mobile health (mHealth)

October 30, 2020: Lessons from Virtual Trials in Time of a Pandemic: Minnesota Hydroxychloroquine Experience (David Boulware, MD, MPH)

Posted on by Gina Uhlenbrauck

Speaker

David R. Boulware MD, MPH
Professor of Medicine
Infectious Disease & International Medicine
Department of Medicine
University of Minnesota

Topic

Lessons from Virtual Trials in Time of a Pandemic: Minnesota Hydroxychloroquine Experience

Keywords

COVID-19; Patient-reported outcomes (PROs); Hydroxychloroquine; Epidemiology; Virtual trials

Key Points

  • These virtual randomized controlled trials evaluated hydroxychloroquine as a post-exposure prophylaxis, pre-emptive early treatment, and pre-exposure prophylaxis for COVID-19.
  • The trial of post-exposure prophylaxis employed patient-reported outcomes around COVID-19 symptoms and severity as well as side effects of hydroxychloroquine.
  • Enrollment and screening of eligible participants was automated through a REDCap survey.

Discussion Themes

Being a virtual trial, were there concerns about practicing medicine “across state lines?”

There has been a mix of science and politics over the course of the COVID-19 pandemic. Because your trial had substantial media coverage, how did the publicity affect enrollment?

Many big strategy questions can be studied virtually. What changes do you see for trials during future pandemics?

Read reports of these virtual trials in New England Journal of Medicine, Annals of Internal Medicine, and the medRxiv preprint server.

Tags

#pctGR, @Collaboratory1

August 18, 2020: Grand Rounds Podcast With C. Michael Gibson on the Democratization of Medicine Is Available

Posted on by Gina Uhlenbrauck

In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez and Dr. C. Michael Gibson continue the discussion of how medicine and medical research are being transformed through patient empowerment and information sharing. Their conversation provides a deeper look into the power of social media and the role of physicians as citizen journalists, innovators, activists, and educators. The full August 7 Grand Rounds webinar with Dr. Gibson is also available.

August 7, 2020: The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research (C. Michael Gibson, MS, MD)

Posted on by Gina Uhlenbrauck

Speaker

C. Michael Gibson, MS, MD
Professor of Medicine
Harvard Medical School
President and CEO
Baim and PERFUSE Research Institutes

Topic

The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research

Keywords

Clinical research; Open access; Social media; Artificial intelligence; Heartline study; WikiDoc; WikiPatient

Key Points

  • As the internet is replacing the printing press, “copyleft” is replacing copyright in the open-access era. It is a participatory community with bidirectional flow of information through social media.
  • Health data does not equal health care. Patients are looking to physicians to curate health information from huge volumes of data.
  • Social media and open access during the COVID-19 pandemic has meant that physicians are citizen journalists, innovators, activists, and educators.
  • In this new world, patients are enrolling in virtual trials via a phone app and will be followed up online through claims data and patient-reported outcomes.

Discussion Themes

The COVID-19 pandemic has been a call to arms to clinicians to combat not only the virus but the misinformation. As educators we must set the path and not allow uninformed people to take control.

Enabling patient-empowered trials has the potential for more generalizable study results and can lead to patient-specific predictions through use of artificial intelligence.

How do we validate the quality of open-access data and reports that are not peer-reviewed?

How can we diminish the hazards of skewed research outcomes arising from trial participant conversations on social media?

Read more from C. Michael Gibson in The Democratization of Medical Research and Education Through Social Media: The Potential and the Peril (JAMA Cardiology 2017).

Tags

#pctGR, @Collaboratory1

June 26, 2020: Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Keys to Success in the Evolving EHR Environment (Keith Marsolo, PhD; Teresa Zayas-Cabán, PhD; George (Holt) Oliver, MD, PhD; Christopher A. Longhurst, MD, MS; Rachel Richesson, PhD, MPH)

Posted on by Gina Uhlenbrauck

Speakers

Guest Moderator:
Keith Marsolo, PhD
Associate Professor, Population Health Sciences
Duke University

Panel:
Teresa Zayas-Cabán, PhD
Chief Scientist
Office of the National Coordinator for Health Information Technology
Office of the Secretary, DHHS

George (Holt) Oliver, MD, PhD
Vice President Clinical Informatics
Parkland Center for Clinical Innovations

Christopher A. Longhurst, MD, MS
CIO and Associate CMO, Quality/Safety
Professor of Pediatrics and Medicine
UC San Diego Health

Rachel Richesson, PhD, MPH
Associate Professor
Duke University School of Nursing

Topic

Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Keys to Success in the Evolving EHR Environment

Keywords

Embedded PCTs; Electronic health records; EHR; Digital health; Data interoperability; Clinical decision support; Information technology

Key Points

  • A defining feature of the 19 NIH Collaboratory embedded pragmatic clinical trials is their use of the EHR, whether for eligibility screening, intervention delivery, and/or outcome assessment.
  • As an example, the ICD-Pieces NIH Collaboratory Trial showed that a standard set of EHR data can be used to identify patients. The study involved a diverse set of health systems, and the study team overcame many IT challenges, including integrating data from 3 different EHR systems.
  • It is possible to implement a system-wide data warehouse, as the University of California has done across its 5 academic medical centers.

