Introduction

The CODE study, performed by our research team between February 2022 and February 2023 in 10 departments of the Ghent university Hospital, suggests for the first time that goal-oriented care operationalized via written do-not-intubate and do-not attempt cardiopulmonary resuscitation (DNI-DNACPR) decisions in hospitalized patients can be improved by coaching doctors in self-reflective and motivating leadership regarding ethical decision-making in teams [1,2] without increasing the mortality at one year. Sixty-tree doctors, 207 nurses and 6614 patients were included in this study. Fifty doctors participated to the coaching intervention for an average of 4.36 ± 2.55 sessions. The qualitative and quantitative analysis of this study further showed the necessity to coach entire teams instead of doctors alone in future interventions [2,3].  

Objectives

To assess whether coaching doctors and nurses regarding ethical decision-making in teams increases 1) the incidence of goal-oriented care operationalized by written DNI-DNACPR decisions in adult patients during their first hospital stay and 2) the perception of the quality of the ethical climate by clinicians. The latter will be measured by the ethical decision-making climate questionnaire (EDMCQ), which was designed and validated internationally by our research team [4,5]

Methods

Similarly to the CODE study, a stepped-wedge cluster randomized controlled trial will be conducted in the medical ICU and 9 referring internal medicine departments of Ghent University Hospital between April 2025 and April 2026. Doctors and nurses in charge of hospitalized patients will fill out the EDMCQ before and after the study period, and will anonymously identify patients potentially receiving excessive treatment via an electronic alert during the entire study period. Patients potentially receiving excessive treatment will be defined similarly to our previous studies [2,5]. These patients will be used during the individual coaching sessions in doctors and team sessions. In absence of such patients the focus will shift to encompass all critical aspects of ethical decision-making pertinent to clinicians. All departments will be randomly assigned to a 4-month coaching. At least one month of coaching will be compared to less than one month coaching and usual care. The first primary endpoint will be the incidence of written DNI-DNACPR decisions in adult patients admitted for the first time in the hospital. The second primary endpoint will be the EDMCQ before and after the study period. The first primary endpoint will be assessed by logistic mixed effect models with random intercept to account for between-department variability, assuming a constant risk before and after intervention, and a linearly changing risk (0 to 1) during the intervention, considering at least one month of coaching for an effect [1,2]. The change in EDMCQ score will be analyzed based on linear mixed effects models including an intervention indicator and a random intercept to account for between-department variability. The power analysis of the CODE II study has still to be performed, however the number of inclusions of the CODE study indicates already that we will be able to include enough clinicians and patients to detect a change in primary and secondary endpoints.     

Conclusion

The CODE II study will be the first stepped-wedge cluster randomized controlled trial that will assess the impact of coaching doctors and nurses regarding ethical decision-making in teams on goal-oriented care in hospitalized patients and the quality of the ethical climate.   

References

1) Benoit DD, Vanheule S, Manesse F et al; 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.

2) Benoit DD, De Pauw A, Jacobs C et al. Coaching doctors to improve ethical decision-making in patients potentially receiving excessive treatment. The CODE stepped-wedge cluster randomized controlled trial. Intensive Care Med 2024 (in press).

3) Piers R, Dillen L, Goethals K et al. Coaching doctors to improve ethical decision-making in patients potentially receiving excessive treatment. Adoption, implementation and maintenance of the CODE study intervention by doctors and nurses. (in review).

4) Van den Bulcke B, Piers R, Jensen HI et al. 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. 

5) Benoit DD, Jensen HI, Malmgren J et al; 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.