12 Clinical Trials for Various Conditions
This survey aims to understand anesthesiologists' opinions on intraoperative/intraprocedural code status management (like for example, Do Not Resuscitate (DNR)) in various patient scenarios. Your valuable input will help us better understand current practices and preferences in the field. The understanding of the perspectives of ASA (American Society of Anesthesiologists) member staff anesthesiologists and staff anesthesiologists in general on this matter is of critical importance in the field of anesthesiology as the intraoperative/intraprocedural patient population continues to collectively get older and sicker in the future. Goal/Aims: The goal of this survey is to ascertain the perspectives of all active ASA member staff anesthesiologists and staff anesthesiologists in general on the matters of intraoperative/intraprocedural code status and intraoperative/intraprocedural code status management plans
This study examines the application of precision treatment intervention for smoking cessation from both the clinician perspective and patient perspective, and compares it to usual care on tobacco treatment in the primary care setting. The precision treatment intervention includes personalized tobacco treatment recommendations using the patient's clinical, genetic, and biomarker information. This approach may increase effectiveness and adherence for the patient, and increase the clinician's likelihood of prescribing.
In a recent report, drug spending increased by 23.4 percent annually in the inpatient setting from 2013 to 2015 with the average inpatient drug spending increasing from $714 to $990 per admission. A retrospective analysis from Johns Hopkins showed potential annual savings of over $1,100,000 dollars with a switch from intravenous (IV) to oral (PO) administration of four inpatient medications. Another study actively encouraging the conversion of IV to PO medications demonstrated a decrease in therapeutic costs. A number of benefits occur at the conversion of IV to oral medications including the reduced risk of secondary cannula- related infections, inflammation, and pain in the area of administration. Most oral agents are less expensive than the related IV medications. Other benefits occur in indirect administration costs such as the expense of nursing labor and equipment. The switch from IV to oral medication has also been shown to result in earlier discharge of patients, potentially saving medical costs. The investigators have chosen to further the research of the conversion of IV to PO medications by combining prior knowledge on the subject with robust clinical decision support. Our research will prompt providers at the right time in the workflow to switch from IV to PO medications. The investigators will exclude patients less than 18 years old, with a NPO status, or a severe disease state (vasopressor dependent, decreased consciousness, seizures, severely immunocompromised (ANC \< 500), or life- threatening infections such as sepsis, Central Nervous System (CNS) infections, endocarditis, osteomyelitis, etc.). The medications eligible for this research project were identified through comparison of the wholesale price of the intravenous and oral formulations. To select medications with a potential for savings, the investigators factored in the frequency of IV administrations in the past five months using our electronic health record system (EHR) to help identify highly utilized medications. The product of the largest cost differential and frequency was used to decide on the following list of medications for this project: Lacosamide, Doxycycline, Levothyroxine, Linezolid, Acetaminophen, Rifampin, Amiodarone and Levofloxacin. The principal trigger for the clinical decision support prompt will be a current diet order listed in the patient's chart or an order for another medication via the oral route. These orders will flag the patient as eligible for po medications. Once the patient has been identified to be eligible for PO medications, the presence of an order for an IV formulation of one of the above drugs will prompt a once-daily alert to the provider upon opening the chart for the conversion to PO medication. Providers will be randomized to receive the alert. Past experience has shown that such an alert will remind providers not only to switch the drug in questions to PO form, but other medications as well. For the providers not receiving the alert, the investigators will record when it would have been triggered for the first time. The trial will run for three months to completion. Analysis at the time of study completion will occur on primary (number of doses of candidate medication administered IV and PO after the alert) and secondary outcomes (number of doses of other medication not on our IV and PO list, cost savings, presence of an iv drip, episodes of sepsis or bacteremia). The investigators will monitor for potential complications by monitoring length of stay after triggering the alert. The investigators will also monitor the doses of hyaluronidase administered to patients after the alert was triggered.
