Studies

Test to Treat

Posted on by Jodi Snare

Study Updated: 04/12/2024

Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Neha Pagidipati
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: Amgen
Funding Date: 2023
Study Duration: 2023 – 2025
Participating Clinical Research Networks: GPC, PaTH, REACHnet, STAR
Therapeutic Area: Cardiovascular
Condition: Atherosclerotic Cardiovascular Disease (ASCVD)

Research Question(s): Can improved coordination of care between inpatient and outpatient teams working with ASCVD patients help prevent another cardiovascular event within one year in this high-risk population?

Measuring Co-creation During the Engagement Process in Research: A Pathway Forward

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Design: Measurement development and validation
PCORnet Infrastructure: Collaboration, Engagement, Single IRB
Principal Investigator: Monica Perez Jolles
Site Name: University of Colorado, School of Medicine
PCORnet® Network Partner: External
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2023
Study Duration: 2023 – 2025
Participating Clinical Research Networks: ADVANCE, PaTH, REACHnet
Therapeutic Area: Other, Engagement
Status: Not yet recruiting

Research Question(s): Through this proposal, the research team will develop and test a new Co-creation in PCOR engagement measure that can be used to evaluate how researchers and community members work collaboratively and co-learn during the engagement process.

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.

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.

TBD: Improving LDLC management in underrepresented populations

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Neha Pagidipati
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: Novartis
Funding Date: 2023
Study Duration: 2023 – 2025
Participating Clinical Research Networks: GPC, OneFlorida+, PaTH, REACHnet, STAR 
Therapeutic Area: Cardiovascular
Condition: Atherosclerotic Cardiovascular Disease (ASCVD)
Status: Not yet 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

Study Updated 03/06/2024

 

Study Design: Development and initial validation of a PCOR engagement tool
PCORnet Infrastructure: Collaboration, Engagement, Single IRB
Principal Investigator: Marc A. Cohen
Site Name: University of Massachusetts, Boston
PCORnet® Network Partner: External
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2023
Study Duration: 2023 – 2025
Participating Clinical Research Networks: GPC, PaTH, STAR
Therapeutic Area: Other, Engagement
Condition: Other; Science of Engagement Award to develop and validate an engagement tool on engagement quality and selected outcomes
Population: 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

Study Updated 03/05/2024

Study Website: https://www.greenlight-program.org/
ClinicalTrials.gov#: NCT04042467
Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM (+ supplemental data), Engagement, Single IRB
Principal Investigator: William Heerman
Site Name: Vanderbilt University Medical Center (VUMC)
PCORnet® Network Partner: STAR
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2018
Study Duration: 2019 – 2024
Participating Clinical Research Networks: INSIGHT, STAR
Therapeutic Area: Mental and Behavioral Health
Condition: Behavior, Health; Child Obesity
Population: up to 21 Days (Child)
Status: Recruiting

Research Question(s):
Does a text-messaging intervention improve healthy weight trajectories among children ages 0-2 compared to a health communication intervention delivered in pediatric primary care clinics?

Bariatric Surgery Impact on Cancer Screening (BASICS)

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Kathleen McTigue
Site Name: University of Pittsburgh/UPMC
PCORnet® Network Partner: PaTH
Funder: NIH/NCI
Funding Date: 2023
Study Duration: 2023 – 2024
Participating Clinical Research Networks: GPC, PaTH, STAR
Therapeutic Area: Oncology
Condition: Obesity
Population: 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?