|PRINCIPAL INVESTIGATOR||SPONSOR – FAIN|
Inpatient Provider Rounding Prioritization of Patients Ready for Discharge
Hospitals around the country face bottlenecks and capacity issues. When hospitals are successful at managing high capacity, this allows for increased access for patients who need this higher level of care and expertise. Unfortunately, hospital discharges frequently occur in the afternoon or evening hours and can adversely affect patient flow throughout the hospital which, in turn, can result in delays in care, medication errors, increased mortality, longer lengths of stay, higher costs, lower patient satisfaction, and decreased access to care at these facilities. While some of the delays in discharges result, appropriately, from the caring of other patients and conducting the necessary tasks and assessments for acutely ill patients, our previous work also identified that providers may be able to prioritize their work in a different way in order to facilitate this throughput. We aim to conduct a randomized controlled trial of physician rounding style at three institutions in order to: (1) determine if prioritizing discharging patients first will result in earlier discharges and decreased lengths of stay, (2) determine if prioritizing discharges first will cause other care delays or affect patient experience and, (3) determine factors that contribute to physician ability to prioritizing discharges first.
Population Health in Pediatric Sex Chromosome Aneuploidies
One in 400 infants have an atypical number of X and Y chromosomes, collectively known as sex chromosome aneuploidies (SCAs). Despite the number of individuals affected by SCAs, they often go unrecognized and are vastly understudied, particularly in children. With recent changes in non-invasive prenatal testing recommendations, more infants with SCAs are being diagnosed. However, our ability to provide accurate counseling to parents or guidelines for clinical practice is limited. This project utilizes data from a large network of major children’s healthcare systems across the US (PEDSnet) to study >4,000 youth with SCAs. In Aim 1 we will quantify co-existing mental and physical health diagnoses and healthcare utilization in youth with Turner, Klinefelter (XXY), Trisomy X, and XYY syndromes compared to the general pediatric population. In Aim 2 we will describe current clinical care practices that children with these conditions are receiving in the US. Finally, in Aim 3 we will prepare for a future comparative effectiveness study of estradiol in girls with Turner syndrome by developing and validating an algorithm using multiple data elements to establish an accurate computable phenotype. Through this novel, population-based approach to study youth with SCAs, we will have an immediate impact on genetic counseling for patients and families, support and inform the development of clinical practice guidelines, and prepare for future high-impact studies for infants, children, and adolescents with these conditions. In addition to advances for SCA research, the data source and methodologies from this project may be translatable to other genetic syndromes and pediatric rare diseases.
The CBER Biologics Effectiveness and Safety (BEST) Initiative: Data, Tools, and Infrastructure for Surveillance of Biologics
The overall goal of this contract is to expand and enhance the current FDA Center for Biologics Evaluation and Research (CBER) capabilities with respect to data sources, infrastructure, methods, and tools and to conduct surveillance and epidemiologic studies that promote the Office of Biostatistics and Epidemiology's mission to assure the safety and effectiveness of biologic products including vaccines, blood and blood products, tissues and advanced therapeutics. The specific objectives of this contract are: (1) to provide the FDA with indirect access to large-scale the United States health care data of millions of patients including administrative and claims as well as electronic health records (EHR) data sources; (2) to build an infrastructure to provide data sources and the capacity to run queries and observational studies on the data sources for CBER-regulated biologic products; and (3) to develop semi-automated processes for medical chart review to augment manual review of charts.
Development and evaluation of a palliative-transitional home health care model
The overall goal of this project is to engage key stakeholders including hospitalists, primary care providers, home health clinicians (e.g., nurses, physical therapists, social workers), patients, and informal caregivers, to develop, refine, and pilot test a Palliative-Transitional Home Health Care (PT HHC) model to provide enhanced support after discharge for patients with additional palliative and transitional care needs. Patients receiving HHC are older and sicker than patients who are discharged home without HHC, yet current HHC does not assess or address palliative care needs. Care models incorporating palliative care principles have reduced health care utilization and improved the quality of care delivery in hospitals, nursing homes, and skilled nursing facilities. However, care models that incorporate both transitional and palliative care in HHC are lacking. Through this work, we aim to improve care for HHC patients with additional palliative and transitional care needs.
