NCT05167019: CODE

Coaching Doctors in Ethical Decision-making (CODE)

Completed NA Last updated 9 May 2024

What this trial tests

NA trial testing CODE intervention in End of Life in 125 participants. Completed in 22 February 2024.

Timeline

21 January 2022

Primary endpoint
19 April 2023

22 February 2024

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	single
Primary purpose	supportive care
Enrollment	125
Start date	21 January 2022
Primary completion	19 April 2023
Estimated completion	22 February 2024
Sites	1 location across Belgium

Drugs / interventions tested

• CODE intervention
• Usual care

Conditions studied

• End of Life — all drugs for End of Life →
• Interdisciplinary Communication — all drugs for Interdisciplinary Communication →
• Leadership — all drugs for Leadership →

Sponsor

University Hospital, Ghent

Who can join

Adults 18 to 110, any sex, with End of Life or Interdisciplinary Communication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

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Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Piers R, Dillen L, Goethals K, Lievrouw A, et al · · 2025 · PMID 41359551 · DOI 10.1371/journal.pone.0337801