Treatment Trials

13 Clinical Trials for Various Conditions

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ENROLLING_BY_INVITATION
Reducing Children's Racial Biases Via a Parent-Led Intervention
Description

The goal of this clinical trial is to test a parent-led program for reducing children's racial biases in White families. The main question it aims to answer is: With training, can parents effectively address their children's racial biases? Parent will receive training and tools for addressing their children's racial biases. Researchers will study effects on both parents' and children's racial biases.

Conditions
WITHDRAWN
Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer
Description

Breast cancer is one of the most common malignancies in women globally, with \~1.4 million new cases diagnosed annually Breast cancer is one of the leading causes of cancer-related morbidity and mortality among women worldwide. While diabetes/insulin-resistance and breast cancer are distinct diseases, insulin-signaling plays a central role in both illnesses. Insulin activates key cancer processes including epithelial-mesenchymal transition (EMT), tissue inflammation, motility, and angiogenesis. There are key opportunities to impact and prevent hyperinsulinemia during breast cancer prevention, surgical assessment, and chemotherapy. Given the high prevalence of undiagnosed pre-diabetes and diabetes in the United States and worldwide, preoperative screening to identify such patients prior to surgical intervention is warranted. While it is not standard of care to test for insulin-resistance during the course of breast cancer screening and treatment, it is standard of care to screen and test high risk women for insulin-resistance as part of whole woman care. Given the important role insulin signaling plays in driving signaling pathways that promote aggressive cancer biology, more attention should be paid by cancer physicians to screening and treating insulin resistance. Several studies have reinforced a link between breast cancer risk and diabetes. Moreover, metformin significantly reduces breast cancer risk, compared to patients who are not using metformin and is independent of diabetes status. As metformin has an association with decreased breast cancer recurrence, as well as potentially improved survival, disparities in insulin resistance between black and white women with breast cancer is important to investigate. It is hypothesized that metformin decreases the development of resistance in breast cancer cells, thereby allowing current chemotherapy agents to work synergistically with metformin. Our objective is to elucidate whether or not metformin is efficacious in improving insulin resistance in black and white women with breast cancer and if racial disparities in breast cancer prognosis can be partially explained by differences in pre-diagnosis insulin resistance which are improved with metformin therapy.

COMPLETED
Today Not Tomorrow Pregnancy and Infant Support Program (TNT- PISP)
Description

This pilot project aims to implement and investigate the feasibility and acceptability of a unique community based prenatal care and support model for African American women and infants in Dane County. The model, the "Today Not Tomorrow Pregnancy and Infant Support Program (TNT-PISP)" builds on emerging evidence about how to effectively implement and sustain prenatal care in black communities. It combines three approaches-community-based doula programs; group-based models of prenatal care, such as Centering Pregnancy; and community-based pregnancy support groups-into once monthly group sessions held during the prenatal and immediate postpartum period. The project is based at the Today Not Tomorrow Family Resource Center in Madison's East Side Community Center, and carried out in close collaboration with Project Babies, Harambee Village Doulas, and the African American Breastfeeding Alliance of Dane County, Inc.

ACTIVE_NOT_RECRUITING
COmmuNity-engaged SimULation Training for Blood Pressure Control
Description

The goal of CONSULT-BP is to train early-stage healthcare providers, including residents and nurse practitioner (NP) students, to mitigate providers' bias, improve communication skills, and enhance providers' ability to develop authentic and meaningful therapeutic alliances with patients. The study setting is an academic safety net hospital that serves a large non-White and poor population. We hypothesize that patients' outcomes (blood pressure levels) will be lower after the training intervention compared with before training (control) periods.

Conditions
COMPLETED
Effect of Physician Race and Gender on Simulated Patients' Ratings
Description

The purpose of the study was to determine whether the race and gender of a simulated doctor affected analog patients' reported confidence and satisfaction in the simulated doctor's diagnosis and treatment plan. The study used two randomized patient analog experiments. This study is complete and pre-analysis plans (PAPs) for each experiment were published prior to data collection. The PAPs are available at: http://aspredicted.org/blind.php?x=43xj25 (Study 1) and https://aspredicted.org/blind.php?x=369st7 (Study 2).

RECRUITING
PAINED: Project Addressing INequities in the Emergency Department
Description

Racial and ethnic inequities in health care quality have been described across a broad range of clinical settings, patient populations, and outcomes. Our overarching goal is to eradicate health care inequities through evidence-based interventions. The objectives of this proposal are to develop and test the impact of two interventions on overcoming clinician implicit bias and mitigating inequities in the management of pain among children seeking care in the emergency department for the treatment of appendicitis or long bone fractures.

ENROLLING_BY_INVITATION
Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial
Description

The primary goal of this study is to assess real-world effectiveness and implementation of an evidence-based multi-component strategy to achieve equity in the allocation rate of advanced heart failure therapies, heart transplants and ventricular assist devices. This study proposes to implement evidence-based strategies that reduce bias, replace subjective evaluations with objective criteria, and improve group dynamics in a randomized cluster trial. This rigorously designed trial may inform national guidelines for advanced heart failure therapy allocation, and data are likely to be generalizable to other organ replacement treatments and advanced chronic disease decision-making processes.

