Active, not recruiting

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.

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?

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.

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

PCORnet® Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults (PCORnetPASC)

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Website: RECOVERCOVID
ClinicalTrials.gov#: NCT05292274
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement, Single IRB
Principal Investigator: Rainu Kaushal
Site Name: Weill Cornell Medicine
PCORnet® Network Partner: INSIGHT
Funder: NIH
Funding Date: 2022
Study Duration: 2022 – 2025
Participating Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Infectious Disease
Condition: COVID-19; SARS CoV 2 Infection
Population: 18 Years and older (Adult, Older Adult)
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, and treat these health effects and prevent future infection?

Primary Publication(s):
Prevalence of Select New Symptoms and Conditions Among Persons Aged Younger Than 20 Years and 20 Years or Older at 31 to 150 Days After Testing Positive or Negative for SARS-CoV-2
Hernandez-Romieu AC, Carton TW, Saydah S, et al. Prevalence of select new symptoms and conditions among person aged younger than 20 years and 20 years or older at 31 to 150 days after testing positive or negative for SARS-CoV-2. JAMA Netw Open. 2022;5(2):e2147053.

Semantic Data Quality Standards for Multi-Center Clinical Research Studies and Networks

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Design: Methods to improve study design; methods to support data research networks
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: L. Charles Bailey
Site Name: The Children’s Hospital of Philadelphia
PCORnet® Network Partner: PEDSnet
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2021
Study Duration: 2021 – 2026
Participating Clinical Research Networks: INSIGHT, PEDSnet, REACHnet
Therapeutic Area: Other, Data Quality Standards
Condition: Data quality assessment, data quality analysis, data quality reporting, standards development
Population: This proposal does not focus on a specific population
Status: Active, not recruiting

Research Question(s):

  1. Can we find ways to more accurately describe how suitable data are to answer a specific research question?
  2. What are the tools that can be used across studies to consistently describe whether the data are high quality?

Utilizing PCORnet to support transition from pediatric to adult centered care and reduce gaps in recommended care in patients with congenital heart disease

Posted on by Jodi Snare

Study Updated 03/06/2024

Study Website: Congenital Heart Initiative
ClinicalTrials.gov#: NCT05185232
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Thomas Carton, Anitha John
Site Name: Louisiana Public Health Institute (LPHI)
PCORnet® Network Partner: REACHnet
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2021
Study Duration: 2021 – 2024
Participating Clinical Research Networks: INSIGHT, OneFlorida+, PEDSnet, REACHnet
Therapeutic Area: Cardiovascular
Condition: Congenital Heart Disease; Comorbidities and Coexisting Conditions
Population: 18 Years and older (Adult,  Older Adult)
Status: Active, not recruiting

Research Question(s):

  1. How does receiving current recommended care affect long-term outcomes and healthcare needs amongst the numerous rare disease subtypes of congenital heart defects?
  2. What factors are associated with gaps in recommended care?
  3. Do patients report feeling better when they remain in specialty care?