ClinicalTrials.Veeva

Menu

Coaching Doctors and Nurses to Improve Ethical Decision-making in Team (CODE II)

G

Ghent University Hospital (UZ)

Status

Begins enrollment this month

Conditions

End of Life Communication
Ethical Sensitivities
Coaching
End of Life Patients
End of Life Decision Making
Decision Making ,Shared
Leadership

Treatments

Behavioral: CODE II intervention
Other: Usual Care Group

Study type

Interventional

Funder types

Other

Identifiers

NCT07327450
ONZ-2025-0602

Details and patient eligibility

About

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 our hospital. In this study, we 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, we 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 our 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 we 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.

Full description

See protocol

Enrollment

360 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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)

Exclusion criteria

  • 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 design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

360 participants in 2 patient groups

Usual care
Active Comparator group
Treatment:
Other: Usual Care Group
CODE II intervention
Experimental group
Treatment:
Behavioral: CODE II intervention

Trial contacts and locations

1

Loading...

Central trial contact

Dominique Benoit, MD, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems