Treatment Trials

30 Clinical Trials for Various Conditions

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NOT_YET_RECRUITING
Text-based Support for Parents of Adolescents Following an Emergency Department Visits
Description

The goal of this study is to determine the effectiveness of an adaptive text-based intervention for parents of adolescents seeking emergency department services for suicide risk concerns.

Conditions
COMPLETED
Developing Text-based Support for Parents of Adolescents After an Emergency Department Visit
Description

The researchers seek to develop a text message intervention for caregivers of adolescents at elevated suicide risk following discharge from emergency department (ED) care.

Conditions
TERMINATED
Reducing Emergency Department Visits and Improving Glucose Control in Uncontrolled Type 2 Diabetes Using CGM Sensors at Hospital Discharge
Description

Quality measures and cost-reduction methods are a high priority in the United States health care system. This includes the high burden of patients with uncontrolled Type 2 Diabetes. Innovative ways to better understand and implement diabetes management plans to reduce the burden of this disease on the system are a necessity. Use of FDA-approved continuous glucose monitoring (CGM) sensors have shown benefit in better management plans in the outpatient setting. Hence, this study hypothesizes that using CGM sensors starting in the inpatient setting will provide better and quicker understanding of the disease to make expedited changes to management plans thereby improving blood glucose control and mitigating some of the health care burden by means of reducing E.D visits and hospital re-admission rates. The study will randomly assign patients to either receive a CGM sensor plus the standard diabetes management and instructions or who will only receive the standard diabetes management. The patients will be followed in the outpatient endocrinology clinic 1-month, 3-month, and 6-month from the time of hospital discharge.

UNKNOWN
IT to Support Integration of Social Determinant of Health Services to Reduce Avoidable Emergency Department Visits
Description

Working through regional Accountable Care Organizations (ACO) the sponsor will establish a 2-year pilot project to demonstrate that early recognition and intervention in the various Social Determinant of Health (SDoH) domains can reduce avoidable Emergency Department (ED) visits by high utilizers. The regional ACO's will contract with Medicaid Managed Care Plans to assign traditional high ED utilizing members to the pilot project. Members will be offered enhanced peer facilitated care management services connecting members with available SDoH community based services. Members fitting our eligibility criteria will self-select by way of completing a pilot project consent form.

TERMINATED
Repeat Emergency Department Visits Among Patients With Asthma and COPD
Description

The purpose of the proposed study is to determine whether the addition of inhaled corticosteroids to treatment with oral corticosteroids and albuterol would reduce repeat emergency department (ED) visits among patients treated for acute exacerbations of asthma and COPD discharged from the emergency department to home. The investigators hypothesize that patients treated with inhaled corticosteroids in addition to oral corticosteroids and albuterol will have lower rates of 30-day return visits to the emergency department than those patients treated with oral corticosteroids and albuterol only.

Conditions
COMPLETED
Health Coach Program to Improve Chronic Disease Outcomes Following an Emergency Department Visit
Description

The purpose of this study is to determine whether health coaching initiated in the emergency department (ED) reduces subsequent ED visits, increases primary care visits, and positively impacts health outcomes in patients with diabetes and/or hypertension.

TERMINATED
Inhaled Steroids at Discharge After Emergency Department Visits for Children With Uncontrolled Asthma
Description

Many children have asthma and this causes problems with their health. A lot of children with uncontrolled asthma use emergency departments for asthma care, and so this is an ideal place for an intervention for these children. One intervention is prescribing inhaled steroids to children with uncontrolled asthma, but currently this is rarely done in the emergency department. Inhaled steroids have been shown to be good at making children better long-term when they have uncontrolled asthma. This study identifies children in the emergency department with uncontrolled asthma using a tool called the Pediatric Asthma Control and Communication Instrument (PACCI). If children meet criteria for uncontrolled asthma they will be randomly assigned to either: 1) routine asthma care which includes close follow up with their doctor or 2) prescribing of an inhaled corticosteroid from the emergency department. The investigators hypothesize that children who are prescribed inhaled steroids for uncontrolled asthma from the emergency department will have better 6 month asthma control than children who receive routine asthma care.

