Clinical trial NCT03872154: Checklist-guided Shared Decision-making for Code Status Discussions in Medical Inpatients.
Official title: Checklist-guided Shared Decision-making for Code Status Discussions in Medical Inpatients. A Cluster-randomized Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Code Status Discussions With Medical In-patients
Keywords: code status discussion
resuscitation
hospitalized patient
cardiac arrest
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Clinical Trial Unit, University Hospital Basel, Switzerland
First posted: 2019-03-13
Enrollment: 2663
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster randomized
Primary purpose: OTHER

Brief summary: This cluster-randomized, multicenter trial is designed to investigate the effect of checklist-guided shared decision-making including decision aids and communication of expected outcome on patients' decision regarding their code status, and at the same time, if it improves decision-making quality as judged by patient's decisional comfort, patient knowledge and involvement in decision-making and patient satisfaction. Patients in whom resuscitation is considered as futile will be treated separately in an ancillary project. In these patients a checklist to communicate the futility and the medical consequences will be used.


Eligibility criteria: Inclusion Criteria:

1. physician level

   - residents on the medical wards will be the primary level of randomization.
2. patient level - any adult (\>18 years) patient that is admitted for in-hospital care will be eligible.

Exclusion Criteria:

1. physician level

   - no exclusion criteria for physicians except if they refuse participation
2. patient level

   * patients unable to complete questionnaires or unable to follow code status discussions due to (1) intoxication, (2) paracusis; (3) serious psychiatric conditions (e.g., psychosis, depression with suicidal tendency, stupor), (4) cognitive impairment (e.g. dementia, delirium).
   * patients prior included in this study (i.e., patients who are hospitalized for the second time)

Primary outcomes:
measure: Frequency of "Do Not Resuscitate" (DNR) code status
timeFrame: Within 24 hours after code status discussion which is performed once at baseline
Secondary outcomes:
measure: Key secondary endpoint: Decisional conflict assessed by Decisional conflict Scale
timeFrame: Within 24 hours after code status discussion
measure: Patients' involvement in shared decision-making process assessed by questionnaire
timeFrame: Within 24 hours after code status discussion
measure: Patients' fears and concerns induced by code status discussion
timeFrame: Within 24 hours after code status discussion
measure: Patients' satisfaction with code status discussion and perceived quality
timeFrame: Within 24 hours after code status discussion
measure: Patients' Knowledge
timeFrame: Within 24 hours after code status discussion
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitätsspital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospial Basel
name: Sabina Hunziker, Prof
role: PRINCIPAL_INVESTIGATOR
References: