Treatment Trials

23 Clinical Trials for Various Conditions

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COMPLETED
Combined Social Worker and Pharmacist Transitional Care Program
Description

In an effort to improve care coordination and reduce hospital readmissions, Rush University Medical Center developed the Combined Social Worker and Pharmacist Program, which targets both the psychosocial and clinical risk factors that can lead to rehospitalization. This study will evaluate the impact of this program on 30-day same hospital readmission rates and total cost of care.

COMPLETED
Enhanced Discharge Planning Program -- Prospective
Description

The Enhanced Discharge Planning Program (EDPP) is an intervention designed to help older adults safely transition to the community after discharge. This is achieved through telephonic care coordination facilitated by social workers. EDPP social workers ensure full implementation of the discharge plan, assist with coordinating community resources and follow-up appointments, and intervene around other issues that may arise as a result of a complex transition. The EDPP intervention is currently being offered to some older adult patients discharged from Rush University Medical Center. Case managers refer older adult patients on selected units who they believe may be at risk for adverse events post-discharge. While this service is being provided to patients, it has not yet been formally evaluated. This randomized controlled trial will provide data necessary for a more rigorous evaluation of the efficacy of this intervention.

WITHDRAWN
Longitudinal Evaluation of Energy Expenditure in ICU Patients From Admission to Discharge Using A Novel Indirect Calorimeter: LEEP-Forward Trial
Description

The purpose of this study is to utilize the new indirect calorimetry Q-NRG device to the measurement of energy expenditure (EE) throughout your intensive care unit (ICU) stay and ultimately address fundamental questions about metabolism and energy requirements for critically ill patients. The study will use a new, investigational calorimeter called the Q-NRG (the study device, supplied by Cosmed, Italy). The word "investigational" means the study drug or device or biologic is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA). A calorimeter is a device that connects to your breathing machine tubing for a short period (about 30 minutes) and helps to determine what nutrition you may need in your current condition. There are FDA approved calorimeters that have been used as the current standard of care. These devices and the new Q-NRG calorimeter measure oxygen consumption and carbon dioxide production (the gas you breathe out when you exhale) and calculate energy expenditure. Unfortunately, previously existing calorimeters are complicated to use, cumbersome and require time for measurements. It is hoped the new calorimeter will be easier and more practical to use and, through the measurements we take, we will have a better understanding of a patient's caloric needs for healing. Muscle mass and quality play a role in determining EE and metabolic needs. Massive loss of muscle mass and quality that occurs in critical illness significantly affects EE and nutritional needs and should be accounted for in clinical nutrition delivery. Imaging (standard of care abdominal CT and MSK ultrasound) will be used to assess muscle mass, and muscle quality (amount of intramuscular adipose content; IMAT).

TERMINATED
ACEI/ARB Study in Ambulatory and Day of Surgery Admission Patients
Description

Angiotensin converting enzyme inhibitors (ACEI's) and Angiotensin receptor blockers (ARB's) are commonly used anti-hypertensive medications that may have implications on the management of a patient undergoing surgery. Limited research has looked at the effects of these medications on perioperative complications and mortality. Some studies conducted on small groups of inpatients with advanced vascular disease undergoing vascular surgery or coronary artery bypass grafting (CABG), suggest exacerbation of hypotension (low blood pressure) in patients who continued taking ACEI's or ARB's on the morning of their procedure. In addition, cases of low blood pressure (BP) that were refractory to standard treatment were reported. One recent retrospective study reported no difference in severe hypotension and only a modest difference in moderate hypotension managed by conventional treatment, but did not adequately address the risk of preoperative hypertension. A study recently published by the investigators (Twersky et al., 2014) in over 600 patients demonstrated no difference in preoperative hypertension in ambulatory surgery and same day admission patients. There has been limited data stratifying the degree of low BP based on severity but these were not done in ambulatory patients, and neither was the degree of high BP from discontinuing these medications addressed. As such, no uniform consensus has been reached and clinicians are unclear as to whether the reported inpatient findings are applicable to the outpatients, since they differ in many respects. The investigators propose to evaluate whether ACEI's and ARB's discontinued preoperatively have a negative impact on perioperative hemodynamics and patient outcome in a group of ambulatory and same day surgical patients. Similar to studies done on inpatients, the investigators will also evaluate patients receiving a standardized general anesthetic for hemodynamics following induction of anesthesia until surgical incision. The investigators hypothesize that continuing ACEI's and ARB's in the preoperative period does not result in an increased risk of severe hypotension (low blood pressure) following induction of general anesthesia.

COMPLETED
Evaluation of a Personalized Care Management Program for High Hospital Utilizers
Description

This randomized clinical trial intends to evaluate the effectiveness of enrollment in Atrium Health's Multiple Visit Patient (MVP) care management program compared to usual care on reducing 12-month total inpatient hospital utilization among patients with high past volume of hospital inpatient stays.

