Coaching Doctors and Nurses to Improve Ethical Decision-making in Team: a Stepped Wedge Cluster Randomized Trial in 10 Departments of the Ghent University Hospital
Phase: NA
Conditions: Decision Making ,Shared, Leadership, End of Life Communication, End of Life Decision Making, End of Life Patients, Ethical Sensitivities, Coaching
Sponsor: University Hospital, Ghent

CODE II study 
 
 
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Coaching doctors and nurses to improve  
ethical decision-making in team: a stepped 
wedge cluster randomized trial in 10 
departments of the Ghent University 
Hospital.  
 
 
Acronym / Protocol code 
 
 
 
CODE II-study 
 
Protocol version and date 
 
 
 
Version 1.1  February 13, 2026 
 
NCT number  
 
 
 
 
NCT07327450 
 
 
 

CODE II study 
 
 
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Coaching doctors and nurses to improve  
ethical decision-making in team: a stepped 
wedge cluster randomized trial in 10 
departments of the Ghent University 
Hospital.  
 
 
Acronym / Protocol code 
 
 
 
CODE II-study 
Protocol version and date 
 
 
 
Version 1.1  February 13, 2026 
Phase  
 
 
 
 
 
NA 
EudraCT n° 
 
 
 
 
 
NA 
Sponsor 
 Ghent University Hospital 
Financial/Material Support: 
 Fund for Innovation and Clinical studies of 
the Ghent University Hospital / BOF Basis 
financiering onderzoek  
 
Coordinating Investigator: 
 
 
 
Dominique D. BENOIT 
 
 
 
 
 
 
 
Department of Intensive Care Medicine 
 
 
 
 
 
 
 
Ghent University Hospital  
 
 
 
 

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Coaching doctors and nurses to improve  
ethical decision-making in team: a stepped 
wedge cluster randomized trial in 10 
departments of the Ghent University 
Hospital  
 
 
Protocol Coordinating Investigator signature page 
 
I certify that I will conduct the study in compliance with the protocol, any amendments, 
GCP and the declaration of Helsinki, and all applicable regulatory requirements. 
 
 
Investigator: 
 
 
Name: Dominique D. BENOIT 
 
 
Function: MD, PhD, Head of the Department of Intensive Care Medicine 
 
 
Institution: Ghent University Hospital, Ghent, Belgium  
 
 
 
Date: February 13 2026  
 
 
 
 
Signature: 
 
 

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TABLE OF CONTENTS 
 
LIST OF ABBREVIATIONS ................................................................................................................. 7 
1. 
Protocol Summary ........................................................................................................................ 8 
1.1. 
Title ......................................................................................................................................... 8 
1.2. 
Protocol specifics .................................................................................................................. 8 
1.3. 
Study Type and Study Phase ............................................................................................. 8 
1.4. 
Aim of the study (including primary endpoints) ................................................................ 8 
1.5. 
Subjects .................................................................................................................................. 8 
1.5.1. 
Number of subjects ....................................................................................................... 9 
1.5.2. 
Target group .................................................................................................................. 9 
1.6. 
Inclusion and exclusion criteria ........................................................................................... 9 
1.7. 
Study Interventions ............................................................................................................. 10 
1.7.1. 
Schematic overview of the data collection & interventions .................................. 12 
1.8. 
Study duration ..................................................................................................................... 14 
1.8.1. 
For an individual subject ............................................................................................ 14 
1.8.2. 
For the whole study .................................................................................................... 14 
2. 
Rationale and background ........................................................................................................ 15 
2.1. 
Risk/Benefit Assessment ................................................................................................... 16 
2.2. 
Limitations ............................................................................................................................ 17 
3. 
Objectives .................................................................................................................................... 18 
3.1. 
Primary Objectives ............................................................................................................. 18 
3.2. 
Secondary Objectives ........................................................................................................ 18 
3.3. 
Tertiary Objectives .............................................................................................................. 19 
End Points + Time Points .................................................................................................................. 20 
3.4. 
Primary End Points + Time Points ................................................................................... 20 
3.5. 
Secondary End Points + Time Points .............................................................................. 20 
3.6. 
Tertiary/Exploratory End Points ........................................................................................ 21 
In order to evaluate the quality of the implementation of coaching, we added process 
measures based on the RE-AIM implementation framework. ................................................. 21 
4. 
Study design ................................................................................................................................ 22 
4.1. 
Description of study design ............................................................................................... 22 
4.1.1. 
For an individual subject ............................................................................................ 22 
4.1.2. 
For the whole study .................................................................................................... 22 

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4.2. 
Estimated duration of the study ........................................................................................ 22 
4.2.1. 
For an individual subject ............................................................................................ 22 
4.2.2. 
For the whole study .................................................................................................... 23 
5. 
Inclusion and Exclusion Criteria ............................................................................................... 24 
5.1. 
Inclusion Criteria ................................................................................................................. 24 
5.2. 
Exclusion Criteria ................................................................................................................ 24 
5.2.1. 
Screen failures ............................................................................................................ 24 
6. 
Target Population ....................................................................................................................... 25 
6.1. 
Subjects ................................................................................................................................ 25 
6.1.1. 
Number of subjects and planned recruitment rate................................................. 25 
6.1.2. 
Withdrawal and replacement of subjects ................................................................ 25 
6.2. 
Method of recruitment ........................................................................................................ 25 
6.3. 
Screening ............................................................................................................................. 26 
7. 
Study Specific Procedures ........................................................................................................ 27 
7.1. 
Recruitment ......................................................................................................................... 27 
7.2. 
Randomisation/blinding ..................................................................................................... 27 
7.3. 
Overview of collected data ................................................................................................ 28 
7.4. 
Schematic overview of the data collection & interventions .......................................... 30 
8. 
Statistical Considerations .......................................................................................................... 31 
8.1. 
Sample size calculation ..................................................................................................... 31 
8.2. 
Type of statistical methods ................................................................................................ 31 
8.3. 
Statistical analysis team .................................................................................................... 32 
8.4. 
Interim analysis ................................................................................................................... 32 
9. 
Data handling .............................................................................................................................. 33 
9.1. 
Method of data collection ................................................................................................... 33 
9.1.1. 
Case Report Form ...................................................................................................... 33 
9.2. 
Data storage ........................................................................................................................ 33 
9.3. 
Archiving of data ................................................................................................................. 34 
9.4. 
Access to data ..................................................................................................................... 34 
10. 
Monitoring/Auditing/Inspection ............................................................................................. 35 
10.1. 
Monitoring ........................................................................................................................ 35 
10.2. 
Inspection ......................................................................................................................... 35 
10.3. 
Non-compliance policy ................................................................................................... 35 
10.4. 
Serious breach to GCP and/or the protocol ................................................................ 35 
11. 
Ethical and legal aspects ....................................................................................................... 36 

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11.1. 
Good Clinical Practice .................................................................................................... 36 
11.2. 
Informed Consent ........................................................................................................... 36 
11.3. 
Approval of the study protocol ...................................................................................... 37 
11.3.1. 
General ..................................................................................................................... 37 
11.3.2. 
Protocol amendments and urgent safety measures .......................................... 37 
11.4. 
Confidentiality and Data Protection .............................................................................. 37 
11.5. 
Liability and Insurance ................................................................................................... 38 
12. 
Publication policy .................................................................................................................... 39 
Reference List ..................................................................................................................................... 40 
13. 
Appendices .............................................................................................................................. 44 
13.1. 
Appendix 1: Coaching protocol ..................................................................................... 44 
 
 
 

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LIST OF ABBREVIATIONS 
 
APPROPRICUS  
=  
Appropriateness of care in the ICU 
CI 
 
 
= 
Coordinating Investigator 
CODE  
 
= 
COaching Doctors and nurses in Ethical decision-making 
CT 
 
 
= 
Clinical Trial Unit 
DISPROPRICUS 
= 
Disproportionate care in the ICUs 
DNI-DNACPR  
= 
 Do-not-intubate 
and 
do-not 
attempt 
cardiopulmonary                      
resuscitation  
EC 
 
 
= 
Ethics Committee 
EDMCQ 
 
= 
Ethical Decision-making Climate Questionnaire 
eCRF  
 
= 
electronic Case Report Form 
EDC 
 
 
= 
Electronic Data Capture 
EPD 
 
 
= 
Electronic Patient Dossier 
FPI 
 
 
= 
First Patient In 
GCP  
 
= 
Good Clinical Practice 
GDPR  
 
= 
General Data Protection Regulation 
HIRUZ  
 
= 
Health, Innovation and Research Institute UZ Ghent 
ICF 
 
 
= 
Informed Consent Form 
ICU 
 
 
=  
Intensive Care Unit 
LVLS  
 
= 
Last Visit, Last Subject 
PI 
 
 
= 
Principal Investigator 
 
 

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1. Protocol Summary 
 
1.1. 
Title 
 
Coaching doctors and nurses to improve  ethical decision-making in team: a stepped wedge 
cluster randomized trial in 10 departments of the Ghent University Hospital  
 
1.2. 
Protocol specifics 
 
EudraCT number : NA 
Sponsor : Ghent University Hospital 
 
1.3. 
Study Type and Study Phase 
 
Stepped wedge cluster randomized study 
 
1.4. 
Aim of the study (including primary endpoints) 
 
The aim of this study is to investigate whether coaching doctors and nurses to enhance ethical 
decision-making in team during 4 months improves 1) goal-oriented care operationalized via 
written do-not-intubate and do-not attempt cardiopulmonary resuscitation (DNI-DNACPR) 
orders in patients potentially receiving excessive treatment during their first hospitalization (first 
primary objective) and 2) the quality of the ethical climate (second primary objective).  
Secondary endpoints aims at assessing whether the intervention reduces the burden on 
patients potentially receiving excessive treatment and their family, clinicians (doctors, nurses 
and allied health professionals) and the society.     
    
1.5. 
Subjects 
 
 
Head of the Department  
 
Junior and senior doctors  
 
Nurses and head nurses 
 
Allied health professionals (psychologists, physical therapists, speech 
therapists, occupational therapists, social workers, spiritual care providers)   
 
Patients potentially receiving excessive treatment who did not yet receive a 
DNI-DNACPR order during their first hospitalization (for rating quality of care / 
communication and psychosocial well-being) 

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 
Relatives of patients potentially receiving excessive treatment who did not yet 
receive a DNI-DNACPR order during their first hospitalization (for rating quality 
of care / communication and psychosocial well-being) 
     
1.5.1. Number of subjects 
 
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. The 
participating departments are : Cardiology, Gastro-enterology and Hepatology, General 
Internal Medicine, Geriatrics, Hematology, Medical Oncology, Neurology, Nephrology 
(including dialysis unit), Pulmonology and the Medical ICU.  
 
1.5.2. Target group 
 
All clinicians (doctors, nurses and allied health professionals)  taking care of hospitalized 
patients in the 10 participating departments of the Ghent University Hospital are eligible for the 
intervention. They will be coached with regard to hospitalized patients who are perceived as 
receiving excessive treatment according to two or more different clinicians in the team. 
Excessive treatment was initially defined in the DISPROPRICUS and CODE study as 
treatment that is perceived to be no longer consistent with the expected survival or quality of 
life (“too much treatment”) or that is perceived as being provided against the patient’s or 
relatives’ wishes [1-3]. This definition entails thus potentially futile, non-beneficial, 
inappropriate or even harmful treatments [4,5] which has been estimated to be provided to 33–
38% of patients near the end-of-life [6], as well as treatments that are potentially being provided 
without voluntary and informed consent [4]. Based on the feedback of participants of the CODE 
study [3], we changed the definition in the current study to “I doubt whether the treatment or 
treatment limitation code is consistent with the expected survival or quality of life (“too much” 
or “excessive treatment”) or whether the treatment or treatment limitation code is in line with 
the patient’s or relatives’ goals. Hereby, we want to reduce the fear of nurses and other health 
care professionals of blaming doctors [3] and subsequently increase early identification of such 
patients in the current study.   
These patients will subsequently be included for data collection at the patient, relative and 
societal level. Because “patients who are perceived as receiving excessive treatment 
according to two or more clinicians” had a probability of surviving with a good quality of life at 
home at one year of 7% in the large multicenter DISPROPRICUS study [1], these patients will 
be systematically denominated from now on as “patients potentially receiving excessive 
treatment” and abbreviated as “PET” throughout the entire protocol for ease of reading. 
 
