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Decision Making ,SharedCODE IINCT07327450

Coaching Doctors and Nurses to Improve Ethical Decision-making in Team

A study testing CODE II intervention in people with Decision Making ,Shared and Leadership, run by University Hospital, Ghent at 1 site in Belgium.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Literature and a pilot study performed in 2019 indicate room for enhancing openness to discuss ethical sensitive issues within and between teams, and improving goal-oriented care and decision-making for the benefit of the patient at end-of-life, worldwide and more specifically in Belgium and in the Ghent University… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CODE II intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteBelgium
Study dates
1 Apr 2026to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients potentially receiving excessive treatment (PET) who are identified by clinicians during their first hospitalization. PET is defined as a patient in whom 2 or more clinicians doubt whether the treatment or treatment limitation code is consistent with their expected survival or quality of life (= "too much" or "excessive treatment") or whether the treatment limitation code is in line with the patient's or relatives' goals.
  • Family members of PET
  • Junior and senior doctors (including Department Heads) taking care of hospitalized patients
  • Nurses (including head nurses) taking care of hospitalized patients
  • Allied health professionals (psychologists, physical therapists, speech therapists, occupational therapists, social workers, spiritual care providers) taking care of hospitalized patients
  • PET admitted / clinicians working in the 10 participating departments of of the Ghent University Hospital (Cardiology, Gastro-enterology and Hepatology, General Internal Medicine, Geriatrics, Hematology, Medical Oncology, Neurology, Nephrology (including dialysis unit), Pulmonology and the Medical ICU)

Who cannot join

  • PET with a previous written DNI-DNACPR order
  • Patients and family members of PET who are less than 18 years old and persons who cannot understand Ducth questionnaires

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dominique Benoit, MD, PhD contact

+32 (9) 332 27 75

dominique.benoit@uzgent.be

Belgium1 site

  • Ghent University Hospital

    Ghent, East-Flanders, 9000

    Domininique Benoit, MD, PhD, +32 (9) 332 27 75, dominique.benoit@uzgent.be

Other trials in Belgium

About this study

Official title: Coaching Doctors and Nurses to Improve Ethical Decision-making in Team: a Stepped Wedge Cluster Randomized Trial in 10 Departments of the Ghent University Hospital

Literature and a pilot study performed in 2019 indicate room for enhancing openness to discuss ethical sensitive issues within and between teams, and improving goal-oriented care and decision-making for the benefit of the patient at end-of-life, worldwide and more specifically in Belgium and in the Ghent University Hospital. The CODE study intervention performed in 2021 suggests already an improvement in goal oriented care operationalized via written Do-Not-Intubate and Do-Not-Attempt Cardio-Pulmonary Resuscitation (DNI-DNACPR orders in the Ghent University Hospital. In this study, the investigators found a nearly doubling of the incidence in written DNI-DNACPR in patient potentially receiving excessive treatment (PET) (from 19.7% to 29.7%, p<0.001) and in patients hospitalized for the first time (from 1.9% to 3.4%, p=0.011) without increasing one-year mortality, after coaching doctors during 4 months in self-reflective and empowering leadership, and coping with group dynamics. However, the investigators found no improvement in the perception of the quality of the ethical climate by clinicians, more specifically by nurses. Despite the fact that ethical decision-making is considered a strategic priority in the Ghent University Hospital and an intense communication campaign, clinicians identified also a much smaller number of PET during this interventional study than during the observational pilot study in 2019. Although fading attention for the study over time and visibility of the electronic CODE alert to identify PET was claimed as the main reasons by 75% and 50.7% of the nurses, respectively, 95% expressed the desire to keep on using this alert in the future. This underscores a deeper concern in nurses. More than 40% expressed fear of blaming doctors or skepticism regarding the impact of identifying PET. Nonetheless, 35% acknowledged improvement in interdisciplinary meetings about end-of-life issues since study initiation. These findings highlights the need to additionally coach the entire team in future studies. Indeed, creating a safe climate which enhances inter-professional shared decision-making for the benefit of the patient requires both, specific self-reflective and empowering leadership skills in doctors and head nurses (including the management of group dynamics in the interdisciplinary team), and confidence in speaking up in nurses and other health care professionals. This is what the investigators want to develop with this intervention. These skills will also help clinicians during patient and family meetings which will enable clinicians to better take into account the patient's and family's wishes.

