Evaluation and lessons learned from the dissemination and implementation science scholars program in the national cancer prevention and control research network.

Background: The Centers for Disease Control and Prevention (CDC)-funded Cancer Prevention and Control Research Network (CPCRN) has been a leader in cancer-related dissemination & implementation (D&I) science. Given increased demand for D&I research, the CPCRN Scholars Program launched in 2021 to expand the number of practitioners, researchers, and trainees proficient in cancer D&I science methods.

Methods: The evaluation was informed by a logic model and data collected through electronic surveys.

A national unmet needs assessment for CTSA-affiliated electronic health record data networks: A customer discovery approach.

Introduction: The expansion of electronic health record (EHR) data networks over the last two decades has significantly improved the accessibility and processes around data sharing. However, there lies a gap in meeting the needs of Clinical and Translational Science Award (CTSA) hubs, particularly related to real-world data (RWD) and real-world evidence (RWE).

Methods: We adopted a mixed-methods approach to construct a comprehensive needs assessment that included: (1) A Landscape Context analysis to understand the competitive environment; and (2) Customer Discovery to identify stakeholders and the value proposition related to EHR data networks.

Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies.

Additional risk minimization strategies may be required to assure a positive benefit-risk balance for some therapeutic products associated with serious adverse drug reactions/risks of use, without which these products may be otherwise unavailable to patients. The goals of risk minimization strategies are often fundamentally to influence the behavior of healthcare professionals (HCPs) and/or patients and can include appropriate patient selection, provision of education and counselling, appropriate medication use, adverse drug reaction monitoring, and adoption of other elements to assure safe use, such as pregnancy prevention. Current approaches to additional risk minimization strategy development rely heavily on information provision, without full consideration of the contextual factors and multi-level influences on patient and HCP behaviors that impact adoption and long-term adherence to these interventions.

The Evolve to Next-Gen ACT Network: An evolving open-access, real-world data resource primed for real-world evidence research across the Clinical and Translational Science Award Consortium.

The ACT Network was funded by NIH to provide investigators from across the Clinical and Translational Science Award (CTSA) Consortium the ability to directly query national federated electronic health record (EHR) data for cohort discovery and feasibility assessment of multi-site studies. NIH refunded the program for expanded research application to become "Evolve to Next-Gen ACT" (ENACT). In parallel, the US Food and Drug Administration has been evaluating the use of real-world data (RWD), including EHR data, as sources of real-world evidence (RWE) for its regulatory decisions involving drug and biological products.

Applying Customer Discovery Method to a Chronic Disease Self-Management Mobile App: Qualitative Study.

Background: A significant health challenge is evident in the United States, with 6 in 10 adults having a chronic disease and 4 in 10 adults having 2 or more. Chronic disease self-management aims to prevent or delay disease progression and disability and reduce mortality risk. The evidence to support the use of information technology tools, including mobile apps, web-based portals, and web-based educational interventions, that support disease self-management and improve clinical outcomes is growing.

Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007-2020).

Introduction: Surveys are commonly used to assess effectiveness of FDA-required risk evaluation and mitigation strategies (REMS) for drugs and biologics in the United States.

Objective: The aim of this study was to assess the scientific rigor of REMS knowledge survey protocols submitted to FDA and compare protocols before and after FDA's 2012 public workshop and 2019 draft guidance.

Method: A content analysis of index survey protocols submitted to FDA (2007-2020) for single-product REMS with elements to assure safe use (39 programs, 78 protocols) was conducted.

Adaptation of a Mobile Interactive Obesity Treatment Approach for Early Severe Mental Illness: Protocol for a Mixed Methods Implementation and Pilot Randomized Controlled Trial.

Background: Obesity is common in individuals with severe mental illness (SMI), contributing to a significantly shortened lifespan when compared to the general population. Available weight loss treatments have attenuated efficacy in this population, underscoring the importance of prevention and early intervention.

Objective: Here, we describe a type 1 hybrid study design for adapting and pilot-testing an existing mobile health intervention for obesity prevention in individuals with early SMI and Class I or early-stage obesity, defined as a BMI of 30-35.

Mixed methods evaluation of the inaugural year of the Cancer Prevention and Control Research Network's (CPCRN) scholars program.

Purpose: A diverse workforce trained in dissemination & implementation (D&I) science is critical for improving cancer outcomes and reducing cancer-related health disparities. This study aims to describe and evaluate impact of the Cancer Prevention and Control Research Network (CPCRN) Scholars Program in preparing scholars for collaborative careers in cancer control and implementation research and practice, and offers evaluation-driven recommendations for program improvements.

Methods: The CPCRN Scholars Workgroup conducted a sequential, mixed methods evaluation.

Core functions and forms of Bright IDEAS: A multi-methods evaluation of the adoption of an evidence-based psychosocial training program through iterative adaptation.

Background: Despite efforts to widely disseminate interventions designed to increase access to quality supportive care to pediatric cancer patients and their families, many of these interventions fail to meet expectations once deployed in real-life clinical settings. This study identifies the functions and forms of Bright IDEAS: Problem-Solving Skills Training, an evidence based psychosocial intervention for caregivers of children recently diagnosed with cancer, to identify pragmatic program adaptations in its real-world clinical implementation. We compare intervention adoption before and after adaptations to the Bright IDEAS training program as part of a national training program designed to disseminate the intervention.

Dissemination of an evidence-based behavioral intervention to alleviate distress in caregivers of children recently diagnosed with cancer: Bright IDEAS.

Background: Four multisite randomized clinical trials of > 1400 caregivers of children newly diagnosed with cancer showed that the Bright IDEAS (BI) paradigm of problem-solving skills training is an acceptable and efficacious approach to alleviating the high levels of distress they experience. To facilitate providing evidence-based caregiver support as recommended in the pediatric oncology standards of care, the project described here was designed to disseminate BI to 200 psychosocial professionals.

Procedure: We partnered with the Children's Oncology Group (COG), Association of Pediatric Oncology Social Workers (APOSW), Association of Pediatric Hematology/Oncology Nurses (APHON), and special interest group in pediatric hematology/oncology of the Society for Pediatric Psychology (SPP).

Using Innovation-Corps (I-Corps™) Methods to Adapt a Mobile Health (mHealth) Obesity Treatment for Community Mental Health Settings.

Background: We employed Innovation Corps (I-Corps™) methods to adaptation of a mobile health (mHealth) short-message-system (SMS) -based interactive obesity treatment approach (iOTA) for adults with severe mentall illness receiving care in community settings.

Methods: We hypothesized "jobs to be done" in three broad stakeholder groups: "decision makers" (DM = state and community clinic administrators), "clinician consumers" (CC = case managers, peer supports, nurses, prescribers) and "service consumers" (SC = patients, peers and family members). Semistructured interviews ( = 29) were recorded and transcribed ver batim and coded based on pragmatic-variant grounded theory methods.

A flexible mixed-data model applied to claims data for post-market surveillance of prescription drug safety behavior.

We develop a new modeling framework for jointly modeling first prescription times and the presence of risk-mitigating behavior for prescription drugs using real-world data. We are interested in active surveillance of clinical quality improvement programs, especially for drugs which enter the market under an FDA-mandated Risk Evaluation and Mitigation Strategy (REMS). Our modeling framework attempts to jointly model two important aspects of prescribing, the time between a drug's initial marketing and a patient's first prescription of that drug, and the presence of risk-mitigating behavior at the first prescription.

Designing for Dissemination and Sustainability to Promote Equitable Impacts on Health.

Designing for dissemination and sustainability (D4DS) refers to principles and methods for enhancing the fit between a health program, policy, or practice and the context in which it is intended to be adopted. In this article we first summarize the historical context of D4DS and justify the need to shift traditional health research and dissemination practices. We present a diverse literature according to a D4DS organizing schema and describe a variety of dissemination products, design processes and outcomes, and approaches to messaging, packaging, and distribution.

Diabetes Prevention and Care Capacity at Urban Indian Health Organizations.