1.6. 
Inclusion and exclusion criteria 
 
 
doctors  

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o inclusion: all junior and senior doctors (including medical head of department) 
taking care of hospitalized patients in the 10 participating departments of the 
Ghent University Hospital 
 
nurses and allied health care professionals 
o inclusion: all nurses (including the head nurses) taking care of hospitalized 
patients in the 10 participating departments of the Ghent University Hospital  
o inclusion: all allied health care professionals  taking care of hospitalized patients 
in the 10 participating departments of the Ghent University Hospital 
 
patients and family members 
o inclusion: First hospitalization of PET hospitalized in the 10 participating 
departments of the Ghent University Hospital who did not yet receive a written 
DNI-DNACPR order.  
o exclusion:  
 
being younger than 18 years old  
 
not able to fill in Dutch questionnaires  
 
1.7. 
Study Interventions 
 
1) All participating health care professionals will be invited for one interactive session of 
approximately 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. This session will present 
coaching as a support mechanism for professional development.  
2) During the intervention coaches and clinicians in charge will be informed of the presence 
of a PET in their ward by an electronic alert. Every clinician will be invited to provide 
perceptions of excessive treatment via the EPD. 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 patient. 
3) The 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.  
Focus of the individual coaching   
a) Learning to acknowledge the patient’s (and relatives’) subjective goals, emotions 
and values, and separate them from own and colleagues’ subjective goals, 
emotions and values trigged by that situation. 
b) Learning to acknowledge patient’s (and relatives’), colleagues’ and own 
spontaneous defensive avoidance strategies in coping with difficult and aversive 
care-related situations, like end-of-life decisions. 
c) Learning to identify and separate internal avoidance strategies from external 
barriers to better delineate the responsibilities of each stakeholder in the process.  

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d) Learning to cope more effectively with these internal and avoidance strategies and 
external barriers to enable more appropriate and timely decisions for the benefit of 
the patient. 
e) Learning to integrate newly acquired insights into an adapted way of thinking and 
relating with others to establish a sustainable effect with regards to ethical 
decision-making. 
f) Learning to transfer these insights into empowering leadership behavior which 
contributes to dialogue during the interdisciplinary meeting. 
 
Focus of the team coaching   
a) Learning to acknowledge the patient’s (and relatives’) subjective goals, emotions 
and values, and separate them from own and colleagues’ subjective goals, 
emotions and values trigged by that situation. 
b) Learning to acknowledge patient’s (and relatives’), colleagues’ and own 
spontaneous defensive avoidance strategies in coping with difficult and aversive 
care-related situations, like end-of-life decisions. 
c) Learning to identify and separate internal avoidance strategies from external 
barriers to better delineate the responsibilities of each stakeholder in the process.  
d) Learning to cope more effectively with these internal and avoidance strategies and 
external barriers to enable more appropriate and timely decisions for the benefit of 
the patient. 
e) Learning to integrate newly acquired insights into an adapted way of thinking and 
relating with others to establish a sustainable effect with regards to ethical decision-
making. 
f) Learning to transfer these insights into self-steering participative behavior which 
contributes to dialogue during the interdisciplinary meeting.  
 
Quality of the coaching  
Coaching and supervision will be done by professionals who are certified by 
international standards, hold a degree in human sciences and have experience in 
leadership development. The independent experienced supervisor has a normative, 
formative and restoring role. The normative role of the supervision aims at monitoring 
the quality of the coaching methodology and ethical aspects with regard to the study 
aims. The formative role aims at supporting the coach in further developing and refining 
his/her skills in general and more specifically with regard to the study aims. The 
restorative role aims at guaranteeing the energy of the coach and at resolving potential 
conflicts due to emotional or unconscious dynamics in the clinical team. This will be 
done in collaboration with the “cell wellbeing” of the Ghent University Hospital, in line 
with the contracted mandate to securing the ethical boundaries of the supervision.  
We refer to the appendix for the detailed methodology 
a) 
the methodology, used by the coaches during the intervention 
b) 
the quality assurance process, used during supervision 
c) 
the references to the international standards 

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1.7.1. Schematic overview of the data collection & interventions 
 
a) Schematic overview of data collection  
 
 
Department characteristics by head nurse and medical head of department:  
T0 + T3  
 
Baseline demographic (age, years pf experience, role…) variables in clinicians 
(T0 + T3)  
 
EDMCQ  by clinicians (nurses, doctors and allied health care professionals):  
T0 + T3. 
 
Daily perceptions of clinicians (nurses, doctors and allied health care 
professionals): daily during the 14 month study period (between T0 and T3). 
 
Inclusion of PETs: daily during the 14 month  study period (between T0 and T3). 
 
Datacollection in PETs: during hospitalization (baseline demographic variables, 
comorbidities, admission reasonEuro-QoL 5D and severity of illness, daily NRS 
and written DNI-DNACPR orders during admission), 3 weeks after discharge 
(Hospital Consumer Assessment of Health care Providers and System 
Instrument, Sinclair Compassion questionnaire-Short form, Euro-FS, HADS), from 
admission up to one year (potentially inappropriate burdensome treatments) and 1 
year after hospital admission (mortality, living at home and EURO-Qol 5D) (T4). 
 
Datacollection in relatives of PETs : 3 weeks after discharge (Hospital Consumer 
Assessment of Health care Providers and System Instrument, Sinclair 
Compassion questionnaire-Short form, Euro-FS, HADS and Euro-QODD 
concerning patient who died in the ward) 
 
 
 
Evaluation of the CODE II coaching intervention in participants  via survey: T2. 
 
T0: Pre-intervention  
T1: start of the intervention period (depends on the randomization per team) 
T2: end of the intervention period of 4 months (depends on the randomization per team) 
T3: end of the study period of 14 months 
T4: Post-intervention  
 
*Patients and their families are asked  
 
during hospitalization: informed consent and basic characteristics during hospitalization 

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 
3 weeks after discharge: survey on wellbeing, rating of quality of care, communication and 
decision-making 
 
*Patients are asked 
1 year after hospital admission: survey on living situation 
 
 
 
 

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b) Schematic overview of stepped wedged protocol  (Fig 1) 
 
 
 
 
The intervention will be conducted in 10 departments over 14 months. A maximum of 4 
departments will be coached at the same time.  
 
1.8. 
Study duration 
 
1.8.1. For an individual subject 
 
 
Clinicians will be  coached during for 4 months (T1-T2) 
 
Clinicians’  daily perceptions: 14 months (T0-T3) 
 
Head nurses and medical heads of department (for department characteristics): T0 
and T3  
 
PET are surveyed upon admission, 3 weeks and 1 year after hospital discharge 
 
Family members are surveyed 3 weeks after hospital discharge 
 
1.8.2. For the whole study 
 
26 months including 14 months of coaching and the collection of the combined endpoint after 
one year    
 
Met opmerkingen [DB1]: Anouska of ruth kunnen jullie 
hier het nieuwe schema toevoegen ? Met dank

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2. Rationale and background 
 
Because of copyright issues and the fact that the rationale and background of the current are 
similar to the CODE study, we refer for these chapters to the CODE study protocol and the 
results that we were published in Plos One [2] and Intensive care Medicine [3], respectively.  
 
Literature [7-18] and a pilot study performed in 2019 [2] 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 [13,19,20] and in the Ghent University Hospital [2]. The CODE study intervention 
performed in 2021 suggests already an improvement in goal oriented care operationalized via 
written DNI-DNACPR in our hospital. In this study, we found a nearly doubling of the incidence 
in written DNI-DNACPR (from 19.7% to 29.7%, p<0.001) in PET after coaching doctors during 
4 months in self-reflective and empowering leadership, and coping with group dynamics [3]. 
However, we found no improvement in the perception of the quality of the ethical climate by 
clinicians [3], more specifically by nurses [21] and despite the fact that ethical decision-making 
is considered a strategic priority in our hospital [3] and an intense communication campaign, 
clinicians identified a much smaller number of PET during this interventional study than during 
our observational pilot study in 2019 [2]. 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 [3]. 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 together with the incidence of written DNI-DNACPR decisions in the 
overall study population that remained low after the intervention (3.4%) in comparison to the 
1-year mortality (14.5%) highlights the need to additionally coach the entire team in future 
studies [3]. 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) [22,24-31], and confidence in speaking up in nurses and other health 
care professionals [7,22-25,30-32]. 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.  
   
The CODE II study intervention will be compared with the standard of care. 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. Therefore, we expect a high variability in ethical decision-
making across wards, as observed in the CODE study. Besides the primary outcomes (written 
DNI-DNACPR orders and EDMCQ) all factors related to quality of end-of-life care (mortality 
and survival with a good quality of live at home, satisfaction of the family with regard to 
communication and end-of-life care…) will be analyzed as secondary outcomes. Since time 
will be taken into account in our analysis, we will also be able to assess the impact of the 
number of coaching sessions on these outcomes within and between wards.  
 
 
 

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2.1. 
Risk/Benefit Assessment 
 
Similarly to the CODE study [2,3], the current intervention is directed towards clinicians  
whereas the impact of the intervention will be measured at the patients’, relatives’ and 
clinicians’ levels. Given the consequences of providing excessive treatment at all levels [1-3, 
8,9,22] our intervention has a favorable risk to benefit ratio.  
1) Only clinicians  who are interested to be coached and as such consent to participate will be 
included in the study. Participating clinicians will be coached by experienced coaches. The 
coaches will be supervised by a supervisor coach. The intervention is endorsed by the strategic 
quality cell and the medical council and is therefore completely embedded in the existing Ghent 
University Hospital structure. The safety, in case of for instance conflicts within the team, will 
be guaranty by the HR department together with the coach supervisor. Potential conflict with 
patients or relatives will be management as usual, by the doctor in charge or the head of the 
department in collaboration with the ombudsperson. Finally, all department heads, head 
nurses and teams of the 10 participating departments were very enthusiastic about the overall 
and department specific CODE study results and subsequently the rationale for this 
intervention during the respective meetings that were organized in Sept 2024-May 2025. They 
see this intervention as a second real opportunity for personal and team development with 
regard to ethically distressing situation rather than as a treat.   
2) One could argue that this intervention may shorten the patient’s life. Firstly, although this 
may be an issue, it is important to note that the primary intention of this intervention is not to 
shorten life but to reduce excessive treatment, and as such, suffering of patients with a high 
risk of dying [2]. By allowing clinicians to express anonymous perceptions of excessive 
treatment and by explicitly include doubt into the adapted definition of excessive treatment 
care, we hope that timely identification of patients potentially receiving excessive treatment  
will improve (sensitivity) on the one hand and that  the quality of decision-making will be better 
guaranty by enhancing reflection and decision-making in team while taking the wishes of 
patients and relatives into account on the other (specificity). It is also of note that patient’s 
safety increases in such a setting because direct communication and negotiation between 
doctors and between doctors and nurses will expand. This will enhance fine-tuned decision-
making for the benefit of the patient, and will reduce avoidance behavior in complex clinical 
situations. Secondly, previous interventions aiming at reducing excessive treatment in the field 
of palliative care, advance care planning or intensive care medicine have shown to increase 
the quality of life in patients at risk of dying without shortening the survival [32-36]. This was 
further confirmed in the CODE study. The intervention increased written DNI-DNACPR orders 
without increasing the one-year mortality in both, PET and the overall patient population [3]. 
Because of all these reasons we decided to further use written DNI-DNACPR orders as a 
surrogate maker for goal-oriented care as primary endpoint and consider mortality and survival 
with a good quality of live at home again as secondary endpoints. Thirdly, treatment-limitation-
decisions, at least written DNI-DNACPR orders, aim at clarifying to the patients, relatives and 
the team what to do in case of deterioration and is therefore also not uniformly associated with 
mortality [2]. Finally, we decided to power our intervention to detect an increase in written DNI-
DNACPR 20% to 40% and not higher, because this would not be a realistic expectation and 
because 7% of patients potentially receiving excessive treatment are still alive, at home with a 
good quality of life after 1 year [1].     
 

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2.2. 
Limitations 
 
Our study has several limitations. Firstly, the participating wards were not selected at random, 
which may affect the external validity of our results. However, although we decided to perform 
this study in wards that were enthusiastic to participate, and hereby already acknowledge room 
for improving in ethical decision-making, we expect a high variability in ethical decision-making 
climates across wards as suggested by the high variability in incidence of patients potentially 
receiving excessive care and written  DNI-DNACPR order in the pilot observation [2]. This was 
confirmed in the CODE study [3]. This will enable us to assess the effect of our intervention 
across different ethical climates and to make recommendations with regards to our intervention 
for other departments centers. Secondly, in contrast to a drug which often has a clear biological 
mechanism, coaching consists of many different techniques which may have different effects 
in different situations. To minimize this issue our coaches will work according to the guideline 
in the appendix, which proposes different techniques for different situations. The different 
techniques and situations will also be collected during the study to perform a post-hoc 
exploratory analysis (see tertiary endpoints). Thirdly, the effect of the intervention may depend 
on the skills and experience of the coach. We decided to work with an experienced coaches 
under supervision of a senior coach to guarantee that across all coaching situations, detailed 
attention is paid to all relevant aspects of the medical ethical decision-making process, and to 
leadership as well as productive and counterproductive group dynamics in the team. Finally, 
the coachability of clinicians might be an issue. Although we acknowledge this potential 
shortcoming, our aim is to stay as close as possible to the real situation at the bedside. 
Moreover, based on the satisfaction of the participants and the feedback of the coaches in the 
CODE study we estimate that few clinicians will be un-coachable in the current study. 
Therefore, we plan only to perform an intention to coach analysis.  
 

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3. Objectives  
 
3.1. 
Primary Objectives 
 
The primary objective of this study is to investigate whether coaching 1) doctors and head 
nurses individually in self-reflective and empowering leadership and in managing team 
dynamics and 2) doctors, nurses and allied health care professionals via multidisciplinary 
coaching during work shift hand-overs and structured case work sessions during 4 months 
with regard to hospitalized PET improves goal oriented care in comparison with standard of 
care. The quality of medical ethical decision-making will be assessed objectively via the 
incidence of written DNI-DNACPR orders in PET (first primary endpoint) and subjectively via 
the EDMCQ that will be filled out by the doctors, nurses and allied health professionals in the 
team (second primary endpoint). This 30-item validated questionnaire consists of 7 main 
domains or factors: F1 “self-reflective and empowering leadership of doctors”, F2 “open and 
interdisciplinary reflection”, F3 “not avoiding end-of-life decisions”, F4 “mutual respect within 
the interdisciplinary team”, F5 “active involvement of nurses in end-of-life care and decision-
making”, F6 “active decision-making by doctors”, F7 “ethical awareness”.    
These primary objectives can be formalized in the following two study hypotheses:  
 
The intervention changes the incidence of written DNI-DNACPR order (over the duration 
of hospital stay) in hospitalized PET without previous written DNI-DNACPR order from 
20% (under standard of care) to 40% (in the intervention arm) over the 14-month study 
period. 
 
The intervention increases the average EDMCQ score in clinicians (doctors and nurses) 
by 2.8 points over the 4-month coaching period.  
 
 
We decided to use two endpoints because ethical sensitive decisions and the climate in 
which these decisions are taken are intrinsically connected with each other. Furthermore, it is 
important to keep in mind that doctors are the only professionals who are medico-legally 
allowed to take written DNI-DNACPR  orders with or without the team (after consent of the 
patient or relatives) while they represent only 20% of the clinicians that will potentially fill out 
the EDMCQ.  
 
 
Both null hypotheses that will be tested express no change (as opposed to change).  
 
 
We refer to the previous chapter (risk / benefit assessment) for the justification of the primary 
endpoints.  
 
3.2. 
Secondary Objectives 
 
The secondary objective of this study is to investigate whether the intervention reduces 
the burden of patients, relatives, clinicians and costs in comparison to standard of care.  
The hypotheses are as follows: 

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 
On patient level 
o No excess 1 year mortality (+ combined endpoint) in PETs who did not 
yet receive a written DNI-DNACPR order  (effectiveness and safety) 
o PETs who did not yet receive a written DNI-DNACPR order feel more 
involved in decision-making and rate care and communication higher 
(effectiveness) without impact on their psychological well-being (safety) 
o Improved quality of death and dying as reported by the relative in PETs 
who did not yet receive a written DNI-DNACPR order who died on the 
ward (effectiveness) 
o Improved symptom management during hospitalization in PETs who did 
not yet receive a written DNI-DNACPR order (effectiveness) 
o Less potentially inappropriate and burdensome treatments  
 
in PETs who did not yet receive a written DNI-DNACPR order 
who died on the ward (effectiveness) 
 
Less ICU use in the final year of life in PETs (effectiveness) 
o Higher incidence of written DNI-DNACPR orders in all first 
hospitalizations on the 10 wards (effectiveness) without excess 1 year 
mortality (safety)  
 
On family level 
o Improved quality of death and dying reported by and less short-term 
psychological burden in families of PETS who did not yet receive a 
written DNI-DNACPR order who died on the ward (effectiveness and 
safety) 
o Families of PET who did not yet receive a written DNI-DNACPR order 
feel more involved in decision-making and are more satisfied with care 
and communication (effectiveness) and report less psychological 
burden (safety) 
 
On clinician level 
o Less moral distress due to PET (effectiveness) 
o Better ethical practice and less absenteeism (effectiveness) 
o Less emotional exhaustion and intentional job-leave (effectiveness) 
o Smaller difference in EDMCQ overall and across factors between 
nurses and doctors.  
 
On society level 
Less hospital costs and use of health resources (hospital and ICU length of stay, number of 
procedures (such as ventilation, dialysis, CPR, surgical procedures, chemotherapy, 
radiotherapy, …), hospital re-admissions, ER visits,…) in PET who did not yet receive a 
written DNI-DNACPR order and overall patients firstly hospitalized (effectiveness). 
 
3.3. 
 Tertiary Objectives 
 
The coach will collect quantitative and qualitative data of the leadership styles of the 
participating doctors and head nurses. These styles will be used in a sub-analysis to further 
explore the relationship between leadership style and the primary and secondary endpoints.    
In order to evaluate the quality of the implementation of coaching, the participating doctors 
and head nurses will fill out a user questionnaire  

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End Points + Time Points 
 
3.4. 
Primary End Points + Time Points 
 
Our study uses two primary endpoints. The first is a patient-specific endpoint, defined as the 
occurrence of written DNI-DNACPR code during the first hospitalization, which will be 
measured in PET who did not yet receive a written DNI-DNACPR order. We focus on this 
endpoint because of its patient centeredness and of its reliability as an objective endpoint that 
can easily be collected via the EPD. The second is a health-care provider-specific endpoint 
given by the EDMCQ score, which will be assessed within 2 weeks (T1) prior and after the 
intervention period in the specific wards. This endpoint is team-centered and is dependent on 
the response rate of clinicians.  
 
3.5. 
Secondary End Points + Time Points 
 
Patients’ level 
We use one-year mortality as an endpoint. Because staying at home with a good quality of life 
is highly valued by patients, the combined one-year patient outcome in this study was defined 
as dead, not at home or a utility score < 0.5 [1]. For the combined endpoint, Euro-QOL-5D 
measures health-related quality of life, with possibility of conversion of each health state in a 
utility index (range -0.1584 to 1.000). This questionnaire measures health in five dimensions: 
mobility, self-care, usual activities, pain/discomfort, and anxiety/depression [37]. 
For quality of care and communication and decision-making, we use the Hospital Consumer 
Assessment of Healthcare Providers and Systems instrument [38], the Sinclair Compassion 
Questionnaire [39] and the Euro-FS [40]. 
In the Hospital Consumer Assessment of Healthcare Providers and Systems instrument to 
measure patient satisfaction in Europe and the US,[38] patients rate their hospitals on a scale 
of 0 to 10 (best) and patients indicate whether they would recommend their hospital to family 
and friends. 
The Sinclair Compassion Questionnaire is a patient reported experience measure that studies 
outcomes valued by the patient such as ‘feeling heard and understood by their clinician’ and 
‘being valued as a person’.[39] 
Euro-FS (European Family Satisfaction in the ICU), which is a validated 18 item questionnaire 
covering satisfaction with 4 domains: communication, empathy, symptom management and 
decision-making. [40]. 
We also use NRS score for pain as objective measure for symptom control during 
hospitalization. [41]. 
For well-being 3 weeks after discharge, we use HADS (Hospital anxiety and depression scale) 
which is a validated 14-item self-report assessment with subscales for anxiety and depression. 
Each domain has a score range of 0-21 with the following interpretation: 0-7 normal, 8-10 mild, 
11-21 moderate to severe [42]. 
For quality of dying in patients who died on the ward, we use QODD (Quality of dying and 
death questionnaire). Euro-QODD family is a 14 item questionnaire to allow families to assess 
patients’ quality of dying and death [43].  

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For the number of potentially inappropriate and burdensome treatments, we assess ventilation, 
dialysis, surgery, chemotherapy and radiologic diagnostics in patients who died on the ward 
and in patients who survived, we assess number of re-admissions and ICU use in the final 
year of life in patients potentially receiving excessive care [44] 
Relatives level 
For quality of care and communication and decision-making, we use the Hospital Consumer 
Assessment of Healthcare Providers and Systems instrument [38], the Sinclair Compassion 
Questionnaire [39] and the Euro-FS [40] (same as patients).  
For family well-being/psychological burden 3 weeks after discharge, we use HADS (same as 
in patients) [42].  
Clinicians’ level 
For clinician well-being, we use absenteeism (team-level) and emotional exhaustion and 
intentional job-leave (individual level) as endpoints. These are frequently used endpoints. 
Societal level 
For hospital costs, we will assess hospital costs by the hospital billing record, and also assess 
hospital and ICU length of stay as well as number of diagnostic procedures (emergency 
department visits, hospitalizations, blood analyses, radiological investigations, surgical 
procedures, and chemotherapeutic and radiotherapeutics treatments)   
 
3.6. 
Tertiary/Exploratory End Points 
 
In order to evaluate the quality of the implementation of coaching, we added process measures 
based on the RE-AIM implementation framework. 
 
- Reach: inclusion rate of participants in the individual and group coaching + number 
of coaching sessions 
- Efficacy: evolution in scores on self-reflective and empowering leadership, 
comparison of competencies (self-reflective and empowering leadership and in the 
management of team dynamics with regard to hospitalized patients potentially 
receiving excessive care, see appendix) and study outcomes 
- Adoption: experiences of doctors and headnurses with the intervention (user 
experience survey) 
- Implementation: experiences and satisfaction with the intervention and the coach, 
(user experience survey) 
- Maintenance: long-term adoption of the intervention (user experience questionnaire) 
 

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4. Study design  
 
4.1. 
Description of study design 
 
The study follows a stepped wedge cluster randomized trial design, run across 10 different 
departments of the Ghent University Hospital. All 10 departments will be randomly assigned 
to start a 4-month coaching period in month k=1,…,10 following a stratified design. The 10 
departments will be randomly assigned to start the intervention according to the schematic 
overview in Figure 1. All departments will be followed in terms of the primary and secondary 
endpoints over the 14-month duration of the study.  
 
End of Study Definition 
4.1.1. For an individual subject 
 
The subject has completed the study if he or she has completed all phases of the study, 
including the last contact via post, email or phone  as described in this protocol (see section 
“9. Study Specific Procedures”). 
 
4.1.2. For the whole study 
 
Overall, the end of the study is reached when the last study procedure for the last subject has 
occurred: last subject, last visit (LSLV). 
As soon as the whole study has ended (cfr. the definition above), the EC shall be notified 
(within 90 days after end of the study, or if the study had to be terminated early, this period 
must be reduced to 15 days and the reasons should clearly explained).  
The summary of the results of the study will be submitted to the Ethics Committee, no later 
than 1 year after the end of the study. 
 
