Additional file 1 of The potential impact fraction of population weight reduction scenarios on non-communicable diseases in Belgium: application of the g-computation approach

Supplementary Material 1

Trial design (stepped wedge cluster randomized controlled trial).

Based on the results of a pilot study (Table 1), we expect that 4 patients per ward per week will be identified by clinicians as potentially receiving excessive care; expanded to 1 month and 10 wards this yields to 160 patients. Taking to account that one in eight patients might be re-admissions and/or patients with length of stay of more than one week, we drop this total amount to 140, of whom 88 without a DNIR code over 10 departments. This yields to 9 patients and 18 coaching sessions (one junior and one senior doctor per patient) per month per department. As 2 to 5 departments will have the intervention at the same time, the expected number of coaching sessions varies between 36 and 90 sessions per month. The black bars indicate the intervention period across all 10 departments. All 10 departments were randomly assigned to start a 4-month coaching period in month k = 1,…,10 following a stratified design. In particular, the 3 departments with the highest incidence of written DNIR orders (based on historical data, Table 1) were randomly assigned to start the intervention in months 2, 4 and 6 (each time together with another ward). The 7 other wards were randomly assigned to start the intervention. Subsequently, departments in which senior doctors remain in charge of their own hospitalized patients (in contrast to departments in which one senior doctor is in charge of all hospitalized patients on a specific ward) were spread in order to reduce the workload of the coach. One month was added to compensate for the absence of the coach for whatever reason.</p

Schedule of enrolment, interventions and assessments.

Schedule of enrolment, interventions and assessments.</p

SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documents*.

SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documents*.</p

Overview of collected data and timelines: Secondary outcomes on family, clinician and societal level.

Overview of collected data and timelines: Secondary outcomes on family, clinician and societal level.</p

Overview of collected data and timelines: Primary outcomes and secondary outcomes on patient level.

Overview of collected data and timelines: Primary outcomes and secondary outcomes on patient level.</p

IRB protocol and approval.

BackgroundFast medical progress poses a significant challenge to doctors, who are asked to find the right balance between life-prolonging and palliative care. Literature indicates room for enhancing openness to discuss ethical sensitive issues within and between teams, and improving decision-making for benefit of the patient at end-of-life.MethodsStepped wedge cluster randomized trial design, run across 10 different departments of the Ghent University Hospital between January 2022 and January 2023. Dutch speaking adult patients and one of their relatives will be included for data collection. All 10 departments were randomly assigned to start a 4-month coaching period. Junior and senior doctors will be coached through observation and debrief by a first coach of the interdisciplinary meetings and individual coaching by the second coach to enhance self-reflection and empowering leadership and managing group dynamics with regard to ethical decision-making. Nurses, junior doctors and senior doctors anonymously report perceptions of excessive treatment via the electronic patient file. Once a patient is identified by two or more different clinicians, an email is sent to the second coach and the doctor in charge of the patient. All nurses, junior and senior doctors will be invited to fill out the ethical decision making climate questionnaire at the start and end of the 12-months study period. Primary endpoints are (1) incidence of written do-not-intubate and resuscitate orders in patients potentially receiving excessive treatment and (2) quality of ethical decision-making climate. Secondary endpoints are patient and family well-being and reports on quality of care and communication; and clinician well-being. Tertiairy endpoints are quantitative and qualitative data of doctor leadership quality.DiscussionThis is the first randomized control trial exploring the effects of coaching doctors in self-reflection and empowering leadership, and in the management of team dynamics, with regard to ethical decision-making about patients potentially receiving excessive treatment.</div

Overview of collected data and timelines: Tertiary outcomes^b'*'.

Overview of collected data and timelines: Tertiary outcomesb'*'.</p

Theoretical background on the primary endpoints.

The quality of medical ethical decision-making will be assessed objectively via the incidence of written Do-Not-Intubate and Resuscitate (DNIR) orders in patients potentially receiving excessive treatment during their first hospitalization and subjectively via the Ethical Decision-Making Climate Questionnaire (EDMCQ) [4] that will be filled out by the doctors and nurses in the team one month prior and after the 12-months study period. The EDMCQ is 32-item validated questionnaire consists of 7 main domains or factors: factor 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”. We expect that an effect on individual decision-making by doctors would affect the incidence of written DNIR orders both directly, and indirectly via F3 and F6. We expect that effect on collective decision-making in team would affect F1, which in turn affects all other EDMCQ factors and via these, the incidence of written DNIR orders. Both null hypotheses that will be tested express no change (as opposed to change).</p

Coaching protocol.

BackgroundFast medical progress poses a significant challenge to doctors, who are asked to find the right balance between life-prolonging and palliative care. Literature indicates room for enhancing openness to discuss ethical sensitive issues within and between teams, and improving decision-making for benefit of the patient at end-of-life.MethodsStepped wedge cluster randomized trial design, run across 10 different departments of the Ghent University Hospital between January 2022 and January 2023. Dutch speaking adult patients and one of their relatives will be included for data collection. All 10 departments were randomly assigned to start a 4-month coaching period. Junior and senior doctors will be coached through observation and debrief by a first coach of the interdisciplinary meetings and individual coaching by the second coach to enhance self-reflection and empowering leadership and managing group dynamics with regard to ethical decision-making. Nurses, junior doctors and senior doctors anonymously report perceptions of excessive treatment via the electronic patient file. Once a patient is identified by two or more different clinicians, an email is sent to the second coach and the doctor in charge of the patient. All nurses, junior and senior doctors will be invited to fill out the ethical decision making climate questionnaire at the start and end of the 12-months study period. Primary endpoints are (1) incidence of written do-not-intubate and resuscitate orders in patients potentially receiving excessive treatment and (2) quality of ethical decision-making climate. Secondary endpoints are patient and family well-being and reports on quality of care and communication; and clinician well-being. Tertiairy endpoints are quantitative and qualitative data of doctor leadership quality.DiscussionThis is the first randomized control trial exploring the effects of coaching doctors in self-reflection and empowering leadership, and in the management of team dynamics, with regard to ethical decision-making about patients potentially receiving excessive treatment.</div