Charles: Participation in a Pragmatic Clinical Trial To Bring Hope to People Coping with Multiple Chronic Diseases
People who have multiple chronic diseases often lead difficult lives, struggling with effects of these conditions on their health and well-being. “Well, everything with me has slowed down … I’m not so active anymore,” says Charles, who has type 2 diabetes, hypertension (high blood pressure), and chronic kidney disease (CKD). “I used to be active all day.” In his mid-thirties, Charles was initially told by his doctor that his blood glucose (sugar) levels were elevated. Although he has struggled with his weight, he was somewhat surprised to learn of this diagnosis because he had always led an active life, playing sports such as football. “I had never been the person who went to the doctor because I was always athletic … always feeling good,” he explains, “all my life, I always felt good.” As his condition worsened to type 2 diabetes, he began taking insulin to manage his blood glucose levels. In the years that followed, he was also diagnosed with CKD and hypertension. For Charles, coping with these three chronic diseases would prove to be a major focal point in his life. By choosing to participate in the NIH-supported Improving Chronic Disease Management with Pieces (ICD-Pieces) clinical trial, Charles is helping researchers find new pathways to better health for people with these life-altering diseases.
The Continual Challenges of Managing Multiple Chronic Disease
“Well, everything with me has slowed down … I’m not so active anymore,” says Charles, who has type 2 diabetes, hypertension (high blood pressure), and chronic kidney disease (CKD). “I used to be active all day.”
Charles, now in his late-fifties, has adjusted many aspects of his life to manage these diseases. His health was a factor in his decision to work as a driver for a day care facility, noting that he was limited in what he could physically do. “Standing—I can’t do that … [lifting] heavy things—I can’t do that either,” he notes, “I’m just able to get by by driving… so I do that.” However, as is often the case, these three chronic diseases may have been the causes of other health issues that have come up to further complicate Charles’s life. He also has other conditions, including bone disease and eye-related health issues. A few years ago, Charles faced another serious health scare—he suffered a stroke, which left an enduring mark, still affecting the right side of his body. “My body is breaking down a little bit,” Charles reflects. In order to manage these diseases, he takes different medications that require specific timing during the day. After his stroke, Charles’s long-term memory is not quite what it used to be, so he has come up with a plan to make sure he takes all of his medicines in a timely manner. “I make things simple for myself,” he explains, “everything is laid out for me in a simple location, in a simple bag … I try to keep it plain and simple for me because I will, I will forget.” Adherence to the proper regimen for each of his medications is just one of the many daily challenges faced by Charles and others with type 2 diabetes, hypertension, and CKD, as well as the spectrum of health complications that these diseases can cause.
The ICD-Pieces Trial—A Pragmatic Approach to Clinical Research
“I make things simple for myself,” he explains, “everything is laid out for me in a simple location, in a simple bag … I try to keep it plain and simple for me because I will, I will forget.” Adherence to the proper regimen for each of his medications is just one of the many daily challenges faced by Charles and others with type 2 diabetes, hypertension, and CKD, as well as the spectrum of health complications that these diseases can cause.
Charles’s struggles illustrate how multiple chronic conditions can exact a serious toll on people’s health and their daily lives. Although research studies over the years have identified potential treatments for these diseases, the application of scientific advances to usual clinical settings has proven difficult. Earlier studies have focused on each disease individually, but not in combination—a complex, clinically important health scenario for many people in the United States. In 2014 the NIH Common Fund and NIDDK began supporting the Improving Chronic Disease Management with Pieces (ICD-Pieces) study—a clinical trial designed to improve health outcomes in people with coexisting type 2 diabetes, hypertension, and CKD. Four health-care systems, three based in Texas and one in Connecticut, are participating in the study. The study implemented a new technological tool, called “PIECES,” that uses electronic health records (EHRs) in the four participating health care systems. The PIECES platform, developed by Pieces Technologies, utilizes data from EHRs in real time to help researchers and clinicians identify patients managing the triad of chronic diseases, improve data collection, discover complications of the three diseases in patients at an early stage, and coordinate care for study participants. Patients enrolled in the ICD-Pieces trial are assigned to one of two groups. In one group, the participants’ health care does not change, but their outcomes are closely monitored—this will serve as the “control” group. In the second group, the patients’ primary care physicians collaborate with subspecialists, for example, kidney disease specialists (nephrologists); these collaborations are supported by “practice facilitators” who work with physicians to help implement best practices and tailor health care plans based on available resources at each site. Frequency of hospitalization for any reason, over the course of 1 year, is the main, or primary, outcome measured in the study. However, researchers are also evaluating a number of secondary outcomes, including disease-specific hospitalizations, emergency room visits, cardiovascular events (e.g., stroke or heart attack), and death.
Charles remains positive about his circumstances, noting that he didn’t choose to have these conditions. “And I can only adapt to it,” he says, “and keep going with my life, and don’t give up.”
ICD-Pieces falls under the “pragmatic clinical trial” category of research studies, which uses real-world, large-scale, often multiple-center health care settings to evaluate different approaches to disease management, leading to findings that are likely to have broader translatability to clinical care. However, in order to conduct a pragmatic clinical trial, several practical challenges unique to these settings must be overcome, such as implementation of appropriate and standardized rules and regulations across the different health care systems. By contrast, more traditional “randomized controlled trials” often occur at a smaller scale and in settings where most variables can be controlled, but findings may not necessarily be as applicable beyond the clinical settings used in the trial. ICD-Pieces plans to enroll more than ten thousand study participants who are already patients across the four participating health care systems. This engagement of diverse health care systems and a broad range of study participants will help expand translation of the research findings.
Charles, a patient within one of the Texas-based health care systems participating in ICD-Pieces, was identified as a potential candidate for the study. He agreed to enroll and in February of 2018 began his 12-month participation in the trial, in which he continued to receive care from his primary care physician, but also began seeing new subspecialists for his chronic conditions. Other health care professionals, including a nutritionist and physical therapist, provided additional support and guidance as well.
Hope Through Research
Findings from ICD-Pieces and other clinical trials will continue building the foundation for better health in people living with complex multiple chronic diseases. “I keep moving,” Charles reflects, “I keep moving every day, and not let this disease … get me down.”
Charles struggles daily with the burden of managing the many health conditions he has—the primary effects of which can change over time. “[My back pain] has made it difficult for me to function like a normal person would, all day,” he explains; “now my back is really my biggest problem.” However, Charles remains positive about his circumstances, noting that he didn’t choose to have these conditions. “And I can only adapt to it,” he says, “and keep going with my life, and don’t give up.” With the invaluable participation of Charles and thousands of others, ICD-Pieces is paving the way to improved treatments for people with type 2 diabetes, hypertension, and CKD, identifying therapeutic approaches that have the highest likelihood of improving health in the real world, not just in an experimental setting. Findings from ICD-Pieces and other clinical trials will continue building the foundation for better health in people living with complex multiple chronic diseases. “I keep moving,” Charles reflects, “I keep moving every day, and not let this disease … get me down.”
This content is provided as a service of the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), part of the National Institutes of Health. NIDDK translates and disseminates research findings to increase knowledge and understanding about health and disease among patients, health professionals, and the public. Content produced by NIDDK is carefully reviewed by NIDDK scientists and other experts.