4.2. 
Estimated duration of the study 
 
4.2.1. For an individual subject 
 
- 
Clinicians are coached for 4 months (T1-T2); timing of T1 and T2 depend on the 
department (cfr stepped-wedge randomization) 
 
- 
Clinicians  give daily perceptions of excessive treatment during the whole 14 month 
study period (T0-T3) 
 
- 
Head nurses and medical heads of department fill out questionnaire on department 
characteristics: (T0 and T3) 
 

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- 
Patients and family:  
o Inclusion during their first hospitalization 
o Survey 3 weeks after discharge 
o Telephone, email or mail  survey in patients or one of their relatives in case of 
incapacity1 year after hospital discharge 
 
4.2.2. For the whole study 
 
FPI: T0 
LSLV: one year after the end of the 14 months study period: T3 + 1 year = 26 months 
 

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5. Inclusion and Exclusion Criteria 
 
5.1. 
Inclusion Criteria 
 
 
Junior and senior doctors (including medical head of department)  
o Inclusion: all junior and senior doctors taking care of hospitalized patients in the 
10 participating departments of the Ghent University Hospital 
 
Nurses (including head nurses) 
o Inclusion: all nurses taking care of hospitalized patients in the 10 participating 
departments of the Ghent University Hospital 
 
Allied health care professionals  
o Inclusion: all allied health care professionals  taking care of hospitalized patients 
in the 10 participating departments of the Ghent University Hospital 
 
Patients and family members 
o inclusion: hospitalized PET who did not yet receive a written DNI-DNACPR 
order 
and 
their 
family 
members  
 
5.2. 
Exclusion Criteria  
 
For doctors, nurses and allied health care professionals there are no exclusion criteria.  
For patients and families; persons younger than 18 years and persons who cannot understand 
Dutch questionnaires are excluded. 
 
5.2.1. Screen failures 
 
Individuals who do not meet the criteria for participation in this study (screen failure) may not 
be rescreened. 
 

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6. Target Population 
 
6.1. 
Subjects 
 
6.1.1. Number of subjects and planned recruitment rate 
 
The number of subjects that will be included in this study is: 
 
Junior and senior doctors (including medical heads of department) : 50 à 75 junior and 
50 à 75 senior doctors 
 
Nurses (including head nurses) : 300 à 500 
 
Allied health professionals working in 10 departments of the Ghent University Hospital: 
100 to 200 
 
 
Patients and family members : 350 to 700 PETs who did not yet receive a written DNI-
DNACPR order and 350 to 700 family members. Drop-outs will not be replaced. It is 
expected that overall an accrual rate of 30 patients per month is realistic in the whole 
study.  
 
6.1.2. Withdrawal and replacement of subjects 
 
Subjects are free to withdraw from participation in the study at any time. A subject must be 
discontinued from the study if the subject/legal representative of the subject withdraws 
consent. 
The reason why a subject withdraws consent, if given, must be recorded in detail in the 
electronic Case Report Form (eCRF) and in the subject’s medical records. The already 
gathered subject data should remain in the study database.  
A subject will be considered lost to follow-up if he or she cannot be reached one year after 
hospital discharge by the study site staff.  
 
The following actions must be taken if a subject fails to return to the clinic for a required study 
visit:  
• 
Before a subject is deemed lost to follow-up, the investigator or designee will make 
every effort to regain contact with the subject (where possible, 3 telephone calls or 
by contacting the general practitioner). These contact attempts should be 
documented in the subject’s medical record or study file.  
• 
Should the subject continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up.  
 
6.2. 
Method of recruitment 
 
 
All departments within the Ghent University Hospital who participated to the CODE 
study were invited to participate to the current CODE II study during team meetings 
organized in 2024-2025 aimed at discussing and reflecting about the general and local 
CODE study results and the impact of providing excessive treatment for patients, 

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relatives and clinicians in our hospital. All 10 departments acknowledge room to further 
improve goal-oriented care  in our hospital and were enthusiastic to participate to this 
study. 
  
 
Junior and senior doctors (including medical heads of department) 
o all junior and senior doctors taking care of hospitalized patients in the 10 
participating departments of the Ghent University Hospital will be informed 
about the study on their medical staff meeting, we will give our contact details 
in order to ask individual questions after the meeting 
o those who give informed consent will be included in the study 
o by means of coaching, participants get the opportunity for personal growth, 
which is the only (but important) incentive 
 
 
Nurses (including head nurses) and allied health care professionals 
o Inclusion: all nurses and allied health care professionals taking care of 
hospitalized patients in the 10 participating departments of the Ghent 
University Hospital will be informed about the study on their staff meetings, we 
will give our contact details in order to ask individual questions after the 
meeting 
o those who give informed consent will be included in the study 
o there is no financial incentive, from former studies (APPROPRICUS,and 
DISPROPRICUS and CODE study) we learnt that nurses were very eager to 
give their anonymous perception about the ethical climate and their perception 
of excessive treatment (when they feel safe). Furthermore by means of 
interprofessional coaching, participants get the opportunity for personal growth, 
which is the only (but important) incentive 
 
 
Patients and family members 
o inclusion: adult PET who did not yet receive a written DNI-DNACPR order (or 
their legal representative in case of incompetence) identified as potentially 
receiving excessive treatment will be asked informed consent by the treating 
physician to fill-out survey 3 weeks after discharge and to be contacted 1 year 
after discharge. They will be asked to indicate 1 family member to be contacted. 
o That family member will be asked informed consent also during hospitalization 
o There is no financial incentive for study participation 
o The investigator or designee will make every effort to regain contact with the 
subject after 1 year to collect living situation 1 year after discharge (where 
possible, 3 telephone calls or by contacting the general practitioner).  
Since our intervention is completely embedded in the hospital, we will be able to count on the 
communication department of the Ghent University Hospital to empower clinicians to 
participate by means of posters, flyers and multimedia.   
 
6.3. 
Screening 
 
Every patient that is identified by clinicians as potentially receiving excessive treatment.   
 

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7. Study Specific Procedures 
 
7.1. 
Recruitment  
 
 
Junior and senior doctors (including medical heads of department) 
o all junior and senior doctors taking care of hospitalized patients in the 10 
participating departments of the Ghent University Hospital will be informed 
about the study on their medical staff meeting, we will give our contact details 
in order to ask individual questions after the meeting 
o they are free in how they accept the offered individual and group coaching 
o they will each be given an electronic link to fill-out the RED-CAP [46] EDMCQ 
at T0 and T3 online and are free to participate or not  
o filling-out the daily perceptions will be seen as consent to participate 
 
 
Nurses and allied health care professionals  
o all nurses and health care professionals taking care of hospitalized patients in 
the 10 participating departments of the Ghent University Hospital will be 
informed about the study on their nursing staff meeting, we will give our 
contact details in order to ask individual questions after the meeting 
o they are free in how they accept the offered individual and group coaching 
o they will each be given an electronic link to fill-out the RED-CAP EDMCQ at 
T0 and T3 online and are free to participate or not  
o filling-out the daily perceptions will be seen as consent to participate 
 
 
Patients and family members 
o All PETs who did not yet receive a written DNI-DNACPR order (or their legal 
representative in case of incompetence) will be asked informed consent by the 
treating physician to fill-out survey 3 weeks after discharge and to be contacted 
1 year after discharge. They will be asked to indicate 1 family member to be 
contacted. 
o That family member will be asked informed consent also during hospitalization 
o There are no financial incentives for study participation 
o The investigator or designee will make every effort to regain contact with the 
subject after 1 year to collect living situation 1 year after discharge (where 
possible, 3 telephone calls or by contacting the general practitioner).  
 
7.2. 
Randomisation/blinding 
 
Randomisation of the 10 departments will be performed by the Ghent University Department 
of Applied Mathematics, Computer Science and Statistics based on a random number 
generator in the software R. As in nearly all stepped wedge designs, the nature of the 
intervention is such that it cannot be blinded to health care providers. However, patients will 
be blind to the intervention. 
 
 

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7.3. 
Overview of collected data 
 
OUTCOME DOMAIN
OUTCOMES
INSTRUMENT 
DATA SOURCE
TIMING OF 
MEASUREMENT 
ETHICAL DECISION-MAKING 
(PRIMARY ENDPOINTS) 
DNI-DNACPR INCIDENCE 
Time from 2PET to 
written DNI-DNACPR 
 
Chart extraction 
Post discharge 
TEAM PERCEPTION OF ETHICAL 
CLIMATE 
Ethical decision-making 
climate 
EDMCQ 
Nurses, doctors 
and allied health 
care professionals 
T0 and T3 
PATIENT-CENTERED OUTCOME
IN ALL PATIENTS 
 
 
 
 
LIVING SITUATION AT 1 YEAR
(Time from 2PET to) 
survival, QOL and place of 
residence in survivors 
Euro-QOL-5D +
survey 
Patien or family 
by telephone call 
email of mail 
1 year after 
discharge 
QUALITY OF CARE, COMMUNICATION 
AND DECISION-MAKING 
Pain 
NRS 
Chart extraction 
Post-discharge 
Symptom management
Euro-FS adapted for 
the patient (part  
Patient 
discharged alive 
3 weeks after 
discharge 
Symptom management
Euro-FS (part 1)
Family
3 weeks after 
discharge 
Quality of communication 
and decision-making 
Euro-FS adapted for 
the patient (part 2), 
Sinclair Compassion 
Questionnaire  VAS 
Patient 
discharged alive 
3 weeks after 
discharge 
WELL-BEING AFTER DISCHARGE
Anxiety and depression 
HADS 
Patient 
discharged alive 
3 weeks after 
discharge 
IN PATIENTS WHO DIED ON THE 
WARD 
 
 
 
 
QUALITY OF DYING
 
 
 
 
Quality of dying
Euro-QODD
Family
3 weeks after 
discharge 
Potentially inappropriate 
treatments at EOL 
Chart extraction: 
ICU stay, surgery, 
chemotherapy, 
radiotherapy 
Post-discharge
 
OUTCOME DOMAIN 
OUTCOMES 
INSTRUMENT  
DATA SOURCE 
TIMING OF 
MEASUREMENT 
FAMILY OUTCOME

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IN PATIENTS WHO WERE 
DISCHARGED ALIVE 
 
 
 
 
WELL-BEING AFTER DISCHARGE 
Anxiety and depression 
HADS 
Family 
3 weeks after 
discharge 
QUALITY OF COMMUNICATION AND 
DECISION-MAKING 
Quality of communication 
and decision-making 
Euro-FS  (part 2), 
Sinclair 
Compassion 
Questionnaire 
and satisfaction 
VAS 
Family 
3 weeks after 
discharge 
IN PATIENTS WHO DIED ON THE 
WARD  
 
 
 
 
WELL-BEING AFTER DISCHARGE 
Anxiety and depression 
HADS 
Family 
3 weeks after 
discharge 
 
 
 
 
QUALITY OF COMMUNICATION AND 
DECISION-MAKING 
Quality of communication 
and decision-making 
Euro-FS (part 2), 
Sinclair 
Compassion 
Questionnaire 
and satisfaction 
VAS 
Family 
3 weeks after 
discharge 
HEALTHCARE COSTS 
 
 
 
 
Cost of the intervention
 
Payer’s hospitalization cost 
 
Hospital billing 
record 
Post-discharge 
 
Hospital (and ICU) length of 
stay and diagnostics 
 
Chart extraction 
Post-discharge 
 
Hospital re-admission rates 
after discharge 
 
Patient or family 
by telephone call, 
email of mail 
1 year after 
discharge 
WELL-BEING OF HEALTH CARE 
PROFESSIONALS 
Emotional Exhaustion and 
Intention to leave job 
 
Nurses and 
physicians 
T0 and T3 
TEAM WELL-BEING AND 
PERFORMANCE 
Absenteeism 
 
 Department 
Heads and Head 
Nurses 
T0 and T3 
 
 
 

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OUTCOME DOMAIN 
OUTCOMES 
INSTRUMENT  
DATA SOURCE 
TIMING OF 
MEASUREMENT 
PROCESS MEASURES 
 
 
 
 
NUMBER OF COACHING 
SESSIONS) 
Survey (by coach)
During intervention
SELF-REFLECTIVE AND 
EMPOWERING LEADERSHIP 
SKILLS 
 
Survey on quality of 
self-reflection 
Coach 
During intervention 
 
 
 
 
 
 
Survey (user 
experience by 
doctors and 
headnurses) 
T2 
 
 
7.4. 
Schematic overview of the data collection & interventions 
 
Procedures 
 
 
 
Inclusion 
during 
hospitalization 
3 weeks post-
discharge 
Follow-up 
1 
year 
after 
hospital 
admission 
4 months : start 
according 
to 
cluster 
randomization
at department 
level 
Informed consent 
X 
 
 
 
Survey 
 
X 
x 
 
Coaching  
 
 
 
x 
 
 
 

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8. Statistical Considerations 
 
8.1. 
Sample size calculation 
 
The outcome(s) on which the sample size calculation is based upon are the incidence of written 
DNI-DNACPR and the EDMCQ.  
For written DNI-DNACPR code, analysis will be based on a logistic mixed effect model in PET 
who did not yet receive a written DNI-DNACPR order. The model will allow for a random 
intercept to account for between-department variability, a fixed coaching effect from time of 
initiation onwards and for a linear period effect, even though no such effects are expected. 
Based on such analysis, a Monte Carlo power evaluation (with 10000 simulations) showed that 
under the considered randomized design, a Wald test at the 5% significance level delivers  
77.2% power to detect an intervention effect when data are available for 3 DNIR-naïve PET 
per department per month (over a period of 12 months) (or 61.1% when data are available for 
2, and 87.4% when data are available for 4 DNI-DNACPR naive patients), if the risk of written 
DNIR order by the end of hospital stay in PET patients increases from 20% before to 40% after 
intervention; with 2 PETs identified in 6% of patients [3]. Independently from each other, 
respectively the scientific experts in the field of coaching and the experienced coach of our 
steering committee estimated that a 4 month intervention would be required to detect an effect 
in the team and at least 5 individual and 5 group coaching sessions to detect an effect at the 
individual level.  
 
The above calculation amounts to a total of 6000 patients, of which 360  (i.e., 6%) patients 
identified with at least 2 perceptions of excessive treatment over a 14 month period. In the 
above power analysis, we considered a design in which all participating departments are 
randomly assigned to start a 4-month coaching intervention in either month 1, 2, 3, ... or 7 
following the previously described design. Moreover, we assumed an intra-class correlation of 
0.025. This means that for 95% of hospital departments, the risk of written DNI-DNACPR  order 
in PET who did not yet receive a written DNI-DNACPR order lies between 12% and 31% before 
intervention, and between 27% and 54% after intervention.  
 
For the EDMCQ, the sample size calculation was based on linear mixed models for the change 
in EDMCQ score after versus before the intervention, including a random intercept to account 
for between-department variability. Based on such analysis, a Monte Carlo power evaluation 
(with 10000 simulations) showed that a Wald test at the 5% significance level delivers 89% 
power to detect an intervention effect when data are available for 5 health care providers per 
department, if the EDMCQ score increases on average with 2.8 units. For this, we assumed 
an intra-department correlation of 0.14 and a total standard deviation of 5.03. 
 
8.2. 
Type of statistical methods 
 
Analysis of the incidence of written DNI-DNACPR order will be based on logistic mixed effects 
models with random intercept to account for between-department variability, assuming a 
constant coaching effect from the start of coaching onwards and allowing for linear period 
effects. The coaching effect will be reported as the odds ratio of having a written DNI/DNACPR 
order in any study month for patients treated in departments where coaching had already been 
implemented versus those where it had not. This effect may be diluted because of spillover 
effects from clinicians who have been previously coached (when they worked in a different 
department) as well as a learning effect of the coaching sessions (which do not immediately 

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attain their full effect). A secondary analysis will therefore include, in each month prior to the 
end of the coaching period, a variable that expresses the average percentage of total coaching 
sessions previously attended by clinicians in the department. The coaching effect in this 
secondary analysis can be defined as the odds ratio of having a written DNI/DNACPR order in 
any study month for patients treated in departments where all clinicians attended all coaching 
sessions versus where no clinicians have received coaching. Additional secondary analyses 
will allow for arbitrary (possibly non-linear) period effects and adjust for patient admission 
characteristics to correct for random imbalances between randomized arms. 
Analysis of the change in ECDMQ score will be based on linear mixed effects models for the 
change in ECDMQ score, including a random intercept to account for between-department 
variability. A secondary analysis will additionally adjust for characteristics of health care 
providers measured prior to coaching to correct for random imbalances between randomized 
arms. 
For secondary endpoints, the analysis of continuous endpoints will be based on linear mixed 
models and the analysis of dichotomous endpoints on logistic mixed models, each time 
including a random intercept at the ward level to account for between-department variability. 
Analyses at the patient level will additionally include a fixed (linear) effect of time to correct for 
period effects. 
 
8.3. 
Statistical analysis team 
 
Analysis of the primary and secondary endpoints will be done by the Department of Applied 
Mathematics, Computer Science and Statistics of Ghent University (responsible: Prof. Stijn 
Vansteelandt). 
 
8.4. 
Interim analysis 
 
No interim analysis is planned. 
 
 

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9. Data handling 
 
9.1. 
Method of data collection 
 
Subjects that are included in the study, will be assigned a unique study number upon their 
registration in REDCap [46]. The subject identification list will be safeguarded by the site. The 
name and any other directly identifying details will not be included in the study database. 
 
9.1.1. Case Report Form 
 
An electronic data capture (EDC) system, i.e. REDCap, will be used for data collection. Data 
reported on each eCRF should be consistent with the source data. If information is not known, 
this must be clearly indicated on the eCRF. All missing and ambiguous data will be clarified.  
Only the data required by the protocol are captured in the eCRF. The eCRFs and the database 
will be developed, based on the protocol. The final eCRF design will be approved by the 
Coordinating Investigator. 
All data entries and corrections will only be performed by study site staff, authorized by the 
investigator. Data will be checked by trained personnel (data manager) and any errors or 
inconsistencies will be clarified. The investigator must verify that all data entries in the eCRF 
are accurate and correct. 
 
REDCap is provided and maintained by Vanderbilt University; a license for use was granted 
to the Health, Innovation and Research Institute (HIRUZ). REDCap is a web-based system 
[46].  
 
The study site staff is responsible for data entry in REDCap.  
 
9.2. 
Data storage 
 
The data is accessed through a web browser directly on the secure REDCap server. The 
server is hosted within the UZ Gent campus and meets hospital level security and back-up 
requirements.  
 
Privacy and data integrity between the user's browser and the server is provided by mandatory 
use of Transport Layer Security (TLS), and a server certificate issued by TERENA (Trans-
European Research and Education Networking Association). All study sites will have access 
to REDCap. Site access is controlled with Internet Protocol (IP) restriction. 
 
 
 

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9.3. 
Archiving of data 
 
The investigator and sponsor specific essential documents will be retained for at least 10 years. 
At that moment, it will be judged whether it is necessary to retain them for a longer period, 
according to applicable regulatory or other requirement(s). 
 
9.4. 
Access to data 
 
The investigators and institutions involved in the study will permit audits and regulatory 
inspections (including provision of direct access to source data and documents).Login in 
REDCap is password controlled. Each user will receive a personal login name and password 
and will have a specific role which has predefined restrictions on what is allowed in REDCap. 
Furthermore, users will only be able to see data of subjects of their own site. Any activity in the 
software is traced and transparent via the audit trail. 
 
 
 

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10. 
Monitoring/Auditing/Inspection 
 
10.1. Monitoring 
 
Not applicable  
 
10.2. Inspection 
 
This study can be inspected at any time by regulatory agencies during or after completion of 
the study. Therefore access to all study records, including source documents, must be 
accessible to the inspection representatives. Subject privacy must be respected at all times, in 
accordance to GDPR, GCP and all other applicable local regulations. 
 
10.3. Non-compliance policy 
 
Sponsor and all investigators agree to take any reasonable actions to correct protocol or other 
non-compliances/violations noted during inspection. All non-compliances must be documented 
on the correct deviation log by the study team that is kept available at any time for inspection 
purposes. 
Subject, site and sponsor non-compliances must be reported in the CRF. In case a (potential) 
critical non-compliance is detected, the sponsor should be contacted within 1 business day of 
awareness and the escalation procedure should be started. 
Under emergency circumstances, deviations from the protocol to protect the rights, safety or 
well-being of human subjects may take place without prior approval of the sponsor and the EC. 
10.4. Serious breach to GCP and/or the protocol 
 
 A ‘serious breach’ means a breach likely to affect to a significant degree the safety and rights 
of a subject or the reliability and robustness of the data generated in the clinical study. 
Any deviation of the approved protocol version that has a major impact on the subject safety 
and/or rights, data integrity and/or study conduct should be clearly documented on the 
applicable deviation log and will be communicated with the Coordinating Investigator, HIRUZ 
CTU and possibly the EC. 
Please contact HIRUZ CTU asap in case of a serious breach: hiruz.ctu@uzgent.be and/or 
+3293320500. 
Early determination of the study may be necessary in case of major non-compliance. 
 

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11. 
Ethical and legal aspects 
 
11.1. Good Clinical Practice 
 
The study will be conducted conform the latest version of the ICH-GCP guidelines, creating a 
standard for the design, conduct, performance, monitoring, auditing, recording, analyses and 
reporting of clinical studies that provides assurance that the data and reported results are 
accurate and that the rights, integrity and confidentiality of study subjects are protected. 
 
11.2. Informed Consent 
 
Eligible subjects may only be included in the study after providing written (witnessed, if needed) 
Ethics Committee-approved informed consent, or, if incapable of doing so, after such consent 
has been provided by a legally acceptable representative(s) of the subject. 
Informed consent must be obtained before conducting any study-specific procedures (as 
described in this protocol).  
 
Prior to entry in the study, the investigator must explain to potential subjects or their legal 
representatives the study and the implication of participation. Subjects will be informed that 
their participation is voluntary and that they may withdraw consent to participate at any time. 
Participating subjects will be told that their records may be accessed by competent authorities 
and by authorized persons without violating the confidentiality of the subject, to the extent 
permitted by the applicable law(s) and/or regulations. By signing the Informed Consent Form 
(ICF), the subjects or legally acceptable representatives are authorizing such access. 
After this explanation and before entry to the study, written, dated and signed informed consent 
should be obtained from the subject or legally acceptable representative. The ICF should be 
provided in a language sufficiently understood by the subject. Subjects must be given the 
opportunity to ask questions. 
The subject or legally acceptable representative will be given sufficient time to read the ICF 
and to ask additional questions. After this explanation and before entry to the study, consent 
should be appropriately recorded by means of either the subject's or his/her legal 
representative's dated signature or the signature of an independent witness who certifies the 
subject's consent in writing. After having obtained the consent, a copy of the ICF must be given 
to the subject. 
In case the subject or legally acceptable representative is unable to read, an impartial witness 
must attest the informed consent. 
Subjects who are unable to comprehend the information provided can only be enrolled after 
consent of a legally acceptable representative. 
 
 

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The following information should be added to the electronic patient dossier (EPD): 
• 
which version of the ICF was obtained 
• 
who signed the ICF  
• 
if sufficient time has been given to consider participation into the study 
• 
which investigator obtained ICF with the date of signature 
• 
if a copy was provided to the patient 
• 
start and end of participation in the study 
 
11.3. Approval of the study protocol 
 
11.3.1. 
General 
 
The protocol has been reviewed and approved by the Ethics Committee of the Ghent University 
(Hospital).  
 
11.3.2. 
Protocol amendments and urgent safety measures 
 
Any significant change or addition to the protocol can only be made in a written protocol 
amendment that must be approved by the Ethics Committee. 
Only amendments that are intended to eliminate an apparent immediate safety threat to 
patients may be implemented immediately. 
Notwithstanding the need for approval of formal protocol amendments, the investigators are 
expected to take any immediate action, required for the safety of any subject included in this 
study, even if this action represents a deviation from the protocol. These actions should always 
be notified to the sponsor. 
 
