Remarks to the National Institutes of Health Conference on the Role of Community Engagement in Translational Research

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by HRSA Administrator Mary K. Wakefield

May 15, 2009
Bethesda, Md.

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Thank you, Dr. Michener (Lloyd Michener, Director, Duke University Center for Community Research), for that generous introduction.

When I was invited to speak to all of you today, I was very excited, of course, because I see translational research as a means to higher quality, more efficient and cost-effective care.

Stated simply, we already know a lot about how to improve the health of people, but that information has power to transform only if we can get the best of it from bench to bedside and out into community usage. From HRSA’s vantage point, that’s from the pages of your research papers and into the populations that HRSA’s programs serve.

Further, we know that these research products must be put into large-scale practice before the benefits will result in a healthier population, high-quality care delivery, and hopefully in many cases reduced costs.

In the context of our current fractious health care system, of course, this is very hard to do.

Among the benefits of health information technology, however, is that it strengthens our health care systems and, increasingly, shows us through community-based research what interventions and care processes work best. And in that lies an opportunity to simplify the equation and extend care to more people.

And that information in the hands of the next generation of digitally proficient practitioners and consumers is what will drive improved health and health care delivery to an increasingly diverse, rapidly aging, and widely dispersed patient population.

To prove out the benefits of data-driven care, however, we need a platform – a test bed, if you will – a place where we can bring these varied components together and show whether and how they work.

Building that research platform is perhaps in some respects the hardest and most expensive part of integrating the key components – ranging from HIT to clinical training. What would this model look like? What would we need in terms of buildings, equipment and staff?

It isn’t just conducting the research. It’s creating a research environment that’s analogous to what we wrestle with in the redesign of a health care system. It isn’t just delivering care, it’s doing it in the organizational culture and socioeconomic context in which our patients live their daily lives.

If we want data-driven health care, focused on outcomes and best practices, we need places to perfect and apply the research…places in the Real World.

Figuratively speaking, I’m here today to hold open a door that you can go through for access to many of these places and community-based programs: the Health Resources and Services Administration.

It is my profound privilege to have been appointed by President Obama as the agency’s new Administrator. And it is my deep conviction that the agency has much to offer as we step boldly forward with these new research applications. We are ready to be your partner.

Let me tell you a little about the business of HRSA and encourage you to consider the potential opportunities it might present.

For a long time now, HRSA has been known as the “Access Agency,” or the “Safety Net Agency.” The main thrust of our programs is to ensure that disadvantaged, geographically remote, and chronically ill patients have an avenue for help.

If it involves at-risk populations – migrant workers, the homeless, people living with HIV/AIDS, public housing residents, poor pregnant women, rural dwellers – HRSA has a hand in it.

The agency is a lifeline for 24 million people nationwide, and those numbers are growing with the economic downturn.

HRSA provides for these patients mainly through its grant-giving authority over a $7 billion budget. We run 80 different programs that provide funds to 3,000 community-based organizations and academic institutions for hands-on care, discount medications, pre-natal supplements and screening, clinician training, research and more.

Here are a few fast facts to give you some sense of the scope of HRSA’s mandate from Congress:

• The agency funds and oversee a nationwide network of 7,500 community health centers serving 17 million patients, about 20 percent of whom have their case files managed through electronic health records systems. Many of these clinics are linked by telehealth equipment to near or distant medical centers and teaching institutions, where patients’ health care needs can be addressed remotely.
• These HRSA-funded health centers are now the largest primary care system in the nation, bigger than the biggest private plan providers by many millions of patients. From a research perspective, it reflects the most diverse patient populations anywhere in the health care system, public or private.

One third of these patients are children.

Four out of 10 are uninsured.

Nine out of ten are below 200 percent of poverty.

• HRSA also is among the largest providers of care to people living with HIV/AIDS. Just about half of the 1.1 million HIV-positive people in the country are receiving medical, dental or other vital health and support services – among them life-sustaining antiretroviral medications – through Ryan White-funded clinics.
• HRSA’s maternal and child health programs – which are among the oldest and most successful in American public health – afford pre- and post-natal care that reaches six out of 10 expectant mothers every year. Sixty percent of pregnant women nationwide and their newborns receive some form of intervention or assistance from a HRSA-funded program: pre-natal vitamins; ultra-sound; screening for heritable disorders; immunizations; smoking cessation.

