Studies

VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Management in Heart Disease (V-INCLUSION)

Posted on by Jodi Snare

Page last updated January 13, 2025

ClinicalTrials.gov#: NCT06249165
Study Design: Intervention Trial
PCORnet Infrastructure: Common Data Model (CDM), Single IRB, Patient partners or engagement
Principal Investigator: Neha Pagidipati
Institution: Duke Clinical Research Institute
PCORnet® Network Partner: The Coordinating Center for PCORnet®
Funder: Novartis
Funding Date: 2023
Study Duration: 2023 – 2026
Participating PCORnet® Clinical Research Networks: GPC, Insight, OneFlorida+, PaTH, REACHnet, STAR 
Therapeutic Area: Cardiovascular
Condition: Atherosclerotic Cardiovascular Disease (ASCVD)
Status: Active, not recruiting

Research Question(s):
Can inclisiran be an effective solution to improve low-density lipoprotein-cholesterol management and close care gaps in an inclusive Atherosclerotic Cardiovascular Disease (ASCVD) and ASCVD risk equivalent population?

Measurement Matters: Refining and Validating a Patient-Centered Outcomes Research Engagement Measure

Posted on by Jodi Snare

Page last updated April 14, 2026

 

Study Design: Other, Development and initial validation of a PCOR engagement tool
PCORnet Infrastructure: Single IRB, Patient partners or engagement
Principal Investigator: Marc A. Cohen
Institution: University of Massachusetts Boston
PCORnet® Network Partner: External
Funder: Patient-Centered Outcomes Research Institute (PCORI); (project webpage)
Funding Date: 2023
Study Duration: 2023 – 2025
Participating PCORnet® Clinical Research Networks: GPC, INSIGHT, PEDSnet, REACHnet, STAR
Therapeutic Area: Engagement Methods
Condition: Other; Science of Engagement Award to develop and validate an engagement tool on engagement quality and selected outcomes
Age Range: PCORI lead investigators and/or those who manage PCORI projects
Status: Not yet recruiting

Research Question(s):

  1. Can we develop a concise way to measure the extent to which researchers engaging older adults in research projects are doing so effectively and can we assign a score that represents a value for the quality of engagement?
  2. Having done this, can we then apply this new measure to score projects that are engaging older adults in research and see whether higher quality engagement scores are related to better short and medium term PCOR project outcomes?

Greenlight Plus Study: A Randomized Study of Approaches to Early Childhood Obesity Prevention

Posted on by Jodi Snare

Page last updated April 14, 2026

Study Website: https://www.greenlight-program.org/
ClinicalTrials.gov#: NCT04042467
Study Design: Intervention Trial
PCORnet Infrastructure (Phase 1): Common Data Model (CDM), Single IRB, Patient partners or engagement
PCORnet Infrastructure (Phase 2): Single IRB, Patient partners or engagement
Principal Investigator: Bill Heerman
Institution: Vanderbilt University Medical Center
PCORnet® Network Partner: STAR
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date (Phase 1): 2018
Study Duration (Phase 1): 2019 - 2025
Funding Date (Phase 2): 2025
Study Duration (Phase 2): 2025 - 2031
Participating PCORnet® Clinical Research Networks: INSIGHT, OneFlorida+, PaTH, STAR
Therapeutic Area: Metabolic Disorders
Condition: Behavior, Health; Child Obesity
Status (Phase 1): Active, not recruiting
Status (Phase 2): Not yet recruiting

Research Question(s):
The research team is recruiting 900 English- and Spanish-speaking parent-infant pairs from six primary care clinics. The team is assigning the pairs by chance to receive either Greenlight or Greenlight Plus for two years. At the start of the study and throughout the child's first two years of life, the team is interviewing families and reviewing medical records to see how each baby is growing. The team wants to know how Greenlight and Greenlight Plus compare in promoting healthy weight gain for different groups based on language, race, ethnicity, and health literacy.

