Nervous System Diseases

Behaviors and Mental Disorders

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Immune System Diseases

Digestive System Diseases

Nutritional and Metabolic Diseases

Infections

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Dementia

Kidney Diseases

Critical Illness

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Parkinson Disease

Heart Failure

Emergencies

Sclerosis

Multiple Sclerosis

Heart Arrest

Hepatic Encephalopathy

Sepsis

Toxemia

Multiple Organ Failure

Lung Diseases

Brain Diseases

Renal Insufficiency, Chronic

Renal Insufficiency

Parkinsonian Disorders

Ganglion Cysts

Synovial Cyst

Basal Ganglia Diseases

Central Nervous System Diseases

Movement Disorders

Synucleinopathies

Neurodegenerative Diseases

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Heart Diseases

Liver Failure

Hepatic Insufficiency

Liver Diseases

Gastrointestinal Diseases

Brain Diseases, Metabolic

Metabolic Diseases

Respiratory Tract Diseases

Shock

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

The interventional group (Ig) will have an early palliative care consultation ordered during their stay in the emergency department.

The control group will be treated as standard of care. Palliative care consultations may or may not be ordered at the attending physician's discretion.

Early order of palliative care consultation

Robert Zalenski, M.D., M.A.

A prospective randomized controlled trial studying the ordering of palliative care consultations in the emergency department (Ig) versus later palliative care consultations in the hospital--ICU or hospital ward(Cg). Patients will be randomly allocated to Ig or Cg with a 1:1 ratio.

Timing of Acute Palliative Care Consultation in Critically Ill Patients

A Randomized Allocation of Palliative Care Consultation in the Emergency Department Compared to Usual Practice

The proportion of patients who received an ACP CMS billing codes (which took effect in January 2016), in Ig vs. Cg will be evaluated using one or both of the new CPT codes for Advance care planning (ACP) services...including the explanation and discussion of advance directives such as standard forms (with the completion of such forms, when performed) by the physician or other qualified health profession; first 30 (15-45)minutes, face to face with the patients, family member(s) and/or surrogate Code 99497; and each additional 30 (46-75 minutes)-Code 99498 (Federal Register, 2015).

The investigators will align treatment preferences with medical orders, replicated as reported in the study by Mack et al. Proportions of patients coded as having a match will be compared across the treatment and control groups. For everyone who gets ACP during the study, patients or their surrogates will be asked by a member of the care team-either palliative care if they are consulted, or the hospital based care team if they are not: "If you could choose, would you prefer (a) treatment that focuses on attempting to extend your time as much as possible, even if doing so means more pain and discomfort, or (b) a plan of care that focuses on relieving pain and discomfort and improving quality of life, even though that may mean not living as long.

This outcome will be measured on a continuous scale. The net-promoter score will be measured at baseline (at randomization) and at hospital discharge for a change in value. It is measured on a scale of 1-10. Whoever signs the consent (patient of LAR) will be asked the net promoter score, and that will be reassessed by them at discharge, unless the patient has died-and the variable will then be recorded as missing. The PSQ will be administered by research assistants at the time of the patient's discharge. If the patient is incapacitated, then it will be asked of the patient's closest family caregiver. So PSQ is only at discharge of patient or available, most involved, family caregiver.

Blue Cross Blue Shield of Michigan Foundation

Wayne State University

Principle Investigator

Wounds and Injuries

Kidney Failure, Chronic

Neoplasm Metastasis

Liver Cirrhosis

Lung Neoplasms

Brain Injuries

Cerebrovascular Disorders

Neoplastic Processes

Craniocerebral Trauma

Trauma, Nervous System

Fibrosis

Respiratory Tract Neoplasms

Thoracic Neoplasms

Vascular Diseases

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.

University of Washington

Research Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Timing of Acute Palliative Care Consultation in Critically Ill Patients	NCT02858778	Multiple Organ ... End Stage Cardi... End Stage Chron... Chronic Kidney ... Hepatic Encepha... Sepsis Dementia Multiple Sclero... Parkinson's Dis... In-Hospital Car... Solid Organ Can...	Early order of ...	65 Years -	Wayne State University
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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