29 Clinical Trials for Various Conditions
This proposal outlines the steps required for the creation of a pilot database of EEG recordings and de-identified medical records from patients internally referred within the UNMH Comprehensive Epilepsy Center. The UNMH EEG Corpus would be the first database of its kind. Other public databases contain either patient EEG signals or medical records, but without both kinds of information, it is impossible to relate pre-treatment neurobiomarkers with post-treatment prognosis. The database will also contain information that can improve seizure localization based off of scalp and intracranial EEG, and the requisite data for the creation of algorithms that forecast seizure activity; a development that could ultimately lead to novel responsive neural stimulation procedures that suppress seizures before they begin.
The purpose of this study is to assess the feasibility of using a mobile-health approach to gather clinical data from patients following discharge from the hospital on outpatient parenteral antibiotic therapy (OPAT). The study population will consist of adult participants who have a smartphone that is capable of both text messaging and pairing with a Bluetooth thermometer that will be provided. Following discharge, patients will be asked to respond to two daily text messages. They will also be reminded to take and send in photos of any skin rashes that may develop as well as their PICC-line site during dressing changes. Text messages will be sent for up to 30 days, but will be stopped sooner if the patient is readmitted to the hospital or if OPAT is discontinued. At the end of the 30 days, all patients will be sent a text message survey about usability, the time it took to complete the study tasks, suggestions for future improvements, and whether they would be willing to be interviewed via phone. A subset of the participants will be interviewed via phone to obtain more detailed feasibility data. Information from the patient's medical record will be collected at the time of hospital discharge as well as at the end of the study period. Additionally, a focus group (via conference call) will be conducted with all research team members and infectious disease physicians involved in OPAT who did not use the system to gauge their needs and to get ideas for future applications of our tools.
This trial collects clinical information and tissue and blood samples from patients with breast cancer that has come back or is stage IV. Collecting clinical information and biospecimen samples to create a registry may help doctors better understand the mechanism of tumor spread and determine why people respond differently to specific cancer treatments.
This biomarker study is a follow-up to CPLATFRM2201. The goal of CBASICHR0005 is to collect another urine sample, interval clinical information, and an optional DNA sample from as many of the original 80 patients as possible. This new information will transform the data obtained in PLATFRM2201 from a cross-section to a temporal profile, which will (a) further enable the identification of biomarkers predictive of faster progression, and (b) satisfy the FDA's recommendation to perform "natural history studies" in rare diseases.
RATIONALE: Gathering health information about patients with non-small cell lung cancer who never smoked cigarettes may help doctors learn more about the disease. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and identify biomarkers related to cancer. PURPOSE: This research study is studying internet-based clinical information and blood sample collection from patients with non-small cell lung cancer who never smoked cigarettes.
We have an active research program in gastrointestinal cancers including clinical trials, epidemiologic, and translational studies. We would like to establish a biospecimen bank linked to useful clinical information in order to learn more about diagnostic, predictive and prognostic markers for gastrointestinal cancers. PRIMARY OBJECTIVES: 1. To collect and store tumor and normal tissue (previously collected paraffin embedded or frozen specimen) and blood in patients with gastrointestinal (GI) cancers. SECONDARY OBJECTIVES: 1. Collect detailed clinical information via a patient questionnaire that includes demographic, socioeconomic, lifestyle, family, past medical, medication and cancer histories 2. Collect details about the tumor specimen extracted from patient charts.
The purpose of initiating the Urology Database is to evaluate the outcomes of urology procedures and medical management to enhance the care and treatment of urology patients.
