AzTrials
AzTrials

End of LifeCODENCT05167019

Coaching Doctors in Ethical Decision-making (CODE)

A study testing CODE intervention in people with End of Life and Interdisciplinary Communication, run by University Hospital, Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Over the last few decades the fast technical and medical progress poses a significant challenge to doctors, who are asked to find the right balance between life-prolonging and palliative care. Read more about this study

Who is it for?
Ages 18 to 110 years
What is being tested?
CODE intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteBelgium
Study dates
21 Jan 2022to 22 Feb 2024
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 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinicians' level : doctors (including department head) and nurses (including head nurses) taking care of adult hospitalized patients in the 10 participating departments
  • Patients' level : first hospitalization of adult patients who are potentially receiving excessive treatment.
  • Family level : family of adult patients who are potentially receiving excessive treatment

Who cannot join

  • Clinicians'level : no exclusion criteria
  • Patients' level : patients who cannot understand Dutch questionnaires
  • Family : persons who cannot understand Dutch questionnaires

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Ghent University Hospital

    Ghent, 9000

Other trials in Belgium

About this study

Official title: Coaching Doctors to Improve Ethical Decision-making in Adult Hospitalized Patients Potentially Receiving Excessive Treatment: a Step Wedge Cluster Randomized Trial in 10 Departments of the Ghent University Hospital (CODE)

Over the last few decades the fast technical and medical progress poses a significant challenge to doctors, who are asked to find the right balance between life-prolonging and palliative care. Previous studies suggest that doctors (unconsciously) prefer to remain prognostically uncertain rather than to gather the information that is required to reduce uncertainty and to effectively timely take decisions in the team for the benefit of the patient. To obtain all that information, the doctor in charge of the patient needs to empower clinicians to speak up while guarantying a safe environment. However, creating a safe climate which enhances inter-professional shared decision-making for the benefit of the patient requires specific self-reflective and empowering leadership skills (including the management of group dynamics in the interdisciplinary team).

The aim of this study is to investigate whether coaching doctors in self-reflective and empowering leadership, and in the management of team dynamics with regard to adult hospitalized patients potentially receiving excessive treatment during 4 months 1) improves ethical decision-making (primary objective) and 2) reduces the burden on patients, relatives, clinicians and the society (secondary objective). The improvement in quality of ethical decision-making will be assessed objectively via the incidence of written do-not-intubate and -resuscitate orders (first primary endpoint) in patients potentially receiving excessive treatment and subjectively via the ethical decision-making climate questionnaire that will be filled out by the team (second primary endpoint). In line with the DISPROPRICUS study, patients potentially receiving excessive treatment will be defined as patients who are perceived as receiving excessive treatment by two or more different clinicians in charge of the patient. The probability of being alive, at home with a good quality of life one year after admission was only 7% in patients potentially receiving excessive treatment in this study. Therefore, perceptions of excessive treatment by two or more clinicians are used in this study as a signal to initiate (self-)reflection in team about the quality of care that is provided to the patient and whether the treatment is in balance with the medical condition of the patient and the patient's goal of care

.

Being tested
CODE intervention, Usual care
Keywords
Treatment limitation decisions, Interdisciplinary collaboration, Coaching, Self-reflective and empowering leadership, Ethical climate, Prognostic uncertainty
Medical subject headings
Death

What participants receive

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

  • CODE interventionBehavioural

    The CODE intervention consists of 1) One interactive session of 2 to 3 hrs focusing on the concepts of medical-ethical decision-making, the psychological challenge of dealing with ethically sensitive medical topics, and empowering leadership. 2) Observation and debrief of the interdisciplinary meeting to enhance self-reflection on empowering leadership and managing group dynamics. 3) Individual coaching on the spot in self-reflective and empowering leadership and in managing groups dynamics with regard to ethical decision-making about patients who are perceived to receive excessive treatment during the intervention period, and in absence of such patients, every item with regard to ethical decision-making that is important for the coachee. 4) During the intervention coaches and doctors in charge will be informed of the presence of a patient potentially receiving excessive treatment in their ward by an electronic alert.

