patient engagement

February 19, 2021: Beyond Politics: Promoting COVID Vaccination in the United States (Kevin A. Schulman, MD)

Posted on by Gina Uhlenbrauck

Speaker

Kevin A. Schulman, MD
Professor of Medicine and Economics
Stanford University

Topic

Beyond Politics: Promoting COVID Vaccination in the United States

Keywords

COVID-19; Vaccine hesitancy; Marketing strategies; Herd immunity; Vaccine adoption

Key Points

  • One key strategy is to promote the COVID-19 vaccine as a tool that will get us back to school and work again.
  • We need targeted COVID-19 marketing campaigns at each health system to achieve 100% vaccination of healthcare workers.
  • It is crucial that we tamp down vaccine misinformation. We must be vocal in telling the accurate stories of people’s experience with the vaccine, as these resonate with the public and can have an impact.

Discussion Themes

Many of these strategies could apply to clinical trials, for example, a scarcity, an honor for participation, a frontier. Could these tactics could be used to increase participation in clinical trials, especially COVID-19 trials?

Another strategy is to just open the floodgates for everyone to get the vaccine, and this will avoid having stock waste on the shelves. If high-risk groups are resistant to vaccination, perhaps highly motivated people can fill the gap.

How can private payers support COVID-19 vaccine marketing efforts?

Read more about Beyond Politics—Promoting Covid-19 Vaccination in the United States in the New England Journal of Medicine.

Tags

#pctGR, @Collaboratory1

January 29, 2021: The COVID-19 Citizen Science Study (Gregory M. Marcus, MD, MAS)

Posted on by Gina Uhlenbrauck

Speaker

Gregory M. Marcus, MD, MAS
Professor of Medicine
University of California, San Francisco

Topic

The COVID-19 Citizen Science Study

Keywords

Eureka digital research platform; COVID-19 infections; Mobile health; Risk factors; Citizen science; Geolocation; Participant engagement

Key Points

  • Eureka is an NIH-supported digital research platform built to use mobile health technology to combat the novel coronavirus, focusing on identifying risk factors for infection, transmission, and severity of disease that may inform best practices.
  • Eureka is also intended to serve as a platform for collaborating investigators to answer their own research questions.
  • As a citizen science project, any adult with a smartphone can participate and contribute information. Nearly 50,000 participants have enrolled to date.

Discussion Themes

The COVID-19 Citizen Science website provides data visualizations that show how people answered the survey questions. A study blog through the app is used to translate key information to participants.

Will this project be collaborating with other entities that are potentially overlapping in terms of their COVID-19 applications?

Best practices in mHealth include keeping it simple, avoiding over-explaining, listening to participants, and providing a feedback pathway.

Learn more about the Eureka platform. The smartphone app is available under the name “UCSF Eureka Research.”

Tags

#pctGR, @Collaboratory1  

October 27, 2020: NIA IMPACT Collaboratory Seeks Nominations for Lived Experience Panel

Posted on by Damon Seils

Logo for the NIA IMPACT CollaboratoryThe NIA IMPACT Collaboratory, in collaboration with the Alzheimer’s Association, is seeking nominations for its Lived Experience Panel. Panel members will provide feedback to researchers and engage in discussions about methods and strategies for studying nonpharmacological interventions to improve the quality of life of people living with dementia and their family members and caregivers.

Read more about the Lived Experience Panel, including frequently asked questions the panelist nomination form.

Participants are asked to serve for 1 year. Participation will include training regarding the goals of the Lived Experience Panel, participation in quarterly conference calls or video meetings of the panel, review of premeeting materials, and evaluation of each meeting after it has completed.

The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging. Its mission is to advance care for persons with dementia and their caregivers in real-world settings by building national capacity to conduct pragmatic clinical trials that test interventions embedded in healthcare systems.

October 20, 2020: All of Us Research Program Issues Funding Opportunity for New Engagement Partners

Posted on by Damon Seils

The All of Us Research Program has issued a new funding opportunity seeking partnerships with national, state, and local engagement partners to recruit and engage participants in the landmark NIH program. Through these partnerships, All of Us aims to create bidirectional and co-equal relationships that engage communities that have historically been underrepresented in biomedical research.