This study is investigating the effects of an established clinical informationist program (evidence-based practice support service in which information professionals with significant clinical knowledge bases and advanced information seeking and appraisal skills) on clinical decision making at selected critical care units at Vanderbilt University Medical Center
Human factors engineering literature makes clear that appropriate, well-designed and well-timed information improves decision making and can reduce mental workload. Data from a previous study showed that appropriate, well-designed and well-timed information is not present in many primary care encounters with elderly patients. This puts primary care physicians at risk of higher mental workload and poor decision making which can affect the quality and safety of care delivered to patients. Elderly patients are at particular risk because they are more likely to have more comorbidities, medications, and cognitive impairments. Dr. Karsh and his research team will test an intervention to improve the performance of primary care physicians and, thus the safety of primary care of the elderly. The investigators will use a randomized experiment, with random assignment at the level of patient, to test and evaluate the intervention. The evaluation will involve 4 primary care clinics, with 4 primary care physicians per clinic. The investigators will collect data from 768 patient visits pre-intervention and 1536 patient visits during the intervention. Intervention patients will be randomly assigned to the intervention or care as usual. The Intervention has two components: Pre-visit care coordination: * 5-7 days prior to a study patient's appointment with his/her doctor, the doctor's nurse/MA will call the study patient and collect pertinent clinical information about the patient using a data collection form the investigators call a Patient Overview Document or POD. * The nurse/MA will ensure that any lab results, consultant reports, ER reports, imaging studies, etc., that will be needed by the physician are available to the doctor. Team Meeting: On the day of the patient's appointment and prior to the beginning of the clinic session, the nurse/MA will meet briefly with the doctor to jointly review the POD. Hypotheses: H1. Primary Care Physician (PCP): The intervention will increase situation awareness, reduce PCP mental workload, reduce PCP perceived likelihood of error, and improve PCP visit satisfaction. PCP efficiency, as measured by encounter problem density during a visit, will also improve. H2. Patient: The intervention will improve patients' perceptions of their visits on a variety of AHRQ CAHPS measures, such as physician knowledge of patient history. H3. Patient: The intervention will not impact the number or types of problems addressed during the visit. H4. Clinic: The intervention will not affect visit RVUs
This proposal is to evaluate the reliability and validity of the Vanderbilt ADHD screening tool for use with adolescents and young adults aged 13-21 years. The Vanderbilt is a previously developed, freely available set of parent- and teacher-report questionnaires designed to identify ADHD and related disorders in children. The Vanderbilt measures have been chosen for inclusion in the new computerized Integrated Clinical Information Sharing System (ICISS) being rolled out in five Boston Children's Hospital (BCH) departments/divisions (Adolescent/Young Adult Practice, Children's Hospital Primary Care Center, Developmental Medicine Center, Department of Neurology, Department of Psychiatry). The Vanderbilt was developed and validated for use among children up to age 12 years (Wolraich et al., 2003; Wolraich et al., 2013; Bard et al., 2013), and little is known about its appropriateness for use among older youth. In addition, there is no self-report version of the Vanderbilt that can be administered directly to adolescents and young adults (ages 13-21 years), for whom parents and teachers are often less knowledgeable reporters. To address these shortcomings, a multidisciplinary team of BCH adolescent health clinicians and researchers modified the parent and teacher Vanderbilt questionnaires to make them age-appropriate for adolescents and young adults and created a complementary self-report version for adolescents and young adults. The goal of the current study is to 1) assess the feasibility and acceptability of online administration through the ICISS system of the new parent, teacher, and youth self-report Vanderbilt measures among adolescent and young adult BCH patients aged 13-21 years; 2) test their reliability in terms of internal consistency reliability, temporal stability of responses over a one-month test-retest, and inter-rater agreement across all informants (parents, teachers, and youths); and 3) test their validity by evaluating their convergence with a similar set of ADHD screening tools, the Conners scales, already validated for use with adolescents and young adults.
In this research study, the investigators are trying to find a better way to set the dose of a common blood-thinning medication. Patients with blood clots or a risk of blood clots (or stroke) sometimes have to take an approved medication called warfarin. Warfarin is a commonly prescribed, approved blood thinning medicine taken by mouth. There is a certain level of warfarin that is best for each patient at a particular time. It is hard for a doctor to choose and maintain the right dose of warfarin for each patient. Too much or too little warfarin in the blood can cause serious health problems. A "nomogram" is a tool that helps doctors decide on the right dose of warfarin. The usual way for finding the right dose of warfarin is for doctors to take an educated guess and use a "trial and error" approach. Patients have frequent blood tests to help doctors keep track of how well the dose level is working. Up until now, if a patient had good blood test results over half of the time, that was as well as doctors could do. The purpose of this study is to see whether the investigators can create a reliable new warfarin nomogram that will allow them to dose a patient correctly more often, perhaps about 3 times out of 4. The nomogram the investigators are studying uses information about a patient's health and genes to decide on the best dose of warfarin. The investigators don't yet have a reliable, safe way to choose the correct dose. In this study, the investigators will use a genetic blood test to try to find a better way. Genes are the parts of each living cell that allow characteristics to be passed on from parents to children. The investigators know that people with certain genes seem to respond to warfarin in a certain way. From a blood sample, the investigators can look at patients' genes and try to predict the response to the blood-thinning medication. There will be about 500 subjects taking part in this study. They will come from participating Partners' Hospitals, including Brigham and Women's Hospital, Massachusetts General Hospital, Faulkner Hospital, Newton-Wellesley Hospital, Spaulding Rehabilitation Hospital, and North Shore Medical Center. The U.S. Food and Drug Administration (FDA) has approved warfarin for use as a blood thinner.
