46 Clinical Trials for Various Conditions
The purpose of this study is to determine the learning curve associated with Ultrasound (US) guided axillary vein access for cardiac device implantation based on length of procedure among operators of various levels of experience and to assess the 30-day complication rate for patients undergoing US guided device placement versus traditional implant methods.
The aim of this study is to demonstrate the feasibility of a new technique using real time ultrasound guided paramedian approach to the epidural space. This approach will use transverse view of the spine utilizing curvilinear low frequency ultrasound probe "Sonosite S nerve" and echogenic 17G tuohy needles " Pajunk TuohySono" The investigators believe that this new technique is helpful to get the best anatomic landmark for epidural catheter placement using the real-time ultrasound. Measurable outcomes: * Block performance time. * Block success rate. * Needle Depth to epidural space Block success rate will be measured as the rate of cases that will have successful insertion of the epidural catheter using ultrasound guidance and the case is done completely under epidural anesthesia. All cases that will be converted to general anesthesia will be counted unsuccessful. Other measurable outcome data that will be collected will include needle depth to the epidural space, and ultrasound measured depth to the lamina
The purpose of the study is to learn if monitoring dialysis access blood flow during dialysis treatment with a transonic machine (an ultrasound technique) will prevent (or reduce) the development of dialysis access thrombosis (clotting). Investigators would like to study if monitoring with a specific technique called ultrasound dilution technique can help prevent problems with access when compared to what is the current standard of care for patients.
The purpose of this study is the creation of a PBRN that will comprise primary care providers, community health organizations, community advocates and a research core of two academic institutions in order to study the healthcare needs of a rapidly growing immigrant population.
This is a pilot study addressing office systems and clinician behavior change surrounding smoking cessation interventions for teens. The investigators' long-term goal is to improve the quality of clinical preventive services in practice-based research network settings. Their specific aims are to: * a) pilot procedures for recruitment and randomization of PROS practices; and b) field trial/pilot PROS practitioner cessation counseling and practices' enrollment of adolescent patients; and * assess the feasibility of pediatric clinician referral of adolescent patients to internet-based adjuncts for smoking cessation. The investigators will evaluate a pilot round of recruitment and randomization, and smoking cessation training and delivery in 10 PROS practice sites; and assess the acceptability of study procedures and on-line internet counseling adjunct referral feasibility within PROS practice sites. Up to 1000 adolescents presenting for well visits will complete a short baseline survey prior to their well-visit. A sample of them will be surveyed by phone at 4-6 weeks to provide preliminary estimates of cessation counseling effectiveness for future studies. The investigators will field test measures, describe the patterns of smoking among youth, and explore how much receiving interventions affects motivation, quitting, abstinence/relapse attitudes, attitudes towards internet-based outreach strategies, and behaviors for 100 smokers. \*\*we have completed recruitment of providers; we are recruiting teens ONLY at this point\*\*
The investigators' long-term goal is to improve the quality of services targeting the prevention of secondhand smoke (SHS). Their specific aims are to: * refine components of office systems and counseling interventions for parental tobacco control in pediatric outpatient settings; and * pilot test the feasibility and efficacy of a parental tobacco control randomized controlled trial in pediatric office settings using 5 intervention and 5 comparison pediatric practice sites. The investigators hypothesize that: * clinicians in intervention practices (compared to those in control practices) will more often implement successful office systems, screen for parental smoking, advise parents to quit and to prohibit smoking and SHS exposure at home, recommend pharmacotherapy, provide adjuncts, and refer parents to cessation programs; and * parents who smoke in intervention practices (measured by 3-month follow-up telephone surveys) will be more likely than those in control practices to have received cessation services, use pharmacotherapy, make lasting quit attempts, and institute rules to prohibit smoking and limit SHS exposure at home.
