Faculty of Medicine
Faculty of Medicine
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[FG] Hunziker Sabina

Projects & Collaborations

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Checklist-guided shared decision-making for code status discussions in medical inpatients A cluster-randomized multicenter trial

Research Project  | 2 Project Members

A patients' decision regarding "Do Not Resuscitate" (DNR) code status, which is a legal order to withhold cardiopulmonary resuscitation (CPR) or advanced cardiac life support in respect of a patient's wish in case of a cardiac arrest or respiratory failure, has important medical and socioeconomic consequences. Yet, hospitalized patients often have insufficient information about expected outcomes from resuscitation measures. Research shows that <20% of in-hospital patients, who require CPR survive and subsequently many have permanent brain damage or disability. Although challenging in clinical routine, sharing information about expected prognosis with patients is a prerequisite for informed decision-making. In a recent hospital-based survey we found that DNR discussions are often insufficient with physicians not actively involving patients in the decision-making process, but relying decisions on the presumed preferences without in-depth discussions of patients' choices and consequences. General aim: This trial is designed to investigate whether checklist-guided shared decision-making including decision aids and communication of expected outcome influences patients' decision regarding DNR code status, and at the same time, improves decision-making quality as judged by patient's decisional comfort, patient knowledge and involvement in decision-making and patient satisfaction. Patient population: Consecutive adult medical patients admitted for in-hospital care, independent of medical diagnosis are eligible. Patients unable to complete questionnaires or unable to follow code status discussions (e.g., due to cognitive impairment such as dementia or delirium) are excluded. Methods: multicenter, cluster randomized controlled trial involving five Swiss university hospitals.Intervention: Medical residents conducting code status discussions will be randomized by an electronic, web-based system to the intervention group with shared decision-making facilitated by a checklist and a decision aid or to the usual care group. The decision aid was developed during a consensus conference, in which feedback from patients and clinicians was sought and integrated, and later field-tested until thematic saturation was achieved. Intervention group residents will receive detailed instructions about the shared decision-making checklist with specific communication teachings. To reduce bias, control group residents will also receive information about the importance of code status discussions and a general communication training, but no teaching regarding shared decision-making and no checklist will be used.Endpoints: The primary outcome is the frequency of DNR code status among patients per resident (i.e., patients choosing that CPR and intubation measures should not be performed in case of acute deterioration). Our key secondary endpoint is the quality of decision-making as judged by patient's decisional comfort assessed through the validated German translation of the Decision Conflict Scale. Additionally, we will investigate patient`s knowledge about resuscitation measures and expected outcome, patients' involvement in the shared decision-making process assessed through the validated German translation of the SDM-q-9 questionnaire, patients' concerns and fears and overall satisfaction with the code status discussion, as well as physicians perceived comfort with patient's choice and satisfaction with code status discussion. At hospital discharge, we will assess length of hospital stay, ICU-admissions, in-hospital resuscitations, code status violations and in-hospital deaths through medical chart review. Sample size and statistics: Based on pilot data in this patient population, we expect that 30% of patients in the usual care control will have a DNR code status, which will increase to 45% in the intervention group. We plan to include 174 residents (cluster) with a mean of 5 eligible patients per week over a 3-week period (total of 15 patients per cluster) in the five participating centers over a total study time of 2 years. Based on these assumptions, we aim to include 2610 patients among 174 residents, which will give this study an 80% power at a 0.05 alpha error with an inter-cluster correlation of 0.5.Discussion: Although code status discussions are a cornerstone of patient-centered care, there is a lack of trials investigating the most appropriate approach for physicians to communicate with patients about their preference. This multicenter randomized-controlled trial will close this important knowledge gap by systematically investigating effects of checklist-guided shared decision-making on patients' decisions regarding DNR status and the quality of decision-making.

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Improving Emergency Management of Status Epilepticus (SESIM)

Research Project  | 4 Project Members

Brief Summary

In the trial the effectiveness of pre-briefing physicians with the current guideline on Status epilepticus (SE) treatment or a consolidated "one page" guideline regarding quality enhancement of the physician's clinical performances is investigated.

Detailed Description

Status epilepticus (SE) is a life-threatening neurological emergency defined as a state of continuous seizure or multiple seizures without full recovery of sensory, motor and/or cognitive function for at least 30 minutes. To achieve high quality management of SE, the American Epilepsy Society published an evidence-based guideline for the treatment of SE, which serves as reference for most national guidelines, but analyses regarding practicability, strict adherence, correct translation into clinical practice, and identification of recommended treatment steps at risk of being modified or missed are lacking. Simulator-based studies offer a platform for the design of standardized clinical scenarios that enable detailed investigations regarding the effect of the implementation and practicability of treatment guidelines.

