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Welcome to the Knowledge Repository, a searchable collection of resources related to pragmatic clinical trials, compiled by the NIH Collaboratory Coordinating Center. For additional content and information about the NIH Collaboratory, visit www.rethinkingclinicaltrials.org.

  
  
  
  
  
  
Effect of Salt Substitution on Cardiovascular Events and Death9/10/2021Grand RoundsDr. Neal shares the results from the SSaSS study on the effects of reduced-sodium, added-potassium salt substitute on stroke, cardiovascular events, and death.
  
Effect of Salt Substitution on Cardiovascular Events and Death9/10/2021Grand RoundsDr. Neal shares the results from the SSaSS study on the effects of reduced-sodium, added-potassium salt substitute on stroke, cardiovascular events, and death.
  
Milrinone as Compared with Dobutamine in the Treatment of Cardiogenic Shock: the DOREMI trial8/27/2021Grand RoundsDr. Hibbert shares the results from the CAPITAL DOREMI study and discusses the importance of randomized pragmatic clinical trials to generate quality data on therapeutics.
  
Milrinone as Compared with Dobutamine in the Treatment of Cardiogenic Shock: the DOREMI trial 8/27/2021Grand RoundsDr. Hibbert shares the results from the CAPITAL DOREMI study and discusses the importance of randomized pragmatic clinical trials to generate quality data on therapeutics.
  
Promoting Both Internal and External Validity: Designing the Trial to Match Its Intention8/26/2021White PaperThis is an introduction to help researchers match the design of their trial to its purpose while maintaining both internal and external validity.
  
Fluvoxamine for early treatment of COVID-19: the STOP COVID clinical trials8/20/2021Grand RoundsDr. Eric Lenze discusses the STOP COVID trials, the latest research on Fluvoxamine for the early treatment of COVID-19.
  
Fluvoxamine for early treatment of COVID-19: the STOP COVID clinical trials8/20/2021Grand RoundsDr. Eric Lenze discusses the STOP COVID trials, the latest research on Fluvoxamine for the early treatment of COVID-19.
  
Zelen design clinical trials: why, when, and how8/17/2021Journal articlePublication from the SPOT Demonstration Project
  
August 16, 2021: MOTIFS Explores Patients’ Reactions to Notifications of Collateral Findings8/16/2021News articleNews article about a MOTIFS publication
  
Got anything for this cough? Outpatient Treatment Trials in the Time of COVID8/13/2021Grand RoundsDr. Smith discusses the history of proposed therapies for COVID-19 and how the Adaptive Platform Trial ACTIV -2 seeks to find a successful new therapy.
  
Got anything for this cough? Outpatient Treatment Trials in the Time of COVID8/13/2021Grand RoundsDr. Smith discusses the history of proposed therapies for COVID-19 and how the Adaptive Platform Trial ACTIV -2 seeks to find a successful new therapy.
  
Patients' reactions to letters communicating collateral findings of pragmatic clinical trials: a national web-based survey8/12/2021Journal articlePublication from the MOTIFS supplement
  
August 11, 2021: EHR Core Facing Familiar Challenges, Intensified by Pandemic8/11/2021News articleNews article about the EHR Core
  
Nudge Study Design Paper8/11/2021Study design paperNudge Study Design Paper
  
August 9, 2021: ‘Pause’ for COVID-19 Complicates Research Embedded in Healthcare Systems8/9/2021News articleNews article about the Health Care Systems Interactions Core
  
Early Treatment of COVID-19 with Repurposed Therapies: The TOGETHER Adaptive Platform Trial 8/6/2021Grand RoundsDr. Mills shares the latest data on Repurposed Therapies for COVID-19 and discusses the elements of successful Adaptive Platform Trials.
  
Early Treatment of COVID-19 with Repurposed Therapies: The TOGETHER Adaptive Platform Trial 8/6/2021Grand RoundsDr. Mills shares the latest data on Repurposed Therapies for COVID-19 and discusses the elements of successful Adaptive Platform Trials.
  
Survivor Corps: Long-Term COVID-19 Patient Engagement8/5/2021PodcastDiana Berrent, JD, and Nick Guthe, both of Survivor Corps, and Natalie Lambert, PhD, of the Indiana University School of Medicine, describe best practices for medical professionals treating patients with long COVID.
  
