|PRINCIPAL INVESTIGATOR||SPONSOR – FAIN|
A retrospective cohort study using administrative claims data to examine the impact of Respiratory Syncytial Virus (RSV) immunoprophylaxis on pediatric respiratory health and economic outcomes, including risk of lower respiratory tract hospitalizations prior to two years of age, risk of asthma after 3 years of age, and total per capita healthcare costs in the first 5 years of life.
Subcontract from CHOP/PCORI
Semantic Data Quality Standards for Multi-Center Clinical Research Studies and Networks
PCOM2 - The Physician Communication Intervention, Version 2.0
Poor quality primary care providers’ vaccine recommendations lead to low adolescent human papillomavirus vaccination rates and hundreds of thousands of adolescents unnecessarily at risk for HPV-associated cancers and diseases. Though our provider communication intervention, called PCOM, was found to be effective for increasing adolescent HPV vaccination in primary care, its dissemination is limited by the need for significant research team involvement to teach providers how to use the intervention’s components. To address this, we propose to develop and test a virtual version of PCOM, use mixed methods to assess contextual factors affecting its use compared to the original PCOM intervention, and develop an optimized version of PCOM for broad dissemination to increase adolescent HPV vaccination nationally.
|Subcontract from CHOP/PCORI|
PEDSnet: Advancing Pediatric Patient-Centered Outcomes Research in PCORnet
Subcontract from Colorado Health Institute (CHI)/CDC
Clinical and Community Data Initiative (CODI) @ CHORDS
|PRINCIPAL INVESTIGATOR||SPONSOR – FAIN|
NFP-PRC Logic Model Consultation
The purpose of this project is to produce a logic model/theory of change that reflects current Nurse-Family Partnership practice and outcomes.
Novel Pediatric Sepsis Criteria and Clinical Decision Support Tools
Sepsis is a life-threatening disease caused by an infection that affects many children around the world and can frequently result in the failure of organs in the human body (for example, the lungs, heart, or kidneys). The current criteria to identify children with sepsis are outdated and have many limitations. The aim of this project is to build a large database containing clinical information about children from both high-income countries and low- and middle-income countries to develop new criteria for sepsis in children using measures of organ function.
Pediatric COVID-19 Severity Dashboard During Delta Variant Circulation (R01 supplement)
Like sepsis, COVID-19 is a life-threatening disease caused by an infection that affects many children around the world and can frequently result in the failure of organs in the human body (for example, the lungs, heart, or kidneys). Detailed national data about the impact of COVID-19 on children over time are not readily available. In this Supplement, we will make information about the trajectories of pediatric COVID-19 hospitalization rates and disease severity readily available for national-level decision-making.
PhotoVoice Project- CDPHE
This project will use the PhotoVoice method to engage youth aged 14 to 17 years to develop messaging on the importance of COVID-19 vaccination to their communities.
Patient Decision Making in Urinary Diversion after Radical Cystectomy
Bladder cancer is a prevalent malignancy representing the 4th most common cancer in men and the 6th most common cancer overall. At a very complex time in their life, patients with bladder cancer face a difficult process that is paramount to their quality of life after surgery for bladder removal. Bladder removal (radical cystectomy) is common and part of the standard treatment for many bladder cancers. When I see bladder cancer patients who will undergo bladder removal, the next step I have to undertake is helping them make a decision about how they want their urine to exit their body after radical cystectomy. This process of shared decision-making (shared decision-making) is where patients are informed about the complexities of each urinary diversion option, risks, and benefits leading to them ultimately making a decision that has a significant impact on their quality of life. It is incredibly important the patient is able to make a very difficult decision with major quality of life implications. This requires patient empowerment and dedication to the provider to provide the empowerment. The objectives of this project are to improve understanding of the overall patient experience and provide critical support for my academic career. We hypothesize patients undergoing radical cystectomy and urinary diversion for bladder cancer that utilizes the patient decision aid before and after surgery developed from this research will find it acceptable.
|01063347 (Prime - 1R01AG068141-01A1)|
The TRAjectories and Clinical ExpeRiences of ICD Therapy (TRACER-ICD) Study
Implantable cardioverter-defibrillators (ICDs) are commonly used in older patients with multiple co-morbidities. This project will use a multi-center cohort study to prospectively define the patient-centered experiences of older patients following ICD implantation. We will then apply these data to the shared decision-making process with individualized decision tools, evaluating the feasibility of a precision approach to ICD use.
|19-017057 (Prime - UCB Biopharma SRL, study #EP0148)|
Retrospective cohort study evaluating treatment pathways through care and potential adverse events in neonatal seizures
The aim of this study is to understand treatment pathways, outcomes, and safety in neonates treated for seizures. This study will evaluate the antiepileptic drug (AED) treatment pathway including dose, time on drugs, the refractory proportion of patients per line of therapy, seizure recurrence and rate, etiology of the seizure, comorbidity, and concomitant prescribing.