This randomized controlled intervention study performed at the simulation center of the medical intensive care units (ICUs) at the University Hospital Basel is to investigate the effectiveness of pre-briefing physicians with both the current guideline on Status epilepticus (SE) treatment or a consolidated "one page" guideline regarding quality enhancement of the physicians' clinical performances..

Physicians from different medical specialties and with different duration of clinical experience will be enrolled. Participants will be randomly assigned to one of the following three pre-briefing groups: (1) no pre-briefing prior to the simulation training; (2) pre-briefing with the current SE treatment guidelines; (3) pre-briefing with the consolidated "one page" SE treatment guideline.

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Effect of bedside patient case presentation compared to outside the room case presentation on patient perception of quality of care and patient outcomes: a randomized-controlled, multicenter trial

Research Project  | 1 Project Members

Patient-centered care may be defined as "providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions. Involving patients in all steps of the healthcare process is thus important. Yet, best presentation of patients' cases during ward rounds remains unknown. During outside the room patient case presentation, the medical team discusses difficult patient or medical issues in the team, and later presents a "patient-friendly" synthesis to the patient. Bedside patient case presentation, on the other hand, allows a patient to be part of the whole team discussion. Yet, there is concern that patients may be unable to cope with the magnitude of medical information and misunderstandings may occur. Currently, there is equipoise regarding both possibilities of patient case presentation with an important lack of trial data. We thus aim to compare the effect of bedside patient case presentation with outside the room patient case presentation during ward rounds ("Chefarztvisite") on different patient- and physician-related endpoints.General aim: To test the hypothesis that bedside patient case presentation compared to outside the room patient case presentation results in better outcomes across different dimensions including patients' understanding and perception of quality of care as well as patient outcomes, physicians' preferences, perception of quality and effectiveness, and timing of the ward rounds, respectively. Methods: pragmatic, multicenter, randomized-controlled, superiority trial Patient population: Consecutive adult medical inpatients during their first ward rounds are eligible independent of main diagnosis. We will exclude patients with dementia/delirium, paracusia, and if unable to complete questionnaires or follow the ward rounds. Intervention: In both groups, the ward rounds will follow the usual ward round procedures (i.e., the junior physician presents the case with discussion of differential diagnoses, further diagnostic tests and therapeutic options). In the bedside group, the case presentation will be at bedside with direct involvement of the patient. In the outside the room group, the main presentation will be outside followed by the team entering the room to inform the patient about the medical situation. Endpoints: The primary endpoint is patients' subjective understanding of disease and its management defined as the average of the visual analog scale (VAS) score across the following three dimensions rated by the patient after the ward round: (I) Patients' understanding of the disease, (II) Patients' understanding of the therapeutic concept; (III) Patients' understanding of the next steps. Secondary endpoints are (a) each of the three individual components of the above mentioned primary endpoint; (b) patients' perception about how well the current ward round improved the understanding of these components; (c) objective patients' understanding of disease and management (compared to medical chart information); (d) patients' perceived overall quality of care; (e) patients' perceptions and outcomes after 30 days of study inclusion (e.g., readmission rates); (f) perception of the physician and nursing staff with ward rounds; (g) timeliness (duration) of the ward round. All communication items will be coded and taped for later analysis of communication-specific items (secondary projects)..Sample size and statistics: The inclusion of 760 patients will provide 90% power to detect a difference in the primary combined endpoint of 5% (average VAS score of 84±17 vs 80±17 points). We will first compare the two conditions in the overall population, and later focus on effects in predefined subgroups by main diagnoses (i.e., cancer, cardiovascular, infection, psychiatric patients, alcoholics), type of patient (gender, age, socio-economic status), need for breaking bad news, need for shared decision making, number of patients per hospital room. Ancillary projects: We will audio-tape the conversations during rounds for detailed analysis of communication patterns to better understand how well these pattern predict patient outcomes (i.e., understanding and perception of the quality of rounds). Discussion: Although ward rounds are a cornerstone of inpatient care, there is a lack of randomized data investigating the most appropriate approach for patient involvement. This multicenter trial is the first to systematically investigate this important question. It will help to close this gap and give important insights into preferences of patients and caregivers regarding ward rounds and thus move closer to patient-centered care.