Treatment Trials

24 Clinical Trials for Various Conditions

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COMPLETED
Emergency Medicine Palliative Care Access
Description

This is a two-arm, multi-site randomized controlled trial of 1,350 older adults (50+ years) with either advanced cancer (defined as metastatic solid tumor) or poor prognosis end-stage organ failure (New York Heart Association (NYHA) Class III or IV Congestive Heart Failure (CHF), End-Stage Renal Disease (ESRD), defined as Glomerular Filtration Rate (GFR) \< 15 ml/min/m2 or dialysis ; or Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III or higher, or oxygen-dependent chronic obstructive pulmonary disease (COPD) who present to the Emergency Department (ED), along with 675 of their informal caregivers. Investigators will compare the effectiveness of two distinct palliative care models: a) nurse-led telephonic case management; and b) facilitated, outpatient specialty palliative care.

COMPLETED
Discussing Death and Dying: An End of Life Curriculum to Empower Residents
Description

This study will evaluate how the educational intervention utilized affects pediatric resident comfort level with EOL discussions.

TERMINATED
The Role of the Pharmacist and Pharmacogenomics in the Care of Seriously Ill Patients
Description

Researchers are trying to learn more about how pharmacists and pharmacogenomic testing can help care providers improve control of symptoms and quality of life in seriously ill patients.

COMPLETED
Statin Discontinuation in Advanced Illness
Description

The purpose of this study is to determine if there is a difference in survival rate at 60 days after enrollment between patients with advanced life-limiting illness for whom statins are discontinued vs. for patients with advanced life-limiting illness who are maintained on the medication. Secondary outcomes of this study will determine the effects of medication cessation on overall survival, important cardiovascular events, quality of life (QOL), symptoms, performance status, polypharmacy issues, satisfaction with care, and costs.

TERMINATED
Efficacy of Ginseng for Patients on Regorafenib
Description

This is a randomized, multi-center phase II study of ginseng in colorectal cancer patients treated with regorafenib to determine if ginseng will reduce fatigue in this patient population and improve adherence to regorafenib. Ninety (90) subjects will be enrolled and randomized using a 2:1 allocation, with 60 subjects enrolled in the regorafenib + ginseng group and 30 enrolled in the regorafenib + no ginseng group.

COMPLETED
Pathways Project: Kidney Supportive Care
Description

The Pathways Collaborative is the first attempt to implement supportive (palliative) kidney care at multiple sites in the United States. While supportive kidney care is growing in other countries, notably Canada, Australia, and Great Britain, it is not yet known how to integrate it into the unique nephrology environment in the United States. In Phase 1 of Pathways (completed), we developed an evidence-based change packet of 14 best practices for integrating supportive care practices into the continuum of care for patients with end stage kidney disease (ESKD). In Phase 2 (described in this application), we will conduct a learning collaborative to help up to 15 dialysis and CKD centers implement these best practices. The learning collaborative is based on the IHI Collaborative Model for Achieving Breakthrough Improvement. This model is a tested systematic approach to quality improvement designed to help organizations close the gap between current and future practice based on evidence-based best practices. The Pathways Project faculty will work with up to 15 change teams at dialysis centers to create a system to identify seriously ill patients with kidney disease; conduct conversations with them so that their values, preferences, and goals for current and future medical treatment are known and respected; assess and address patients' physical, psychological and spiritual needs; and coordinate care throughout the healthcare system so patients receive only the care they want in settings in which they wish to be.

COMPLETED
Palliative Care in Heart Failure
Description

The primary aim of the PAL-HF trial is to assess the impact of an interdisciplinary palliative care intervention combined with usual heart failure management on health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale.

COMPLETED
Palliative Care for Heart Failure Patients
Description

The purpose of this study is to assess the impact of palliative care consultation on quality of life and symptom management for patients hospitalized with acute heart failure with a randomized control trial at Abbott Northwestern Hospital.

