141 Clinical Trials for Various Conditions
The Systematic Implementation of Patient-centered Care for Alcohol Use Trial is a pragmatic, cluster-randomized, effectiveness-implementation trial testing two interventions in Kaiser Permanente Washington to systematically implement shared decision-making with primary care patients with symptoms due to alcohol use: a primary care intervention and a centralized intervention. An anticipated 25 primary care clinics will be randomized to one of three conditions: usual care or the primary care or centralized interventions.
The key to patient-centered care is to identify what the patient perceives as meaningful. The primary objective of this research is to evaluate which aspects of patient-centered care are priorities to infertility patients, and if those priorities vary by geographical region.
This pilot clinical trial studies an electronic monitoring device of patient-reported outcomes (PROs) and function in improving patient-centered care in patients with gastrointestinal cancer undergoing surgery. Electronic monitoring is a technology-based way of asking patients about the quality of life, symptoms, and activity using online surveys and an activity tracking watch may make it easier for patients to tell their doctors and nurses about any issues before and after surgery. Electronic systems of assessing PROs may increase the depth and accuracy of available clinical data, save administrative time, prompt early intervention that improves the patient experience, foster patient-provider communication, improve patient safety, and enhance the consistency of data collection across multiple sites.
Several screening methods exist to screen patients for CRC ranging from invasive (i.e., colonoscopy) to less invasive (i.e., testing the stool for blood). Although choice between screening methods is recommended, patients are not currently offered an unbiased choice and physicians generally recommend only colonoscopy. In this project, the investigators will answer the following questions: 1) Is it feasible to incorporate a DA in the AHP protocol?; 2) Is it feasible to incorporate mailing patients a stool blood test?; 3) Does the DA change CRC screening decision quality, using proxy measures such as knowledge and intent; and 4) Does the DA change the proportion of participants that complete a CRC screening test? To answer these questions the investigators will compare survey responses and CRC test type completed between two AHP CRC surveillance patients groups - those that received usual care versus those that received the DA.
This research study is evaluating if co-management by a geriatrician embedded in the oncology clinic can improve outcomes for frail older adults with blood cancers. A rigorous pre-entry frailty assessment by a trained research assistant will be followed by randomization to geriatrician co-management versus usual care for patients found to be frail or pre-frail.
Funded by the Patient Centered Outcome Research Institute (PCORI), nationally recognized leaders in health care and research methods are partnering with patients and caregivers to evaluate the effectiveness of current efforts at improving care transitions and develop recommendations on best practices for patient-centered care transitions and guidance for spreading them across the U.S.
The nation's trauma care system, which includes trauma center hospitals \& emergency departments, is where over 30 million Americans receive care after traumatic injuries each year. Injury victims are diverse patients who suffer from complications of the initial injury as well as from multiple complex medical \& mental health conditions. Currently, high-quality patient-centered care is not the standard of care throughout US trauma care systems. Injured trauma survivors treated in trauma care systems frequently receive fragmented care that is not coordinated across hospital, emergency department, outpatient, \& community settings. Post-injury care is frequently not individualized to integrate the patient's most pressing post-traumatic concerns \& preferences into medical decision making. The investigators, as a group of front-line trauma center providers, patients, researchers \& policy makers, have been working together for over a decade to integrate patient-centered care into US trauma care systems. The investigators began this work by asking groups of injured patients the key patient-centered question: "Of everything that has happened to you since your injury, what concerns you the most?" The investigators developed scientifically sound assessment tools that allowed us to follow patient concerns after injury hospitalization. In May of 2011, the investigators convened an American College of Surgeons' policy summit that addressed mental health \& patient-centered care integration across US trauma care systems. As part of this policy summit, patient members of our team presented their experiences of traumatic injury \& recovery. While giving injured patients a "voice" at the summit, these narratives did not move surgical policy makers to develop mandates or guidelines for patient-centered care. In contrast, presentations that included information from randomized comparative effectiveness trials \& standardized outcome assessments convinced surgical policy makers to develop US trauma care system policy mandates \& best practice guidelines for post-traumatic stress disorder \& alcohol use problems. Our team now realizes that in order to optimally integrate patient-centered care into US trauma care systems, the investigators must use the best scientific methods that capture the highest-quality data. This PCORI proposal aims to demonstrate that a patient-centered care management treatment that addresses patient's post-injury concerns \& integrates patient concerns \& preferences into medical decision making, while also coordinating care, can improve outcomes of great importance to patients \& their caregivers, front-line providers \& policy makers. This proposal directly addresses two PCORI patient-centered research questions: "After a traumatic injury, what can I do to improve the outcomes that are most important to me?" \& "How can front-line providers working in trauma care systems help me make the best decisions about my post-injury health \& health care?"
