Completed

HERO-TOGETHER: A Safety Surveillance Study of Post- Vaccination Events of Interest among People Vaccinated Against COVID-19

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, Engagement, Single IRB
Principal Investigator: Emily O’Brien
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: Pfizer
Funding Date: 2020
Study Duration: 2020 – 2022
Participating Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Infectious Disease
Status: Completed

Research Question(s): In this study, the research team wanted to learn if taking HCQ was safe and prevented COVID-19 in healthcare workers.

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

 

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.

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.

Empagliflozin Diabetic Kidney Disease (Empa DKD)

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Neha Pagidipati
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: Boehringer Ingelheim
Funding Date: 2021
Study Duration: 2021 – 2024
Participating Clinical Research Networks: OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Cardiovascular
Condition: Diabetes/Cardiovascular
Population: 18 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s):

  1. Can we better understand why patients with type-2 diabetes may not receive guideline-recommended screening for diabetic kidney disease?
  2. Which medications may be most effective at improving kidney and heart outcomes in patients with and without type-2 diabetes?

Comparing patient-reported impact of COVID-19 shelter-in-place policies and access to containment and mitigation strategies, overall and in vulnerable populations

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Website: COVID-19 Citizen Science
ClinicalTrials.gov#: NCT5548803
Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Mark Pletcher
Site Name: University of California, San Francisco
PCORnet® Network Partner: REACHnet
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2020
Study Duration: 2020 – 2023
Participating Clinical Research Networks: GPC, INSIGHT, REACHnet
Therapeutic Area: Health Disparities
Condition: COVID-19
Population: 18 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s):

  1. What is the comparative impact of different shelter-in-place/reopening policies, overall and in vulnerable populations, on patient-reported financial insecurity, mental health, and other subjective outcomes important to patients?
  2. What is the comparative effectiveness of county-level containment and mitigation strategies at achieving timely access to testing, healthcare, information, and contact tracing, overall and in vulnerable populations?
  3. What is the comparative accuracy of different algorithms designed to predict risk of infection and severe COVID-19 among patients with symptoms, overall and in vulnerable populations?

Primary Publication(s):
The COVID-19 Citizen Science Study: Protocol for a Longitudinal Digital Health Cohort Study
Beatty AL, Peyser ND, Butcher XE, et al. The COVID-19 citizen science study: protocol for a longitudinal digital health cohort. JMIR Res Protoc, 2021; 10(8):e28169.

Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Non-Cancer Pain in Primary Care

Posted on by Jodi Snare

Study Updated 03/05/2024

ClinicalTrials.gov#: NCT03537573
Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Kevin Kraemer
Site Name: University of Pittsburgh/UPMC
PCORnet® Network Partner: PaTH
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2017
Study Duration: 2018-2021
Participating Clinical Research Networks: GPC, PaTH
Therapeutic Area: Health Disparities
Condition: Acute Pain; Headache; Musculoskeletal Pain
Population: 18 Years and older (Adult,  Older Adult)
Status: Completed

Research Question(s):

What is the comparative effectiveness of different payer or health system strategies that aim to prevent unsafe opioid prescribing while ensuring access to non-opioid methods for pain management with the goal of reducing pain and improving patient function and quality of life outcomes, while reducing patient harm?