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Notice of Intent to publish a new funding opportunity for IMPACT Pilot Grants

Posted on by Sonya Sutton

The NIA IMPACT Collaboratory plans to publish a Request for Applications (RFA) for Pilot Grants on August 16, 2021 with Letters of Intent due September 17, 2021.

IMPACT funds several one-year awards of pilot pragmatic clinical trials (ePCTs) that test non-pharmacological interventions embedded in health care system(s) for people living with Alzheimer’s Disease (AD) and AD-related dementias (ADRD) and their care partners. Under this mechanism, interventions must be linked to the needs of a health care system. For more information, please see our Pilot Grants page.

All applications will be considered with priority given to applications for interventions in this population that aim to:

  • Improve care through behavioral economics “nudge” interventions;
  • Reduce inequities in health care;
  • Reduce potentially inappropriate medications through de-prescribing; and
  • Improve care in emergency department.

The goal of the pilot projects is to generate the preliminary data necessary to design and conduct a future full-scale Stage IV effectiveness ePCT (based on the NIH Stage Model). The IMPACT Collaboratory will give preference to applications that address dementia care for populations traditionally marginalized or underrepresented in clinical trials and those that promote health equity. It is anticipated that Pilot Projects will be funded for up to $175,000 in direct costs for a maximum of 12-months.

Stay tuned for updates regarding the release of the RFA, an informational webinar and application deadline. If you have questions related to this funding opportunity, please contact IMPACTcollaboratory@hsl.harvard.edu.

IMPACT Collaboratory supplement study finds real-world effectiveness of mRNA COVID-19 vaccines in reducing infection in nursing home residents

Posted on by Sonya Sutton

Asymptomatic and symptomatic infection rates fell dramatically after vaccinations in a large multi-state sample of nursing home residents, reported Wednesday in the New England Journal of Medicine

A study of more than 22,000 nursing home residents shows that the COVID-19 mRNA vaccines are highly effective under real-world conditions in reducing infection in this vulnerable population. The study, based at Brown University through a supplement award to the National Institute on Aging (NIA) IMbedded Pragmatic Alzheimer’s disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory, uses electronic health record data from Genesis HealthCare, one of the largest long-term care providers in the US. This is one of the first studies to report individual-level vaccine effectiveness data on nursing home residents, who were excluded from the vaccine clinical trials and often have reduced immune responses to vaccines.

The findings were shared as a research letter in the New England Journal of Medicine on May 19, and are attributed to a year-long collaboration between Brown University and Genesis HealthCare that has leveraged real-time clinical data to investigate COVID-19 outcomes in nursing homes. Led by Elizabeth White, PhD, APRN of the Center for Gerontology and Healthcare Research at the Brown University School of Public Health, the study team included Xiaofei Yang, ScM, Vincent Mor, PhD, and Stefan Gravenstein, MD, MPH from Brown University; and Carolyn Blackman, MD, and Richard Feifer, MD, MPH of Genesis HealthCare. Dr. Mor is one of two principal investigators of the IMPACT Collaboratory.

The study team examined clinical data from 280 nursing homes in 21 states. A total of 18,242 nursing home residents received at least one vaccine dose, and 13,048 of those received both doses as of February 15, 2021.  An additional 3,990 residents were unvaccinated. Residents were observed for new infections through March 31, 2021. Residents underwent regular testing, and were assessed daily by nurses for new symptoms.

The incidence of asymptomatic and symptomatic infection fell for both vaccinated and unvaccinated residents over time. Of the 13,048 fully vaccinated residents, 38 (0.3%) developed incident infection more than 14 days after the second dose, but only 9 (0.1%) were symptomatic. Most infections were asymptomatic. The study results are in line with a recent CDC study of Chicago-area nursing homes, but expand upon those findings with a larger and more geographically diverse sample.

The reduced infections in unvaccinated residents suggest that robust resident and staff vaccine coverage, together with continued use of facemasks and other infection control measures, likely affords protection for small numbers of unvaccinated residents in congregate settings. Still, the continued observation of post-vaccine incident cases highlight the critical need to make vaccines and surveillance testing continuously available to nursing homes to mitigate future outbreaks.

“These findings clearly demonstrate the effectiveness and importance of vaccination among nursing home residents, particularly considering their frailty and weakened immune systems. Moreover, the data reinforce the need to maximize vaccine acceptance within this most vulnerable population” says Dr. Feifer, Chief Medical Officer for Genesis HealthCare.

Read the full letter and supplemental materials here.

Two supplement awards to IMPACT Collaboratory will link big data and the impact of COVID-19 on people living with dementia

Posted on by Sonya Sutton

The National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer’s Disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory has been awarded two COVID-19 Supplements partnering with major retail pharmacies to create a massive monitoring system of the long-term safety and efficacy of COVID-19 vaccination on people with AD/ADRD.