Conditions
COMPLETED
Critical Care and Palliative Care Medicine Together in the ICU
Description

Will earlier palliative care medicine consultation in the ICU result in decreased length of stay in the ICU and hospital, as well as, increased patient and family satisfaction. Secondary questions to be answered is if this early consultation changes ICU and hospital death, discharge destinations, hospice admissions, code status changes, and withdrawal of life sustaining interventions.

RECRUITING
AIMS Medical Outcomes Study
Description

This epidemiologic research is being conducted as an observational prospective case series outcomes study of the use of advanced integrative specialty medical care and its effect on adult and pediatric patients with chronic or serious illnesses or mental health disorders.

WITHDRAWN
Palliative, Rehabilitation, and Integrated Medicine Handbook for Self Care at Work
Description

This study investigates the usefulness of the Self Care at Work Handbook in order to generate an improved version. Information from this study may help researchers identify potential factors associated with perception and usefulness of the Self Care at Work Handbook.

ACTIVE_NOT_RECRUITING
Primary Palliative Care for Emergency Medicine (PRIM-ER)
Description

This proposal builds upon the evaluation of Primary Palliative Care Education, Training, and Technical Support for Emergency Medicine (PRIM-ER) implemented in 33 Emergency Departments (EDs). This is a retrospective cohort study that seeks to measure the effect of PRIM-ER on older adults with serious illness on aspects of: 1) ED disposition to an acute setting; 2) healthcare utilization in the 6 months following the index ED visit; 3) survival following the index ED visit; and 4) determine site, provider, and patient-level characteristics that are associated with variation in impact of PRIM-ER across sites.

Conditions
RECRUITING
Comparative Effectiveness of Palliative Surgery Versus Additional Anti-Seizure Medications for Lennox-Gastaut Syndrome
Description

Lennox-Gastaut syndrome is a serious and rare form of epilepsy that begins in infancy and early childhood. Seizures and their consequences need medical attention, emergency encounters, and hospitalizations. Seizures disrupt home life for the patient and for family. Lennox-Gastaut syndrome is typically accompanied by disabilities in motor, communication, eating, and other skills needed for daily function. Lennox-Gastaut syndrome (LGS) has no cure. Although current treatments may help reduce the number of seizures, none are expected to eliminate them entirely; these treatments are palliative. The main treatments include anti-seizure medications and some surgical approaches, including the implantation of a vagus nerve stimulator (a pacemaker-like generator implanted in the chest wall and programmed by a physician to stimulate the vagus nerve in the neck) and corpus callosotomy (cutting through the band of fibers that connect the two sides of the brain). While both types of treatment (medications and surgeries) produce some benefit by reducing how often the seizures occur, both also have some risks. All medications can, in some patients, produce moderate to severe side effects. This is true of anti-seizure medications. Most patients with LGS take several anti-seizure medications at a time. Surgeries can also have associated risks and is additionally stressful for parents and family members. Currently, there is no strong evidence to support parents and physicians in deciding which type of treatment (more medicines or surgery) will be most successful for a child with LGS, and whether one or the other approach may lessen the toll that seizures take on a child's development and ability to function. This study has two components. It will engage a network of seven pediatric hospitals in the United States where children with Lennox-Gastaut syndrome are cared for and determine whether seizure-related emergency department visits and hospitalizations are more likely to be reduced following the use of additional medications or adding palliative surgery to existing medications. The investigators will determine whether medical versus surgical treatment is more likely to lessen some of the developmental and functional difficulties that affect patients with LGS. The study will also determine whether starting therapies at a younger versus older age makes a difference. The second component of the study will provide a description of the use of surgical versus medical treatment approaches across 18 pediatric hospitals in the United States (seven plus 11 centers). The investigators will describe how treatments differ across hospitals and over time. The results from this study will help parents and providers make more informed choices about treatment for children with Lennox-Gastaut syndrome and will highlight areas for improvement in providing the best possible health care for this severe, lifelong disorder.