Discussion Themes

The vision is to ensure that healthcare systems are able to learn from every patient, at every visit, every time.

A common challenge for trials embedded in healthcare delivery is access to operational IT expertise and the relative priority in those environments. How can we more effectively partner with our IT colleagues in these trials?

The U.S. Department of Health and Human Services released a comprehensive strategy to reduce the regulatory and administrative burden related to the use of health IT, including EHRs. Visit HealthIt.gov for more information.

Tags

#pctGR, @Collaboratory1

May 8, 2020: Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Real World Evidence: Contemporary Experience and Future Directions (Patrick Heagerty, PhD, Jacqueline Corrigan-Curay, JD, MD, Joshua C. Denny, MD, MS)

Posted on by Gina Uhlenbrauck

Speakers

Guest Moderator:
Patrick J. Heagerty, PhD
Professor, Department of Biostatistics, University of Washington

Panel:
Jacqueline Corrigan-Curay, JD, MD
Director of CDER’s Office of Medical Policy (OMP)
U.S. Food and Drug Administration (FDA)

Joshua C. Denny, MD, MS, FACMI
Chief Executive Officer, All of Us Research Program, NIH

Topic

Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Real World Evidence: Contemporary Experience and Future Directions

Keywords

Electronic health records; Real-world evidence; RWE; Real-world data; RWD; FDA; All of Us; Phenotypes; Regulatory; Fit-for-use data; Digital heath

Key Points

  • To create quality clinical/research records, we must design for multiuse by integrating standards-based tools in the EHR to bring together health care and research. 
  • Quality real-world evidence cannot be built without quality real-world data. With greater efficiencies in data capture, randomization with real-world data provides a pathway for reliable—and persuasive—real-world evidence.

Discussion Themes

Patient-generated health data is part of FDA’s MyStudies Application, designed to facilitate the input of real-world data directly by patients, which can be linked to electronic health data supporting traditional clinical trials, pragmatic trials, observational studies, and registries.

In assessing data quality we can ask, How does a data element travel from clinical care to a research data set?

The NIH’s All of Us program is building a diverse database that can inform thousands of studies on a variety of health conditions.

The All of Us study is tracking COVID-19 in its patients. Sites have identified their COVID-19 participants and relevant labs. Consent is obtained for future sharing of data.

Tags

#pctGR, @Collaboratory1

May 5, 2020: Dr. Robert Califf Discusses Next Steps for Reforming the Evidence Generation Ecosystem After COVID-19

Posted on by Gina Uhlenbrauck

In case you missed the May 1 keynote address by Robert M. Califf, MD, MACC, you can now listen to the recorded webinar and Q&A. Dr. Califf, head of strategy and policy for Verily Life Sciences and Google Health, kicked off the Collaboratory’s Grand Rounds workshop series, Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials.

His presentation outlined several opportunities to drive change and rebuild clinical research in the aftermath of COVID-19, including:

  • Evaluate what has and has not worked in the changes that have been made in response to the crisis
  • Allocate a significant part of recovery funding to transition issues in evidence generation, especially at the interface of medicine and public health
  • Do everything possible to fix the “purposefulness issue”:
    • Create methods for deciding the most important questions
    • Reward behavior that gets important questions answered quickly
  • Develop inclusive networks driven by people with the health problems of interest; increase incentives for clinicians and investigators that lead to reliable and faster evidence generation (balance financial focus with purpose); and automate mapping of EHR data beyond individual systems

“The effective use of digital information such as electronic health records, telehealth, applications, and patient-reported outcomes should free up effort to fix the human components that are holding us back.” – Dr. Robert Califf

View the full presentation for more insights from Dr. Califf.

Stay tuned for these upcoming presentations in the series:

May 1, 2020: Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Keynote-Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem? (Robert Califf, MD, MACC)

Posted on by Gina Uhlenbrauck

Speaker

Robert Califf, MD, MACC
Head of Strategy and Policy
Verily Life Sciences and Google Health

Topic

Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Keynote-Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem?