The monitoring system was first established in February and is led by IMPACT Multiple Principal Investigator Vincent Mor, PhD.  Mor and his team initially created the monitoring system through a partnership with  Acumen, LLC and CVS, with data from more than 13 million CVS customers. The newest supplement, announced May 10 2021, adds data from 13.2 million Walgreens customers, effectively doubling the size of the securely monitored data pool. The combined system matches pharmacy customer records from CVS and Walgreens with Medicare claims to create a data infrastructure that is updated weekly, which will provide near real-time insight into the use, effects and outcomes related to use of COVID vaccines among this frail population and introduce the potential of using big data to improve our national response to the pandemic and public health outcomes for older adults.

“Since society cannot wait to vaccinate this population with an effective vaccine, we must establish an active post-vaccination surveillance system of a large population to report vaccine safety,” Mor said. “Monitoring rare adverse events requires very large populations. This project is allowing us to determine the immediate and long-term effects of vaccination on tens of millions of elderly people — nearly half the population of Medicare beneficiaries.”

These two studies are:

Monitoring Medicare Beneficiaries’ Response to COVID vaccines (CVS Project)

This project established an active post-vaccination surveillance system of a large population to track and report safety and outcomes related to SARS-CoV-2 vaccine(s).  Working jointly with CVSHealth and the Medicare & Medicaid Resource Information Center (MedRIC) at Acumen, LLC, the project established a data infrastructure to monitor the effects of COVID-19 vaccines administered to Medicare beneficiaries by CVS across the country.  Data transfers from the national retail pharmacy chain are merged with Medicare data. The resulting data base is analyzed to identify demographic, race/ethnicity, clinical (e.g., ADRD), and health care system factors associated with being vaccinated, estimate the rate of adverse events attributable to the vaccine and estimate breakthrough COVID illness among vaccinated Medicare beneficiaries.  This program provides the basis for assessing mid- to long-term safety and efficacy of the different vaccines being distributed for use in the elderly population in the country.

Medicare Match for post-vaccination monitoring (Walgreens)

This project builds on the researchers’ partnership with CVS to establish a data infrastructure to monitor the effects of COVID-19 vaccines administered to Medicare beneficiaries by CVS across the country.  The goal of this project is to add data from Walgreen’s 13,231,175 million Medicare beneficiary pharmacy customers to the existing infrastructure which will increase the research team’s capacity to track immediate and long term effects of vaccination on nearly half the population of Medicare beneficiaries.

The need for a larger study population is particularly important because those with ADRD already suffering from neurodegenerative diseases may be at greater risk of serious neurological adverse events of vaccines. In addition, the unknown potential for adverse events may result in high rates of incomplete vaccination (both shots) among older adults. Such uncertainty contributes to vaccine hesitancy and may result in large disparities in SARS-CoV-2 vaccination among racial/ethnic groups, for which disparities in seasonal influenza vaccination already exist.

To learn more about these studies, visit this page on Building Infrastructure Supplement Awards, and the press release from Brown University at this link.

Second Annual IMPACT Steering Committee and Business Planning Meeting highlights

Posted on by Sonya Sutton

The NIA IMPACT Collaboratory hosted the second annual Steering Committee & Business Planning Meeting on April 6-7, 2021.  The meeting was virtual this year due to the pandemic, and included more than 130 participants.

Highlights from the event include remarks from Richard Hodes, MD, the director of National Institutes on Aging, a Mission Moment presented by Brenda Nicholson, MD, retired physician and person living with dementia, and updates from IMPACT leadership.  Presentations highlighted IMPACT activities, funded investigators, and research efforts related to COVID-19.

The meeting began with a welcome from the IMPACT Collaboratory Principal Investigators Susan Mitchell, MD, MPH and Vince Mor, PhD. The director of the National Institute on Aging, Richard Hodes, MD, added remarks about how IMPACT has worked toward its goals in the past two years.

Brenda Nicholson, MD, a retired physician, member of the Stakeholder Engagement Team Executive Committee, and person living with dementia, provided the meeting Mission Moment. Mission Moments are designed to provide real-word insight into the IMPACT Collaboratory mission of building the nation’s capacity to conduct pragmatic clinical trials embedded within healthcare systems for people living with dementia and their care partners. Dr. Nicholson’s Mission Moment reflected on her experience of living with dementia during COVID-19.

Dr. Mitchell shared the IMPACT Collaboratory’s accomplishments since the beginning of the project in September 2019. Click here to see a larger image of the accomplishments to date.

Accomplishments of the NIA IMPACT Collaboratory since November 2019

Other meeting highlights included updates from the IMPACT Pilot Grant Awardees on the progress of their projects, and achievements of the Health Equity Team, Pilot Studies Core, data sharing, and Ethics and Regulation Core. Investigators also provided updates on three Intervention Supplements, which connect projects and data sources to the broader IMPACT mission.

Day 1 ended with updates from the Training Core and introductions to the first group of Career Development Awardees.