Conditions
COMPLETED
"Anticipatory Guidance in the Nursery and Its Impact on Non-urgent Emergency Department Visits"
Description

Kennedy et al, in a study of pediatric Emergency Department (ED) use by newborns less than 14 days of age, revealed that half of all visits in this population were non-acute problems. Other pediatric ED utilization studies have shown similar findings in that 32% to 72% of all visits were for non-urgent problems. Many studies have found that primiparity and young maternal age are associated with non-acute ED presentations. A recent factor that has been investigated is the effect of early neonatal discharge. Some other factors are nonwhite mothers and mothers on Medicaid. Zandieh et al, found additional predisposing determinants for non-urgent ED visits, such as single parenthood, Hispanic ethnicity, and having perceptions that their child's overall physical health was poor. Paradis et al found that parents receiving a video intervention rated higher confidence with specific infant care skills and reported feeling better prepared to care for their baby, compared to parents receiving only handouts. However, there isn't any reported study that evaluates the benefits of receiving both, a video intervention along with handouts. Aim: to demonstrate whether conducting anticipatory guidance related to non-urgent problems will reduce non-urgent ED visits, compared to care as usual (CAU) anticipatory guidance (Sudden Infant Death Syndrome and Shaken Baby Syndrome videos; and unstructured talk about jaundice, vaccinations, appointments, care of umbilical stump, normal urination and bowel movement, fever).

COMPLETED
STAT-ED: Suicidal Teens Accessing Treatment After an Emergency Department Visit
Description

This study looks to implement a novel intervention (STAT-ED) for children who screen positive to suicide ideation. The intervention looks to collect data from several different measures and then randomize participants into one of two groups: a control group where the participant will be set up with a mental health referral from a psychiatric social worker; or if randomized into the STAT-ED intervention, the adolescent and parent will receive a brief motivational interview, barrier reduction discussion, referral and limited case management by the study social worker to enhance outpatient mental health follow up after discharge from the ED. The hypothesis of the study is patients who are randomized into the STAT-ED intervention group will have a significantly higher rate of initiating mental health treatment and will attend more mental health treatment sessions in the two months after the ED visit compared with adolescents in the control group. Secondary aims of this study look to determine whether the effectiveness of the STAT-ED intervention differs by age, gender, or ethnicity; and evaluate predictors and mediators of mental health treatment engagement.

Conditions
TERMINATED
Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)
Description

This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)

COMPLETED
Educational Video for Improving Follow-up After an Emergency Department Visit for Asthma
Description

The study will assess the efficacy of a three-part Emergency Department (ED)-based "Asthma Belief and Control" intervention on healthcare utilization, asthma controller medication use, symptoms, and quality of life during the 6 months following an Emergency Department visit.

Conditions
NOT_YET_RECRUITING
Acute Hospital Care at Home for People Living With Dementia
Description

The investigators will perform a parallel-group multicenter randomized controlled trial of a 1-year pre-enrolled acute hospital care at home intervention vs usual care for people living with dementia. Patients will be randomized only after eligibility determination and after the family caregiver agrees to enroll; people living with dementia will assent when able. Patients will be allocated in a concealed fashion to the control and intervention groups in randomly selected block sizes of 4 or 6 in 4 strata reflecting their functional status (activities of daily living: 0, 1, 2-3, 4-6). Although family and clinicians cannot be blinded, the investigators will blind the data collectors and assessors.

COMPLETED
Wisconsin Evaluation of Emergency Department Care Coordination
Description

The State of Wisconsin is now expanding its investment in care coordination models as an effort to reduce inappropriate hospital emergency department (ED) use, improve health outcomes, and reduce Medicaid expenditures. This effort begins with a pilot program to support emergency department care coordination in hospitals and health systems that apply and are selected to participate in the pilot program. The Wisconsin Medicaid program seeks to understand whether this program achieves its intended goals and, specifically, whether the Medicaid payment for such care coordination services produces the intended program outcomes. Hospitals will select members that will receive care coordination services. In a quasi-experimental approach, the study team will compare members that do vs. do not receive the services will be used examine the effects of care coordination and referrals on total ED visits, primary-care treatable ED visits, non-emergent ED visits, and health care costs, as well as the specific effects of referring patients to providers who offer low-cost and after-hours care. To assess the importance of targeting, study team will conduct stratified analyses of vulnerable groups such as people with disabilities and individuals with specific clinical needs.