Logo for the All of Us Research Program

All of Us, a historic effort to accelerate research and improve health, launched nationally in 2018 to create one of the most comprehensive and diverse biomedical data resources of its kind. More than 358,000 participants have enrolled in the program. This latest funding opportunity illustrates the program’s commitment to partnering with organizations that are influential in their respective communities, especially those organizations that work with diverse communities.

The program anticipates funding at least 6 awards in fiscal year 2021 through this latest funding opportunity, each with a total project period of 5 years. Applications are due on November 23, 2020.

All of Us encourages eligible applicants with experience working with and engaging underrepresented communities to apply for this funding. All of Us considers the following populations underrepresented in research: racial and ethnic minority groups; children and seniors; sexual and gender minorities; people living with disabilities; people with barriers in access to care; people who have low income or low educational attainment; and rural residents.

For full details regarding this opportunity, please see the funding announcement.

October 2, 2020: Driving Toward Health Impact: Our Journey and Path Forward (Nakela Cook, MD, MPH)

Posted on by Gina Uhlenbrauck

Speaker

Nakela L. Cook, MD, MPH
Executive Director
Patient-Centered Outcomes Research Institute (PCORI)

Topic

Driving Toward Health Impact: Our Journey and Path Forward

Keywords

PCORI; Health outcomes; Health disparities; Patient-centered research; Comparative clinical effectiveness; COVID-19; Maternal health

Key Points

  • Despite improvements in health, disparities and variation in care remain—especially underscored by the unprecedented COVID-19 pandemic.
  • PCORI funds studies that can help patients and those who care for them make better informed healthcare choices.
  • PCORI has funded the HERO Registry to assess COVID-19 exposure responses and outcomes within the community of healthcare workers. Other research support is targeted toward vulnerable populations, healthcare delivery, and emerging health trends.
  • With PCORI 2.0, new funding will be available for large-scale, high-impact comparative effectiveness trials. Each study will include an initial phase to determine the feasibility and viability of the study and maximize the likelihood of success during the full-scale phase.

Discussion Themes

What are your observations regarding COVID-19’s impact on health, healthcare, and research that you think will be critical for PCORI's strategy? What will bring about the necessary innovations to the system?

Addressing maternal health disparities is a high priority in PCORI 2.0. The next phase will also expand PCORI’s role in collecting and generating relevant evidence and focusing on a deliberate and transparent process for implementation.

How will PCORI broaden its reach to reduce outcome disparities among people with disabilities?

Read more about PCORI.

Tags

#pctGR, @Collaboratory1

August 14, 2020: Learning While Sprinting: A One-Year Retrospective from the NOHARM Pragmatic Trial (Jon Tilburt, MD; Andrea Cheville, MD)

Posted on by Gina Uhlenbrauck

Speakers

Jon Tilburt, MD
Professor of Medicine and Biomedical Ethics
Mayo Clinic

Andrea Cheville, MD
Professor of Physical Medicine and Rehabilitation
Mayo Clinic

Topic

Learning While Sprinting: A One-Year Retrospective from the NOHARM Pragmatic Trial

Keywords

PRISM; NIH Heal Initiative; NOHARM; Postoperative care; Nonpharmacologic pain care (NPPC); Stepped wedge; Cluster-randomized trial; Electronic health records (EHRs); Patient engagement; Clinical decision support

Key Points

  • The Nonpharmacologic Options in Postoperative Hospital-based and Rehabilitation Pain Management (NOHARM) NIH Collaboratory Trial is completing its pilot phase. This embedded, stepped-wedge PCT will test a sustainable strategy in perioperative, nonpharmacologic pain management that preserves patient function, honors patient values, and maintains the availability of opioids as a last resort.
  • NOHARM is a pragmatic, EHR-integrated intervention that bundles a portal-based conversation guide that captures patient preferences for postsurgical pain care and a clinician-directed decision support tool.
  • Nonpharmacologic pain care management options include walking, yoga, tai chi, acupressure, massage, meditation, and relaxation.