Background: HIV testing is cost-effective in unselected general medical populations, yet testing rates among those at-risk remain low, even among those with regular primary care. HIV rapid testing is effective in many healthcare settings but scant research has been done within primary care settings, nor within the US Department of Veteran's Affairs Healthcare System. Objectives: We evaluated three methods proven effective in other diseases/settings: Nurse standing orders for testing, streamlined counseling, and HIV rapid testing. Design: Randomized, controlled trial with three intervention models: Model A (traditional counseling/testing); Model B (nurse-initiated screening, traditional counseling/testing); Model C (nurse-initiated screening, streamlined counseling/rapid testing). Participants: 251 patients with primary/urgent care appointments in two VA clinics in the same city (one large urban hospital, one freestanding outpatient clinic in a high HIV prevalence area) Measurements: Rates of HIV testing and receipt of results; sexual risk reduction; HIV knowledge improvement. Results: Testing rates were 40.2% (Model A), 84.5% (Model B), and 89.3% (Model C) (p=\<.01). Test receipt rates were 14.6% (Model A), 31.0% (Model B), 79.8% (Model C) (all p=\<.01). Sexual risk reduction and knowledge improvement did not differ significantly between counseling methods. Conclusions: Streamlined counseling with rapid testing significantly increased testing and receipt rates over current practice without changes in risk behavior or post-test knowledge. Increased testing and receipt of results could lead to earlier disease identification, increased treatment and reduced morbidity/mortality. Policymakers should consider streamlined counseling/rapid testing when implementing routine HIV testing into primary/urgent care.
The goal of this clinical trial is to improve communication among clinicians, patients with memory problems, and their family members. We are testing a way to help clinicians have better conversations to address patients' goals for their healthcare. To do this, we created a simple, short guide called the "Jumpstart Guide." The goal of this research study is to show that using this kind of guide is possible and can be helpful for patients and their families. Patients' clinicians may receive a Jumpstart Guide before the patient's clinic visit. Researchers will compare patients whose clinician received a Jumpstart Guide to patients whose clinician did not receive a guide to see if more patients in the Jumpstart Guide group had conversations about the patient's goals for their healthcare. Patients and their family members will also be asked to complete surveys after the visit with their clinician.
The mobile health clinic evaluation study examines the impact of mobile health clinics on access reproductive and sexual healthcare services in underserved communities. Multiple mobile clinics operating throughout the U.S. are participating by implementing the same evaluation plan for their programs and contributing de-identified data into a shared database. This allows the investigators to both determine the impact of individual programs and to compare and contrast their impact across different programs, states, population densities (rural, urban, suburban), and populations.
The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients 55 years or older with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1. To evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion in the period between randomization and 30 days following randomization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 7 and 30-day hospital readmissions. 2. To conduct a mixed-methods evaluation of the implementation of the intervention, guided by the RE-AIM framework for implementation science, incorporating quantitative evaluation of the intervention's reach and adoption, as well as qualitative analyses of interviews with participants, to explore barriers and facilitators to future implementation and dissemination.
This study is a randomized clinical trial of an intervention to improve outcomes for patients and their family by using ICU nurse facilitators to support, model, and teach communication strategies that enable patients and their families to secure care in line with patients' goals of care over an illness trajectory, beginning in the ICU and continuing to care in the community.
The overall aim of this project is to improve the quality of the handoffs between hospitalists on the general medicine service at Durham Regional Hospital with the intent of improving transitions of care. The intervention will be an improved and more structured face to face sign-out process using a standardized admission sign-out sheet, which is not part of the official medical record. Daytime admitting physicians will assign an acuity score to their patients in which the severity of illness will be scored from 1-7, with 7 being the most sick / likely to have rapid response team (RRT) or adverse event. The assignment of this score would be based off of the clinician's judgment in the patient's overall assessment. All patients, age \>18 years, admitted to the non-resident hospital medicine general medicine service at DRH will be study eligible. Data analysis will examine aggregate hospitalist perception of sign-out practice before and after intervention, total number of RRTs, unplanned transfers, and rapid responses pre and post intervention, percentage of hospitalist based patients of overall rapid responses pre and post intervention, percentage of hospitalists using acuity scores, and average and mean severity score of patients with rapid responses compared with those admitted. Patients have a risk of loss of confidentiality.
The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study is particularly interested in understanding the effect of the intervention to improve quality of palliative care for patients with Alzheimer's disease and related dementias (ADRD) but will also include other common chronic, life-limiting illnesses. The specific aims are: 1. To evaluate the efficacy of the EHR-based clinician-facing Jumpstart, drawn from the electronic medical record (EHR), the survey-based bi-directional Jumpstart, drawn from patient or family completed surveys, and usual care for improving quality of care provided to patients with chronic illness experiencing a hospitalization. The primary outcome is EHR documentation of a goals-of-care discussion, assessed from randomization through 30 days. Secondary outcomes include: a) intensity of care outcomes (e.g., ICU use, ICU and hospital free days, hospital readmissions, costs of hospital care); and b) patient- and family-reported outcomes assessed by surveys at 3-5 days and 4-6 weeks after randomization, including occurrence and quality of goals-of-care discussions in the hospital, goal-concordant care, psychological symptoms, and quality of life. 2. To conduct a mixed-methods evaluation of the implementation of the interventions, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative evaluation of the interventions' reach and adoption, as well as qualitative analyses of interviews with participants, to explore barriers and facilitators to future implementation and dissemination.
