Code Status Discussions With Medical In-patientsNCT03872154
Checklist-guided Shared Decision-making for Code Status Discussions in Medical Inpatients.
A study testing Checklist-guided shared decision-making in people with Code Status Discussions With Medical In-patients, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Code Status Discussions With Medical In-patients
- What is being tested?
- Checklist-guided shared decision-making
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,663 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Jun 2019to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- physician level
- no exclusion criteria for physicians except if they refuse participation
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitätsspital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: 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.
- Being tested
- Checklist-guided shared decision-making
- Keywords
- code status discussion, resuscitation, hospitalized patient, cardiac arrest
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checklist-guided shared decision-makingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Checklist-guided shared decision-making |
| Usual Care | No intervention | In this group (control), physicians will conduct code status discussions as usually. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of "Do Not Resuscitate" (DNR) code status
Frequency of patients that forego resuscitation measures in case of a cardiac arrest
Measured: 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
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Within 24 hours after code status discussion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start13 Jun 2019
- Primary completion1 Mar 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Code Status Discussions With Medical In-patientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,663 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Responsible party
- Sponsor
- Investigators
- Sabina Hunziker, Prof, Principal investigator, University Hospial Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872154
- Sponsor's protocol ID
- Code status 2019
- Status last verified
- Mar 2024
- First submitted
- 15 Jan 2019
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40996760Becker 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.
PubMed 40261118
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Checklist-guided Shared Decision-making for Code Status Discussions in Medical Inpatients. A Cluster-randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT03872154
- Acronym / sponsor ID
- Code status 2019
- Keywords
- code status discussion, resuscitation, hospitalized patient, cardiac arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,663 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- cluster randomized
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Checklist-guided shared decision-makingIn 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. |
| Usual Care | No intervention | –In this group (control), physicians will conduct code status discussions as usually. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- physician level
- patient level - any adult (>18 years) patient that is admitted for in-hospital care will be eligible.
Key exclusion criteria (5 listed)
- physician level
- patient level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Checklist-guided shared decision-makingPhysicians 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. | Other | Intervention |
Primary outcome
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
5 secondary outcomes
Key secondary endpoint: Decisional conflict assessed by Decisional conflict Scale
Time frame: Within 24 hours after code status discussion
Patients' involvement in shared decision-making process assessed by questionnaire
Time frame: Within 24 hours after code status discussion
Patients' fears and concerns induced by code status discussion
Time frame: Within 24 hours after code status discussion
Patients' satisfaction with code status discussion and perceived quality
Time frame: Within 24 hours after code status discussion
Patients' Knowledge
Time frame: Within 24 hours after code status discussion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Derived from this study: PubMed 40996760Arpagaus 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.
- Derived from this study: PubMed 40261118Becker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabina Hunziker, Prof principal investigator
University Hospial Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Checklist-guided shared decision-making in people with Code Status Discussions With Medical In-patients, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of "Do Not Resuscitate" (DNR) code status (time frame: Within 24 hours after code status discussion which is performed once at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03872154, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024; AzTrials last refreshed its copy on 27 Oct 2026.