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Completed

NCT Number: NCT03872154

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

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.

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Key information

Conditions

Code Status Discussions With Medical In-patients Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsspital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

Checklist-guided shared decision-making

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Clinical Trial Unit, University Hospital Basel, Switzerland

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2019
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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