NOT_YET_RECRUITING
Palliative Care Health Literacy Education and QOL Compared to Usual Care
Description

The goal of this pilot randomized controlled trial is to compare health literacy (HL) and quality of life (QOL) among older adults with chronic obstructive pulmonary disease (COPD) who completed a series of standardized palliative care (PC) educational video learning modules to usual care (US). The main question\[s\] it aims to answer are: Between Groups: * What effect does completing a series of standardized PC education video learning modules have on HL among older adults with COPD treated in the emergency department (ED) compared to usual care? * What effect does completing a series of standardized PC education video learning modules have on QOL among older adults with COPD treated in the ED compared to usual care? Within Groups: * What is the change from baseline to study completion for older adults with COPD who receive the educational intervention series of PC learning modules on HL? * What is the change from baseline to study completion for older adults with COPD who receive the educational intervention series of PC learning modules on QOL? * What is the change from baseline to study completion for older adults with COPD who receive UC on HL? * What is the change from baseline to study completion for older adults with COPD who receive UC on QOL? All participants will complete a baseline and study completion health literacy questionnaire (HLQ) and Medical Outcomes Study: Short Form 36 survey. The treatment group will view one standardized learning module per week for four weeks provided by Get Palliative Care and log their weekly completion in REDCap. The control group will receive usual COPD care. Researchers will compare the treatment group receiving weekly palliative care education to usual care to see if HL and QOL change.

Conditions
COMPLETED
Community Health Workers and Precision Medicine
Description

The purpose of this randomized controlled trial is to evaluate whether a trained community health worker (CHW) who engages with newly diagnosed patients after a diagnosis of cancer can effectively improve knowledge and receipt of evidence-based precision medicine cancer care services among low-income and minority patients.

Conditions
COMPLETED
Standardized Patient-Centered Medication Review in Home Hospice
Description

This is a pilot cluster randomized trial that tests the effect of a novel intervention that trains hospice staff to 1. regularly review, simplify, and align patients' prescribed medications with their goals of care as their illness progresses, and 2. support family caregivers with education that empowers them to understand each medication's use, develop skills for safe administration, and 3. understand when stopping medications may be beneficial.

COMPLETED
Emergency Department-Based Palliative Care for Advanced Cancer Patients
Description

The purpose of this study is to: 1) identify the palliative care needs of Emergency Department patients with advanced cancer, and determine if these needs can be rapidly assessed in the ED; 2) determine whether early palliative care consultation improves survival, quality of life and other burdensome symptoms and decreases utilization as compared to usual care.

COMPLETED
A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone
Description

The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.

COMPLETED
Results From a Health System-wide Implementation of a Quality of Life Questionnaire
Description

The purpose of this retrospective chart review pilot study is to research the results and scores of the QOL questionnaire implemented across Allina Health clinics. This study will investigate average QOL scores by clinical population and demographic group, the change in scores over time, and the effect of clinical interventions on QOL scores. The results will provide insight into QOL trends within different patient populations and provide guidance regarding optimal treatment plans so that Allina caregivers can positively impact patients' QOL.

COMPLETED
Music Therapy Intervention to Reduce Caregiver Distress at the End of Life
Description

This is a study to assess the feasibility and acceptability of implementing a music therapy intervention for caregivers of hospitalized patients who are referred to inpatient hospice.

COMPLETED
Impact of Massage Therapy and Music Therapy on the Quality of Life of Hospice Patients
Description

This is a cohort study where subjects will receive either massage therapy or music therapy interventions to evaluate their impact on hospice patients.

COMPLETED
Impact of Massage Therapy on the Quality of Life of Hospice Patients
Description

This is a pilot study to evaluate the impact of massage therapy in hospice patients.

COMPLETED
Massage Therapy for Cancer-Related Fatigue
Description

The purpose of this study is to develop methods for studying the effect of bodywork therapy on symptoms of fatigue in patients undergoing cancer chemotherapy.

COMPLETED
Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer
Description

This study investigates the effect of acupuncture in reducing symptom distress in adults with advanced colon cancer.