Coaching Doctors in Ethical Decision-making (CODE)

Sponsor

University Hospital, Ghent (Other)

Overall Status

Recruiting

CT.gov ID

NCT05167019

Collaborator

(none)

1,700

Enrollment

Location

Arms

Anticipated Duration (Months)

68.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Over the last few decades the fast technical and medical progress poses a significant challenge to doctors, who are asked to find the right balance between life-prolonging and palliative care. Previous studies suggest that doctors (unconsciously) prefer to remain prognostically uncertain rather than to gather the information that is required to reduce uncertainty and to effectively timely take decisions in the team for the benefit of the patient. To obtain all that information, the doctor in charge of the patient needs to empower clinicians to speak up while guarantying a safe environment. However, creating a safe climate which enhances inter-professional shared decision-making for the benefit of the patient requires specific self-reflective and empowering leadership skills (including the management of group dynamics in the interdisciplinary team).

The aim of this study is to investigate whether coaching doctors in self-reflective and empowering leadership, and in the management of team dynamics with regard to adult hospitalized patients potentially receiving excessive treatment during 4 months 1) improves ethical decision-making (primary objective) and 2) reduces the burden on patients, relatives, clinicians and the society (secondary objective). The improvement in quality of ethical decision-making will be assessed objectively via the incidence of written do-not-intubate and -resuscitate orders (first primary endpoint) in patients potentially receiving excessive treatment and subjectively via the ethical decision-making climate questionnaire that will be filled out by the team (second primary endpoint). In line with the DISPROPRICUS study, patients potentially receiving excessive treatment will be defined as patients who are perceived as receiving excessive treatment by two or more different clinicians in charge of the patient. The probability of being alive, at home with a good quality of life one year after admission was only 7% in patients potentially receiving excessive treatment in this study. Therefore, perceptions of excessive treatment by two or more clinicians are used in this study as a signal to initiate (self-)reflection in team about the quality of care that is provided to the patient and whether the treatment is in balance with the medical condition of the patient and the patient's goal of care

Condition or Disease	Intervention/Treatment	Phase
End of Life Interdisciplinary Communication Leadership	Behavioral: CODE intervention Other: Usual care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1700 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Sample size for this stepped wedge randomised controlled trial is listed for patients potentially receiving excessive treatment (n=1700) together with one of their relatives who will be identified by junior doctors (n=75) , senior doctors (n=75) and nurses (n= 600) working in 10 departments of the Ghent university hospital during a 12 months period. Junior and senior doctors working in each department will be coached in self-reflective and empowering leadership, and in managing group dynamics with regard to patients potentially receiving excessive treatment for whom they are in charge of during a 4 month period. The impact of the intervention on the quality of ethical decision-making will be assessed at the patient (n=1700), relatives (n=1700) and team level (n=750).Sample size for this stepped wedge randomised controlled trial is listed for patients potentially receiving excessive treatment (n=1700) together with one of their relatives who will be identified by junior doctors (n=75) , senior doctors (n=75) and nurses (n= 600) working in 10 departments of the Ghent university hospital during a 12 months period. Junior and senior doctors working in each department will be coached in self-reflective and empowering leadership, and in managing group dynamics with regard to patients potentially receiving excessive treatment for whom they are in charge of during a 4 month period. The impact of the intervention on the quality of ethical decision-making will be assessed at the patient (n=1700), relatives (n=1700) and team level (n=750).

Masking:

Single (Participant)

Masking Description:

Patients will be blinded to the 4 months intervention period in junior and senior doctors.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 21, 2022

Anticipated Primary Completion Date :

Feb 20, 2023

Anticipated Study Completion Date :

