Treatment Trials

56 Clinical Trials for Various Conditions

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RECRUITING
Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions
Description

This prospective, observational study is designed to investigate clinical outcomes and collect patient feedback on the use of Wellinks, an integrated virtual chronic obstructive pulmonary disease (COPD) management solution, for patients recently discharged from the hospital due to an acute exacerbation of their COPD.

RECRUITING
Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease
Description

The purpose of this study is to compare the efficacy and safety of a real time video telehealth pulmonary rehabilitation intervention with standard of care in patients hospitalized for an exacerbation of chronic obstructive pulmonary disease (COPD) to determine the impact on hospital readmissions and respiratory morbidity, and to investigate the cost-effectiveness of the intervention.

RECRUITING
Care Coordination to Assess Improvement in Outcomes in Hospital Readmissions
Description

Heart failure is a syndrome that is defined by distinctive clinical, hemodynamic, and neurohormonal findings. HF represents a final common pathway for many different cardiovascular diseases, including coronary disease, hypertension, Valvular disease, and many primary heart muscle diseases. Clinically, HF patients experience dyspnea, fatigue and diminished exercise tolerance, reflecting elevated left and/or right ventricular filling pressures and decreased cardiac output.

ACTIVE_NOT_RECRUITING
A-SPIRE Heart Failure: Utilizing Health Tags to Identify Patients at Risk for Hospital Readmissions
Description

To evaluate the use of the Spire Health Tags in heart failure patients to determine the feasibility of capturing signals of respiration, pulse rate, activity, sleep patterns, and stress levels following HF hospitalization.

Conditions
COMPLETED
Electronic S3 Prediction of Hospital Readmissions for HF Exacerbation
Description

The study objective is to measure the value of the third heart sound (S3) for the prediction of recurrent heart failure (HF). For the purpose of this study, a heart failure event will be defined as a hospitalization with a primary diagnosis of heart failure. The main hypothesis of the study is that measurement of S3, using a microelectronic machine microphone positioned in a wearable device (Nanowear Wearable Congestive Heart Failure Management System) near the time of discharge from a hospitalization for heart failure, can predict which patients will be at high risk for a heart failure event, thereby identifying a group in whom increased surveillance and monitoring may decrease hospital readmissions for worsening heart failure.

ACTIVE_NOT_RECRUITING
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
Description

The goal of this study is to assess the impact of pharmacist-led benefits investigations and application of clinical practice guidelines on patient access to inhalers and time to hospital readmission or Emergency Department (ED) visit.

Conditions
COMPLETED
Evaluation of Hospital Readmission Rate Dependent on Post-Operative Follow-Up Procedure
Description

This study is a randomized clinical trial among colorectal surgery patients that will compare the efficacy of two different discharge protocols - current standard of care follow-up at two weeks post-op versus a 3-day phone call intervention. The overall aim of the study is to identify areas of improvement for discharging and following patients within 30 days of colorectal surgery.

SUSPENDED
Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized Cardiac Patients
Description

The purpose of this study is to determine whether early diagnosis of obstructive sleep apnea and initiation of and adherence to CPAP therapy in hospitalized cardiac patients would impact 30-day hospital readmission rates.

NOT_YET_RECRUITING
Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized COPD Patients
Description

The purpose of this study is to determine whether early diagnosis of OSA and initiation of and adherence to CPAP therapy in patients hospitalized for chronic obstructive pulmonary disease reduce 30-day hospital readmission rates.

COMPLETED
Heart Failure Hospital Readmissions and Physical Therapy
Description

This is a dissertation study which is divided into three different studies in order to answer the main research question (Study 3). The primary aim of this research (dissertation) is to investigate all-cause 30-day hospital readmission using functional mobility (5mWT, 30STS, 6MWT, TUG), psychosocial attributes (KCCQ-12, HADS, ESSI), adherence to home exercise program, participation in a supervised exercise program, and number of follow up checkups with physicians or advanced health providers of patients with Acute Decompensated Heart Failure (ADHF) diagnosis who were discharged from a tertiary teaching hospital. Study 1: What is the effect of acute physical therapy on functional ability in individuals admitted with ADHF? Study 2: What is the effect of acute physical therapy on psychosocial attributes in individuals admitted with ADHF? Study 3: Which factors such as functional mobility (5mWT, 30STS, 6MWT, TUG), psychosocial attributes (KCCQ-12, HADS, ESSI), adherence to home exercise program, participation in a supervised exercise program, and number of follow up checkups with physicians or advanced health providers predict all-cause 30-day hospital readmission in patients discharged from a tertiary, teaching hospital with ADHF diagnosis?

