Participation of persons with dementia and their caregivers in research
July 10, 2021
Author: Sonya Sutton
Promises and Pitfalls of Existing Data in Nursing Homes
June 2021 – In Grand Rounds 18, Drs. Teno and Saliba discuss the use of administrative data, including the Minimum Data Set (MDS) in pragmatic clinical trials and share examples of how they have used this data in their own pragmatic clinical trials.
Speakers
Joan M. Teno, MD, MS
Professor of Medicine, Oregon Health & Science University
Adjunct Professor of Health Services, Policy, & Research, Brown University School of Public Health Physician Scientist, VA Los Angeles, GRECC and HSR&D COIN
Debra Saliba, MD, MPH
Anna & Harry Borun Endowed Chair, Geriatrics and Gerontology, UCLA
Director, UCLA/JH Borun Center for Gerontological Research
Physician Scientist, VA Los Angeles, GRECC and HSR&D COIN
Learning Objectives
- Pros and cons of administrative data for use in pragmatic trials
- Address potential limitations of using administrative data to infer the quality of care
- Discuss a controversial claim that pragmatic trials of decision-making for persons with dementia need to consider adding PCROs:
- Addressing understanding, coercion
- Addressing safety, “balance measures - Identify advantages & challenges of using MDS assessment items
- Describe some of the MDS data elements and their performance implications for persons with cognitive impairment
- Understand performance of resident self-report items
- Identify pragmatic skills for direct interviews
Podcast
Additional Resources
Notice of Intent to publish a new funding opportunity for IMPACT Pilot Grants
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.
Pilot and feasibility studies for pragmatic cluster randomised trials
May 2021 – In Grand Rounds 17, Claire Chan presents on the growing number of studies described as pilot or feasibility studies, and describes the challenges in defining and designing these studies.
Speaker
Claire Chan, MSc
Statistician
Institute of Population Health Sciences (IPHS)
Queen Mary University of London
Webinar Recording
Learning Objectives
- To understand what pilot and feasibility studies are and how to design them
- To understand some of the special considerations for pilot and feasibility studies in advance of a pragmatic trial
- To understand some of the special considerations for cluster randomised trials
Podcast
s
Podcast Transcript: Download the transcript here.
Additional Resources
IMPACT Collaboratory supplement study finds real-world effectiveness of mRNA COVID-19 vaccines in reducing infection in nursing home residents
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.
Two supplement awards to IMPACT Collaboratory will link big data and the impact of COVID-19 on people living with dementia
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
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.
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.
Mor and team share results of IMPACT supplement award study evaluating impact of SARS-CoV-2 vaccine among nursing home residents
Vince Mor, PhD, one of IMPACT Collaboratory’s two Principal Investigators, and team recently shared results from their investigation into the impact of SARS-CoV-2 vaccine among nursing home residents from 280 nursing homes in 21 states. Results were published in the Journal of the American Geriatrics Society on April 16th.
Researchers partnered with Genesis Healthcare, the largest long-term care provider in the country, for the study, which was a supplement award through the IMPACT Collaboratory. They monitored the impact of the SARS-CoV-2 vaccine rollout among nursing home residents in 280 nursing homes within 21 states. Both the Moderna and Pfizer-BioNTech vaccines were included in the study. Researchers created two groups of participating facilities based on the date of their initial vaccine clinic and conducted a matched pair analysis of outcomes.
One week after their initial vaccine clinics, nursing homes with earlier clinics had 2.5 fewer new SARS‐CoV‐2 infections per 100 at‐risk residents than expected based on the experiences of matched facilities with later clinics. Cumulatively over 7 weeks, earlier vaccinated facilities had 5.2 fewer infections per 100 at‐risk residents and 5 fewer hospitalizations and/or deaths per 100 infected residents than expected without vaccinations. These results indicate that the vaccine led to a reduction in incident infections, morbidity, and mortality in this large multi-state nursing home population.
The researchers also suggested the findings support efforts to begin resuming family visitation and lessen other restrictions in nursing homes.