UF Health Research: On the Same Page With Our Patients

While the nameplate of this newsletter, “On the Same Page,” was chosen in part to promote alignment between our faculty and our hospital staff, the concept is broader than that. It is clearly important, for example, to be on the same page with our patients and their families.

The question we address in this installment of “On the Same Page” extends to our research mission. What do our patients want from research studies at UF Health and how can they help us ask the right research questions? To attempt to answer this question, and to introduce the readership of this newsletter to Tom Pearson, M.D., Ph.D., who was recently appointed to lead the research and education missions at the Health Science Center, I have asked Tom to write out his thoughts as a guest writer for this newsletter. In turn, he has sought input from Betsy Shenkman, Ph.D., professor and chair of the Department of Health Policy and Outcomes, and Linda Cottler, Ph.D., M.P.H., professor and chair of the Department of Epidemiology, who shared their thoughts in what follows:

What do our patients want from research studies at UF Health and how can they help us ask the right research questions?

Unfortunately, researchers do not always think in these terms. After all, scientists are the ones who know the research questions that need asking, right? The trends over the past 15 years or so strongly disagree with this scientist-centered approach. Patient groups have increasingly asked for a voice to request more support for research relevant to problems they deem important.

There has been a crescendo of interest in research that deals with human problems, performed in human subjects, with direct application to their care. The vigorous advocacy by the HIV/AIDS community for effective drugs to be made quickly available is a successful example of this trend. Congress and other funders have been listening and over the past decade have directed substantial funding to research that translates science into clinical application that solves human problems. This has evolved into a demand for patient-centered research, which by definition involves patients at all stages of research, including planning, data collection, choice of intervention, analysis of results and implementation of findings into clinical practice and improved health.

Benefits of Patient Engagement and Patient-centered Research

What could patients or family members bring to a sophisticated research study? It turns out they bring a great deal. It has long been recognized that results of studies performed in specialized research clinics, staffed by highly trained physicians and nurses, could not always be replicated in the “real world.” Patient groups can also help with recruitment of patients representative of the patients most burdened by the disease under study. This is especially true of inclusion of racial, ethnic, aged and low-resourced groups. Such groups often take on a disproportionate share of disease but are rarely included in the studies to test or improve the treatment. Inclusion of such groups will also provide insights into the likelihood that patients would comply with the experimental treatments over the course of the study, as well as report side effects or other reasons for quitting the treatment regimen.

Patients can also help in the development of study materials, and procedures, so that patients can understand what to expect and make informed choices about whether to participate. They can also identify culturally insensitive materials or procedures that could distress patients and cause them to refuse participation. This extends to the interpretation of results that often find differences between sexes, races, ages, etc.; these differences should be communicated with sensitivity, so as to not represent certain subgroups in a negative way. Finally, patients can be of enormous help in the recruitment of research subjects and the dissemination of results leading to appropriate use of a newly proven treatment. The concept of the patient as research partner is here to stay, based on necessity and efficiency.

Patient Outreach and Community Engagement at UF Health

In preparation for this article, the six UF-HSC Colleges were solicited for programs engaging communities and patients. The response was impressive and across all colleges, with a long list of activities, including student interactions, outreach clinics, health fairs, educational offerings and others too numerous to mention. A summary of these outreach studies, involving thousands of persons in North Florida and beyond, is published annually, as required by governmental funding agencies.

The number of projects engaging patients in research, however, was smaller. We chose two large projects to focus this report, HealthStreet and the Implementation Science Program, or ISP. Both are sponsored by the Clinical and Translational Science Institute to fulfill the requirement for Community Engagement as required by its NIH funding mechanism. Community Engagement is defined as the process of working collaboratively with and through groups of people affiliated by geographic proximity, special interest or similar situations to address issues affecting their well-being. Patient-centered research could be considered a form of community engagement research, in which the group is defined by having a disease or health condition. In our view, Community Engagement is one of the strongest programs in our CTSI as well as nationally.