Reducing Asthma Attacks in Disadvantaged School Children with Asthma
Asthma is a leading cause of children’s hospitalizations, missed school days and caregivers’ missed work days that has a significant impact on low income families. We seek to increase asthma control for children with uncontrolled asthma and health disparities, in order to improve the outcomes of activity, symptoms, and reduce asthma exacerbations. We will evaluate whether two interventions, an evidence-based school asthma program and an assessment of social determinants of health (with the aid of an asthma navigator and school nurse champion) can be disseminated and implemented in other school settings to reduce the risk of asthma attacks.
|PRINCIPAL INVESTIGATOR||SPONSOR – FAIN|
Developing and Evaluating a Community-Based System for Rapid Dissemination of Evidence-Based Information and Research Specific to COVID-19
The long-term objective is to create a thriving community-academic partnership actively engaged in disseminating and conducting COVID-19 patient-centered outcomes and comparative effectiveness research (PCOR/CER). The purpose of this project is to develop the infrastructure necessary to achieve this goal. The specific aims are: 1) increase community stakeholder capacity for COVID-19 PCOR/CER, 2) create infrastructure for disseminating and implementing COVID-19 PCOR/CER results in the community, and 3) build community stakeholder-academic partnerships. The aims will be completed by the following objectives: 1) adapt Boot Camp Translation for rapid and virtual implementation, 2) establish a COVID-19 community action council 3) create a brief COVID-19 capacity building training, 4) develop infrastructure for community-based dissemination and implementation of COVID-19 research, 5) identify COVID-19 PCOR/CER questions, and 6) develop and disseminate a formal report on project outcomes.
Calcaterra, Susan L
Understanding Factors that Limit Access to Opioid Use Disorder Treatment in the Hospital to Inform Innovative Approaches to Expand Hospital-Based Treatment
Expanding access to medications for opioid use disorder, including buprenorphine for opioid use disorder treatment and naloxone for overdose reversal, is a critical piece in a comprehensive plan for addressing the opioid epidemic. The proposed research will contribute knowledge about existing barriers to integrating evidence-based opioid use disorder treatment in the hospital setting and aims to expand access to buprenorphine and naloxone for hospitalized patients with opioid use disorder. The proposal closely aligns with NIDA’s strategic goal to “to help people with addiction achieve a meaningful recovery”.
|DCRI HERO-HCQ TRIAL|
Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial)
Severe acute respiratory syndrome coronavirus 2 associated disease or COVID-19 is caused by a novel betacoronavirus, SARS-CoV-2, that was first isolated in January 2020 and has since caused a global pandemic unseen in decades in cases and mortality. At the time of initial protocol submission in April 2020, human vaccine clinical trials had just begun and experts predicted that a vaccine would not be available until April 2021 at the earliest; therefore new measures remain desperately needed to prevent the spread of disease. In vitro studies suggest a potential moderate antiviral effect of hydroxychloroquine (HCQ) and its well-known safety profile and oral formulation make it an ideal drug candidate for prevention. The primary objective of this study is to evaluate the efficacy of HCQ to prevent COVID-19 clinical infection in healthcare workers (HCWs).
Development of Neuropsychiatric Adverse Events Research Platform
The primary goal of this collaboration is to develop and validate an approach to accurately identify incident pediatric neuropsychiatric events to evaluate adverse drug events in children.
The HPV9-10 Trial: Early Initiation of HPV Vaccination
Every year, thousands of Americans die from cancers related to human papillomavirus (HPV). The vast majority of those deaths could be prevented with a safe and effective vaccine, yet many parents choose not to have their children vaccinated when it is recommended at age 11 or 12. In this study, we will examine in a randomized trial whether earlier initiation of the vaccine at age 9-10 years will result in less parental refusal and higher rates of full vaccination at younger ages, before early sexual activity begins.
