Resuscitation Outcomes in the Netherlands Flashmob Questionnaire (ROUTINE-F)

July 14, 2019 updated by: Marc Schluep, Erasmus Medical Center

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

1136

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Hilversum, Netherlands
        • Tergooi Ziekenhuizen
      • Rotterdam, Netherlands, 3015CE
        • Erasmus MC
      • Rotterdam, Netherlands
        • Franciscus Gasthuis & Vlietland
      • Rotterdam, Netherlands
        • Ikazia
      • Rotterdam, Netherlands
        • Maasstad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • structured interview

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert Jan Stolker, MD PhD, Erasmus MC
  • Principal Investigator: Monique van Dijk, MD PhD, Erasmus MC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

February 7, 2019

Study Completion (Actual)

February 7, 2019

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 14, 2019

Last Verified

July 1, 2019

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)?

No

IPD Plan Description

Because of the personal nature of data (reg. age, sex, religion, eductional level) we will not make it available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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