Read the detailed description

See protocol

Being tested
Usual Care Group, CODE II intervention
Keywords
Coaching, Shared decision-making, Goal-oriented care, Ethical climate, Leaderschip, Communication, End-of-life
Medical subject headings
Communication, Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual Care GroupOther

    The control group will receive usual care in which the quality of the ethical decision-making is determined by the clinical team according to their usual pratice. Except from a treatment-limitation-decisions guideline which focuses on the legal and deontological framework, no other guideline with regard to ethical decision-making has been implemented at the Ghent University Hospital.

  • CODE II interventionBehavioural

    1. One interactive session of two hours focusing on the concepts of medical-ethical decision-making, the psychological challenge of dealing with ethically sensitive medical topics, empowering leadership and the importance of "speaking up" within the team. 2) Every clinician will be invited to provide perceptions of excessive treatment via the electronic patient file. Once a patient is identified by two or more different clinicians, an email will be sent to coaches and the clinicians in charge of the PET during intervention period. 3) The 4 months coaching intervention will consist of : a. Doctors and head nurses : individual coaching sessions in self-reflective and empowering leadership and in managing groups dynamics with regard to ethical decision-making in team about PET patients. b. All clinicians : multidisciplinary coaching during work shift hand-overs and structured metareflective sessions on specific themes related to ethical decision-making in team about PET.
Study groups in NCT07327450
Study groupRoleWhat they receive
Usual careActive comparatorNot described
Receives: Other: Usual Care Group
CODE II interventionExperimentalNot described
Receives: Behavioral: CODE II intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of written DNI-DNACPR order between hospital admission and the end of the first hospital stay

    Patient-specific endpoint

    Measured: At the end of the 14 months study period

  2. Ethical decision-making climate questionnaire (EDMCQ)

    Clinician specific endpoint. Factorscores on 7 domains, which is normally distributed, centred at mean of zero, with standard deviation 5.5 (minimum score -25, maximum score 25). Higher scores indicate higher quality of interdisciplinary ethical decision-making

    Measured: at the start and the end of the 14 month study period

Secondary outcomes (29)

  1. Hospital Consumer Assessment of Healthcare Providers and Systems instrument

    Patient-specific endpoint. Patients rate the quality of their hospital stay on a scale of 0 (worst) to 10 (best) and indicate whether they would recommend their hospital to family and friends.

    Measured: 3 weeks after the patient's hospital discharge

  2. Sinclair Compassion Questionnaire-Short Form (SCQ-SF)

    Patient-specific endpoint. The SCQ is a validated instrument for quantifying compassion in healthcare from multiple perspectives (e.g., patients, family, clinicians). It studies outcomes valued by the patient such as 'feeling heard and understood by their clinician' and 'being valued as a person'. The Belgian version of the 5-item SCQ-SF (Sinclair Compassion Questionnaire-Short Form) is used with each item rating on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is calculated as the mean of the five items, resulting in a theoretical range from 1 to 5. A higher SCQ score is indicative of higher compassionate care.

    Measured: 3 weeks after the patient's hospital discharge

  3. Satisfaction according to the European Family Satisfaction in the ICU (Euro-FS) score

    Patient-specific endpoint. Validated 18 item questionnaire covering satisfaction with 4 domains: communication, empathy, symptom management and decision-making. The investigators will use the single-item assessment of satisfaction of this score raning from 0 to 10. higher values indicate higher satisfaction.

    Measured: 3 weeks after the patient's hospital discharge

  4. Hospital Anxiety and Depression Scale (HADS)

    Patient-specific endpoint. Validated 14-item self-report assessment with subscales for anxiety and depression. Each domain has a score range of 0-21 with the following interpretation: 0-7 normal, 8-10 mild, 11-21 moderate to severe

    Measured: 3 weeks after hospital discharge

  5. European quality of dying and death family questionnaire (Euro-QODD)

    Patient-specific endpoint filled out by the relatives. Euro-QDDD family is a 14 item questionnaire to allow relatives to assess patients quality of dying and death.

