Code Status Discussions With Medical In-patients Clinical Trial
Official title:
Checklist-guided Shared Decision-making for Code Status Discussions in Medical Inpatients. A Cluster-randomized Multicenter Trial
| Verified date | March 2024 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 2663 |
| Est. completion date | April 14, 2023 |
| Est. primary completion date | March 1, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Universitätsspital Basel | Basel | Basel-Stadt |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland | Clinical Trial Unit, University Hospital Basel, Switzerland |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |