VA Research: Diabetes Care
By Craig Collins
DIABETES MELLITUS – A CHRONIC DISEASE in which the body can’t produce or properly use insulin, the hormone that transfers sugar from the bloodstream into cells – is a serious and worsening public health issue in the United States, where it’s the seventh-leading cause of death. More than 30 million Americans, including more than 7 million who remain undiagnosed, have the disease. According to the U.S. Centers for Disease Control and Prevention (CDC), 84 million more Americans are at risk to develop the disease, and 1.5 million more are diagnosed every year.
Ninety percent of the people with diabetes suffer from the type 2 form of the disease, in which the pancreas fails to meet the body’s demand for insulin. High blood sugar levels can eventually damage blood vessels and organs, and diabetes is a leading cause of blindness, end-stage renal disease, and amputation for Department of Veterans Affairs (VA) patients. One of the most common diagnostic tools for diabetes is the hemoglobin A1c test, which estimates an average level of blood sugar over three months. A1c levels of 6.5 percent or more indicate a diabetes diagnosis; levels between 5.7 and 6.4 – above normal, but not yet meeting the criteria for type 2 diabetes – indicate a diagnosis of prediabetes.
For a number of reasons, veterans have a much higher risk for diabetes than the general population: 25 percent of veterans have diabetes, compared to about 10 percent of Americans overall. A major risk factor for diabetes is obesity, and nearly 80 percent of veterans are overweight or obese.
Care providers in the Veterans Health Administration (VHA) are focusing resources and expertise on the nearly 1.5 million veterans with diabetes – and also on the millions more with prediabetes, whom research has shown can prevent or delay onset of the disease through healthy diet, weight loss, and exercise. To help guide these efforts and optimize outcomes for veteran patients, researchers in the VA’s Health Services Research and Development (HSR&D) Service evaluate diabetes care from every angle, examining patients’ access to care as well as the most effective and efficient means of delivering it.
These studies of health care delivery are particularly important for veterans with diabetes, said the VA’s Matthew Crowley, MD, because, “Diabetes is a profoundly self-managed disease. The patient is responsible for taking care of their own diabetes for 99.9 percent of their time. Most days, weeks, and months, they are not interfacing with their care providers.” The VA, to maximize interaction between diabetes patients and its health care system, has been a leader in telemedicine: provider/ patient contact through telecommunications technology. While the efforts of researchers and clinicians have improved control of diabetes overall across the VA, veterans with persistent poorly controlled diabetes (PPDM) haven’t benefited from these efforts. Despite receiving clinic-based care, 12 percent of veterans with type 2 diabetes have PPDM and are at greater risk of complications.
Crowley, an endocrinologist at the Durham, North Carolina VA and an associate professor of medicine at Duke University, recently launched a study that will examine an intensive telemedicine intervention, known as PRACTICE-DM, designed for delivery within the VA’s existing telemedicine infrastructure. Crowley’s team defined PPDM as a hemoglobin A1c level greater than 8.5 percent, persisting for more than a year despite engaging with standard VA diabetes care.
The study will compare outcomes between two groups of veteran patients with PPDM, at sites in Durham and Richmond, Virginia. One group will receive the standard home-telehealth care coordination and telemonitoring, and another will receive the PRACTICE-DM.
The difference between the two programs, Crowley said, is significant. While the standard telemedicine protocol focuses largely on telemonitoring and data collection, “PRACTICE-DM is a comprehensive approach that combines a number of different telehealth-based approaches, all for delivery by clinical VA telehealth staff.” Bundled into the program are five different activities: telemonitoring; a self-management support module for educating patients; diet and activity support, which will help patients develop individualized plans for nutrition and exercise; depression support, linking patients with active depression symptoms to VA resources; and medication management, done in coordination with a VA provider. “It’s very comprehensive,” Crowley said, “and targets many of the factors that typically underlie persistently poor control in veterans with type 2 diabetes.”
Crowley’s team is on track to complete enrollment by the end of 2019 and begin reporting data sometime next year. While his team is working blind and can’t predict what they’ll see, he said, “We would consider a clinically significant difference between the two interventions to be about half a point in A1c. In some of our pilot work, we saw improvements that were substantially greater than that, so we hope we’ll see similar results in this larger study.”
