18 Years and older (Adult, Older Adult)

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.

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?

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?

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.

Neuroendocrine Tumors – Patient Reported Outcomes (NET-PRO)

Posted on by Jodi Snare

Study Updated 03/25/2024

ClinicalTrials.gov#: NCT05064150
Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement, Single IRB
Principal Investigator: Michael O’Rorke
Site Name: University of Iowa
PCORnet® Network Partner: GPC
Funder: Patient-Centered Outcomes Research Institute (PCORI), project website
Funding Date: 2021
Study Duration: 2021 – 2024
Participating Clinical Research Networks: GPC, OneFlorida+, PaTH, STAR
Therapeutic Area: Oncology
Condition: Neuroendocrine Tumors; Gastroenteropancreatic Neuroendocrine Tumor; Lung Neuroendocrine Neoplasm; Neuroendocrine Carcinoma
Population: 18 Years and older (Adult, Older Adult)
Status: Enrolling by Invitation

Research Question(s):

Which care options work, for whom, and under which circumstances in order to improve symptom management, treatment outcomes and quality of life among NET patients?

  • Common treatment combinations and their relation to disease symptoms and quality of life
  • Identification of the best ordering of treatments and relation to patient outcomes and survival
  • The impact of patient traits and tumor characteristics on treatment choice(s) and survival

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?

A Patient-Centered PaTH to Addressing Diabetes

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Website: The PaTH to Health: Diabetes Study
ClinicalTrials.gov#: NCT02788903
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement
Principal Investigator: Jennifer Kraschnewski
Site Name: Pennsylvania State University
PCORnet® Network Partner: PaTH
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2016
Study Duration: 2016 – 2021
Participating Clinical Research Networks: GPC, PaTH
Therapeutic Area: Metabolic Disorders
Condition: COVID-19; Diabetes; Obesity
Population: 18 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s):

  1. How often is intensive behavioral therapy (IBT) being utilized in primary care and how has it impacted weight and diabetes outcomes for patients with and at-risk of type 2 diabetes?
  2. What is the impact of telemedicine utilization during the COVID-19 pandemic for patients with and at-risk of type 2 diabetes?
  3. What are demographic and clinical characteristics associated with severe COVID-19 outcomes across multiple phases of the COVID pandemic for patients with or at-risk of type 2 diabetes?

Primary Publication(s):
A Patient-Centered PaTH to Address Diabetes: Protocol for a Study on the Impact of Obesity Counseling
Kraschnewski JL, Kong L, Francis E, Yeh HC, Bryce C, Poger J, Lehman E. A Patient-Centered PaTH to Address Diabetes: Protocol for a Study on the Impact of Obesity Counseling. JMIR Res Protoc. 2019 Apr 4;8(4):e12054. doi: 10.2196/12054. PubMed PMID: 30946024

Estimating the Burden of Nonalcoholic Steatohepatitis Using a Multistate Electronic Health Record Data Network

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Kathleen McTigue
Site Name: University of Pittsburgh/UPMC
PCORnet® Network Partner: PaTH
Funder: Pfizer
Funding Date: 2020
Study Duration: 2020 – 2023
Participating Clinical Research Networks: OneFlorida+, PaTH, REACHnet
Therapeutic Area: Gastroenterology
Condition: Non-alcoholic Fatty Liver Disease (NAFLD)
Population:

Research Question(s):

  1. How do patients with non-alcoholic steatohepatitis (NASH) or non-alcoholic fatty liver disease (NAFLD) compare with those who do not have these diagnoses?
  2. How is risk for liver fibrosis (calculated from 4 validated scores) distributed among patients with and without diagnoses for NASH or NAFLD?

Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell via Mobile Applications (CaRISMA)

Posted on by Jodi Snare

Study Updated 02/29/2024

Study Website: CaRISMA
ClinicalTrials.gov#: NCT04419168
Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM, Engagement, Single IRB
Principal Investigator: Charles Jonassaint
Site Name: University of Pittsburgh/UPMC
PCORnet® Network Partner: PaTH
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2019
Study Duration: 2020 – 2024
Participating Clinical Research Networks: PaTH, STAR
Therapeutic Area: Mental and Behavioral Health
Condition: Chronic Pain; Depression; Anxiety; Opioid Use
Population: 18 Years and older (Adult, Older Adult)
Status: Active, not recruiting

Research Question(s):
Does mobile phone-delivered computerized cognitive behavioral therapy provide a greater benefit for daily pain and depression in adult patients with sickle cell disease than digital education?

Primary Publications(s):
Comparing the Effectiveness of Education Versus Digital Cognitive Behavioral Therapy for Adults With Sickle Cell Disease: Protocol for the Cognitive Behavioral Therapy and Real-time Pain Management Intervention for Sickle Cell via Mobile Applications (CaRISMA) Study
Badawy SM, Abebe KZ, Reichman CA, et al.Comparing the effectiveness of education versus digital cognitive behavioral therapy for adults with sickle cell disease: protocol for the cognitive behavioral therapy and real-time pain management intervention for sickle cell via mobile applications (CaRISMA) study. JMIR Res Protoc, 2021; 10(5):e29014.