COMPLETED
CMSL Ambulatory Sensitive Condition Nudge
Description

The project aims to evaluate a nurse-led intervention to reduce inappropriate emergency department (ED) use among adult patients seen at Geisinger's Community Medicine Service Line (CMSL) clinics. The intervention occurs immediately following an appointment where they received a diagnosis of an ambulatory sensitive condition (ASC). The evaluation will compare eligible patients with an ASC who were randomly assigned to receive follow-up outreach from a nurse (who was automatically prompted via the Epic electronic health record system to initiate outreach) with those who were randomly assigned to receive standard care. Analyses will be intent-to-treat. The primary outcome is ED use in the week following the appointment.

RECRUITING
Emergency Care at Home
Description

This study will assess the efficacy of receiving emergency care at home versus in the brick-and-mortar emergency department.

WITHDRAWN
Effectiveness of the NoseFrida Compared With Bulb Suction at Relieving Objective Signs of Nasal Obstruction and Reducing Return Visits in Pediatric Patients Presenting to the Emergency Department
Description

The mainstay of treatment in viral upper and lower respiratory tract disease is airway clearance. Viral respiratory tract infections account for a substantial amount of emergency department (ED) visits, financial and stress burden on caregivers. In addition, they also account for a large number of ED return visits. While airway clearance is considered a mainstay of treatment the pragmatic effectiveness of various devices remain unstudied in patients who are discharged from the ED. The objectives of this study are to compare the pragmatic effectiveness of two commonly used suction devices the NoseFrida and bulb suction and to provide a descriptive analysis on 72 hour return to ED rates and readmission rates. Patients will be enrolled October 15, 2018 to October 15, 2019 or until NoseFrida supplies are depleted. Fridababy will supply 500 NoseFrida devices and replacement filters. Patients aged 1 day to 24 months presenting Vanderbilt Childrens ED with symptoms of nasal congestion or bronchiolitis who require suctioning and will be discharged from the ED will be approached for enrollment. Exclusion criteria include no upper airway abnormalities or previously enrolled in study. The study design is a prospective and retrospective observational study. We anticipate about 500 patients to be enrolled in this study. Families will then be approached for consent to participate. Caregiver will fill out a data collection form then be instructed on how to use the NoseFrida. Next, family with trial it on their child while in the ED. Caregivers will then fill out a 7 point Likert survey on both the bulb suction and NoseFrida device. The family will go home with this device and a set of replacement filters and instructed to suction their child as needed. The primary investigator (PI) will then complete a 72 hour chart review to determine the number of return to ED visits and readmission rates. To compare ED returns with retrospective data, KSP will conduct a review of the business objects database using ICD9 codes specific for viral respiratory tract infections over the past 3 years to determine a control return ED visit rate. Data will be compared using a paired T-test. If data is not normally distributed we will use a Wilcoxon signed-rank test. We will also use a multivariable logistic model to examine associations adjusted for age and illness severity.

COMPLETED
Comparative Effectiveness of 7 Versus 21 Home-delivered Medically Tailored Meals to Improve Malnutrition Risk in Malnourished Patients With Heart Failure
Description

This protocol is designed to compare the effectiveness of two dietary intervention doses for patients with heart failure (HF) and malnutrition risk or malnutrition at hospital discharge. This random order crossover design will provide evidence as to whether the provision of dinner meals alone versus all 3 daily meals to patients' homes is more effective at improving malnutrition risk score, and secondarily unplanned emergency department visits and readmissions.

COMPLETED
Diabetes Interprofessional Team to Enhance Adherence to Medical Care
Description

The overall goal of this randomized controlled trial is to test the efficacy of DM I-TEAM (Diabetes Interprofessional Team to Enhance Adherence to Medical Care) to reduce emergency department (ED) visits and hospitalizations over 12 months in older African Americans (AAs) with diabetes mellitus (DM). DM I-TEAM is a multidisciplinary behavioral intervention that comprises a community health worker (CHW), the participant's primary care physician (PCP), a diabetes nurse educator, and a clinical geriatric pharmacist. In DM I-TEAM, the CHW conducts in-home sessions to: (1) provide diabetes education, (2) facilitate adherence to diabetes self-management behaviors (e.g., medication adherence glucose monitoring, diet, exercise); and (3) build trust between patients and their primary care team. This is accomplished by: (1) using culturally relevant diabetes educational materials; (2) facilitating telehealth visits with the participant's PCP and the diabetes nurse educator via JeffConnect; and (3) having the study pharmacist review participants' medication regimens to identify potentially inappropriate medications, simplify medication regimens if possible, and to reduce medication side effects.