COMPLETED
Comprehension of Discharge Instructions for Diabetes Therapy and Hospital Readmission
Description

The purpose of this study is to identify and explore the existing components of discharge planning provided to patients with insulin treated diabetes in the inpatient setting and to examine the contribution of glycemic excursions as well as comprehension of discharge instructions among patients with diabetes, in predicting hospital readmissions.

TERMINATED
Improving Mental and Physical Health and Decreasing Hospital Readmission After Pancreatectomy Through Enhanced Patient and Caregiver Education and Engagement
Description

The study of readmission is in its infancy in the surgical world, and there are no prospective studies, to the investigators' knowledge, evaluating the efficacy of interventions on preventing readmission following pancreatectomy. Undoubtedly, patients and their caregivers will play a key role in any useful intervention to reduce readmission. Therefore, the investigators' approach is to target perioperative education and engagement of patients and their caregivers in the postoperative recovery of pancreatectomy patients.

Conditions
WITHDRAWN
Collaborative Home Visits to Reduce Hospital Readmissions and Improve Medication Use During Transitions of Care
Description

The primary objective is to develop a sustainable practice model emphasizing home visits by a collaborative physician and pharmacist team to decrease unplanned emergency department visits and hospital readmissions at 30 and 90 days for high-risk home bound patients. Secondary objectives include (1) tracking the number, type, and severity of adverse drug events (ADE) and potential adverse drug events (pADE) that occur following hospital discharge and (2) resolving any identified ADE and pADE within 7 days of hospital discharge. Adult patients will be scheduled for a home visit by the Healthy at Home Columbus program at the time of hospital discharge. The home visit will occur within 7 days of hospital discharge and will consist of a complete hospital and medication review by a physician or nurse practitioner and a pharmacist (including all lab tests, imaging studies, medication changes, and proposed plan of care at the time of discharge). The investigators hypothesize these home visits will reduce 30 and 90 days hospital readmission rates and ED visits. The number of emergency department visits and unplanned hospital readmissions will be tracked at 30 and 90 days following discharge from the hospitalization that led to study enrollment. A comparison cohort of patients discharged in the 12 months prior to study initiation will be used to compare the effectiveness of the home visit program. The number and type of adverse drug events (ADE) and potential adverse drug events (pADE) that occur during transitions of care will also be characterized. All ADE and pADE will be resolved during the initial home visit and will be classified based on severity. All ADE and pADE will be evaluated independently by two pharmacist reviewers; each reviewer will independently assign a severity rating to each ADE and pADE.

COMPLETED
Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions
Description

This study will assess Specialized Community Disease Management (SCDM), an intervention which employs various evidence-based strategies to engage substance using co-morbid patients while in the hospital and follow them into the community via an empirically validated telephone approach as well as contact with a trained community health worker peer specialist. The investigators will first adapt and refine the core SCDM intervention with patient, provider, and stakeholder input through an active community advisory board. The investigators will then conduct a three-year, randomized controlled trial of 222 patients enrolled prior to hospital discharge who are diagnosed with congestive heart failure, pneumonia, acute myocardial infarction, chronic obstructive pulmonary disease, diabetes mellitus, or end-stage renal disease, and a substance use disorder (SUD). Patients will be randomized to either the SCDM intervention or Treatment as Usual (TAU), in which a team of nurse navigators and community health workers follow patients (primarily by telephone) for 90 days post-discharge, but do not address the specific needs of SUDs. The investigators will test the following four hypotheses: (1) patients randomized to SCDM will demonstrate larger reductions in substance use measured by urine-confirmed self-reported days using over the 6-month follow-up compared to patients randomized to TAU, (2) patients randomized to SCDM will attend more specialty substance abuse intervention and treatment sessions over the 6 month follow-up than patients randomized to TAU, (3) patients randomized to SCDM will demonstrate reduced HIV transmission risk behaviors and greater rates of HIV testing over the 6 month follow-up than patients randomized to TAU, and (4) patients randomized to SCDM will experience fewer days of rehospitalization and use of acute emergency services than patients randomized to TAU.

