Studies

HERO Registry & Trial: Healthcare Worker Exposure Response and Outcomes

Posted on by Jodi Snare
Study Updated 03/28/2024
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):
Design of the Healthcare Worker Exposure Response and Outcomes (HERO) research platform
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.

Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial (HERO-HCQ)
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: https://doi.org/10.1101/2021.08.19.21262275

 

Computational Drug Repurposing for AD/ADRD with Integrative Analysis of Real-World Data and Biomedical Knowledge

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement
Principal Investigator: Jiang Bian
Site Name: University of Florida and University of Florida Health
PCORnet® Network Partner: OneFlorida+
Funder: NIH
Funding Date: 2022
Study Duration: 2022 – 2027
Participating Clinical Research Networks: INSIGHT, OneFlorida+
Therapeutic Area: Neurosciences
Condition: Dementia
Population: 18 Years and older (Adult,  Older Adult )
Status: Active, not recruiting

Research Question(s): Can existing drugs be repurposed to treat Alzheimer’s disease and related dementia?

Primary Publication(s):

Newer glucose-lowering drugs and risk of dementia: A systematic review and meta-analysis of observational studies
Tang H, Shao H, Shaaban CE, et al. Newer glucose-lowering drugs and risk of dementia: A systematic review and meta-analysis of observational studies. J Am Geriatr Soc. 2023;71(7):2096-2106. doi: 10.1111/jgs.18306.

Assess the documentation of cognitive tests and biomarkers in electronic health records via natural language processing for Alzheimer’s disease and related dementias
Chen Z, Zhang H, Yang X, et al. Assess the documentation of cognitive tests and biomarkers in electronic health records via natural language processing for Alzheimer’s disease and related dementias. Int J Med Inform. 2023. doi: 10.1016/j.ijmedinf.2022.104973.

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

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Jiang Bian
Site Name: University of Florida and University of Florida Health
PCORnet® Network Partner: OneFlorida+
Funder: NIH
Funding Date: 2022
Study Duration: 2022 – 2026
Participating Clinical Research Networks: OneFlorida+, STAR
Therapeutic Area: Rare Disease
Condition: Granulomatosis with Polyangiitis (GPA); Psoriatic Arthritis (PsA)
Population: 18 Years and older (Adult, Older Adult )
Status: 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?

Understanding How Antibiotic Use Affects Childhood Obesity and Growth

Posted on by Jodi Snare

Study Updated 03/05/2024

ClinicalTrials.gov#: NCT02744846

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Jason Block
Site Name: Harvard Pilgrim Healthcare Institute
PCORnet® Network Partner: Legacy PCORnet Partner
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2015
Study Duration: 2015 – 2018
Participating Clinical Research Networks: ADVANCE, GPC, INSIGHT, OneFlorida+, PEDSnet, REACHnet, STAR
Therapeutic Area: Metabolic Disorders
Population: 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):
Early Antibiotic Exposure and Weight Outcomes in Young Children
Block JP, Bailey LC, Gillman M, et al. Early Antibiotic Exposure and Weight Outcomes in Young Children. Pediatrics, 2018; 142(6), p.e20180290.

Maternal antibiotic use during pregnancy and childhood obesity at age 5 years
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

Study Updated 03/05/2024

Study Website: The PCORnet Bariatric Study (PBS)
ClinicalTrials.gov#: NCT02741674
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: David Arterburn
Site Name: 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 Clinical Research Networks: ADVANCE, GPC, INSIGHT, OneFlorida+, PaTH, PEDSnet, REACHnet, STAR
Therapeutic Area: Gastroenterology
Condition: Bariatrics, Body Weight, Diabetes, Gastric Bypass, Obesity
Population: 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):
Comparative effectiveness of bariatric procedures among adolescents: the PCORnet bariatric study
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.

Comparing the 5-Year Diabetes Outcomes of Sleeve Gastrectomy and Gastric Bypass: The National Patient-Centered Clinical Research Network (PCORNet) Bariatric Study
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. Epub 2020 May 20. PMID: 32129809; PMCID: PMC7057171.