Bariatric Surgery Impact on Cancer Screening (BASICS)

Posted on by Jodi Snare

Page last updated September 2, 2025

Study Design: Retrospective Observational Study
PCORnet Infrastructure: Common Data Model (CDM), Patient partners or engagement
Principal Investigator: Kathleen McTigue
Institution: University of Pittsburgh
PCORnet® Network Partner: PaTH
Funder: NIH/NCI
Funding Date: 2023
Study Duration: 2023 – 2025
Participating PCORnet® Clinical Research Networks: GPC, INSIGHT, PaTH, REACHnet, STAR
Therapeutic Area: Oncology
Age Range: Adults with BMI 35+ who have had bariatric procedures
Status: Active, not recruiting

Research Question(s):

  1. How are patients' cancer screening practices impacted by bariatric surgery for weight loss?

HERO Registry & Trial: Healthcare Worker Exposure Response and Outcomes

Posted on by Jodi Snare

Page last updated October 29, 2025

Study Website: HERO Research Program
ClinicalTrials.gov#: NCT04342806
Study Design: Other, Registry and Intervention Trial
PCORnet Infrastructure: Single IRB, Patient partners or engagement
Principal Investigator: Adrian Hernandez
Institution: Duke Clinical Research Institute
PCORnet® Network Partner: The Coordinating Center for PCORnet®
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2020
Study Duration: 2020 – 2022
Participating PCORnet® Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, PEDSnet, REACHnet, STAR
Therapeutic Area: Infectious Disease
Condition: Health Care Worker (HCW); COVID-19
Age Range: 18 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s): Can a research registry of people working in healthcare help to answer important questions about the COVID-19 pandemic on medications, vaccines and healthcare worker well-being?

Primary Publication(s):

Friedland A, Hernandez AF, Anstrom KJ, et al. Design of healthcare worker exposure response and outcomes (HERO) research platform. Contemp Clin Trials, 2021; 109:106525. doi.org/10.1016/j.cct.2021.106525

Naggie S, Milstone A, Castro M, et al. Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial (HERO-HCQ). Medrxiv, 2021. doi.org/10.1101/2021.08.19.21262275

PANDA – MSD: Predictive Analytics via Networked Distributed Algorithms for Multi – System Diseases

Posted on by Jodi Snare

Page last updated November 07, 2025

Study Design: Retrospective Observational Study
PCORnet Infrastructure: Common Data Model (CDM), Patient partners or engagement
Principal Investigator: Jiang Bian
Institution: University of Florida and University of Florida Health
PCORnet® Network Partner: OneFlorida+
Funder: NIH
Funding Date: 2023
Study Duration: 2023 – 2026
Participating PCORnet® Clinical Research Networks: OneFlorida+
Therapeutic Area: Rare Diseases
Condition: Granulomatosis with Polyangiitis (GPA); Psoriatic Arthritis (PsA)
Age Range: 18 Years and older (Adult, Older Adult )
Status: Active, not recruiting

Research Question(s):
Can the use of EHR data develop predictive tools to assist healthcare providers in reaching earlier diagnoses and interventions, and improve the diagnostic journey and clinical outcomes of patients with rare diseases?

Primary Publication(s):

Jian X, Zhang D, Yu Z, et al. Leveraging undecided cases in chart-reviewed phenotypes to enhance EHR-based association studies. J Biomed Inform. 2025;166:104839. doi:10.1016/j.jbi.2025.104839

Tong J, Li L, Reps JM, et al. Advancing Interpretable Regression Analysis for Binary Data: A Novel Distributed Algorithm Approach. Stat Med. 2024;43(29):5573-5582. doi:10.1002/sim.10250

Wu Q, Tong J, Zhang B, et al. Real-World Effectiveness of BNT162b2 Against Infection and Severe Diseases in Children and Adolescents. Ann Intern Med. 2024;177(2):165-176. doi:10.7326/M23-1754

Understanding How Antibiotic Use Affects Childhood Obesity and Growth

Posted on by Jodi Snare

Page last updated February 4, 2026

ClinicalTrials.gov#: NCT02744846
Study Design: Retrospective Observational Study
PCORnet Infrastructure: Common Data Model (CDM), Patient partners or engagement
Principal Investigator: Jason P. Block
Institution: Harvard Pilgrim Health Care
PCORnet® Network Partner: Other
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2015
Study Duration: 2015 - 2018
Participating PCORnet® Clinical Research Networks: ADVANCE, GPC, INSIGHT, OneFlorida+, PEDSnet, REACHnet, STAR
Therapeutic Area: Metabolic Disorders
Age Range: up to 11 Years (Child)
Status: Completed

Research Question(s):
How does antibiotic use before age two affect weight and growth in children?