HERO: Healthcare Worker Exposure Response and OutcomesThis project aims to expand the HERO (Healthcare Worker Exposure Response and Outcomes) community by leveraging our partnerships with sites that have been affiliated with a HERO project and empowering these sites to directly help enroll participants into HERO. The objectives are to: (1) locally and regionally engage healthcare workers and their families and communities, and promote enrollment of a diverse array of healthcare workers into the HERO Registry; (2) understand the approaches – and value propositions – that are successful in enrolling participants; and (3) continue to understand the unique challenges and experiences facing Registry members, and their priorities for research.
|SRS-HHS-CU-CDSCDC-01 (Prime - 75P00120F80182)|
CDS for CDC Opioid Guidelines
The purpose of this project is to provide support to the Office of the National Coordinator for Health IT (ONC) and the CDC for the refinement and development of electronic clinical decision support (CDS) to be used in and by electronic health records (EHRs) to incorporate recommendation statements from the CDC Opioid Prescribing Guideline and draft updates to that Guideline. The scope of this work will build on previously conducted work that supported the initial development of electronic CDS interventions.
|PRINCIPAL INVESTIGATOR||SPONSOR – FAIN|
Family Inclusive Childhood Obesity Treatment designed for Low Income and Hispanic Families
Childhood obesity is a major public health problem that disproportionately affects low-income Hispanic children. Hispanic families, especially Spanish Speakers, have been under-represented in studies of childhood obesity treatment, and existing interventions have not demonstrated effectiveness for this group. The goal of this project is to evaluate a novel family-inclusive childhood obesity treatment program designed for low-income and Hispanic, including Spanish Speaking, families.
ACCORDS Primary Care Research Fellowship
The Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS) Fellowship in Primary Care will be a collaborative training program between the University of Colorado Anschutz Medical Campus as well as affiliated institutions Kaiser Permanente of Colorado and Denver Health. The goal of the Fellowship is to train post-doctoral professionals to become primary care research leaders to address the nation’s primary care health delivery challenges. The Fellowship is built upon the extensive mentorship experience of the Director and the mentorship team, a curriculum developed over many years of successfully training primary care researchers, and strong methodological expertise in 5 key proposed areas of emphasis: 1. dissemination and implementation (D&I) science, 2. economic analysis to assess value-based care, 3. community-based participatory research (CBPR), 4. health equity, and 5. mixed methods/qualitative methods.
|GRT-00000248 (Prime - 5U01FD006292-03)|
Establishment of the National Evaluation System for Health Technology Coordinating Center (NESTcc) - Comparative Effectiveness of Alternative Approaches for Wound Closure
The mission of the National Evaluation System for health Technology Coordinating Center (NESTcc) is to catalyze the timely, reliable, and cost-effective development of real-world evidence (RWE) to enhance regulatory, clinical, and coverage decision-making throughout the total product lifecycle (TPLC) of a medical device. NESTcc enables research using real-world data (RWD), serves as a Collaborative Community for ecosystem-wide initiatives, and develops capabilities in Active Surveillance for medical device safety. NESTcc provides the infrastructure and expertise to lead the development of RWE research and surveillance activities.
|AWD-213130 (Prime - Study #EP0155)|
Pharmacokinetics and Exposure Outcome in Neonates Administered Lacosamide
Seizures are one of the most common neurologic emergencies in neonates, arising in ~3/1,000 term live births and are associated with significant mortality and neuro-developmental disability. In contrast to seizures in older children, most neonatal seizures result from acute symptomatic etiologies rather than epilepsy. Treatment is largely guided by physician preference and tradition, due to a lack of data from well-designed clinical studies. Based on these factors, UCB Biopharma SRL (UCB) has decided to set up an epidemiological neonatal seizure study evaluating pharmacokinetics (PK) and effectiveness outcome to support development of a clinical study and provide evidence for the clinical and patient community. The study will include all neonates initially exposed to iv Lacosamide (LCM) in PEDSnet and PCORnet.
Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities
In the U.S., 8.37 million adults over age 65 will experience a hospital stay during the next year, which often has serious and long-lasting consequences including profound deterioration in physical function. Following a hospital stay, around 1.35 million patients with deconditioning require rehabilitation in a skilled nursing facility (SNF) each year to address the deleterious musculoskeletal and functional deficits from deconditioning. Unfortunately, current rehabilitation paradigms in SNFs do not adequately restore physical function, which directly contributes to poor community discharge rates. Strikingly, only 52% of all patients admitted to SNFs are discharged to a community setting (e.g., home), which suggests a paradigm shift is required to optimize rehabilitation within SNFs. Currently, usual care rehabilitation in SNFs consists of low-intensity rehabilitation interventions, which are physiologically inadequate to induce meaningful changes in skeletal muscle strength and physical function. To address these pitfalls, a high-intensity resistance rehabilitation paradigm has been shown to improve outcomes including better physical function, increased community discharge rates, and cost-effective reductions in length of stay. The proposed pragmatic study seeks to apply this rehabilitation paradigm to multiple SNFs to further evaluate the effectiveness of high-intensity resistance rehabilitation (Aim 1), while evaluating processes, mechanisms, and determinants of successful implementation (Aim 2).
|1815 (Prime - 1R61HD105619-01)|
COVID-19 Network of Networks Expanding Clinical and Translational approaches to Predict Severe Illness in Children (CONNECT to Predict SIck Children)
The SARS-CoV-2 pandemic has manifested in children with a wide spectrum of clinical presentations ranging from asymptomatic infection to devastating acute respiratory symptoms, appendicitis (often with rupture), and Multisystem Inflammatory Syndrome in Children (MIS-C), a serious inflammatory condition presenting several weeks after exposure to or infection with the virus. These presentations overlap in their clinical severity while maintaining distinct clinical profiles. Public health and clinical approaches will benefit from an improved understanding of the spectrum of illness associated with SARS CoV-2 and from the capacity to integrate data to achieve two goals: (i) to identify the clinical, social, and biological variables that predict severe COVID-19 and MIS-C, and (ii) to target those populations and individuals at greatest risk for harm from the virus. We propose the COVID-19 Network of Networks Expanding Clinical and Translational approaches to Predict Severe Illness in Children (CONNECT to Predict SIck Children) comprising eight partners providing access to data on >15 million children. Our network will systematically integrate social, epidemiological, genetic, immunological, and computational approaches to identify both population- and individual-level risk factors for severe illness. Our underlying hypothesis is that a combination of multidimensional data – clinical, sociodemographic, epidemiologic, and biological – can be integrated to predict which children are at greatest risk to have severe consequences from SARS-CoV-2 infection.
|3200004059-21-335 (Prime - 5R01HL152714-02)|
Implementing an Evidence-Based mHealth Diet and Activity Intervention: Make Better Choices 2 for Rural Appalachians
We propose a type 1 hybrid effectiveness-implementation study to test an adapted evidence-based intervention and explore critical implementation issues, including feasibility, acceptability, and costs, that influence scale-up and sustainment. We will focus this adaptation, effectiveness, and implementation study on underserved rural residents, a population that maintains extremely high rates of suboptimal diet and sedentary behaviors, placing them at elevated risk for cardiovascular disease, obesity, diabetes, cancer, and other chronic conditions. Within the vulnerable low socioeconomic status population of rural residents, Appalachian Kentuckians experience even worse health outcomes, including among the highest rates of morbidity and mortality in the nation. Such adversity is exacerbated by and associated with inadequate community resources. Increasingly, however, Appalachian residents and other vulnerable populations are gaining access to modalities that may be useful in addressing these health challenges, including internet connectivity and nearly ubiquitous cell phone use. Despite this accelerating technology use, the evidence base on personal technology-associated interventions (mHealth) in a rural, high need population remains sparse. We propose finalizing adaptation and testing of an evidence-based multicomponent mHealth intervention, Make Better Choices 2 (MBC2), a behavioral program consisting of personalized health coaching, an app, accelerometer, and financial incentives.
|PRINCIPAL INVESTIGATOR||SPONSOR – FAIN|
(Prime - 7K23HL141704-03)
Developing a Novel Decision Aid for Tracheostomy to Support Shared Decision-Making in the Intensive Care Unit
Tracheostomy utilization is increasing in the United States but evidence suggests patients and their decision- makers experience substantial decisional conflict and regret exists as they feel uninformed about prognosis and feel that their values and preferences were not considered. In order to better improve the patient centeredness of care, align treatments with patient values, reduce unwanted procedures, and reduce healthcare costs, multiple societies strongly recommend the use of shared decision-making in the intensive care unit which can often be facilitated with decision aids. Our proposal seeks to combine qualitative value assessments with long-term outcome predictions for patients with tracheostomy in order to create a personalized web based tracheostomy decision aid that we hypothesize will reduce decisional conflict and regret as well as better align patient care with underlying values and expectations.