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

Posted on by Jodi Snare

Study Updated 03/06/2024

ClinicalTrials.gov#: NCT05539443
Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Cheryl Bushnell
Site Name: Wake Forest University Health Sciences
PCORnet® Network Partner: STAR
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2021
Study Duration: 2022 – 2028
Participating Clinical Research Networks: OneFlorida+, STAR
Therapeutic Area: Neurosciences
Condition: Hypertension Secondary
Population: 18 Years to 75 Years (Adult, Older Adult)
Status: Active, not recruiting

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

Study Updated 03/28/2024

Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Eric Peterson, Ann Marie Navar
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: Amgen
Funding Date: 2021
Study Duration: 2021 – 2026
Participating Clinical Research Networks: GPC, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Cardiovascular
Condition: Atherosclerotic Cardiovascular Disease (ASCVD)
Population: 18 Years and older (Adult, Older Adult)
Status: Active, not recruiting

Research Question(s):

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

The RECOVER Post-Acute Sequelae of SARS-CoV-2 (PASC) Electronic Health Record (EHR) Cohort Study

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Website: RECOVERCOVID
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement, Single IRB
Principal Investigator: Christopher Forrest, L. Charles Bailey, Grace Lee
Site Name: The Children’s Hospital of Philadelphia
PCORnet® Network Partner: PEDSnet
Funder: NIH
Funding Date: 2021
Study Duration: 2022 – 2025
Participating Clinical Research Networks: ADVANCE, GPC, PaTH, PEDnet, STAR
Therapeutic Area: Infectious Disease
Condition: COVID-19; SARS-CoV-2 Infection
Population: Pediatrics 21 years and younger
Status: Active, not recruiting

Research Question(s):

  1. What are the long term health effects of COVID-19 after a person has recovered from infection?
  2. How can we better detect, predict, treat these health effects and prevent future infection?

Primary Publication(s):
Severity of Acute COVID-19 in Children <18 Years Old March 2020 to December 2021
Forrest CB, Burrows EK, Mejias A, et al. Severity of Acute COVID-19 in Children <18 Years Old March 2020 to December 2021. Pediatrics. 2022 Apr 1;149(4):e2021055765. doi:10.1542/peds.2021-055765. PMID: 35322270.

Clinical Features and Burden of Postacute Sequelae of SARS-CoV-2 Infection in Children and Adolescents
Rao S, Lee GM, Razzaghi H, et al. Clinical Features and Burden of Postacute Sequelae of SARS-CoV-2 Infection in Children and Adolescents. JAMA Pediatr. 2022;176(10):1000–1009. doi:10.1001/jamapediatrics.2022.2800

Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term (ADAPTABLE)

Posted on by Jodi Snare

Study Updated 03/04/2024

Study Website: ADAPTABLE
ClinicalTrials.gov#: NCT02697916
Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM (+ supplemental data), Engagement, Single IRB (hybrid)
Principal Investigator: Matt Roe, then William Jones
Site Name: Duke University
PCORnet® Network Partner: STAR
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2015
Study Duration: 2016 – 2020
Participating Clinical Research Networks: ADVANCE, GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Cardiovascular
Condition: Atherosclerotic Cardiovascular Disease (ASCVD)
Population: 18 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s):
Which dose of daily aspirin offers the right balance of effectiveness and minimal risk of bleeding? Can PCORnet be used to find the answer using a clinical trial model wherein patients are drivers of engagement?

Primary Publication(s):
Rationale and Design of the Aspirin Dosing-A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) Trial
Marquis-Gravel G, Roe MT, Robertson HR, et al. Rationale and design of the apsirin dosing- a patient-centric trial asessing benefits and long-term effectiveness (ADAPTABLE) Trial. JAMA Cardiol, 2020; 5(5): 598-607.

Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease
Jones WS, Mulder H, Wruck LM, et al. Comparative effectiveness of aspirin dosing in cardiovascular disease. N Engl J Med, 2021; 384(21); 1981-1990.

Characterization of Patients with Heart Failure and Patients with Atrial Fibrillation and Atrial Flutter in PCORnet Data

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Manesh Patel
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: Bayer
Funding Date: 2020
Study Duration: 2020 – 2025
Participating Clinical Research Networks: GPC, STAR
Therapeutic Area: Cardiovascular
Condition: Congestive Heart Failure
Population: 18 Years and older (Adult,  Older Adult )
Status: Completed

Research Question(s):
What is the occurrence of vascular, bleeding, or other events in Atrial Fibrillation or Atrial Flutter Patients patients?

Primary Publication(s):
Electronic Health Record Characterization and Outcomes of Heart Failure with Preserved Ejection Fraction
Rao VN, Cyr D, Wruck L, et al. Electronic health record characterization and outcomes of heart failure with preserved ejection fraction. American Heart Journal. 2023. In press, journal pre-proof.