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

Primary Purpose

End of Life, Interdisciplinary Communication, Leadership

Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
CODE intervention
Usual care
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End of Life focused on measuring Treatment limitation decisions, Interdisciplinary collaboration, Coaching, Self-reflective and empowering leadership, Ethical climate, Prognostic uncertainty

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

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

Exclusion criteria :

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

Sites / Locations

  • Ghent University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care

The CODE intervention

Arm Description

Usual care

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of death one year 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).
Patient-specific endpoint
Number of days admitted in the hospital up the end of the first hospital stay
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
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
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
Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of receiving cardio-pulmonary resuscitation up to the end of first hospital stay
Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of admission in the intensive care unit up to the end of first hospital stay
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
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
Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of receiving dialysis up to the end of first hospital stay
Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of receiving a surgical procedure up to the end of first hospital stay
Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of receiving a chemotherapeutic treatment up to the end of first hospital stay
Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of receiving a radiotherapeutic treatment up to the end of first hospital stay
Patient-specific endpoint
Satisfaction according to the European Family Satisfaction in the ICU score (Euro FS)
Patient-specific endpoint. The investigators will use the single-item assessment of satisfaction of this score ranging from 0 to 10. Higher values indicate higher satisfaction
Hospital anxiety and depression scale (HADS)
Patient-specific endpoint. This score is interpreted as follows : 0-7 (normal), 8-10 (mild), 11-21 (moderate to severe)
European quality of dying and death family questionnaire (Euro-QODD nurse)
Patient-specific endpoint filled out by nurses. The investigators will use the single-item assessment of quality of dying and death of this score ranging from 0 to 10. Higher values indicate higher quality
European quality of dying and death family questionnaire (Euro-QODD family)
Patient-specific endpoint filled out by the relatives. The investigators will use the single-item assessment of quality of dying and death of this score ranging from 0 to 10. Higher values indicate higher quality
Satisfaction according to the European Family Satisfaction in the ICU score (Euro FS)
Family-specific endpoint. The investigators will use the single-item assessment of satisfaction of this score ranging from 0 to 10. Higher values indicate higher satisfaction
Hospital anxiety and depression scale (HADS)
Family-specific endpoint. This score is interpreted as follows : 0-7 (normal), 8-10 (mild), 11-21 (moderate to severe)
Impact of events scale-revised (IES-R)
Family-specific endpoint. This score is interpreted as follows: Low risk (0-11), moderate risk (12-32), high risk (33 or higher) for post-traumatic stress disorder.
Percentage of (mild-moderate-severe-extreme) stress related to a perception of excessive treatment
Clinician-specific endpoint
Percentage of clinicians with intention of leaving their job
Clinician-specific endpoint
Percentage of clinicians with sick leave
Team-specific endpoint
Ethical pratice score
Team-specific endpoint. This scores consist of 12 items. The investigators will use the 10 department specific items (minus the 2 country-specific items). This score ranges from 0 to 10 with higher scores indicating a higher degree of ethical pratice organization
Health-care utilization : total hospital cost by the hospital billing record up to the end of first hospital stay
Society-specific endpoint
Health-care utilization : total number of emergency department visits
Society-specific endpoint
Health-care utilization : total number of hospital admissions
Society-specific endpoint
Health-care utilization : total number of admissions in the intensive care unit
Society-specific endpoint
Health-care utilization : total number of days in the hospital
Society-specific endpoint
Health-care utilization : total number of days in the intensive care unit
Society-specific endpoint
Health-care utilization : total number of dialyses
Society-specific endpoint
Health-care utilization : total number of surgical procedures
Society-specific endpoint
Health-care utilization : total number of chemotherapeutic treatments
Society-specific endpoint
Health-care utilization : total number of radiotherapeutic treatments
Society-specific endpoint
Health-care utilization : total number of blood analyses
Society-specific endpoint
Health-care utilization : total number of radiological investigations
Society-specific endpoint

Full Information

First Posted
October 1, 2021
Last Updated
April 20, 2023
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT05167019
Brief Title
Coaching Doctors in Ethical Decision-making (CODE)
Acronym
CODE
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 21, 2022 (Actual)
Primary Completion Date
April 19, 2023 (Actual)
Study Completion Date
February 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End of Life, Interdisciplinary Communication, Leadership
Keywords
Treatment limitation decisions, Interdisciplinary collaboration, Coaching, Self-reflective and empowering leadership, Ethical climate, Prognostic uncertainty