Discussion Themes

Opioids are insufficient in postsurgical care. Guidelines recommend nonpharmacologic pain care (NPPC), but there have not been studies showing how to make NPPC more viable.

The COVID-19 pandemic caused disruption in scheduled surgeries and also air travel, which precluded on-the-ground support at two study sites. However, the team was able to adjust recruitment methods during the pilot phase.

What was the team’s proactive process in working with the IRB in order to obtain a waiver of consent?

The NOHARM intervention has sustained high-level institutional support despite the impact of COVID-19.

Read more about the NOHARM NIH Collaboratory Trial.

Tags

#pctGR, @Collaboratory1

June 12, 2020: A Cluster Randomized Pragmatic Trial of an Advance Care Planning Video Intervention in Long-Stay Nursing Home Residents: Main Findings from the PROVEN Trial (Susan Mitchell, MD, MPH)

Posted on by Gina Uhlenbrauck

Speaker

Susan L. Mitchell, MD, MPH
Senior Scientist
Hebrew SeniorLife
Hinda and Arthur Marcus Institute for Aging Research
Professor of Medicine
Harvard Medical School

Topic

A Cluster Randomized Pragmatic Trial of an Advance Care Planning Video Intervention in Long-Stay Nursing Home Residents: Main Findings from the PROVEN Trial

Keywords

Embedded pragmatic trial; PROVEN; Advance care planning; Nursing homes; Video intervention; Medicare; Care preferences; Decision support tool; Minimum data set; Intention to treat

Key Points

  • The PROVEN trial was the first large-scale embedded pragmatic trial conducted in nursing homes.
  • The advance care planning (ACP) video intervention in PROVEN was meant as an adjunct to first-person discussions with the clinical care provider.
  • The levels of care preferences described in the ACP videos were life prolongation, limited care, and comfort care.
  • PROVEN’s primary outcome was the number of transfers to the hospital from the nursing home.

Discussion Themes

Widely adoptable, effective interventions to improve ACP in nursing homes remain elusive.

Of the challenges of conducting PCTs embedded in nursing homes, it is important not to overlook the real-world priorities of stakeholders. A high level of endorsement, from C-suite to frontline care providers, is needed before attempting such a trial.

While a priority for nursing home administrators is the number of residents who transfer to the hospital, an essential question for patients and palliative care experts is whether patients receive care that matches their goals and preferences. This is hard to ascertain in a pragmatic way.

Read more about the PROVEN trial, and learn about a new research initiative built on the success of the NIH Collaboratory: the National Institute on Aging’s IMPACT Collaboratory, which is directly funding pilots of embedded PCTs across diverse healthcare settings to improve the care of patients with dementia and their caregivers.

Tags

#pctGR, @Collaboratory1

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 17, 2020: The HERO Program: PCORnet® at Work to Create a Healthcare Worker Community for Rapid Cycle Evidence (Nakela Cook, MD, MPH; Josie Briggs, MD; Susanna Naggie, MD; Emily O’Brien, PhD; Russell Rothman, MD; Chris Forrest, MD, PhD)

Posted on by Gina Uhlenbrauck

Speakers

Nakela Cook, MD, MPH
Executive Director
PCORI

Josie Briggs, MD
Acting Chief Science Director
PCORI

Susanna Naggie, MD
Principal Investigator, HERO-HCQ Clinical Trial
Duke University

Emily O’Brien, PhD
Principal Investigator, HERO-Registry
Duke University

Russell Rothman, MD, MPP
Chair, HERO Steering Committee
Vanderbilt University

Chris Forrest, MD, PhD
Chair, HERO Registry
Children’s Hospital of Pennsylvania

Topic

The HERO Program: PCORnet® at Work to Create a Healthcare Worker Community for Rapid Cycle Evidence

Keywords

Coronavirus; Virus pandemic; COVID-19; PCORI; Patient-Centered Outcomes Research Institute; Frontline health workers; Hydroxychloroquine; Healthcare systems; HERO-HCQ