DIABETES CARE FOR WOMEN AND MINORITY VETERANS
VA’s attempt to optimize diabetes care for veterans is complicated by the fact that differences – in incidence of the disease, access to care, and outcomes – persist among subgroups of the veteran population. Researchers throughout the VA conduct numerous studies devoted to mitigating or eliminating these disparities.
The fastest-growing segment of VA health care users is women. In 1988, when the VA established its Women Veterans Health Program, a little over 4 percent of veterans were women. Today, the VA estimates that percentage to be 10 percent. Much of what VA investigators have learned about diabetes care for women veterans has been revealed in their examinations of different interventions and models of care.
Tannaz Moin, MD, an endocrinologist at the VA Greater Los Angeles Healthcare System, core investigator at the HSR&D Center for the Study of Healthcare Innovation, Implementation and Policy (CSHIIP), and an assistant professor of medicine at the University of California-Los Angeles, has studied VA’s diabetes programs for years now, including comparisons of the Diabetes Prevention Program (DPP) – an intensive, structured, in-person program Moin has called the “gold standard” of prevention programs for adults with prediabetes – and the MOVE! program, which has fewer sessions, is designed for flexibility, and does not specifically focus on adults with prediabetes. Moin’s research has already yielded important discoveries, such as the finding that online diabetes programs are as effective as in-person sessions for weight loss – and that weight loss and patient satisfaction outcomes are generally better among veterans enrolled in the DPP than among those enrolled in MOVE!
When Moin and colleagues recruited participants for one of her initial comparison studies, she noticed that despite the fact that more than 7,000 women veterans were receiving care in the Los Angeles VA System, very few women – two, to be exact – signed on for her study.
In response, Moin designed a study that became one of several administered through a new VA Quality Enhancement Research Initiative (QUERI) program known as Enhancing Mental and Physical Health of Women through Engagement and Retention (EMPOWER). “In EMPOWER,” Moin said, “our philosophy is that while VA is doing amazing things, delivering evidencebased preventive services … women are still considered a vulnerable population with unique needs.”
Moin’s team found that many women veterans weren’t comfortable working in predominantly male group-based programs such as the DPP and MOVE! When they offered a prevention program in a woman-only group, they had greater success recruiting participants. Women veterans were screened for overweight and prediabetes, a process that led to an unforeseen result: Very few women veterans with prediabetes were aware of it, and the medical record review and patient notification process itself resulted in a 187 percent increase in the number of women aware of their prediabetes diagnosis. Women participants were then offered the choice of participating in an in-person, womenonly DPP group led by another woman coach or a remotely delivered online version of the DPP.
The aim of this study – Tailoring VA’s Diabetes Prevention Program to Women Veterans’ Needs – wasn’t really to measure the weight loss outcomes, which have been demonstrated by the prior work of Moin’s team, but at increasing enrollment. And by this measure, it was a success. “This was supposed to be a tiny pilot,” said Moin, “with 40 women. And we were able to recruit three times that number – 120 participants. The enthusiasm of the women was high because they got a choice, and believed the VA cared about them enough to say: ‘You choose what works better for you.’” Two-thirds of the participants preferred the online version.
Moin and her team are in the process of submitting a proposal for a larger-scale study. While women-only in-person groups are a feasible option for densely populated areas such as Los Angeles, women veterans living elsewhere – Bakersfield, for example – may benefit from the online option. “Eventually we’d like to see the online DPP more broadly available,” Moin said. “I believe in providing choice.”
Choice is a key principle of HSR&D investigations, many of which aim at expanding access to care among veterans overall, and particularly at expanding access for vulnerable populations. According to the CDC, rates of diagnosed diabetes are higher among African-Americans, Native Americans, and Hispanic Americans than they are among white and Asian Americans.
