Treatment Trials

81 Clinical Trials for Various Conditions

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RECRUITING
Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF): A Type 1 Hybrid Effectiveness- Implementation Trial
Description

This study is trying to improve the hospital-to-home transition for people with heart failure who receive home care services. The study will test an intervention called I-TRANSFER-HF, which differs from usual care by combining early home health nurse visits and outpatient medical appointments. The study is interested in two questions: 1. Is I-TRANSFER-HF better than usual care at preventing heart failure patients from returning to the hospital within 30 days? 2. Are there parts of I-TRANSFER-HF that are easy or hard to implement in the real world? The researchers will answer these questions by testing the intervention among pairs of hospitals and home health agencies across the country. During the study, the hospital-agency pairs will be asked to implement I-TRANSFER-HF. The researchers will then compare the results from before and after I-TRANSFER-HF was adopted. They will also interview people from these hospitals and agencies to see how I-TRANSFER-HF is being implemented under real-world conditions.

Conditions
ACTIVE_NOT_RECRUITING
Deprescribing for Older Adults After Hospital Discharge in Home Health Care
Description

The purpose of this study is to examine the feasibility of providing a medication optimization program to improve patient health outcomes during the transition from hospital to home. This is because the period after hospital discharge is critical to long-term recovery, overall quality of life, and prevention of future hospitalizations.

Conditions
COMPLETED
Making Health Care Safer for Older Adults Receiving Skilled Home Health Care Services After Hospital Discharge
Description

Care transitions are the movement of a person from one healthcare setting to another. Older adults who require skilled home health care ("home health") services (e.g., home-based nursing) after hospital discharge are at high risk of experiencing early re-hospitalization. Home health agencies need strategies to ensure safe transitions, yet there is relatively little research to guide improvement efforts. The goal of the study is to develop and test tools to allow home health agencies to identify and act upon threats to older adults' safety in real time. The investigators first analyzed threats to older adult safety during hospital-to-home health transitions and refined a bundle of interventions through stakeholder engagement. This prospective pilot will implement and measure the bundle of interventions.

WITHDRAWN
Managing Wounds With Allevyn Life in a Home Health Care Environment
Description

When elderly patients need help caring for wounds, physicians may refer patients to home health care providers. The home health provider sees the patient in the patient's home and assists the patient with wound care. Working with the patient's physician, the home health provider will use the appropriate wound covering ("dressing" or "bandage") to cover the wound. The goal of the home health provider is to ensure that the wound stays clean and progresses toward closure. The home health provider will conduct in-home patient visits at appropriate intervals to assess the status of the wound. Extensive resources are required to see patients in their own homes. If a dressing could effectively manage wounds and allow longer time between in-home visits (without affecting patient safety or progress of the wound toward closure), then resources could be saved. Thus, newer dressings are designed for longer wear times, using advanced foam pads and adhesives that help keep the dressing in place. The hypothesis of this study is that the use of Allevyn Life will decrease the number of in-home visits by home health providers without sacrificing patient safety.

COMPLETED
Protecting Home Healthcare Workers: An Interactive Video-based App to Coach Workers Through Challenging Health and Safety-related Situations
Description

This project will create a video-based app that empowers home healthcare workers to communicate with clients and their families about managing health and safety hazards in client homes. Using a participatory approach, home healthcare workers will 1) review and revise video scripts and recordings that demonstrate effective and less effective communication strategies when talking to clients, families, and other stakeholders about health and safety hazards and 2) contribute to the creation and review of an interactive app that they perceive to be useful, usable, and desirable.

UNKNOWN
Effectiveness of a Depression Care Management Initiative in Home Healthcare
Description

Depression in older home healthcare patients occurs very often, is typically not treated appropriately, and leads to poor health outcomes. This study tests an intervention, called "Depression Care for Patients at Home" or the Depression CAREPATH, designed to help home healthcare nurses work with the patients, their family, and their doctors in managing depression treat depression according to clinical guidelines and to manage its treatment over time. Patient outcomes, measured at 3, 6, and 12 months, include guideline-consistent changes in depression treatment and reduction in depressive symptoms.

Conditions
RECRUITING
Interactive Virtual Occupational Safety Training Designed for Home Healthcare Workers
Description

Overview. The investigators will collect preliminary data on the extent to which the knowledge gained from the enhanced HH-VSTS transfers to a real-world environment. Following abbreviated use of the enhanced HH-VSTS, participants will perform a walk-through of a realistic environment to assess their learning.

Conditions
COMPLETED
A Workflow and Satisfaction Study Evaluating the Implementation of a New "Smart" Ambulatory Infusion System
Description

The purpose of this study is to describe the home healthcare organization ambulatory infusion pump programming workflow and the process that was followed to introduce the new CADD®-Solis VIP System to each home healthcare organization or facility. In addition, this study will characterize the overall clinician (Phase 1) and patient (Phase 2) ease of use and satisfaction with the CADD®-Solis VIP System.