Healthcare providers play an important role in helping patients be actively involved in treatment and recover from mental illness. But mental health clinicians, like other healthcare providers, are at risk for experiencing burnout-feeling emotionally drained from their work, having cynical thoughts toward patients and others, and feeling little accomplishment in their work. Burnout can lead to problems for the clinician including poor overall health, depression, and lower job satisfaction. Burnout also can impact how clinicians perform on the job; for example, people with high levels of burnout take more time off, show lower commitment to their job, and are more likely to quit or be fired. There is some evidence that burnout can affect the quality of care for patients, but very little rigorous research has tested this assumption. The purpose of our study is threefold. First, we will investigate how patients perceive burnout in clinicians and whether (and/or how) burnout impacts the care they receive. Next, we will test an intervention to reduce clinician burnout called Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE). BREATHE brings together tools that mental health clinicians are already familiar with, including relaxation and mindfulness exercises, setting boundaries, using social supports, and changing negative thought patterns and replacing them with more helpful ways of thinking. We have found this intervention effective in reducing burnout in other organizations, but have yet to study whether it also can improve patient outcomes. Clinicians (approximately 200) who participate will receive either the BREATHE intervention or training in motivational interviewing, which could also improve patient involvement in treatment and patient outcomes, but is unlikely to significantly reduce clinician burnout. We will also recruit up to 600 adult patients served by participating clinicians. We will survey clinicians and interview patients over a 12-month period after the intervention to determine how the intervention impacts clinician burnout and patient perceptions of care (relationship with the clinician, degree of autonomy in decision making), patient involvement in care, and outcomes (confidence in managing mental health, symptoms, functioning, and hope). Finally, this study will use a statistical procedure called Structural Equation Modeling to test a theoretical model of the relationship between burnout and patient outcomes. Findings from this study will show whether reducing clinician burnout can improve patient outcomes and the quality of care that patients receive. Our intervention will have the potential to be easily implemented in a variety of settings where burnout is a problem. Knowing how clinician burnout impacts patient outcomes, and whether improving burnout can improve patient care, can help improve the healthcare system.
Liver cancer and hepatitis B are health disparities for Asian Americans, and hepatitis C is a rising problem. Little is known about how to improve the quality of health care Asian Americans receive for viral hepatitis. Technology, specifically mobile applications, can provide a flexible and efficient way to address these challenges. This project seeks to develop, implement, and test an intervention to increase hepatitis B and C screening for Asian Americans in 2 healthcare systems in San Francisco. The research team will develop, implement, and evaluate the efficacy of an interactive, patient- centered mobile app for use on a tablet computer to increase hepatitis B and C screening among unscreened Asian Americans age 18 and older. The team will use their experience in health promotion to develop the intervention by working with patients, community leaders and advocates, clinical staff, healthcare providers, and healthcare system administrators from a county safety net system and an academic primary care practice in the San Francisco Bay Area. The mobile application will include video clips with a physician (Video Doctor) addressing patient concerns regarding hepatitis B and C screening in the patient's preferred language, English, Chinese, or Vietnamese. A patient who has not been screened for hepatitis B will answer questions about his or her characteristics and preferences using the mobile application. The mobile application will then show 30-60 seconds video clips with messages that address the patient's responses related to hepatitis B screening and that are delivered by an actor playing a physician. Those who are born between 1945 and 1965 also receive messages about hepatitis C screening. At the end, the tablet computer will generate a provider alert to let the treating provider know what the patient's preferences are regarding testing for viral hepatitis. Once developed, the intervention will then be used in combination with a physician panel notification and tested against physician panel notification only in a randomized controlled trial to see which approach is better in increasing the rate of hepatitis B and C screening. The team will also work with the 2 healthcare system to ensure that the interventions will be practical and easily adopted once the study is over. The findings of this project will greatly expand understanding about how to use technology- based interventions to improve quality of healthcare in diverse patient populations.
This study involves development and testing of a patient and family-centered transitional care program for patients who are hospitalized with Chronic Obstructive Pulmonary Disease (COPD) exacerbations. The study intervention includes tailored services to address individual patients' biopsychosocial needs, starting early during hospital stay and continuing for 3 months post hospital discharge. The study hypothesis is that compared to usual care, the study intervention will : a) Improve patient health- related quality of life and survival, and reduce use of hospital and emergency room visits; b) result in improved patient experience, self- confidence, and self-care behaviors; c) result in improved family caregivers coping skills, self-confidence, and problem solving skills to address patient barriers to care and treatment.
