32 Clinical Trials for Various Conditions
This is a randomized controlled trial with a mixed method design to determine the impact of coaching on self-perceived medical errors, burnout, and resilience. The study team developed a novel coaching curriculum based in principles of positive psychology and self-reflection with the hypothesis that the coaching intervention will lead to decreased medical errors, decreased burnout, and increased resilience in trainee and faculty participants. Resident and fellow trainees as well as faculty members were recruited across departments and randomized to coaching or control. Faculty in the coaching arm were trained in coaching techniques and paired with a trainee coachee. Survey results as well as focus groups will be used to analyze the impact of the coaching program as compared to standard mentorship (control).
The purpose of this study is to determine whether reducing intern work hours and eliminating extended shifts in the intensive care unit will reduce prescribing errors and improve intern well-being.
Newborns in the neonatal intensive care unit (NICU) are at high risk for wrong-patient errors. Effective 2019, The Joint Commission requires that health systems adopt distinct methods of newborn identification as part of its National Patient Safety Goals. Displaying patient photographs in the electronic health record (EHR) is a promising strategy to improve identification of children and adults, but is unlikely to be effective for identifying newborns. This study assesses the use of Pictographs as a "photo equivalent" for improving identification of newborns in the NICU. This multi-site, two-arm, parallel group, cluster randomized controlled trial will test the effectiveness of Pictographs for preventing wrong-patient order errors in the NICU. Pictographs consist of three elements: 1) pictorial symbols of easy-to-remember objects (e.g., rainbow, lion); 2) the infant's given name (when available); and 3) a color-coded border indicating the infant's sex. The study will be conducted at three academic medical centers that utilize Epic EHR. All parents or guardians will be asked to select a unique Pictograph for each infant admitted to the NICU to be displayed on the isolette and in the EHR for the duration of the infant's hospital stay. All clinicians with the authority to place electronic orders in the study NICUs will be randomly assigned to either the intervention arm (Pictographs displayed in the EHR) or the control arm (no Pictographs displayed in the EHR). The main hypothesis is that clinicians assigned to view Pictographs in the EHR will have a significantly lower rate of wrong-patient order errors in the NICU versus clinicians assigned to no Pictographs. The primary outcome is wrong-patient order sessions, defined as a series of orders placed for a single patient by a single clinician that contains at least one wrong-patient order. The Wrong-Patient Retract-and-Reorder (RAR) measure, a validated, reliable, and automated method for identifying wrong-patient orders, will be used as the primary outcome measure. The Wrong-Patient RAR measure identifies one or more orders placed for a patient that are retracted within 10 minutes, and then reordered by the same clinician for a different patient within the next 10 minutes. In the validation study conducted at a large academic medical center, real-time telephone interviews with clinicians confirmed that 76.2% of RAR events were correctly identified by the measure as wrong-patient orders.
This is a multi-site, 4-arm randomized controlled trial to test the effectiveness of patient photographs displayed in electronic health record (EHR) systems to prevent wrong-patient order errors. The study will be conducted at several academic medical centers that utilize two different EHR systems. Because EHR systems have different functionality for displaying patient photographs, two different study designs will be employed. In Allscripts EHR, a 2-arm randomized trial will be conducted in which providers are randomized to view order verification alerts with versus without patient photographs when placing electronic orders. In Epic EHR, a 2x2 factorial trial will be conducted in which providers are randomized to one of four conditions: 1) no photograph; 2) photograph displayed in the banner only; 3) photograph displayed in a verification alert only; or 4) photograph displayed in the banner and verification alert. The main hypothesis of this study is that displaying patient photographs in the EHR will significantly reduce the frequency of wrong-patient order errors, providing health systems with the evidence needed to adopt this safety practice.