Reducing Asthma Attacks in Disadvantaged School Children with Asthma
(Diversity Supplement - postdoctoral support for Udoko Mfonobong) 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|
Dorsey Holliman, Brooke
Enhancing Maternal/Birth-Outcomes Research by Advancing Culturally-Informed Engagement
In the United States, Black women (BW) experience severe maternal morbidity and mortality at a notably higher rate than their non-Black counterparts. Recent population-based data analyses have found that non-Hispanic BW are 3.4 times more likely to experience pregnancy-related mortality than non-Hispanic White women. In addition, across the country, BW bear the greatest burden of severe pregnancy-related complications such as hemorrhage, eclampsia, and stroke, among others. Disparities in severe maternal morbidity and mortality can result from patient, community/neighborhood, provider, or healthcare system factors occurring at any level of maternal care (preconception to postpartum). While patient-level factors may contribute to differences in maternal health care and outcomes, evidence suggests that provider- and system-level factors are strong contributors to negative maternal health outcomes experienced by BW. Regionally, the impact of each of these factors on maternal health outcomes for BW vary. To date, much patient-centered outcomes research (PCOR) related to severe maternal morbidity and mortality is being conducted in regions in which there is a significant Black population. Similarly, the development of and evaluation of resources to improve outcomes for this population are becoming increasingly accessible in those areas. However, similar disparities in maternal morbidity and mortality are observed across states and communities, regardless of demographic distribution. In Colorado, non-Hispanic Black people make up less than 5% of the overall population and only 5.4% of births are to BW; however, this population accounts for nearly 10% of Colorado’s maternal deaths. The top severe maternal morbidity events leading to pregnancy-related death in Colorado include cardiovascular conditions (e.g., cardiomyopathy), infection, and hemorrhage.
01062185 (Prime - 5R01AG065311-02)
A Conversation Aid on Mammography Screening to Support Shared Decision Making between Clinicians and Women Aged 75 and Older
Since the utility of breast cancer screening in later life varies according to women's life expectancy, risk of breast cancer, and preferences, experts and guidelines recommend that primary care clinicians engage women aged 75 and older in shared decision making around mammography screening (meaning that primary care clinicians inform women of the possible benefits and harms of screening, elicit patient values and preferences, and together decide on a course of action); however, primary care clinicians report feeling ill- prepared and request support for these conversations. Therefore, with help from primary care clinicians, women aged 75 and older, their family members, medical assistants, and other expert stakeholders, we aim to develop and test in diverse “real-world” primary care practices an easy-to-use, flexible, and adaptable, interactive web-based conversation aid that will provide personalized estimates of the benefits and harms of mammography screening for older women using the most up-to-date data and simulation modeling methods. We anticipate that use of our conversation aid will allow primary care clinicians to feel more supported and prepared to engage older women in shared decision making around mammography screening and as a result older women will make more informed decisions around mammography screening consistent with their values.
|AWD-211586 (Prime - NU38OT000316-03-02)|
COVID-19 Electronic Health Data Initiative
The COVID-19 electronic healthcare data initiative project will demonstrate PCORnet sites' ability to collect information on COVID data through the implementation of a nationally distributed data infrastructure. The collection of these COVID-19 data will help to answer critical questions to assist in the emergency response to the COVID-19 pandemic.
Understanding Affective Processing of Scientific Evidence to Promote Informed Choice for Breast Cancer Screening
Given past health messages that strongly promoted mammography screening, recent revisions to guidelines that promote informed choice constitute a health message reversal that can be difficult for many women to accept. This research will employ nationally representative and longitudinal surveys of women 40-49 that aim to understand women’s affective reactions to screening evidence and the consequences of those reactions for screening preferences and shared decision making with a primary care provider. This research will directly inform how to more effectively communicate about breast cancer screening to maintain credibility and trust when health messages change.
