Treatment Trials

25 Clinical Trials for Various Conditions

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RECRUITING
Telehealth-delivered Peer Support to Improve Quality of Life Among Veterans With Multimorbidity
Description

The VetASSIST study is a randomized clinical trial testing whether receiving virtual health coaching from Veteran peers improves the physical and mental health-related quality of life of Veterans with multiple chronic health conditions and complex healthcare needs. VetASSIST will test the efficacy of an intervention that matches Veteran patients with multimorbidty with Veteran health coaches who will provide education, resources, guidance and support to help them manage their physical and mental health over the course of a year.

Conditions
RECRUITING
Transition to Cardiac Rehabilitation (T2CR) to Address Barriers of Multimorbidity and Frailty
Description

Cardiac rehabilitation (CR) is a secondary prevention program for patients with cardiovascular disease (CVD). It is especially valuable as CVD increasingly occurs in combination with comorbidity, frailty, and complexities of care that predispose patients to functional decline, disability, and high costs. Still, few Veterans participate in CR, in part because of the difficult logistics to attend. Promising Practice home-based CR (HBCR) was developed to increase CR participation, but many Veterans remain too limited by comorbidity and frailty for participation. A Transition to CR (T2CR) intervention is a face-to-face program that fosters vital skills, education, insights, motivation, and patient-provider relationships conducive to successful HBCR thereafter. This study compares Veterans eligible for CR who are randomized to T2CR intervention versus usual care. Differences in functional capacity, HBCR participation, and healthy days at home are compared over one year. Patients' experiences and providers' perspectives of barriers and facilitators to T2CR are also compared.

COMPLETED
Living With Multimorbidity: CO-ORDINATE Program
Description

Multimorbidity is common and is the coexistence of two or more chronic conditions in the same individual. People with multimorbidity suffer from a high symptom burden, directly affecting quality of life (QOL). Hospitalization can be a window of opportunity to initiate interventions to promote recovery and resilience and enhance QOL. However, interventions targeting the symptom trajectory and burden of patients with multimorbidity are lacking. Thus, the investigators envisage a nurse-led pre-discharge intervention augmented by telephone support, focusing on care coordination and symptom management. This approach is anticipated to help reduce symptom burden and improve QOL.

COMPLETED
SPIRIT for Persons With Dementia and Complex Multimorbidity
Description

In this study, 30 patient and caregiver dyads will be randomized to receive the SPIRIT-dementia intervention or usual care. Participants will be follow-up with 2-3 days after the intervention to evaluate the impact of SPIRIT on preparedness outcomes. Additional follow up with caregivers will occur 6 months later.

COMPLETED
Improving Communication About Patient Priorities in Multimorbidity
Description

The goal of this study is to develop and test Customized Care, an intervention to help patients dealing with depression and/or anxiety in the context of multiple chronic conditions. Customized Care is designed to help patients communicate about important issues, such as financial and safety concerns, with their primary care providers (PCPs). The intervention will be delivered in patient waiting rooms prior to a routine follow-up visit with the PCP. Phase 1 of the project will ensure that the main components of Customized Care are acceptable to patients and PCPs. Phase 2 will include a pilot study to test the effects of Customized Care on patient-PCP communication. Participants aged 40 years or older who have a diagnosis of two or more common chronic medical conditions will be recruited from primary care clinics. Patients screening positive for either depression or anxiety will be randomized to Customized Care vs. an active control. The investigators hypothesize that the Customized Care will improve patient-Primary Care-Provider communication.

Conditions
RECRUITING
Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of Complex Health Conditions
Description

Medically complex older Veterans are at greater risk for progressive declines in physical function, lower quality of life, and increasing care needs. Additionally, older Veterans experience social isolation and loneliness, and have low levels of physical activity. While the Veterans Health Administration has established programs to address rehabilitation needs, these programs tend to be diagnosis-focused, lack self-management approaches, include low-intensity rehabilitation, and typically require in-person attendance. A MultiComponent TeleRehabilitation (MCTR) program that includes high-intensity rehabilitation and self-management interventions, social support, and telehealth and technology supports may be more effective in improving and sustaining physical function for older Veterans with complex health conditions. Therefore, this project is designed to determine whether the MCTR program improves strength and physical function more effectively than traditional interventions.