Survivor Corps: Long-Term COVID-19 Patient Engagement8/5/2021TranscriptDiana Berrent, JD, and Nick Guthe, both of Survivor Corps, and Natalie Lambert, PhD, of the Indiana University School of Medicine, describe best practices for medical professionals treating patients with long COVID.
  
Diversity Workshop Series: Increasing Diversity in Pragmatic Clinical Trials8/2/2021PodcastPanel discussion about the series on Inclusion of Diverse Participants in Pragmatic Clinical Trials with Dr. Robin Boineau, Dr. David Chambers, Dr. Lesley Curtis, Dr. Emily O'Brien, Dr. Wendy Weber, and Dr. Kanecia Zimmerman.
  
Diversity Workshop Series: Increasing Diversity in Pragmatic Clinical Trials8/2/2021TranscriptPanel discussion about the series on Inclusion of Diverse Participants in Pragmatic Clinical Trials with Dr. Robin Boineau, Dr. David Chambers, Dr. Lesley Curtis, Dr. Emily O'Brien, Dr. Wendy Weber, and Dr. Kanecia Zimmerman.
  
Inclusion of Diverse Participants in Pragmatic Clinical Trials: Diversity in the PCT Ecosystem – How Do We Develop a Pipeline of Diverse Investigators and Leaders in PCTs?7/30/2021Grand RoundsDr. Curtis moderates a discussion with Drs. Bernard, Mensah, and Morone about initiatives and best practices to address structural racism and promote diversity in clinical research teams.
  
Inclusion of Diverse Participants in Pragmatic Clinical Trials: Diversity in the PCT Ecosystem – How Do We Develop a Pipeline of Diverse Investigators and Leaders in PCTs?7/30/2021Grand RoundsDr. Curtis moderates a discussion with Drs. Bernard, Mensah, and Morone about initiatives and best practices to address structural racism and promote diversity in clinical research teams.
  
TSOS Closeout Snapshot7/28/2021HandoutCloseout snapshot of the TSOS Demonstration Project
  
Long Term COVID Patient Engagement: Best Practices Informed By Patients’ Experiences Seeking Medical Care7/23/2021Grand RoundsDiana Berrent and Nick Guthe, members of Survivor Corps, share their first-hand experiences with long-term COVID-19, while Dr. Lambert presents best practices for medical professionals treating patients experiencing debilitating effects of COVID-19.
  
Long Term COVID Patient Engagement: Best Practices Informed By Patients’ Experiences Seeking Medical Care 7/23/2021Grand RoundsDiana Berrent and Nick Guthe, members of Survivor Corps, share their first-hand experiences with long-term COVID-19, while Dr. Lambert presents best practices for medical professionals treating patients experiencing debilitating effects of COVID-19.
  
Inclusion of Diverse Participants in Pragmatic Clinical Trials: Maximizing Diversity in Pragmatic Clinical Trials – What Can We Learn From Implementation Trials? 7/16/2021Grand RoundsDrs. Midboe and Trontell discuss methods to increase diverse patient engagement in implementation trials as part of the Inclusion of Diverse Participants in Pragmatic Clinical Trials Grand Rounds Series.
  
Inclusion of Diverse Participants in Pragmatic Clinical Trials: Maximizing Diversity in Pragmatic ClinicalTrials – What Can We Learn From Implementation Trials? 7/16/2021Grand RoundsDrs. Midboe and Trontell discuss methods to increase diverse patient engagement in implementation trials as part of the Inclusion of Diverse Participants in Pragmatic Clinical Trials Grand Rounds Series.
  
Data Monitoring in PCTs-Points to Consider7/13/2021White PaperThis white paper explores considerations specific to data monitoring in PCTs.
  
COVID-19 Vaccine Efficacy Studies: Challenges and Successes7/9/2021Grand RoundsDr. El Sahly discusses lessons learned from the COVID-19 vaccine efficacy studies.
  
COVID-19 Vaccine Efficacy Studies: Challenges and Successes7/9/2021Grand RoundsDr. El Sahly discusses lessons learned from the COVID-19 vaccine efficacy studies.
  
July 6, 2021: New Quick Start Guide Offers Advice for Partnering With Healthcare System Leaders7/6/2021News articleNews article about Quick Start Guide for partnering with HCS leaders
  
July 1, 2021: NIH Collaboratory Leadership Asks, ‘Is Learning Worth the Trouble?’7/1/2021News articleNews article about Coordinating Center manuscript.
  
ePCT Quick Start Guide for Researcher and Healthcare Systems Leader Partnerships6/30/2021HandoutHandout designed to help clinical investigators successfully partner with healthcare system leaders.
  