Primary Publication(s):

Block JP, Bailey LC, Gillman M, et al. Early Antibiotic Exposure and Weight Outcomes in Young Children. Pediatrics, 2018; 142(6), p.e20180290. doi:10.1542/peds.2018-0290

Heerman WJ, Daley MF, Boone-Heinonen J, et al. Maternal antibiotic use during pregnancy and childhood obesity at age 5 years. Int J Obes (Lond). 2019;43(6):1202-1209. doi:10.1038/s41366-018-0316-6

Comparing the Benefits and Harms of Three Types of Weight Loss Surgery — The PCORnet® Bariatric Study

Posted on by Jodi Snare

Page last updated November 12, 2025

Study Website: The PCORnet Bariatric Study (PBS)
ClinicalTrials.gov#: NCT02741674
Study Design: Retrospective Observational Study
PCORnet Infrastructure: Common Data Model (CDM), Patient partners or engagement
Principal Investigator: David Arterburn
Institution: Kaiser Permanente Washington Health Research Institute
PCORnet® Network Partner: Legacy PCORnet Partner
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2015
Study Duration: 2016 – 2018
Participating PCORnet® Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, PEDSnet, REACHnet, STAR
Therapeutic Area: Metabolic Disorders
Condition: Bariatrics, Body Weight, Diabetes, Gastric Bypass, Obesity
Age Range: up to 79 Years (Child,  Adult,  Older Adult)
Status: Completed

Research Question(s):
We don’t know much about the long-term effectiveness of bariatric interventions. Can we use PCORnet to compare compare weight loss and safety among three popular bariatric procedures?

Primary Publication(s):

Inge TH, Coley RY., Bazzano LA,. et al. Comparative effectiveness of bariatric procedures among adolescents: the PCORnet bariatric study. SOARD, 2018, 14(9):1374-1386. doi.org/10.1016/j.soard.2018.04.002

McTigue KM, Wellman R, Nauman E, et al. PCORnet Bariatric Study Collaborative. Comparing the 5-Year Diabetes Outcomes of Sleeve Gastrectomy and Gastric Bypass: The National Patient-Centered Clinical Research Network (PCORNet) Bariatric Study. JAMA Surg. 2020;155(5):e200087. doi:10.1001/jamasurg.2020.0087

TEAMS-BP: Telehealth-Enhanced Assessment and Management after Stroke-Blood Pressure

Posted on by Jodi Snare

Page last updated April 14, 2026

ClinicalTrials.gov#: NCT05539443
Study Design: Intervention Trial
PCORnet Infrastructure: Common Data Model (CDM), Single IRB, Patient partners or engagement
Principal Investigator: Cheryl Bushnell
Institution: Wake Forest University School Health Sciences
PCORnet® Network Partner: STAR
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2021
Study Duration: 2022 – 2028
Participating PCORnet® Clinical Research Networks: OneFlorida+, STAR
Therapeutic Area: Neurology
Condition: Hypertension Secondary
Age Range: 18 Years to 75 Years (Adult, Older Adult)
Status: Terminated

Research Question(s):

  1. Can remote blood pressure monitoring with cellular devices and tailored lifestyle coaching more effectively help reduce blood pressure and prevent secondary (another) stroke, especially among older adults, Black/Hispanic/other underrepresented adults, and/or adults with cognitive and/or physical disabilities, compared to in-person clinic management?

Cardiovascular Multicenter Observational Investigation of Lipid Care in the United States-2 (cvMOBIUS2)

Posted on by Jodi Snare

Page last updated February 4, 2026

Study Design: Prospective Observational Study
PCORnet Infrastructure: Common Data Model (CDM), Patient partners or engagement
Principal Investigators: Eric Peterson and Ann Marie Navar
Institution: Duke Clinical Research Institute
PCORnet® Network Partner: The Coordinating Center for PCORnet®
Funder: Amgen
Funding Date: 2021
Study Duration: 2021 - 2026
Participating PCORnet® Clinical Research Networks: GPC, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Cardiovascular
Condition: Atherosclerotic Cardiovascular Disease (ASCVD)
Age Range: 18 Years and older (Adult, Older Adult)
Study Status: Active, not recruiting

Research Question:

Can we reduce the number of people who die from atherosclerotic cardiovascular disease (ASCVD) related deaths by using PCSK9 medicines to lower their cholesterol?

Primary Publication(s):

Navar AM, Shah NP, Shrader P, et al. Achievement of LDL-C <55 mg/dL among US adults: Findings from the cvMOBIUS2 registry. Am Heart J. 2025;279:107-117. doi:10.1016/j.ahj.2024.06.012

Shoji S, Shah NP, Shrader P, et al. Achievement of guideline-based lipid goals among very-high-risk patients with atherosclerotic cardiovascular disease and type 2 diabetes: results in 213,380 individuals from the cvMOBIUS2 registry. Am J Prev Cardiol. 2024;21:100921. Published 2024 Dec 21. doi:10.1016/j.ajpc.2024.100921