Health care provider completes triage survey of 15 fictional patient case scenarios using the standard SCCMP to prioritize each for admission.

Health care provider completes triage survey of 15 fictional patient case scenarios using SCCMP in addition to a newly designed flowchart-based triage guide to prioritize each for admission.

Survey of 15 fictional patient case scenarios to be assessed by participant using the standard prioritization or modified SCCMP to prioritize each patient scenario into one of a 5-point likert-scale categories for ICU admission. SCCMP scale categorized as 1-Critically ill to 4-Less likely to require ICU.

Survey

Newly designed flowchart-based triage guide to prioritize each patient case scenario into one of the 5-point likert-scale categories, used in conjunction with SCCMP for ICU admission.

Algorithm-based Triage Tool

Nisha Rathi, MD

The primary objective of this study is aimed at analyzing the ICU triage practices of clinicians at a cancer hospital with and without the use of an algorithm-based triage tool, and to assess whether or not the triage tool improves the consensus amongst practioners on the prioritization of patients for ICU admission. Secondary objectives include assessment of whether or not triage practices based on guidelines correlate with what is done in actual practice.

This is a prospective study designed to evaluate the ICU triage practices of clinicians at MD Anderson Cancer Center using the standard Society of Critical Care Medicine Prioritization Model (SCCMP) versus a uniquely designed flowchart-based triage tool created specifically for the oncologic setting.

Study participants will initially receive either an email explaining the study and asking if they would agree to participate in the survey, or a hard copy of an identical letter. Their participation will remain anonymous, and will strictly be on a volunteer basis. If the participant wishes to participate, they will be given either a link to the survey using an institutionally improved electronic survey tool, or alternatively a hard copy of the survey with identical instructions.

The survey consists of 15 fictional patient case scenarios, and participants will be asked to use the modified SCCMP to prioritize each patient scenario into one of the 5-point likert-scale categories for admission. The participants will be randomized with 1:1 ratio to use either a) the standard SCCMP or b) the SCCMP in addition to a newly designed flowchart-based triage guide to prioritize each patient case scenario into one of the 5-point likert-scale categories.

ICU Triage Practices in a Cancer Hospital

Intensive Care Unit (ICU) Triage Practices in a Cancer Hospital

Survey responses used to evaluate the ICU triage practices of clinicians using the standard SCCMP versus a uniquely designed flowchart-based triage tool created specifically for the oncologic setting. Participants are randomized to use either a) the standard SCCMP or b) the SCCMP in addition to a newly designed flowchart-based triage guide to prioritize 15 fictional patient case scenarios into one of the 5-point likert-scale categories for admission.

SCCMP system defines those that will benefit most from the ICU (Priority 1) to those that will not benefit at all (Priority 4) from ICU admission. Reported proportion of clinicians choosing category i in the 5-point likert-scale, i=1, 2, 3, 4a or 4b, for a particular patient case. The range of the entropy is between 0 (perfect agreement among the clinicians) and 1.61 (total disagreement among the clinicians).

M.D. Anderson Cancer Center

Neoplasms

All Conditions

Head and Neck Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Adjuvants, Anesthesia

Psychotropic Drugs

Platelet Aggregation Inhibitors

Anesthetics

Oxycodone

Dexmedetomidine

Midazolam

Propofol

Sevoflurane

Hypnotics and Sedatives

Etomidate

Head and neck tumor resections were performed in general anesthesia. Midazolam and etomidate or propofol were used in introduction and then anesthesia was maintenance with sevoflurane. Patients received intravenous continuous infusion of oxycodone as an analgesic component and sedatives (propofol/dexmedetomidine/midazolam) during analgosedation in ICU.

Infusion Intravenous

Agnieszka Bienert, MSC, PhD

Edmund Grzeskowiak, MSC, PhD

Treatment personalization could ensure better outcome than standard procedures. It is particularly important in intensive care units where patients received many drugs and procedures. Their health status can change very fast. The oncologic patients treated in intensive care units are a special group of patients. Factors related to cancer influence extra their health status. The aim of this study is population pharmacokinetic-pharmacodynamic analysis drugs that are routinely used during an analgosedation in ICU oncologic patients. Analgosedation is monitored by drugs plasma concentration, the depth of sedation (bispectral index) and vital parameters like: systolic and diastolic blood pressure, mean arterial pressure, heart rate. Moreover, the TNM Staging System, biochemical parameters, The American Society of Anesthesiologists (ASA) physical status classification will be checked like potential factors influencing on pharmacokinetics and pharmacodynamics drugs used in the study.

The oncologic patients are qualified to head and neck tumor resection in general anesthesia. The anesthesia introduction is performed with single dose of midazolam, fentanyl, rocuronium and propofol/etomidate. Sevoflurane is used in anesthesia maintenance. Patients are transported to ICU after operation. Then they are kept for several hours in analgosedation. All used drugs are given by intravenous continuous infusion. Oxycodone is an analgesic component of analgosedation. Midazolam, dexmedetomidine and/or propofol are used as sedatives (2-3 drugs in every patient). Whole blood samples (2.0 ml) are collected during the study to measure drugs concentrations - 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation. Vital parameters and bispectral index are monitored during analgosedation and 6 hours after the infusion cessation and noted every 15-60 minutes.

