Pragmatic Trials and Evaluation

The Pragmatic Trials and Evaluation Program in the Mayo Clinic Kern Center for the Science of Health Care Delivery provides an unbiased evaluation of practice innovations. The program ensures that implementation of such innovations will bring patients higher quality, safer and more efficient care, and make Mayo Clinic a better place to work.

The team conducts evaluation projects embedded in the Mayo Clinic learning health system. Researchers use cutting-edge methods and emerging data and technologies.

Areas of focus

• Collaborative projects. Scientists in the Pragmatic Trials and Evaluation Program work with stakeholders to develop and conduct comparative effectiveness research projects. They focus on projects that will have a sustained, powerful influence on clinical practice. Patients, clinicians, allied health staff and others can join these studies as co-investigators or participants.
• Consultation and partnerships. The team provides expert consultation and seeks to build trusted research partnerships to provide evidence-based healthcare delivery solutions. Together, they use pragmatic trials within a learning health system framework to improve practice outcomes.
• Education. The Pragmatic Trials and Evaluation Program aims to grow pragmatic research at Mayo Clinic. To this end, the program organizes educational seminars and provides updates about ongoing pragmatic trials and essential topics in the field.
• Pragmatic trials toolkit. Program experts have created and now maintain a living pragmatic trials toolkit. It includes sample projects and statistical plans, protocol documents, and other tools. The purpose of the toolkit is to increase competency and help teams develop and run pragmatic trials at Mayo Clinic.

Projects

Evaluating AI technologies

Program experts collaborated on a study in which they enrolled patients from 40 states in a digitally enabled, decentralized trial. The trial evaluated interventions without requiring patients to travel to Mayo Clinic. In another cluster-randomized trial assessing an AI technology, the team enrolled 358 primary care clinicians and 22,641 adult patients from 45 clinics or hospitals.

Related publications:

• Artificial intelligence-enabled electrocardiograms for identification of patients with low ejection fraction: A pragmatic, randomized clinical trial.
• Artificial intelligence-guided screening for atrial fibrillation using electrocardiogram during sinus rhythm: A prospective non-randomised interventional trial.
• Prospective evaluation of smartwatch-enabled detection of left ventricular dysfunction.

Pairing observational studies with randomized trials

In some studies — including ones funded by the National Institutes of Health and the Food and Drug Administration — experts from the Pragmatic Trials and Evaluation Program investigate how well clinical trials can be generalized. They also study the internal validity of observational data.

Related publications:

• Atrial fibrillation ablation in practice: Assessing CABANA generalizability.
• Emulating the GRADE trial using real world data: Retrospective comparative effectiveness study.
• Generalizability of the CASTLE-AF trial: Catheter ablation for patients with atrial fibrillation and heart failure in routine practice.

Evaluate new care delivery models

The program team led an investigation comparing a hospital-at-home program with traditional brick-and-mortar hospital care. Researchers evaluated the outcomes and value of care for acutely ill patients.

Related publication:

• Effect of hospital-at-home vs. traditional brick-and-mortar hospital care in acutely ill adults: Study protocol for a pragmatic randomized controlled trial.

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