With the possible exception of the Veterans’ Administration, no other single agency of the U.S. Government has as much experience as HRSA in providing frontline Primary Care. Most of what we do involves Primary Care. Our grantees are predominately in Primary Care.

With the aging of the population, we also are increasingly involved in chronic care.

Our Community Health Center grantees have over 100,000 employees – including 8,000 physicians, 2,100 dentists and 4,700 physician’s assistants and advanced practice nurses. Alongside these practitioners is a staff of almost 10,000 nurses in a varied array of care settings.

Some, for example, work in mobile field clinics, providing outreach to the homeless and migrant farm workers.

At last count, our health center grantees had 230 of these clinics on wheels.

So, by now, you’ve begun to see HRSA’s potential as a research facilitator – and you have begun to appreciate the agency’s ability to promote widespread incorporation into practice of research results. In fact, it’s what we try to do, every day, across all of our programs.

The quest for the latest and best in forward-thinking innovation is not only built into the agency’s culture, it is an organizational imperative.

As but one example: the average annual cost per-patient receiving regular Primary Care in a HRSA Community Health Center is $562. Pretty efficient by virtually any measure.

If you want to see a vision of the future in Primary Care, visit a HRSA health center. There is a strong likelihood that some mix of their people, organization and processes is where reform could take us.

HRSA has been in the Primary Care business for four decades, and some of our programs have existed longer than that. So we like to think we make a significant contribution in this arena – and I think we can do much more.

For one thing, I think we are that platform – that test bed -- I was talking about a moment ago.

The President’s investment in our agency – $2.5 billion through the Recovery Act – represents the single largest infusion of capital funding into Primary Care in decades. And the main message I came here today to deliver is this: HRSA is open to, welcomes, and very much encourages partnership with you in your endeavors.

We are convinced that translational research has the potential to improve quality of care for our patients; increase our cost effectiveness and allow us to efficiently strengthen and expand our care network.

We are just as certain that many of our grantees are ready, able and willing to assist with this initiative.

They are, in many instances, as hopeful about this as the people in this room today.

And in meetings with my senior staff, we don’t think they will require a long ramp-up period…

…because many of our grantees are already involved – and have been involved for years – in research projects with HRSA, AHRQ, the CDC, NIH, USDA, State Health Departments, and private foundations. They already have Institutional Review Boards. They already are engaged in data collection and analysis. And they have been pushing ahead with health information technology.

As but one telling benchmark: nine out of 10 of the current grantees in the NIH-CTSA program already are HRSA partners. Decades of trust and good will are built into these relationships.

And their expertise is growing. Many HRSA grantees, for example, have joined together to establish Health Center Controlled Networks that allow them to centralize, share and correlate data electronically.

These Health Center networks mirror features of Practice-Based Research Networks, and they’ve already yielded important insights into clinical trends and health disparities across multiple clinics within states and across state lines. As closely connected as HRSA is to its grantees at ground-level, we are beginning to get a detailed view of the challenges they face that neither they, nor we had before.

Among other examples I could give you, our HCN grantee in Chicago has uncovered some compelling information about asthma and colon screening in minority populations.

By their very nature, however, the health centers themselves are not ready-made research venues – anymore than your average solo practitioner might be. Most lack the resources and personnel to carry forth a demanding clinical trial or broad-based population study.

Rather, they are community-based, community-governed, and intensely focused on clinical practice tailored to the immediate needs of their patient populations. They are, of course, clinical care settings first.

In speaking to my senior staff this week, the consensus is that the pace of practice, the size of our grantees’ patient bases, and their narrow financial margins make it prohibitive for them to do much with their own data.

Even those health centers with fairly well developed electronic databases are not usually staffed to do extensive correlation and analysis. As for those still working on paper-based systems, of course, it becomes a case of finding the proverbial needle in a haystack.

