Managing low-density lipoprotein cholesterol (LDL-C) is a critical step in reducing the risk of future heart attacks and strokes, yet many patients leave the hospital without appropriate LDL-C testing or treatment. The PCORnet® Study Test 2 Treat aimed to identify practical strategies that could improve cholesterol management in real-world care settings.
The study, which was funded by Amgen, evaluated two complementary approaches for patients hospitalized after a heart attack or stent placement to restore blood flow to the heart: a hospital-level intervention designed to improve LDL-C testing and treatment during hospitalization and a patient-level intervention designed to support cholesterol management after discharge.
Test 2 Treat demonstrates how the patient engagement resources, research-ready community, and national data infrastructure available through PCORnet can support pragmatic research across diverse health systems.
Patients and Clinicians Helped Shape the Study
Patient and clinician partners played an important role in shaping the study. Before enrollment began, patient partners worked with the research team to ensure the study addressed issues that mattered to patients recovering from cardiovascular events. They also provided input on educational materials that were given to all participants, including a placemat with tips to improve heart health and a pocket-sized card to help participants organize provider contacts, prescriptions, and medication reminders. The patient partners’ engagement will continue through the development of lay summaries and dissemination planning.
The study team also engaged clinicians across five geographically diverse health systems to ensure the hospital-level intervention aligned with real-world workflows. Physicians, trainees, advanced practice providers, pharmacists, clinical leaders, and other healthcare professionals assessed LDL-C testing practices, identified site-specific barriers to LDL-C testing and treatment, and informed the development of tailored care pathways.
Clinician input informed practical implementation strategies, including updates to inpatient admission order sets and discharge templates, pharmacist review of LDL-C values and lipid-lowering therapy, and targeted education for care teams. Ongoing site reviews allowed participating teams to monitor progress and refine implementation throughout the study.
PCORnet® Resources Supported Efficient Study Implementation
A distinctive strength of the network also contributed to the study’s successful implementation. The research-ready community within PCORnet provided access to investigators, site coordinators, nurses, pharmacists, and other care team members with experience in conducting pragmatic research in real-world healthcare settings. Together, these teams established referral pathways, identified potential participants, and integrated study activities into routine care.
Study coordinators and Care Champions, who helped participants stay on track with their recovery plans as they transitioned from inpatient to outpatient care, shared best practices to increase enrollment across participating sites. By drawing on lessons learned across sites while refining study processes for local clinical workflows, the team completed enrollment for the patient-level program ahead of schedule.
The PCORnet® Common Data Model (CDM) provided the standardized foundation needed to evaluate the hospital-level intervention across five health systems. Using a single distributed research query, the study team extracted pre- and post-intervention data from participating sites, supporting efficient and consistent analyses.
“Being able to extract timely data in the standard PCORnet® CDM format was critical to the completion of our inpatient, hospital-level intervention,” said Co-Principal Investigator Neha Pagidipati, MD, MPH, Duke University.
Findings Highlight Opportunities to Improve LDL-C Management
The study found that the multifaceted hospital-level intervention helped sites improve inpatient LDL-C testing, suggesting a trend towards promising, scalable strategies to reduce patients’ risk of heart attacks and strokes.
In the patient-level program, participants were assigned to either usual care or additional support from Care Champions, who helped them stay on track with their recovery plan. Compared with usual care plus education, Care Champion support did not significantly reduce LDL-C levels, indicating a need to further explore strategies to help patients manage their cholesterol.
Less than a year after the last participant enrolled, Co-Principal Investigator Nishant Shah, MD, at Duke University, shared the study’s findings during a late-breaking presentation at the American Heart Association’s Scientific Sessions.
“Having a resource like the PCORnet® CDM allowed us to rapidly obtain data in a standardized way and helped streamline our analyses to be able to deliver results,” said Dr. Shah.
The PCORnet infrastructure is designed to be flexible, accommodating the different needs of studies funded by academic institutions, industry, federal agencies, and other partners. Investigators who partner with PCORnet can connect with research and engagement experts who offer guidance and resources to help your patient-centered health research go further, faster.
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