- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03807206
Resuscitation Outcomes in the Netherlands Flashmob Questionnaire (ROUTINE-F)
Resucitation Outcomes in the Netherlands: Flash Mob Research on the Subject of Patient Experiences Regarding Do Not Resuscitate Orders.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Arnhem, Netherlands
- Rijnstate
-
Breda, Netherlands
- Amphia
-
Delft, Netherlands
- Reinier de Graaf Gasthuis
-
Den Bosch, Netherlands
- Jeroen Bosch Ziekenhuis
-
Den Haag, Netherlands
- Haaglanden Medisch Centrum
-
Dordrecht, Netherlands
- Albert Schweitzer Ziekenhuis
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Enschede, Netherlands
- Medisch Spectrum Twente
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Hilversum, Netherlands
- Tergooi Ziekenhuizen
-
Rotterdam, Netherlands, 3015CE
- Erasmus MC
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Rotterdam, Netherlands
- Franciscus Gasthuis & Vlietland
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Rotterdam, Netherlands
- Ikazia
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Rotterdam, Netherlands
- Maasstad
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
Patient questionnaire
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of DNR-orders
Time Frame: 1 day
|
Percentage of DNR-orders in the total cohort as noted in the electronic patient file
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DNR-order discussion prevalence
Time Frame: 1 day
|
Number of patients who have had a DNR discussion with their physician
|
1 day
|
DNR-order discussion experience
Time Frame: 1 day
|
Patient experience with the DNR-order discussion; was it timely, was the explanation clear?
|
1 day
|
DNR-order discrepancy
Time Frame: 1 day
|
DNR-order reported by the patient, compared to DNR-order from the electronic patient file
|
1 day
|
Quality of life
Time Frame: 1 day
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General demographic data
Time Frame: 1 day
|
Demographic profile of inpatients in the Netherlands: age, sex, religion, education, no. of diseases, no. of medications
|
1 day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Jan Stolker, MD PhD, Erasmus MC
- Principal Investigator: Monique van Dijk, MD PhD, Erasmus MC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ROUTINE-F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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