2019 Pilot Grant Recipients

1. COHA Bioethics Pilot Final Sarah Moore OSU

Investigators

Principal investigator:

Sarah Moore, DVM, DACVIM (Neurology)

The Ohio State University

College of Veterinary Medicine

Moore.2204@osu.edu

Co-investigators:

Cheryl London, DVM, PhD, DACVIM (Oncology)

Tufts University

College of Veterinary Medicine

Cheryl.london@tufts.edu

Joan Coates, DVM, MS, DACVIM (Neurology)

University of Missouri, Columbia

College of Veterinary Medicine

coatesj@missouri.edu

Natasha Olby, DVM, PhD, DACIVM (Neurology)

North Carolina State University

College of Veterinary Medicine

njolby@ncsu.edu

Angela McCleary-Wheeler, DVM, PhD, DACVIM (Oncology)

University of Missouri, Columbia

College of Veterinary Medicine

mcclearywheelera@missouri.edu

Collaborators:

Helen O’Meara, MS, CPIA

Associate Director, IACUC/IBC

Office of Research, Office of Responsible Research Practices

The Ohio State University

omeara.15@osu.edu

Kim Toussant, MBOE, MA, CRA

Director, Office of Responsible Research Practices

Office of Research

The Ohio State University

Toussant.3@osu.edu

Universities:

The Ohio State University

Tufts University

University of Missouri, Columbia

North Carolina State University

Abstract: Veterinary clinical trials are uniquely positioned to contribute substantially to translational science, ultimately benefiting both pets and people. However, no formal guidance exists pertaining to ethical conduct of veterinary trials. As such, individual institutions have established site-specific protocols for approval and monitoring, making a harmonized approach challenging, particularly in an era where multi-site trials are becoming the norm. The work described in this proposal originates from the Clinical Studies Subcommittee and leverages complimentary clinical trial and regulatory expertise from four CTSA One Health Alliance (COHA) hubs

(The Ohio State University, University of Missouri, Tufts, and North Carolina State University) to address several important elements of ethical research that the subcommittee has identified as important opportunities for advancement: subject selection and enrollment, study protocol review and approval, and owner/patient engagement. We will survey the COHA community as a whole to document the current landscape and will then convene a two-day meeting with working groups formed around each key area. Outcomes of the meeting will include a gap analysis focusing on these three areas in the context of NIH’s 8 guiding ethical principles, and a guidance document addressing identified needs and a proposed framework to address them will be distributed across the COHA network for feedback and then published. This guidance document will serve as a blueprint for a planned administrative supplement application [NIH Administrative Supplement for Research on Bioethical

Issues (PA-19-217)] addressing needs identified from gap analysis and network feedback.

Specific Aims: With increasing collaborative initiatives across the landscape of human and veterinary medicine, a unique opportunity exists for comparative medicine that leverages veterinary patients to positively impact translational medicine efforts. However, a major impediment to more broadly engaging the scientific community in the use of spontaneous models is the lack of clear guidance regarding oversight of clinical trials that use client owned animals. While reduced regulatory burden can enhance the pace of science, a lack of guidance or universal protocols opens the veterinary community to scrutiny, particularly when adverse outcomes occur in animals enrolled in veterinary clinical trials. Moreover, the absence of standard processes and procedures has created an environment in which individual institutions have established site-specific protocols for approval and monitoring of clinical research, and as such, harmonizing cross-institutional efforts is challenging. Exempt from federal laws such as the Animal Welfare Act, which was developed to provide ethical standards for the use of animals in laboratory research, ethical considerations relevant to veterinary clinical research now more closely resemble those of human clinical trials. These include the use of healthy client-owned animals in research, enrollment of vulnerable health populations, and historically limited collaboration with community members and partners. Despite an abundance of important bioethical considerations, there are currently no resources providing guidance for the ethical design and conduct of clinical research in companion animals.

The goal of this pilot application, originating from the COHA Clinical Studies Subcommittee and addressing important subcommittee priorities, is to work toward development of structured guidance related to bioethical principles in veterinary clinical research. We will perform a gap analysis centering on

NIH-defined key elements of ethical clinical research in order to identify opportunities and challenges in the veterinary research community that can be transformed into actionable items targeting improved trial rigor and efficiency. This will facilitate enhanced integration of veterinary clinical trials on the translational spectrum while integrating important ethical principles that protect the owner, the patient, and the clinician. Ultimately, we will use this process to develop a draft guidance document detailing proposed solutions and a framework to address the identified gaps will be shared across the COHA community and with the COHA Steering Committee. Input from these groups will further enhance network-wide acceptance of proposed solutions.