Conditions
COMPLETED
Opportunities in Outpatient Care
Description

The purpose of this research study is to determine whether there are things that Intermountain can do to break down barriers to helping patients see their primary doctors or other outpatient clinics. To do this we will develop and test a classification scheme to help us understand how we might reduce some avoidable emergency department and InstaCare visits.

Conditions
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.

COMPLETED
Asthma Express: Bridging the Emergency to Primary Care in Underserved Children
Description

Asthma is the number one cause of pediatric emergency department (ED) visits in young minority children and is responsible for high healthcare costs. The ED is often the point of contact for many inner city children and many families view the ED as the child's primary source of asthma care. This study plans to test a new model of asthma care, Asthma Express (AEx), that includes a follow-up asthma visit in the ED for an asthma "check-up" , asthma education, a prescription for preventive asthma medications, an appointment for the child to see their pediatric provider and a home visit to assist families with environmental control methods to prevent asthma symptoms.

Conditions
UNKNOWN
Diagnosing Adverse Drug Reactions Registry
Description

This multicenter Registry is to assess whether the use of pharmacogenomic data results in a meaningful change in a subject's drug or dose regimen. In addition, the Registry will evaluate the relationship between adverse drug reactions (ADR) and genotype and assess resource utilization (emergency department visits and hospitalizations) associated with ADR.

COMPLETED
READI (Readiness Evaluation And Discharge Interventions) Study
Description

Preparation of patients for discharge is a primary function of hospital-based nursing care and readiness for discharge is an important outcome of hospital care. Inadequacies in discharge preparation have been well-documented and linked to difficulty with self-management after hospital discharge and with increased likelihood of emergency department (ED) use and readmission. Prior studies by the research team have led to recommendations for implementation of discharge readiness assessment as a standard nursing practice for hospital discharge. The investigators will conduct a multi-site study to determine the impact on post-discharge utilization (readmission and ED visits) and costs of implementing discharge readiness assessment as a standard nursing practice for adult medical-surgical patients discharged to home. The study tests, in a stepped approach, the impact of implementing discharge readiness assessment by the discharging nurse as standard nursing practice (RN-RHDS protocol), the incremental value of informing the nurse assessment with the patient's perspective (RN-RHDS+PT-RHDS protocol), and of requiring that the nurse initiates and documents risk-mitigating actions for patients with low readiness scores (RN-RHDS+PT-RHDS+NIAF protocol). HYPOTHESIS 1: Patients discharged using the RN-RHDS protocol will have fewer hospital readmissions and ED visits within 30 days post-discharge compared to patients discharged under usual care conditions. HYPOTHESIS 2: Patients discharged using the RN-RHDS+PT-RHDS protocol will have fewer hospital readmissions and ED visits within 30 days post-discharge compared to patients discharged using the RN-RHDS protocol. HYPOTHESIS 3: Patients discharged by nurses using the RN-RHDS+PT-RHDS protocol plus a Nurse-Initiated Action Form \[NIAF\] (RN-RHDS+PT-RHDS+NIAF protocol) will have fewer post-discharge readmissions and ED visits than patients discharged using the RN-RHDS+PT-RHDS protocol; the effect will be strongest for patients with low RHDS scores. Aim 4: Conduct cost-benefit analysis of implementing discharge readiness assessment as standard practice, by comparing cost-savings from reduced post-discharge utilization against implementation costs.

COMPLETED
Feasibility and Impact of "ABCs of Diabetes" Self-Management Education Program at an Urban Public Library
Description

A concise diabetes self-management education (DSME) program on the "ABCs of Diabetes" will be placed in an urban public library to assess the feasibility of using this community setting for the delivery of health care education in an urban African American population. Impact on knowledge of, prescriptions for, and control of blood sugar (A1C), blood pressure (BP) and LDL cholesterol (LDL-C)before and after participation in the program will be assessed. We will also examine the frequency of emergency department (ED) visits and hospitalizations for uncontrolled diabetes at 6 months post-DSME intervention.