One way to help Veterans improve their diabetes control is through the use of technology to help provide information, motivation, and reminders necessary to support diabetes self-management. The study will seek input from diverse groups of Veterans living with diabetes to help develop a new customizable, interactive texting intervention that allows Veterans to choose what kinds of diabetes self-management support they need, and when. This diabetes support will be provided to Veterans through "Annie for Veterans", a VA texting system for self-management support. Patients will be randomized to receive a once-daily standard diabetes self-management texting intervention called DSMS based on standard diabetes self-management education content or a customizable, patient-centered diabetes self-management support intervention with additional features called DSMS Plus (DSMS+) in order to test the comparative effectiveness of these two texting interventions.
The National Committee for Quality Assurance has worked with the National Coalition for Cancer Survivorship, the American Society of Clinical Oncology, Oncology Management Services, Independence Blue Cross, and RAND, as well as a broader multi-stakeholder advisory group, to define the Patient-Centered Oncology Care model. The purpose of this project was to pilot and evaluate this model. Specific research questions were: 1. Does Patient-Centered Oncology Care improve patient experiences and quality of care? Does it reduce undesirable events like emergency department visits and hospital stays? 2. How does adoption of Patient-Centered Oncology Care vary across a variety of practices and what factors affect adoption? The demonstration occurred in oncology practices in southeastern Pennsylvania. Practices received implementation support during the 24-month demonstration period. They were evaluated using patient surveys, quality measures, and measures of emergency department and hospital use. Results from these practices were compared in two ways: 1) with their performance before they became oncology medical homes and 2) with other similar practices.
In light of the importance of pain and widespread interest in patient-centeredness, the Department of Veterans Affairs (VA) has been emphasizing and successfully making pain and its management a routine feature of the health record and a focus of care. Awareness of pain and efforts to improve pain management rest on the VA's '5th Vital Sign' - a policy and practice of nursing staff routinely screening for 'pain now' at every health encounter using a 0-10 Numeric Rating Scale (NRS). The team's previous research on VA's '5th Vital Sign' informs the specific design of this Effective Screening for Pain (ESP) study as well as the proposed research products. Alternatives to the current pain screening approach may improve the sensitivity and specificity of screening for chronic pain. These alternatives include the nurse administered NRS with a one week look back period and a three item scale (PEG) incorporating intensity and emotional and physical interference. The PEG is very similar to the gold standard Brief Pain Inventory (BPI) from which it is derived, in its sensitivity, specificity, and sensitivity to change in detecting clinically important, functionally impairing pain. The investigators plan to evaluate alternatives to the VA's current '5th Vital Sign' for pain screening, focusing on simple, feasible measures that can be used cross-sectionally for pain screening. In the setting of a primary care clinic, the investigators plan to cross-sectionally evaluate three arms - a tablet based DVPRS, a tablet computer-based NRS one week, and a tablet computer-based PEG. All arms will be compared with the nurse administered NRS.
People with serious mental illness have difficulty making good use of primary care, and die, on average, years earlier than others in the population. The greatest contributors to this premature mortality are medical illnesses, especially cardiovascular disease and cancer. The Patient Centered Medical Home is a model for reorganizing primary care practice so that healthcare is more effective, efficient, and user-friendly. It has been implemented across VA as the, "Patient Aligned Care Team" (PACT). It is unclear, however, how this PACT model applies to people whose predominant illness is treated by specialists. This is the case for people with serious mental illness (SMI), many of whom receive ongoing treatment at mental health clinics. To achieve optimal health outcomes in the population with SMI, it may be necessary to adapt the PACT model so that it includes approaches that have proven to improve healthcare in this population. This project implements an adapted "SMI-PACT" model, and evaluates its effect on Veterans with SMI.