VA health care researchers are still trying to pin down the reasons for these disparities. Brian Neelon, PhD, a research health scientist at the Charleston VA Medical Center and associate professor of biostatistics at the Medical University of South Carolina, is leading an ambitious analysis of personal and environmental factors that, over time, affect outcomes for veterans with diabetes. He and other researchers have already gathered data suggesting that disparities in uncontrolled blood sugar and length of diabetes-related hospital stays are explained in part by where veterans live, but demography and residential location don’t provide the full picture. Neelon is studying other factors, essentially overlaying multiple data sets, beginning with the identification of “hotspots,” or geographic clusters of high or low HbA1c, health care costs, emergency room visits, and other outcomes among veterans with type 2 diabetes. “By identifying locations with poor diabetes-related outcomes,” said Neelon, “policymakers and health providers can begin to design targeted interventions” – such as additional community-based outpatient clinics or telemedicine systems – “to improve outcomes in these communities.”
Neelon’s analysis will also involve developing a “neighborhood deprivation index” of factors – such as income, education, employment levels, neighborhood walkability, and access to healthy food – to see whether more deprived areas correlate with poorer outcomes. Finally, he and his colleagues will develop a new “workforce deprivation index” that will comprise information such as average wait times for primary care, the overall availability of primary care, and the presence of team care, in addition to basic access measures such as distance to a VA medical center. His team will use this index to identify facilities that may benefit from increased staffing, efficient patient portals, or telehealth programs to reduce patient demand. Ultimately, they want to determine how neighborhood and workforce deprivation impact the long-term health of veterans with type 2 diabetes and to identify resource-deprived areas that are ideal targets for health promotion efforts. “The overarching premise of our grant is that some areas may be doing well,” he said, “while others could potentially benefit from interventions to improve health outcomes. Our aim is to pinpoint areas that are in greatest need of such interventions.”
Donna L. Washington, MD, directs the Office of Health Equity-QUERI National Partnered Evaluation Center and leads the women’s health-focused research area at the CSHIIP. She’s devoted her career to addressing the health care needs of vulnerable and underserved patient populations. Veterans from racial or ethnic minority groups with diabetes carry what she calls a “double burden”: Not only do they have diabetes at higher rates, but among patients who have diabetes – both within and outside the VHA system – they are less likely to have their blood sugar under control.
These two factors are the starting point of one of Washington’s recent studies, launched last year: “Mitigating Racial/Ethnic and Socio-economic Disparities in VA Care Quality and Patient Experience.” The investigation will be an observational study of a national cohort of veterans, correlating “social determinants” of health care outcomes (such as socio-demographics and residential characteristics) with health care data, characteristics and behaviors of health care providers (i.e., prescribing habits), and system-level data, including sitelevel implementation of patient-aligned care teams (PACTs) and VA quality measures of patient experiences. LaCresha Mitchum, a registered nurse, certified diabetes educator, and diabetic coordinator at the Williams Jennings Bryan Dorn VA Medical Center in Columbia, South Carolina, listens to U.S. Army veteran William Baker, a patient with type 2 diabetes, as he describes some health issues. An investigation launched last year, “Mitigating Racial/Ethnic and Socio-economic Disparities in VA Care Quality and Patient Experience,” aims to understand how betterperforming VA systems provide diabetes care to racial/ethnic minority veterans, with the hope that systems with better health outcomes can help other facilities or systems improve.
Understanding how better-performing systems deliver diabetes care can help other facilities or systems improve monitoring and controlling blood sugar among racial/ethnic minority veterans. “This is really one of the very unique aspects of the study I’m leading,” said Washington. “We believe health care systems can vary how they deliver care, so that even if there are social determinants of health present, we believe some health care systems are more successful in figuring out how to account for them and get better outcomes for their patients.”
The VA has been a pioneer in developing and field-testing evidence-based interventions that reduce disparities in health care outcomes among vulnerable patient populations. “VA studies have found that a peer coach or peer support improves control of diabetes and reduces disparities,” Washington said, “and that’s one of many different examples of evidence-based practices to help with diabetes control.”
The way in which these interventions are implemented may differ outside the controlled environment of a study group, however, and these differences are part of what Washington and her team plan to evaluate. “In other words,” she said, “how have some sites translated these evidence-based findings into practice, and what are some of the lessons that can be applied to other sites?”
It’s an ambitious research undertaking, involving several layers of data, and is likely to take at least a couple of years to complete – but it’s an ambition in line with the VA’s mission to provide the highest-quality diabetes care, and achieve the best possible outcomes, for all veterans regardless of who they are or where they live.