For this reason, among many others, HRSA promotes the formation of networks throughout its grantee system that thread the safety net together. For example, linking local health centers to HRSA-funded state Primary Care Associations (PCAs). Or connecting the PCAs to a state’s Health Department and major academic institutions. And, lately, funding projects to build electronic telemedicine hubs that tie them even more tightly together.

All are HRSA grantees on paper, but the larger aim is to assist them in functioning as an organic whole – from the local clinical provider, through a central PCA to the State health surveillance agency, to the data analysis expert at a school of public health, which may also be receiving HRSA grants to expand training in a critical profession, such as nursing.

Frankly, the most sporadically funded of these components, certainly in recent years, have been the research and training functions.

Still, some very important – and highly pragmatic – research has been done.

Here’s what one of those projects looks like in the Real World:

• In South Carolina, where 140 HRSA clinics serve a predominately African-American population of 294,000 people, one health center is engaged in research into vitamin deficiency in pregnant women and infants, and into the efficacy of primary care providers performing routine colonoscopies.

The organizing agency was the South Carolina Primary Health Care Association, which gained the approval of the local governing board for the projects and also serves in the IRB capacity.

Funding is provided by the NIH. In the vitamin study, a private foundation was the initiating agent, with technical support from the Medical University of South Carolina.

The Vitamin D study has advanced through the data analysis and patient survey phases, and the center is looking to conduct human clinical trials soon to devise new protocols to improve patient outcomes in the clinic’s target population – and onward into statewide dissemination through the health center system.

The South Carolina Primary Health Care Association, which has worked to gain approval of the local communities for projects such as this, is assisting the center in proceeding to clinical trials. The Association will serve as the organizing agency for the involvement of all SC centers in clinical trials, and will also serve in the IRB capacity.

This, I think, is a very good practical model for translational research – in this case, with the state PCA in the driver’s seat. But it’s not difficult to imagine any number of other partnering options.

The contact person on the South Carolina projects is Lathran Woodard, a 22-year veteran of public health delivery in a largely rural state in which homes in some counties don’t have phone service. Here’s what she had to say about the experience:

“The soil has been tilled now, and the health centers are seeing the benefits of this research in concrete terms. We’re centralizing all of our health center data here at the PCA. We’ve gotten to the point that about half our centers are HIT-equipped. And we’re moving toward the point of being able to take on larger research projects in more locations.

“It has helped that it’s been such a gradual process, because it gave people time to accept it -- a level of trust had to be developed. NIH is considered the gold standard.”

But in the early phases, even the name “NIH” was not enough to blunt the pain that many African-Americans associate with another name: “Tuskegee.”

We know, most recently from a survey by Dr. Neil Powe at Johns Hopkins of 700 outpatient clients in Maryland, that African-Americans are far less willing than whites to take part in clinical trials – even when their own physicians recommend it.

As Lathran Woodard put it: “The resistance in a lot of places is just automatic. The thing that’s different here is that we control the IRB, and the community is heavily represented. That removes a lot of the stigma.”

This suspicion is something we encounter on a fairly regular basis in the HRSA-funded care network – among migrant farm workers, for example, and patients with substance abuse issues, and young HIV-positive males of color.

Breaking through is seldom easy. But in many instances, it is, literally, a matter of life and death. Here’s one such case:

• In our HIV-AIDS Bureau at HRSA, which has an on-going relationship with the CDC, it became quite clear some years ago that Young Men of Color living in medically underserved communities were one of the fastest growing “reservoir populations” for the virus.

In epidemiological terms, arresting the spread within these communities is confounded by a number of problems: language barriers (many are Latino); a scarcity of local HIV screening facilities; overarching social and religious stigma; and widespread “recreational” drug use.

Preliminary findings of a five-year demonstration and evaluation project funded by a HRSA program called Special Projects of National Significance (or SPNS) found, for example: that even when they know they have tested positive, many adolescent males will wait up to 6-7 months to present for treatment; and once they do present, it is difficult to retain them in treatment. So multiple drug resistance is a common part of the profile.

Eight grantees in seven states were chosen to design, implement and evaluate behavioral interventions within a nationwide population of young men of color, ages 16-24.