The initial aim of this study will be to assess current methods of heart failure (HF) patient education in terms of patient satisfaction, level of preparedness for home, and care provider satisfaction. The second aim will be to design and create a "living with HF at home" simulation session. The third aim will test the hypothesis that hospitalized HF patients who receive education in a simulation room in addition to usual HF education will have improved qualitative and quantitative outcomes as compared to those who do not receive the additional education support.
This study will use a multi-phase mixed-methods approach to develop and test a patient inventory to facilitate patient-centered care delivery. In Phase I the investigators will identify which factors should be considered for inclusion in the patient inventory. This will involve qualitative data collection with providers and patients using interviews and focus groups, respectively; and developing a question repository. The interviews and focus groups will take place at the six study sites: Hines VA Hospital and two Community Based Outpatient Clinics(CBOCs) in LaSalle, Illinois (IL) and Kankakee, IL; Jesse Brown VA Medical Center; and two CBOCs in Crown Point, IN; and Chicago Heights, IL. The question repository will involve a research assistant (RA) performing a literature review to gather items related to areas of patient context. Phase II will develop and test an item inventory using a Delphi panel - a panel of stakeholders including Veteran representatives, VA providers, researchers and representatives from the investigators' operations partners. The panel of at least 14 respondents will develop a questionnaire through three rounds of email exchanges ranking the list of items to be included in the patient inventory. Once the patient inventory is finalized, it will be integrated into an iPad application for patient use. In Phase III the investigators will test the patient inventory in a randomized trial. The investigators will conduct a randomized trial of the patient inventory to a control condition (e.g., healthy living video) to assess whether use of the inventory results in care that is more patient-centered and decisions that are more collaborative. Eligible participants will be identified and recruited from the Patient Aligned Care Team (PACT) clinics at Hines and Jess Brown VA facilities. Patients will be randomly assigned to either complete the patient inventory on the iPad or watch a health video on the iPad. Patients in the Intervention group will give a copy of the summary of the inventory to their provider. Both groups will be asked to carry a concealed tape recorder during their visit. Following the visit, patients in both groups will complete a set of questionnaires about the encounter including the CARE and CCM. The recordings will be analyzed by the team using a coding system developed in a previous Health Services Research and Development (HSR\&D) study to see if the use of the patient inventory facilitated patient-centered care during the encounter. A second coding scheme, the Informed Decision Making (IDM) will also be applied to examine collaborative decision making.
The purpose of this study is to examine the effect of different methods of providing education about sleep apnea and continuous positive airway pressure therapy (CPAP) use and how that education might help to improve health outcomes and the amount of time CPAP is used.
The purpose of this randomized clinical trial is to examine the effect of Patient-Centered Care (PCC) on a patient's level of satisfaction on discharge from an acute healthcare setting. Findings from this study will assist in determining if PCC, administered by nurses, should be instituted hospital wide. SPECIFIC AIMS: 1. To examine the effect of Patient-Centered Care on patient satisfaction. 2. To examine the effect of Patient-Centered Care on the quality of patient care. 3. To examine the effect of patient's perception of nursing care on patient satisfaction.
Building upon our experience with a very sophisticated preventive services prompt and reminder system, the Preventive Services Reminder System (PSRS), the investigators propose to conduct a systematic three-year study with the following aims: 1. To develop, field test, and refine an Internet-based patient Wellness Portal linked to PSRS to facilitate patient-centered, preventive care in primary care practices; 2. To determine the impact of the Wellness Portal on the process of patient-centered preventive care by examining the behavior and experiences of both patients and providers and the degree to which recommended services are individualized; and 3. To develop model Wellness Portal practices and disseminate the Wellness Portal technology and knowledge derived from Aims 1 and 2 findings.
Project Objectives: The proposed randomized, controlled trial will evaluate the effects of procedures to reduce medications among hospitalized older Veterans discharged to nursing homes using an hybrid study design to inform future efforts to spread it across VA. Project Background/Rationale: Patients discharged to nursing homes for short stays represent the largest group of Medicare beneficiaries discharged to post-hospital services and are a particularly high risk group for loss of independence and other poor clinical outcomes. This investigative team recently completed a VA-funded Quality Improvement Award and a Centers for Medicare and Medicaid Services (CMS) Innovation Award, both of which provide strong results related to the occurrence of polypharmacy and the relationship between polypharmacy and geriatric syndromes (e.g., medications associated with falls) in this patient population. Based on these data, the investigators developed and pilot-tested a patient-centered deprescribing set of procedures combined with standardized questions for eight geriatric syndromes to be implemented in the hospital and monitored during the nursing home stay. Project Methods: The investigators propose an innovative hybrid study design that will be conducted in one VA hospital. The goal of the proposed DROP intervention is to safely deprescribe medications, as defined by reducing doses or stopping medications, based on a combination of clinical criteria and Veteran preferences. This randomized, controlled trial conducted over three years will evaluate the effects of this hospital-based intervention on medication use, geriatric syndromes, and health status across Veterans' care transitions from the hospital to nursing home to home to include a 90-day follow-up period after leaving the nursing home. The hypothesis is that reducing medications for older Veterans will favorably impact geriatric syndromes. Additionally, the investigators aim to understand Veteran, both VA and non-VA provider and system-level factors that help or hinder how well the deprescribing procedures are implemented to inform future clinical uptake and dissemination throughout the VA.
