112 Clinical Trials for Various Conditions
The purpose of this study is to evaluate the effectiveness and implementation considerations of a video aid to improve communication and patient-centered outcomes in older injured adults
This study aims to determine the ways in which clinician implicit racial biases affect clinician communication with family members of patients near the end of life and to test a novel physician training intervention to reduce the effects of implicit racial bias on quality of communication. Phase 1: A sample of 50 physicians who care for seriously ill patients, including oncologists, critical care physicians and hospital-based internists will participate in a simulated clinical encounter with a Black standardized family member (actor) of a hypothetical case patient. Measures of implicit and explicit bias will be correlated with verbal and nonverbal communication behavior. Phase 2: This is a 2-arm randomized feasibility pilot of an intervention to mitigate the effects of clinician implicit bias on communication behavior. Physicians who treat patients with serious illness including oncologists, critical care physicians and hospital-based internists will be recruited to participate in a communication training session to reduce the effects of implicit bias or a control training session focusing only on communication skills. Their communication behavior will be videotaped during a simulated encounter with a Black standardized family member (actor) of a hypothetical patient with serious illness before and after the training sessions. The communication behavior before and after the training session will be compared between physicians that received the communication skills only intervention versus the physicians that received the communication skills and bias mitigation training. The primary hypothesis is that physicians who receive both the communication skills and the bias mitigation training will have greater improvements in communication skills with the Black standardized caregiver (actor) compared with those who receive only the communication skills training. This registration is inclusive of phase 2 only as phase 2 is the clinical trial portion of this research. Phase 1 is not a clinical trial as it was an observational study that did not include an intervention. Phase 1 data was used to inform the structure and analysis of phase 2.
Dying in the intensive care unit (ICU) can be a source of trauma for patients and their families. The 3 Wishes Program is a palliative care initiative in which healthcare workers fulfills small wishes to provide a personalized, humanizing experience at the end of life (EOL) for dying patient and their families. The investigators' objective is to assess families' ratings of EOL care for ICU decedents who received the 3WP as part of their EOL care versus usual care.
The demographics of the U.S. prison population are shifting at a dramatic rate requiring new approaches to prison healthcare. Current estimates suggest that there are 2.3 million incarcerated persons in the U.S. Similar to the free world, the aging of the Baby Boom generation is occurring in prisons. Notably, inmates 50 and older constitute over 20% of prisoners in state or federal facilities. From 1996-2016, there was an 280% growth in the number of state and federal prisoners age 55 or older, which is in sharp contrast to younger inmates that grew by only 3% during this time period. A surge in older adult offenders in the U.S. has not occurred but rather statutes now impose stiffer sentences, resulting in longer periods of incarceration, such as life without parole or 20+ years. At the same time, early release policies remain restrictive. As a result, sentenced offenders are living through middle and older adulthood within the confines of prisons.
Overall objective is to test whether the 5-weekly family home palliative and end-of-life care (FamPALcare) intervention educational and supportive sessions will improve rural home end-of-life and palliative care (EOLPC) for advanced heart failure at 6 months follow up.
Racial differences in health care are documented across the health care continuum and persist in aging and end-of-life (EOL) care. African Americans (AA) and other underrepresented minorities often choose more aggressive therapies in the terminal stages of illness. Main reasons for these EOL disparities include: lack of knowledge of and misperceptions about palliative and hospice care, spiritual beliefs, and mistrust in the health care system. Despite the presence of national hospice guidelines, interventions addressing these disparities have been limited and often not rigorously evaluated. Most interventions to promote EOL care were done in majority populations and focused predominantly on trying to change physician awareness of patient's pain, symptoms, and values or to change physician communication behavior. While these early studies made tremendous contributions to the study of EOL care and the needs of the terminally ill, the interventions associated with these studies did not reach their desired effectiveness. The investigator proposes an innovative strategy that would focus specifically on previously identified physician and patient barriers to utilization of advance directives, palliative care, and hospice care among AA cancer patients. The goal of this patient-centered project is to increase the awareness of and willingness to discuss EOL care options among AAs with metastatic cancer. To overcome the dual challenges of physicians' difficulty with prognostication and reluctance to discuss EOL care, the investigator will harness data in the electronic medical record (EMR) to automatically identify AA patients with metastatic breast, lung, colorectal, prostate and other serious cancer who are eligible for counseling about palliative and EOL care options. To change AA patients' knowledge and attitudes toward palliative and EOL care options, and address issues of medical mistrust, the investigator will design and pilot test a culturally sensitive, patient-targeted intervention that will combine multimedia materials and a culturally concordant lay health advisor (LHA) who will deliver tailored education and counseling. The investigator has chosen a LHA delivery strategy because past studies have shown that they are best suited to address medical mistrust and perceived conflict between spiritual beliefs and health care decisions.
