Translational Research Pilot Focus Areas

Quality, safety, and outcomes could be markedly improved if demonstrated best practices were universally adopted. However, the traditional healthcare system does not promote a culture of institutional learning to improve practices, apply research principles, evaluate change, or share best practices between systems to rapidly and widely disseminate innovations.¹ Advocate Health are growing as an academic Learning Health System. Expanding from the standard definition of a Learning Healthcare System,² (see definition below), we define an Academic Learning Health System (aLHS) as a particular Learning Health System built around a robust academic community with a central academic mission,³ with six differentiating features (see full definition below).  Aligned with the national CTSA program emphasis on implementation, a further recent commentary has highlighted the potential role of dissemination and implementation science in addressing challenges in operationalizing LHS.⁴   

As academic Learning Health Systems seek to integrate research and clinical operations, so does this pilot award. The academic Learning Health System Pilot Award is designed to incentivize and support a broad range of research (exploratory studies, QI projects, evaluations of interventions, evaluations of barriers to implementing interventions) that either answer questions about how to create an academic Learning Health System, or where and how research is an intentional element in the growth to an academic Learning Health System. Thus, the purpose of this RFA is to stimulate innovative research ideas that can transform the way we deliver care. 

Definitions:

• A Learning Healthcare System is defined, by the Institute of Medicine, as a system in which, “science, informatics, incentives and culture are aligned for continuous improvement and innovation, with best practices seamlessly embedded in the delivery process, patients and families active participants in all elements, and new knowledge captured as an integral by-product of the delivery experience.”²   Five key components of LHS include Organizational Learning (innovation and quality improvement), Translating Research into Practice, Engagement with Key Stakeholders (e.g.: leaders, clinical teams, clinicians, patients, community and state organizations), and Building New Knowledge.⁵
  
  
• An Academic Learning Health System (aLHS) as a particular Learning Healthcare System built around a robust academic community with a central academic mission. An aLHS 1. capitalizes on embedded academic expertise in health system sciences; 2. engages the full spectrum of translational investigation from mechanistic basic sciences to population health; 3. builds pipelines of experts in Learning Health Systems Sciences and clinicians with fluency in practicing in learning health systems; 4. applies core LHS principles to the development of curricula and clinical rotations for medical students, house staff, and other learners; 5. disseminates knowledge more broadly to advance the evidence for clinical practice and health systems science methods; 6. addresses social determinants of health and creates community partnerships to mitigate disparities and improve health equity. ³
  
  
• Translational science, as defined by the NIH, “represents each stage of research along the path from the biological basis of health and disease to interventions that improve the health of individuals and the public. Translation is the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public — from diagnostics and therapeutics to medical procedures and behavioral changes. Translational Science is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process.” ⁶

Projects that address the academic Learning Health System topic and are both generalizable and translational are encouraged. These include, but are not limited to projects that:

• Move QI / system change projects into publishable and generalizable research. Examples: Test whether process changes that worked at WF also work at other hospitals; implement a tested quality improvement method at WF; increase the reliability of quality improvement initiatives by incorporating prospective non-randomized controlled trial designs or quasi-experiments (enhanced observational study designs), using staggered implementation, risk adjustment, or case matching approaches.
  
  
• Import practices from other healthcare systems. The challenges we face as a healthcare system are certainly not unique. We should learn from others who have managed the same challenges. Example: Import features of other healthcare systems -national or international- and adapt them for use in our system.
  
  
• Test ways to engage clinicians in research. Bringing together clinicians (who can identify healthcare delivery problems) and researchers (who can develop and test research questions) can lead to an evidence-based pipeline that moves clinicians’ ideas into research and then back into clinical practice. Examples: Embed a researcher into a service line to find healthcare delivery problems we need to address with research. Invite clinicians to bring the top two clinical issues they have observed to a meeting with researchers (“Which process issues you have observed? What do you notice every time you deliver care to a certain group of people? Which questions would you test if only you could pull the data from the EMR?”). Test strategies to bring clinicians into clinical trials or other ongoing studies. The success of the clinician-researcher interactions might be measured via process measures such as the number of ideas generated, or whether a clinical issue is turned into a research question that is explored further (e.g., results in a ticket to Encompass for a data pull).
  