    Measured: 3 weeks after the patient's hospital discharge

  6. Pain according to the Numeral Rating scale (NRS) : sum of the average daily score up to the end of the first hospital stay

    Patient-specific endpoint; Single-item assessment of pain ranging from 0 (no pain) to 10 (worst possible pain)

    Measured: at the end of the 14 month study period

  7. Pain according to the Numeral Rating Scale (NRS) : number of days with an average score > 3 up to the end of the first hospital stay

    Patient-specific endpoint. Single-item assessment of pain raging from 0 (no pain) to 10 (worst possible pain).

    Measured: at the end of the 14 month study period

  8. Incidence of death up to one year after first hospital admission

    Patient-specific endpoint

    Measured: 12 months after first hospital admission

  9. Percentage of patients who achieved the combined one year outcome (dead, not at home or utility <0.5 according to the European Quality-of-life 5 dimension instrument(Euro-QOL-5D))

    Patient-specific endpoint. Euro-QOL-5D measures health-related quality of life, with possibility of conversion of each health state in a utility index (range -0.1584 to 1.000). This questionnaire measures health in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression

    Measured: 12 months after first hospital admission

  10. Potentially inappropriate or burdensome treatments : incidence of achieving the combined patient burdensome treatments outcome (achieving outcome 13,14,15,16,17,18 or 19) up to one year after the first hospitalisation

    Patient-specific endpoint

    Measured: At the end of the 14 months study period

  11. Potentially inappropriate or burdensome treatments : incidence of receiving cardio-pulmonary resuscitation up to one year after the first hospitalisation

    Patient-specific endpoint

    Measured: at the end of the 14 months study period

  12. Potentially inappropriate or burdensome treatments : incidence of admission in the intensive care unit up to one year after the first hospitalisation

    Patient-specific endpoint

    Measured: At the end of the 14 month study period

  13. Potentially inappropriate or burdensome treatments : incidence of receiving invasive mechanical ventilation up to one year after the first hospitalisation

    Patient-specific endpoint

    Measured: At the end of the 14 month study period

  14. Potentially inappropriate or burdensome treatments : incidence of receiving dialysis up to one year after the first hospitalisation

    Patient-specific endpoint

    Measured: At the end of the 14 month study period

  15. Potentially inappropriate or burdensome treatments : incidence of receiving a surgical procedure up to one year after the first hospitalisation

    Patient-specific endpoint

    Measured: At the end of the 14 month study period

  16. Potentially inappropriate or burdensome treatments : incidence of receiving chemotherapy up to one year after the first hospitalisation

    Patient-specific endpoint

    Measured: At the end of the 14 month study period

  17. Potentially inappropriate or burdensome treatments : incidence of receiving radiotherapy up to one year after the first hospitalisation

    Patient-specific endpoint

    Measured: At the end of the 14 months study period

  18. Hospital Consumer Assessment of Healthcare Providers and Systems instrument

    Family-specific endpoint. Family rate the quality of their hospital stay on a scale of 0 (worst) to 10 (best) and indicate whether they would recommend their hospital to family and friends.

    Measured: 3 weeks after the patient's hospital discharge

  19. Sinclair Compassion Questionnaire-Short Form (SCQ-SF)

    Family-specific endpoint. The SCQ is a validated instrument for quantifying compassion in healthcare from multiple perspectives (e.g., patients, family, clinicians). It studies outcomes valued by the patient such as "feeling heard and understood by their clinicians" and "being valued as a person". The Belgian version of the 5-item SCQ-SF (Sinclair Compassion Questionnaire-Short Form) is used with each item rating on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is calculated as the mean of the five items, resulting in a theoretical range from 1 to 5. A higher SCQ score is indicative of higher compassionate care.

    Measured: 3 weeks after the patient's hospital discharge

  20. Satisfaction according to the European Family Satisfaction in the ICU (Euro-FS) score

    Family-specific endpoint. Validated 18 item questionnaire covering satisfaction with 4 domains: communication, empathy, symptom management and decision-making. The investigators will use the single-item assessment of satisfaction of this score raning from 0 to 10. higher values indicate higher satisfaction.