RECRUITING
High-Risk Veteran Initiative
Description

Veterans at high-risk for hospitalization, including those with complex care needs, represent a large population of VHA patients who often do not receive evidence-based primary care practices that would help them avoid the hospital and improve their health. The high-RIsk VETerans (RIVET) Program will implement evidence-based practices that can support VHA Primary Care teams to deliver more comprehensive and patient-centered care, better strategies to manage medications, and avoid unnecessary hospitalizations. The RIVET Program is designed to find the most effective approaches to increasing use of evidence-based practices for high-risk Veterans in primary care, provide rapid data feedback to VHA on high-risk patient care, build capacity for the implementation of evidence-based practices, and train future leaders in high-risk Veteran care.

Conditions
COMPLETED
Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach
Description

The aims of this study are to determine the feasibility and acceptability of a multicomponent telerehabilitation program for medically complex older Veterans and to preliminarily assess participant outcomes (physical activity, physical function, quality of life, loneliness) to the program.

COMPLETED
Improving Patient and Caregiver Engagement by Sharing Annotated Audio-recorded Clinic Visits
Description

In this project, the investigators will conduct a three-arm patient-randomized pilot trial in older adults with multimorbidity in ambulatory care settings to determine the feasibility, usability, and acceptability of an audio-based PHL developed with older adults and caregivers, HealthPAL.

Conditions
COMPLETED
Evaluating the Accuracy of an Integrated Vital Sign Measurement Platform
Description

Partners Connected Health will conduct a clinical validation study to evaluate the accuracy of measurement for each vital sign with the Vital Moto Mod platform, compared to appropriate reference devices used in the hospital setting. The study will recruit volunteers from the Partners Healthcare network of clinics and hospitals and the general public.

Conditions
COMPLETED
Evaluation of the Philips Lifeline CareSage Risk Assessment System
Description

This study is being done to evaluate the impact of a system called CareSage. The CareSage system is a technology that uses clinical data to monitor, identify and target care to patients at risk of being transported to the hospital. The investigators want to see whether the CareSage system is effective in helping to identify hospital admissions which can be prevented.

Conditions
COMPLETED
Video-Enhanced Care Management for Medically Complex Veterans
Description

The purpose of this study is to examine the feasibility and acceptability of a 12-week care management program for medically complex Veterans with cognitive impairment, delivered via telephone or videoconferencing.

COMPLETED
Discharge Information and Support for Patients Receiving Outpatient Care in the Emergency Department
Description

The Veterans' Health Administration (VHA) is committed to improving primary care through the implementation of Patient Aligned Care Teams (PACTs). Improving access to services and care coordination are among the primary goals of PACTs; however, there remain many unanswered questions about how best to use the limited time of PACT team members, such as nurse care managers, to accomplish this. This study will evaluate the effectiveness of a nurse-led telephone support program for Veterans who have been treated recently in the emergency department (ED) and are at high risk for repeat visits. The program's goals are to reduce the need for future ED use and improve satisfaction among Veterans by providing information and support related to the ED visit, enhancing chronic disease management and educating Veterans and family members about PACT and other VA and community services. If proven effective, this program could improve health and healthcare for a large, vulnerable group of Veterans and be cost saving for VHA.