Preventing contextual errors requires heightening clinician responsiveness to clues that there are contextual factors during the clinical encounter, in real time. These clues, termed contextual red flags are evident in two sources: the medical record and from patients directly. An effective intervention would prompt clinicians to determine whether there are underlying contextual factors that could be addressed in the care plan, averting contextual error. This desirable process is termed contextual probing. While clinical decision support (CDS) has been used to provide physicians with timely biomedical information at the point of care to prevent errors and promote appropriate care, this technology also affords an opportunity to draw physician attention to both contextual red flags and contextual factors in order to avert contextual errors. This study assesses the potential of "contextualized CDS" to improve contextualization of care through a randomized controlled intervention trial, with assessment measures of both patient health care outcomes and averted costs associated with overuse and misuse of medical services. The three hypotheses are that CDS: 1. Reduces contextual error: CDS tools that inform clinicians of contextual factors and prompt them to explore contextual red flags should result in a reduction in contextual error. 2. Improve health care outcomes: Contextualized CDS predicts improved health care outcomes defined as a partial or full resolution of the contextual red flag (e.g. elevated HgB A1c) after the index visit. 3. Reduces avoidable health care costs: Contextualized CDS is associated with a reduction in misuse and overuse of inappropriate or unnecessary medical services.
This study is designed to achieve the following aims: 1. Assess the relationship between the number of records open at the time of placing an order, and the risk of placing an order on the wrong patient. 2. Compare the incidence of wrong-patient orders in a "restricted environment" that limits its providers to only one record open at a time to an "unrestricted environment" where users can open a maximum of four records at once. 3. The results of this study will help inform decisions on how to safely implement EHR systems. 4. The results of this study will inform a larger scale health IT implementation research project evaluating the balance between the wrong-patient error risks and potential efficiency gains of having multiple records open at once, with rigorous research methodologies.
Because communication and handoff failures are a root cause of two-thirds of "sentinel events"- serious, often fatal preventable adverse events in hospitals improving handoffs has been identified by AHRQ and the Joint Commission as a priority in nationwide efforts to improve patient safety. Comparative Effectiveness Research on handoff tools and processes has identified specific strategies to improve handoffs and reduce medical errors: 1) team training; 2) verbal mnemonics; and 3) use of written/computerized tools to supplement verbal sign-outs. To accelerate residents' use of CER-based handoff practices and improve patient safety, the investigators are implementing the three inventions above as a Resident Handoff Bundle (RHB) in eight pediatric hospitals in the United States and Canada.
The investigators sought to determine if implementing a standardized sign out process would reduce the amount of medical errors related to patient sign out. The standardized process included the following interventions: implementation of a data resident to review patients lab values, vital signs, radiologist results, and orders in real time, conducting sign out in a standardized location and using the attending physician as an "interruption manager." The investigators defined medical errors related to sign out as any piece of information was incorrectly reported or omitted during sign out that caused a change in treatment or disposition discussed during sign out. The investigators hypothesis was that implementing a standardized sign out process would lead to a decrease in the amount of sign out related errors.
The investigators propose to test the hypothesis that implementation of a comprehensive handoff program (CHP) - i.e., implementation of a computerized handoff tool along with teamwork training for internal medicine residents on inpatient units at Walter Reed and Madigan Army Medical Centers - will lead to reductions in resident miscommunications / medical errors and improvements in workflow and experience on the wards.