RECRUITING
Point of Care Ultrasound to Predict Intensive Care Unit Admission of Patients Presenting With Sepsis to the Emergency Department
Description

The FloPatch device will be applied to 150 septic patients in the emergency department before they receive fluid resuscitation. This study will assess whether initial FloPatch measured volume-responsiveness and volume of fluids used will predict a composite outcome of mortality, intensive care unit admission, or rapid response team activation. The development of fluid unresponsiveness throughout the initial fluid resuscitation will be assessed and its association with the composite outcome will be assessed.

Conditions
WITHDRAWN
A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain
Description

This study aims to determine, relative to telemetry admission, if admission to an unmonitored floor bed saves resources without an increased rate of adverse events in emergency department (ED) patients admitted with chest pain and low-risk features.

TERMINATED
The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea
Description

The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy (NOXT) on the mortality and morbidity of patients with stable heart failure and a reduced ejection fraction (HFrEF), already receiving optimal guideline-directed medical therapy (GDMT), who have central sleep apnea (CSA).

COMPLETED
Feasibility of a Standardized Video for Patient Education and as a Decision Aid on Code Status for Patients in the Emergency Department Pending Admission to the Hospital
Description

The researchers hypothesize that patients and their families will be comfortable watching standardized CPR informational videos and that they would recommend that others watch the videos. Furthermore, the researchers hypothesize that patients and their families will find the videos helpful in their own end-of-life planning.

COMPLETED
Patient-Centered Tablets: Applications for Inpatient Admissions
Description

RESEARCH QUESTION: Are hospitalized patients able to use a tablet computer (iPad) to take brief surveys, access their patient portal (MyChart), and watch informational videos about their condition?

Conditions
WITHDRAWN
Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in HF Patients (CONFIRM-HF)
Description

A research study to determine if heart failure can be medically managed using data collected from cardiac monitoring devices

Conditions
COMPLETED
Intervening With and Improving Care for Patients at Risk for Frequent Hospital Admissions
Description

Patients with frequent hospital admissions account for a disproportionate share of visits and costs. An intervention that can bridge the gap between hospital and community based care for a population of patients with frequent hospital admissions may offer both improved care and cost savings if hospital admissions can be appropriately reduced. We are now using data from our previous research to inform the development and implementation of an intervention at Bellevue Hospital, which will bridge the gap between hospital and community based care for a population of patients with frequent hospital admissions. We hypothesize that such an intervention can offer both improved care and cost savings if hospital admissions can be appropriately reduced. In this protocol we outline a strategy to pilot a small-scale intervention on a small subset of patients admitted to an urban public tertiary care safety net hospital who are defined by our study criteria as at high risk for future readmission. By piloting components of the intervention, we aim to assure the intervention functions as planned, and can deliver the needed services to high risk patients in a seamless and patient-centered manner. The purpose of this "feasibility study" is to ensure that when our intervention is implemented on a larger scale, it appropriately serves enrolled patients needs, and that we are able to effectively follow patients during the intervention period.

RECRUITING
Impact of Patient Selected Visual Art in the Hospital Room During Antepartum Admission on Hospital Satisfaction Scores and Patient Experience
Description

The purpose of this study is to assess whether patient-selected visual art for patients admitted to the antepartum unit will increase hospital satisfaction compared to routine care.

RECRUITING
Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)
Description

The PRESC1SE-MI study compares two algorithms for triage of patients presenting with chest pain and symptoms of heart attack (myocardial infarction) to the emergency department. Both algorithms are recommended by the European Society of Cardiology: the 0/3-hour algorithm and the 0/1-hour algorithm. Currently, most emergency departments worldwide use the 0/3-hour troponin algorithm. Cardiac troponin (cTn) is a heart-specific biomarker which indicates damage of the heart muscle and which increases after a heart attack. In the 0/3-hour algorithm, the amount of troponin in the bloodstream is measured with a high-sensitivity assay at admission and 3 hours thereafter. Likewise, the 0/1-hour algorithm means that the blood sample in which the troponin is measured is collected at admission and 1 hour later. Since recent clinical studies suggest that the 0/1-hour algorithm is superior to the 0/3-hour algorithm, many hospitals consider switching to the 0/1-hour algorithm. The aim of this study is to assess how feasible the time-saving 0/1-hour algorithm would be in reality and whether it provides the same accuracy and safety in the diagnosis of myocardial infarction as the current practice the 0/3-hour algorithm.

TERMINATED
Early CPAP in COVID-19 Confirmed or Suspected Patients
Description

There is surge in COVID infected patients in New York City with a shortage of hospital beds, ICU beds and ventilators. Strategies to reduce the need for all of the above are immediately needed. Further, few interventions are targeted in COVID infected patients early in the course of their disease and especially in the community/home settings. Respiratory decompensation appears to occur later in the disease process (i.e. 7-10 days after becoming symptomatic) therefore many patients are sent home from the Emergency Room and they subsequently decompensate later at home. Some patients die at home and others are returning to the Emergency Room with hypoxemic respiratory failure. There is no treatment offered to this population of patients, i.e. COVID suspected or confirmed and with respiratory symptoms or abnormal chest x-ray at the time of presentation. Based on experience across the globe, these patients are likely to worsen at home. The study team therefore proposes a prospective, single-center, parallel group, open-label, randomized clinical trial to assess the efficacy of fixed low continuous positive airway pressure therapy (CPAP) (FDA approved and often used for treatment of sleep apnea) in COVID confirmed or suspected patients with abnormal chest x-ray or respiratory symptoms who do not require hospital admission and are discharged home from the emergency room.

