PCORI

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.

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?

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

 

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.

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?

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.

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.

Comparative Effectiveness of Palliative Surgery vs Additional Anti-Seizure Medications for Lennox-Gastaut Syndrome

Posted on by Jodi Snare

Study Updated 03/05/2024

ClinicalTrials.gov#: NCT05374824
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Sandi Lam
Site Name: Lurie Children’s Hospital
PCORnet® Network Partner: PEDSnet
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2021
Study Duration: 2022 – 2025
Participating Clinical Research Networks: GPC, OneFlorida+, PaTH, PEDSnet, STAR
Therapeutic Area: Neurosciences
Condition: Lennox Gastaut Syndrome
Population: up to 25 Years (Child,  Adult)
Status: Recruiting

Research Question(s):

  1. Which treatment options are most likely to improve important clinical outcomes in my child (or patient) with LGS?
  2. My child has hundreds of seizures a week, and multiple different drugs have failed to get her seizures under control. What is the best possible next step?

PRECIDENTD – PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Website: PRECIDENTD
ClinicalTrials.gov#: NCT05390892
Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Brendan Everett
Site Name: Brigham and Women’s Hospital
PCORnet® Network Partner: External
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2021
Study Duration: 2022 – 2028
Participating Clinical Research Networks: GPC, INSIGHT, PaTH, STAR
Therapeutic Area: Cardiovascular
Condition: Type2Diabetes; Atherosclerotic Cardiovascular Disease (ASCVD)
Population: 40 Years to 80 Years (Adult, Older Adult)
Status: Recruiting

Research Question(s):

  1. In patients with type 2 diabetes, are SGLT2 inhibitors or GLP-1 recent agonists better for preventing heart attack, stroke, blood vessel disease, heart failure, kidney disease, and death?
  2. Is combination therapy with both medication classes better than one therapy alone?