Research Studies and Clinical Trials
Louisiana Experiment Assessing Diabetes Outcomes (LEAD Study)
The objective of this study is to examine the impacts of Medicare reimbursement for non-face-to-face chronic care management services on diabetes-related outcomes. This 5-year National Patient-Centered Clinical Research Network (PCORI)-funded project is led by Dr. Lizheng Shi at Tulane University in partnership with REACHnet’s member health systems in Louisiana. This project is one of eight policy-focused studies that comprise the Natural Experiments for Translation in Diabetes 2.0 (NEXT-D2) Network.
Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)
The objective of this nationwide randomized clinical trial is to compare the effectiveness of 81mg versus 325mg daily aspirin dose for preventing heart attacks and strokes in patients living with heart disease. REACHnet’s participating health systems include Ochsner Health System and Baylor Scott & White Health. Ochsner was one of the first two sites to begin recruiting and is the third-highest enrolling site among the 40 participating health systems across PCORnet. ADAPTABLE aims to generate evidence to inform care and improve outcomes in millions of patients with heart disease and prevent as many as 88,800 deaths per year worldwide.
Genomic Approaches to Treatment (GEARx)
This prospective randomized trial compares the effectiveness of combinatorial pharmacogenomics (PGx) guided treatment versus best-practice guideline concordant treatment on well-being and depression severity in patients with major depressive disorder. Through REACHnet, University Medical Center New Orleans (UMC) is participating in this PCORI-funded trial lead by Massachusetts General Hospital. Results from GEARx may help improve personalized treatment for patients living with depression.
PCORnet Blood Pressure Control Laboratory (BP Control Lab)
REACHnet partnered with University of California San Francisco, the American Heart Association (AHA), and the American Medical Association (AMA) on a PCORI-funded project that compares two different ways of helping clinical practices control blood pressure — giving access to several AMA/AHA materials that can help doctors improve methods, with or without a practice facilitator to guide their use of those materials. The study will also test two types of home blood pressure monitors—one that connects with a smartphone and one that does not—to see which is more effective for helping patients achieve their personal goals for blood pressure control. Results from this study will provide real-world evidence for improving blood pressure control in the United States.
Genetic testing to Understand Renal Disease Disparities across the U.S. (GUARDD-US)
GUARDD-US is a pragmatic clinical trial that aims to determine the effects of returning APOL1 genetic test results to African ancestry patients with hypertension and their primary care providers. Hypertensive patients with positive APOL1 results are at greater risk of developing chronic kidney disease, so more intensive blood pressure monitoring and control is recommended. The primary outcome is systolic blood pressure (SBP) at three months, when comparing patients with high-risk APOL1 variants (positives) versus no high-risk variants (negatives). The co-primary outcome is three-month SBP in those who receive a positive result at baseline versus those who receive delayed testing (six months later). Secondary outcomes include renal disease screening and psycho-behavioral factors. GUARDD-US is led by Mount Sinai in partnership with REACHnet (Baylor Scott & White Health and University Medical Center New Orleans) and other sites in the Midwest, East Coast, and Southern U.S., as part of the National Human Genome Research Institute (NHGRI)-funded Implementing Genomics in Practice (IGNITE) Network.
PCORnet Bariatric Study
The objective of this study is to compare the benefits and risks of the three most common bariatric surgery procedures—Roux-en-y gastric bypass, adjustable gastric banding, and sleeve gastrectomy. The study employs an observational design using electronic health record (EHR) data of more than 65,000 patients from 41 participating healthcare organizations across the country. Data were collected through the PCORnet distributed research infrastructure from 11 clinical research networks (CRNs), including REACHnet. Peer-reviewed publications include:
- The National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study Cohort: Rationale, Methods, and Baseline Characteristics in JMIR Research Protocols
- Comparative Effectiveness of Bariatric Procedures for Weight Loss and Safety in Annals of Internal Medicine
- Comparative Effectiveness of Bariatric Procedures among Adolescents: The PCORnet Bariatric Study in Surgery for Obesity and Related Diseases
- Combining distributed regression and propensity scores: a doubly privacy-protecting analytic method for multicenter research in Clinical Epidemiology
Short- and Long-term Effects of Antibiotics on Childhood Growth
The objective of this study is to compare the effects of different types, timing, and amounts of antibiotic use in the first two years of life on body mass index (BMI) and obesity at ages five and 10 years, and on growth trajectories to age five. The study employs an observational design using electronic health record (EHR) data of more than 362,000 patients from 35 participating healthcare organizations nationwide. Data were collected through the PCORnet distributed research infrastructure from 11 clinical research networks (CRNs), including REACHnet. Peer-reviewed publications include:
- Early Antibiotic Exposure and Weight Outcomes in Young Children in Pediatrics
- Early Antibiotics and Childhood Obesity: Do Future Risks Matter to Parents and Physicians? in Clinical Pediatrics
- Maternal antibiotic use during pregnancy and childhood obesity at age five years in International Journal of Obesity
- Comparing Prescribing and Dispensing of the PCORnet Common Data Model using PCORnet Antibiotics and Childhood Growth Study in eGEMs (Generating Evidence & Methods to improve patient outcomes)
REACHnet is performing a sub-study, in partnership with Humana and Harvard Pilgrim Health Care, to link health insurance claims data with EHR data and re-analyze the main study aims using claims records for antibiotic prescriptions filled.
Rapid Cycle Research Projects
REACHnet is leading a rapid cycle project titled “PCORnet for Outcome Measurement and Process Dissemination: Accelerating Evidence Development for the Opioid Overdose Epidemic” to demonstrate PCORnet’s capacity to create a more robust opioid surveillance dataset and address current gaps in timely access to clinical data necessary for surveillance, prevention, and intervention. This study leverages PCORnet data to characterize risk factors, clinical processes, and outcomes of the opioid epidemic and analyze relationships between patient- and provider-level risk factors, process metrics, and outcomes.
REACHnet partnered with Vanderbilt University on a Diabetes Incidence Prevalence and Medications Use project focused on using PCORnet data to describe and validate the use of several major classes of glucose-lowering medications for type 2 diabetes. REACHnet is performing a sub-study in partnership with Tulane University and Blue Cross Blue Shield of Louisiana to link clinical data with claims records and perform comparison analyses to describe and enumerate differences in clinical outcomes and medication patterns.
REACHnet partnered with University of Florida on a study called “PCSK9 Inhibitor Use in the Real World: Data from the National Patient Centered Research Network (PCORnet)” which used electronic health record data to characterize the early utilization of PCSK9 inhibitors in addition to standard lipid lowering therapies among real-world patients with varying degrees of cardiovascular risk. Data for this study were collected from eighteen geographically diverse healthcare systems.
REACHnet partnered with the CDC and OCHIN on a project to evaluate the utility of data generated through routine healthcare delivery as a surveillance tool for latent tuberculosis infection (LTBI). The study aims to provide accurate LTBI screening metrics by identifying patients at risk for LTBI using electronic health record data in the PCORnet Common Data Model.