Conditions
COMPLETED
Minnesota Care Coordination Effectiveness Study
Description

Medical care has improved greatly over the past 50 years. Treatments for most medical conditions can help us lead longer and healthier lives, but there are still problems. Many patients with two or more conditions see many different doctors and sometimes take more medications than needed. These patients can feel lost and confused. In addition, non-medical issues involving housing, food, transportation, employment, income, support from others, and language barriers can have a large impact on our health. In Minnesota, many primary care clinics are using a method called care coordination to improve the health of patients who have a number of chronic diseases (some examples of chronic diseases include diabetes, heart disease, asthma and depression). With care coordination, a nurse in the clinic helps the various doctors, clinics, and specialists to work together, in the interest of the patient. In some clinics, a social worker also helps with care coordination. These social workers help with issues like housing, transportation, or employment. Care coordination can help reduce patient confusion. It also can improve health and lower patient burdens and costs of getting medical care. To help find out what types of care coordination are most successful, we are proposing a study. Our plan is to track the health of patients receiving care coordination and compare two types: A. Care coordination done by a nurse or other clinic staff B. Care coordination where a licensed social worker also assists the patient In this study, we will measure many things, including: 1. Control of chronic conditions like diabetes, heart disease, asthma, and depression 2. Hospitalizations 3. Emergency department visits 4. Use of medications and diagnostic tests 5. Use of specialty care 6. General health status 7. Patient satisfaction and access to care 8. Use of shared decision-making (where the doctor and the patient make treatment decisions together) 9. Patient burden (how much time and effort the patient spends trying to get healthy) 10. Patients' out-of-pocket medical costs This project will be important to patients because it could reduce confusion and fragmented care while improving all the items above. Those improvements will be more likely because this project takes advantage of engagement with patients and others. We have four patient partners who will help conduct the study and interpret and broadly share the results. The project was developed with the input from patients, clinic leaders, people from state government, and experts on health and quality care. By measuring a wide variety of outcomes for the adults receiving coordination services in these clinics, we hope to identify the specific actionable information that will allow these and other clinics to improve their services for these patients with complex needs. Throughout the project, we will communicate our findings to clinics and health systems. As a result, many people may receive better care.

RECRUITING
Pilot Feasibility Trial of HEALthy Beginnings for Middle-Aged, and Older Homeless Women
Description

This is a mixed methods pilot feasibility trial of HEALthy Beginnings, an innovative, nurse-driven intervention. Middle-aged and older, homeless women (MAO-HW) will participate in the HEALthy Beginnings intervention and select MAO-HW will be invited to participate in post-intervention qualitative focus groups to evaluate the program.

NOT_YET_RECRUITING
Optimizing Prescribing Decisions for Hospitalized Older Adults with Chronic Conditions
Description

The goal of this pilot clinical trial is to learn if providing a clinical decision framework for managing older adults chronic conditions during hospitalization to inpatient clinicians improves clinicians' ability to individualize chronic condition prescribing decisions for hospitalized older adults (65 and older). The main questions it aims to answer are: * Will the clinical decision framework lead to clinicians having greater confidence to individualize discharge prescribing? * Will clinicians using the framework discharge make fewer changes to hospitalized older adults with home diabetes and hypertension medications than they did prior to receiving the framework? * Will older adult patients of participating clinicians will report fewer gaps in understanding of medication changes after the clinician is exposed to the framework? Researchers will compare participating clinician survey responses and prescribing records from before and after an educational session presenting the clinical decision framework. Participants will be asked to * Attend a one-time educational session on the clinical decision framework * Complete 2 electronic surveys, one before and one following the educational session. * Agree for researchers to contact their patients, in order for patients to complete a one-time phone survey about changes made to home medications during hospitalization and quality of communication from the hospital team.

COMPLETED
2nd AC+: New Village Model
Description

This study evaluates implementation of the Village Model to support older people living with HIV.

COMPLETED
Self-Management Interventions Using Mobile Health for the Multimorbid
Description

The purpose of this pilot study is to evaluate the feasibility and impact of delivering mobile health self-management interventions to improve adherence to the prescribed treatment in a multimorbid population returning home after hospital discharge.

ACTIVE_NOT_RECRUITING
Emulated Study of Vitamin D Correction Vs Non-Correction
Description

* This is a single-site retrospective electronic chart review of Cooper Health System Inpatients and Outpatients from 2008 through 2023 aged eighteen years or older. This review is designed as an emulation of a randomized clinical trial with a nonrandomized database. * The primary objectives are to compare healthcare costs and healthcare utilization between subjects who have corrected low vitamin D levels and those without corrected low vitamin D levels.

RECRUITING
Comparing Healthcare Visit Recording and Open Notes to Improve Chronic iLlness Care Experience in Older Adults
Description

CHRONICLE is a randomized trial assessing the comparative effectiveness of providing written visit information via the patient portal (NOTES) versus NOTES plus visit audio recording (AUDIO) to older adult patients with chronic diseases on quality of life and other outcomes. During the trial, the team will also invite caregivers identified by patients to join the project.