This study will test if giving parents access to their child's medical notes on a bedside tablet: * helps them get more involved in their care * helps identify safety concerns Parents of hospitalized children will be randomly assigned to either use the Bedside Notes tool or follow usual care. To see if this approach improves care and safety, researchers will measure: * note access * parent-reported safety concerns * overall experiences
In this proposal, we seek to address conclusively two knowledge gaps: 1) the lack of data on the relationship between PGY2+ (post graduate year 2) sleep deprivation and patient safety; and 2) the lack of data on the relationship between resident sleep deprivation and preventable patient injuries. Through the Clinical and Translational Science Award (CTSA)-funded Sleep Research Network, the largest and only federally-funded sleep science network in the U.S., we propose conducting a multi-center randomized crossover trial in six pediatric ICUs staffed by PGY2 and PGY3 residents. We will compare rates of all serious errors (i.e., rates of harmful and other serious medical errors due to any cause, including but not limited to fatigue-related errors, handoff errors, and provider knowledge deficits) of a sleep and circadian science-based (SCS) intervention schedule with a traditional schedule that includes frequent shifts of 24 hours or longer. Our specific aims will be: 1. To test the hypothesis that PGY2\&3 residents working on an SCS intervention schedule will make significantly fewer harmful medical errors (preventable adverse events) and other serious medical errors (near misses) while caring for ICU patients than residents working on a traditional schedule; (primary endpoints: resident-related preventable adverse events and near misses) 2. To test the hypothesis that rates of harmful medical errors (preventable adverse events) and other serious medical errors (near misses) throughout the ICU (i.e., those involving and those not involving residents) will be lower in ICUs when PGY2\&3 residents work on an SCS intervention schedule than when residents work on a traditional schedule; (major secondary endpoints: ICU-wide preventable adverse events and near misses) 3. To test the hypothesis that resident physicians' risk of neurobehavioral performance failures and motor vehicle crashes - as assessed through simple visual reaction time tasks \[Johns Drowsiness Score (JDS) and Psychomotor Vigilance Task (PVT) lapses\] - will be lower on the SCS intervention schedule than on the traditional schedule. (major secondary endpoints: resident neurobehavioral performance and predicted driving safety)
Chronic kidney disease (CKD) is common, but it is often over-looked in patients with this disease when they are getting medical treatment. Patients with CKD have special needs for their medical treatment. When these special needs are not considered their medical care may lead to unintended harm (called safety events) which can cause hospitalization, more kidney problems, and even death. This research study has two purposes. The first purpose is to determine how participants feel about wearing a medical alert bracelet or necklace that alerts health care workers that the user of the bracelet or necklace has decreased kidney function. Medical alert bracelets are often recommended for people who have other medical problems, such as diabetes. This medical alert bracelet or necklace has an address to an informational website about the safe care of patients with kidney problems. The investigators think that alerting health care workers that a person has decreased kidney function may decrease their chances of having a medical injury and improve the safety of their care. The second purpose of this research study is to track how often people with kidney problems may be exposed to medicines, tests, or procedures that might increase their chance of having an accidental medical injury or safety event. Though some medical injuries can not be prevented, the investigators want to find out what medical events in patients with kidney problems might be preventable. The investigators also want to find out if other things might increase a patient's chances of getting a medical injury, such as physical weakness or medical instructions that might be confusing.
With the increased adoption of CPOE systems, it is important to recognize that design flaws have resulted in the creation of new types of iatrogenic medical errors. An example of a new type of iatrogenic medical error introduced by CPOE systems has been named "juxtaposition errors". Juxtaposition errors, as defined by Ash, et al. are "errors that can result when something is close to something else on the screen, and the wrong option is too easily clicked in error." Juxtaposition errors can lead to a patient receiving a medication, a test, or a treatment intended for another patient, sometimes with dire consequences. Juxtaposition errors are likely a subclass of a broader group of wrong-patient CPOE errors that have multiple etiologies. The primary objectives of this research proposal is to investigate the prevalence of wrong-patient near miss CPOE errors, to investigate the root cause of these errors, and to investigate and compare the efficacy and workflow impact of two distinct interventions to prevent these errors.
Medication reconciliation, a process by which a provider obtains and documents a thorough medication history with specific attention to comparing current and previous medication use, can prevent medication-related errors and harm. The aims of this study are: 1) To adapt medication reconciliation to include information from a computerized regional health information exchange (RHIO) in the Bronx, 2) To conduct a trial of the adapted medication reconciliation process and examine effects on medication errors, harm, and hospital costs, and 3) To identify factors that are barriers to adoption of the RHIO tool by James J. Peters (Bronx) VA providers. Findings from this project will provide an understanding of the effect of the RHIO tool on reducing harmful VA and non-VA medication use. It will also provide information on the feasibility of incorporating RHIO tool use into every day work flow for pharmacists and physicians.
