Resuscitation Outcomes in the Netherlands Flashmob Questionnaire

Cardiopulmonary Arrest Clinical Trial

— ROUTINE-F  

Official title:

Resucitation Outcomes in the Netherlands: Flash Mob Research on the Subject of Patient Experiences Regarding Do Not Resuscitate Orders.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807206
• Other study ID #: ROUTINE-F
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: February 7, 2019

Study information

• Verified date: July 2019
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1136
• Est. completion date: February 7, 2019
• Est. primary completion date: February 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Arrest
• DNR-orders
• Heart Arrest

Intervention

Behavioral:
• Questionnaire
Patient questionnaire

Locations

Country	Name	City	State
Netherlands	Rijnstate	Arnhem
Netherlands	Amphia	Breda
Netherlands	Reinier de Graaf gasthuis	Delft
Netherlands	Jeroen Bosch ziekenhuis	Den Bosch
Netherlands	Haaglanden Medisch Centrum	Den Haag
Netherlands	Albert Schweitzer ziekenhuis	Dordrecht
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Tergooi ziekenhuizen	Hilversum
Netherlands	Erasmus MC	Rotterdam
Netherlands	Franciscus Gasthuis & Vlietland	Rotterdam
Netherlands	Ikazia	Rotterdam
Netherlands	Maasstad	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	European Society of Anaesthesiology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General demographic data	Demographic profile of inpatients in the Netherlands: age, sex, religion, education, no. of diseases, no. of medications	1 day
Primary	Prevalence of DNR-orders	Percentage of DNR-orders in the total cohort as noted in the electronic patient file	1 day
Secondary	DNR-order discussion prevalence	Number of patients who have had a DNR discussion with their physician	1 day
Secondary	DNR-order discussion experience	Patient experience with the DNR-order discussion; was it timely, was the explanation clear?	1 day
Secondary	DNR-order discrepancy	DNR-order reported by the patient, compared to DNR-order from the electronic patient file	1 day
Secondary	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".	1 day