TERMINATED
Impact of Pharmacist Post-discharge Phone Calls on Hospital Readmission and Patient Medication Literacy and Adherence
Description

A significant portion of avoidable healthcare expenditures has been attributed to preventable hospital readmissions; thus, reducing hospital readmission rates has become a national healthcare agenda item. Despite much study of this topic, efforts to date have not been especially fruitful in either predicting which patients will require hospital readmission. Preventing readmissions has been even more difficult. We recently examined a pharmacist intervention that assessed patients' medication literacy and adherence at hospital admission. In this retrospective data, low medication adherence levels were predictive of hospital readmission. There was a non-significant trend between low medication literacy and increased hospital readmissions. We have now decided to prospectively study this intervention. Prospective study will allow for several improvements on our prior work. 1. We have consulted the literature to more carefully examine existing instruments to measure medication adherence and literacy. Based on this review, and based on our prior results, we have made adjustments to these instruments which should improve reliability, validity, and granularity. 2. In our retrospective work, our intervention of pharmacist counseling was not randomized. Although there were large differences in readmission rates between the patients selected to receive counseling and those who were not thought to require it, there may have been unmeasured confounding variables. Randomizing this intervention will greatly enhance the likelihood that we are comparing two similar groups of patients.

COMPLETED
Reducing Hospital Readmissions in Patients With Depressive Symptoms
Description

Project Re-Engineered Discharge (Project RED) has previously demonstrated that patients who received the RED were 30% less likely than patients receiving usual care to access inpatient or emergency services within 30 days of discharge. In this project, the investigators add a new dimension to RED by integrating screening, referral and treatment for depression into the original RED intervention and determining if this enhanced intervention increases the effectiveness of RED in preventing readmissions and controlling costs in the 180 days after discharge for patients with signs of depression.

Conditions
RECRUITING
IV Ensure in Patients Receiving OPAT
Description

The purpose of remote therapeutic monitoring is to provide oversight and evaluation of patients receiving IV medications in the home setting post-acute. The goal is to improve patient outcomes and decrease re-admission rates for related diagnoses due to poor adherence. Remote therapeutic monitoring provides data used in the determination of dates, times, and duration of doses administered in the home setting to support real-time intervention by dedicated care managers to support improved adherence with prescribed dosing regiments. The objectives of the study are to: 1. Determine adherence rates for IV medications administered in the home. 2. Assess re-admission against adherence rates.

COMPLETED
Validation and Implementation Design of an Epic Systems 30-day Unplanned Readmission Risk Model
Description

The objective is to assess the implementation of a computerized clinical decision support (cCDS) tool for identifying patients at high risk of unplanned readmission who could benefit from existing care programs aimed at reducing readmissions

ACTIVE_NOT_RECRUITING
Enhancing the Care Transitions Intervention With Peer Support to Reduce Disparities
Description

Unplanned hospital readmissions are extremely costly to patients and our healthcare system. Being readmitted to the hospital also leads to increased risk of health complications for patients including infections and impairments in functioning. Hospital readmissions are particularly common among older adults. Further, racial/ethnic disparities are evident in readmission rates and are the greatest among African American and Latino/Hispanic older adults. Effective, sustainable, and culturally appropriate interventions to improve outcomes, reduce unplanned hospital readmissions, and reduce health disparities are urgently needed. The proposed randomized controlled trial will evaluate the effectiveness of a novel transitional care strategy designed to avoid unplanned hospital readmissions and improve patient health outcomes in a racially/ethnically diverse sample of older adults who have been admitted to the hospital due to a chronic health condition. Eric Coleman's Care Transitions Intervention (CTI) has been identified as the strategy most successfully implemented and evaluated in multiple settings and systems of care. CTI has been shown to reduce hospital readmissions for non-Hispanic White older adults, however its' effects have not been as strong for minority older adults in some studies and research trials have not recruited a sufficient number of racial/ethnic minorities to examine outcomes by race or ethnicity. Thus, it is unknown whether CTI is effective for racial/ethnic minority older adults who suffer disproportionately high readmission rates. Further, studies of transitions interventions suggest that older adult and racial/ethnic minority patients require additional assistance and support during transitions in care. The researchers hypothesize the addition of peer support will enhance and maximize the benefit of the CTI and increase its' cultural sensitivity and future sustainability. The proposed 3-arm trial is designed to evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), as compared to usual care (UC), on unplanned all-cause hospital readmissions occurring within 6 months (assessed at 30 days, 90 days and 6 months) and secondary health system (i.e., ED visits) and patient-centered outcomes (i.e., self-efficacy managing chronic disease, quality of life, functional status and mortality) among 402 hospitalized African American and Latino/Hispanic older adults (age 60+) who have a chronic physical illness (e.g., cardiovascular disease, diabetes, COPD) and are being discharged from the hospital back to the community.