Pharmacotherapy Personalization of Cancer Patients

Pharmacotherapy Personalization of Cancer Patients Based on Modern Analytical and Computational Techniques

pharmacokinetic and pharmacodynamic data (concentration/effect/time profiles) of individuals will be available

Continuous measurement of the depth of sedation using bispectral index during analgosedation in intensive care unit.

Measurements of oxycodone and noroxycodone plasma concentrations \[ng/ml\] during and after analgosedation. Whole blood samples (2.0 ml) were collected according to the study protocol.

Measurements of dexmedetomidine plasma concentrations \[ng/ml\] during and after analgosedation. Whole blood samples (2.0 ml) were collected according to the study protocol.

Measurements of midazolam and alfa-hydroxymidazolam plasma concentrations \[ng/ml\] during and after analgosedation. Whole blood samples (2.0 ml) were collected according to the study protocol.

Measurements of propofol plasma concentrations \[ng/ml\] during and after analgosedation. Whole blood samples (2.0 ml) were collected according to the study protocol.

Measurements of systolic blood pressure during analgosedation in intensive care unit.

Measurements of diastolic blood pressure during analgosedation in intensive care unit.

Measurements of heart rate during analgosedation in intensive care unit.

Measurements of mean arterial pressure during analgosedation in intensive care unit.

The Greater Poland Cancer Centre

Medical University of Gdansk

Poznan University of Medical Sciences

Full Professor

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Heart and Blood Diseases

Digestive System Diseases

Nervous System Diseases

Wounds and Injuries

Rare Diseases

Critical Illness

Pulmonary Disease, Chronic Obstructive

Kidney Failure, Chronic

Renal Insufficiency

Heart Failure

Neoplasm Metastasis

Liver Cirrhosis

Lung Neoplasms

Lung Diseases

Chronic Disease

Brain Injuries

Cerebrovascular Disorders

Multiple Organ Failure

Heart Diseases

Neoplastic Processes

Respiratory Tract Diseases

Brain Diseases

Central Nervous System Diseases

Craniocerebral Trauma

Trauma, Nervous System

Fibrosis

Liver Diseases

Gastrointestinal Diseases

Disease Attributes

Lung Diseases, Obstructive

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Renal Insufficiency, Chronic

Vascular Diseases

Shock

Chronic Graft Versus Host Disease

The 'Facilitator-Based Intervention' includes patient and family member subjects.

The 'Usual Care' arm includes patient and family member subjects.

Facilitators interact in person or by telephone with patients, family, and clinicians both during and following the patient's ICU stay for 3 months. In-person contacts include visits to patients' homes and/or care facilities; phone contacts include calls to patients, families and clinicians. Patients and families have access to facilitators through phone and email 5 days per week. Facilitators may attend clinic visits with patients. In addition to checking directly with patients/families during regular contacts, facilitators also access the electronic health record to ensure they have accurate information about appointments and treatment plans and to document key points for the clinical team. Facilitators encourage referral to inpatient or outpatient palliative care services when needs are identified.

Facilitator-Based Intervention

Ruth A Engelberg, PhD

This study is a randomized clinical trial of an intervention to improve outcomes for patients and their family by using ICU nurse facilitators to support, model, and teach communication strategies that enable patients and their families to secure care in line with patients' goals of care over an illness trajectory, beginning in the ICU and continuing to care in the community.

The impact of critical illness is increasing due to an aging population as well as advances in effectiveness and availability of critical care. Critically ill patients and their families suffer a high burden of symptoms of depression, anxiety, and post-traumatic stress due, in part, to fragmented medical care that is often poorly aligned with their goals. Fragmented care includes numerous transitions for patients and families across clinicians and across settings, starting in the intensive care unit (ICU) and extending to acute care, skilled nursing facilities, or home. As illness progresses, patients and families struggle to navigate the spectrum of goals of care, to match their values and goals with treatments, to communicate their goals to their clinicians, and to make difficult medical decisions without letting unmet emotional needs interfere. Poor communication exacerbated by these transitions compounds an already stressful experience, causing distress to patients and their families. Taken together, these issues lead to ineffective communication during and after the ICU which can often result in high intensity "default" care that may be unwanted.

Using a randomized trial, this project aims to evaluate an innovative model of care in which ICU nurse facilitators support, model, and teach communication strategies that enable patients and families to secure care in line with their goals over an illness trajectory, beginning in the ICU and continuing into the community. Facilitators use communication skills, attachment theory, and mediation to improve: 1) patients' and families' self-efficacy to communicate with clinicians within and across settings; 2) patients' and families' outcome expectation that communication with clinicians can improve their care; and 3) patients' and families' behavioral capability through skill building to resolve barriers to effective communication and mediate conflict. Facilitators work with seriously ill patients and their families beginning with a critical care unit stay and following them over the course of three months.