  • Usual careOther

    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 practice. 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. In one ward (geriatrics), there is a ongoing project in which a clinical nurse specialist stimulates and performes advance care planning conversations with patient and/or relatives at request of the team and who organizes debriefings when needed based on the ethical concerns of the nurses.

Study groups in NCT05167019
Study groupRoleWhat they receive
Usual careActive comparatorUsual care
Receives: Other: Usual care
The CODE interventionExperimentalThe CODE intervention consists of 4 items, of which individual coaching sessions of 1 hour. In total each doctor taking care of hospitalized patients will be able to receive maximum 16 individual coaching sessions during the 4 months intervention period (one weekly). Every doctor will be invited to participate to at least 8 coaching sessions, to be extended on request, during the intervention period.
Receives: Behavioral: CODE intervention

What is being measured

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

  1. Incidence of written do-not-intubate and -resuscitate (DNIR) order between hospital admission and the end of first hospital stay

    Patient-specific endpoint

    Measured: at the end of the 12 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 iindicate higher quality of ethical decision-making

    Measured: at the start and end of the 12 month study period

Secondary outcomes (37)

  1. Incidence of death one year after first hospital admission

    Patient-specific endpoint

    Measured: 12 months after first hospital admission

  2. Percentage of patients who achieved the combined one year patient 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

    Measured: 12 months after first hospital admission

  3. Number of days admitted in the hospital up the end of the first hospital stay

    Patient-specific endpoint

    Measured: at the end of the 12 months study period

  4. Pain according to the Numeral rating scale (NRS) : sum of the average daily score up to the end of 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 12 months study period

  5. Pain according to the Numeral rating scale (NRS) : number of days with an average score > 3 up to the end of 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 12 months study period

  6. Potentially inappropriate or burdersome treatments : incidence of achieving the combined patient burdersome treatment endpoint (achieving outcome 9,10,11,12,13,14,15 or 16) up to the end of first hospital stay

    Patient-specific endpoint

    Measured: at the end of the 12 months study period

  7. Potentially inappropriate or burdersome treatments : incidence of receiving cardio-pulmonary resuscitation up to the end of first hospital stay

    Patient-specific endpoint

    Measured: at the end of the 12 months study period

  8. Potentially inappropriate or burdersome treatments : incidence of admission in the intensive care unit up to the end of first hospital stay

    Patient-specific endpoint

    Measured: at the end of the 12 months study period

  9. Potentially inappropriate or burdersome treatments : incidence of invasive mechanical ventilation in the intensive care unit up to the end of first hospital stay

    Patient-specific endpoint

    Measured: at the end of the 12 months study period

  10. Potentially inappropriate or burdersome treatments : incidence of non-invasive mechanical ventilation in the intensive care unit up to the end of first hospital stay

    Patient-specific endpoint

    Measured: at the end of the 12 months study period

  11. Potentially inappropriate or burdersome treatments : incidence of receiving dialysis up to the end of first hospital stay

    Patient-specific endpoint

    Measured: at the end of the 12 months study period

  12. Potentially inappropriate or burdersome treatments : incidence of receiving a surgical procedure up to the end of first hospital stay

    Patient-specific endpoint

    Measured: at the end of the 12 months study period

  13. Potentially inappropriate or burdersome treatments : incidence of receiving a chemotherapeutic treatment up to the end of first hospital stay

    Patient-specific endpoint

    Measured: at the end of the 12 months study period

  14. Potentially inappropriate or burdersome treatments : incidence of receiving a radiotherapeutic treatment up to the end of first hospital stay

    Patient-specific endpoint

    Measured: at the end of the 12 months study period

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

    Patient-specific endpoint. The investigators will use the single-item assessment of satisfaction of this score ranging from 0 to 10. Higher values indicate higher satisfaction

    Measured: 3 weeks after hospital discharge

  16. Hospital anxiety and depression scale (HADS)

    Patient-specific endpoint. This score is interpreted as follows : 0-7 (normal), 8-10 (mild), 11-21 (moderate to severe)