11.4. Confidentiality and Data Protection 
 
All study data will be handled in accordance with the law on General Data Protection 
Regulation (GDPR) and institutional rules (in Belgium: in accordance with the Belgian laws 
dated on 30 July 2018 and 22 August 2002). 
 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to fulfill the objectives of the study. These data must 
be collected and processed with adequate precautions to ensure confidentiality and 
compliance with applicable data privacy protection laws and regulations.  
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor and site personnel whose responsibilities require 
access to personal data agree to keep the identity of subjects confidential. 
 
 

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Site personnel informs the subject about the processing of personal data and direct access for 
the investigator/institution to his or her original medical records (source data/documents) for 
audit, EC review and regulatory inspection. The subject is also informed about the transfer of 
the data to other entities, if applicable. 
 
All data will be pseudonymised. Pseudonymisation is the responsibility of the PI. 
Pseudonymisation can be done by the PI or any other investigator appointed by the PI and 
legally authorized to do so (therapeutic relationship with the participant). The key for encryption 
and decryption of pseudonymized data is kept by the PI and other investigators authorized by 
the PI. Data is processed in an electronic, secure database (REDCap), in accordance with the 
technical and organizational security measures of the Ghent University Hospital. 
 
Privacy and confidentiality of data generated in the future on stored samples will be protected 
by the same standards applicable to all other clinical data. 
 
 
11.5. Liability and Insurance 
 
The sponsor has taken a no fault insurance for this study (applicable in Belgium), in 
accordance with the relevant legislation (article 29, Belgian Law of May 7, 2004). 
Sponsor: Ghent University Hospital 
Insurance Details: Allianz Global Corporate & Specialty, Uitbreidingstraat 86, 2600 Berchem, 
Belgium, tel: +32 33 04 16 00 
Policy number: BEL001889 
 
 

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12. 
Publication policy 
 
This study will be registered at ClinicalTrials.gov, and results information from this study will 
be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in 
peer-reviewed journals. 
The local investigators are responsible for recruiting patients according to the inclusion and 
exclusion criteria, collecting informed consent and empowering teams to provide PETs during 
the entire 12 months study period together with the study nurse, coach, communication 
department of the Ghent University Hospital and the principal investigators.   
Similarly tot the CODE study, all local investigators who fulfill the authorship requirements will 
be coauthor of at least one of the principal publications. In case the journal does not allow a 
high number of coauthors (members of the steering committee + local investigators of 10 
wards), co-authorship will be divided among the first main publications. Local investigators 
may subsequently become first authors of  publications on CODE II study sub-analyses once 
the initial main results have been published.  
Professional medical writers will not be hired. Every person who collaborated with this study 
outside the steering committee and the list of local investigators will be acknowledged in the 
publications. Funding will be acknowledged appropriately.   
 

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13. 
Appendices 
 
13.1. Appendix 1: Coaching protocol 
Coaching & Intervention Protocol  
The intervention that is central to this study consists of implementing individual and group 
coaching sessions with multidisciplinary teams in a hospital context. The individual sessions 
will be organised for doctors and head nurses. For doctors they will aim at facilitating self-
reflective and empowering leadership, and at improving medical doctors’ competence in 
managing team dynamics with regard to ethically sensitive medical topics, in line with the 
theoretical framework elaborated by Van den Bulcke et al. This framework starts from the 
point of view that doctors need first to collect detailed information to be able to take in all 
conscious a decision for the benefit of the patient. Although, this seems obvious, 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 take 
decisions in the team (Palda 2005, Piers 2014). This information may be objective or 
subjective, and may come directly or indirectly from the patient, relatives, clinicians or any 
other party. All upfront clinicians may and will have potential important information about the 
patient, regardless of their role, knowledge or experience (Curtis 2010, Van den Bulcke 
2018, Moynihan 2021, Michalsen 2019). To obtain all that information, the doctor in charge of 
the patient needs to empower clinicians to speak up while guarantying a safe environment. 
This enables to shift from pure knowledge and experience driven discussions often led by the 
doctor solely, to participative knowledge, experience and value driven reflection in team (Van 
den Bulcke 2018); however, sharing viewpoints or questioning authority might often be felt as 
taking an interpersonal risk. That is also why head nurses will receive individual coaching 
too, as they are often the primus inter pares between the doctor and the clinicians team. For 
head nurses the individual coaching will aim at two main themes: processing the impact of 
their role in the system in which they operate and offering them a structural sounding board 
where they can develop opportunities to strengthen their facilitative role. The group sessions 
will aim at lowering a feeling of interpersonal risk by fostering a culture of open speech where 
participating clinicians feel at ease to contribute to the conversation. People’s perceptions of 
the consequences of taking interpersonal risks inhibits psychological safety and a culture of 
speaking up. Therefore, it is imperative to create a psychologically safe space as it plays a 
vital role in helping people overcome barriers to learning and change in interpersonally 
challenging work environments. (Edmondson 2014, 2016).  Apart from reducing avoidance 
and tension in teams, and indecision in doctors, sharing emotions and values stimulates a 
sense of meaning, and thus ethical awareness and well-being in the team. This collective 
awareness enriches the ethical decision-making process for the benefit of the patient and 
supports the doctor to effectively communicate decisions on patient care (Van den Bulcke 
2018).  
Study Focus 
A key systems-psychodynamic hypothesis guiding the intervention is that ethically sensitive 
medical topics are inherently anxiety provoking. They confront professionals with death and 

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suffering, with uncertainty and powerlessness in aversive situations, and with the prospect 
that decisions and actions might have an aggravating impact on aversive situations. Such 
confrontations have a shocking effect and provoke mixed feelings. Shame, pity, compassion 
and guilt might come to the fore, but the bottom-line reaction to death and decay is desperate 
anxiety.  
In her seminal psychodynamic studies on how medical professionals work, Menzies Lyth 
(1988, p. 43-88) described that if this elementary anxiety is not faced and worked through, all 
kinds of dysfunctional defences ruin collaborations and undermine thoughtful medical ethical 
decision-making. Working through means that challenging situations are faced and 
discussed in plain but respectful terms, such that the complexity of the situation is 
acknowledged, and affective reactions are contained in the interactions between 
professionals, patients and families. Dysfunctional defensive reactions in their turn come to 
the fore as people avoid thoughtful deliberation about sensitive medical topics, and shy away 
from such situations, e.g. by avoiding close commitment to patients, fleeing in 
depersonalized and neutral interactions, focusing on technical details in treatments only, 
emotional unresponsiveness, or scheduling no time to address worries and concerns in team 
meetings.  
Given this challenge, the coaching sessions will aim at helping the team to work through 
ethically sensitive medical topics and to facilitate a culture of open speech, defined within the 
context of empowering leadership. 
In this study, coaching is implemented with a dual focus: 1) helping medical doctors and 
head nurses to address ethically sensitive issues in multidisciplinary teams and to optimise 
their decision process for the benefit of the patient and leadership for the team; 2) helping all 
members of the multidisciplinary team to address ethically sensitive issues by processing 
known group defence mechanisms so to stimulate their contribution to the collective 
decision-making process. 
Four coaching interventions of 4 months will be conducted in 10 internal medicine and 
neurology wards over a period of 12 months. During that period individual - and team 
coaching will take place in self- reflection and self-regulation with regard to ethical decision-
making in patients potentially receiving excessive care and in coping with group dynamics in 
the multidisciplinary team, with the intention to achieve following specific objectives. 
Objectives for the individual coaching 
a) Learning to acknowledge the patient’s (and relatives’) subjective goals, emotions and 
values, and separate them from own and colleagues’ subjective goals, emotions and values 
trigged by that situation.  
b)  Learning to acknowledge patient’s (and relatives’), colleagues’ and own spontaneous 
defensive avoidance strategies in coping with difficult and aversive care-related situations, 
like end-of-life decisions. 

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c)  Learning to identify and separate internal avoidance strategies from external barriers to 
better delineate the responsibilities of each stakeholder in the process. 
d)  Learning to cope more effectively with these internal and avoidance strategies and 
external barriers to enable more appropriate and timely decisions for the benefit of the 
patient. 
e)  Learning to integrate newly acquired insights into an adapted way of thinking and relating 
with others to establish a sustainable effect with regards to ethical decision-making. 
f)  Learning to transfer these insights into empowering leadership behaviour which 
contributes to dialogue during the interdisciplinary meeting. 
Objectives for the team coaching 
a) Learning to acknowledge the patient’s (and relatives’) subjective goals, emotions and 
values, and separate them from own and colleagues’ subjective goals, emotions and values 
trigged by that situation.  
b)  Learning to acknowledge patient’s (and relatives’), colleagues’ and own spontaneous 
defensive avoidance strategies in coping with difficult and aversive care-related situations, 
like end-of-life decisions. 
c)  Learning to identify and separate internal avoidance strategies from external barriers to 
better delineate the responsibilities of each stakeholder in the process. 
d)  Learning to cope more effectively with these internal and avoidance strategies and 
external barriers to enable more appropriate and timely decisions for the benefit of the 
patient. 
e)  Learning to integrate newly acquired insights into an adapted way of thinking and relating 
with others to establish a sustainable effect with regards to ethical decision-making. 
f)  Learning to transfer these insights into self-steering participative behaviour which 
contributes to dialogue during the interdisciplinary meeting. 
Focus one 
In 2018 Van den Bulcke and colleagues reviewed literature on medical ethical decision-
making and based on psychometric research of a newly constructed questionnaire (EDMCQ) 
they discerned seven key domains that make up a medical ethical decision-making climate: 
(1) self-reflective and empowering leadership by physicians; (2) practice and culture of open 
multidisciplinary reflection; (3) culture of not avoiding end-of-life decisions; (4) culture of 
mutual respect in the multidisciplinary team; (5) active involvement of nurses in end-of-life 
care and decision-making; (6) active decision-making by physicians; and (7) practice and 
culture of ethical awareness. In this study, we will focus on coaching doctors and head 

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nurses in self-reflective and empowering leadership, which by itself will have an effect on all 
other factors in the team (Vandenbulcke 2018, Benoit 2023, 2024). 
The coachee will be invited to have individual coaching sessions. By stimulating open 
speech and reflection on ethically sensitive medical topics, like disagreements on 
interventions, difficulties in taking EOL decisions, or challenges of dealing with conflicting 
opinions in the doctor-patient relationship, the intervention will intend at strengthening their 
capacities to reflect and communicate about difficult decisions in uncertain circumstances 
and to guide their multidisciplinary teams in dealing with such topics.  
Focus two 
The teams will be assisted through two parallel group interventions: the team coach 
facilitating the work shift hand-over by clinicians and the team coach facilitating structured 
metareflective sessions on specific themes related to ethical decision-making by 
multidisciplinary teams. Similar to the individual coaching sessions, stimulating open speech 
and reflection on ethically sensitive medical topics, like disagreements on interventions, 
challenges of dealing with conflicting opinions in the team, emotional pressure by anxiety 
provoking events, the intervention will intend at strengthening participating health workers’ 
capacities to reflect and communicate about difficult decisions in uncertain circumstances. 
Interventions 
Intervention one: Individual coaching for doctors and head nurses 
Session focus 
In hospital teams doctors and head nurses typically occupy a leadership role. It is under their 
responsibility that crucial decisions are taken and that team dynamics take shape. Our 
intervention aims at supporting them in effectuating an empowering leadership style. As Kets 
de Vries (Kets de Vries, 2014) indicates, “Empowering concerns the leader’s ability to 
delegate authority to others. An empowering leader involves others in the decision-making 
process thereby indicating his or her high expectations and confidence in them. An 
empowering leader also works to minimise secrecy and to create an open and transparent 
environment. He or she also tolerates mistakes and failures as part of the learning process.”. 
The session will focus on discussing: (a) challenges and opportunities in dealing with ethical 
and medical dilemmas; (b) challenges and opportunities in relating with colleagues and team, 
and with patients and families; (c) challenges and opportunities in taking up an empowering 
leadership role. The coach will aim at increasing awareness and efficacy in dealing with 
these topics and transferring these into leadership behaviour, starting from a collaborative 
relationship with the coachee.  
Method 
Each time that at least two clinicians of the team for which a doctor is responsible indicates 
that for one the patients under treatment they are facing an ethical dilemma in the direction of 