Evaluate the long-term effectiveness of implementing vouchers as a linkage strategy in a population requiring recovery support services (RSS) when no other funding sources are available. A within-subjects study design will be used to test the effectiveness of the Kentucky Access to Recovery (KATR) last resort voucher linkage approach to reduce the risk of nonfatal and fatal overdoses by (a) increasing an individual's recovery capital; (b) reducing resumption of illicit substance use; and (c) promoting relinking to RSSs if illicit substance use is resumed.
This project builds on the Michigan Contraceptive Access Research and Evaluation Study (M-CARES) to evaluate the long-term effects of mothers' access to free contraceptives and reductions in unintended pregnancies on their children's well-being.
M-CARES will use large-scale administrative data complemented by follow-up surveys and a randomized control trial (RCT) to estimate the causal impact of greater financial access to contraception on a comprehensive set of outcomes. Outcomes include contraceptive use, pregnancy, childbearing, and parenting strategies; partnership decisions and relationship quality; health and health care use; education, labor market success, and public assistance receipt; financial security; neighborhood quality; mental health and stress; and life plans. The resulting estimates will inform a more complete understanding of the costs and benefits of financial access to contraception and, therefore, the investment value of related policies and programs.
This study is being done to evaluate if the Vscan Access R2 Ultrasound System can measure Fetal Heart Rate (FHR) in humans when compared against a reference device (GE Corometrics 170 Series Fetal Monitor), and to gather feedback from device operators on the usability of the device.
The purpose of this study is to reduce, by using the ultrasound guided technique, the minor surgical procedures that might be required to deliver fluids into the blood of critically ill patients simply because the patients' veins cannot be located through the manual technique.
This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.
This is a large pragmatic, randomized controlled trial to test the real-world effectiveness of inpatient palliative care consultative services in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The investigators hypothesize that improved patient-centered outcomes can be achieved without higher costs by simply changing the default option for inpatient palliative care consultation for eligible patients from an opt-in to an opt-out system. To test this hypothesis the investigators will conduct a clinical trial at 11 hospitals using the same electronic health record within Ascension Health, the largest non-profit health system in the U.S.
The goal of this clinical trial is to compare a sterile vapocoolant spray to EMLA cream in children with access ports. Participants will receive either the spray or cream prior to port access and rate pain on a scale. Researchers will compare spray vs cream to see if the spray is as effective as the cream in reducing pain associated with port puncture.
Sugar-sweetened beverages (SSBs) are a major caloric source and the largest source of added sugars in the American diet. While many cities around the country have adopted anti-SSB policies such as soda taxes to reduce SSB intake, there has yet to be any studies to evaluate if the effects of these taxes, coupled with increased water access and promotion effort can lead to decreased sugar sweetened beverage consumption and increased water consumption. This quasi-experimental study evaluates how implementation of SSB taxes, installation of new water stations, and a multicultural water promotion campaign in parks impacts beverage intake in these settings as compared to soda taxes alone.
Intracerebral hemorrhage (ICH) is the most severe form of stroke: early mortality is 40%, and 80%-of survivors are physically disabled with high rates of cognitive impairment and depression. In an effort to address the issues with conventional treatments, a new integrated systematic approach has been developed. This approach utilizes an educational process where specific core competencies (pillars) of mapping, navigation, access, optics and automated resection have been integrated into a single standardized system to deliver targeted therapy for an individual patient based on location and patient factors. This system has demonstrated safety and efficacy in oncology patients and is also FDA approved for use in the ICH patient population as well. This registry will collect data form multiple site that preform the MiSPACE procedure as part of clinical care. The intent of this registry is to collect data on the economic impact as well as clinical outcomes using the MiSPACE approach with the integrated technology in the early treatment of ICH.
Narrative-based tiered asynchronous psychosocial and behavioral whole health support for people adjusting to living with COPD. The intervention is administered by experienced LCSWs under the PI's supervision.
The purpose of this pilot study is to hopefully generate interest that will lead to more robust trials evaluating FreeStyle Libre 2 sensors in patients with type 2 diabetes on any diabetes regimen. Hopefully the trial will ultimately pave the way to future trials that will prompt clinicians, policymakers, and insurers to re-evaluate the current criteria defining the coverage of continuous glucose monitors (CGM). The objectives of the study are to 1) Determine if there is difference in diabetes control in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2, 2) Compare participant satisfaction with glucose monitoring and diabetes distress in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2 and 3) Compare the frequency of hypoglycemia in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2.
The objective of this post-market clinical follow-up study is to evaluate the clinical outcomes of patients receiving PhotoFix as a patch within a vascular repair or reconstruction procedure.