COMPLETED
Patient Perceptions of Physician Education and Quality by Race
Description

Research has documented positive effects of doctor-patient race concordance, suggesting that increasing diversity among healthcare professionals may play an important role in addressing well-documented racial health disparities in the US. It also remains critical to improve the quality of interactions in race discordant doctor-patient relationships. However, as health systems consider policies to increase the number of minority healthcare professionals, especially among doctors, questions about the equilibrium effects of such initiatives naturally emerge. In this project, the investigators examine whether and how patients vary their perceptions of healthcare professionals by race.

RECRUITING
PRISM Race and Communication Pilot RCT
Description

This is a pilot randomized trial of 60 patients to test feasibility, acceptability and efficacy of PRISM to improve resilience and facilitate improved patient-clinician communication in racially minorities patients with serious illness.

COMPLETED
REACH Implicit Bias Training Project
Description

The overall goal and theme of the Duke Center for Research to Advance Equity in Healthcare is to reduce racial and ethnic disparities in health through interventions that affect the clinical encounter. To achieve this goal, there is an urgent need for interventions that address implicit bias in healthcare. Implicit bias training is widely used to raise self-awareness and provide self-management tools. The overall objective is to test the hypothesis that implicit bias training for healthcare providers will reduce racial and ethnic disparities in patient- centered care. The proposed project will lay the groundwork for testing that hypothesis by using patient focus groups to garner a deeper understanding of perceptions of implicit bias in the clinical encounter; provider and health system stakeholder semi-structured interviews to inform refinement of the existing implicit bias training at Duke; and perform a pilot study of implicit bias training for providers. At the conclusion of this study, the investigators will have the necessary preliminary data to propose a definitive trial to determine the impact of an implicit bias training intervention for providers on racial and ethnic disparities in patient-centered care. This research will ultimately lead to the delivery of equitable, evidence-based, patient-centered care for all.

RECRUITING
One Talk at a Time: A Racial-ethnic Socialization Intervention for Diverse Families
Description

This study is a randomized effectiveness trial that tests the online delivery of a video-based intervention (One Talk at a Time (OTAAT)) relative to a control group over a one-year span. Hypotheses include: 1.) The OTAAT intervention will increase parental motivation to engage in racial-ethnic socialization (RES) conversations, their skills and confidence in having these conversations, and the frequency and quality of these conservations; 2.) The OTAAT intervention will increase youth reports of their coping with discrimination, perceived efficacy in coping with discrimination in the future, ethnic-racial identity, and youth mental and academic outcomes; 3.) Greater parental discrimination and youth discrimination will moderate links between OTAAT intervention and parental ethnic-racial motivation + competency as well as youth ethnic-racial identity, coping, and psychosocial outcomes.

COMPLETED
Developing Inclusive Youth: Promoting Intergroup Friendships and Inclusive Classrooms in Childhood
Description

The goal of this clinical trial is to test the beneficial impacts of a web based intervention program called Developing Inclusive Youth for children in 3rd, 4th, and 5th grade. The main questions it aims to answer are: * Does the Developing Inclusive Youth (DIY) program, which is a web-based curriculum tool with a teacher-led classroom discussion, reduce prejudicial attitudes and biases as well as increase intergroup friendships for a sample of 8 -11 year old children enrolled in 3rd , 4th, and 5th grade U.S. classrooms? * Does the Developing Inclusive Youth (DIY) program lead to grade-related, gender-related and ethnic-related differences regarding reducing prejudicial attitudes and increasing intergroup friendships? * Does the Developing Inclusive Youth (DIY) program change teacher attitudes regarding the malleability of prejudice, the importance of intergroup friendships, and comfort levels with discussing social inclusion and exclusion experiences in the classroom? Student participants will take 15-20 minutes to use a Chrome notebook and headphones to access the online tool and the teacher will then lead a classroom discussion lasting 25-30 minutes. The intervention program will occur once a week for eight weeks. The student outcome measures, given at pretest and posttest, are also assessed with Chrome notebooks while children are sitting at their desks in the classroom. The outcome measures take 25-30 minutes. Researchers will compare children in the intervention classes to children in other classes of the same grade at their school to see if the tool promotes positive peer relationships and reduces prejudice and bias. Teacher participants will take a 25-minute online pretest and posttest survey in their classroom to assess their theories of prejudice, their awareness of their students' intergroup friendships, comfort with discussing peer social inclusion and exclusion in class, and their awareness of student experiences of exclusion.

COMPLETED
Assessing Patient-provider Interactions During the Preoperative Anesthesia Consult
Description

This will be a prospective, observational, single-center study to evaluate the effect of race and ethnicity on anesthesia provider-patient interactions. The investigators will also attempt to validate a new tool for assessing non-verbal communication during the preanesthesia consult. Masking: 1. Patient 2. Anesthesia providers (attending anesthesiologist and resident or Certified Registered Nurse Anesthetist) The patient and anesthesia provider(s) will not be told that the purpose of the study is to compare provider-patient interactions with minority patients to provider-patient interactions with Caucasian patients. The patient and anesthesia provider will be told that the investigators are conducting a study to evaluate provider-patient communication in the preanesthesia setting. The outcome assessor will be part of the research team. Accordingly, they will not be masked. This is a pilot study void of sample size calculations. The investigators hope to enroll 100-200 patients in the study. While not a randomized study, the investigators hope to achieve a balanced number of minority and Caucasian patients.