Keywords

Electronic health records; Digital health; Mobile health; Coronavirus; COVID-19; Ecosystem; Clinical trials; Evidence generation

Key Points

  • The HERO Registry and RECOVERY Trial are good examples of a rapid clinical research response to the urgent COVID-19 health crisis.
  • Among the essential steps to move the evidence generation system in the right direction:
    • Evaluate what has and has not worked in the changes made in response to the crisis
    • Allocate a significant part of recovery funding to transition issues in evidence generation, especially at the interface of medicine and public health
    • Increase purposefulness by creating methods for deciding the most important questions and rewarding behavior that gets those questions answered quickly

Discussion Themes

The COVID-19 pandemic has shone a spotlight on disparities in our current healthcare delivery system. How can we avoid leaving the most vulnerable of society behind?

Telemedicine can be a framework for the integration of research and clinical care. But the digital element must be integrated with the human element. The routine and effective use of digital information should free up effort to fix the human components that are holding us back.

We’ve been trying to modernize clinical trial design for decades (factorial/sequential/adaptive designs for example). While some positive movement in the past month has been made, the research enterprise remains largely conservative when it comes to design modernization. How do we make more rapid progress?

Tags

#pctGR, #COVID19, @Collaboratory1, @Califf001

April 13, 2020: New Living Textbook Chapter on Pragmatic Mobile Health (mHealth) Trials

Posted on by Damon Seils

A new chapter in the Living Textbook provides expert advice for investigators considering using mobile technologies in pragmatic clinical trials. The chapter outlines many of the possibilities, advantages, and challenges associated with mobile health (mHealth) interventions, with a particular focus on design and evaluation of these programs in pragmatic clinical trials.

“We will illustrate many design and evaluation challenges, culminating with a discussion of how these considerations influence the ongoing development of the Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) project.”—Real-World Evidence: Mobile Health (mHealth)

For more on using real-world evidence in pragmatic trials, see the Living Textbook chapter Choosing and Specifying Endpoints and Outcomes.

February 21, 2020: Nudge Study Updates (Michael Ho, MD, PhD; Sheana Bull, PhD, MPH)

Posted on by Gina Uhlenbrauck

Speakers

Michael Ho, MD, PhD
Professor of Medicine, University of Colorado School of Medicine
Staff Cardiologist, Rocky Mountain Regional VA Medical Center

Sheana Bull, PhD, MPH
Professor, Colorado School of Public Health
Director, mHealth Impact Laboratory

Topic

Nudge Study Updates

Keywords

Cardiovascular health; Behavioral nudges; Disease self-management; Pharmacy data; Text messaging; mHealth; Medication adherence; Choice architecture

Key Points

  • Up to 50% of patients do not take their cardiovascular medications as prescribed. Nonadherence is associated with increased cardiovascular events.
  • Nudges prompt small, incremental changes in behavior and can be delivered through text messaging.
  • The Nudge pragmatic study was piloted across 3 integrated healthcare systems. The intervention uses pharmacy data to monitor gaps in patients’ cardiovascular medication refills. Patients with gaps receive text messages on their mobile phone to remind them to refill their medication.

Discussion Themes

A “chatbot” is used in one of the study arms to interact with the patient through the mobile phone application. As part of the analytic plan, the study team will be evaluating engagement with the interactive chatbot and the dose response.

The Nudge study gives patients two opportunities to opt out of participating. The study team is tracking demographics of patients who opted out as well as their reasons for opting out.

How do you handle the roughly 10% of people who receive care from more than one health system? That is, patients may be receiving conflicting advice, including directions to discontinue their medications.

Learn more about the Nudge NIH Collaboratory Trial.

Tags
#pctGR, @Collaboratory1

February 24, 2020: Study Snapshots for Six UH3 NIH Collaboratory Trials Are Available

Posted on by Gina Uhlenbrauck

Want to know more about the goals and challenges of the NIH Collaboratory Trials? New downloadable handouts summarize the study aims, implementation lessons, and recent publications and presentations from these innovative pragmatic clinical trials.

Study Snapshots are accessible from each NIH Collaboratory Trial page and the links below:

  • ACP PEACE: Improving Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly
  • EMBED: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder
  • GGC4H: Guiding Good Choices for Health: Testing Feasibility and Effectiveness of Universal Parent-Focused Prevention in Three Healthcare Systems
  • HiLo: Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis
  • Nudge: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications
  • PRIM-ER: Primary Palliative Care for Emergency Medicine