Day 2 featured the convening of the IMPACT External Advisory Panel and Steering Committee, and four Special Sessions led by the Health Equity Team, Design and Statistics Core, and the Ethics and Regulatory Core.

IMPACT COLLABORATORY HOSTS FIRST ANNUAL TRAINING WORKSHOP & RETREAT

Posted on by Erin Luers

IMPACT Collaboratory held its first annual Training Workshop and Retreat, “Building Skills to Conduct Embedded Pragmatic Clinical Trials for People Living with Dementia (PLWD) and their Care Partners,” on April 7-8. The training was open to early to mid-career researchers seeking to develop competence in designing and conducting ePCTs of interventions to improve care for PWLD and their care partners.

The IMPACT originally expected to have about 25 participants in the virtual 1.5-day workshop and retreat, but to due to high levels of interest, the final workshop included 65 participants from 26 institutions. The curriculum provided a foundation in practical aspects of designing and conducting ePCTs in AD/ADRD through a combination of panel discussions, small group sessions, and networking opportunities with experts in the field. Workshop modules focused on healthcare systems, implementation science, and study design.

One participant described their experience: “This was a great entry into ePCTs for me. The leaders in the field are incredibly gracious sharing their time and lessons learned with the next generation of scholars.”

Our second annual Training Workshop and Retreat will be held virtually January 26-27, 2022. Applications are expected to be open mid-September 2022.

Mor receives highest faculty honor from Brown University

Posted on by Sonya Sutton

Vincent Mor, PhD,  IMPACT Multiple  Principal Investigator and longtime professor of health services, policy and practice at Brown University, was one of two recipients of the Susan Colver Rosenberger Medal of Honor during Brown’s graduation service on May 2nd.

Mor was recognized for the “stunning impact” of his service, leadership and research over four decades at Brown, as well as for his devotion to the health and well-being of individuals and to the public good.   Mor was just the 33rd person to receive this honor since its establishment in 1919.

A longtime advocate for vulnerable elders, Mor directed the Center for Gerontology and Health Care Research at Brown for 10 years, and he has been principal investigator of more than 40 National Institutes of Health-funded grants focused on the uses and outcomes of health services by frail and chronically ill people. During the COVID-19 pandemic, in recognition of the urgency of his research, Mor and his team have been awarded multiple supplemental grants related to COVID-19 testing and the adverse health impacts of COVID-19 vaccination in elderly nursing home residents.

Mor said before Sunday’s ceremony that he is deeply honored to receive the award with Julie Strandberg and hopes that their separate efforts at building significant programs at Brown will have lasting value: “What we’ve built, in our respective fields, lays the groundwork for future scholarship and societal improvement,” he said.

Read the full announcement from Brown University at this link.

Notice of Intent (NOI) to publish a new funding opportunity announcement for upcoming IMPACT Pilot Grants

Posted on by Sonya Sutton

The NIA IMPACT Collaboratory plans to publish a Request for Applications (RFA) for Pilot Grants on August 16, 2021 with Letters of Intent due September 17, 2021.

IMPACT funds several one-year awards of pilot pragmatic clinical trials (ePCTs) that test non-pharmacological interventions embedded in health care system(s) for people living with Alzheimer’s Disease (AD) and AD-related dementias (ADRD) and their care partners. Under this mechanism, interventions must be linked to the needs of a health care system. More information on the IMPACT Pilot Grants Program can be found here.

The goal of the pilot projects is to generate the preliminary data necessary to design and conduct a future full-scale Stage IV effectiveness ePCT (based on the NIH Stage Model). The IMPACT Collaboratory will give preference to applications that address dementia care for populations traditionally marginalized or underrepresented in clinical trials and those that promote health equity. It is anticipated that Pilot Projects will be funded for up to $175,000 in direct costs for a maximum of 12-months.

NIH Health Care Systems Research Collaboratory to host special diversity workshop series

Posted on by Sonya Sutton

The NIH Health Care Systems Research Collaboratory is launching a special workshop series on its popular Grand Rounds program to explore the inclusion of diverse participants in pragmatic clinical trials. This series will include topics on increasing engagement of diverse participants and building trust, including diverse sites, learning from implementation science to maximize diversity, and developing a pipeline of trainees from underrepresented groups to be leaders in pragmatic clinical research. The seminar on June 25 will include Jonathan Jackson, PhD, member of the IMPACT Health Equity Team.

The webinar series will kick off on Friday, May 14, at 1 p.m. ET with a keynote presentation by Dr. Clyde Yancy, Vice Dean of Diversity and Inclusion and Chief of Cardiology in the Department of Medicine at Northwestern University Feinberg School of Medicine.

The series will include four moderated webinar discussions with panels of experts, wrapping up with a podcast discussion in August. Download the Diversity Workshop Series Flyer and see the full schedule below. All sessions are free and open to the public; no registration required. Recordings will be archived on the Grand Rounds website.