Underreporting of Early Nursing Home COVID-19 Cases and Deaths in Federal Data
September 9, 2021
News
Notice of Intent (NOI) to Publish a New Funding Opportunity for the IMPACT Demonstration Project Program
Demonstration Project Grants Cycle 2
We are pleased to announce that the NIA IMPACT Collaboratory plans to publish a Request for Applications (RFA) for Demonstration Project Grants on October 4, 2021. Letters of Intent are required and due no later than October 29, 2021.
IMPACT will fund Demonstration Projects (maximum duration 24 months) designed as full-scale, Stage IV effectiveness embedded pragmatic clinical trials (ePCT) (based on the NIH Stage Model) that test, measure and evaluate the effect of a care delivery intervention program in a health care system for people living with Alzheimer’s Disease (AD) and AD-related dementias (ADRD) and their care partners.
The intervention will typically encompass relatively simple system changes or direct patient outreach, or successfully piloted programs ready for testing at scale. Demonstration Projects will allow health care systems and investigators to gain real-world experience integrating pragmatic non-pharmacologic interventions into usual clinical workflow and health care delivery practices in a controlled manner that provides clear information on the impact of the intervention program. Under this mechanism, interventions must be linked to the needs of a health care system.
The goal of the Demonstration Project is to generate evidence on effective care delivery practices that can be expanded and/or implemented in other systems. The IMPACT Collaboratory will give preference to applications that address dementia care for populations historically marginalized or underrepresented in clinical trials and those that promote health equity. It is anticipated that Demonstration Projects will be funded for up to $500,000 in direct costs for a maximum of 24-months.
Stay tuned for updates regarding the release of the RFA, an informational webinar and application deadline. Visit IMPACTcollaboratory.org to learn more about the Demonstration Projects Grants Program and currently awarded grants. If you have questions related to this funding opportunity, please contact IMPACTcollaboratory@hsl.harvard.edu.
NEW FUNDING OPPORTUNITY: Request for Applications for the Pilot Grants Program Cycle 3B
Pilot Grant Program – Cycle 3B
The IMPACT Collaboratory is pleased to announce a Request for Applications for the Pilot Grants Program Cycle 3B.
In this cycle, the IMPACT Collaboratory will fund up to five one-year awards for 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 (HCS). For more information, please see our Pilot Grants Program page.
The IMPACT Collaboratory will consider all applications for pilot ePCTs that evaluate non-pharmacological interventions to improve the care of people living with AD/ADRD and their care partners. However, this grant cycle will prioritize applications for interventions in these populations that aim to:
- Improve care through behavioral economics “nudge” interventions;
- Reduce inequities in health care;
- Reduce potentially inappropriate medications through de-prescribing; or
- Improve care in emergency departments.
The goal of the pilot studies 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) funded through other grant mechanisms (NIH or other sources). Preference will be given to applications that address dementia care for populations traditionally marginalized or underrepresented in clinical trials and those that promote health equity.
All applications should make a convincing case that the pilot ePCT proposed can be scaled up to a full-scale, Stage IV effectiveness ePCT as the next step. It is anticipated that Pilot Studies will be funded for up to $175,000 in direct costs for a maximum of 12-months.
Informational Webinar
An optional informational webinar will be hosted to provide investigators with an overview of application details and an opportunity to ask questions. Pre-registration is required using the link below.
- Tuesday, August 23, 2021 at 2:00 pm ET: Registration closed.
Letter of Intent (LOI) Due – Required
Interested applicants are required to submit an LOI. LOIs are accepted on a rolling basis through:
- September 17, 2021 @ 5pm ET
Full Proposals Due – By invitation only
Applications selected for further consideration will be invited to submit a full proposal due:
- January 14, 2022 @ 5pm ET
Read the full RFA here. Learn more about our previous Pilot Grant Awardees here.
If you have any questions regarding this funding opportunity, please refer to our Frequently Asked Questions or email IMPACTcollaboratory@hsl.harvard.edu.