The mission of corrections is to provide care, custody, and control for incarcerated individuals. United State prisons are required by constitutional law to provide adequate care for growing numbers of older inmates who will likely spend their final days in prison. This Phase I project focuses on research and development of highly interactive computer-based learning modules for inmate peer caregivers to promote an integrated systems approach to enhancing the care of the aged and dying in prisons.
To test the efficacy of FACE-TC on key outcomes, the investigators propose using an intent-to-treat, longitudinal, prospective, multi-site, randomized controlled trial (RCT) design. Adolescents with cancer, aged 14 up to 20 years, and their families (N=130 dyads; N=260 participants) will be recruited and randomized to FACE-TC or Treatment as Usual (TAU) control. Participants will complete standardized questionnaires at baseline and 3, 6, 12, and 18 months post-intervention. Our goal is to assess the extent to which FACE-TC helps adolescents and young adults with cancer and their families: (1) reach and maintain better congruence in treatment preferences over time; (2) improve their quality of life; and (3) document goals of care and advance directives earlier in the course of their potentially life limiting illness.
Racial differences in health care are documented across the health care continuum and persist in aging and end-of-life (EOL) care. African Americans (AA) and other underrepresented minorities often choose more aggressive therapies at the end of life and are less likely to utilize hospice care in the terminal stages of their illness. Potential reasons for these disparities include: lack of knowledge of and misperceptions about palliative and hospice care, spiritual beliefs, and mistrust in the health care system, among others. Despite the literature on disparities in end-of-life (EOL) care and reasons for underuse and the presence of national EOL care guidelines, attempts to address this problem have been limited and often not rigorously evaluated. The majority of interventions to promote EOL care were done in majority populations and focused predominantly on trying to change physician awareness of patient's pain, symptoms, and values or to change physician communication behavior. While these early studies made tremendous contributions to the study of EOL care and the needs of the terminally ill, the interventions associated with these studies did not reach their desired effectiveness. The investigators propose a different strategy that would focus specifically on previously identified barriers to utilization of advance directives, palliative care, and hospice care among African Americans - including physicians' difficulty and discomfort with prognostication, AA patients' knowledge, attitudes and beliefs towards hospice and palliative care, conflict between patients' spiritual beliefs and the general hospice and palliative medicine philosophy of care, and medical mistrust. The goal of this project is to improve methods of prognostication for physicians and increase awareness of EOL care options for AAs. To overcome the dual challenges of physicians' reluctance to discuss EOL care and patients' discomfort in engaging in such conversations, the investigators will use the electronic medical record (EMR) to automatically identify AA patients with life-limiting illness who are eligible for counseling about EOL care options. To change knowledge and attitudes toward EOL care options among AA patients, the investigators will design a culturally sensitive intervention that will combine multimedia materials and a culturally concordant lay health advisor who will deliver tailored education and counseling.
This study aims at assessing factors that affect patient choices for end of life care. 300 patients would be assigned either to a control arm (questionnaire alone) or intervention arm (standardized explanation+ questionnaire). Our intervention is a standardized explanation which explains what code status, advance directive and end of life care mean. Based on patient responses, factors that affect choices of code status would be analyzed. We will also evaluate if a standardized explanation improves patient understanding of end of life issues. This would be determined by generating a composite score of correct responses to a subset of objective questions in the questionnaire
The purpose of this study is to improve the quality of care provided for head and neck cancer patients. By better understanding the end of life experiences of dying patients and their families, the investigators hope to better anticipate and improve upon the experiences of future patients and their families.