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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).
Masking
Participant
Masking Description
Patients will be blinded to the 4 months intervention period in junior and senior doctors.
Allocation
Randomized
Enrollment
1700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care
Arm Title
The CODE intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CODE intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of written do-not-intubate and -resuscitate (DNIR) order between hospital admission and the end of first hospital stay
Description
Patient-specific endpoint
Time Frame
at the end of the 12 months study period
Title
Ethical decision-making climate questionnaire (EDMCQ)
Description
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
Time Frame
at the start and end of the 12 month study period
Secondary Outcome Measure Information:
Title
Incidence of death one year after first hospital admission
Description
Patient-specific endpoint
Time Frame
12 months after first hospital admission
Title
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).
Description
Patient-specific endpoint
Time Frame
12 months after first hospital admission
Title
Number of days admitted in the hospital up the end of the first hospital stay
Description
Patient-specific endpoint
Time Frame
at the end of the 12 months study period
Title
Pain according to the Numeral rating scale (NRS) : sum of the average daily score up to the end of first hospital stay
Description
Patient-specific endpoint. Single-item assessment of pain ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame
at the end of the 12 months study period
Title
Pain according to the Numeral rating scale (NRS) : number of days with an average score > 3 up to the end of first hospital stay
Description
Patient-specific endpoint. Single-item assessment of pain ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame
at the end of the 12 months study period
Title
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
Description
Patient-specific endpoint
Time Frame
at the end of the 12 months study period
Title
Potentially inappropriate or burdersome treatments : incidence of receiving cardio-pulmonary resuscitation up to the end of first hospital stay
Description
Patient-specific endpoint
Time Frame
at the end of the 12 months study period
Title
Potentially inappropriate or burdersome treatments : incidence of admission in the intensive care unit up to the end of first hospital stay
Description
Patient-specific endpoint
Time Frame
at the end of the 12 months study period
Title
Potentially inappropriate or burdersome treatments : incidence of invasive mechanical ventilation in the intensive care unit up to the end of first hospital stay
Description
Patient-specific endpoint
Time Frame
at the end of the 12 months study period
Title
Potentially inappropriate or burdersome treatments : incidence of non-invasive mechanical ventilation in the intensive care unit up to the end of first hospital stay
Description
Patient-specific endpoint
Time Frame
at the end of the 12 months study period
Title
Potentially inappropriate or burdersome treatments : incidence of receiving dialysis up to the end of first hospital stay
Description
Patient-specific endpoint
Time Frame
at the end of the 12 months study period
Title
Potentially inappropriate or burdersome treatments : incidence of receiving a surgical procedure up to the end of first hospital stay
Description
Patient-specific endpoint
Time Frame
at the end of the 12 months study period
Title
Potentially inappropriate or burdersome treatments : incidence of receiving a chemotherapeutic treatment up to the end of first hospital stay
Description
Patient-specific endpoint
Time Frame
at the end of the 12 months study period
Title
Potentially inappropriate or burdersome treatments : incidence of receiving a radiotherapeutic treatment up to the end of first hospital stay
Description
Patient-specific endpoint
Time Frame
at the end of the 12 months study period
Title
Satisfaction according to the European Family Satisfaction in the ICU score (Euro FS)
Description
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
Time Frame
3 weeks after hospital discharge
Title
Hospital anxiety and depression scale (HADS)
Description
Patient-specific endpoint. This score is interpreted as follows : 0-7 (normal), 8-10 (mild), 11-21 (moderate to severe)
Time Frame
3 weeks after hospital discharge
Title
European quality of dying and death family questionnaire (Euro-QODD nurse)
Description
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
Time Frame
within 1 week after death
Title
European quality of dying and death family questionnaire (Euro-QODD family)
Description
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
Time Frame
3 weeks after the patient's death
Title
Satisfaction according to the European Family Satisfaction in the ICU score (Euro FS)
Description
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
Time Frame
3 weeks after the patient's hospital discharge
Title
Hospital anxiety and depression scale (HADS)
Description
Family-specific endpoint. This score is interpreted as follows : 0-7 (normal), 8-10 (mild), 11-21 (moderate to severe)
Time Frame
3 weeks after the patient's hospital discharge
Title
Impact of events scale-revised (IES-R)
Description
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.
Time Frame
3 weeks after the patient's death
Title
Percentage of (mild-moderate-severe-extreme) stress related to a perception of excessive treatment
Description
Clinician-specific endpoint
Time Frame
at the end of the 12 month study period
Title
Percentage of clinicians with intention of leaving their job
Description
Clinician-specific endpoint
Time Frame
at the start and end of the 12 month study period
Title
Percentage of clinicians with sick leave
Description
Team-specific endpoint
Time Frame
at the start and end of the 12 month study period
Title
Ethical pratice score
Description
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
Time Frame
at the start and end of the 12 month study period
Title
Health-care utilization : total hospital cost by the hospital billing record up to the end of first hospital stay
Description
Society-specific endpoint
Time Frame
at the end of the 12 months study period
Title
Health-care utilization : total number of emergency department visits
Description
Society-specific endpoint
Time Frame
12 months after first hospital discharge
Title
Health-care utilization : total number of hospital admissions
Description
Society-specific endpoint
Time Frame
12 months after first hospital discharge
Title
Health-care utilization : total number of admissions in the intensive care unit
Description
Society-specific endpoint
Time Frame
12 months after first hospital discharge
Title
Health-care utilization : total number of days in the hospital
Description
Society-specific endpoint
Time Frame
12 months after first hospital discharge
Title
Health-care utilization : total number of days in the intensive care unit
Description
Society-specific endpoint
Time Frame
12 months after first hospital discharge
Title
Health-care utilization : total number of dialyses
Description
Society-specific endpoint
Time Frame
12 months after first hospital discharge
Title
Health-care utilization : total number of surgical procedures
Description
Society-specific endpoint
Time Frame
12 months after first hospital discharge
Title
Health-care utilization : total number of chemotherapeutic treatments
Description
Society-specific endpoint
Time Frame
12 months after first hospital discharge
Title
Health-care utilization : total number of radiotherapeutic treatments
Description
Society-specific endpoint
Time Frame
12 months after first hospital discharge
Title
Health-care utilization : total number of blood analyses
Description
Society-specific endpoint
Time Frame
12 months after first hospital discharge
Title
Health-care utilization : total number of radiological investigations
Description
Society-specific endpoint
Time Frame
12 months after first hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Exclusion criteria : Clinicians'level : no exclusion criteria Patients' level : patients who cannot understand Dutch questionnaires Family : persons who cannot understand Dutch questionnaires
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Benoit, MD,PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

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Coaching Doctors in Ethical Decision-making (CODE)

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