COMPLETED
Aiming to Improve Readmissions Through InteGrated Hospital Transitions
Description

The purpose of this study is to better enhance transitions of care for the highest risk, complex patients, Carolinas HealthCare System (CHS) has designed an Integrated Practice Unit, called Transition Services (CHS-TS).CHS-TS aims to improve patient outcomes through innovative approaches that leverage analytics and technology, while bridging care coordination and communication gaps. During their hospitalization, CHS-TS patients enter into a transition pathway that includes the following key services: integrated access to medical, pharmacist, and specialty providers; access to CHS disease specific management programs; dedicated care management services delivered in home and at the clinic; lab and infusion services; palliative care consultations when appropriate; and paramedicine for 24 hour support. AIRTIGHT (Aiming to Improve Readmissions Through InteGrated Hospital Transitions) is a pragmatic, randomized quality improvement evaluation, which seeks to evaluate the effects of the role-out of CHS-TS services for patients at high risk for a 30-day readmission. AIRTIGHT will test the hypothesis that patients that receive care through CHS-TS will have a lower all cause, 30-day readmission rate than patients that receive usual care.

COMPLETED
Evaluating Sequential Strategies to Reduce Readmission in a Diverse Population
Description

Hospital readmissions are common, costly, and potentially preventable. They are also potentially responsive to health system interventions. However, it is uncertain which components of care transition interventions are efficacious, for which populations, and at what cost. This randomized controlled study is part of a larger project that will evaluate a three-tiered quality improvement (QI) intervention intended to reduce hospital readmissions within 30 days post-discharge from an urban safety net hospital that serves a racially and linguistically diverse population (the randomized controlled study evaluates Tier 3). Few studies have evaluated care transition interventions to reduce readmissions among low-income, diverse patient populations, and the accumulated evidence on the effects of these multi-faceted interventions on readmission rates has been inconclusive. This project will take advantage of a unique sequence of three QI innovations to reduce hospital readmissions implemented beginning in 2007 in an integrated safety net health care system. The "discharge-transfer" tiers are as follows: 1) Tier 1 includes a comprehensive, individualized home care plan (HCP) reviewed by the medical service floor nurse with the patient prior to discharge; 2) Tier 2 adds the electronic transmission of the HCP to the patient's primary care medical home where, on the business day following discharge, a Registered Nurse makes an outreach telephone call to the discharged patient to confirm comprehension of the HCP and to address medical questions or needs; 3) Tier 3 further adds a community health worker, the Patient Navigator, to participate in bedside discussions to develop rapport and learn about patients' home situations, weekly outreach calls to assess patients' needs and to facilitate communication between the patient and the primary care team, and reminder calls to patients prior to all medical appointments to eliminate barriers to outpatient follow-up. The Aim of the study being registered is to evaluate the effects of an ongoing randomized natural experiment on readmissions, health care use, adherence to medication instructions, and preparedness for discharge. This natural experiment features random assignment to one of two QI interventions, Tier 2 or Tier 3, and exclusively targets patients at high risk for readmission, those with one or more of the following risk factors for readmission: discharge diagnosis of congestive heart failure or COPD; length of stay \> 3 days; age \> 60; or previous hospitalization within the past six months. The investigators hypothesize that the Patient Navigator intervention (Tier 3) compared to usual care (Tier 2) will increase the rates of 30-day post-discharge PCP visits; reduce 30-day hospital readmission rates; and reduce the total number of days in hospital in the 180 days following the index admission for high risk patients. The investigators further expect that the PN intervention will improve patient adherence to medication instructions in the HCP and reduce the probability of reported problems with post-discharge care.

COMPLETED
Study of the Impact of a Hospital Discharge Care Coordination Program in an Elderly Population
Description

The purpose of this research study is to evaluate the effect of a health information exchange (HIE)-supported care coordination package on 30-day readmission rates in a frail elderly population.