Interviewing hospital executives, physician administrators and hospital legal counsel who work in a hospital setting (academic, governmental, private or community hospital) about their perceptions concerning current and future end-of-life care provided in their facilities
Hattie Larlham is a specialized long-term care facility for pediatric and young adult residents who are medically fragile and intellectually disabled, whose daily care is provided by direct care staff, Habilitation Assistants (HA), in conjunction with nurses and other direct care providers. The purpose of this study is to assess the perspectives of HA and parents/legal guardians on end-of-life care in a long-term care facility for pediatric and young adult residents who are medically fragile and intellectually disabled.
The purpose of this study is to examine key organizational structures and processes (leadership, teamwork, communication, palliative care) and their impact on the quality of end-of-life care for dying residents and their family members.
RATIONALE: Palliative care may help patients with advanced cancer live more comfortably. PURPOSE: This randomized clinical trial is studying an early intervention palliative care program to see how well it works compared to a standard care program in improving end-of-life care in patients with advanced lung , gastrointestinal, genitourinary, or breast cancer.
The investigators propose to conduct a feasibility study of identifying high-risk ICU patients using previously validated integrated prediction model and employing early palliative care intervention. The study will consist of two four-month time periods: usual care in time period one and usual care plus targeted pro-active palliative care intervention within 48 hours of ICU admission in time period two.
People with life-limiting illness often receive more aggressive healthcare than desired including costly procedures that provide little medical benefit. Advance Directives (AD) can reduce this effect but various factors limit their adoption. A randomized trial will target hospitalized patients with a serious, life limiting illness to test if the behavioral economics principles of endowment (possessing something) and focusing (featuring something important to patients) can motivate AD completion. Investigators will examine if offering patients an AD by default, in combination with framing the rationale for AD completion (emphasizing patient control or caregiver burden) improves AD completion and family conversation compared to a no-intervention group. The study hypothesis is to determine if rates of AD completion and family conversations will be highest among patients receiving the intervention focused on reduced caregiver burden; and if the two intervention groups will have higher rates of both than the control group. The investigators suspect that a small change in how patient information is framed (endowment and focusing used in tandem) will potentially leverage large increases in AD completion and that targeting HHC patients allows AD discussions early in the disease trajectory when they can participate in care decisions.
The purpose of the study is to evaluate the impact of implementing a "Serious Illness Conversation Guide" to guide patient/family-clinician discussions and planning about end-of-life care decisions. The goal of the intervention is to improve achievement of patient care priorities and peacefulness at the end of life for patients with serious and life-threatening illness and their families. We hypothesize that patients whose physician is trained to use and adheres to the elements of the Serious Illness Conversation Guide will demonstrate enhanced consistency between documented key priorities and care received, and will experience greater peace in the final month of life; similarly, their families will experience higher satisfaction with care.
This is a randomized pilot study to test the feasibility and acceptability of a patient decision aid on conservative care among older patients with advanced CKD and their close persons.
This is a randomized pilot study to test the feasibility and acceptability of a tool to promote discussion about conservative kidney management (CKM) among older patients with advanced CKD and their providers.
This project has three specific aims: (1) culturally tailor the content of the Make Your Wishes about You (MY WAY) ACP curriculum and guide for one American Indian tribe; (2) assess the feasibility of the culturally-tailored MY WAY ACP curriculum and patient education guide with the tribe; and (3) examine preliminary outcomes of the culturally-tailored MY WAY ACP curriculum and guide with 70 tribal members. Upon successful completion, it is expected that this project will develop a feasible culturally-tailored MY WAY that through a quasi-experimental waitlist design shows promise as an efficacious program with respect to self-efficacy, readiness, and ACP completion that increases facilitators and decreases barriers to ACP.
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. We will conduct a multicenter randomized trial among 370 incapacitated, critically ill older adult patients at high risk of death or severe functional impairment, their surrogate decision-makers, and their ICU clinicians to determine whether a multi-component family support intervention can improve the patient- and family-centeredness of care (primary outcome), as well as positively impact a variety of other patient, family, and healthcare delivery outcomes. The multicomponent intervention involves: Proactive family meetings scheduled within 48 hours of ICU admission and approximately every 5-7 days after that. Surrogates will have access (computer, tablet, or mobile phone) to the interactive web-based Family Support Tool. The tool will familiarize families with the ICU and prepare them for their interactions with the clinical team by completing specific sections of the Family Support Tool upon study enrollment, before family meetings, and any other time they wish. The ICU team will receive a tool-generated summary of information about the family before each family meeting, including their main questions and concerns, information about the patient's values and preferences, prognostic expectations, and unmet psychological needs.