The investigators propose to test the hypothesis that implementation of a comprehensive handoff program (CHP) - i.e., implementation of a computerized handoff tool along with teamwork training for pediatric residents on inpatient units at Children's Hospital Boston - will lead to reductions in resident miscommunications / medical errors and improvements in workflow and experience on the wards.
The study will measure the effect of basic clinical decision support on medical errors and adverse drug events in the ambulatory setting.
This study will test the feasibility and effectiveness of protected time for physicians in training during 30 hour shifts in a medical intensive care unit. The primary outcome will be fatigue. Secondary outcomes include the amount slept while on call, depression, and burnout.
The Neonatal Resuscitation Program (NRP) is the curriculum used to teach providers how to care for newborns in the delivery room. Breakdowns in teamwork and communication contribute to NRP quality problems. Adding teamwork instruction to NRP may be a method to improve communication, teamwork, and the overall quality of neonatal resuscitation. This study uses simulation to incorporate team training into NRP and to evaluate both the effectiveness and duration of the team training. Furthermore, because high fidelity simulation is very expensive and not widely available, we will compare NRP with low fidelity team training to NRP with high fidelity team training. Our hypotheses are: 1. NRP with low fidelity team training results in a) better teamwork, and b) better quality of care compared with standard NRP. 2. NRP with high fidelity team training does not result in better teamwork or better quality of care than NRP with low fidelity simulation. 3. NRP with high fidelity team training does not produce a longer lasting effect on teamwork than NRP with low fidelity simulation.
The Emergency Department (ED) is a unique environment in medicine, and many safety mechanisms used in other hospital settings cannot be applied in the ED. For example, clinical pharmacists have traditionally provided extra layers of protection to hospital inpatients by cross-checking provider orders for appropriate dosing, contraindications, and interactions. Because medications in the ED must be accessed immediately and are often one-time doses, the use of central pharmacy services would introduce an unacceptable delay to the administration of medication. Although some hospitals have programs in place in which a pharmacist responds to the ED for cardiac arrests or trauma team activations, few have reported programs which involve a clinical pharmacist assigned exclusively to the emergency department. Nonetheless, published reports have asserted that ED-based pharmacists can increase patient safety. Although this concept appears logical, no study has attempted to show that these programs reduce potential adverse drug events in the ED. We propose to implement and optimize an ED Pharmacist (EDP) program as a safe practice intervention in a large ED. The hospital has provided funding for two permanent full time positions starting at the beginning of the award period. In the initial phase interviews of physicians, nurses, pharmacists, and patients will be conducted and the results will be used to optimize the EDP role. A large-scale chart review study will then be conducted to evaluate whether there is a reduction in frequency of potential and adverse drug events during times that the EDP is on duty. Staff perceptions of the effectiveness of this program will also be evaluated. The overall goal of this initiative is to create an effective EDP program that will decrease the rate of adverse drug events in ED patients, and to create a "toolkit" to facilitate the introduction of similar programs into other EDs. This toolkit will include a description of the formal, optimized role of the EDP, challenges and solutions in implementation, and evidence to support the efficacy of such a program.
The purpose of this study is to determine if a modified paper prescribing form decreases prescribing errors compared to a traditional or standard paper prescribing form.
The purpose of this study is to better understand outpatient prescribing errors through clinic and pharmacy-based error reporting systems.
The transition from hospital to home is a high-risk period in a patient's illness. Poor communication between healthcare providers at hospital discharge is common and contributes to adverse events affecting patients after discharge. The importance of good communication at discharge will increase as more primary care providers delegate inpatient care to hospitalists. Any process that improves information transfer among providers at discharge might improve the health and safety of patients discharged from U.S. hospitals each year, and to appreciably reduce unnecessary healthcare expenditures. Information transfer among healthcare providers and their patients can be undermined because of inaccuracies, omissions, illegibility, logistical failure (e.g., information is never delivered), and delays in generation (i.e., dictation or transcription) or transmission. Root causes include recall error, increased physician workloads, interface failures (e.g., physician-clerical) and poor training of physicians in the discharge process. Many of the deficiencies in the current process of information transfer at hospital discharge could be effectively addressed by the application of information technology. The proposed study will measure the value of a software application to facilitate information transfer at hospital discharge. The study is designed to compare the benefits of discharge health information technology versus usual care in high-risk patients recently discharged from acute care hospitalization. The design is a randomized, single-blind, controlled trial. The outcomes are readmission within 6 months, adverse events, and effectiveness and satisfaction with the discharge process from the patient and physician perspectives. The cost outcome is the physician time required to use the discharge software.
