Lotrel

The goal of this clinical trial is to test two implementation strategies (digital strategy vs. care navigator strategy) to promote family cascade screening for familial hypercholesterolemia (FH) in Penn Medicine patients diagnosed with FH ("probands"). The main questions this study aims to answer are: (1) evaluating the effect of the approaches on reach (proportion of probands who have at least one family member who completes screening), number of family members screened, proband engagement with the study, and proband LDL-C levels; and (2) use mixed methods to identify implementation strategy mechanisms. Participants (probands) will receive messaging that provides education about FH and provides instructions for participating in family cascade screening. A subset of participants will be invited to complete a qualitative interview about their experience receiving the implementation strategy. The research team will compare the arms to evaluate their effectiveness at promoting cascade screening.

This study tests whether adding CHW support to usual nutrition care helps adults with type 2 diabetes, hypertension, or chronic kidney disease manage their diet and health. At Caridad Center, a free clinic in Palm Beach County, Florida, usual care includes medical nutrition therapy from a registered dietitian and medically tailored groceries. Many patients find it hard to keep up dietary changes because of limited nutrition knowledge, cooking skills, food costs, and cultural fit. Two hundred adults will be randomly assigned to usual care or usual care plus INTEGRATE-CHW, a 12-week program of six sessions with a trained CHW. In each session the participant selects one or two goals from the dietitian's plan and builds an action plan with the CHW. The dietitian remains responsible for the nutrition plan. The study will compare nutrition self-efficacy, nutrition literacy, diet quality, food security, and clinical measures between groups at baseline and Week 12. It will also evaluate how well the program fits into routine clinic care.

SWAP-CKM (SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome) is a pragmatic, cluster-randomized clinical trial designed to evaluate whether electronic health record (EHR)-based alerts can improve medication prescribing among adults with cardiovascular, kidney, and metabolic (CKM) conditions. The study will include all eligible adult patients receiving care within Kaiser Permanente Northern California (KPNC) who have CKM conditions and opportunities for therapeutic medication substitution. Fifteen service areas are randomly assigned to either an intervention group or a usual care group. Clinicians in the intervention group will receive EHR-based Best Practice Advisories (BPAs) identifying opportunities to replace potentially inappropriate medications with guideline-recommended therapies. The intervention may also include audit-and-feedback reports to support medication optimization. Clinicians retain full discretion over treatment decisions. The primary outcome is the proportion of eligible therapeutic optimization opportunities achieved at 9 months. Secondary outcomes include medication initiation and discontinuation, medication optimization at 18 months, and polypharmacy burden.

The GOAL-BP pilot study will help determine whether a study comparing two blood pressure goals can be carried out in adults with end-stage kidney disease and high blood pressure who receive peritoneal dialysis. The main questions it aims to answer are whether eligible patients can be recruited for the study. Researchers will compare two goals for the top blood pressure number (systolic blood pressure): below 120 mmHg versus below 140 mmHg.This pilot study will help plan a larger trial in the future. Participants will: * Be assigned by chance to one of the two blood pressure goals. * Have their blood pressure measured at clinic visits about every two weeks. * Work with their kidney doctor on recommended changes to fluid management, peritoneal dialysis treatment, or blood pressure medicines to reach their assigned goal. * Be part of the study for about four and a half months.

The original, "Cut Your Pressure Too: The LA Barbershop Blood Pressure Study (LABBPS)" (NCT02321618) was a highly successful cluster-randomized trial of a community centered blood pressure (BP) reduction program focused on Non-Hispanic (NH) black men who experience the highest rates of hypertension (HTN) and its complications. Patrons of 52 barbershops in Los Angeles County were randomly assigned to either an intervention arm in which barbers encouraged meetings with trained clinical pharmacists who provided HTN treatment in the barbershops or a control arm in which barbers provided educational pamphlets on HTN and encouraged physician appointments. After 6 months, the intervention group had a statistically significant reduction in systolic BP (SBP) of 21.6 mmHg compared to the control group. Results were durable at 1 year. Thereafter, a pilot study (NCT03726710) aimed at improving the efficiency of the barbershop model of HTN care by substituting in-person visits with video visits once BP was at goal was undertaken in 10 hypertensive barbershop patrons. The intervention effect was unchanged. The current study represents Aim 3 of an NIH funded renewal application entitled, "Barber and Pharmacist Coordination to Improve Blood Pressure Management in Black Men." It will build upon the foundational work of the original study and telemedicine pilot by evaluating the efficacy of a fully remote hypertension management program.