COMPLETED
Synergizing Home Health Rehabilitation Therapy
Description

The objective of this project is to pilot test an ADL (activities of daily living)-enhanced program as an adjuvant therapy to usual home health rehabilitation to improve patient outcomes. The project will compare the ADL-enhanced program plus usual care with usual care using an RCT design in home health patients.

COMPLETED
Leveraging Home Health Aides to Improve Outcomes in Heart Failure
Description

The purpose of the study is to determine the effectiveness of an intervention among home health aides caring for adults admitted to home care with a primary diagnosis of heart failure at VNS Health Partners in Care (home care agency). The study will examine the interventions' effect on home health aides' heart failure knowledge and confidence caring for adults with heart failure, as well as on the client's overall health (visits to the emergency department and hospital readmissions).

COMPLETED
Pharmacogenetic Testing Among Home Health Patients
Description

Patients meeting eligibility criteria will be randomized into two groups, one receiving pharmacogenetic testing and the other not receiving pharmacogenetic testing. In this open-label trial, a pharmacist will make medication therapy recommendations using YouScript® Personalized Prescribing System for patients who receive genetic testing and standard drug information resources per usual for patients who do not undergo pharmacogenetic testing.

TERMINATED
Educational-Medical-Behavioral Treatment of Fecal Incontinence
Description

In previous studies at a university referral center the investigators demonstrated that a multicomponent conservative treatment for fecal incontinence was effective. The treatment combines patient education with medical management of diarrhea and constipation plus behavioral training. The purpose of this study is to determine whether this treatment is effective when delivered by home health care nurses to frail elderly patients.

COMPLETED
Home Care Medication Management Program for the Frail Elderly
Description

The purpose of this study is to determine whether a home care medication management program which includes nurse coordination and use of the MD.2 medication-dispensing machine will affect older adults' health outcomes, satisfaction, use of health care services, and health care costs over a one year period. The investigators propose a longitudinal three group repeated measures design, enrolling, and randomly assigning, clients who are discharged from a home health care agency with documented problems in medication management. One group will receive the MD.2 medication dispensing device and nurse coordination, the second group will receive a Medplanner: a simple box that has separate compartments for individual medication times over the course of a week plus nurse coordination, and the final group will receive Usual Care. The study hypotheses are the following: H1: With respect to health status outcomes, the MD.2 group will exhibit a more positive trajectory in physical and mental health status, functional status, cognitive status and depressive symptoms over the course of a year than will the Medplanner Group. H2: With respect to health status outcomes, the Medplanner Group will exhibit a more positive trajectory in physical and mental health status, functional status, cognitive status and depressive symptoms over the course of a year than will the Usual Care Group. H3: The rate of hospitalization, hospital days and emergency department visits will be significantly lower for the MD.2 Group as compared to the Medplanner Group. H4: The rate of hospitalization, hospital days and emergency department visits will be significantly lower for the Medplanner Group as compared to the Usual Care Group. H5: The nursing home admission rate will be significantly lower for the MD.2 Group as compared to the Medplanner Group. H6: The nursing home admission rate will be significantly lower for the Medplanner Group as compared to the Usual Care Group. H7: The total cost of care will be significantly lower for the MD.2 Group as compared to the Medplanner Group. H8: The total cost of care will be significantly lower for the Medplanner Group as compared to The Usual Care Group. H9: There will be incremental savings in terms of costs per quality adjusted life year (QALY) gained in the MD.2 group compared with the Medplanner Group. H10: There will be incremental savings in terms of costs per QALY gained in the Medplanner group compared with the Usual Care Group.

COMPLETED
PACT: Providers and Alzheimer's Caregivers Together
Description

The primary goal of the study is documentation of effectiveness of a home-based intervention to reduce caregiver burden related to dementia caregiving, improve caregiver health status, and reduce caregiver and care recipient resource utilization.

COMPLETED
Home Visiting for Low Income, Pregnant Women
Description

In the Pico-Union/Koreatown community of Los Angeles investigators are designing a preventive health care model that increases the opportunities for families to make healthy choices -- in their homes, schools \& communities. The project's key element is: Lay community health workers (paraprofessionals) - Mentor Mothers (MM) (promotoras) - who make home visits to pregnant mothers \& newly-delivered mothers who have agreed to participate in the research study. Investigators hope to achieve the following outcomes: 1) lower maternal BMI at 6 months post-birth; 2) longer duration of breastfeeding; 3) less alcohol, smoking, and drug use during pregnancy; and 4) increased and consistent prenatal and postnatal healthcare adherence. Investigators will implement the study with 6 MMs, who will maintain an average caseload of 16 women each across an 18-month period. Each participant will be visited (or receive the intervention by telephone) twice per month. Separate Assessment Team members will conduct assessments at: Baseline, within a week of birth of the target child, and 6 months from birth.

