February 6, 2022
Administration
Challenges Implementing Innovative Programs in Long Term Care: Examples from Pragmatic Trials
September 2021 – In Grand Rounds 19, Dr. Mor discusses the complexities of making changes in health care systems through four examples of embedded pragmatic clinical trials.
Speaker
Vincent Mor, PhD
Florence Grant Pirce Professor of Community Health
Brown University School of Public Health
Learning Objectives
- Understand the complexities of Making Changes in Health Care Systems
- Understand the kinds of Implementation Challenges that arise in conducting ePCTs in nursing homes
- Understand the Implications of how difficult it is to Change Care Practices to improve Dementia care
Results from TRAIN-AD study published in JAMA Internal Medicine
A study team led by IMPACT’s Multiple Principal Investigator Susan Mitchell, PhD, MPH recently published results of a Trial to Reduce Antimicrobial Use in Nursing Home Residents with Alzheimer’s Disease and Other Dementias (TRAIN-AD). The journal article and an accompanying editorial were published in JAMA Internal Medicine on July 12th.
Mitchell and colleagues conducted a cluster randomized clinical trial of a multicomponent intervention designed to improve management of suspected urinary tract infections (UTIs) and lower respiratory infections (LRIs) for nursing home residents with advanced dementia. The trial was conducted at 28 Boston-area nursing homes (14 per arm). The intervention, which targeted nursing home care providers, integrated best practices from infection diseases and palliative care for management of suspected UTIs and LRIs in residents with advanced dementia. Researchers observed a clinically significant 33% reduction in antimicrobial courses for suspected lower respiratory infections (LRIs) and urinary tract infections (UTIs) among participants living in facilities assigned to the intervention. Although this result was underpowered to show a statistically significant reduction, the TRAIN-AD study was unique in that it completed a rigorous evaluation of an intervention to reduce antibiotics in people with advanced dementia.
The study team found that despite a comprehensive training approach that included an in-person seminar, online course, management algorithms, communication tips, and feedback reports and a high adherence to the training, the intervention did not significantly reduce antimicrobial use among nursing home residents with advanced dementia. However, both Mitchell’s team and the commentary authors noted the potential of the intervention to yield more significant results when scaled up and applied to a broader range of nursing home settings.
The study results were accompanied by an invited commentary from Shiwei Zhou, MD and Pretti N. Malani, MD, noting these strengths and describing the study as a “a low-cost, low risk, scalable intervention that is associated with a reduction in inappropriate antibiotic prescriptions is worthy of replication” from a stewardship perspective.
Read the full article here and commentary here.
Citation: Mitchell SL, D’Agata EMC, Hanson LC, et al. The trial to reduce antimicrobial use in nursing home residents with Alzheimer disease and other dementias (TRAIN-AD): a cluster randomized clinical trial. JAMA Intern Med. Published online July 12, 2021. doi:10.1001/jamainternmed.2021.3098
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.