COMPLETED
Support From Hospital to Home for Elders: A Randomized Controlled Study
Description

The investigators will randomize 700 non-psychiatric, non-obstetric, non-surgical patients aged 55 years and older at San Francisco General Hospital (SFGH) to usual care (ten days of prescription medication, discharge summary sent to primary care provider (PCP), and outpatient appt made for patient, and patient's nurse reviews discharge plan,) or usual care plus a peridischarge intervention (a visit with specialized in-hospital discharge nurse, development of personalized discharge plan, two phone calls from a nurse practitioner(NP)/physician assistant (PA) after discharge and availability of additional calls back from NP/PA, upon patient request, to help answer questions and assist patient's transition to outpatient care, and communication with primary care/subspecialty providers). The usual care and usual care plus intervention groups will be assessed for differences in mortality and rates of rehospitalization and emergency department use 30, 90 and 180 days following discharge from the hospital. The discharge process from the hospital to home is frequently marked by poor quality and high risk of adverse events and readmissions. It has been hypothesized that better coordinated care, personalized patient education, and follow-up calls to identify potential sources of adverse events, such as medical complications and medication errors can reduce rehospitalization and emergency room visits following discharge from the hospital. Although these interventions have been shown to reduce combined hospital readmissions and emergency department visits in English-speaking patients, none has focused on elderly patients in a diverse urban public hospital setting that includes non-English-speakers, who might benefit more than other populations from enhanced services during and after discharge from the hospital. Further, these labor-intensive interventions are costly to implement, and it is unknown whether opportunity cost of providing additional services in a limited-resource environment such as San Francisco General Hospital (SFGH) outweighs the unknown clinical benefits.

COMPLETED
Study of Physician Awareness of and Communication About Patient Readmissions to the Hospital
Description

Patients admitted to inpatient medicine services often require early hospital readmission, and often they are readmitted to different physician or team, potentially without the knowledge of the prior physician or team. Thus, physicians may lose the opportunity to share valuable information about readmitted patients, which may be detrimental to continuity of care and patient safety. The purpose of this study is to determine baseline awareness and communication rates among physicians regarding readmissions, and then measure the effect of automatic notification on these rates.

RECRUITING
Hearing Impairment, Strategies and Outcomes in VA Emergency Departments
Description

HearVA involves six VA facility emergency departments (ED) over a 3-year intervention period. The first part of this study will test whether providing personal amplifiers to Veteran ED patients who self-report hearing difficulty is acceptable to these patients, can improve their hearing, enhance understanding of discharge instructions, and can reduce the risk of coming back to the ED in a short period of time (3 days and 30 days). The second part of the study will then identify whether ED staff can implement this program and achieve similar results. The second part will give ED staff increasing levels of responsibility for screening Veterans for hearing difficulty and providing personal amplifiers when such difficulty is detected.

COMPLETED
Hearing Impairment, Strategies, and Outcomes in Emergency Departments
Description

Aim 1: Establish the feasibility of screening for hearing loss in the ED Aim 2: Determine the acceptability of the screening procedure (among the ED population) Aim 3: Derive a preliminary estimate of the effect size of primary outcomes Aim 4: Identify the evidence that decision makers in Veteran Affair Medical Centers, ED and Audiology Services need to commit to this approach

COMPLETED
Transport PLUS Intervention
Description

Hypothesis: 'Transport PLUS,' a low cost, easily generalizable intervention performed by Emergency Medical Technicians while transporting a patient home from the hospital, can improve transitions of care and improve patient safety following hospitalization as measured by decreased rates of falls and reduced rates of return to the hospital.

RECRUITING
Pericardiotomy in Cardiac Surgery
Description

PRINCE is an international, multicentre, randomized controlled trial of posterior pericardiotomy in patients without a history of atrial fibrillation (AF) or flutter undergoing cardiac surgery.

RECRUITING
Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up
Description

The Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS) study is an effectiveness-implementation hybrid design. The effectiveness evaluation is designed as a multiple interrupted time series (mITS) analysis to test the impact of implementing an adapted Sepsis Transition and Recovery (STAR) program on enhancing post sepsis outcomes in new hospital settings.

Conditions
RECRUITING
Teamwork Makes the Dream Work
Description

Exploring the effect of team-based ARTAS intervention in an inpatient setting on HIV linkage to care and hospital readmission rates.