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
|Condition or disease||Intervention/treatment||Phase|
|Code Status Discussions With Medical In-patients||Other: Checklist-guided shared decision-making||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2610 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||cluster randomized|
|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|
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.
- 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
- 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
- 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.
- 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
- 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
- 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
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
|Contact: Sabina Hunziker, Prof.||+41 61 328 email@example.com|
|Contact: Christoph Becker, MD||+41 61 328 firstname.lastname@example.org|
|Basel, Basel-Stadt, Switzerland, 4031|
|Contact: Sabina Hunziker, MD, PhD +41 61 328 5262 email@example.com|
|Contact: Christoph Becker, MD, PhD +41 61 328 5712 firstname.lastname@example.org|
|Principal Investigator:||Sabina Hunziker, Prof||University Hospial Basel|