The purpose of this study is to address priority Research Area 3 in PAR-08-270: Health information technology (HIT) to improve health care decision making through the use of integrated data and knowledge management. The proposed study will evaluate the use of HIT for clinician decision support and tailored patient education on the implementation of the current guidelines for the prevention of obesity-related chronic conditions in health disparity populations of poor, minority youth who access care through SBHCs. The specific aims are: 1. To evaluate the effectiveness of web-based training with and without computerized clinical decision support on provider's process and outcome behaviors related to implementing the current guidelines for prevention of obesity and related conditions. a. Process variables include the following: i. Provider knowledge, attitudes, and barriers to implementing the guidelines. ii. Parent perception of the interpersonal process of care (i.e., provider communication, collaborative decision making, and interpersonal style). iii. Parent perception of provider support for their child's healthy eating and exercise. b. Behavior outcomes include the following: i. Provider self-reported behaviors of identification and assessment of overweight, counseling on nutrition and physical activity, use of behavioral interventions, referrals, and cultural competency. ii. Documentation by chart review of body mass index (BMI) percentile for age and sex; appropriate diagnosis when BMI \> 85th percentile; blood pressure (BP) percentile for age, height, and sex; and ordering appropriate laboratory tests when indicated. 2. To explore the role of HIT in the processes of system change for implementation of the guidelines for prevention of obesity and related conditions, including the facilitators, barriers, and impact of the care model on change.
Health literacy is an integral part of the pathway for the successful transfer of information between patients and providers. Parents of children with Attention Deficit/ Hyperactivity Disorder (ADHD) play an essential role in chronic care as they offer critical information to providers that drives appropriate education and disease management. We propose the development and evaluation of an electronic data entry tool that enables parents to communicate data essential to treatment of their children, regardless of their own literacy skills. The research plan addresses a question central to patient-centered information management: how does health literacy influence parents' report of data on ADHD and the process-level events that result from parent-provider communication? The following specific aims organize the clinical study: proposal: 1) To assess the effect of health literacy on successful completion of parent-reported ADHD health information in both paper-based and PCHR formats, and, 2): To determine the association between health literacy and process-level outcomes for ADHD that stem from parent-provider exchange of information. The formal evaluation will study a diverse cohort of parents in a randomized trial of data entry (paper versus PCHR) for ADHD-specific information. Primary care records for children of this cohort will be analyzed for the prior 12 month period. Both a retrospective examination of documented ADHD processes of care and a prospective evaluation of the utility of data from the PCHR will occur. Literacy level is a primary variable of interest throughout the evaluation.
This study will examine the impact of providing patient-reported outcomes measurement information system (PROMIS) scores to patients before appointments with their healthcare provider.
This project will investigate how review of collateral information sources (CIS) may impact clinical decision-making across the lifespan.
To implement and evaluate a health information technology platform designed to support the management of patients with head and neck cancer in an urban, publicly-funded outpatient setting. This is an observational study; researchers will not assign specific interventions to study participants.
The specific aim of the study in our example is to conduct a feasibility translational home-based exercise trial established in the LEADERS (R2) project with the TExt-ME tele-exercise training system for participants with neurologic disability. We hypothesize that participants in this home-based tele-exercise training program will achieve similar gains in health and function outcomes as the onsite exercise training program. Further, there will be no difference in adverse side effects (safety) between the home-based and onsite exercise treatment groups.
Background: Electronic health records contain a vast amount of data about diseases and treatments. Researchers could use this data to test their ideas, but they would need to use records from more than just their own group of patients. But access to those records is restricted to ensure patient privacy. U.S. National Library of Medicine (NLM) has created a computer tool called NLM Scrubber. This program recognizes and deletes personal information from health records. The researchers who developed this program now need access to the original records. This will allow them to see how well the program removes personal information from patient records and how they can make it more accurate. Objectives: To find ways to improve clinical text de-identification. Eligibility: No new participants. Researchers will review data that have already been collected. Design: Researchers will collect a random sample of reports. These will be from different doctors in different fields. Researchers will manually remove personal information from the records. Researchers will also automatically remove personal information from original records using NLM-Scrubber. Researchers will compare the results of the computer program versus the manual changes. They will note when the program has not been removing personal information correctly. They will also note when the program has been deleting nonpersonal health information incorrectly. Researchers will use the results to revise the program. They will keep testing it until the de-identification process is complete.
The purpose of the study is to see if tumors respond to endocrine therapy by taking a total of 21 doses of Tamoxifen before and after surgery. Tamoxifen is currently approved by the FDA (Food and Drug Administration) for use in the treatment of hormone positive breast cancer.