    Measured: 3 weeks after the patient's hospital discharge

  21. Hospital Anxiety and Depression Scale (HADS)

    Family-specific endpoint. Validated 14-item self-report assessment with subscales for anxiety and depression. Each domain has a score range of 0-21 with the following interpretation: 0-7 normal, 8-10 mild, 11-21 moderate to severe

    Measured: 3 weeks after the patient's hospital discharge

  22. Differences in EDMCQ between doctors and nurses

    Clinician spefic endpoint. Factorscores on 7 domains, which is normally distributed, centred at mean zero, with standard deviation 5.5 (minimum score -25, maximum score 25). Higher difference in scores between doctors and nurses indicate a greater gap in the perception of the ethical climate between roles.

    Measured: at the start and end of the 14 month study period

  23. Percentage of (mild-moderate-severe-extreme) stress related to a perception of excessive treatment

    Clinician-specific endpoint

    Measured: At the end of the 14 month study period

  24. Percentage of clinicians with intention of leaving their job

    Clinician-specific endpoint

    Measured: At the start and end of the 14 month study period

  25. Percentage of clinicians with sick leave

    Team-specific endpoint

    Measured: At the start and end of the 14 month study period

  26. Ethical pratice score

    Team-specific endpoint. This score consists of 12 items. The investigators will use the 10 department specific items (minus the 2 country-specific items). This score ranges between 0 to 10 with higher scores indicating a higher degree of ethical pratice organization

    Measured: At the start and end of the 14 month study period

  27. Incidence of written DNI-DNACPR order between hospital admission and the end of the first hospital stay in the overall patient population admitted in the participating wards

    Patient-specific endpoint

    Measured: At the end of the 14 months study period

  28. Incidence of death up to one year after first hospital admission in the overall patient population admitted in the participating wards

    Patient-specific endpoint

    Measured: At the end of the 14 month study period

  29. Health-care utilization : total number of chemotherapeutic treatments up to one year after the first hospital admission

    Society-specific endpoint

    Measured: 12 months after the first hospital admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Sequential
Model description
In total 50 to 75 junior doctors, 50 to 75 senior doctors (including medical head of department), 300 to 500 nurses (including head nurses) and 100 to 200 allied health professionals working in 10 departments of the Ghent University Hospital are eligible for this study and about 350 to 700 adult patients potentially receiving excessive treatment who did not yet receive a written DNI-DNACPR order together with one of their relatives. Stepped wedge cluster randomized trial in 10 hospital wards combined with pre- and post-measurement of the ethical climate.
Masking
Single blind
Who is masked
Participant
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07327450
Sponsor's protocol ID
ONZ-2025-0602
Acronym
CODE II
Status last verified
Apr 2026
First submitted
24 Dec 2025
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: In order to guaranty the entire safety of the participating departments and as such the change management trajectories of these departments, IPD will not be shared. Specific departments admit specific patient population : therefore, the quality of the ethical climate per department cannot be anonymized.

Publications

  • Gerritsen RT, Koopmans M, Hofhuis JG, Curtis JR, Jensen HI, Zijlstra JG, Engelberg RA, Spronk PE. Comparing Quality of Dying and Death Perceived by Family Members and Nurses for Patients Dying in US and Dutch ICUs. Chest. 2017 Feb;151(2):298-307. doi: 10.1016/j.chest.2016.09.003. Epub 2016 Sep 19.

    PubMed 27660153

  • Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM. A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med. 1997 Mar;27(2):363-70. doi: 10.1017/s0033291796004382.

    PubMed 9089829

  • Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

    PubMed 6226917

  • Jensen HI, Gerritsen RT, Koopmans M, Downey L, Engelberg RA, Curtis JR, Spronk PE, Zijlstra JG, Ording H. Satisfaction with quality of ICU care for patients and families: the euroQ2 project. Crit Care. 2017 Sep 7;21(1):239. doi: 10.1186/s13054-017-1826-7.

    PubMed 28882192

  • Sinclair S, Kondejewski J, Hack TF, Boss HCD, MacInnis CC. What is the Most Valid and Reliable Compassion Measure in Healthcare? An Updated Comprehensive and Critical Review. Patient. 2022 Jul;15(4):399-421. doi: 10.1007/s40271-022-00571-1. Epub 2022 Feb 2.

