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

Checklist-guided Shared Decision-making for Code Status Discussions in Medical Inpatients. A Cluster-randomized Multicenter Trial

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 Overview

• Status: Completed
• Conditions: Code Status Discussions With Medical In-patients
• Intervention / Treatment: Other: Checklist-guided shared decision-making

• Study Type: Interventional
• Enrollment (Actual): 2663
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • Universitatsspital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: Usual Care; In this group (control), physicians will conduct code status discussions as usually.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Key secondary endpoint: Decisional conflict assessed by Decisional conflict Scale	Patients' comfort with decision assessed through a validated German translation of the Decisional conflict Scale (DCS) The DCS is a 16 item-scale grouped into five sub-scales: certainty, information, clarification of values, external support or pressure and the patients perception of the quality of the decision process The score ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict). According to literature, individuals whose scores are greater than 37.5 are uncomfortable with the decision and tend to delay it	Within 24 hours after code status discussion
Patients' involvement in shared decision-making process assessed by questionnaire	Patients' involvement in shared decision-making (SDM) process assessed via a validated German translation of the SDM-q-9 questionnaire The SDM-q-9 is a 9-item instrument to measure the process of SDM in the medical consultation from the patients' perspective.	Within 24 hours after code status discussion
Patients' fears and concerns induced by code status discussion	Patients' concerns brought up by the code status discussion e.g. general concerns, concern of suffering from a cardiac arrest, concern of being seriously ill, patient's perception of feeling under pressure to discuss code status, each rated on a visual analogue scale (VAS) 0-10	Within 24 hours after code status discussion
Patients' satisfaction with code status discussion and perceived quality	Satisfaction with code status discussions and perceived quality e.g. satisfaction with discussion, perceived transparency of discussion, perceived comprehensibility of information, perceived right to be heard, how well questions were answered, perceived competence of resident, perceived resident's ability to listen to patient, each rated on a VAS 0-10	Within 24 hours after code status discussion
Patients' Knowledge	Patient's Knowledge assessed by a Knowledge Assessment Questionnaire being used in previous studies This tool is a 6-item questionnaire with five true/false and one multiple choice question to assess patients understanding of resuscitation and medical care. Scores range from 0 to 6, with higher scores reflecting greater knowledge	Within 24 hours after code status discussion

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Clinical Trial Unit, University Hospital Basel, Switzerland
• Investigators: Principal Investigator: Sabina Hunziker, Prof, University Hospial Basel

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): April 14, 2023

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: cardiac arrest; resuscitation; code status discussion; hospitalized patient
• Other Study ID Numbers: Code status 2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No