  
• Engage patients and other healthcare stakeholders to influence research and improve care. Example: Engaging non-traditional research partners and incorporating perspectives beyond those of the research team – from topic selection to outcome selection and study design to conduct and dissemination of the results – can improve the utility of research for patients and providers. For example, one approach could involve capturing ideas from patients (or parents of patients) treated within our healthcare system, asking them about their concerns, and then rank ordering them (using the Delphi method). Items could be ranked as most pressing or most testable (e.g., medication list is not current on the patient printout; test results are shared with the patient through myAtriumHealth before the clinician interprets them).
  
  
• Test ways to change culture / form identity so that all faculty and staff understand that they are part of a Learning Healthcare System. Example: Strategies could focus on education about research or evidence-based practice, institutional campaigns, or group discussions. For example, one approach might be to ask staff at department meetings to list how they are contributing to a LHS and to conduct a pre/post-test of clinicians and staff identifying as researchers after the intervention. Test strategies to develop and maintain a continuous learning culture, or strategies to align healthcare delivery incentives to support the Learning Healthcare System goals.

 

Examples of projects that focus on aLHS will meet some or all of the below criteria:

• Project addresses a real problem facing the Advocate Health system.
• The project involves the development of practices, treatments, tools or approaches that will improve care.
• If the project involves an intervention, the intervention is informed by published research (i.e., based on pre-existing evidence).
• Inclusion of both a skilled researcher and clinician with expertise relevant to the project contributes to designing and implementing the approach used for learning and for testing the intervention.
• Results from the research are delivered in a timely/expedited fashion.
• The analysis of clinical data is a central aspect of the project.
• Results from the learning process are disseminated throughout the organization in a manner that leads to better patient care and improved organizational practices and policies.
• The project has demonstrated support from a clinical unit, service, and/or leadership, and the clinical unit, service, and/or leadership has participated in the conceptualization of the pilot.
• The project products could be more widely adopted by Advocate Health if the strategy being implemented was found to be effective.
• The project will test strategies designed to translate research into practice (specifically to implement into practice guidelines, processes, delivery models, new tools and other innovations that are supported by the prior literature and/or national organizations).
• The project will result in pilot data that can be leveraged to apply for a larger grant from an external funding entity (NIH, NSF, PCORI, non-governmental, etc).
• The project holds the potential for intellectual property development through Wake Forest Innovations.
• The project involves inter-professional collaboration.

References

1. IOM (Institute of Medicine). Best care at lower cost: The path to continuously learning health care in America. Washington, DC: The National Academies Press; 2012. 
2. Committee on the Learning Health Care System in America, Institute of Medicine. In: Smith M, Saunders R, Stuckhardt L, McGinnis JM, eds. Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. Washington, DC: National Academies Press (US), National Academy of Sciences.; 2013.
3. Rosenthal, Gary E. MD; McClain, Donald A. MD, PhD; High, Kevin P. MD, MS; Easterling, Douglas PhD; Sharkey, Angela MD; Wagenknecht, Lynne E. DrPH; O’Byrne, Christopher MS; Woodside, Rachel MA; Houston, Thomas K. MD, MPH. The Academic Learning Health System: A Framework for Integrating the Multiple Missions of Academic Medical Centers. Academic Medicine ():10.1097/ACM.0000000000005259, April 25, 2023. | DOI: 10.1097/ACM.0000000000005259
4. Trinkley KE, Ho PM, Glasgow RE, Huebschmann AG. How dissemination and implementation science can contribute to the advancement of learning health systems. Academic Medicine 2022;97(10):1447-1458. doi:10.1097/acm.0000000000004801.
5. Easterling D, Perry AC, Woodside R, Patel T, Gesell SB.  Clarifying the concept of a learning health system for healthcare delivery organizations: Implications from a qualitative analysis of the scientific literature. Learning Health Systems.  https://doi.org/10.1002/lrh2.10287 . 2021
6. NIH (National Institutes of Health) / NCATS (National Center for Advancing Transactional Sciences. Translational Science Spectrum. NCATS 2015: https://ncats.nih.gov/translation/spectrum

The primary focus of the Patient Engagement Research and/or Community-Engaged Research award supplement is to promote the development or application of patient or community engaged research, community-based participatory research (CBPR), or citizen science projects.