    PubMed 35107822

  • US Department of Health and Human Services. Hospital compare quality of care. 2011. www.hospitalcompare.hhs.gov

  • Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.

    PubMed 11491192

  • Benoit DD, De Pauw A, Jacobs C, Moors I, Offner F, Velghe A, Van Den Noortgate N, Depuydt P, Druwe P, Hemelsoet D, Meurs A, Malotaux J, Van Biesen W, Verbeke F, Derom E, Stevens D, De Pauw M, Tromp F, Van Vlierberghe H, Callebout E, Goethals K, Lievrouw A, Liu L, Manesse F, Vanheule S, Piers R. Coaching doctors to improve ethical decision-making in adult hospitalized patients potentially receiving excessive treatment. The CODE stepped-wedge cluster randomized controlled trial. Intensive Care Med. 2024 Oct;50(10):1635-1646. doi: 10.1007/s00134-024-07588-0. Epub 2024 Sep 4.

    PubMed 39230678

  • Benoit DD, Vanheule S, Manesse F, Anseel F, De Soete G, Goethals K, Lievrouw A, Vansteelandt S, De Haan E, Piers R; CODE study group. Coaching doctors to improve ethical decision-making in adult hospitalised patients potentially receiving excessive treatment: Study protocol for a stepped wedge cluster randomised controlled trial. PLoS One. 2023 Mar 21;18(3):e0281447. doi: 10.1371/journal.pone.0281447. eCollection 2023.

    PubMed 36943825

  • Benoit DD, Jensen HI, Malmgren J, Metaxa V, Reyners AK, Darmon M, Rusinova K, Talmor D, Meert AP, Cancelliere L, Zubek L, Maia P, Michalsen A, Vanheule S, Kompanje EJO, Decruyenaere J, Vandenberghe S, Vansteelandt S, Gadeyne B, Van den Bulcke B, Azoulay E, Piers RD; DISPROPRICUS study group of the Ethics Section of the European Society of Intensive Care Medicine. Outcome in patients perceived as receiving excessive care across different ethical climates: a prospective study in 68 intensive care units in Europe and the USA. Intensive Care Med. 2018 Jul;44(7):1039-1049. doi: 10.1007/s00134-018-5231-8. Epub 2018 May 28.

    PubMed 29808345

  • Bekelman JE, Halpern SD, Blankart CR, Bynum JP, Cohen J, Fowler R, Kaasa S, Kwietniewski L, Melberg HO, Onwuteaka-Philipsen B, Oosterveld-Vlug M, Pring A, Schreyogg J, Ulrich CM, Verne J, Wunsch H, Emanuel EJ; International Consortium for End-of-Life Research (ICELR). Comparison of Site of Death, Health Care Utilization, and Hospital Expenditures for Patients Dying With Cancer in 7 Developed Countries. JAMA. 2016 Jan 19;315(3):272-83. doi: 10.1001/jama.2015.18603.

    PubMed 26784775

  • Kompanje EJ, Piers RD, Benoit DD. Causes and consequences of disproportionate care in intensive care medicine. Curr Opin Crit Care. 2013 Dec;19(6):630-5. doi: 10.1097/MCC.0000000000000026.

    PubMed 24240830

  • Curtis JR, Vincent JL. Ethics and end-of-life care for adults in the intensive care unit. Lancet. 2010 Oct 16;376(9749):1347-53. doi: 10.1016/S0140-6736(10)60143-2. Epub 2010 Oct 11.

    PubMed 20934213

Questions about this trial

What is this clinical trial studying?

A study testing CODE II intervention in people with Decision Making ,Shared and Leadership, run by University Hospital, Ghent at 1 site in Belgium.

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 6 inclusion and 2 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: opening soon, as of the sponsor's last update on 9 Apr 2026. 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 Belgium. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dominique Benoit, MD, PhD (+32 (9) 332 27 75, dominique.benoit@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of written DNI-DNACPR order between hospital admission and the end of the first hospital stay (time frame: At the end of the 14 months study period). The study lists 2 primary outcomes in all. 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 NCT07327450, which also lists 13 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 9 Apr 2026.

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