    Measured: 3 weeks after hospital discharge

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

    Patient-specific endpoint filled out by nurses. The investigators will use the single-item assessment of quality of dying and death of this score ranging from 0 to 10. Higher values indicate higher quality

    Measured: within 1 week after death

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

    Patient-specific endpoint filled out by the relatives. The investigators will use the single-item assessment of quality of dying and death of this score ranging from 0 to 10. Higher values indicate higher quality

    Measured: 3 weeks after the patient's death

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

    Family-specific endpoint. The investigators will use the single-item assessment of satisfaction of this score ranging from 0 to 10. Higher values indicate higher satisfaction

    Measured: 3 weeks after the patient's hospital discharge

  20. Hospital anxiety and depression scale (HADS)

    Family-specific endpoint. This score is interpreted as follows : 0-7 (normal), 8-10 (mild), 11-21 (moderate to severe)

    Measured: 3 weeks after the patient's hospital discharge

  21. Impact of events scale-revised (IES-R)

    Family-specific endpoint. This score is interpreted as follows: Low risk (0-11), moderate risk (12-32), high risk (33 or higher) for post-traumatic stress disorder.

    Measured: 3 weeks after the patient's death

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

    Clinician-specific endpoint

    Measured: at the end of the 12 month study period

  23. Percentage of clinicians with intention of leaving their job

    Clinician-specific endpoint

    Measured: at the start and end of the 12 month study period

  24. Percentage of clinicians with sick leave

    Team-specific endpoint

    Measured: at the start and end of the 12 month study period

  25. Ethical pratice score

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

    Measured: at the start and end of the 12 month study period

  26. Health-care utilization : total hospital cost by the hospital billing record up to the end of first hospital stay

    Society-specific endpoint

    Measured: at the end of the 12 months study period

  27. Health-care utilization : total number of emergency department visits

    Society-specific endpoint

    Measured: 12 months after first hospital discharge

  28. Health-care utilization : total number of hospital admissions

    Society-specific endpoint

    Measured: 12 months after first hospital discharge

  29. Health-care utilization : total number of admissions in the intensive care unit

    Society-specific endpoint

    Measured: 12 months after first hospital discharge

  30. Health-care utilization : total number of days in the hospital

    Society-specific endpoint

    Measured: 12 months after first hospital discharge

  31. Health-care utilization : total number of days in the intensive care unit

    Society-specific endpoint

    Measured: 12 months after first hospital discharge

  32. Health-care utilization : total number of dialyses

    Society-specific endpoint

    Measured: 12 months after first hospital discharge

  33. Health-care utilization : total number of surgical procedures

    Society-specific endpoint

    Measured: 12 months after first hospital discharge

  34. Health-care utilization : total number of chemotherapeutic treatments

    Society-specific endpoint

    Measured: 12 months after first hospital discharge

  35. Health-care utilization : total number of radiotherapeutic treatments

    Society-specific endpoint

    Measured: 12 months after first hospital discharge

  36. Health-care utilization : total number of blood analyses

    Society-specific endpoint

    Measured: 12 months after first hospital discharge

  37. Health-care utilization : total number of radiological investigations

    Society-specific endpoint

    Measured: 12 months after first hospital discharge

Timeline

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

  1. First posted22 Dec 2021
  2. Study start21 Jan 2022
  3. Primary completion19 Apr 2023
  4. Study completion22 Feb 2024

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
Randomised
Intervention model
Sequential
Model description
Sample size for this stepped wedge randomised controlled trial is listed for patients potentially receiving excessive treatment (n=1700) together with one of their relatives who will be identified by junior doctors (n=75) , senior doctors (n=75) and nurses (n= 600) working in 10 departments of the Ghent university hospital during a 12 months period. Junior and senior doctors working in each department will be coached in self-reflective and empowering leadership, and in managing group dynamics with regard to patients potentially receiving excessive treatment for whom they are in charge of during a 4 month period. The impact of the intervention on the quality of ethical decision-making will be assessed at the patient (n=1700), relatives (n=1700) and team level (n=750).
Masking
Single blind
Who is masked
Participant
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05167019
Sponsor's protocol ID
BC-09828
Acronym
CODE
Status last verified
May 2024
First submitted
1 Oct 2021
Last updated
9 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Smith AK, White DB, Arnold RM. Uncertainty--the other side of prognosis. N Engl J Med. 2013 Jun 27;368(26):2448-50. doi: 10.1056/NEJMp1303295. No abstract available.