Feb 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Usual care Usual care	Other: Usual care The control group will receive usual care in which the quality of the ethical decision-making is determined by the clinical team according to their usual practice. Except from a treatment-limitation-decisions guideline which focuses on the legal and deontological framework, no other guideline with regard to ethical decision-making has been implemented at the Ghent University Hospital. In one ward (geriatrics), there is a ongoing project in which a clinical nurse specialist stimulates and performes advance care planning conversations with patient and/or relatives at request of the team and who organizes debriefings when needed based on the ethical concerns of the nurses.
Experimental: The CODE intervention The CODE intervention consists of 4 items, of which individual coaching sessions of 1 hour. In total each doctor taking care of hospitalized patients will be able to receive maximum 16 individual coaching sessions during the 4 months intervention period (one weekly). Every doctor will be invited to participate to at least 8 coaching sessions, to be extended on request, during the intervention period.	Behavioral: CODE intervention The CODE intervention consists of 1) One interactive session of 2 to 3 hrs focusing on the concepts of medical-ethical decision-making, the psychological challenge of dealing with ethically sensitive medical topics, and empowering leadership. 2) Observation and debrief of the interdisciplinary meeting to enhance self-reflection on empowering leadership and managing group dynamics. 3) Individual coaching on the spot in self-reflective and empowering leadership and in managing groups dynamics with regard to ethical decision-making about patients who are perceived to receive excessive treatment during the intervention period, and in absence of such patients, every item with regard to ethical decision-making that is important for the coachee. 4) During the intervention coaches and doctors in charge will be informed of the presence of a patient potentially receiving excessive treatment in their ward by an electronic alert.

Arm

Intervention/Treatment

Active Comparator: Usual care

Usual care

Other: Usual care

The control group will receive usual care in which the quality of the ethical decision-making is determined by the clinical team according to their usual practice. Except from a treatment-limitation-decisions guideline which focuses on the legal and deontological framework, no other guideline with regard to ethical decision-making has been implemented at the Ghent University Hospital. In one ward (geriatrics), there is a ongoing project in which a clinical nurse specialist stimulates and performes advance care planning conversations with patient and/or relatives at request of the team and who organizes debriefings when needed based on the ethical concerns of the nurses.

Experimental: The CODE intervention

The CODE intervention consists of 4 items, of which individual coaching sessions of 1 hour. In total each doctor taking care of hospitalized patients will be able to receive maximum 16 individual coaching sessions during the 4 months intervention period (one weekly). Every doctor will be invited to participate to at least 8 coaching sessions, to be extended on request, during the intervention period.

Behavioral: CODE intervention

The CODE intervention consists of 1) One interactive session of 2 to 3 hrs focusing on the concepts of medical-ethical decision-making, the psychological challenge of dealing with ethically sensitive medical topics, and empowering leadership. 2) Observation and debrief of the interdisciplinary meeting to enhance self-reflection on empowering leadership and managing group dynamics. 3) Individual coaching on the spot in self-reflective and empowering leadership and in managing groups dynamics with regard to ethical decision-making about patients who are perceived to receive excessive treatment during the intervention period, and in absence of such patients, every item with regard to ethical decision-making that is important for the coachee. 4) During the intervention coaches and doctors in charge will be informed of the presence of a patient potentially receiving excessive treatment in their ward by an electronic alert.

Outcome Measures

Primary Outcome Measures

Incidence of written do-not-intubate and -resuscitate (DNIR) order between hospital admission and the end of first hospital stay [at the end of the 12 months study period]
Patient-specific endpoint
Ethical decision-making climate questionnaire (EDMCQ) [at the start and end of the 12 month study period]
Clinician specific endpoint. Factorscores on 7 domains, which is normally distributed, centred at mean of zero, with standard deviation 5.5 (minimum score -25, maximum score 25). Higher scores iindicate higher quality of ethical decision-making