CTSA One Health Alliance (COHA) Pilot Grant Program

2. “Advancing One Health through Interprofessional Education in Veterinary Professional Curricula”

Investigators

Principle Investigator:

Amara H. Estrada, DVM, Diplomate ACVIM (Cardiology), University of Florida

On behalf of the Clinician-Scientist Training Subcommittee of COHA

Co-investigator:

Amy Blue, Clinical Professor, Associate Vice President for Interprofessional Education – University of Florida, Associate Dean for Educational Affairs, College of Public Health and Health Professions

Co-I:

Ruthanne Chun, Associate Dean for Clinical Affairs and Hospital Director, Department of Medical Sciences, School of Veterinary Medicine, University of Wisconsin-Madison

Co-I:

Hossein Khalili, Director, Center for Interprofessional Practice and Education (CIPE), University of Wisconsin-Madison, Co-Founder & Co-Lead Interprofessional Research Global, Board Member, Global Confederation for Interprofessional Practice& Education

Executive Board Member, Canadian Interprofessional Health Collaborative

Co-I:

Laura Molgaard, Associate Professor and Senior Associate Dean for Academic and Student Affairs, at the University of Minnesota College of Veterinary Medicine

Co-I:

Brian Sick, Associate Professor, Internal Medicine and Pediatrics, Division Director, General Internal Medicine, Interprofessional Academic Deputy, University of Minnesota AHC

Universities:

University of Florida

University of Wisconsin-Madison

University of Minnesota

Abstract:

The proposal will support the networking and collaboration of a working group focused on advancing One Health through interprofessional education (IPE) in veterinary professional curricula. Translational medicine cannot be successful without effective working teams of professionals across varied professions. Veterinary medicine, which often provides the access to many translational disease models, is a critical profession to include in One Health translational medicine. Veterinary medicine is also strongly connected to zoonotic disease and plays a critical role in global health. Unfortunately, the current professional training in Veterinary curricula does not include many interprofessional opportunities. One Health, while widely recognized in Veterinary academia, is generally left to faculty to practice and role model for veterinary students. In other health professions, the focus of interprofessional education is primarily on the individual patient healthcare team with little emphasis on the broader concept of One Health. With an IPE curriculum that intentionally provides students an experience of working with even just one other health profession, IPE activities can serve as a gateway to translational science and One Health. Effective implementation of IPE lays the foundation for future clinicians and scientists to participate in the exact endeavors needed for translational medicine. The working group set out in this proposal seeks to facilitate implementation of IPE through the development of One Health focused IPE core competencies. Utilizing a collaborative meeting space and agenda, the working group will bring together IPE and One Health champions from multiple institutions to network and compose the project deliverables.

Specific Aims

Interprofessional Education (IPE) has become a key focus in the curricula of multiple health professions, sometimes including veterinary medicine. It is required in several health professions per accreditation standards (HPAC, 2019). The broad purpose of IPE is to provide educational opportunities between two or more professions that lead to current and future cross collaboration with the objective of improving patient and client care and health outcomes (CAIPE, 2018, WHO, 2010). One of the challenges for implementing IPE programs that include veterinary medicine is understanding the role of the veterinarian in the health team. The One Health initiative, with its focus on interprofessional collaboration, shares many similar themes with IPE and is widely utilized in veterinary medical education. The project outlined in this pilot proposal intends to leverage this relationship in accomplishing three specific aims listed below.

Specific Aim 1: Establish a shared working definition of One Health. One Health has been widely accepted as the next step in the evolution of public health. The initiative recognizes how the health of people, animals and the environment they share is intertwined and the goal of multidisciplinary collaboration is to solve targeted health issues. Veterinary medicine has rightfully stepped up to fulfill its role in this effort with most colleges actively affiliated or even leading their institution’s One Health centers. The challenge, however, is that each institutional definition of One Health is established through their own organizational lens. The University of Florida, for example, incorporates big data in its definition, while the University of Minnesota’s definition focuses more on its global impact. Therefore, the first aim of the project is to establish a shared working definition of One Health in the interprofessional educational context, specifically in the relationship between veterinary medical education and other health professions education

Specific Aim 2: Outline how Interprofessional Education supports the One Health mission. IPE focuses on educational opportunities that bring together different health-related professions to learn with, from and about each other to improve collaboration and quality care. The focus on interprofessional interaction clearly aligns with the broader One Health goals. Working from the established definition from specific aim 1, the project will next identify how IPE supports the goals of One Health. This will provide the foundation for development of plans and initiatives for One Health focused IPE modules, courses, and curricula.

