Treatment Trials

13 Clinical Trials for Various Conditions

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COMPLETED
Doctor-Patient Communication About Colorectal Cancer Screening
Description

The purpose of this study is to learn more about doctor-patient communication about colon cancer screening. This study will also look to see if there are differences in those who get colon cancer screening based on the discussion the doctor had with the patient.

TERMINATED
Doctor-Patient Communication in Spanish
Description

Does use of a translator or use of less than perfect Spanish diminish provider-patient communication compared to a native speaker.

COMPLETED
Palliative Care Educator
Description

The investigators propose to conduct a stepped wedge cluster randomized trial of an advance care planning (ACP) educator-led intervention among hospitalized patients aged 65 and over, or any patient with Alzheimer's Disease and Related Dementias (ADRD) and their proxy decision-makers in the ward and ICU settings of two major hospitals: Boston Medical Center and North Shore University Hospital in New York. Patient outcomes will be abstracted from electronic health records with Natural Language Processing. The effectiveness of the intervention will be evaluated by comparing the following outcomes among 9,000 hospitalized patients (Aim 1): ACP documentation; preferences for resuscitation; palliative care consults; and, hospice use. The investigators will characterize caregiver-centered outcomes of patients with ADRD, including (Aim 2): (1) knowledge, (2) confidence in future care, (3) communication satisfaction, and (4) decisional certainty in 600 caregivers of patients with ADRD admitted to the hospital. COVID-19 poses a unique dilemma for older Americans and patients with ADRD and their caregivers, who must balance their desire to live against the risk of a lonely and potentially traumatic hospital death. Video decision support is a practical, evidence-based, and innovative approach to assist patients facing such choices. If proven effective, this innovative care model can be immediately deployed across the country to improve the quality of care for millions of Americans.

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
ENROLLING_BY_INVITATION
I Kua na'u Advance Care Planning for Native Hawaiian Elders
Description

Communication surrounding serious illness decision making is formalized in Advance Care Planning (ACP), a process involving verbal or written information designed to inform patients of possible medical options including palliative and hospice care services. Numerous studies have suggested that improved ACP rates better align health care delivery with patient preferences. Despite expansion of ACP services in the health care system, Native Hawaiians (NHs) consistently have negligible rates of ACP and low use of palliative and hospice care services. To address these shortcomings, our multi-disciplinary community and research group has partnered to create the I kua na'u "Let Me Carry Out Your Last Wishes" ACP video intervention. Our Community-Based Collaborative Approach will create, develop and test the I kua na'u comprehensive video-based ACP program honoring the history, opinions, and culture of NHs. Indeed, NH culture is primarily an oral tradition in which the spoken word permeates the life of NHs and is the normal way of interacting with neighbors, including in its most recent adaptation with the use of video media. The I kua na'u program will include videos tailored for the different settings in which older NHs live and get medical care. The videos will explain the importance of ACP, empower NHs to tell their story ('olelo Kama'ilio; "Talk Story") by allowing the recording of personal video declarations of ACP wishes, and the ability to share the personal video declaration with family, friends and clinicians. The overall objective is to conduct a five-year program that includes two years of development of the I kua na'u ACP video program with focus group testing, and then three years of implementation in the NH community. Demonstrating the effectiveness of using the video program in NHs represents an essential step to implement this tool in practice. The Specific Aim is to compare the ACP engagement, knowledge, decisional conflict, and ACP completion rates in 220 NHs over the age of 55 in: (a) a pre-post study design in 110 people living on Homestead or Assisted Living using the video intervention, and (b) a randomized trial of 110 people recruited from Ambulatory Clinics.

COMPLETED
Electronic Pre-visit Questionnaire to Prompt Discussions of Youth Violence in Primary Care
Description

Pediatricians are supposed to talk about youth violence at all heath supervision visits, however these types of conversations rarely occur. There have been no studies assessing tools to prompt these discussions. The goal of this study is to see if electronic pre-visit questionnaires (PVQs) prompt patient-provider discussion of youth violence (YV) in the primary care setting. Additionally, patient-provider characteristics are explored as mediators to youth violence discussions, as well as feasibility and acceptability of the PVQ by patients and providers. Adolescents ages 13 to 21 who come to the Hasbro Primary Care Clinics for annual physicals will be recruited. A baseline phase was conducted to look at how often providers ask about health-related teen behaviors, assessed by exit survey. The experimental period will involve adolescents completing health-related behavior PVQ, given to their doctor prior to the visit. Exit survey will assess topics discussed. Experimental group will differ from control group based on PVQ containing extra questions about youth violence.