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“too much treatment”, respectively the doctor and the head nurse will be invited for an 
individual coaching session. 
Generally speaking, individual coaching is a form of “leadership development where a leader 
has a series of contracted and confidential conversations with a coaching psychologist or 
development expert. It is a form of organisational learning through one-to-one conversations, 
which facilitates development for an individual” (de Haan, Molyn & Nilsson, 2020, p. 2). The 
input coachees typically bring to coaching session can cover a spectrum of themes varying 
between personal dynamics influencing or disturbing work situations, dilemmas and 
difficulties related to their work setting or exploring opportunities for growth. During coaching 
“coachee and coach collaborate to assess and understand the coachee and his or her 
leadership developmental tasks, to challenge current constraints while exploring new 
possibilities, and to ensure accountability and support for reaching goals and sustaining 
development” (Ting & Hart, 2004, p. 116). It is supporting someone to adapt his/her 
relationship to a specific reality. Often an individual cannot overcome the issue by him-
/herself as some variables are unknown and require multiple learning loops to understand 
specific internal and external dynamics which inhibit our performance (Heifetz, 1997). Since 
furthermore, “because of the personalized nature, the high confidentiality, and the possibility 
for deep understanding and challenge, coaching seems to work at relational and personal 
depths” (de Haan, Gray & Boneywell, 2019, p. 586). 
The individual coaching we implement will start from the principles described by Kets de 
Vries (2006, 2007) and de Haan (2008, 2014, 2019).  
Kets de Vries’ coaching methodology is based on the combination of two concepts: a 
psychodynamic perspective and a systemic perspective. This is defined as the ‘clinical 
paradigm’, a conceptual framework that builds on psychoanalytical concepts and techniques 
and which considers the dynamics of organisational behaviour (Kets de Vries, 2006). He 
argues that leadership behaviour is driven by the interplay between conscious and 
unconscious processes, the so-called ‘inner theatre’ – the roles we have developed over the 
course of life and which permanently influence our thinking. Therefore, this coaching 
methodology intends to help the leader make sense of the invisible deeper thoughts, 
feelings, motives and anxieties that influence his/her cognitive processes such as decision-
making and daily leadership behaviour. 
 
Next to intrapersonal dynamics, the leader is also influenced by interpersonal dynamics. A 
leader takes up distinct formal and informal roles in various social constructions that affect 
his/her intrapsychic life. This implies that decision-making behaviour is undoubtedly 
influenced by the interpretation of these interactions. Finally, leaders also act according to 
organisational expectations, often derived from formal rules and so-called ‘organisational 
myths’, i.e. normative narratives that indicate how people should collaborate. As Kets de 
Vries (2006, p. 308) indicates, “subjection to these myths may come at the cost of personal 
responsibility and independence”.  
De Haan’s coaching methodology is based on a relational model, in which the working 
alliance between coach and coachee is seen as a predictor of present and future leadership 
effectiveness (de Haan, Gray & Boneywell, 2019, p. 585). De Haan describes relational 

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coaching as a dual active effort. On the one hand the coach is requested to understand all 
leadership dynamics from the perspective of the relationships the coachee is involved in, 
being previous, current and in-the- moment relationships. On the other hand the coach helps 
the coachee to make his/her professional relationships as strong and productive as possible 
– considered from the perspective of the coachee. Consequently, the coach needs “to 
explore regularly with the coachee how the relationship is progressing” (de Haan, 2008, 
p.53).  
Research shows that “professional coaches who specialize in the coaching profession 
perceive more typical nondirective and client-centred coaching behaviours over time”. It is 
argued that coaches “have a wide array of behavioural responses at their disposal and as 
they mature, they will reflect on which of their interventions to use” (de Haan & Nilsson, 2017, 
p. 328). This might imply that starting from a client – centred approach requires the coach to 
apply a wider portfolio of potential responses and methods. By becoming more skilful over 
time, this will provide greater flexibility to design approaches specific to the individual (Cox, 
Bachkirova, Clutterbuck, 2010, p.419-420). However, this also means that the coach will 
always influence the conversation, both intentionally and unintentionally, by every 
contribution to that conversation. The coachee, as second element in the relationship, will 
equally bring a plethora of variables into the conversation. “An orderly, well-controlled 
conversation is out of the question; there are simply too many variables” (de Haan & Burger, 
2014, p. 15). Consequently, de Haan argues it is the coach’s responsibility to keep a window 
onto the coachee’s contribution to the conversation because the coachee’s issues are data 
and material to work with. And it is the reciprocal relation, where coach and coachee explore 
the map of experiences in the moment, that defines the foundation of the coaching work.  
Objectives 
Each coaching session will consist of an in-depth discussion of the decision-making process 
around the case of the patient of which an alert was given.  
The coach invites the coachee to describe and discuss:  
 
The currently challenging situation 
 
Perceived subjective reactions by him-/herself and others (patient, family, colleagues) 
to the situation  
 
Perceived challenges in the mutual communication about the situation, whereby 
attention is paid to characteristics of the own communication style and the style of the 
others involved  
 
Perceived challenges in the medical ethical decision process in the challenging 
situation, whereby attention is paid to differences and similarities in goals and values 
between all parties involved 
By discussing these topics, the coach aims at addressing and fostering insight in:  
 
Avoidance reactions in how the coached doctor and head nurse, their team, and the 
patient and their family cope with the challenging situation 

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 
Helping and obstructing relational patterns in relation to the team as well as in relation 
to the patient and his family  
 
Own communicative style 
 
Own decision-making style 
 
Own strengths and weaknesses at the level of empowering leadership 
Depending on the challenging situation and the coachee’s style and trajectory the coach will 
direct sessions towards:  
 
Acknowledging and gaining insight in avoidance reactions, relational patterns, 
communicative processes, decision making processes and empowering leadership  
 
Confronting the coachee with processes he/she fails to acknowledge  
 
Reflecting with the coachee on dealing with and intervening upon such processes  
Succes indicators, to be rated post - intervention by the coach  
1. The intervention was based on the procedural alert. If not, please specify the trigger.  
2. The coachee became more aware of his/her subjective reaction to the uncertainty of 
the prognosis.  
3. The coachee became more aware of his/her subjective reaction to the anticipated 
decision.  
4. The coachee shared his understanding about the doubt of others in relation to the 
described therapy.  
5. The coachee gave proof through specific comments of insight into the perspective of 
the patient. 
6. The coachee gave proof through specific comments of insight into the perspective of 
the family. 
7. The coachee gave proof through specific comments being able to separate internal 
avoidance strategies from external barriers. 
8. The coachee described an increased insight on dealing with conflict. 
9. The intervention took place in an appropriate coaching setting (i.e. confidential, 
discrete, serene, not be pressured by time...). 
10. We were able to process multiple learning loops which fostered the coachee’s 
thinking. 
11. The coachee demonstrated his/her ability to implement newly acquired insights 
during the interdisciplinary meeting. 
12. The coachee described empowering leadership skills applied during the 
interdisciplinary meeting.  
Intervention two: facilitation of interprofessional reflection on patient cases 
Session focus 
A work shift hand-over is a moment in which a collection of possible perceived pressures 
might arise at both the team ending their shift as well as the team starting their shift. The 
team handing over is still processing data from their shift experience, doesn’t want to forget 
anything for the hand-over, is aware the work is about to end, is moving into a transitional 

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zone of ‘work’ ending and ‘not-work’ starting, all in which an authority figure is present. The 
team starting the work shift is equally still processing data from the not-work world they just 
left, is moving into a transitional zone of ‘not-work’ ending and ‘work’ starting, doesn’t want to 
miss anything during the hand-over, is under time pressure as patients are waiting, all in 
which an authority figure is present. 
The team coach will focus on facilitating a conversation in which: (a) challenges and 
opportunities in exchanging complex data occur; (b) challenges and opportunities in relating 
with colleagues and team occur; (c) challenges and opportunities in speaking up during a 
time - pressured moment occur. The team coach will aim at increasing awareness and 
efficacy in dealing with these topics starting from a collaborative relationship with all 
attendees.  
Method 
Over a period of 16 weeks with 2 à 3 interventions per week, a team coach will facilitate the 
hand-over of the clinician team. The team coach will be randomly allocated from the pool of 
team coaches, always different from the individual coach, so to avoid reciprocal 
contamination of findings between the individual work and the work with the team. 
The team facilitation we implement will start from the principles described by Ancona & 
Bresman (2007, 2023) and Edmondson (2014, 2016). 
It is first important to coin a definition of team within the context of the research. 
Organisations use a variety of types of teams. Team type may vary in different ways: they 
might be spread across several dimensions, being cross-functional as opposed to single-
function, being time-limited or enduring over longer periods of time, being manager-led or 
self-led. The teams we are working with hold following attributes: a collection of several 
disciplines, attendance based on working shifts, connected to the world outside the team 
through different stakeholders (family, social services, compliance systems, specialty 
disciplines). We firstly argue that the composition and purpose of the concerned teams can 
be defined as an X-team. “X-teams combine internal focus with a strong orientation toward 
external outreach and learning.” Consequently, the team is not a closed circle but has a more 
permeable boundary. “X-team members are active in crossing team boundaries and bringing 
others in.” (Ancona & Bresman, 2023). A second argument to define the concerned teams as 
X-teams is the changing circumstances to which these teams are permanently exposed. 
Teams face changes to (1) the power structures in which teams operate, (2) the structure of 
knowledge with which they work, and (3) the structure of tasks they perform. (Ancona & 
Bresman, 2007). 
As findings suggest, psychological safety is essentially a group-level phenomenon in which 
group defence mechanisms might influence the primary task of the team. “Some of this 
variance can be attributed to supervisor behaviours, which convey varying messages about 
the consequences of taking the interpersonal risks associated with behaviours such as 
admitting error, asking for help, or speaking up with ideas.” (Edmondson, 2014). On top, 
those on the front line of providing critical human services often feel less psychologically 
safe. Especially in health care where team-based efforts focused on learning can “be 

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thwarted by the challenge of speaking up across status lines. When such status differences 
are not overcome, errors and other service delivery problems can happen.” (Edmondson, 
2016). The team coach intends to foster psychological safety through facilitation of the hand-
over by stimulating open speech. “Team psychological safety is defined as a shared belief 
that the team is safe for interpersonal risk-taking. It should facilitate learning behaviour in 
work teams because it alleviates excessive concern about others' reactions to actions that 
have the potential for embarrassment or threat, which learning behaviours often have.” 
(Edmondson, 1999). Therefore, the team coach uses in-the-moment experiences to help 
understand inhibitors of a culture of open speech. By speaking to what was happening in the 
conversation it will contribute to providing insight and to upskilling the conversation 
techniques of the clinicians.  
Objectives 
The team coach will facilitate the hand-over to achieve following objectives: 
 
Fostering a blame-free environment by creating a climate where clinicians feel 
safe to report concerns, near misses, or uncertainties without fear of blame or 
retribution. 
 
Encouraging questions and clarifications by actively prompting team members to 
ask questions or clarify uncertainties, regardless of role or seniority. 
 
Actively inviting participation from less vocal members to avoid dominance by a few 
voices, in line with inclusive communication. 
 
Acknowledging external inputs by inviting to integrate relevant updates from 
external units and consider family or patient-reported concerns. 
 
Reducing power dynamics and enhancing inclusive collaboration by inviting input 
from all attending team members, especially nurses, junior doctors, and other health 
staff. 
 
Empowering distributed leadership by enabling team members to take the lead on 
different aspects of the conversation or decision-making, fostering shared 
responsibility and adaptability. 
 
Reflecting on what was difficult or unusual during the shift and what the team learned 
to build a learning culture and team cohesion. 
 
Encouraging proactive discussion of anticipated challenges for the next shift (e.g., 
potential discharges, difficult families, critical cases) to promote anticipation and 
adaptability. 
 