IMPACT Collaboratory mentioned in JAMA article about expanding evidence for clinical care of older adults
The efforts of the NIA IMPACT Collaoratory to enhance embedded pragmatic clinical trials (ePCTs) in people living with dementia was included in a recent JAMA viewpoint, “Expanding Evidence for Clinical Care of Older Adults Beyond Clinical Trial Traditions and Finding New Approaches.”
Authors Michael Steinman, MD, Cynthia M. Boyd, MD, MPH, and Kenneth E. Schmader, MD, explore alternative approaches to delivering evidence needed to inform care for older adults in the viewpoint piece. In addition to ePCTs, they discuss strategies for analyzing existing clinical trial data and observational evidence to extrapolate them to populations of interest.
In the viewpoint, they state that the IMPACT Collaboratory “…is facilitating development of a number of pragmatic trials embedded in health systems that address different aspects of care for older adults with dementia. Because such trials typically forgo dedicated research visits, measuring aspects of geriatric health status can be challenging. Nonetheless, creative strategies can be used to measure these important domains, such as brief telephone-based assessments of function and cognition, extraction of functional status data from Medicare annual health risk assessment forms, and use of existing data to construct frailty index models.”
Read the full article here.
Patient and Caregiver Relevant Outcomes iLibrary now available to help design pragmatic clinical trials
The NIA IMPACT Collaboratory Patient and Caregiver Relevant Outcomes (PCRO) Core has created the IMPACT PCRO iLibrary to help investigators seeking to develop pragmatic clinical trials in people living with Alzheimer’s disease and related dementias (AD/ADRD).
The IMPACT PCRO iLibrary is an online, searchable and interactive resource containing information on selected outcome measures derived from existing data sources for pragmatic trials enrolling people with AD/ADRD. The members of the PCRO core selected the outcome measures based on their relevance to the lived experience of people with AD/ADRD and their care partners. In addition, the selected outcomes have pragmatic characteristics that make them good candidates for use in embedded pragmatic clinical trials (ePCTs). Pragmatic outcome measures allow for efficient and uniform data capture across multiple sites and large diverse populations, while minimizing burden on people living with dementia or their care partners.
“The IMPACT PCRO iLibrary is a unique resource for investigators who lead pragmatic trials to improve outcomes for people living with dementia and their care partners,” Laura Hanson, MD, MPH, PCRO Core Leader.
“When designing a clinical trial, the first question is often, ‘What outcome are we trying to improve?” said Dr. Hanson. “When we began the work of the PCRO Core, we quickly recognized that it’s easy to find outcome measures, but really challenging to learn if these outcomes fit the needs of a pragmatic trial.”
Dr. Hanson led the effort to create the library supported by Project Manager Kathryn Wessell, MPH. They began by organizing information about potential outcome measures in existing data sources. PCRO Core Executive Committee Members, Joan Teno, MD, MS and Debra Saliba, MD, MPH, shared their expertise working with the Minimum Data Set for Nursing Homes (MDS), Consumer Assessment of Healthcare Providers and Systems (CAHPS) Hospice Survey, and claims data to create the initial version of the library. Spencer Hey, PhD, of the IMPACT Ethics and Regulation Core, used AirTable to create the library and developed an instructional video on how to use the resource. Other members of the PCRO Core who contributed to the library include:
- Antonia Bennet, PhD
- Amy Kelley, MD, MSHS
- Joshua Niznik, PharmD, PhD
- Christine Ritchie, MD, MSPH
- Sheryl Zimmerman, PhD
“The PCRO iLibrary will grow and expand with the broader IMPACT Collaboratory, as more ADRD investigators conduct ePCTs, and share what works to capture relevant outcomes,” said Dr. Hanson. “Within the next year, the PCRO iLibrary will expand to include selected patient or caregiver-reported outcomes rated for their pragmatic properties.”
Phase 2 of the PCRO iLibrary will also include collaboration with David Meyers, PHD, MPH, of the IMPACT Technical Data Core, to continue to expand the library.
To learn more about the PCRO iLibrary and use this resource, visit https://impactcollaboratory.org/pcro-library/.
