NIH Collaboratory Launches New ePCT Training Resources
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The NIH Collaboratory is pleased to announce
new training resources available in the Living Textbook. These resources are being shared with the research community to provide guidance about building partnerships with health systems and overcoming the challenges of conducting embedded pragmatic clinical trials. The materials reflect the knowledge, insight, and best practices acquired by the NIH Collaboratory program and its Demonstration Projects.
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PROVEN Team Uses PRECIS-2 to Evaluate Ongoing Trial Implementation: In a novel effort, researchers with the PROVEN trial used the PRECIS-2 tool during the conduct of the study to assess the effects of midtrial changes in implementation. The investigators concluded that some pragmatic trials, such as those conducted in complex health care systems like nursing homes, "may benefit from a more dynamic approach to implementation which allows for fluidity between pragmatic and explanatory features."
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ADAPTABLE Patient-Reported Health Data Codes Now Available: ADAPTABLE investigators developed a LOINC patient-reported item set, which is now publicly available. The development of the item set is part of the ADAPTABLE Supplement, an initiative to develop best practices for capturing patient-reported outcome data and optimal analytic approaches for using the data in pragmatic clinical trials. The project will inform future efforts to integrate patient-reported data in electronic health records and provide opportunities to streamline data for use in pragmatic trials.
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Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge): More than half of patients with prescriptions for cardiovascular medications do not take their medications as prescribed. The Nudge study will use mobile phone text messages and an artificial intelligence chatbot to deliver behavioral "nudges" to patients to improve medication adherence. The study will access population-level pharmacy data in 3 integrated health care delivery systems to test the effectiveness of the nudges on adherence and outcomes among patients with chronic cardiovascular conditions who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia. Watch a
video interview with co–principal investigators Dr. Sheana Bull and Dr. Michael Ho, and read more about
Nudge.
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In our latest Grand Rounds podcast, Dr. Jeffrey Botkin and Dr. Consuelo Wilkins discuss returning individual research results to participants. In their conversation with Dr. Adrian Hernandez, Drs. Botkin and Wilkins emphasize the importance of returning results to participants, present challenges, and their hopes for the process in the next 5 years.
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Featured in the Living Textbook
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Embedded pragmatic clinical trials often contain rich information extracted from health system records. These studies can present challenges for provider and institutional confidentiality, consent, and data security. Learn more about these challenges, and how to address them, in the
Data Sharing and Embedded Research chapter of the
Living Textbook.
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