COMPLETED
Using Effective Provider-Patient Communication to Improve Cancer Screening Among Low Literacy Patients
Description

What's the purpose of this study? This 4-year study is designed: (1) to teach primary care physicians how to recognize low health literacy patients and effectively counsel them on cancer screening using risk communication and shared decision making and (2) to assess the impact of training on changes in physician communication behavior and changes in low health literacy patients' cancer screening behaviors. This study proposal is based on the hypothesis that physician training in cancer screening guidelines, health literacy, and communication skills will improve provider-patient interactions during encounters dealing with preventive health maintenance especially cancer screening. How will the proposed study be implemented? Thirty-two physicians in the New Orleans metropolitan area will be recruited and randomly assigned to one of two groups. The unit of randomization will be the health care organization or clinic. The intervention group will receive training in health literacy, cancer screening, risk communication and shared decision-making. The control group will not receive communication training until the end of the study. Physicians in both groups will undergo three clinic visits with standardized patients (actors trained to portray real patients; mystery shoppers) but they will not be aware that they are conducting visits with actors. The visits will occur at study enrollment and at 6 and 12 months. At the end of each clinic visit, the standardized patients will rate the physicians' communication skills. Each physician assigned to the intervention group will receive verbal feedback on communication skills from the standardized patients and complete a web-based tutorial. Physicians in the control group will not have access to the web-based tutorial until the end of the study. For each physician, 10-15 patients with limited health literacy will be recruited to the study. Each patient will rate his/her perceived involvement with care and global satisfaction with care at study enrollment and annually for three years. Age and gender-appropriate referral rates for breast, cervical and colorectal cancer screening and patients' receipt of such screening will be assessed annually for three years. All study physicians, regardless of group assignment, will receive performance feedback (report cards) on their cancer screening rates among low health literacy patients in their clinic.

COMPLETED
Reactions to Disease Risk Information
Description

This study is part of an effort to learn about interactions between doctors and patients. The study will use virtual reality technology to examine how patients and doctors interact when they discuss disease risks. Men and women between the ages of 25 and 40 who have access to the Internet and were born and raised in the United States may be eligible for this study. Participants will be recruited from the Washington D.C. area. Participants undergo the following procedures: * Complete an online questionnaire about their health-related background, family health history, cancer risk perceptions, and demographic information (e.g., age, marital status, education, etc.). * Participate in activities in a virtual reality environment in which they interact with a virtual doctor in a virtual clinical scenario. For this experiment, participants wear a head-mounted display that allows them to see the virtual world images. * Fill out a second questionnaire after completing the virtual reality activities. This questionnaire includes information on the participants virtual reality experience, the information provided in the experience, and questions about themselves and their background.

Conditions
NOT_YET_RECRUITING
Advancing Decisions About Virtual Service Encounters
Description

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).

COMPLETED
Effect of Telemedicine on Physician-Patient Communication
Description

The purpose of this study is to determine whether the physical separation between patient and physician required during telemedicine has an affect on physician-patient communication and related outcomes, including patient and physician satisfaction, patient compliance, and patient understanding of medical care.

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.

COMPLETED
Patient Centered Evaluation of Computerized Patient Records System
Description

The VHA is a leader in electronic medical records (EMR) use for patient care. It is believed that EMR use by doctors will improve patient-centeredness of visits, and improve clinical care. The proposed study will determine how doctors should use the EMR during patient consultations. We will also develop a training program to improve doctors ability to communicate with patients while using EMR.

COMPLETED
Study of the Therapeutic Use of Language in Patients With Metastatic Colorectal Cancer
Description

The purpose of this study is to determine if the degree of agreement between patients and their physicians regarding the "story" of the illness correlates with improved patient symptom control and quality of life. Another goal of the study is to examine the actual language used by patients and physicians in a specific clinical situation.