RECRUITING
The Effect of Clinic Visit Audio Recordings for Self-management in Older Adults
Description

The objective of this study is to conduct a multisite trial evaluating the impact of adding an audio recording of clinic visits (AUDIO) to usual care in older adults with multimorbidity, including diabetes, compared to After Visit Summary (AVS) alone (Usual Care; UC).

Conditions
WITHDRAWN
High Risk Outpatient Intern-led Care (HeROIC) Clinic Initiative
Description

Background: A small subset of the patient population is responsible for a significant proportion of healthcare expenditures. These patients are cared for in academic medical centers by internal medicine residents however there has been no research to date about the education or the management of patients with complex multimorbidity in the outpatient setting. Objective: To evaluate the impact of the High Risk Outpatient Intern-led Care (HeROIC) Clinic on internal medicine interns' perceived ability to manage complex outpatients as well as pre and post intervention total patient healthcare cost. Methods: The investigators created the HeROIC outpatient clinic environment to comprise longer visit time slots, "bedside" presentations, and team-based care (one intern primary care provider, one secondary intern, and one longitudinal attending). All non-preliminary interns based at one primary care site participated in the intervention while interns at a second site continued to practice in the usual outpatient clinic environment. The interns in the HeROIC clinic arm assumed the roles of primary care providers for 34 complex patients in total. The primary outcome was the perceived confidence in the management of complex outpatients as assessed by a survey. Secondary outcomes included perceptions about the ability to provide high-quality outpatient and evidence-based outpatient care, as well as statewide pre-post patient healthcare cost data.

COMPLETED
Optimal Medication Management in Alzheimer's Disease and Dementia
Description

The study objective is to conduct a pragmatic deprescribing intervention for people with Alzheimer's Disease or Related Dementia with Multiple Chronic Conditions (ADRD-MCC) so that these patients are on 'just right' medication regimens. The intervention will be a pragmatic, cluster randomized trial of medication optimization through increased awareness of deprescribing for the ADRD-MCC population. It will be delivered in primary care at the clinic level with a wait-list control design. As a pragmatic intervention it is designed to be relatively simple, have broad inclusion/exclusion criteria, and be implemented across the Kaiser Permanente Colorado (KPCO) system. The intervention will have two components: a patient/care partner component focused on education and activation about potential deprescribing including sending out a brochure, and a clinician component focused on increasing clinician awareness through monthly Tip Sheets about options and processes for deprescribing in the ADRD-MCC population linked to upcoming visits. The intervention will take place at 18 primary care offices in the Denver-Boulder service delivery area with 9 as initial intervention sites and 9 as delayed intervention sites.

Conditions
COMPLETED
Health Literacy Assessment and Intervention to Reduce Disparities: FLIGHT/VIDAS II
Description

The purpose of this study will to be to evaluate the effects of a mobile intervention focused on improving the chronic disease self management skills of individuals with low health literacy. The intervention will provide information that culturally and linguistically tailored to participants' level of health literacy.

COMPLETED
Mi Puente: My Bridge to Better Cardiometabolic Health and Well-Being
Description

Mi Puente (or "My Bridge") is a culturally-tailored, interdisciplinary approach designed to support at-risk Hispanic patients and their caregivers pre- and post-hospital discharge as they navigate the multi-level barriers that contribute to inequities in health care access and use, and in turn, perpetuate disparities in cardiometabolic and behavioral health. Mi Puente utilizes a sustainable nurse + volunteer peer team-based model, bridging partnership between inpatient and outpatient care settings to meet the integrated (i.e., physical and behavioral) health needs of Hispanics who are hospitalized with multiple chronic cardiometabolic conditions and one or more behavioral health concern(s). Participants will be tested at Scripps Mercy Hospital - a large, non-profit, safety net hospital located in the US/Mexico border region of South San Diego County, California. The proposed randomized controlled trial will test Mi Puente versus Usual Care (evidence-based, best practice discharge procedures) in improving hospital utilization, patient-reported, and cost effectiveness outcomes. Electronic medical records (EMR) will be used to identify eligible patients and examine primary outcomes.