 

Justification for the Patient Engagement Research and/or Community-Engaged Research project should include the following:

• Explanation of how patient engagement research, community-engaged research (CEnR), community-based participatory research (CBPR), and/or citizen science best practices will be applied
• Describe how community and patient partners will inform and guide the study across the research process from idea generation, study design and methods, recruitment and retention, data collection, interpretation and dissemination of results.
• Include a description of how this role is reflected in the research study budget (e.g. stipend, honorarium, consultant fees, percentage of salary, flat payment amount)
• Describe the relevance of the community and patient engagement as it relates to the study focus and design. 

 

Projects that are Patient Engagement Research and/or Community-Engaged Research (for the purposes of this award) must include the following:

• Roles, and/or tasks and activities that are included in the project, specifically for patient, family of patient, or community partners in the research other than research participant (e.g. Co-PI, consultant, member of steering committee, advisory group, working group, community engagement studio)
• Process for bidirectional communication between the members of the research team and select members of the patient population, family member of patient, and/or select community members outside of the research team.
• Bidirectional communication and co-learning.

 

Examples of Projects that are NOT Patient Engagement Research and/or Community-Engaged Research (for the purposes of this award):

• Projects whose aim is to improve patient health or improved community health, but do not have an active role for patient, family or community representatives in the research other than research participant.
• Projects that are community-oriented but lack scientific rigor and the use of best practices will not be funded.

 

Definitions and related references can be found below:

• Community Engagement
  According to the CDC, community engagement is the process of working collaboratively with groups of people who are affiliated by geographic proximity, special interests, or similar situations with respect to issues affecting their well-being. In practice, community engagement is a blend of science and art.

• Community-Engaged Research (CEnR)
  Community-engaged research includes local people in the research process, especially people who could benefit from or be affected by the research. Community representatives bring their lived experiences, insights and strengths to these studies to:
  - Craft research questions and inform study details
  - Collect research data using community-informed strategies to connect with participants and get meaningful data
  - Advise on policies and decisions related to safe and effective research conduct
  - Co-create interventions or programs that fit well within the community
  - Co-design appropriate materials and messages tailored for specific cultures and languages
  - Analyze and report data in a way that is relevant and meaningful to the community while acknowledging strengths and opportunities

For further detail, see: https://nihceal.org/about-community-engaged-research-and-ceal#:~:text=Community%2Dengaged%20approaches%20effectively%20address,improves%20the%20health%20of%20communities.

• Patient Engagement in Research
  Patient engagement in research involves patients and/or family of patients working with researchers to improve the quality of research and services. The goal is to improve healthcare outcomes by actively involving patients at various levels of the research process.  Patient engagement in research is intended to foster a more accountable research agenda, enhance the usefulness and relevance of findings, and increase the uptake of evidence in clinical care. For further details, see: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7206899/pdf/cer-09-387.pdf or https://cihr-irsc.gc.ca/e/documents/spor_framework-en.pdfhttps://cihr-irsc.gc.ca/e/documents/spor_framework-en.pdf

• Community-Based Participatory Research (CBPR)
  Community-based participatory research is: An applied collaborative approach that enables community residents to more actively participate in the full spectrum of research (from conception – design – conduct – analysis – interpretation – conclusions – communication of results) with a goal of influencing change in community health, systems, programs or policies. Community members and researchers partner to combine knowledge and action for social change to improve community health and often reduce health gaps. Academic/research and community partners join to develop models and approaches to building communication, trust and capacity, with the final goal of increasing community participation in the research process. It is an orientation to research, which properly involves all partners in the research process and recognizes the unique strengths that each brings.

