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Completed

NCT Number: NCT03807206

Resuscitation Outcomes in the Netherlands Flashmob Questionnaire

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jeroen Bosch ziekenhuis, 's-Hertogenbosch, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Behavioral

Patient questionnaire

Other names: structured interview

Primary outcomes

  1. Prevalence of DNR-orders

    Time frame: 1 day

    Percentage of DNR-orders in the total cohort as noted in the electronic patient file

Secondary outcomes

  1. DNR-order discussion prevalence

    Time frame: 1 day

    Number of patients who have had a DNR discussion with their physician

  2. DNR-order discussion experience

    Time frame: 1 day

    Patient experience with the DNR-order discussion; was it timely, was the explanation clear?

  3. DNR-order discrepancy

    Time frame: 1 day

    DNR-order reported by the patient, compared to DNR-order from the electronic patient file

  4. 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".

Other outcomes

  1. General demographic data

    Time frame: 1 day

    Demographic profile of inpatients in the Netherlands: age, sex, religion, education, no. of diseases, no. of medications

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • European Society of Anaesthesiology

Registry information

Official study title

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

Acronym: ROUTINE-F

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2019
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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