American Indian and Alaska Native (AI/AN) people suffer a disproportionate burden of diabetes and cardiovascular disease. Urban Indian Health Organizations (UIHOs) are an important source of diabetes services for urban AI/AN people. Two evidence-based interventions-diabetes prevention (DP) and healthy heart (HH)-have been implemented and evaluated primarily in rural, reservation settings.

Development of a Health Information Technology Tool for Behavior Change to Address Obesity and Prevent Chronic Disease Among Adolescents: Designing for Dissemination and Sustainment Using the ORBIT Model.

Health information technology (HIT) has not been broadly adopted for use in outpatient healthcare settings to effectively address obesity in youth, especially among disadvantaged populations that face greater barriers to good health. A well-designed HIT tool can deliver behavior change recommendations and provide community resources to address this gap, and the Obesity-Related Behavioral Intervention Trials (ORBIT) model can guide its development and refinement. This article reports the application of the ORBIT model to (1) describe the characteristics and design of a novel HIT tool (the PREVENT tool) using behavioral theory, (2) illustrate the use of stakeholder-centered "designing for dissemination and sustainability" principles, and (3) discuss the practical implications and directions for future research.

The Effect of the Affordable Care Act on Women's Postpartum Insurance and Depression in 5 States That Did Not Expand Medicaid, 2012-2015.

Background: Before the Affordable Care Act (ACA), most women who gained pregnancy-related Medicaid were not eligible for Medicaid as parents postpartum. The ACA aimed to expand health insurance coverage, in part, by expanding Medicaid; introducing mandates; reforming regulations; and establishing exchanges with federal subsidies. Federal subsidies offer a means to coverage for individuals with income at 100%-400% of the federal poverty level who do not qualify for Medicaid.

Fostering innovation at Academic Medical Centers: The Case of University of Colorado Anschutz Medical Campus.

Commercializing biomedical discoveries is a challenging process for many reasons. However, Academic Medical Centers (AMC) that have teaching, patient care, research, and service engrained in their mission are well poised to host these discoveries. These academic discoveries can lead to improvement in patient health and economic development if supported to cross the "valley of death" through institutional assistance, by providing guidance, gap funding and product development expertise.

Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014-2018).

Background: A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program for certain medications with serious safety concerns required by the U.S. Food and Drug Administration (FDA) of manufacturers to implement to help ensure the benefits of the medication outweigh its risks.

I-Corps@NCATS trains clinical and translational science teams to accelerate translation of research innovations into practice.

Introduction: A key barrier to translation of biomedical research discoveries is a lack of understanding among scientists regarding the complexity and process of implementation. To address this challenge, the National Science Foundation's Innovation Corps™ (I-Corps™) program trains researchers in entrepreneurship. We report results from the implementation of an I-Corps™ training program aimed at biomedical scientists from institutions funded by the National Center for Advancing Translational Sciences (NCATS).

Scale-up of the Accrual to Clinical Trials (ACT) network across the Clinical and Translational Science Award Consortium: a mixed-methods evaluation of the first 18 months.

Introduction: The Clinical and Translational Science Award (CTSA) Program is a Consortium of nearly 60 academic medical research centers across the USA and a natural network for evaluating the spread and uptake of translational research innovation across the Consortium.

Methods: Dissemination of the Accrual to Clinical Trials (ACT) Network, a federated clinical informatics data network for population-based cohort discovery, began January 2018 across the Consortium. Diffusion of innovation theory guided dissemination design and evaluation.

The effect of direct cognitive assessment in the Medicare annual wellness visit on dementia diagnosis rates.

Objective: To evaluate the relationship between direct cognitive assessment introduced with the Medicare Annual Wellness Visit (AWV) and new diagnoses of dementia, and to determine if effects vary by race.

Data Sources: Medicare Limited Data Set 5% sample claims 2003-2014 and the HRSA Area Health Resources Files.

Study Design: Instrumental Variable approach estimating the relationship between AWV utilization and new diagnoses of dementia using county-level Welcome to Medicare Visit rates as an instrument.