• Citizen Science
  Citizen science is scientific work undertaken by members of the general public, often in collaboration with or under the direction of professional scientists and scientific institutions. Citizen science efforts are driven by community concerns. Citizen scientists, in the modern sense, are defined as a scientist whose work is characterized by a sense of responsibility to serve the best interests of the wider community. For further detail, see: https://scistarter.org/citizen-science and https://www.citizenscience.gov/#

 

 

References

 

Community Engaged Research

• Clinical and Translational Science Awards Consortium, Community Engagement Key Function Committee Task Force on the Principles of Community Engagement (eds.) (2011). Principles of Community Engagement. Ed. 2. NIH Publication No. 11-778
• Israel B, Eng E, Schulz A, et al., (eds). (2013). Methods in Community-Based Participatory Research for Health. Ed. 2. San Francisco, CA: Jossey-Bass
• Minkler M and Wallerstein N. (eds). (2008). Community-Based Participatory Research for Health: From Process to Outcomes. (2nd edition). San Francisco, CA: Jossey-Bass
• Ortiz, Kasim, Nash, Jacob, Shea, Logan, Oetzel, John, Garoutte, Justin, Sanchez, Youngman, Wallerstein, Nina. (2020). Partnerships, Processes, and Outcomes: A Health Equity-Focused Scoping Meta-Review of Community Engaged Scholarship. Annual Review of Public Healt
• Rhodes SD (ed). (2014). Innovations in HIV Prevention Research through Community Engagement. New York: Springer
• Viswanathan M, Ammerman A, Eng E, et al., (eds). (2004). Community-Based Participatory Research: Assessing the Evidence. Rockville, MD: Agency for Healthcare Research and Quality.
• Wallerstein N, Duran B, Oetzel J, Minkler M (eds.) (2018). Community-Based Participatory Research for Health. Ed. 3. San Francisco, CA: Jossey-Bass.
• Wallerstein, Nina. (2020). Commentary on Community-Based Participatory Research and Community Engaged Research in Health for Journal of Participatory Research Methods. Journal for Participatory Research Methods, Vol 1, Issue 1. https://doi.org/10.35844/001c.13274.

Citizen Science

• Citizen Science.gov. (n.d.). https://www.citizenscience.gov/#
• National Institute of Environmental Health Sciences. (2022). Community-engaged Research and Citizen Science.https://www.niehs.nih.gov/research/supported/translational/community
• SciStarter. (n.d.). https://scistarter.org/citizen-science

Patient Engagement Research

• Institute for Patient-and Family-Centered Care. (2024). A Toolbox for Creating Sustainable Partnerships with Patients and Families in Research. https://www.ipfcc.org/bestpractices/sustainable-partnerships/index.html
• Kaiser Permanente Center for Health Research. (2024). Patient Engagement Toolkit.  https://research.kpchr.org/Patient-Engagement-Toolkit
• Strategy for Patient-Oriented Research Putting Patients First. (2014). Patient Engagement Framework. https://cihr-irsc.gc.ca/e/documents/spor_framework-en.pdf

The primary focus of a Health Informatics project is to address gaps in knowledge or other barriers to translational research problems by leveraging one or more Informatics tools and methods.

 

A project focused on biomedical informatics is intended to evaluate strategies in one of the following areas:

1. Creation, evaluation, and implementation of Clinical Decision Support Systems;
2. Improving and evaluating electronic information capture and data flow of both clinical and patient derived data;
3. Development of improved analytical methods for clinically derived data;
4. Creation of informatics tools to improve population health management;
5. Creation, evaluation, or implementation of Health Informatics tools and algorithms.

 

The project must be translational in nature and should help to close the gaps in establishing a true Learning Healthcare System.

 

Successful proposals will create, evaluate, or implement Health Informatics tools and algorithms while providing a rationale for local relevance and potential for generalizability, explaining how the proposed project advances research in Health Informatics, and identifying translational roadblocks that the proposed project will address and the anticipated benefits of overcoming them with the informatics.

The primary focus of an Implementation Science award is support the development of methods to promote the dissemination, adoption, integration, and/or effectiveness of promising practices, strategies, and/or technologies in clinical and/or community settings. Implementation scientists are committed to closing the gap between “what we know” as scientists and “what we do” as practitioners. A pilot focusing on implementation science is intended to elicit proposals that evaluate different strategies for closing the research-to-practice chasm through the development and testing of tailored implementation frameworks, identification of organizational and community levers to facilitate translation, determination of the feasibility of new implementation models, identification of strategies for scale-up, and/or development of strategies to disseminate knowledge or practices to a broad audience.

 

Successful proposals should test a practice, strategy, or technology that can be used to foster the translation of “what we know” to “what we do”.