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

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ClinicalTrials.gov Identifier: NCT03872154
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Code Status Discussions With Medical In-patients Other: Checklist-guided shared decision-making Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2610 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: cluster randomized
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Checklist-guided Shared Decision-making for Code Status Discussions in Medical Inpatients. A Cluster-randomized Multicenter Trial
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : March 3, 2022

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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Key secondary endpoint: Decisional conflict assessed by Decisional conflict Scale [ Time Frame: Within 24 hours after code status discussion ]
    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

  2. Patients' involvement in shared decision-making process assessed by questionnaire [ Time Frame: Within 24 hours after code status discussion ]

    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.


  3. Patients' fears and concerns induced by code status discussion [ Time Frame: Within 24 hours after 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

  4. Patients' satisfaction with code status discussion and perceived quality [ Time Frame: Within 24 hours after code status discussion ]
    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

  5. Patients' Knowledge [ Time Frame: Within 24 hours after code status discussion ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872154


Contacts
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Contact: Sabina Hunziker, Prof. +41 61 328 5262 sabina.hunziker@usb.ch
Contact: Christoph Becker, MD +41 61 328 5712 christoph.becker@usb.ch

Locations
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Switzerland
Universitätsspital Basel Recruiting
Basel, Basel-Stadt, Switzerland, 4031
Contact: Sabina Hunziker, MD, PhD    +41 61 328 5262    sabina.hunziker@usb.ch   
Contact: Christoph Becker, MD, PhD    +41 61 328 5712    christoph.becker@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Clinical Trial Unit, University Hospital Basel, Switzerland
Investigators
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Principal Investigator: Sabina Hunziker, Prof University Hospial Basel

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03872154     History of Changes
Other Study ID Numbers: Code status 2019
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
code status discussion
resuscitation
hospitalized patient
cardiac arrest