COMPLETED
Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)
Description

This study plans to learn more about the impact of enteral nutrition on bacteria in critically ill trauma patients with brain injury. Specifically, it seeks to understand the effect that a prebiotic containing enteral feeding formula (Nutraflora scFOS in Vital AF) has on the gut, oral, and skin bacteria. A prebiotic is a special form of dietary fiber that acts as a fertilizer for good bacteria. The prebiotic Nutraflora scFOS has been cleared by the U.S. Food and Drug Administration and is not considered investigational as used in this study. Enteral feeding is a way to give nutrition to critically ill people who are unable to eat.

COMPLETED
Effect of Teledermatology on Length of Hospital Admission, Length of Stay, 30 Day Readmission Rate, and Antibiotic Use in Patients Presenting With Cellulitis vs Pseudocellulitis in an Academic ED Setting
Description

The effect of teledermatology on length of hospital admission, length of stay, 30 day readmission rate, and antibiotic use in patients presenting with cellulitis vs pseudocellulitis in an academic emergency department setting.

Conditions
COMPLETED
The Effect of Dermatology and Teledermatology Consultations on Length of Hospital Admission, 30 Day Readmission Rate, and Antibiotic Use in Patients Presenting With Cellulitis vs Pseudocellulitis in an Academic Inpatient Setting
Description

The effect of teledermatology on length of hospital admission, length of stay, 30 day readmission rate, and antibiotic use in patients presenting with cellulitis vs pseudocellulitis in an academic emergency department setting.

Conditions
COMPLETED
Patient and Caregiver Psychological Functioning Following Neuro-ICU Admission: A Prospective Investigation
Description

The current study has the following objectives: 1. To determine predictors of time 2 and 3 (3 and 6 months post-ICU admission) depression, PTSD, satisfaction with life and quality of life in both patients and caregivers, after controlling for injury severity and impairment. 2. To determine factors associated with patient and caregiver satisfaction with medical care at time 2 and time 3. The investigators would thus be able to identify the best time point for intervention delivery, intervention targets, and risk factors for chronic psychological distress.

COMPLETED
Ambulatory Care Characteristics as Predictors of Mortality and Re-Admission
Description

The aim of this study is to construct a prognostic model to identify risks of poor outcomes at one year following hospital discharge of patients treated in an ambulatory cate setting. The study will incorporate pre-hospitalization characteristics, hospitalization events, comorbidity burden, psychosocial measures and post-hospitalization care characteristics to predict re-hospitalization and mortality at one year.

COMPLETED
New Onset Weakness in Critically Ill Patients and the Risk of Death and Recurrent ICU Admission
Description

This study seeks to define the morbidity of critical care polyneuropathy and to confirm that this diagnosis is, in fact, independently associated with increased mortality. Secondary information regarding the reasons for ICU readmission in patients with weakness may help in formulating cogent discharge strategies for these patients. Measurement of weakness using handgrip strength may provide a useful surrogate marker for weakness that may be more easily and uniformly applied. Primary hypothesis: * The development of ICU-associated weakness is independently associated with excess attributable mortality. Secondary hypothesis: * The development of ICU-associated weakness is associated with an increased need for ICU readmission. * Readmission to the ICU will be a result of the development of recurrent respiratory failure or insufficiency * Handgrip strength testing will detect ICU-associated weakness with an equivalent sensitivity as the comprehensive bedside muscle strength exam.

COMPLETED
Pediatric Intensive Care Units (ICUs) at Emory-Children's Center Glycemic Control: The PedETrol Trial
Description

The primary goal of this project is to determine whether normalizing hyperglycemia is a safe approach to improve multisystem organ function in critically ill children requiring intensive care. The will are conducting the "PedETrol" (the "Pediatric ICUs at Emory-Children's Center Glycemic Control: The PedETrol Trial) Trial, a 4-year single-center, prospective, randomized clinical trial to evaluate the outcome benefit, safety and resource utilization impact of maintaining strict glucose control in children with life-threatening conditions. \*\*\*This study is supported by an Research Project Grant (RO1 grant) (MRR) via the National Heart, Lung, and Blood Institute (NHLBI).

COMPLETED
Shared Decision Making in the Emergency Department: Chest Pain Choice Trial
Description

Our long-term goal is to promote evidence-based patient-centered evaluation in the acute setting to more closely tailor testing to disease risk. To compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration, we propose the following: 1. Test if Chest Pain Choice safely improves validated patient-centered outcome measures in a pragmatic parallel patient randomized trial. Hypothesis: The intervention will significantly increase patient knowledge, engagement, and satisfaction with no increase in adverse events. 2. Test if the decision aid has an effect on healthcare utilization within 30 days after enrollment. Hypothesis: The intervention will significantly reduce the rate of hospital admission, rate of cardiac testing, and total healthcare utilization.