This study evaluates the clinical outcomes of a novel program designed to target patients who are high-utilizers of hospital services. Patients who are frequently admitted to medical services - "high-utilizers" - present a unique set of challenges to providers and the health care system that require a different way of approaching chronic illness. The Complex High Admission Management Program (CHAMP) is an innovative model of care consisting of a small team of providers who establish continuity relationships with high-utilizer patients. CHAMP strives to provide effective, high value care via a longitudinal relationship-based care model through provider continuity, intensive case management, and personalized care plans. To better understand the potential outcomes of CHAMP, this study is a longitudinal, prospective, randomized, controlled trial of medical high-utilizers enrolled in CHAMP compared to a group of high-utilizer patients receiving usual care.
The primary study goal is to improve the quality of care transitions for patients with new episodes of venous thromboembolism (VTE). Primary Outcomes: To measure differences in the quality of care transition, as measured by the Care Transition Measure (CTM)-15 in the investigators target population of patients with incident VTE randomized to either a multicomponent, anticoagulation medical home intervention or usual care. Secondary Major Outcomes: To measure the difference in recurrent VTE, major hemorrhage, all-cause re-admissions, and mortality between the investigators intervention and comparison groups at 30 and 90 days in the investigators target population. Secondary Other Outcomes: To measure patient knowledge, health-related quality of life, and time in the therapeutic range (TTR) for patients on warfarin in the investigators target population.
The purpose of this research study is to explore ways to improve appropriate colorectal cancer (CRC) screening in the elderly by attempting to target screening in those most likely to benefit and avoiding screening in those least likely to benefit.
Expanded availability of virtual care encounters in Primary Care provides new opportunities to improve Veterans' outcomes by aligning encounter modalities with their needs and preferences. Yet, Veterans and their Primary Care physicians (PCPs) lack personalized information about the benefits and costs of different Primary Care modalities that is needed to maximize the value of Primary Care encounters. To address this problem, in this study the investigators will use surveys and interviews to identify what Veterans and PCPs perceive to be the benefits and optimal uses of different Primary Care encounter modalities. They will then supplement their existing system for communicating encounter costs to Veterans and PCPs with new interactive messaging about benefits and optimal uses of different encounter modalities. Finally, this novel Advancing Decisions about Virtual Service Encounters (ADViSE) intervention will be optimized through user-centered refinement before evaluating its effects on Veteran-centered outcomes, use of virtual care, and intermediate health outcomes in a randomized controlled trial (RCT).
The increasing morbidity and mortality of the opioid epidemic has necessitated a reevaluation of current addiction treatment paradigms: medications for opioid use disorder, such as buprenorphine and methadone, are effective in decreasing one's risk of death and disability from opioid use, but are underutilized and often difficult to access. The 5000 Emergency Departments (EDs) in the US are potential additional locales for medication initiation, but currently only a small minority of ED patients with opioid use disorder are started on medications. This study will refine and pilot an intervention called Talk About It which aims to foster patient-centered care, 'meet patients where they are' for addiction treatment, and increase treatment initiation and adherence via facilitating Shared Decision-Making in the ED around these potentially life-saving options.
An increasing number of guideline-directed medical therapies (GDMT) have been developed for patients with chronic heart failure with reduced ejection fraction (HFrEF). When used in combination at recommended doses, patients often experience significant improvements in cardiac function, quality of life, and survival.1,2 However, GDMT underuse occurs for the vast majority of patients with HFrEF. Two recent trials demonstrated improved GDMT prescribing during a clinic visit, each using automated delivery of a patient-centered decision support tool to promote a proactive and holistic approach to prescribing: EPIC-HF (NCT03334188) tested a brief video and checklist document sent to patients just prior to a clinic visit encouraging them to work with their clinicians to make at least 1 positive change to their GDMT; PROMPT-HF (NCT05433220) tested tailored electronic health record (EHR) alerts for GDMT intensification delivered to clinicians during clinic visits. The current I-I-CAPTAIN-HF study aims to broadly implement and test the EPIC-HF patient-facing and PROMPT-HF clinician-facing tools for HFrEF medication intensification at 5 health systems around the country through a pragmatic cluster-randomized implementation-effectiveness trial. This will occur through an initial phase of adaptation of the 2 tools at each health system. Once ready, the 2 tools will be tested using a 2x2 randomization at the clinician-level. In parallel, formal assessment of the implementation of EPIC-HF and PROMPT-HF will work to understand the most effective means of intervention design and delivery, as well as adaptations due to contextual factors to optimize use.