Decision Support for Older and Frail Patients Considering Advanced Cardiovascular Therapies: Improving Models of Personal Values Clarification
The drive to be “person-centered” in the care of patients in advanced cardiac care is both intuitive and politically popular – enjoying explicit support from the IOM, AMA, AGS, ACC, FDA, the UN High Commissioner for Human Rights, in the Patient Protection & Affordable Care Act, and elsewhere. Optimal means by which to be patient-centered in the real-world, however, is unknown. Critically examining the ways in which healthcare providers assess patient values will be necessary to innovate the manner in which this assessment occurs and is integrated into care for patients. The overarching objective of this career development award is to continue the professional and methodologic growth of Christopher Knoepke, PhD, MSW, LCSW, into an independent clinical social work scientist leading the field of cardiology toward improved patient-centered care by means of 1) contextually-appropriate qualitative assessment of patient values in clinical settings; 2) understanding what clinical providers need in order to actually implement improved values clarification methods into practice; and 3) studying the effectiveness and implementation integration of new models of patient decision support using pragmatic trial techniques.
Masoudi, Frederick A
Effect of Hospital-Cardiologist Integration on Clinical Practice, Healthcare Quality and Medicare Spending
Understanding the effects of vertical integration on healthcare quality, patient outcomes, and cost will be of high importance to payers and policymakers, in deciding how to respond to the vertical integration trend. If we find quality improvements, this would justify investing in and encouraging vertical integration. If we find no significant effects or negative effects on quality, this would support policies that discourage integration.
Improving Communication and Healthcare Outcomes for Patients with Communication Disabilities: the INTERACT Trial
In the United States, 14% of all adults report a speech, language, voice, and/or hearing disability (collectively known as communication disabilities, CD). Patients with CD experience inequities in receipt of and access to high-quality healthcare services, including primary care. Poor patient-provider communication is a significant contributor to these disparities. When healthcare providers use evidence-based communication strategies, patients with CD have improved communication outcomes and satisfaction. Unfortunately, providers rarely use these strategies in practice. We will compare the effectiveness and implementation of 2 interventions to increase primary care providers' use of communication strategies, improving the quality of their communication with patients with CD.
Virtual Network to Investigate the Trajectory of COVID-19-Related Severe Outcomes
This project will leverage existing collaboration among multiple health systems to pilot and understand the use and limitations of existing medical, laboratory, pharmaceutical, and vaccination records for conducting research on COVID-19. The network of collaborating sites can address gaps in our understanding of the risk of COVID-19, its complications, and eventually the effectiveness of vaccination.
Schilling, Lisa M
iAGREE: A Multi-Center, Networked Patient Consent Simulation Study
Honoring patient preferences for sharing their electronic health records in a way that meets institutional requirements for adoption is a challenge. Through our study, we propose to find a solution for both, which will result in a system that authenticates patients, allows them to make sharing choices, and change sharing choices based on each study’s parameters. In addition, we will incorporate the needs and input of stakeholders (e.g., patients, institutional leaders, IRB experts) during each stage of the project.
Rapid Response Data for Discoveries: COVID-19 Clinical Data Collection to Promote Better Outcomes
The pSCANNER network includes 11 health systems, including the VA in all US states, and sites in California, Colorado, and Texas, covering over 30 million patients. The Gordon and Betty Moore Foundation funded pSCANNER to create a rapid response system to answer COVID-19 research questions. Researchers & clinicians anywhere can submit a question online and review previously asked and answered questions from a public website.
New Frontier: Using Health Care Data to Improve Population Health CHORDS
The primary goals of this project are to (1) provide aggregate data to inform the public health response to COVID and Colorado’s understanding of the impact of telehealth during COVID, (2) gain greater insights into how data partners are capturing telehealth visits in their electronic medical records, and (3) update the CHORDS data model to include codes and modifiers relevant to telehealth.