Poor adherence to pain management and high pain intensity associated with serious, advanced illness is a major public health concern. This randomized clinical trial will test the efficacy of a newly enhanced digital pain and pain management application (e-PainSupport) for use in a home hospice setting. The e-PainSupport application delivers an education module about pain management to patients and caregivers, expedites pain reporting to nurses, and facilitates adherence to pain management. The overall goal of the e-PainSupport application is to improve pain management and reduce patient pain intensity in the home hospice setting.
Children with ultra-rare or complex rare diseases are routinely excluded from research studies because of their conditions, creating a health disparity. However, new statistical techniques make it possible to study small samples of heterogeneous populations. We propose to study the palliative care needs of family caregivers of children with ultra-rare diseases and to pilot test a palliative care needs assessment and advance care planning intervention to facilitate discussions about the future medical care choices families are likely to be asked to make for their child.
Good communication among patients, their families and loved ones, and their medical care providers is important when figuring out how to treat chronic diseases like kidney disease. A lot of people may not know all of their choices for how to treat kidney disease, and this can lead to rushed decisions or even a sense that there weren't any choices to make. In this study, the investigators are trying to find out if a decision-aid program on a computer can help people with kidney disease have more confidence in their decisions and have better agreement about their decisions with their families and loved ones. The DART study will be conducted at four sites in different areas of the country: Boston, Massachusetts; Portland, Maine; Chicago, Illinois; and San Diego, California. The study will enroll a total of 400 people with kidney disease at these four sites.
This study compares the effectiveness of two different approaches to advance care planning among older African Americans and older Whites living in the community. The two approaches are a structured approach with an advance care planning conversation led by a trained person using Respecting Choices (First Steps) and a patient-driven approach which includes a Five Wishes advance care planning form written in plain language. The study will determine which approach is more effective at increasing advance care planning within each racial group and reducing differences between the two groups in advance care planning.
The purpose of this research is to assess the effect of a cardiopulmonary resuscitation (CPR) decision aid video on CPR knowledge and end-of-life preferences in women with advanced gynecologic malignancy. We will assess the baseline CPR knowledge in our research population, gauge the improvement after viewing a decision aid video, and evaluate its effects on patient preferences regarding CPR.
The mission of corrections is to provide custody, control and care for incarcerated individuals. United States prisons are required by constitutional law to provide adequate care for growing numbers of older inmates who will likely spend their final days in prison. This Phase II project focuses on the correct users accessing correct learning strategies in the correct setting (i.e., interdisciplinary prison staff accessing high quality products designed to educate and lead practice change initiatives within the walls of prisons), by continuing research and development of a learning system that promotes an integrated systems approach to enhancing the care of the aged and dying in prisons.
The purpose of this study is to evaluate, through a randomized controlled trial, the impact of integrated comprehensive palliative care services on time to first hospital readmission and other hospital utilization outcomes, quality of life, and patient/caregiver outcomes. The intervention includes comprehensive, standardized palliative care services for adult hepatology cirrhosis patients for which prognosis is poor.
Background: Some people cannot make medical treatment decisions on their own. The people who make decisions on their behalf are called medical surrogates. Sometimes surrogates cannot predict which treatment course the person or their loved ones would have chosen. The surrogates often become distressed because of making these decisions. Researchers think a tool called a Patient Preference Predictor (PPP) may be able to make the process easier. The PPP would predict what treatment the person would want. This is based on treatment preferences of similar people in a similar circumstance. Researchers want to interview surrogates to explore their views on the PPP. Objective: To explore surrogates views on incorporating a PPP into shared medical decision-making. Eligibility: People 18 years or older who: Have acted as a surrogate medical decision-maker within the past 3 years. This includes decisions about treatment, medication, hospice care, hospital admission, or discharge. Are not pregnant Design: Participants will be screened by meeting with clinicians in person or by phone to discuss the study. Participants will take part in a focus group. This is a small group of people discussing their thoughts and opinions. This will last for about 2 hours. Participants will be served a light meal. Participants will provide information about themselves and their views. They will talk about their past experiences making medical decisions for someone. They will discuss how they felt about these decisions. The PPP will be explained to participants. They will give their views on it. The research team will audio record the focus group and take notes. Participants will fill out questionnaires.