Coaching Doctors and Nurses to Improve Ethical Decision-making in Team

NCT07327450 | Not Yet Recruiting DMC

• 1 other identifier: ONZ-2025-0602
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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 the Ghent University Hospital. In this study, the investigators 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, the investigators 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 the 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 the investigators 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.

Conditions

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

Keywords

Coaching; Shared decision-making; Goal-oriented care; Ethical climate; Leaderschip; Communication; End-of-life

Outcome Measures

Primary Outcomes (2)

• Incidence of written DNI-DNACPR order between hospital admission and the end of the first hospital stay

  Patient-specific endpoint

  At the end of the 14 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 indicate higher quality of interdisciplinary ethical decision-making

  at the start and the end of the 14 month study period

Secondary Outcomes (29)

• Hospital Consumer Assessment of Healthcare Providers and Systems instrument

  3 weeks after the patient's hospital discharge

• Sinclair Compassion Questionnaire-Short Form (SCQ-SF)

  3 weeks after the patient's hospital discharge

• Satisfaction according to the European Family Satisfaction in the ICU (Euro-FS) score

  3 weeks after the patient's hospital discharge

• Hospital Anxiety and Depression Scale (HADS)

  3 weeks after hospital discharge

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

  3 weeks after the patient's hospital discharge

Other Outcomes (11)

• Health-care utilization : total hospital cost by the hospital billing record up to one year after the first hospital admission

  12 months after first hospital admission

• Health-care utilization : total number of emergency department visits up to one year after the first hospital admission

  12 months after first hospital admission

• Health-care utilization : total number of hospitalizations up to one year after the first hospital admission

  12 months after first hospital admission

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Other: Usual Care Group

CODE II intervention

EXPERIMENTAL

Behavioral: CODE II intervention

Interventions

Usual Care Group 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 pratice. 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.

Usual care

CODE II intervention BEHAVIORAL

1\) One interactive session of two hours focusing on the concepts of medical-ethical decision-making, the psychological challenge of dealing with ethically sensitive medical topics, empowering leadership and the importance of "speaking up" within the team. 2) Every clinician will be invited to provide perceptions of excessive treatment via the electronic patient file. Once a patient is identified by two or more different clinicians, an email will be sent to coaches and the clinicians in charge of the PET during intervention period. 3) The 4 months coaching intervention will consist of : a. Doctors and head nurses : individual coaching sessions in self-reflective and empowering leadership and in managing groups dynamics with regard to ethical decision-making in team about PET patients. b. All clinicians : multidisciplinary coaching during work shift hand-overs and structured metareflective sessions on specific themes related to ethical decision-making in team about PET.

CODE II intervention

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, East-Flanders, 9000, Belgium

Location

Related Publications (13)

• Gerritsen RT, Koopmans M, Hofhuis JG, Curtis JR, Jensen HI, Zijlstra JG, Engelberg RA, Spronk PE. Comparing Quality of Dying and Death Perceived by Family Members and Nurses for Patients Dying in US and Dutch ICUs. Chest. 2017 Feb;151(2):298-307. doi: 10.1016/j.chest.2016.09.003. Epub 2016 Sep 19.

  PMID: 27660153 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

• 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

• 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

• Sinclair S, Kondejewski J, Hack TF, Boss HCD, MacInnis CC. What is the Most Valid and Reliable Compassion Measure in Healthcare? An Updated Comprehensive and Critical Review. Patient. 2022 Jul;15(4):399-421. doi: 10.1007/s40271-022-00571-1. Epub 2022 Feb 2.

  PMID: 35107822 BACKGROUND

• US Department of Health and Human Services. Hospital compare quality of care. 2011. www.hospitalcompare.hhs.gov

  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

• 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 BACKGROUND

• Benoit DD, Vanheule S, Manesse F, Anseel F, De Soete G, Goethals K, Lievrouw A, Vansteelandt S, De Haan E, Piers R; 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. doi: 10.1371/journal.pone.0281447. eCollection 2023.

  PMID: 36943825 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

• Bekelman JE, Halpern SD, Blankart CR, Bynum JP, Cohen J, Fowler R, Kaasa S, Kwietniewski L, Melberg HO, Onwuteaka-Philipsen B, Oosterveld-Vlug M, Pring A, Schreyogg J, Ulrich CM, Verne J, Wunsch H, Emanuel EJ; International Consortium for End-of-Life Research (ICELR). Comparison of Site of Death, Health Care Utilization, and Hospital Expenditures for Patients Dying With Cancer in 7 Developed Countries. JAMA. 2016 Jan 19;315(3):272-83. doi: 10.1001/jama.2015.18603.

  PMID: 26784775 BACKGROUND

• Kompanje EJ, Piers RD, Benoit DD. Causes and consequences of disproportionate care in intensive care medicine. Curr Opin Crit Care. 2013 Dec;19(6):630-5. doi: 10.1097/MCC.0000000000000026.

  PMID: 24240830 BACKGROUND

• Curtis JR, Vincent JL. Ethics and end-of-life care for adults in the intensive care unit. Lancet. 2010 Oct 16;376(9749):1347-53. doi: 10.1016/S0140-6736(10)60143-2. Epub 2010 Oct 11.

  PMID: 20934213 BACKGROUND

MeSH Terms

Conditions

Communication; Death

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dominique Benoit, MD, PhD

CONTACT

+32 (9) 332 27 75; dominique.benoit@uzgent.be

Study Design

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

Model Details: In total 50 to 75 junior doctors, 50 to 75 senior doctors (including medical head of department), 300 to 500 nurses (including head nurses) and 100 to 200 allied health professionals working in 10 departments of the Ghent University Hospital are eligible for this study and about 350 to 700 adult patients potentially receiving excessive treatment who did not yet receive a written DNI-DNACPR order together with one of their relatives. Stepped wedge cluster randomized trial in 10 hospital wards combined with pre- and post-measurement of the ethical climate.

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)