This study assessed whether a medical education intervention improves the quality of medical decision making in the care of patients with complex psychosocial -- or contextual -- needs that are essential to address when planning their care. A group of internal medicine residents were randomly assigned to participate in the seminar and practicum and then they, along with a control group that had not participated, were assessed for the quality of their clinical decision making and its impact on patient care. The study also assessed whether contextualization of care is associated with better patient health care outcomes
Original study: Study aims to enroll 3-5 children with confirmed Urinary Cycle Disorder (UCD). Subjects meeting the inclusion and exclusion criteria are included during the baseline visit. All subjects will receive the investigational product for a period of 16 weeks. At baseline, 2, 4, 8, 12 and 16 weeks the study parameters are assessed. The study amendment aims to collect case studies retrospectively of children who have used UCD Anamix Infant for at least 16 weeks, in countries where UCD Anamix Infant is already available on the market. It is aimed to collect the same study parameters of the original study at preferably the same timepoints.
This project will introduce and evaluate an intervention designed to improve diagnostic decision making. The intervention will attempt to increase clinician mindfulness and reduce environmental distractions to promote focused thinking. A meta-cognitive intervention using a structured checklist will be evaluated to identify improvement in diagnostic and therapeutic decision-making and examine the role of mindfulness and architectural design in enhancing patient safety.
During the project, fourth-year medical students participating in a Medicine sub-internship will be randomized to an intervention group or a control group; the intervention group will receive additional training in the application of qualitative methodology to elicit and incorporate contextual factors in the clinical encounter. All students will participate in an SP assessment consisting of four standardized patients (SPs), blinded to trial arm, presenting cases with and without important biomedical and contextual factors in a counterbalanced factorial design. Performance will be compared between trial arms; the investigators hypothesize better performance in the intervention arm. In addition, performance will be compared with United States Medical Licensing Exam (USMLE) Step 2 clinical knowledge scores to determine whether contextualizing ability is independent of clinical knowledge, and consistency of performance across individual SP cases will be studied to determine the number of cases necessary to achieve sufficient reliability for the assessment to be used.
The purpose of this study is to determine how effective ward-based clinical pharmacists and computerized physician order entry systems are in reducing serious medication errors in pediatric inpatients.
This study determines whether the mHealth intervention, Meds@HOME, helps caregivers improve medication administration to Children with Medical Complexity (CMC) who use high-risk medications. A total of 152 primary caregivers, 152 children, and up to 304 secondary caregivers will be recruited and can expect to be on study for up to 6 months.
The Taconic IPA, a 2,500 physician independent practice association (IPA) located in Fishkill, New York (NY), is involved in an information technology project to improve the quality, safety and efficiency of healthcare in the region. Over the past three years, the organization has worked with area hospitals and laboratories to create a community wide electronic data exchange. Currently, the Taconic IPA is in the midst of implementing a full electronic health record in some practices and e-prescribing in other practices. The purpose is to study the impact of an electronic health record on safety and quality measures.
This study includes four projects aimed to improve the quality and safety of pediatric care through the implementation of four clinical decision support services in the electronic health record (EHR). The four projects will measure the effect of each clinical decision support feature including: weight-based dosing; smart forms for chronic conditions; guideline reminders; and a results manager to track abnormal lab result follow-up. Hypothesis: Implementation of the clinical decision support features will decrease medication errors and adverse drug events, assist physicians in adhering to clinical practice guidelines and protocols for certain chronic illnesses, improve physician follow-up for abnormal lab results, and overall improve the safety and quality of pediatric clinical practice.