Childhood Obesity Data Initiative (CODI) @ CHORDS
The purpose of the Childhood Obesity Data Initiative (CODI) is to facilitate access to integrated multi-sector data from pediatric care and weight management programs (WMPs) based in clinical or community settings. The project seeks to build data capacity for research that assesses strategies to prevent and treat childhood obesity and to integrate with the CHORDS data network infrastructure.
|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.
|PRINCIPAL INVESTIGATOR||SPONSOR – FAIN|
Parents as their Child's Certified Nursing Aide: Evaluation of a Unique HOme Health Care Model for Children with Medical Complexity
This project aims to increase knowledge of Colorado’s Parent as their Child’s Certified Nursing Aide Program, a unique home health care model for children with medical complexity. This project is a focused research agenda designed to addresses the evidence gap in understanding of a family-centered self-management program that can be enhanced and disseminated to improve health outcomes and quality of life for patients, families, and communities.
Pragmatic Implementation Science Approaches to Assess and Enhance Value of Cancer Prevention and Control in Rural Primary Care
We work with rural primary care clinic partners - including their clinical staff, patients, and families - to support the rapid development, testing, and refinement of innovative approaches to implement a range of evidence-based cancer control interventions such as shared decision making around lung cancer screening and smoking cessation in ways that enhance value. We provide leadership for an Implementation Science consortium across this and other Cancer Moonshot initiatives.
Engaging practices and communities in the development of interventions to promote HPV vaccine uptake
The overall goal of this project is to engage key stakeholders with providers and researchers to develop and evaluate the impact of a novel and innovative intervention strategy for improving the uptake of HPV vaccine in the primary care setting.
Publishing and Disseminating a National Research Agenda for CYSHCN
The current US health care system is not set up well to serve children and youth with special health care needs (CYSHCN). Comprehensive health system standards for CYSHCN have recently been developed, but these standards are seldom met. To better achieve these standards, CYSHCN deserve their own health system research focus. CYSHCNet, a national health systems research network is developing a national research agenda to help steer this work. During the past year and a half, we have gathered extensive data to develop the agenda through a rigorous, multi-stakeholder group process approach. This grant will help publish this agenda in detail and disseminate it using a multi-modal approach including: 1) creating 6 to 9 articles comprising the national research agenda and publishing them in a peer-reviewed journal supplement; 2) adapting each article to an online e-learning platform, where users can access information about research priority areas in more detail; and 3) disseminating the national research agenda using a multi-channel approach including a webinar series.
Evaluation of the SHARE Approach Model
The purpose of this task order is to evaluate the effectiveness of the SHARE Approach model in guiding clinicians’ shared decision-making (SDM) conversations with patients who have diverse clinical conditions and face a variety of decision-making situations. The overarching goal of the project is to learn if a generic approach to SDM such as SHARE works to improve SDM in clinical practice. In order to answer this question, clinicians and health professionals will need to be trained in the SHARE approach and may need additional support to ensure that the approach is implemented as intended.
|Mechanistic Machine Learning|
Albers, David PhD
|CDKL5 Deficiency Disorder: Development of the International CDKL5 Clinical Research Network|
This is an award to establish the infrastructure necessary for a multi-site, international clinical research network – The international CDKL5 Clinical Research Network (ICCRN). The ICCRN is dedicated to the characterization of key clinical features, improvement of supportive care and development of better clinical trial ready outcome measures specific to CDKL5 Deficiency Disorder. The ICCRN led by Drs. Scott Demarest and Tim Benke, Children’s Hospital Colorado includes: Boston Children’s Hospital, Cleveland Clinic, Washington University, Children’s Hospital of Philadelphia, Columbia University, Texas Children’s Hospital and Telethon Kids in Perth, Australia and is supported by the International Foundation for CDKL5 Research.
|Adapting Motivational Interviewing for Maternal Immunization (MI4MI)|
Vaccinating pregnant women affords a unique opportunity to protect both mother and child against influenza and pertussis, yet uptake of maternal immunizations remain far below national target goals. This study will adapt motivational interviewing to the ob-gyn setting to provide information about how to improve provider communication and increase vaccine uptake among pregnant women.
Group B Strep DBS Study
This project serves to collect data to better understand immunologic endpoints of Group B Streptococcus (GBS) disease in infected young infants. The project will help determine how and which immunologic endpoints can help with development of vaccines that target GBS.
