Checklist-guided Shared Decision-making for Code Status Discussions in Medical Inpatients. A Cluster-randomized Multicenter Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,663
- Locations
- 1
- Primary Endpoint
- Frequency of "Do Not Resuscitate" (DNR) code status
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •physician level
- •- residents on the medical wards will be the primary level of randomization.
- •patient level - any adult (>18 years) patient that is admitted for in-hospital care will be eligible.
Exclusion Criteria
- •physician level
- •- no exclusion criteria for physicians except if they refuse participation
- •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)
Arms & Interventions
Usual Care
In this group (control), physicians will conduct code status discussions as usually.
Intervention
In this group (intervention), physicians will conduct checklist-guided shared decision making to determine the patient's code status. Additionally, physicians will be given a decision aid, which they are told to use to illustrate impact and outcome of in-hospital cardiac arrests.
Ancillary project (patients considered as futile): In this group (intervention), physicians will conduct checklist-guided communication.
Intervention: Checklist-guided shared decision-making (Other)
Outcomes
Primary Outcomes
Frequency of "Do Not Resuscitate" (DNR) code status
Time Frame: Within 24 hours after code status discussion which is performed once at baseline
Frequency of patients that forego resuscitation measures in case of a cardiac arrest
Secondary Outcomes
- Key secondary endpoint: Decisional conflict assessed by Decisional conflict Scale(Within 24 hours after code status discussion)
- Patients' involvement in shared decision-making process assessed by questionnaire(Within 24 hours after code status discussion)
- Patients' fears and concerns induced by code status discussion(Within 24 hours after code status discussion)
- Patients' satisfaction with code status discussion and perceived quality(Within 24 hours after code status discussion)
- Patients' Knowledge(Within 24 hours after code status discussion)