ALIGN: A Focused Palliative Care Intervention for Cancer Patients Discharging to Skilled Nursing Facilities
This study is part of a program of research that aims to improve palliative care outcomes for patients with advanced care who discharge to a skilled nursing facility (SNF) for rehabilitation after an acute care hospitalization. SNF patients with advanced cancer have high mortality rates, increased symptom burden, and low rates of future oncologic receipt after an acute care hospitalization. Identifying successful models of palliative care delivery that assist patients and caregivers with advance care planning, facilitates ongoing prognosis communication, and enables high quality communication between patients and their care teams is necessary to provide high quality care for this vulnerable population.
Communities Helping the Hearing of Infants by Reaching Parents: The CHHIRP Navigator
Hearing loss is the most common sensory congenital disorder and this condition is diagnosable and treatable. Infants who are born with hearing loss must undergo several hearing tests to diagnose the condition, and many families are delayed in receiving this testing or never obtain the necessary testing and treatment. This study evaluates (1) whether patient navigation in state-funded clinics throughout Kentucky increases parents' follow- through with testing, (2) factors that promote or impede its delivery, and (3) cost-effectiveness of this approach.
COVID-19 effects on children who are deaf or hard of hearing and their families: Rapid and rigorous mixed-methods research to inform care
This study will assess the effects of COVID-19 on deaf/hard of hearing (DHH) children and their families, particularly on (1) access and use of hearing healthcare and related services, and (2) quality of life. Administrators and direct service providers will identify barriers and facilitators to providing services and support to DHH children and their families during the COVID-19 public health crisis. Combined results from parents and providers will be disseminated to a broad range of stakeholders to inform practice and policy to meet the needs of this vulnerable population.
Urban-Rural Disparities in Healthcare Quality for Children with Complex or Disabling Health Conditions
One in five American children live in rural regions, and almost 3 million of these have chronic health conditions. The overall objective of this project is to analyze three States’ all-payer claims data to comprehensively evaluate urban-rural disparities in healthcare utilization and quality for children with complex or disabling health conditions, and to identify community and health system factors associated with these disparities. This research will be the first population-level analysis to characterize the magnitude of urban-rural disparities in healthcare quality for children with chronic and disabling conditions, generating foundational knowledge to improve clinical care and public health support for this vulnerable population.
|PRINCIPAL INVESTIGATOR||SPONSOR – FAIN|
DeKeyser, Heather, MD, MSCS
Treatment Phenotypes for Adolescents with Asthma
Technology has become available that allows for medication usage tracking for adolescents with asthma, who are at high risk for medication non-adherence. This project seeks to evaluate medication usage patterns in adolescents with asthma, utilize in-depth interview techniques to understand how to improve medication use, and create interventions tailored to each individual. We will then test these interventions to see how feasible they are for implementation in the clinical setting.
Multi-site Validation of a Suite of Clinical Outcome Measures for Clinical Trial Readiness in the CDKL5 Deficiency Disorder
The aim of this project is to develop validated outcome measures for CDKL5 Deficiency Disorder with the goal of developing clinical trial readiness.
The Colorado Pragmatic Research in Health Conference (COPRH): Advancing Pragmatic Science for Health Services Research
The Colorado Pragmatic Research in Health Conference (COPRH): Advancing Pragmatic Science for Health Services Research aims to bring together investigators and statisticians with the goal to address issues in appropriate and
effective use of pragmatic research design and methodology. Our overarching theme for the three conferences are “methods, models, and measures” for pragmatic science for health services research. The University of Colorado
will host an annual national conference featuring experts in pragmatic science. Conference activities will inform design of pragmatic science capacity building tools for application of pragmatic methods and fostering team science
through conference collaborations and our virtual learning community.