HealthStreet

HealthStreet is a well-established community engagement program begun in 1989 by Linda Cottler, Ph.D., M.P.H. at Washington University in St. Louis, Mo. Dr. Cottler took the position of professor and chair of the new Department of Epidemiology at UF in 2011, and brought Health Street with her. It has grown steadily since then with its headquarters southwest of the HSC on 2401 Archer Road. Its four aims are to: 1) assess medical problems and health concerns from the viewpoint of community residents, 2) have two-way communication with the community on how to promote health, 3) link people with needs and concerns to medical and social services as well as opportunities to participate in UF research, and 4) increase the community’s trust in research by collaborating and partnering with them in the process.

HealthStreet is active in every imaginable community setting in Gainesville and in Jacksonville. Since October 2011, more than 4,700 persons from the Gainesville community have been assessed by Community Health Workers for their needs and concerns through HealthStreet; another 750 persons have participated in some form in the Jacksonville community. Most belong to low-income, underrepresented minority communities. Only 15% had ever participated in a health research study, but a large proportion stated that they would be willing to do so in the future. Importantly, assessment of their health concerns revealed the top five to be hypertension, diabetes, overweight/obesity, heart disease and cancer.

HealthStreet has referred people for studies in 10 UF colleges, including the College of Medicine in Jacksonville, and 67 different studies to date have enrolled HealthStreet members. More than 1,900 participants are currently planned for 16 studies conducted at our HealthStreet facility. Many other referrals have led to services in agencies outside UF (e.g., housing, education), social services provided at HealthStreet, or health screenings, also provided by HealthStreet. Partnerships with a long list of community organizations and agencies across North Florida also provide opportunities for participants and faculty. A Community Advisory Board representing a large number of community organizations meets twice a year to provide guidance to the programs. HealthStreet is clearly a national model for a way that an academic health center can engage the communities around it.

Implementation Science Program

Betsy Shenkman, Ph.D., who has chaired the Department of Health Policy and Outcomes since 2005, brings a nationally prominent career in community-engaged research to the UF CTSI. For the past couple of years, Dr. Shenkman has developed the Implementation Science Program to strengthen UF Health’s capacity in comparative effectiveness research, or CER. CER is “the generation and analysis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor a clinical condition to improve the delivery of care.” CER emphasizes research in “real-world settings,” such as actual health care facilities out in the community.

The Affordable Care Act (also known as Obamacare) created a public-private organization, the Patient-Centered Outcomes Research Institute, which accesses over $300 million per year for CER research, with the goal of improving outcomes in our health care system. PCORI solicits, receives and reviews applications for research contracts for CER projects. The projects must be patient-centered, meaning that representative patients must be involved in all stages of the research.

Many early applicants (including those at UF) submitted applications to PCORI without demonstrated engagement of patient groups, only to have them rejected for lack of collection of the patients’ self-assessed needs and concerns as well as an organization in which patients and researchers partnered to develop and carry out research that was meaningful to the patients.

To improve the skills of faculty to write these new kinds of proposals, Dr. Shenkman and her staff established ISIS, Implementation Science Innovation Studios. During the ISIS sessions, faculty, patients and other community members share ideas about research topics, discuss research proposals that are in their early stages of development and develop strategies to strengthen the proposals through patient and community partnerships.

Another effort has been to encourage engagement with more patient groups. In October 2013, the PCORI announced the Pipeline to Proposal Program, a funding opportunity to develop engagements with patients around common health care research interests, to build a community of patients, care providers and researchers that could carry out patient-centered outcomes research. The odd thing about the funding opportunity is that its applicants are limited to those in the Mountain and Pacific Time Zones of the US. Our response, as a partnership between the CTSI and UF Health, was to use our own funds to offer a Pipeline-to-Proposal Program here at UF, funding nine-month pilot grants to engage new patient and community groups as partners with UF researchers.