The objective of this study is to use a decision-support system combined with an electronic anesthesia record to detect double low clinical conditions (Mean Arterial Pressure (MAP) \< 75 mmHg, and Bispectral Index (BIS) \< 45) and generate alerts suggesting hemodynamic support. Specifically, the project will test the hypothesis that providing Double Low alerts reduces 90-day mortality. Secondary outcomes will be the fraction of alerts that generate early clinician responses, subsequent changes in MAP and hospital length of stay.
The goal of this project is to use health information technology and team-based care in novel ways to support the establishment of a Patient-Centered Medical Home model of care aimed at improving the diagnosis and management of hypertension. Compared with patients who receive usual care, patients who receive intervention will have a lower average systolic blood pressure 9 months after randomization.
This three-year, grant funded project will be conducted by the Division of Clinical Informatics in the Department of Community and Family Medicine at Duke University Medical Center. The project seeks to improve care quality and safety in an ambulatory care setting through clinical decision support for evidence-based (EB) pharmacotherapy delivered as point-of-care reports to clinic-based practitioners and as population health-based alerts to care managers. This project will build upon a regional Health Information Exchange (HIE) network created to connect providers serving 37,000 Medicaid beneficiaries from both rural and urban settings in a 5 county region in the Northern Piedmont of North Carolina. This network includes 16 private practices, 3 federally qualified health centers, 5 rural health centers, 3 urgent care facilities, 10 government agencies, 5 hospitals, and 2 cross-disciplinary care management teams. The proposed information system will be based on an emerging standard for decision support and will utilize routinely available claims and scheduling data in order to serve as a replicable model for broader use of decision support for medication management. Increased availability and use of decision support tools for medication management can be expected to reduce medication errors, improve health care quality at an acceptable cost, and augment disease management for patients and populations.
The purpose of this study is to determine the value of shared health information on care quality and costs when this information is used to notify care providers about concerning health events for patients cared for by a community-based network of providers.
The Vermont Diabetes Information System (VDIS) is a registry-based decision support and reminder system based on the Chronic Care Model and targeted to primary care physicians and their patients with diabetes. It will be evaluated by a randomized, controlled study in 60 Primary Care practices in Vermont and nearby New York.
The purpose of this study is to evaluate the impact of integrating ambulatory computerized physician order entry (ACPOE) and advanced clinical decision support systems (CDSS) on safety and quality domains in the ambulatory setting, including: a) medication monitoring, b) preventive care and chronic disease management, and c) test result follow-up. In addition we will evaluate the impact on organizational efficiency, physician workflow and satisfaction, and perform a cost-benefit analysis. We hypothesize that the value of ACPOE integrated with advanced CSDSS lies in improved medication safety and guideline compliance, but also improved efficiencies for the provider and the health-care system.
The goal of this clinical trial is to study systemic inflammatory response syndrome (SIRS) electronic health record (EHR) alerts for sepsis in the inpatient setting. The main question it aims to answer is: do nurse alerts, prescribing clinician alerts, or both nurse and prescribing clinician alerts improve time to sepsis treatment for patients in the inpatient setting? Nurses and prescribing clinicians will receive SIRS alerts based on the group to which the patient is randomly assigned. Researchers will compare four groups: no alerts, nurse alerts only, prescribing clinician alerts only, or both nurse and prescribing clinician alerts.
The goal of this clinical trial is to study systemic inflammatory response syndrome (SIRS) electronic health record (EHR) alerts for sepsis in the emergency department (ED). The main question it aims to answer is: do nurse alerts, prescribing clinician alerts, or both nurse and prescribing clinician alerts improve time to sepsis treatment for patients in the ED? Nurses and prescribing clinicians will receive SIRS alerts based on the group to which the patient is randomly assigned. Researchers will compare four groups: no alerts, nurse alerts only, prescribing clinician alerts only, or both nurse and prescribing clinician alerts.
The purpose of this randomized clinical trial is to determine whether two low-intensity, technology based interventions, when compared to each other and to usual care, improve adherence to selected medications that are used to treat people with cardiovascular disease (CVD) and diabetes.
The purpose of this study is to improve patient care and safety while decreasing ED visit rates by sending specific information about care transitions related to hospital admission and discharge and emergency department and specialty care visits to primary care practices, care managers and patients with the use of health information technology (HIT) shared across a community-based network of providers. Cycle 1 focuses on the impact of notices about ED encounters and hospitalizations derived from billing data that are sent to care managers for all 47,000 patients in the Northern Piedmont Community Care Network (NPCCN). Cycle 2 explores the impact of letters sent to patients, and care event reports sent to a patient's medical home in addition to notices sent to care managers about ED encounters, hospitalization and specialty care based on ADT (Admission Discharge Transfer) and billing data on 4,600 patients with complex health needs.