COMPLETED
Remote Monitoring and Home-based Health Care for Treatment of Bone Marrow Transplant Patients
Description

This study is designed to assess the potential for successfully using technology-assisted in-home oncology care, including remote patient monitoring (RPM), telemedicine, and home-based health care services to support improved care management and appropriate referral to treatment for bone marrow transplant (BMT) patients.

UNKNOWN
PEARL Intervention to Reduce Depression Among Adults With Epilepsy
Description

The purpose of this study is to test the effectiveness of a home-based depression treatment intervention called "Program to Encourage Active, Rewarding Lives (PEARL)". We hypothesize that over a 12-month period, compared to usual care, those receiving the PEARL intervention will show more improvement with their depression, have higher quality of life and function, and use fewer medical services.

COMPLETED
A Randomized Controlled Trial of In-Home Tele-Behavioral Health Care Utilizing Behavioral Activation for Depression
Description

This study will evaluate the effectiveness of a web-based behavioral activation(BA) treatment for depression by comparing it to in-person BA treatment in Soldiers and Veterans with Major and Minor Depressive Disorder. We will test the hypothesis that 8 sessions of in-home BA delivered via a webcam will be as safe and effective in reducing symptoms of hopelessness and depression as in-person BA treatment for depression.

Conditions
UNKNOWN
Mobile Biosensor for Measuring Vital Signs in Healthcare and Home Settings
Description

This study will record vital signs (heart rate and blood oxygen levels) using a new cell phone integrated biosensor and compare it to routine measurements carried out in the clinics and hospital at UCSD. Cell phones will be given to a selected group of subjects for use at home and data collected.

Conditions
COMPLETED
Promoting Seniors' Health With Home Care Aides
Description

This study aims to test whether a safe physical activity program with a built-in motivational enhancement component, performed in a seated position, preserves the function and well-being of older home care clients.

Conditions
COMPLETED
Effects of Home-based Exercise Rehabilitation on Healthcare Utilization in HeartMate 3 Patients
Description

To demonstrate that home-based exercise rehabilitation (HER) compared to usual care (UC) results in a significant reduction in healthcare utilization in HeartMate 3 (HM3) left ventricular assist device (LVAD) patients.(defined as rehospitalization, VAD Clinic visits, and ER visits during the 1st year after index discharge following LVAD implantation).

COMPLETED
Improving Osteoporosis Care in High-Risk Home Health Patients
Description

SPECIFIC AIMS: We propose a three-year study to develop a high-intensity intervention to improve osteoporosis care and test a novel intervention in a group-randomized trial of 27 home health offices and 1,000 patients referred to home health care with a history of fracture. Aim 1. Develop an intervention to promote osteoporosis treatment that includes: (1) training to enhance nurse-patient and nurse-physician risk communication regarding osteoporosis and fracture risk; (2) automated prompts within the home health agency's electronic medical record system to promote appropriate osteoporosis management; and (3) implementation of osteoporosis-related standardized care pathways and order sets. Aim 2. Conduct a group-randomized trial to test the effectiveness of the intervention to promote initial use of osteoporosis medications and adherence to treatment after discharge from home health. We hypothesize that: H1: Patients in the intervention group will have increased initial receipt of osteoporosis prescription medications and calcium/vitamin D supplements to prevent and treat osteoporosis compared to patients receiving usual care; H2: Patients in the intervention group will demonstrate increased persistence in the use of these therapies compared to those receiving usual care. Secondary Aims (SA) will include exploratory analyses of fracture related morbidity and mortality, patient-reported quality of life, and health services utilization and costs.

COMPLETED
Human Microbiome and Healthcare Associated Infections - Nursing Home Dwelling Older Veterans
Description

The purpose of the research is to find out the effect of commonly used topical antibiotics on the bacteria that live in the nose, throat and on the skin of older adults. In addition, the investigators want to determine if these topical antibiotics affect how bacteria are spread in Community Living Centers of the VA Maryland Health Care System.

COMPLETED
Home-Based Palliative Care Impact on Providers
Description

This research challenges our current approach to fee-for-service palliative care and is significant because it will advance the fields of palliative and person-centered care, clinical practice, public policy, and health care financing. However, the most important effect will be on seriously ill patients and their families through increased access to palliative care outside of hospitals, enhanced palliative continuity across health settings, and improved affordability via reformed payment structures. Nation-wide replication of reimbursable HBCP models is anticipated.