The intervention's effectiveness will be measured with patient- and family-centered outcomes at 1-, 3-, and 6-months post-randomization. The primary outcome is family members' burden of symptoms of depression over the 6 months. The investigators also evaluate whether the intervention improves the value of healthcare by reducing healthcare costs while improving patient and family outcomes. Finally, investigators use qualitative methods to explore implementation factors (intervention, settings, individuals, processes) associated with improved implementation outcomes (acceptability, fidelity, penetration) to inform dissemination of this type of intervention to support patients and their families. This study aims to address key knowledge gaps while evaluating a methodologically rigorous intervention to improve outcomes for patients with serious illness and their families across the trajectory of care and the spectrum of goals of care.

Facilitating Communication Study

Evaluating Effectiveness of a Communication Facilitator to Reduce Distress and Improve Goal Concordant Care for Critically Ill Patients and Their Families: A Randomized Trial

Qualitative interviews after individual participation. Interviews will be guided by the Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation, including aspects of the intervention, inner and outer settings, individuals, and processes of care. Individual constructs within these domains were chosen to fit this specific intervention and context.

Qualitative interviews after individual participation. Interviews will also explore three key implementation outcomes (acceptability, fidelity, penetration) that will guide future dissemination of the intervention.

Family member symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS), which has become standard for ICU and post-ICU studies. The HADS is a reliable and valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety and seven evaluate depression. Each item is scored on a 4-point scale (ranging from 0-3) with scores for each subscale (anxiety and depression) ranging from 0-21. HADS has been used in over 700 studies with evidence of reliability, validity and responsiveness among critically ill patients and their family.

Concordance between the care patients want and the care they are receiving will be measured with two questions from the SUPPORT study. The first defines patients' preferences: "If the patient had to make a choice at this time, would the patient prefer a course of treatment focused on extending life as much as possible, even if it means having more pain and discomfort, or would the patient want a plan of care focused on relieving pain and discomfort as much as possible, even if that means not living as long?" The second question assesses perceptions of current treatment using the same two options. The outcome is a dichotomous variable of whether the preference matches the report of care received. Although this creates a "false dichotomy" in that many patients want both, this "forced choice" helps identify patients' top priority. Based on prior studies, we expect only 50-60% of controls will report goal-concordant care. Items completed by family respondents.

The Impact of Event Scale-6 (IES-6), derived from the IES-R, uses 6 self-report items to assess subjective distress caused by a traumatic event. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely").

The Perceived Competence Scale (PCS) is a short, 4-item questionnaire assessesing participants' feelings of competence. Items can be worded differently for different target behaviors. Validity was established in a study of medical students, and then in studies of diabetes self-management. Cronbach's alpha has consistently been above 0.80 in multiple studies. The scale has been used in several studies.The mean of 4 items is used as the scale score. The 4 items have also been used to form a latent variable, and assessed for change over time. Responses range from "Not at all true" (1) to "Very True" (7); higher score on the latent variable would indicate greater competence.

We will measure hospital readmission after initial hospital discharge through the electronic health record (EHR), institutional billing systems and, patient/family self-reports. All hospitals are in one system facilitating data collection. By using all three sources for data, we will capture hospitalizations regardless of healthcare system. Our primary focus will be readmission within 30 days as this is a national standard, but we will also collect data from the EHR and from patient/family interviews to record all readmissions, emergency department visits, clinic visits, inpatient and outpatient palliative care consults, and home care over 6 months. All occasions of healthcare use will be confirmed through chart review and valued using the Medical Expenditure Panel Survey and the Healthcare Cost and Utilization project, with additional information from institutional financial systems, to capture costs of care rather than charges.

Family member assessment of perceived financial stress will be measured with the 11-item COST instrument which has demonstrated reliability and validity in measuring financial toxicity.

Measure of family experience of patients with serious illness. The QUAL-E (Fam) is a validated \~17-item companion instrument to the patient QUAL-E measure of quality of life at the end of life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ICU Triage Practices in a Cancer Hospital	NCT03401411	Intensive Care ... Triage	Survey Algorithm-based...	-	M.D. Anderson Cancer Center
ICU Triage Practices in a Cancer Hospital	NCT03401411	Intensive Care ... Triage	Survey Algorithm-based...	-	M.D. Anderson Cancer Center
Pharmacotherapy Personalization of Cancer Patients	NCT04866498	Head and Neck N... Oncologic Patie...	Infusion Intrav...	18 Years -	Poznan University of Medical Sciences
Facilitating Communication Study	NCT03721952	Chronic Disease Neoplasm Metast... Lung Neoplasm Pulmonary Disea... Heart Failure, ... Liver Cirrhosis Kidney Failure,... Multiple Organ ... Health Care Qua... Intensive Care ... Palliative Care... Palliative Care... Lung Diseases Cerebrovascular... Brain Injuries	Facilitator-Bas...	18 Years -	University of Washington

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