Advanced liver disease is a serious illness that disproportionately affects Veterans, many of whom hope for curative liver transplantation. However, too few receive a transplant and most continue to suffer from increasing symptoms and hospitalizations. The proposed project uses a whole person, Veteran-centered approach that identifies Veterans with advanced liver disease using a population-based health management system and integrates curative and early supportive care using a telemedicine-based nurse care counselor to (1) discuss patient's understanding of illness severity and prognosis, (2) identify priorities and care preferences and (3) align curative and supportive care options to achieve patient priorities. Study outcomes include changes in (1) rates of consideration for liver transplantation, and (2) completion of serious illness discussions. Findings will inform adaptations to the intervention and facilitators for its dissemination.
This study will compare the postoperative recovery of two patient cohorts who attended outpatient physical therapy at two clinics in the Greenville, South Carolina area. The Usual Care cohort received care according to each clinic's pre-existing care guidelines. The CDS Cohort received care informed by a new clinical decision support (CDS) tool.
The aim of this study is to evaluate the impact of virtual family-centered rounds in the neonatal intensive care unit on parental and neonatal outcomes.
Compare the effectiveness of automatic vs as-needed (PRN) post-hospitalization follow-up for children who are hospitalized for common infections.
The PCORI HIGHway project name embodies its goal: the way to "Honor Individuals Goals and Hopes". HIGHway trains and supports dialysis center social workers and nurses to communicate with their patients about their hopes and goals for their future care plans. This process, known as advance care planning (ACP), helps relieve patient concerns about the future, lays the foundation for better goal-concordant care at the end of life, and fosters deeper connection between patient and the dialysis care team. The HIGHway project will provide training and ongoing coaching to social workers and other change team members at 50-60 dialysis centers throughout the US. The goal is to integrate advance care planning conversations between dialysis patients and their health care team into the ongoing workflow of dialysis centers. The project is funded by the Patient Centered Outcomes Research Institute (PCORI), a non-profit organization chartered by Congress to fund projects to promote patient-centered care.
This study will examine the impact of a new clinical decision support tool for rehabilitation after total knee arthroplasty (TKA). Typically, TKA rehabilitation is generic with most patients receiving the same dosage and contents of rehabilitation despite notable diversity among patients who undergo TKA. The investigators clinical support decision tool is designed to help physical therapists tailor rehabilitation treatments and dosages to the individual needs, goals, and preferences of Veterans recovering from TKA. This study has the potential to improve Veterans' functional recovery after TKA, while simultaneously reducing the average number of physical therapy visits Veterans attend after surgery by tailoring rehabilitation dosage based upon need. This will ensure the Veterans Health Administration (VHA) has the resources and capacity to provide adequate rehabilitation to every Veteran seeking TKA in the VHA system. Additionally, if successful, this clinical decision support tool could be used to improve outcomes and access for additional patient populations in the future.
The investigators will conduct a randomized control trial enrolling 366 older Veterans with multiple chronic conditions receiving primary care at the Michael E. DeBakey VA Medical Center and VA Connecticut Medical Center to determine if Patient Priorities Care reduces treatment burden, increases priorities-aligned home and community services, and sets shared health outcome goals compared with usual care. The investigators will randomize at the patient level rather than clinic or clinician level to evaluate the effect of identifying patient priorities on clinician decision making and alignment of care with identified priorities.
The National Academy of Medicine and the National Institutes of Health have called for urgent action to improve the care delivered to the nearly 1,000,000 older Americans who die in intensive care units (ICUs) annually, or survive with substantial impairments. These patients often die with distressing symptoms and may receive more invasive, life-prolonging treatment than they would choose for themselves. Moreover, their family members acting as surrogate decision makers often experience lasting psychological distress from the ICU experience. The investigators will conduct a randomized trial among 500 patients and 750 surrogates and up to 150 clinicians to determine whether early integration of specialty palliative care with standard critical care can improve outcomes for critically ill older patients at high risk of death or severe functional impairments and their family members.