    PubMed 23802514

  • Van den Bulcke B, Piers R, Jensen HI, Malmgren J, Metaxa V, Reyners AK, Darmon M, Rusinova K, Talmor D, Meert AP, Cancelliere L, Zubek L, Maia P, Michalsen A, Decruyenaere J, Kompanje EJO, Azoulay E, Meganck R, Van de Sompel A, Vansteelandt S, Vlerick P, Vanheule S, Benoit DD. Ethical decision-making climate in the ICU: theoretical framework and validation of a self-assessment tool. BMJ Qual Saf. 2018 Oct;27(10):781-789. doi: 10.1136/bmjqs-2017-007390. Epub 2018 Feb 23.

    PubMed 29475979

  • 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

  • Piers RD, Azoulay E, Ricou B, DeKeyser Ganz F, Max A, Michalsen A, Azevedo Maia P, Owczuk R, Rubulotta F, Meert AP, Reyners AK, Decruyenaere J, Benoit DD; Appropricus Study Group of the Ethics Section of the European Society of Intensive Care Medicine. Inappropriate care in European ICUs: confronting views from nurses and junior and senior physicians. Chest. 2014 Aug;146(2):267-275. doi: 10.1378/chest.14-0256.

    PubMed 24832567

  • Palda VA, Bowman KW, McLean RF, Chapman MG. "Futile" care: do we provide it? Why? A semistructured, Canada-wide survey of intensive care unit doctors and nurses. J Crit Care. 2005 Sep;20(3):207-13. doi: 10.1016/j.jcrc.2005.05.006.

    PubMed 16253788

  • Jensen HI, Hebsgaard S, Hansen TCB, Johnsen RFA, Hartog CS, Soultati I, Szucs O, Wilson ME, van den Bulcke B, Benoit DD, Piers R. Perceptions of Ethical Decision-Making Climate Among Clinicians Working in European and U.S. ICUs: Differences Between Nurses and Physicians. Crit Care Med. 2019 Dec;47(12):1716-1723. doi: 10.1097/CCM.0000000000004017.

    PubMed 31625980

  • 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

  • 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

  • Gerritsen RT, Jensen HI, Koopmans M, Curtis JR, Downey L, Hofhuis JGM, Engelberg RA, Spronk PE, Zijlstra JG. Quality of dying and death in the ICU. The euroQ2 project. J Crit Care. 2018 Apr;44:376-382. doi: 10.1016/j.jcrc.2017.12.015. Epub 2017 Dec 26.

    PubMed 29291585

  • 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

  • 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

  • van der Ploeg E, Mooren TT, Kleber RJ, van der Velden PG, Brom D. Construct validation of the Dutch version of the impact of event scale. Psychol Assess. 2004 Mar;16(1):16-26. doi: 10.1037/1040-3590.16.1.16.

    PubMed 15023089

  • Piers R, Dillen L, Goethals K, Lievrouw A, Versluys K, 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, Geboes K, Manesse F, Vanheule S, Benoit DD. Coaching doctors to improve ethical decision-making in adult hospitalized patients potentially receiving excessive treatment: Process evaluation study of the CODE intervention in doctors and nurses working in ten acute hospital wards. PLoS One. 2025 Dec 8;20(12):e0337801. doi: 10.1371/journal.pone.0337801. eCollection 2025.

    PubMed 41359551

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing CODE intervention in people with End of Life and Interdisciplinary Communication, 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 3 inclusion and 3 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 9 May 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 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?

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?

Incidence of written do-not-intubate and -resuscitate (DNIR) order between hospital admission and the end of first hospital stay (time frame: at the end of the 12 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 NCT05167019, which also lists 14 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 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in