Secondary Outcome Measures

Incidence of death one year after first hospital admission [12 months after first hospital admission]
Patient-specific endpoint
Percentage of patients who achieved the combined one year patient outcome (dead, not at home or utility <0.5 according to the European Quality-of-life 5 dimension instrument (Euro-QOL-5D). [12 months after first hospital admission]
Patient-specific endpoint
Number of days admitted in the hospital up the end of the first hospital stay [at the end of the 12 months study period]
Patient-specific endpoint
Pain according to the Numeral rating scale (NRS) : sum of the average daily score up to the end of first hospital stay [at the end of the 12 months study period]
Patient-specific endpoint. Single-item assessment of pain ranging from 0 (no pain) to 10 (worst possible pain).
Pain according to the Numeral rating scale (NRS) : number of days with an average score > 3 up to the end of first hospital stay [at the end of the 12 months study period]
Patient-specific endpoint. Single-item assessment of pain ranging from 0 (no pain) to 10 (worst possible pain).
Potentially inappropriate or burdersome treatments : incidence of achieving the combined patient burdersome treatment endpoint (achieving outcome 9,10,11,12,13,14,15 or 16) up to the end of first hospital stay [at the end of the 12 months study period]
Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of receiving cardio-pulmonary resuscitation up to the end of first hospital stay [at the end of the 12 months study period]
Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of admission in the intensive care unit up to the end of first hospital stay [at the end of the 12 months study period]
Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of invasive mechanical ventilation in the intensive care unit up to the end of first hospital stay [at the end of the 12 months study period]
Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of non-invasive mechanical ventilation in the intensive care unit up to the end of first hospital stay [at the end of the 12 months study period]
Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of receiving dialysis up to the end of first hospital stay [at the end of the 12 months study period]
Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of receiving a surgical procedure up to the end of first hospital stay [at the end of the 12 months study period]
Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of receiving a chemotherapeutic treatment up to the end of first hospital stay [at the end of the 12 months study period]
Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of receiving a radiotherapeutic treatment up to the end of first hospital stay [at the end of the 12 months study period]
Patient-specific endpoint
Satisfaction according to the European Family Satisfaction in the ICU score (Euro FS) [3 weeks after hospital discharge]
Patient-specific endpoint. The investigators will use the single-item assessment of satisfaction of this score ranging from 0 to 10. Higher values indicate higher satisfaction
Hospital anxiety and depression scale (HADS) [3 weeks after hospital discharge]
Patient-specific endpoint. This score is interpreted as follows : 0-7 (normal), 8-10 (mild), 11-21 (moderate to severe)
European quality of dying and death family questionnaire (Euro-QODD nurse) [within 1 week after death]
Patient-specific endpoint filled out by nurses. The investigators will use the single-item assessment of quality of dying and death of this score ranging from 0 to 10. Higher values indicate higher quality
European quality of dying and death family questionnaire (Euro-QODD family) [3 weeks after the patient's death]
Patient-specific endpoint filled out by the relatives. The investigators will use the single-item assessment of quality of dying and death of this score ranging from 0 to 10. Higher values indicate higher quality
Satisfaction according to the European Family Satisfaction in the ICU score (Euro FS) [3 weeks after the patient's hospital discharge]
Family-specific endpoint. The investigators will use the single-item assessment of satisfaction of this score ranging from 0 to 10. Higher values indicate higher satisfaction
Hospital anxiety and depression scale (HADS) [3 weeks after the patient's hospital discharge]
Family-specific endpoint. This score is interpreted as follows : 0-7 (normal), 8-10 (mild), 11-21 (moderate to severe)
Impact of events scale-revised (IES-R) [3 weeks after the patient's death]
Family-specific endpoint. This score is interpreted as follows: Low risk (0-11), moderate risk (12-32), high risk (33 or higher) for post-traumatic stress disorder.
Percentage of (mild-moderate-severe-extreme) stress related to a perception of excessive treatment [at the end of the 12 month study period]
Clinician-specific endpoint
Percentage of clinicians with intention of leaving their job [at the start and end of the 12 month study period]
Clinician-specific endpoint
Percentage of clinicians with sick leave [at the start and end of the 12 month study period]
Team-specific endpoint
Ethical pratice score [at the start and end of the 12 month study period]
Team-specific endpoint. This scores consist of 12 items. The investigators will use the 10 department specific items (minus the 2 country-specific items). This score ranges from 0 to 10 with higher scores indicating a higher degree of ethical pratice organization
Health-care utilization : total hospital cost by the hospital billing record up to the end of first hospital stay [at the end of the 12 months study period]
Society-specific endpoint
Health-care utilization : total number of emergency department visits [12 months after first hospital discharge]
Society-specific endpoint
Health-care utilization : total number of hospital admissions [12 months after first hospital discharge]
Society-specific endpoint
Health-care utilization : total number of admissions in the intensive care unit [12 months after first hospital discharge]
Society-specific endpoint
Health-care utilization : total number of days in the hospital [12 months after first hospital discharge]
Society-specific endpoint
Health-care utilization : total number of days in the intensive care unit [12 months after first hospital discharge]
Society-specific endpoint
Health-care utilization : total number of dialyses [12 months after first hospital discharge]
Society-specific endpoint
Health-care utilization : total number of surgical procedures [12 months after first hospital discharge]
Society-specific endpoint
Health-care utilization : total number of chemotherapeutic treatments [12 months after first hospital discharge]
Society-specific endpoint
Health-care utilization : total number of radiotherapeutic treatments [12 months after first hospital discharge]
Society-specific endpoint
Health-care utilization : total number of blood analyses [12 months after first hospital discharge]
Society-specific endpoint
Health-care utilization : total number of radiological investigations [12 months after first hospital discharge]
Society-specific endpoint

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria

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