Is learning worth the trouble? Improving health care system participation in embedded research6/26/2021Journal articlePublication from the Coordinating Center
  
Inclusion of Diverse Participants in Pragmatic Clinical Trials: Meeting Participants Where They Are – Outreach, Trust, and Consent to Maximize Diversity6/25/2021Grand RoundsA moderated discussion about how to plan for and implement diversity in PCTs, focusing on strategies for outreach, trust, and consent.
  
Inclusion of Diverse Participants in Pragmatic Clinical Trials: Meeting Participants Where They Are – Outreach, Trust, and Consent to Maximize Diversity 6/25/2021Grand RoundsA moderated discussion about how to plan for and implement diversity in PCTs, focusing on strategies for outreach, trust, and consent.
  
Accounting for quality improvement during the conduct of embedded pragmatic clinical trials within healthcare systems: NIH Collaboratory case studies6/24/2021Journal articlePublication from the Health Care Systems Interactions Core
  
June 24, 2021: New Article Offers Guidance on Accounting for Quality Improvement Activities During Embedded Pragmatic Trials6/24/2021News articleNews item about manuscript on QI co-occurring with PCTs.
  
The MITIGATE Study: Insights from a Decentralized, Virtual, Electronic Health Record-Based Pragmatic Clinical Trial 6/18/2021Grand RoundsDrs. Ambrosy and Go present early insights from the MITIGATE trial that is evaluating an FDA-approved medication to prevent or reduce viral upper respiratory illness–related morbidity and mortality in patients with cardiovascular disease.
  
The MITIGATE Study: Insights from a Decentralized, Virtual, Electronic Health Record-Based Pragmatic Clinical Trial 6/18/2021Grand RoundsDrs. Ambrosy and Go present early insights from the MITIGATE trial that is evaluating an FDA-approved medication to prevent or reduce viral upper respiratory illness–related morbidity and mortality in patients with cardiovascular disease.
  
The TSOS Effectiveness-Implementation Hybrid Study: Health Care System Level Theoretical Considerations & Pragmatic Trial Results6/11/2021Grand RoundsDr. Zatzick, PI of the TSOS effectiveness-implementation pragmatic clinical trial, presents the results and additional theoretical considerations.
  
The TSOS Effectiveness-Implementation Hybrid Study: Health Care System Level Theoretical Considerations & Pragmatic Trial Results6/11/2021Grand RoundsDr. Zatzick, PI of the TSOS effectiveness-implementation pragmatic clinical trial, presents the results and additional theoretical considerations.
  
UH3 Reporting Site User Guide6/10/2021WebsiteThis is the user guide for the UH3 Enrollment Reporting Site tool for the NIH Collaboratory Demonstration Project study data.
  
June 8, 2021: PCT Grand Rounds to Feature Results of the TSOS Demonstration Project6/8/2021News articleNews article about TSOS Grand Rounds.
  
Inclusion of Diverse Participants in Pragmatic Clinical Trials: Planning for Diversity – Stakeholder Engagement and Site Selection to Maximize Diversity6/4/2021Grand RoundsPrincipal investigators of 2 Demonstration Projects discuss how to plan for and maximize clinical trial diversity through stakeholder engagement and site selection.
  
Inclusion of Diverse Participants in Pragmatic Clinical Trials: Planning for Diversity – Stakeholder Engagement and Site Selection to Maximize Diversity 6/4/2021Grand RoundsPrincipal investigators of 2 Demonstration Projects discuss how to plan for and maximize clinical trial diversity through stakeholder engagement and site selection.
  
Acupuncture for chronic pain in adults with sickle cell disease: a mixed-methods pilot study6/3/2021Journal articlePublication from the GRACE Demonstration Project
  
Nudge me: tailoring text messages for prescription adherence through N-of-1 interviews6/3/2021Journal articlePublication from the Nudge Demonstration Project
  
Online Recruitment in the Era of COVID-19 - Pitfalls and Progress6/2/2021PodcastDr. Ranney discusses aspects of participant recruitment in clinical trials using social media and digital technologies during the COVID-19 pandemic.
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