The grantees range from county public health agencies and academic medical centers to street-level, non-profit outreach organizations. Technical assistance, staff training, evaluation and data analysis are provided by George Washington University, which also serves as the data repository for the project.

HRSA provides overall project oversight.

There are over 900 clinical sites providing care in HRSA’s Ryan White Program, many of which are research institutions that already are affiliated with the NIH and CDC.

But make no mistake about this, as one of our senior staffers in the HIV-AIDS Bureau put it: “A doctor in a lab coat cannot walk into a lot of places, and expect to be taken too seriously.”

In this instance, the brunt of the information-gathering and outreach is borne by the people in the trenches, at the community level, who are bilingual and as no-nonsense as the conditions require. When their final report is published, I think their findings will point the way toward important changes in practice throughout the system.

And I want to emphasize again that much of the technical research capacity had to be provided within the context of a very busy clinical environment.

• I want to leave you with one more thought on the importance of “networks” in this kind of research.

Almost everything HRSA achieves in delivering care to 24 million people it does with a staff of 1,400 full-time federal employees – within a cooperative system that involves thousands of public and private partners, in every state, U.S. possession and territory.

If you want to do research in Guam, we have partners in Guam.

HRSA’s relationships run through major research universities and teaching colleges, state health departments, small rural hospitals, street corner clinics, school inoculation programs, prenatal classes in church basements, and out into the farmlands where migrant workers congregate every harvest.

Nearly half of all uninsured people in America live within 5 miles of a HRSA-funded health center.

HRSA’s presence in these communities comes by many names, and in many forms:

There are Area Health Education Centers (AHECs); Health Disparities Collaboratives; and Centers of Excellence – to name a few. Much of what we know about the populations we serve comes bubbling up through these portals... through on-going engagement with people in the communities we serve.

As one recent example, HRSA, in partnership with the CDC, was able to flood these networks with health bulletins at the onset of the recent H1N1 flu outbreak -- with the result that community health center clinicians were among the first to confirm cases in their cities and states. They also were in a position to exert a calming influence as local experts in media reports and community forums, at a time when parents and school officials were understandably anxious.

With the President’s investment in Health Information Technology, these networks will strengthen and extend their reach.

And with the application of translational research on a wider scale, we will have an unprecedented opportunity to build a research agenda from the ground up, informed by the field.

To more fully understand what all of this means to our patients in the Real World, one need only consider for a moment HRSA’s Maternal and Child Health Bureau.

MCHB’s ties to communities nationwide extend all the way back to 1912 – to the federal government’s first involvement with the health of women, children and their families.

In the fight against infant mortality, MCHB was and still is a leader. In the decades-long push to extend universal immunization, MCHB was there. In some of the earliest research into the impact of environmental factors on children’s health, MCHB was the facilitator.

The MCH Bureau conducts the most comprehensive inventory of children’s health – and of children with special health needs – in the U.S.. It compiles, analyzes and presents data; propagates best practices to state health departments; and encourages young researchers to choose careers in public health through doctoral fellowships, and clinical training rotations.

Through its Special Projects of Regional and National Significance, MCHB promotes translational research in children’s emergency medicine, teen pregnancy, drug abuse interventions, prenatal diet and more.

Eighty percent of local projects funded by SPRANS continue to operate on their own at completion of the grant cycle.

Of course, too, the Bureau also runs the $98 million Healthy Start program to fight infant mortality in 100 low-income minority communities.

So, to go back to where we began, I think HRSA is the platform we are looking for – the “test bed” we need – as we move forward with transforming research into practice.

I believe this because I see it every day, in action, in health centers and Ryan White clinics and well-baby programs nationwide. I see it in the numbers – 24 million patients served; half of the HRSA clinics in South Carolina wired for HIT; and so on.

With the Administration poised to invest billions in Health Information Technology, I see that network expanding exponentially.

And with the help of two of the world’s most renowned public health agencies – NIH and CDC – I am confident that HRSA can be of even greater service in achieving the change we seek.

Ladies and gentlemen, thank you for the opportunity to speak to you today.