High blood pressure, also called hypertension, raises the risk of heart disease, stroke, and kidney disease. Medications work well for many people, but some people still have blood pressure that stays too high, or they have side effects from their medications. Researchers are looking for treatments that do not involve taking more medication. Nerves help control blood pressure by changing how blood vessels tighten and how hard the heart pumps. Because of this, treatments that act on nerves may be able to lower blood pressure. Spinal cord stimulation is a treatment already used to manage long-term pain. It uses a small device, placed under the skin during a standard operation, that sends mild electrical signals to the spine. Laboratory studies suggest that stimulating the lower part of the mid-back may also lower blood pressure, but this has not been carefully studied in people who already use these devices. This study will look at whether changing the settings on a spinal cord stimulator affects blood pressure. About 11 adults who have high blood pressure and who already have a spinal cord stimulator for long-term pain. No new device will be placed, and no surgery or other invasive procedure will be done for this study. Participants attend a series of study visits. At each visit, trained staff record blood pressure and heart rate while the stimulator is turned on, turned off, and set to other settings that the person's care team has approved and that the person finds comfortable. There are rest breaks between each setting. Over successive visits, the study team works to identify the settings that best lower blood pressure. Participants can stop at any time, and their usual settings are restored at the end of each visit. The study will also look at whether this kind of testing is practical and comfortable for participants. The results will help researchers decide whether larger studies of spinal cord stimulation for blood pressure control are worth doing.

This study will test the mechanisms of a multi-component, nurse-led, primary palliative care intervention, HEart failure Resilience Intervention for Caregivers (HEROIC) to improve caregiver mental well-being, patient health-related quality of life and unplanned acute care in the setting of advanced heart failure. The investigators will conduct a multi-site, randomized controlled trial to test proposed mechanisms of action in a large sample (N=500) of persons with heart failure and the caregivers. The investigators will also examine variation in response to HEROIC components by heart failure subgroup (ventricular assist device, heart transplant or medically managed heart failure).

Living with heart failure for adults over age 50 is hard. Older adults have to take many medicines to address heart failure and other health problems. That group of individuals must decide which medications to take and which devices to use to support heart health. Doctors, nurses, and social workers help patients understand these options but do not always know what is most important to them. Talking with patients about what the patients are hoping for, what the patients are worried about, and how much the patients understand about the illness is called a serious illness conversation, and it is hard to do. Doctors, nurses, and social workers are very busy and worry about upsetting patients by bringing up hard topics. The Serious Illness Care Program helps doctors, nurses, and social workers have these conversations by giving the staff a script to follow on what to say. The program also includes ways to make sure staff remember to have the conversation, a brief training, and how to document what is said during the conversation. But, nobody has studied the Serious Illness Care Program in a heart failure clinic, so it has not been customized to meet the needs of heart failure teams or older adults with heart failure. Many programs that are supposed to help patients fail in the real world. One reason is that patients do not include the needs of those who will receive and deliver it. Before this project, the team interviewed heart failure doctors, nurses, social workers, and other staff at a heart failure clinic. As well as interviewing older adults and care partners. The team asked staff how the Serious Illness Care Program can be changed to fit the needs and work in the clinic. The program includes a conversation guide that helps the team know what to say, so the study team asked patients and care partners what the thoughts on the language used and the topics covered. Then, the team practiced putting the program in place at the clinic and trained clinicians on using the Serious Illness Care Program with older adults and family members. Now the team wants to see if the heart failure team likes it and if it is doable. The team will also ask patients and care partners about the conversation and about feelings of anxiety before, during, and after the conversation. Lastly, the team will ask the individuals before and after the conversation about patients' knowledge of heart failure and how prepared the care partner feels to care for the individual. The team also want to explore how the program helps clinicians understand patients' symptoms, quality of life, and illness knowledge. Ultimately, this project establishes a structured framework to facilitate goals-of-care discussions between heart failure teams, patients, and families. These conversations empower patients to make immediate and future medical decisions aligned with personal values and lifestyle preferences. This values-based decision-making process optimizes care delivery and supports patients in achieving optimal health outcomes.