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 announces recipients of four funding mechanisms
The NIA IMPACT Collaboratory is pleased to announce the awardees of the Pilot Grants Cycle 2B, Career Development Award, and two new funding mechanisms: the Demonstration Projects Program and Health Care Systems (HCS) Scholars Program. Awardees of these funding opportunities will be supported by the IMPACT cores and teams to conduct embedded pragmatic clinical trials (ePCTs) of non-pharmacological interventions within healthcare systems to improve care for people living with Alzheimer’s Disease (AD) and AD-related dementias (ADRD) and their care partners. IMPACT prioritizes applications that promote health equity and address dementia care for people of all backgrounds. Learn more about the NIA IMPACT Collaboratory on the website. Read more about these opportunities and our newest awardees below.
The Pilot Grant Program funds several one-year pilot ePCTs that test non-pharmacological interventions embedded in health care systems to improve care for people living with AD/ADRD and their care partners. Pilot studies are conducted to generate the preliminary data necessary to design and conduct future full-scale Stage IV effectiveness ePCT (based on the NIH Stage Model) that will be funded through other grant mechanisms (National Institutes of Health or other sources).
Recipients of the Pilot Cycle 2B awards:
- Michael Lepore, PhD, LiveWell Alliance
Cognitive Stimulation Therapy for Mild to Moderate Dementia
- Medha Munshi, MD, Joslin Diabetes Center, Harvard Medical School
Deprescribing of Diabetes Treatment Regimens in Long Term Care Residents with ADRD
- Aanand Naik, MD, Baylor College of Medicine
Patient Priorities Care for Hispanics with Dementia (PPC-HD)
- Annette Totten, PhD, Oregon Health & Science University
ADVANCE-PC: Testing Critical Components for a Trial of Advance Care Planning in Primary Care for Dementia
Demonstration Projects Program
The Demonstration Projects Program is a new funding mechanism to support full-scale, Stage IV effectiveness ePCTs testing non-pharmacological interventions for people living with AD/ADRD and their care partners that are linked to the needs of a health care system. The intervention typically includes relatively simple system changes, direct patient outreach, or successfully piloted programs ready for testing at scale. The goal of the demonstration project is to generate evidence on effective care delivery practices that can be expanded and/or implemented in other systems.
Recipients of the Demonstration Projects awards:
- Xiaojuan Li, PhD and Richard Platt, MD, MSc, Harvard Medical School and Harvard Pilgrim Health Care Institute
Collaborative Care Coordination Program for Alzheimer’s Disease and Related Dementias (Co-CARE-AD)
- Michael Parchman, MD, MPH, Kaiser Permanente of Washington Health Research Institute
Can Value Champions Reduce Inappropriate Prescribing for People with Dementia?
Career Development Award Program
The Career Development Award Program prepares early-stage investigators for research careers designing and conducting ePCTs for people living with AD/ADRD and their care partners.
Recipients of the Cycle 2 Career Development Awards:
- Rupak Datta, MD, PhD, Yale School of Medicine
Antibiotic Stewardship in Homebound People Living with Dementia
- Chanee Fabius, PhD, Johns Hopkins Bloomberg School of Public Health
Engaging and Integrating Direct Care Workers in Care Delivery for Persons Living With Dementia in the Community
- Cameron Gettel, MD, Yale School of Medicine
Development and Validation of a Novel Caregiver-Reported Outcome Measure
The new Health Care Systems Embedded Research Scholars Program offers investigators an opportunity to work directly with health care systems interested in improving the care provided to people living with AD/ADRD and their care partners. The goal of the HCS Scholars Program is to embed investigators in health care systems to strengthen collaborations and learn how to successfully implement new programs that may lead to pilot studies or demonstration projects.
Recipients of the first HCS Scholar awards:
- Hillary Lum, MD, PhD, University of Colorado School of Medicine
Extraordinary Partners in Dementia: UCHealth Capacity for Pragmatic Interventions
- Quincy Samus, PhD, MS, Johns Hopkins University School of Medicine
Health Care Systems Embedded Research Program: MIND at Home at Centene Corporation