Specific Aim 3: Create an action plan for the development and integration of One Health focused IPE core competencies. IPE can be difficult to implement at any university. The logistical challenges, with different health profession programs on different class schedules, alone create formidable obstacles. The organizational and perception barriers to including IPE in curricula make it difficult to enact at any institution. The objective of this aim is to build upon the previous two aims in developing a set of talking points for IPE champions, in all health professions, to use in proposing and implementing One Health focused IPE initiatives at their university. The creation of these talking points will allow us to disseminate what we have learned (veterinary and non-veterinary) to our colleagues across professions in order to facilitate change management strategies.

3. Effective Branding of the One Health Campaign

CTSA One Health Alliance (COHA) Communication and Collaboration Subcommittee

COHA Pilot Grant Proposal

Investigators:

Personnel (biosketches for Co-PIs attached):

The eight investigators on this proposal already collaborate as members of the COHA Communication and Collaboration Subcommittee.

Co-PI: Gary A. Anderson, DVM, MS, PhD, Professor/Director

Animal Health & Food Safety Institute, Kansas State University *Lead institution

Co-PI: Tracy L. Webb, DVM, PhD, Research Scientist II

Clinical Sciences Department, Colorado State University

Co-investigators:

Michael O. Childress, DVM, MS, DACVIM (Oncology), Associate Professor

College of Veterinary Medicine, Purdue University

Lisa M. Freeman, DVM, PhD, DACVN, Professor

Cummings School of Veterinary Medicine, Tufts University

Carolyn Henry, DVM, MS, DACVIM (Oncology), Professor, Dean

College of Veterinary Medicine, University of Missouri

Martin H. Moen, Director of Advancement

College of Veterinary Medicine, University of Minnesota

Jorge Piedrahita, MSc, PhD, Professor; Director, Comparative Medicine Institute

College of Veterinary Medicine, North Carolina State University

Shelley C. Rankin, BSc (Hons), PhD, Professor

School of Veterinary Medicine, University of Pennsylvania

Universities:

Kansas State University

Colorado State University

Purdue University

Tufts University

University of Missouri

University of Minnesota

North Carolina State University

University of Pennsylvania

Abstract:

Despite continued efforts, many healthcare practitioners, scientists, public health officials, and community workers are not aware of the One Health concept and its benefits. One Health activities are most often initiated by veterinarians in academia. In order to increase awareness of the opportunities and benefits of collaborative One Health teams, it is essential to educate and engage the community and human health researchers and providers. Accordingly, we propose to strategically develop a strong message and compelling story to tell that will enhance awareness, knowledge, and value of One Health to a broader audience. The Story Lab in Lenexa, KS, specializes in assisting clients to tell their story by developing plans through a “share, shape, and show” model of communication that has proven to accelerate adoption, which is exactly what is needed to further advance the One Health initiative locally, regionally, and nationally. Working with a highly experienced and effective company will enable the Communication and Collaboration Subcommittee to create the strong and consistent messaging needed to accelerate awareness and adoption of One Health. The Story Lab helps teams create and connect their future state storylines to a clear strategic plan that can be put into action. The team will engage organizations, industry, community members, and researchers to not only develop a strong, compelling message but also a story campaign including story trailers (short videos) and brand-style guides that will enhance awareness, knowledge, and value of One Health. The end result will be storylines created and connected to a clear strategic plan that can be put into action across multidisciplinary teams and universities.

Specific Aims:

Aim 1: Engage Story Lab and jointly develop the One Health “Story”.

A strong, creative One Health message will be developed utilizing a storytelling concept. Story Lab will create the message and facilitate adoption by applying principles of story structure, diffusion on innovation, and behavior change.

COHA Communication and Collaboration co-investigators will provide content and current perspectives while Story Lab will provide expertise, facilitate the development process, and deliver selected communication methods to be used by

COHA members in a manner that can be personalized to individual groups and institutions.

Aim 2: Develop a campaign to launch the One Health “Story”.

A list of target audiences will be developed for sharing and showing the One Health “Story” that will be put into action.

Aim 3: Develop and administer a pre- and post-survey to assess One Health awareness and knowledge following the “Story” campaign.

A survey will be developed for assessing awareness and knowledge pre- and post-campaign launch. The same population will be surveyed both pre- and post-campaign to assess changes in awareness and knowledge of One Health.