Coaching Doctors in Ethical Decision-making (CODE) (CODE)

Coaching Doctors to Improve Ethical Decision-making in Adult Hospitalized Patients Potentially Receiving Excessive Treatment: a Step Wedge Cluster Randomized Trial in 10 Departments of the Ghent University Hospital (CODE)

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

.

Study Overview

• Status: Completed
• Conditions: End of Life; Interdisciplinary Communication; Leadership
• Intervention / Treatment: Other: Usual care; Behavioral: CODE intervention

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

1. Clinicians' level : doctors (including department head) and nurses (including head nurses) taking care of adult hospitalized patients in the 10 participating departments
2. Patients' level : first hospitalization of adult patients who are potentially receiving excessive treatment.
3. Family level : family of adult patients who are potentially receiving excessive treatment

Exclusion criteria :

1. Clinicians'level : no exclusion criteria
2. Patients' level : patients who cannot understand Dutch questionnaires
3. Family : persons who cannot understand Dutch questionnaires

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care	Other: Usual care; 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.
Experimental: The CODE intervention; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of death one year after first hospital admission	Patient-specific endpoint	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).	Patient-specific endpoint	12 months after first hospital admission
Number of days admitted in the hospital up the end of the first hospital stay	Patient-specific endpoint	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	Patient-specific endpoint. Single-item assessment of pain ranging from 0 (no pain) to 10 (worst possible pain).	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	Patient-specific endpoint. Single-item assessment of pain ranging from 0 (no pain) to 10 (worst possible pain).	at the end of the 12 months study period
Potentially inappropriate or burdersome treatments : incidence of achieving the combined patient burdersome treatment endpoint (achieving outcome 9,10,11,12,13,14,15 or 16) up to the end of first hospital stay	Patient-specific endpoint	at the end of the 12 months study period
Potentially inappropriate or burdersome treatments : incidence of receiving cardio-pulmonary resuscitation up to the end of first hospital stay	Patient-specific endpoint	at the end of the 12 months study period
Potentially inappropriate or burdersome treatments : incidence of admission in the intensive care unit up to the end of first hospital stay	Patient-specific endpoint	at the end of the 12 months study period
Potentially inappropriate or burdersome treatments : incidence of invasive mechanical ventilation in the intensive care unit up to the end of first hospital stay	Patient-specific endpoint	at the end of the 12 months study period
Potentially inappropriate or burdersome treatments : incidence of non-invasive mechanical ventilation in the intensive care unit up to the end of first hospital stay	Patient-specific endpoint	at the end of the 12 months study period
Potentially inappropriate or burdersome treatments : incidence of receiving dialysis up to the end of first hospital stay	Patient-specific endpoint	at the end of the 12 months study period
Potentially inappropriate or burdersome treatments : incidence of receiving a surgical procedure up to the end of first hospital stay	Patient-specific endpoint	at the end of the 12 months study period
Potentially inappropriate or burdersome treatments : incidence of receiving a chemotherapeutic treatment up to the end of first hospital stay	Patient-specific endpoint	at the end of the 12 months study period
Potentially inappropriate or burdersome treatments : incidence of receiving a radiotherapeutic treatment up to the end of first hospital stay	Patient-specific endpoint	at the end of the 12 months study period
Satisfaction according to the European Family Satisfaction in the ICU score (Euro FS)	Patient-specific endpoint. The investigators will use the single-item assessment of satisfaction of this score ranging from 0 to 10. Higher values indicate higher satisfaction	3 weeks after hospital discharge
Hospital anxiety and depression scale (HADS)	Patient-specific endpoint. This score is interpreted as follows : 0-7 (normal), 8-10 (mild), 11-21 (moderate to severe)	3 weeks after hospital discharge
European quality of dying and death family questionnaire (Euro-QODD nurse)	Patient-specific endpoint filled out by nurses. The investigators will use the single-item assessment of quality of dying and death of this score ranging from 0 to 10. Higher values indicate higher quality	within 1 week after death
European quality of dying and death family questionnaire (Euro-QODD family)	Patient-specific endpoint filled out by the relatives. The investigators will use the single-item assessment of quality of dying and death of this score ranging from 0 to 10. Higher values indicate higher quality	3 weeks after the patient's death
Satisfaction according to the European Family Satisfaction in the ICU score (Euro FS)	Family-specific endpoint. The investigators will use the single-item assessment of satisfaction of this score ranging from 0 to 10. Higher values indicate higher satisfaction	3 weeks after the patient's hospital discharge
Hospital anxiety and depression scale (HADS)	Family-specific endpoint. This score is interpreted as follows : 0-7 (normal), 8-10 (mild), 11-21 (moderate to severe)	3 weeks after the patient's hospital discharge
Impact of events scale-revised (IES-R)	Family-specific endpoint. This score is interpreted as follows: Low risk (0-11), moderate risk (12-32), high risk (33 or higher) for post-traumatic stress disorder.	3 weeks after the patient's death
Percentage of (mild-moderate-severe-extreme) stress related to a perception of excessive treatment	Clinician-specific endpoint	at the end of the 12 month study period
Percentage of clinicians with intention of leaving their job	Clinician-specific endpoint	at the start and end of the 12 month study period
Percentage of clinicians with sick leave	Team-specific endpoint	at the start and end of the 12 month study period
Ethical pratice score	Team-specific endpoint. This scores consist of 12 items. The investigators will use the 10 department specific items (minus the 2 country-specific items). This score ranges from 0 to 10 with higher scores indicating a higher degree of ethical pratice organization	at the start and end of the 12 month study period
Health-care utilization : total hospital cost by the hospital billing record up to the end of first hospital stay	Society-specific endpoint	at the end of the 12 months study period
Health-care utilization : total number of emergency department visits	Society-specific endpoint	12 months after first hospital discharge
Health-care utilization : total number of hospital admissions	Society-specific endpoint	12 months after first hospital discharge
Health-care utilization : total number of admissions in the intensive care unit	Society-specific endpoint	12 months after first hospital discharge
Health-care utilization : total number of days in the hospital	Society-specific endpoint	12 months after first hospital discharge
Health-care utilization : total number of days in the intensive care unit	Society-specific endpoint	12 months after first hospital discharge
Health-care utilization : total number of dialyses	Society-specific endpoint	12 months after first hospital discharge
Health-care utilization : total number of surgical procedures	Society-specific endpoint	12 months after first hospital discharge
Health-care utilization : total number of chemotherapeutic treatments	Society-specific endpoint	12 months after first hospital discharge
Health-care utilization : total number of radiotherapeutic treatments	Society-specific endpoint	12 months after first hospital discharge
Health-care utilization : total number of blood analyses	Society-specific endpoint	12 months after first hospital discharge
Health-care utilization : total number of radiological investigations	Society-specific endpoint	12 months after first hospital discharge

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Dominique Benoit, MD,PhD, University Hospital, Ghent

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Actual): April 19, 2023
• Study Completion (Actual): February 22, 2024

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Treatment limitation decisions; Interdisciplinary collaboration; Coaching; Self-reflective and empowering leadership; Ethical climate; Prognostic uncertainty
• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: BC-09828

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No