The goal of this clinical trial is to test the effect of a video game on the implementation of clinical practice guidelines in trauma triage. The main question it attempts to answer is whether exposure to the game improves compliance with guidelines by emergency medicine physicians working at non-trauma centers in the US. Participants randomized to the intervention condition will be asked to play a customized, theory-based video game for 2 hours immediately after enrollment, and then return to the game for 20 minutes every three months for the next 9 months. Participants in the control condition will receive usual care.
In 2016 and 2017 the investigators conducted two clinical trials in which emergency medicine physicians were randomized either to an intervention (customized, theoretically-based video games) or to a control (nothing or text-based education). This study will now assess long-term outcomes for physicians enrolled in those two trials to evaluate the effect of the interventions on triage practices for trauma patients who presented initially to non-trauma centers in the US between December 2016 and November 2018.
Mayo Clinic's Traumatic Brain Injury (TBI) Model System Center (TBIMSC) will capitalize on longstanding collaborations with the non-profit Minnesota Brain Injury Alliance (MN BIA) and Minnesota Department of Health (MDH) to test a new way of delivering medical and social services. This trial will address chronic unmet needs expressed by individuals with TBI and their families in the U.S. pertaining to the ineffective connection to specialized medical and community resources in the transition from hospital to community-based care, limited access to TBI experts, and lack of primary care provider (PCP) knowledge about the complex needs of individuals with TBI. Target populations for this study are: 1) individuals with TBI eligible for MN BIA provided Resource Facilitation (RF), 2) their families, and 3) their PCPs. This clinical trial will use a theory-driven complex behavioral intervention that integrates the medical-rehabilitation, therapy, and TBI expertise of Mayo's Brain Rehabilitation Clinic (BRC) with MN BIA's highly developed RF program (a free two-year telephone support service offering assistance in navigating life after brain injury). Mayo Clinic's medical-rehabilitation expertise will be integrated with RF services to deliver direct clinical care remotely using telemedicine and other information and communication technology to test whether outcomes over time are better in a group receiving this model of care compared to a group that receives usual care in their communities. Costs between usual care and intervention groups will be compared in collaboration with the MDH. The overarching goal is development of a replicable, sustainable, and cost effective model of telemedicine care that integrates TBIMS Centers and BIAs nationwide and builds TBI expertise and capacity among PCPs.
This large scale multi-center cluster randomized controlled trial (RCT) is designed to assess the comparative effectiveness of three interventions in diverse ambulatory care settings and patient populations. Findings will help healthcare systems decide which approach to adopt to empower patients and enable providers to engage in patient centered communication. The specific aims are to: 1. Engage with patients and healthcare providers who have used the tools in the pilot study (ClinicalTrials.gov Identifier NCT02522286) at the Sutter Health Palo Alto Medical Foundation (PAMF), as well as new stakeholders at University of California San Diego Health System and Meyers Primary Care Institute at University of Massachusetts and Reliant Medical Group, to further refine and adapt these patient-centered interventions to be integrated into real world primary care clinics. 2. Conduct a large scale cluster RCT with three arms, to evaluate the comparative effectiveness of three interventions: OPEN with in-person SPI training (High Touch), OPEN with online SPI training (High Tech), and ASK. Primary outcomes will include patient perceptions of how well their PCPs have engaged them in patient centered communication. The investigators will also measure patients' confidence in managing their health, intention to follow through with care plans, and downstream behaviors in following through with care plans, use of services such as phone calls, secure messaging, and additional visits. 3. Identify the strategy that has the most potential for sustained impact and replication within and across healthcare systems. The investigators will analyze the fidelity to the intervention protocols, including consistency of delivery as intended and the time/effort involved in implementing the interventions. The investigators will also assess the extent to which the programs become institutionalized. The investigators anticipate that this multi-level healthcare system intervention will result in significant improvement in: patient satisfaction with how PCP has engaged them in the visit, confidence in selfcare; patients' intention to adhere to care plan, and clinical indicators. Furthermore, more effective communication would lower health service utilization after the visit. The investigators further expect that the intervention will affect physicians', medical assistants' and nurses' experience as well as healthcare system leaders' intention to implement in routine practice.