NOT_YET_RECRUITING
The Care for America's Aging Study
Description

Care for America's Aging is a randomized pilot study investigating whether a home health aide training intervention consisting of enhanced dementia-specific curriculum content will improve: 1) behavioral symptoms of older adult persons living with dementia or cognitive impairment (PLWD/CI) and 2) global health-related quality of life among PLWD/CI and their care partners.

COMPLETED
CAPABLE Transitions: A Home Health-Based Intervention for the Hospital or Post-Acute Care Facility-to-Home Transition
Description

This clinical study is designed to test the feasibility of a new intervention, CAPABLE Transitions. CAPABLE Transitions is based on the Community Aging in Place, Advancing Better Living for Elders (CAPABLE) intervention designed by Dr. Sarah Szanton at Johns Hopkins University. Similar to CAPABLE, CAPABLE Transitions consists of an occupational therapy (OT)-led intervention in which the study OT, nurse, and handyman deliver an in-home intervention over 3-4 months. This intervention is designed to help with the transition of care from a hospital or post-acute care facility discharge as well as to optimize functioning and home safety. This clinical study plans to recruit a total of 60 older adults with and without dementia admitted to a home health agency following discharge from a hospital or post-acute care facility. Given that this is a feasibility study, it is not designed or powered to test hypotheses.

WITHDRAWN
Home Visits for Patients at Risk for Appointment No-shows
Description

Unused clinic visits due to patient no-shows continue to plague American healthcare as a large source of waste and avoidable constraint on access. The average no-show rate across 105 studies was 23% though with wide variation (4% to 79%). No-show behavior has adverse effects on patients, providers, and healthcare organizations' operational and financial outcomes. Patients that miss clinic visits are more likely to need acute care and suffer poor health outcomes. There have been increasingly sophisticated efforts focused on predicting which patients are likely to no-show. This can allow for tactful over-booking and/or patient outreach. At Hopkins, investigators have implemented a novel machine learning based approach for identifying those patients at high-risk for no-show. Offering home visits for patients who are most likely to no-show is an appealing strategy to connect medical providers with patients who need care but are otherwise unlikely to receive it. Yet, it is unclear if this would be helpful to engage patients in their care, and encourage subsequent attendance, or if it would encourage future missed appointments, fostering a reliance on possible ongoing home visits. This study would link existing efforts with no-show prediction to home visits by internal medicine residents and evaluate its clinical impact. Patients at high-risk for no-show will be randomized into the control arm where patients will be called to remind patients of their visits. Those randomized into the intervention arm will be offered a one time home visit in lieu of their in-person visit to help understand barriers to in-person care and build rapport. Outcomes evaluated include future in-person show rates and healthcare cost/utilization

ACTIVE_NOT_RECRUITING
Advanced Heart Care At Home
Description

End-of-life (EOL) care for heart failure (HF) patients includes high healthcare utilization and costs, in part due to the lack of integration of optimal HF management and home-based palliative care. In a pilot quality improvement project of clinician "nudges" to enroll seriously ill HF patients in a home-based, integrated HF and palliative care platform, the investigators demonstrated decreased healthcare utilization and costs and increased hospice utilization among seriously ill HF patients. The investigators propose a pragmatic randomized trial for clinicians of seriously ill HF patients admitted to three University of Pennsylvania Health System Hospitals, randomly assigning an opt-in approach (usual care) versus a "nudge" or opt-out approach of a visit from an Advanced Heart Care at Home (AHCAH) liaison to clinicians of eligible patients to discuss and enroll in the AHCAH program, to rigorously and scientifically evaluate clinical, utilization, and cost outcomes among high-risk HF patients at the EOL, and to promote physician uptake of best practices.

COMPLETED
A Medical Home-Based Intervention to Prevent Child Neglect in High-Risk Families
Description

Child maltreatment, particularly neglect, disproportionally affects low-income children with special health care needs (CSHCN) and has serious short and long-term consequences. Currently, few replicable, evidence-based preventive services exist for such families, particularly within the context of the patient-centered medical home. Child Abuse Prevention Problem Solving (CAPPS), a targeted problem solving intervention that addresses key risk and protective factors for child neglect, has the potential to improve key parenting skills and overall wellbeing, ultimately improving outcomes for high-risk children. This study is a multi-center randomized controlled efficacy trial of CAPPS to determine the impact on child neglect, adherence to recommended medical care, and family stressors and strengths.

Conditions
COMPLETED
Feeding and Transition to Home for Preterms at Social Risk
Description

Premature infants are at high risk of suboptimal health and development. This randomized clinical trial evaluated the impact of a developmentally based intervention, H-HOPE (Hospital-home transition: optimizing prematures' environment), for infants born between 29-34 weeks gestational age (GA) with at least two social-environmental risk factors. H-HOPE will improve infant behavior, mother care for the infants, mother-infant interaction and will reduce health care costs.

Conditions