PCORI

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?

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

Pediatric KIDney Stone (PKIDS) Care Improvement Network

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Website: Pediatric KIDney Stone (PKIDS) Care Improvement Network
ClinicalTrials.gov#: NCT04285658
Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Gregory E. Tasian
Site Name: The Children’s Hospital of Philadelphia
PCORnet® Network Partner: PEDSnet
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2019
Study Duration: 2020 – 2024
Participating Clinical Research Networks: GPC, OneFlorida+, PaTH, PEDSnet, STAR
Therapeutic Area: Renal
Condition: Kidney Stone; Nephrolithiasis
Population: 8 Years to 21 Years (Child, Adult)
Status: Active, not recruiting

Research Question(s):
What are the differences in stone clearance and the lived experiences of youth, age 8-21 years, following ureteroscopy (URS), shock wave lithotripsy (SWL), and percutaneous nephrolithotomy (PCNL) for the removal of kidney and ureteral stones?

Primary Publication(s):
Comparative effectiveness of paediatric kidney stone surgery (the PKIDS trial): study protocol for a patient-centred pragmatic clinical trial
Ellison JS, Lorenzo M, Beck H on behalf of the Pediatric KIDney Stone Care Improvement Network, et al. Comparative effectiveness of paediatric kidney stone surgery (the PKIDS trial): study protocol for a patient-centred pragmatic clinical trial. BMJ Open 2022;12:e056789. doi: 10.1136/bmjopen-2021-056789

Preserving Kidney Function in Children with Chronic Kidney Disease (PRESERVE)

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Website: Preserving Kidney Function in Children with Chronic Kidney Disease
ClinicalTrials.gov#: NCT05169411
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Christopher Forrest
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 – 2024
Participating Clinical Research Networks: GPC, OneFlorida+, PaTH, PEDSnet, STAR
Therapeutic Area: Renal
Condition: Chronic Kidney Disease Stage 2; Chronic Kidney Disease Stage 3; Pediatric Kidney Disease
Population: 1 Year to 17 Years (Child)
Status: Enrolling by Invitation

Research Question(s):

Which blood pressure monitoring strategies, urine protein monitoring strategies, and blood pressure medication strategies are most effective in preserving kidney function in pediatric patients with Chronic Kidney Disease (CKD), and what is the lived experience of families and patients living with pediatric CKD?

Implementation of Patient-Reported Outcomes Measurement in Routine Clinical Practice for Heart Patients in PCORnet

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Justin Bachmann
Site Name: Vanderbilt University Medical Center (VUMC)
PCORnet® Network Partner: STAR
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2017
Study Duration: 2019 – 2021
Participating Clinical Research Networks: PaTH, STAR
Therapeutic Area: Cardiovascular
Condition: Congestive Heart Failure
Population: 75 Years and older (Older Adult )
Status: Completed

Research Question(s):
Can PCORnet be leveraged to implement patient-reported outcome measures in routine clinical practice for heart failure patients at three different institutions?

Evaluating the Comparative Effectiveness of Telemedicine in Primary Care: Learning from the COVID-19 Pandemic

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Website: Evaluating the Comparative Effectiveness of Telemedicine in Primary Care: Learning from the COVID-19 Pandemic
ClinicalTrials.gov#:NCT04684836
Study Design: Telephone survey of primary care practice leadership, Qualitative interview study with patients and primary care providers, Observational data analysis
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Rainu Kaushal, Jessica Ancker
Site Name: Weill Cornell Medicine
PCORnet® Network Partner: INSIGHT
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2020
Study Duration: 2020 – 2022
Participating Clinical Research Networks: INSIGHT, OneFlorida+, STAR
Therapeutic Area: Health Disparities
Condition: Asthma; Chronic Obstructive Pulmonary Disease (COPD); Congestive Heart Failure; Diabetes; Hypertension
Population: 19 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s):
What are the features of primary care telemedicine programs that have been newly implemented or expanded in response to the COVID-19 pandemic, and how do diverse populations experience these programs?

Primary Publications(s):
An urgent need for guidelines for telemedicine use. Lin JJ, Horowitz CR, Ancker JS. Journal of General Internal Medicine. 2022;38(4):1061-1062. doi:10.1007/s11606-022-07905-7

Patient experiences with and preferences for telemedicine relative to in-person care during the COVID-19 pandemic. Yu J, Andreadis K, Schpero WL, Abedian S, Kaushal R, Ancker JS. Telemedicine and e-Health. Published online 2023. doi:10.1089/tmj.2022.0311

Provider and patient experiences of delays in primary care during the early COVID-19 pandemic. Journal for Healthcare Quality. 2023;45(3):169-176. doi:10.1097/jhq.0000000000000380