdam
country: Netherlands
facility: Maasstad
Study officials:
affiliation: Erasmus Medical Center
name: Robert Jan Stolker, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Monique van Dijk, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: