Pragmatic Research Resources

Consultations

Pragmatic research consults are available for CCTSI investigators. Please complete the request form below.

Education Opportunities

The Colorado Pragmatic Research in Health Conference (COPRH Con) is a national conference hosted by The Adult and Child Center for Outcomes Research and Delivery Science (ACCORDS) and co-sponsored by the CCTSI with the purpose of training and engaging researchers in methods and applications that support research for having a real world impact. COPRH Con is ideal for clinical and translational researchers, including statisticians, dissemination and implementation scientists, health services and public health researchers, program evaluators. Junior faculty with career development awards, fellows, and anyone wanting to learn and apply new methods directly from world-renowned experts are encouraged to attend.

PEET Program Overview

The goal of the CCTSI’s Pragmatic Electronic Health Record (EHR)-Embedded Trials (PEET) program is to establish infrastructure and procedures to facilitate pragmatic trials through EHR integration. Guided by health equity principles of accessibility, diversity, and inclusivity, the PEET program aims to enhance the representation of all populations in research. PEET addresses clinical and translational science challenges by reducing the burden on participants, clinicians, and researchers in research approval and conduct. This is achieved through partnerships with health system and university research regulatory, informatics, and data science units. Community engagement in designing and implementing patient-centered materials and protocols aims to build trust and ensure representativeness in trial participation. Scientific advisory on pragmatic trial design, dissemination and implementation science, and community engagement enhances research rigor. PEET supports multiple EHR integration features, including streamlined resources for decentralized clinical trials (e.g., e-consent, portal-based patient recruitment), cohort identification, randomization, intervention delivery, trial accrual monitoring, and data collection and analysis.

To develop and refine processes for local approval and conduct of pragmatic, EHR-embedded trials, the PEET program funds pilot demonstration projects. Requests for Applications (RFAs) are made available each year for 2-year pilot trials. Current priorities relate to studies conducted in adult populations within UCHealth.

Request for Applications (RFA)

The RFA describes eligibility and application requirements

Information & Resources

If you have any questions about eligibility or the application please contact Sarah Kautz, PEET Program Coordinator.

Pragmatic Clinical Trials

Large-scale trials conducted in routine clinical care settings, involving:

• Interventions delivered by existing  health care personnel through usual processes and systems of care
• Evaluations of outcomes using data collected as part of routine care 
  
  

EHR-Embedded Trials

Use of EHR systems to conduct pragmatic clinical trials to facilitate: 

• Identifying patient participants/cohorts and/or clinical phenotypes
  
• E-consent and participant communication 
  
• Randomization, assignment, and delivery of interventions
  
• Assessment of outcomes/safety (including patient-reported outcomes and free text/narrative)
  
• Real-time tracking of accrual, trial data, diversity, and representativeness

Previously Funded PEET Demonstration Projects

PEET Demonstration Project #1: A randomized, Pragmatic, Adaptive Trial of Metformin for Glucose Intolerance or Increased Body Mass Index in Prostate Cancer Patients (PragMet) (Principal Investigator: Thomas Flaig, MD) The goal of the study is to compare patients with prostate cancer who make changes in lifestyle with patients who make changes in lifestyle and also take a medicine called Metformin to reduce the risk of metabolic disorders.

PEET Demonstration Project #2: Optimizing Care in Critically ill at UCHealth by Liberalizing the Target O2 in mechanically-ventilated ICU patients (OCCULT O2) (Principal Investigators: Neil Aggarwal, MD and Peter Sottile, MD) The goal of the study is to significantly reduce the frequency of unrecognized or missed hypoxemia in patients who are mechanically ventilated in the ICU.

Meet the PEET Team

Adit Ginde

Adit Ginde, MD, MPH is the Professor and Vice Chair for Research in the Department of Emergency Medicine, Medical Director of Clinical Research in the Department of Anesthesiology, and Director of the CCTSI Trial Innovation Network Hub. His research focuses on epidemiological and clinical trials in the acute care setting, with a particular focus on early care of critically ill and injured patients. Specifically, he has extensive experience with designing, overseeing, and implementing clinical trials in a variety of clinical environments including emergency department, inpatient, perioperative, and outpatient settings, leveraging traditional, pragmatic, and EHR-embedded designs. He has been the lead investigator for 7 large multicenter clinical trials and participated in the design (as protocol committee member and co-investigator) and implementation (as site PI) of over a dozen other clinical trials. National leadership in clinical trials networks include NIH (NHLBI, NIAID, NCATS), Department of Defense, PCORI, and CDC.

Bethany Kwan

Bethany Kwan, PhD, MSPH is Professor and Associate Vice Chair for Research in the Department of Emergency Medicine at the University of Colorado School of Medicine, Anschutz Medical Campus. As an investigator in the University of Colorado’s Adult & Child Center for Outcomes Research and Delivery Science (ACCORDS), she conducts pragmatic, patient-centered research and evaluation on health and health care in a variety of areas. With an emphasis on stakeholder engagement and dissemination and implementation (D&I) methods, her work addresses the integration of physical and behavioral health, chronic disease self-management, improving processes and systems of care to achieve the Quadruple Aim, pragmatic trials using electronic health data, and enhancing quality of life for patients and care partners. She works with patients and other stakeholders at all phases of research, from prioritization, to design, implementation, and dissemination of research. She mentors and teaches students, trainees, and fellow faculty on Designing for Dissemination to ensure that research innovations are efficiently and effectively adopted, used, and sustained in real world settings to improve health and well-being for all. Dr. Kwan is a member of the ACCORDS D&I program and directs the Colorado Clinical & Translational Sciences Institute (CCTSI) Dissemination & Implementation Research Core.

Sarah Kautz

Sarah V. Kautz, PhD, LCSW, is the Program Coordinator for PEET. She earned her doctorate in clinical social work from the Institute of Clinical Social Work. She has worked in program evaluation for more than five years. Her research interests include working with various stigmatized groups (such as families in the child welfare system or overweight or obese children) and historically marginalized populations (such as children and families who have family members incarcerated).

Pragmatic Research in Health (pragmaticresearch.org) brings together established and emerging pragmatic methods, measures, and models, many of which come from the blossoming field of dissemination and implementation (D&I) science. These methods help to ensure that pragmatic research is not seen as messy or poorly done research, but rather as both relevant and rigorous.

How to use this tool

This guide may be used as a comprehensive, stage-by-stage guide to planning and conducting pragmatic research, or may also be navigated by jumping directly to topics of interest. Each section includes extra resources such as videos, publications and links to key resources – expand the right-hand sidebars in each section to access these items.

Visit Pragmatic Research in Health