In November, we solicited brief proposals from faculty across UF, including the HSC in Gainesville and the Jacksonville campus of UF. We received 14 applications for up to $15,000 representing eight UF Colleges and both the Gainesville and Jacksonville campuses. Despite initial plans to fund two projects, the quality of the applications was so good that funds were found to fund four projects. Those promising projects that could not be funded were encouraged to continue to develop their partnerships with the chance for another round of funding next year. Our four finalists are described here, as examples of opportunities to develop patient-centered research programs in four new areas:

“Building Capacity and Forging Collaborations in Autism Research for Underserved Families”

Jennifer Elder, Ph.D., R.N., a professor of nursing, will lead a team of faculty and students from the UF colleges of Education, Liberal Arts and Sciences, Medicine, Nursing and Public Health and Health Professions as well as the UF Center for Autism and Related Disorders and Health Street to engage parents of individuals with autism spectral disorder from rural areas and underserved race/ethnic groups, as well as their health care and service providers and their teachers. Together, they will learn more about barriers to early intervention and treatment, establish a Community Advisory Board and carry out a survey of Florida’s 66 public health departments about resources and barriers to the care of these needy children, as targets for future research.

“Development of Online COPDFlix: Comparative Effectiveness Research Network”

Michael Stellefson, Ph.D., an assistant professor in the UF College of Health and Human Performance, will organize a team of faculty and staff that also includes the College of Public Health and Health Professions, HealthStreet and a private sector partner, Expert Health Data Systems International LLC. This unique project will use social media to create a community, COPDFlix, to bring medically underserved patients with emphysema and bronchitis (COPD, chronic obstructive pulmonary disease) together with their informal caregivers, their clinical care providers, and COPD researchers. This virtual advisory board will define strategies such as rehabilitation, patient education, case management and medical homes, which have been used to coordinate care for COPD patients in our region. Questions that might be addressed with CER will be developed by this partnering group.

“Reducing Dentally Related Emergency Department Visits in Alachua County, FL”

Scott Tomar, D.M.D., Dr.PH.,a professor in the UF College of Dentistry, will lead a team of faculty from the UF colleges of Dentistry, Medicine, and Public Health and Health Professions to engage patients who go to the emergency room for acute dental problems. Emergency departments do not provide dental services and dental care requests are an inappropriate use of emergency services. The team hopes to better understand these patients’ attitudes toward dentistry, their overall knowledge of oral health and potential barriers to seeking dental care in more appropriate settings. They will conduct telephone interviews with patients who have sought dental care in emergency rooms, convene a focus group and organize patient and stakeholder groups to plan interventions to address this problem.

“Multidisciplinary Academic-Community Symposium Series to Build an Obesity Disparity Research Infrastructure and Agenda”

Carolyn Tucker, Ph.D., a professor in the UF College of Liberal Arts and Sciences and in the UF College of Medicine, will team up with faculty from the UF colleges of Agricultural and Life Sciences, Liberal Arts and Sciences, and Medicine in Gainesville and Jacksonville, as well as the College of Public Health and Health Professions. The team will partner with adult and older children who are obese and receive health care at any of the five patient-centered clinics affiliated with UF Health Jacksonville, as well as with their family members and health care providers. The goal is to identify the perceived causes of obesity disparities and the health care and policy changes needed to reduce these disparities, and to create a research team to create and advance an obesity disparities research agenda.

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What do our patients want from research studies at UF Health and how can they help us ask the right research questions? The examples provided by Dr. Pearson highlight new efforts by UF researchers to understand their patients’ and communities' needs from research and to “get it right” in terms of the research questions asked, patients involved, interventions tested, outcomes measured and results interpreted. We believe this is a great strength here at UF and one that will be increasingly important as we expand CER to more patient groups in our “Learning Health System.”

Forward Together,

David S. Guzick, M.D., Ph.D. Senior Vice President, Health Affairs President, UF Health