Fostering a psychologically safe culture of co-owned improvement by soliciting 
feedback on the hand-over process itself and iterate improvements collaboratively. 
Succes indicators, to be rated post - intervention by the coach  
1. Team members openly asked clarifying or probing questions without hesitation, 
regardless of seniority. 
2. Each expressed concerns or uncertainties about patient care, even if it involved 
potential errors or ambiguous situations. 
3. All contributed to the discussion - not just the most senior staff. 

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4. Team members built on each other’s input by referencing and developing the ideas 
or observations of others, showing active listening and shared problem-solving. 
5. Team members admitted knowledge gaps or uncertainty without embarrassment or 
defensiveness. 
6. Body language showed openness - eye contact, nodding, relaxed postures - rather 
than disengagement or tension. 
7. Updates or insights from other departments (e.g., lab, radiology, specialists) were 
shared and brought into the conversation. 
8. The team discussed expected changes in patient status, potential risks, and 
contingency plans for the upcoming shift – without perceived judgement of others. 
9. Different team members led parts of the hand-over depending on their role or 
knowledge, rather than waiting for hierarchy to guide the conversation. 
10. Team members could express fatigue or emotional impact (e.g., after a difficult case) 
without stigma or shutdown. 
11. The group occasionally reflected on how they worked together during the previous 
shift - what went well and what could be improved. 
12. Team members suggested ways to improve the hand-over process itself, and 
authority was receptive to them. 
 
Intervention three: facilitation of structured metareflective sessions on specific themes related 
to ethical decision-making with multidisciplinary teams 
Session focus 
Medical professionals are confronted with death and suffering, with uncertainty and 
powerlessness in aversive situations, and with the prospect that decisions and actions might 
have an aggravating impact on those aversive situations. Such confrontations have a 
shocking effect and provoke mixed feelings. Shame, pity, compassion and guilt might come 
to the fore, but the bottom-line reaction to death and decay is desperate anxiety. As 
described by Menzies Lyth (1988): if elementary anxiety is not faced and worked through, all 
kinds of dysfunctional defences ruin collaborations and undermine thoughtful medical ethical 
decision-making. 
Given this challenge, the structured metareflective group sessions will aim at helping the 
team to: (a) discern which sensitive themes were currently affecting the team; (b) reflect on 
how the team is currently facing or avoiding difficult questions and discussions concerning 
these topics; (c) evaluate each owns role and strategies in facilitating or obstructing open 
reflection; (d) reflect on how the team is dealing with the emotional distress that ethically 
sensitive medical topics provoke. 
Method 
Over a period of 4 months with 1 intervention per month, a team coach will facilitate 
structured metareflective group sessions based on experienced cases during the last month. 
The team coach will be randomly allocated from the pool of team coaches, always different 

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from the individual coach, so to avoid reciprocal contamination of findings between the 
individual work and the work with the team. 
The team facilitation we implement will started from four principles of the field of Systems 
Psychodynamics.  
The structured metareflective group sessions will consist of involved practitioners from 
different areas of expertise yet having participated in either individual coaching upon alert or 
team coaching during the work shift hand-over. Consequently, all potential attendees might 
have experienced similar challenges. 
Firstly, like all human beings, the clinician is individually subject to varying degrees of 
unconscious defences such as repression, minimisation, and denial of negative emotions 
and thoughts. These responses are particularly reinforced in the face of death, suffering, 
uncertainty, and a sense of powerlessness in distressing situations. Such defences serve to 
help us make sense of recurring difficult experiences and protect us from confronting painful 
realities we may wish to avoid. However, they can also distort our perception of reality and 
hinder our capacity to absorb new insights about ourselves and the world around us (Steiner, 
2017, p. 54). By helping clinicians making sense of their unprocessed defences, the team 
coach intends to ease possible pain. 
Second, clinicians operate in rotating teams. “People stretched across many teams face 
issues of fragmented attention, task switching, conflicting demands, and work overload. 
These, in turn affect their individual cognitions, behaviours, and performance as well as both 
learning and productivity at the team and organisational levels.” (Mortensen and Gardner, 
2017). Next to this reality, the clinicians’ team is subject to group behaviour, as researched 
by Bion. Bion identified two modes of group functioning: the work group, focused on the task, 
and the basic assumption group, driven by unconscious emotional needs (e.g. dependency, 
fight-flight, pairing). In practice, a facilitator trained in Bion’s theory can observe when a team 
deviates from task-focused behaviour - for example, when members avoid responsibility 
(dependency) or scapegoat others (fight-flight). However, individuals are often unaware of 
those phenomena, which contribute to the separation of their stated intentions from their 
hidden agendas. “The hidden agendas of the individuals within the group collectively make 
up the latent (covert) aspects of group behaviour.” (Armstrong, Sher, Lawlor, 2022, p. 122). 
By naming and addressing these phenomena, the team coach helps the group return to 
productive engagement. This enhances team effectiveness, psychological safety, and 
decision-making under pressure. 
Third, all involved practitioners in the study belong to the same institution. It is argued that 
unconscious processes within institutions can hinder change because institutions, as 
collective entities, develop structures and routines not only to fulfil their primary tasks but 
also to manage underlying anxieties. These unconscious dynamics often manifest as 
resistance when change threatens established norms and the psychological equilibrium of 
the organisation. Therefor it is important trying to recognize and address these hidden forces 
in order to facilitate effective transformation. (Obholzer A., 1987). By exploring unconscious 
factors and helping them to surface, the team coach supports the clinicians in better 
navigating change and avoiding the pitfalls of unacknowledged resistance. 

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Fourth, as any individual operating in an organisation, clinicians are subject to social 
defences. ‘Social defences are “collective arrangements, such as an organisational structure, 
a work method, or a prevalent discourse, created or used by an organisation’s member as a 
protection against disturbing affect derived from external threads, internal conflicts, or the 
nature of their work.” (Petriglieri, 2010, p. 47). By helping clinicians making sense of their 
social defences, the team coach intends to lower the individual anxiety and consequently to 
contribute to a higher mental well-being. 
It is the primary task of the team coach to help attendees exploring their unconscious and 
invisible psychodynamic processes and structures within the context of their organisation’s 
internal and social dynamics. “A well-trained developmental coach should at least be able to 
develop hypotheses and interventions both at an individual level as well as a group level.” 
(Compernolle T., in Kets de Vries, M., Korotov, K., Florent-Treacy, E., 2007, p.35). The main 
focus is to support the group in progressing with the task by enhancing the quality of their 
interactions (Thornton, 2016, p. 38). It is also of utmost importance for the team coach to 
monitor consistently focus on the primary task to avoid the abuse of power and “to keep at a 
relative minimum the occurrence and spread of basic assumption activity.” (Obholzer A., 
Zagier Roberts V., 2019, p.55). Consequently, the team coach needs to be aware of their 
own anxieties, being able to observe for themselves what actually goes on, apart from what 
is stated and then be able to reflect on the significance of what has been observed.  
Objectives 
The team coach will facilitate the structured group reflection to support attendees in: 
 
Recognising unconscious individual defence mechanisms (e.g., repression, 
denial, minimisation) in their responses to distressing clinical experiences. 
 
Understanding how unacknowledged negative emotions can distort perception and 
hinder personal and professional development. 
 
Reflective group dialogue on emotionally charged clinical events by exploring 
the emotional undercurrents of recent clinical cases. 
 
Recognizing group patterns such as dependency, fight-flight, and pairing, and 
consequently the group return to task-focused work. 
 
Identifying how institutional routines and structures may produce social defences and 
unconsciously serve to avoid anxiety, and how this undermines learning. 
 
Applying systems psychodynamic thinking to formulate a working hypothesis about 
unconscious dynamics at individual and group levels. 
 
Maintaining focus on the primary task in group facilitation through techniques to 
help the group stay focused on their collective task, resisting distractions or 
unconscious diversions. 
 
Applying ethical awareness in managing group dynamics and facilitator power 
through reflection on their own use of authority, managing the tension between 
containment and control to avoid misuse of power. 
 
Using self-as-instrument in observing and interpreting group processes by 
cultivating the ability to observe their own emotional reactions and use them as data 
in understanding and intervening in group dynamics. 

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Succes indicators, to be rated post - intervention by the coach  
1. Participants contributed to reflective conversations with honesty and vulnerability, 
particularly around emotionally charged clinical experiences. 
2. Participants showed sensitivity in how they express opinions or take initiative, 
balancing assertiveness with attentiveness to group safety and boundaries. 
3. Participants demonstrated an ability to notice and articulate emotional discomfort 
(e.g., anxiety, frustration) without immediately resorting to defensive responses. 
4. Participants were able to articulate collective behaviours such as avoidance 
(fight/flight), dependency, or undue optimism (pairing). 
5. Participants described their connection between their unprocessed emotional 
experiences and specific impacts on clinical judgement, learning, or interpersonal 
behaviour. 
6. Participants critically reflected on organisational norms, taken-for-granted routines, 
or structures that may unconsciously act as barriers to emotional insight or learning. 
7. Participants offered thoughtful interpretations of group or individual behaviour, by 
means of testing these hypotheses through observation and discussion. 
8. Participants described changes in clinical, interpersonal, or team behaviours by 
referring back to insights from prior sessions and indicated how these have 
influenced their clinical or interpersonal conduct. 
 
 
 

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Quality assurance  
To secure the quality of the intervention the coach will work under the guidelines of the 
Ashridge Code of Conduct (see appendix).  
The quality of the coaching we implement will be also supervised by an independent third-
party supervisor; governed by ethical standards and principles as adopted from de Haan (de 
Haan, 2019). Five moral foundations which support integrity in coaching and research were 
applied: (a) independence to guard the physician’s and clinician’s autonomy; (b) informed 
consent so the physician/clinician knows what he/she is getting involved in; (c) confidentiality 
to safeguard the physician/clinician; (d) respect and diversity to allow multiple voices and 
perspectives and care about vulnerable parties; (e) integrity and trust to comply with 
legislation and to handle data in an ethical way.  
This supervisor has a normative, formative and restoring role (Proctor, 2006). The normative 
role of the supervision aims at monitoring the quality of the coaching methodology and 
ethical aspects with regard to the study purpose. The formative role aims at supporting the 
coach in further developing and refining his/her skills in general and more specifically about 
the study purpose. The restorative role aims at guarantying the energy of the coach and at 
resolving potential conflicts due to emotional or unconscious dynamics in the team.  
Coaching Supervision is about ensuring high quality coaching provision and takes the form of 
ongoing meetings between the supervisor and the coach. One way of looking at the process 
of supervision is provided by the Seven-eyed model (Hawkins and Shohet, 2000). Originally 
developed for use with psychotherapists and counsellors, it is now being applied to coaching 
and mentoring. It describes the 7 areas that supervision can focus on:  
1. The coachee: The focus is on the coachee’s situation – the case the coachee wants 
help with, how they present the issues and the choices they are making.  
2. The coach’s Interventions: The focus is on the interventions the coach made, how 
and why they made them, and what else they might have done. 
3. The relationship between the coach and coachee: The focus is on neither the coach 
nor the coacheebut on the conscious and unconscious interactions between the two 
of them, so that the coach develops a better understanding of the dynamics of the 
coaching relationship. 
4. The coach: The focus is on the coach’s own experience as an instrument for 
registering what is happening beneath the surface of the coachee’s system. 
5. The supervisory relationship: The focus is on what the coach has absorbed from the 
coachee’s system and how it may be playing out in the relationship between coach 
and supervisor. 
6. The supervisor’s self-reflection: The focus is the supervisor’s “here and now” 
experience with the coach and how this can be used to shed light on the 
coach/coachee relationship. 
7. The wider context: The focus is on the wider organisational, social, cultural, ethical, 
and contractual context within which the supervision is taking place.  

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In focusing on areas 1-3, the supervision is concerned with reflecting on the coaching 
session itself – its content, the interventions made, and the dynamics of the coaching 
relationship.  
In areas 4-6, the supervision is concerned with the coaching session as it is reflected in the 
here and now experience of the supervision session.  
The value of this model is that it maps the areas that supervision can focus on, making it 
easier to ensure that we have covered the ground.  
 
 
 
 
 
 
 
 
 
 
 
 
 

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