Coaching Doctors in Ethical Decision-making (CODE)

NCT05167019 | Completed DMC

• 1 other identifier: BC-09828
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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. 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 .

Conditions

End of Life; Interdisciplinary Communication; Leadership

Keywords

Treatment limitation decisions; Interdisciplinary collaboration; Coaching; Self-reflective and empowering leadership; Ethical climate; Prognostic uncertainty

Outcome Measures

Primary Outcomes (2)

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

  Patient-specific endpoint

  at the end of the 12 months study period

• 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

  at the start and end of the 12 month study period

Secondary Outcomes (37)

• Incidence of death one year after first hospital admission

  12 months after first hospital admission

• 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).

  12 months after first hospital admission

• Number of days admitted in the hospital up the end of the first hospital stay

  at the end of the 12 months study period

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

  at the end of the 12 months study period

• Pain according to the Numeral rating scale (NRS) : number of days with an average score > 3 up to the end of first hospital stay

  at the end of the 12 months study period

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Usual care

Other: Usual care

The CODE intervention

EXPERIMENTAL

The 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.

Behavioral: CODE intervention

Interventions

CODE intervention BEHAVIORAL

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.

The CODE intervention

Usual care OTHER

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.

Usual care

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients' level : patients who cannot understand Dutch questionnaires
• Family : persons who cannot understand Dutch questionnaires

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Publications (14)

• 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.

  PMID: 23802514 BACKGROUND

• 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.

  PMID: 29475979 BACKGROUND

• 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.

  PMID: 29808345 BACKGROUND

• 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.

  PMID: 24832567 BACKGROUND

• 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.

  PMID: 16253788 BACKGROUND

• 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.

  PMID: 31625980 BACKGROUND

• 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.

  PMID: 11491192 BACKGROUND

• 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.

  PMID: 28882192 BACKGROUND

• 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.

  PMID: 29291585 BACKGROUND

• 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.

  PMID: 6226917 BACKGROUND

• 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.

  PMID: 9089829 BACKGROUND

• 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.

  PMID: 15023089 BACKGROUND

• 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.

  PMID: 41359551 DERIVED

• 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.

  PMID: 39230678 DERIVED

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dominique Benoit, MD,PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded to the 4 months intervention period in junior and senior doctors.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: December 22, 2021
• Study Start: January 21, 2022
• Primary Completion: April 19, 2023
• Study Completion: February 22, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

BE (1)