18 Years and older (Adult, Older Adult)

The COVID-19 and Diabetes Assessment (CODA) Study

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Russell Rothman
Site Name: Vanderbilt University Medical Center (VUMC)
PCORnet® Network Partner: STAR
Funder: NIDDK/NIH
Funding Date: 2023
Study Duration: 2023 – 2027
Participating Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, PEDSnet, REACHnet, STAR
Therapeutic Area: Metabolic Disorders
Condition: COVID-19, Diabetes
Population: 18 Years and older (Adult, Older Adult)
Status: Not yet recruiting

Research Question(s):  The study will answer important questions patients are asking about the link between diabetes and COVID-19.

  1. To what extent does COVID-19 cause worse glycemic control, vascular function, inflammation, and increased risk for blood clots in people with either type 1 or type 2 diabetes?
  2. The study will also explore the role of genomic, social, and environmental factors on metabolic function and the impact of COVID-19 infection and COVID-19 treatments on diabetes-related outcomes.

Understanding the Short- and Long-term Effects of the COVID-19 Pandemic on the Opioid Overdose Crisis

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Magdalena Cerdá
Site Name: New York University Langone Health
PCORnet® Network Partner: INSIGHT
Funder: NIDA
Funding Date: 2023
Study Duration: 2023 – 2028
Participating Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Health Disparities
Condition: COVID-19, Opioid Use
Population: 18 Years and older (Adult, Older Adult )
Status: Active, not recruiting

Research Question(s):

  1. Did a community rise in COVID-19 hospitalizations and deaths contribute to an increase in the risk of overdose among PCORnet patients?
  2. What role did public health and economic policies enacted during the COVID-19 pandemic play in explaining whether a rise in community COVID-19 burden contributed to a rise in overdose?
  3. Did the impact of the COVID-19 pandemic on overdose depend on the socioeconomic, social, and policy characteristics the community had in place prior to the pandemic?

Characterizing the ILD (interstitial lung disease) Care Continuum Using Real World Evidence

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Aparna Swaminathan
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: Genentech
Funding Date: 2021
Study Duration: 2022 – 2024
Participating Clinical Research Networks: GPC, INSIGHT, PaTH, STAR
Therapeutic Area: Pulmonary
Condition: Idiopathic Pulmonary Fibrosis (IPF)
Population: 18 Years and older (Adult,  Older Adult )
Status: Active, not recruiting

Research Question(s):

Idiopathic pulmonary fibrosis (IPF) is a progressive fibrotic lung disease, affecting over 3 million individuals worldwide and causing progressive lung function deterioration and death within a median of 3-5 years after diagnosis. This project will help to characterize the interstitial lung disease (ILD) patient care continuum across ILD subtypes.

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?

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?

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.

Using PCORnet to Compare Blood Pressure Control Strategies

Posted on by Jodi Snare

Study Updated 03/06/2024

Study Website: Using PCORnet to Compare Blood Pressure Control Strategies
ClinicalTrials.gov#: NCT03796689
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement
Principal Investigator: Mark Pletcher
Site Name: University of California, San Francisco
PCORnet® Network Partner: REACHnet
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2018
Study Duration: 2018 – 2023
Participating Clinical Research Networks:ADVANCE, GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Cardiovascular
Condition: Hypertension
Population: 18 Years and older (Adult,  Older Adult)
Status: Completed

Research Question(s):
How well are clinics and patients controlling blood pressure, and would new programs or technologies help improve blood pressure control?

Primary Publication(s):
Tracking Blood Pressure Control Performance and Process Metrics in 25 US Health Systems: The PCORnet Blood Pressure Control Laboratory
Cooper-DeHoff RM, Fontil V, Carton T, et al. Tracking blood pressure control performance and process metrics in 25 US health systems: The PCORnet Blood Pressure Control Laboratory. J Am Heart Assoc, 2021; 10(21): e022224.