Key Points

  • With the onset of the coronavirus pandemic, the U.S. healthcare system faces an unprecedented stress test to adapt to meet new demands.
  • Those on the frontline of caring for patients—healthcare workers—are at risk of developing or transmitting COVID-19. Evidence is urgently needed to keep healthcare workers and their families safe and healthy, which ultimately will help protect us all.
  • The HERO (Healthcare Worker Exposure Response & Outcomes) Program has three broad focus areas to develop rapid evidence around healthcare workers’ outcomes related to COVID-19:
    • Emphasis on the adaptations in how healthcare is delivered
    • Emphasis on vulnerable populations
    • Emphasis on the well-being of the healthcare worker
  • HERO will consist of a registry study of healthcare workers and a randomized controlled trial called HERO-HCQ that will evaluate the safety and efficacy of hydroxychloroquine to prevent COVID-19 clinical infections in healthcare workers.

Discussion Themes

The goal of the HERO registry is to understand all aspects of healthcare workers’ lives—those with direct impact and those with indirect impact.

What mechanisms are you envisioning for new study proposals that would be conducted via the HERO platform?

Serologic testing will have a significant role in understanding prior infection and potential immunity.

The HERO Registry is open to any healthcare worker to join at https://heroesresearch.org/. Enrollment takes only a few minutes; participation is free and voluntary. It is not restricted by profession. All data are kept confidential.

Tags
#HeroRegistry, #pctGR, @Collaboratory1, @PCORI, @PCORnetwork, @HeroesResearch

April 3, 2020: Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): Participant-Centered, Rapidly-Deployed, Digitally-Enabled Research (Harlan Krumholz, MD; Bala Hota, MD, MPH; Graham Nichol, MD, MPH)

Posted on by Gina Uhlenbrauck

Speakers

Harlan M. Krumholz, MD
Harold H. Hines Jr. Professor of Medicine, Yale University
Director, Yale New Haven Hospital Center for Outcomes Research and Evaluation
Co-Founder Hugo Health

Bala Hota, MD, MPH
Professor of Internal Medicine, Rush University
Chief Analytics Officer, Rush University Medical Center

Graham Nichol, MD, MPH
Medic One Foundation Endowed Chair for Pre-hospital Emergency Care
Professor of Emergency Medicine
University of Washington

Other Panelists:

Jacqueline Rollin, Administrative Fellow
Rush University Medical Center

Wade Schulz, MD, PhD
Assistant Professor of Laboratory Medicine
Director, CORE Center for Computational Health

Matthew J. Thompson, MB, ChB, DPhil
Helen D. Cohen Endowed Professorship in Family Medicine
Professor of Global Health and Medicine, University of Washington

Deb R. Chromik, Participant Experience
Hugo Health

Dave Hutton, Product Lead
Hugo Health

Topic

Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): Participant-Centered, Rapidly-Deployed, Digitally-Enabled Research

Keywords

Coronavirus; Virus pandemic; INSPIRE Registry; COVID-19 directed research program; SARS-COV-2; Longitudinal data; Hugo Health digital research platform

Key Points

  • In the face of the coronavirus pandemic, there is an urgent need for rapid knowledge generation and actionable insights. Evidence needed includes:
    • The number of cases, including milder ones
    • Risk factors and timing of transmission
    • Severity and attack rate
    • Risk factors for infection and severe outcomes, including death
    • Infectiousness timing and intensity
  • Patients must be considered part of the team; involved, engaged, and respected, with agency over their data.
  • To better understand the experience of people with COVID-19, Rush University Medical Center and Hugo health are piloting the COVID INSPIRE registry. INSPIRE is a rapidly-deployed, digitally-enabled, participant-centered platform to collect longitudinal data and facilitate observational and experimental studies.

Discussion Themes

Even with social distancing, the coronavirus is in a rapid escalation phase; this rapid pace has our attention.

People are interested in participating in research now more than ever. The call to action is to build a human-connected system that treats patients compassionately and supports patients in real time.

Are there existing systems that could be built on or adapted for COVID-19? Are there potential for linkages to other systems?

Tags
#pctGR, @Collaboratory1, @HMKYale, @BalaHota, @GrahamNichol