Checklist-guided Shared Decision-making for Code Status Discussions in Medical Inpatients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2663 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-13

Study Completion Date

2023-04-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Code Status Discussions With Medical In-patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

cluster randomized

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Checklist-guided shared decision-making

Intervention Type OTHER

Physicians will receive a checklist and a decision aid for shared decision-making during code status discussion.

Ancillary project: Physicians will receive a checklist to communicate the futility.

Usual Care

In this group (control), physicians will conduct code status discussions as usually.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Checklist-guided shared decision-making

Physicians will receive a checklist and a decision aid for shared decision-making during code status discussion.

Ancillary project: Physicians will receive a checklist to communicate the futility.

Intervention Type OTHER

Eligibility Criteria

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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

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes