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

NCT03872154 | Completed DMC

• 1 other identifier: Code status 2019
• Study Type: interventional
• Target: 2,663
• Locations: 1 country
• Sites: 1

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.

Conditions

Code Status Discussions With Medical In-patients

Keywords

code status discussion; resuscitation; hospitalized patient; cardiac arrest

Outcome Measures

Primary Outcomes (1)

• Frequency of "Do Not Resuscitate" (DNR) code status

  Frequency of patients that forego resuscitation measures in case of a cardiac arrest

  Within 24 hours after code status discussion which is performed once at baseline

Secondary Outcomes (5)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Checklist-guided shared decision-making

Usual Care

NO INTERVENTION

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

Interventions

Checklist-guided shared decision-making 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• physician level
• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator

Study Sites (1)

Universitätsspital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (2)

• Arpagaus A, Arpagaus L, Becker C, Gross S, Gossi F, Bissmann B, Zumbrunn SK, Schuetz P, Leuppi JD, Aujesky D, Hug B, Peters T, Bassetti S, Hunziker S. Checklist-Guided Code Status Discussions in Patients for Whom Cardiopulmonary Resuscitation Is Considered Futile: An Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2533638. doi: 10.1001/jamanetworkopen.2025.33638.

  PMID: 40996760 DERIVED

• Becker C, Gross S, Beck K, Amacher SA, Vincent A, Mueller J, Loretz N, Blatter R, Bohren C, Urben T, Arpagaus A, Schaefert R, Schuetz P, Kaegi-Braun N, Stalder L, Leuppi JD, Aujesky D, Baumgartner C, Hug B, Schmieg H, Delfine V, Peters T, Templeton AJ, Bassetti S, Hunziker S. A Randomized Trial of Shared Decision-Making in Code Status Discussions. NEJM Evid. 2025 May;4(5):EVIDoa2400422. doi: 10.1056/EVIDoa2400422. Epub 2025 Apr 22.

  PMID: 40261118 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sabina Hunziker, Prof

  University Hospial Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cluster randomized

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: March 13, 2019
• Study Start: June 13, 2019
• Primary Completion: March 1, 2023
• Study Completion: April 14, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

CH (1)