This research study is designed to answer the question: How does professional coaching impact early career academic emergency medicine physician goal attainment, leadership strengths, well-being, and burnout?
This pragmatic trial examines the uptake and effects of primary care clinician commitments to follow 3 Choosing Wisely® recommendations. The investigators hypothesize that pre-encounter invitations to clinicians to commit to the recommendations will decrease ordering of: (1) imaging tests for low back pain, (2) antibiotics for acute sinusitis, and (3) imaging tests for headaches. The study is a mixed-methods, stepped wedge cluster randomized trial in which the intervention will be sequentially introduced to 6 clinics in southeastern Michigan in a randomly assigned order.
Nursing home (NH) patients with Alzheimer's disease and related dementias often receive unwanted, burdensome treatments such as hospitalization. Advance care planning (ACP) is a key strategy to support patients and family-caregivers in making informed decisions and ensuring treatment preferences are proactively known and honored. The ACP Specialist Program will improve care and reduce unwanted, burdensome hospitalizations through improved ACP procedures, standardized staff education on ACP, and systematic ACP facilitation delivered by existing NH staff.
Hypothesis: The use of a mobile robotic telepresence system for off-hours rounding in the surgical intensive care unit has an impact on nurse-physician collaboration. Study question: Does the addition of mobile video communication provided by RTP affect nurse-physician collaboration during off shift rounding in the surgical intensive care unit when compared to the more common clinical practice of off-shift rounding using the telephone?
Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). HCV treatment leading to sustained viral response (SVR) is associated with increased survival. However, IDUs have had poor access to HCV care and their success in HCV treatment has been limited. With direct-acting antiviral agents, HCV treatment delivered within large clinical trials leads to SVR or cure in over 70% of genotype-1 infected patients, compared to 45% with previous therapies. However, SVR rates are as low as 14% in real-world settings. The majority of patients who fail to achieve SVR will develop drug resistance, but the optimal adherence level to minimize resistance is unknown. If HCV treatment continues to be delivered within current models of care, most IDUs will not only fail treatment and develop resistance, but may transmit resistant viruses to others. We have previously developed a multidisciplinary model of HCV care which integrates on-site primary care, substance abuse treatment, psychiatric care, and HCV-related care within opiate agonist treatment clinics. To maximize treatment outcomes, we piloted two models of intensive HCV-related care: directly observed therapy (DOT), and concurrent group therapy (CGT). In our DOT model, pegylated interferon is administered once weekly, if applicable, and one daily dose of oral medication is administered at the methadone window. In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides powerful social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections, if applicable. It is unknown whether either model is better or more cost-effective than standard on-site care. PREVAIL 1: In the proposed study, 150 IDUs with chronic HCV (genotype 1) will be recruited from methadone clinics and randomized to one of three models of care: DOT; concurrent group treatment; or standard on-site care. Our specific aims are: 1) To determine whether either of two intensive on-site HCV treatment models (DOT or concurrent group treatment) is more efficacious than standard on-site treatment for enhancing adherence and SVR, and decreasing drug resistance; (2) To determine the incidence and factors associated with the development of drug resistance in IDUs; (3) To perform cost and cost-effectiveness analyses of each model; (4) To examine the impact of HIV coinfection on adherence and virologic outcomes among HCV-infected IDUs. PREVAIL 2: In the proposed study, 60 IDUs with chronic HCV (genotypes 1 2, 3 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and (2) to determine adherence rates over time in drug users (genotype 3 and genotype 1 / IFN-ineligible) initiating a 24 week IFN-free regimen. PREVAIL 3: In the proposed study, 60 IDUs with chronic HCV (genotype 1 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and (2) to determine adherence rates over time in drug users.