COMPLETED
Dissemination of Injury Interventions
Description

An important challenge for the field of injury prevention and control is the translation of research findings into effective community-based prevention programs and practices. The National Center for Injury Prevention and Control believes that dissemination research can overcome this challenge by providing insight into the structures and methods needed to translate injury control research into everyday practice. The proposed dissemination research study will rigorously assess whether the use of a "facilitative system" can successfully bridge the gap between injury prevention and control research and the implementation of evidence-driven, community-based programs, policies, and practices. The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation. The study will use a randomized community trial design to evaluate fall injury occurrence and process measures of program implementation in three groups of communities: * a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process; * a "Standard Program" group receiving modest funding to implement an "evidence-based" fall prevention program in their local community; * a "Facilitative System" group receiving facilitative system support in addition to the resources provided the Standard Program group. We hypothesize that the Facilitative System program will be more effective at: * reducing fall-related injuries in the elderly; * building community coalitions that are goal-oriented and sustainable; * implementing community-based, evidence-driven fall prevention programs that are both tailored to the community needs and yet faithful to empirically-tested fall prevention research studies

Conditions
RECRUITING
Healing, Equity, Advocacy and Respect for Mamas
Description

The goal of the proposed research is to test the comparative effectiveness of AIM safety bundles for post-partum women delivered in-person vs. via text/phone to improve early detection of and timely care for complications during the first six weeks postpartum for women experiencing significant health disparities.

COMPLETED
Interactive Care Coordination and Navigation:RCT To Assess the Impact of a mHealth Intervention for Homeless Individuals
Description

People experiencing homelessness (PEH) are at exceptionally high risk of frequent emergency department (ED) and hospital use, poor functional outcomes, and increased morbidity and mortality from poorly managed chronic health conditions and complex social needs. Evidence-based interventions of particular promise for reducing ED and hospital utilization and improving health outcomes and meeting social needs involve:1) providing care in the community to overcome barriers including transportation and fear of stigmatization; 2) coordination of care transitions following ED or hospital discharge to improve access to needed community supports and reduce the risk of readmission; and 3) using mHealth technology to link PEH with appropriate community-based health and social services. This project builds on evidence from two feasibility studies in order to integrate and test a mHealth intervention, comprised of GPS technology and text messaging components, into a community setting to connect PEH with a community-based case manager and healthcare and social services. Our hypothesis is that integrating the mHealth intervention into an established, trusted navigation center for PEH will mitigate barriers to care and gaps in the care continuum resulting in decreased ED and hospital use and improved health outcomes and attainment of social needs. The study aim is to conduct a stratified RCT to compare a mHealth intervention with usual care community-based case management to examine the impact on healthcare utilization (primary outcome), medication adherence, social support, psychological distress and social needs attainment (secondary outcomes) in PEH.

COMPLETED
Reducing Emergency Department Utilization With an After Visit Summary Nudge Toward Alternative Care Options
Description

Decreasing utilization of the Emergency Department (ED) is a priority for the system. Often, ED visits can be avoided if patients contact Geisinger first to get appropriate direction for their concern or are otherwise better informed about reasons to visit the ED vs. urgent care or primary care facilities. The study team is working to reduce ED utilization by including additional information in adult outpatient After Visit Summaries (AVSs). The study will involve will involve A/B testing different AVS versions, including 1) a version that encourages patients to contact Geisinger via different contact methods, 2) a version that includes a map to the patient's closest ConvenientCare location and accompanying information about ConvenientCare, and 3) a version that includes a self-triage guide. A control group will receive the current standard AVS. Analysis results will be assessed to determine which version is most effective at reducing ED use.

COMPLETED
Nudging High-acuity Emergency Department Patients to Schedule a Follow-up Visit
Description

The goal of this campaign is to reduce unnecessary emergency department (ED) visits by encouraging patients with high acuity visits to follow up with an appropriate primary care provider (PCP) or specialist and therefore obtain appropriate care outside of the ED. In this campaign, patients will be assigned to receive or not receive outreach following ED discharge that is aligned with the goal. Outreach will occur via a text message and information added to the patient's after visit summary, and will include a contact number to schedule and hyperlink to allow self-scheduling. The study will assess whether ED use differs across patients in different outreach conditions. It will also examine whether patients followed through on the calls to action in the messages differently across conditions.

COMPLETED
Stop Emergency Room Visits for Hyperglycemia Project - District of Columbia (DC)
Description

To demonstrate that a focused Emergency Department (ED) intervention for uncontrolled hyperglycemia enables safe and effective glycemic management and reduces emergency room re-visits. We assessed hypoglycemia BG \< 60mg/dL; change in mean blood glucose and A1C, and ED revisits for hyperglycemia.