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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent

About this trial

Literature and a pilot study performed in 2019 indicate room for enhancing openness to discuss ethical sensitive issues within and between teams, and improving goal-oriented care and decision-making for the benefit of the patient at end-of-life, worldwide and more specifically in Belgium and in the Ghent University Hospital. The CODE study intervention performed in 2021 suggests already an improvement in goal oriented care operationalized via written Do-Not-Intubate and Do-Not-Attempt Cardio-Pulmonary Resuscitation (DNI-DNACPR orders in the Ghent University Hospital. In this study, the investigators found a nearly doubling of the incidence in written DNI-DNACPR in patient potentially receiving excessive treatment (PET) (from 19.7% to 29.7%, p\<0.001) and in patients hospitalized for the first time (from 1.9% to 3.4%, p=0.011) without increasing one-year mortality, after coaching doctors during 4 months in self-reflective and empowering leadership, and coping with group dynamics. However, the investigators found no improvement in the perception of the quality of the ethical climate by clinicians, more specifically by nurses. Despite the fact that ethical decision-making is considered a strategic priority in the Ghent University Hospital and an intense communication campaign, clinicians identified also a much smaller number of PET during this interventional study than during the observational pilot study in 2019. Although fading attention for the study over time and visibility of the electronic CODE alert to identify PET was claimed as the main reasons by 75% and 50.7% of the nurses, respectively, 95% expressed the desire to keep on using this alert in the future. This underscores a deeper concern in nurses. More than 40% expressed fear of blaming doctors or skepticism regarding the impact of identifying PET. Nonetheless, 35% acknowledged improvement in interdisciplinary meetings about end-of-life issues since study initiation. These findings highlights the need to additionally coach the entire team in future studies. Indeed, creating a safe climate which enhances inter-professional shared decision-making for the benefit of the patient requires both, specific self-reflective and empowering leadership skills in doctors and head nurses (including the management of group dynamics in the interdisciplinary team), and confidence in speaking up in nurses and other health care professionals. This is what the investigators want to develop with this intervention. These skills will also help clinicians during patient and family meetings which will enable clinicians to better take into account the patient's and family's wishes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients potentially receiving excessive treatment (PET) who are identified by clinicians during their first hospitalization. PET is defined as a patient in whom 2 or more clinicians doubt whether the treatment or treatment limitation code is consistent with their expected survival or quality of life (= "too much" or "excessive treatment") or whether the treatment limitation code is in line with the patient's or relatives' goals.

Family members of PET

Junior and senior doctors (including Department Heads) taking care of hospitalized patients

Nurses (including head nurses) taking care of hospitalized patients

Disqualifiers

PET with a previous written DNI-DNACPR order

Patients and family members of PET who are less than 18 years old and persons who cannot understand Ducth questionnaires

Trial design

Design model

Sequential

Treatments tested in this trial

  • Usual Care Group

    Other intervention

    The control group will receive usual care in which the quality of the ethical decision-making is determined by the clinical team according to their usual pratice. Except from a treatment-limitation-decisions guideline which focuses on the legal and deontological framework, no other guideline with regard to ethical decision-making has been implemented at the Ghent University Hospital.

  • CODE II intervention

    Behavioral

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

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: Usual careActive comparator 1 intervention
Group B: CODE II interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Patient-specific endpoint

Time frame
At the end of the 14 months study period
2

Ethical decision-making climate questionnaire (EDMCQ)

Clinician specific endpoint. Factorscores on 7 domains, which is normally distributed, centred at mean of zero, with standard deviation 5.5 (minimum score -25, maximum score 25). Higher scores indicate higher quality of interdisciplinary ethical decision-making

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

Secondary outcomes

1

Hospital Consumer Assessment of Healthcare Providers and Systems instrument

Patient-specific endpoint. Patients rate the quality of their hospital stay on a scale of 0 (worst) to 10 (best) and indicate whether they would recommend their hospital to family and friends.

Time frame
3 weeks after the patient's hospital discharge
2

Sinclair Compassion Questionnaire-Short Form (SCQ-SF)

Patient-specific endpoint. The SCQ is a validated instrument for quantifying compassion in healthcare from multiple perspectives (e.g., patients, family, clinicians). It studies outcomes valued by the patient such as 'feeling heard and understood by their clinician' and 'being valued as a person'. The Belgian version of the 5-item SCQ-SF (Sinclair Compassion Questionnaire-Short Form) is used with each item rating on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is calculated as the mean of the five items, resulting in a theoretical range from 1 to 5. A higher SCQ score is indicative of higher compassionate care.

Time frame
3 weeks after the patient's hospital discharge
3

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

Patient-specific endpoint. Validated 18 item questionnaire covering satisfaction with 4 domains: communication, empathy, symptom management and decision-making. The investigators will use the single-item assessment of satisfaction of this score raning from 0 to 10. higher values indicate higher satisfaction.

Time frame
3 weeks after the patient's hospital discharge
4

Hospital Anxiety and Depression Scale (HADS)

Patient-specific endpoint. 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

Time frame
3 weeks after hospital discharge

Other outcomes

1

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

Society-level endpoint

Time frame
12 months after first hospital admission
2

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

Society-specific endpoint

Time frame
12 months after first hospital admission
3

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

Society-specific endpoint

Time frame
12 months after first hospital admission
4

Health-care utilization : total number of admission in the Intensive care Unit up to one year after the first hospital admission

Society-specific endpoint

Time frame
12 months after first hospital admission

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: