PCORnet Facilitates New Research on Drugs' Effectiveness for COVID-19
ACTIV-6 — a new clinical trial platform unveiled by the National Institutes of Health — will use PCORnet®, the National Patient-Centered Clinical Research Network, to help determine if some prescription and over-the-counter medications can effectively treat COVID-19 in non-hospitalized patients. While some drugs approved for other conditions have been studied to treat mild to moderate cases of COVID-19, ACTIV-6 aims to provide definitive evidence for patients and clinicians seeking to manage the disease and avoid hospitalization.
Changes to Telehealth Policy, Delivery, and Outcomes in Response to COVID-19
During the COVID-19 pandemic, there has been a rapid shift toward virtual visits and digital tools to monitor and help patients manage their health care. PCORI solicited a landscape review to summarize how reimbursement, regulatory, and delivery systems have changed for telehealth during the coronavirus pandemic. The goal was to use this information, in combination with conversations with key stakeholders, to better understand how changes in the delivery system during COVID-19 might alter PCORI’s strategic focus on future investment in telehealth research. This report provides a rich summary of changes under the pandemic and highlights some areas in telehealth where additional research may be valuable.
PCORI-Funded Research Studies and Engagement Awards
In August and September 2020, PCORI approved funding for nine new studies assessing various healthcare approaches to improve outcomes among people infected by the novel coronavirus and lessen its effects on patients, healthcare workers, and communities. Among the first seven approved studies are projects comparing the impacts on patients from state and local pandemic containment and mitigation policies, as well as projects on healthcare access and disparities in outcomes among racial and ethnic minorities and underserved populations.
An eighth study will look at the effects of policy changes relating to COVID-19-related medication-assisted treatment on people with opioid use disorders, and a ninth study will investigate different types and intensities of four basic preventive interventions in reducing rates of COVID-19 and related hospitalization and mortality in staff and adult residents with serious mental illness (SMI) and intellectual or developmental disabilities in congregate care settings.
More than 150 investigator-initiated proposals were submitted in 2020 to address the COVID-19 public health crisis from our existing awardees. The submitted proposals offer ways to transform existing awards to serve their original aims while offering findings related to COVID-19. The projects cover a range of health conditions, including mental health, cardiovascular diseases, and respiratory diseases, and a variety of health intervention strategies, such as telemedicine and behavioral interventions. PCORI approved these award enhancements on a rolling basis. Learn about the projects and the focus of their award enhancements.
|View the Draft Final Research Report Instructions for COVID-19 Enhancement Projects|
In April 2020, PCORI sought proposals for projects that would help communities increase their capacity to participate across all phases of the research process while responding to contextual changes as a result of the COVID-19 pandemic. The special funding announcement also facilitated the exploration of virtual and distanced methods of engagement, and the generation of new questions and evidence needs across stakeholder groups. Through the special announcement, PCORI funded 25 projects.
Telehealth's use has risen sharply during the pandemic and is likely to remain a fixture of health care. PCORI-funded researchers are answering important questions about how best to harness its power and how to reach populations with limited access to technology or who need culturally tailored interventions.
We revisit a Spring 2020 webinar series, which PCORI hosted and featured more than 20 healthcare and operations management experts, who discussed strategies for fine-tuning hospital capacity, staffing, and patient flow amid the coronavirus pandemic.
With the coronavirus pandemic limiting in-person activities, researchers will need options for shifting in-person Engagement activities to a virtual format. Three PCORI-funded researchers offer tips to engage remotely while maintaining safety.
|➤ March 31: First of six-part PCORI-sponsored webinar series, "Report from the Field: How We are Managing Incident Command," features health system leaders discussing their response to the pandemic|
|➤ April 1: Board of Governors approves up to $110 million in COVID-19-related funding:
♦ $20 million for enhancements/adaptations to currently funded projects
♦ $30 million for new projects
♦ $50 million for Healthcare Worker Exposure Response and Outcomes (HERO) Registry and Trial Program
➤ April 7: Second COVID-19 webinar held on managing demand in emergency departments and coordinating the flow of very sick patients in hospitals
➤ April 13: HERO Registry and HERO-HCQ Trial Program launches
➤ April 14: Third COVID-19 webinar held on strategies for managing urgent surgeries amid pandemic
➤ April 20: Engagement Awards COVID-19 Special Cycle opens for proposals supporting engagement in and dissemination of research
➤ April 21: Fourth COVID-19 webinar held on crucial nursing issues, including managing of personal protective equipment<
➤ April 28: Fifth COVID-19 webinar held on challenges hospitals encountered in discharging patients
|➤ May 5: Final COVID-19 webinar held on the growth and ongoing use of telehealth during the pandemic, and lessons learned
➤ May 5: PCORI posts COVID-19 Targeted Funding Announcement for research into three priority areas:
♦ Adaptations to healthcare delivery
♦ Impact on vulnerable populations
♦ Impact of healthcare workforce well-being, management, and training
|➤ June 9: PCORI publishes first Biweekly COVID-19 Scan
➤ June 23: PCORI Board approves up to $50 million for new COVID-19 funding opportunities, as well as enhancements to existing studies
|➤ August 12: PCORI publishes first quarterly Horizon Scanning COVID-19 Supplement Status Report
➤ August 18: $22.6 million in COVID-19 targeted research awards announced
|➤ September 1: PCORI awards $2.3 million for COVID-19 targeted research project on medication-assisted treatment policy changes and patients with opioid use disorders
➤ September 10: PCORI awards $5 million for targeted research project on preventing COVID-19 illness in people with serious mental illness, developmental disabilities
➤ September 16: Breakout session at PCORI's 2020 Virtual Annual Meeting includes high-level perspective on the shift in healthcare delivery toward telehealth under the coronavirus pandemic, and a look at two PCORI studies that used patient-centered telehealth to address COVID-19-related health concerns
|➤ October 20: New blog post highlights PCORI's portfolio of funded research projects on telehealth and the lessons learned so far, and projects seeking to address questions related to the COVID-19 pandemic
➤ October 26: PCORI publishes first COVID-19 Supplement High Impact Report
Future funding announcements will indicate our ongoing interest in studying COVID-19 impacts.
Healthcare Workers Registry and Study
Learn more about the newly launched HERO Registry, which will answer crucial questions about the impact of novel coronavirus on healthcare workers' lives.
PCORI is supporting a registry and study of the effectiveness of hydroxychloroquine in preventing COVID-19 infections in US healthcare workers.
These funding opportunities are now closed.
Engagement Award: Building Capacity for PCOR/CER for Topics Related to COVID-19
Increasing Vaccine Confidence among Long-Term Care Workers
|COVID-19-Related Enhancements to Existing PCORI-Funded Project
PCORI sought proposals from PCORI-funded study principal investigators and project leads that address the COVID-19 public health crisis through enhancements of their ongoing studies/projects.
View the closed announcements
|COVID-19 Targeted PFA (Cycle 2 2020)
PCORI sought proposals for research that seeks to strengthen our understanding of ways to mitigate the virus’s impact and provide evidence to inform clinical and public health responses and planning.
View the closed funding opportunity
|Engagement Award: Supporting Engagement in and Dissemination of PCOR/CER in the Context of COVID-19
PCORI sought proposals for projects that would help communities increase their ability to participate across all phases of research while responding to societal changes resulting from the pandemic.
View the closed funding opportunity
April 15, 2020—After recognizing this public health crisis and the impact that COVID-19 will have on our nation, our senior leaders, staff, and Board of Governors pivoted to focus on what PCORI could do in coordination with ongoing efforts across government, industry, and other funders.
|Nakela L. Cook, MD, MPH
Our attention turned to critical dimensions of this pandemic, particularly the healthcare workers on the front lines—physicians, nurses, respiratory therapists, and all personnel, both medical and nonmedical, who work each day in hospitals, triage tents, drive-through testing stations, and clinics providing compassionate care to individuals with COVID-19. The Board of Governors earlier this month approved up to $50 million to fund a registry and randomized clinical trial of the effectiveness of hydroxychloroquine in preventing COVID-19 infections in healthcare workers. Our respect and gratitude for these essential workers is beyond measure.
Our thoughts are also with the many patients, families, caregivers, and friends grappling with this disease’s devastating toll. PCORI is uniquely poised to focus on patients and their caregivers; it is in our organizational DNA. Thus, since the beginning of this crisis, we have collaborated with our funded researchers to explore adding COVID-19-related aims to existing patient-centered projects.
Last week, we posted funding opportunities of up to $20 million for such work. Following a board vote early this month that provided up to $30 million for new COVID-19-related research, we are putting the pieces into place to solicit innovative research projects from the nation’s investigators and healthcare stakeholder communities to support new COVID-19-related research, engagement, and dissemination projects.
Urgent and unknowable concerns related to COVID-19 will emerge over the arc of time. At times like these, I am reminded of the lessons in humility that science and medicine teach me every day. These lessons will help us persevere through the challenging COVID-19 pandemic and enable us to attend to the next decade of leadership in comparative clinical effectiveness research.
Note: This message was adapted from a blog post by Dr. Cook, titled "Our Shared Journey to Enduring Success."
March 27, 2020—In light of the spread of COVID-19 caused by the novel coronavirus, the health and well-being of everyone is our primary concern as we endeavor to continue carrying out our mission with a concentration on reacting quickly to the current public health emergency.
|Josie P. Briggs, MD
Former Interim Executive Director
Safety and well-being are integral to our research funding, engagement with stakeholders, and other services, business processes, and infrastructure. We are assessing the situation daily, remaining vigilant, and following all recommendations from the World Health Organization, U.S. Centers for Disease Control and Prevention, and federal and state authorities.
Staff Availability: Following federal and state guidance to promote social distancing, PCORI’s staff has shifted to telework and is conducting meetings and other business through virtual platforms such as teleconferencing and videoconferencing. We will strive to be accessible and minimize disruptions as much as possible under the circumstances. We appreciate your understanding and patience as we engage with you under extraordinary conditions.
Meetings: We are curtailing all business travel by PCORI staff for the foreseeable future. During that same period, we are postponing, switching to all-virtual formats, or canceling PCORI-hosted meetings. We appreciate your understanding. We are continuing with preparations for the 2020 PCORI Annual Meeting, scheduled for September 16-17 in the Washington, D.C., metropolitan area. However, we may have to make appropriate adjustments to our plans, if necessary. We are also working with awardees to support their efforts to convert their planned in-person meetings to all-virtual formats or to postpone or cancel their meetings.
Funding Opportunities and Deadlines: As necessary, we are adjusting the deadlines related to our funding announcements and quickly exploring ways that PCORI can contribute to the evidence base for addressing this public health crisis. Revised deadlines and opportunities are noted in the Funding Opportunities section of our website and in these FAQs.
As we chart our course through these uncertain times together, we affirm PCORI’s ongoing commitment to our core activities of supporting engagement in research and studies that provide information people need to make better-informed healthcare decisions. We will continue to provide updated information and guidance through our website to awardees, applicants, and other stakeholders as the situation develops.
Communities are facing enormous challenges and PCORI is committed to contributing to the important work needed to address the many uncertainties that face us all.
Last Updated: June 9, 2021