The researchers will invite 30 patients in primary care who have high blood pressure to participate in this health program with a supportive partner of their choosing (these will be the "participant pairs"). Participant pairs will be invited to complete the Heart Care Pairs health program that will include up to six sessions each including 1) some education on a health habit like physical activity and heart healthy foods, 2) goal setting together, and 3) talk about healthy communication to support one another with heart healthy habits. The researchers will work with participants to address things that get in the way of coming for visits like offering transportation and offering telehealth visits. The researchers are seeing how this program works in real life so participants will be asked to complete as many sessions as they want to and can attend. The researchers will be interested in what participants think about the sessions, if they were satisfied with the visits, and if they would recommend the program to others in their community. The researchers will ask these questions in interviews with participants. The researchers will also ask up to 25 primary care workers about how they view the program as helpful to their work with patients with high blood pressure and whether they would refer more patients to the program in the future.

Vascular risk factors drive stroke, heart disease, and dementia, but translating lifestyle guidelines into routine clinical care remains challenging. To address this, we developed BASIC-S (Blood Pressure, Activity, Sleep, Interaction, Consumption, and Support), a framework targeting Blood pressure, Activity, Sleep, Interaction (socially), Consumption (nutrition), and Support using partner support and motivational interviewing. This individual-focused approach bypasses the logistical and financial barriers of complex clinical interventions by using sustained behavioral science to support gradual lifestyle changes. This study is a single-center, mixed-methods, cluster-randomized pilot trial evaluating the feasibility of the BASIC-S protocol in an occupational setting. A maximum of 60 households (120 participants) will be randomized 1:1 to either the BASIC-S intervention (motivational coaching, secure video check-ins, automated text messages, and a digital workbook) or standard care. Outcomes will assess feasibility, acceptability, and the validity of new tracking metrics to inform a future full-scale trial.

Physical activity is known to help patients with heart failure feel better and live longer though few patients with heart failure are sufficiently active. This study is evaluating whether a mobile health intervention can help patients with heart failure increase physical activity levels and remain active over time. The mobile health intervention consists of three parts: Notifications encouraging physical activity, a digital health coach trained in motivational interviewing, and a mobile application which encourages goal setting and activity monitoring.

The purpose of the BRIDGE study is to learn whether supplementing traditional center-based cardiac rehabilitation (CBCR) with a mobile health technology intervention can help patients monitor their health, stay engaged in healthy lifestyle behaviors, better manage cardiovascular risk factors, and improve overall health outcomes. Cardiac rehabilitation is an evidence-based outpatient program designed to help people recover from heart-related conditions through supervised exercise, education, counseling, and support for healthy lifestyle changes. Although cardiac rehabilitation is highly recommended and beneficial, many patients do not receive the full benefits of the program. Some patients attend fewer sessions than recommended, and many find it difficult to maintain healthy habits outside of the clinic, such as regular physical activity, heart-healthy eating, taking medications as prescribed, monitoring blood pressure, and managing weight. This study will test whether combining CBCR with mobile health tools may improve participation and support healthy behaviors at home. Mobile health tools include mobile phone applications, connected devices such as a weight scale, blood pressure monitor, and activity tracker, as well as personalized text messages designed to encourage and support healthy self-care. This study will help determine whether these mobile health tools can make cardiac rehabilitation more effective and help patients maintain healthy behaviors beyond the clinic setting.