University of Maryland - DP2LM012890
Incorporating Bayesian reasoning into physician testing and treatment decisions
Recent research has shown that fewer than 20% of physicians understand the frequency of false positives in testing. When given an example of testing for a rare disease with a 95% specific test, most physicians answered that 95% of positive tests were true positive, whereas the correct answer was ~2%. Physicians are not trained on Bayesian thinking and as a result often significantly overestimate the positive impact of tests and treatments, which results in the harms of overdiagnosis and overtreatment. To reach our goal of reducing harms of medical care while maintaining benefits, in this project we are surveying physicians to explore factors associated with physician Bayesian reasoning and developing and testing an educational game to provide medical students (and seasoned physicians) with a fun and engaging way to improve their test interpretation accuracy.
A Health Information Resource Technology to Reduce Disparities in Transgender
Using user-centered design principles, project will create an information resource for the transgender community (TGc), including those considering, transitioning, or currently living as transgender. Delivered through a mobile application it will provide tailored health and well-being information, support and other yet unidentified needs of the TGc. Resource designed to enhance adoption, dissemination, and sustainability.
The ROUTT-B (Reduce Over-Utilized Tests and Treatments in Bronchiolitis) Study:
Developing a Roadmap for De-Implementation
The proposed research will advance “de-implementation” science by identifying processes and strategies to stop or reduce over-testing and over-treatment that can be broadly adapted to varied contexts and disease processes to improve the delivery of guideline concordant, evidence-based care and improve patient outcomes.
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Improving Immunization Rates in Transplant Candidates Through the Use of a
Project investigates the barriers to immunization of pediatric transplant candidates and develops a health information technology tool to overcome these barriers, increase pre-transplant immunization rates, decrease VPIs post-transplant, and ultimately improve the health of transplant recipients. This tool has the potential to have widespread applicability to all children with chronic diseases and complex medical needs who require co-management by subspecialists and primary care providers
|NIH - R36AG064135||Underutilization of Hospice in Older African Americans|
There are several potential reasons hospice is underutilized in African Americans including health literacy, lack of knowledge, mistrust in healthcare and perceived discrimination. This project addresses these barriers and evaluates if a hospice specific patient decision aid mitigates the effects of the potential barriers.
SPONSOR - FAIN
Noninvasive cardiovascular tests such as echocardiography and stress tests are critical to the care of patients with cardiovascular disease, but underuse and overuse of testing has led to adverse patient outcomes. This research will use a real-world approach (positive deviance) to identify effective strategies to optimize quality in the use of noninvasive cardiovascular tests. The overarching objective of this award is to ensure the growth of Dr. Vinay Kini, MD, MSHP, into an independent physician investigator who will expand knowledge in the field of cardiovascular quality by conducting research that enables optimized diagnostic testing and improved patient outcomes.
|Background: Patients with disabilities experience disparities in the receipt of high-qualityhealthcare services. These disparities can result when discriminatory attitudes, inaccessible physical environments, and a lack of appropriate accommodations exist. Section 1557 of the Affordable Care Act prohibits healthcare organizations (HCOs) from discriminating against patients with disabilities and mandates HCOs with 15 or more employees to designate an employee to coordinate compliance efforts. As a result, HCOs are hiring Disability Accessibility Coordinators (DACs).|
Proposed Solution to the Problem: We propose developing the Learning CollaborativE to Address Disability Equity in HealthcaRe (LEADERs), a sustainable Learning Collaborative of DACs, patients with disabilities and their caregivers, and researchers across the United
States who will work together to engage in the development, conduct, and dissemination of patient-centered outcomes research (PCOR) that aims to ensure equitable care to patients with disabilities.
|Variations in Use of Heart Replacement Therapies Among Patients with Advanced Heart Failure: An advanced, end-stage heart failure patient’s pathway to receiving heart replacement therapies (i.e., heart transplants or left ventricular assist devices) is dependent on 3 critical steps: (1) referral to an advanced heart failure center, (2) clinical evaluation at the center, and (3) case review by a multidisciplinary selection committee. Currently, this pathway is extremely heterogeneous between centers with no universal consensus or agreement, increasing disparities and access to potentially life-saving care for some while simultaneously exposing others to therapies that are not in line with their needs and preferences.|
The Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) requirement for Biologics Effectiveness and Safety (BEST) Initiative:
Data, Tools and Infrastructure for Surveillance of Biologics. The primary goal of the contract is to expand and enhance the current CBER
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|Matlock, Dan, MD, MPH|
NIH – R21
Pilot Evaluation of Hospice Decision Support Tools
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