Building the nation’s capacity to conduct pragmatic clinical trials embedded within healthcare systems for people living with dementia and their care partners
The NIA IMPACT Collaboratory’s multiple principal investigators, Susan L. Mitchell, PhD, MPH, and Vincent Mor, PhD, shared the vision and goals of the project with LeadingAge in an article from January 17.
“We are confident that the NIA IMPACT Collaboratory will transform the delivery, quality, and outcomes of care provided to Americans with dementia, and their caregivers, by accelerating the testing and adoption of evidence-based interventions within health care systems,” says Mitchell.
The article includes a description of the problem of Alzheimer’s disease and related dementias, as well as how the structure of the IMPACT Collaboratory will help researchers who seek to conducted embedded pragmatic clinical trials to combat these conditions.
IMPACT leaders hope their collaborative efforts will identify and validate evidence-based programs that can be adopted across PLWD communities and help people live a higher quality of life. “The goal,” concludes Mor, “is to reduce the suffering of persons living with dementia, reduce the burden on the caregivers, and ease the challenge of humanely meeting the needs of this difficult-to-serve population, while maintaining their dignity—and I am confident we can achieve this.”
IMPACT Steering Committee and Design and Statistics Core member Monica Taljaard, PhD, will be part of a panel at the 13th University of Pennsylvania Conference on Statistical Issues in Clinical Trials on April 29th. The conference will focus on challenges and opportunities in cluster randomized clinical trials. Registration is now open.
Keith Goldfeld, DrPH, MS, MPA, member of the IMPACT Collaboratory Design and Statistics Core Executive Committee wrote a blog post about the network and how it can help with pragmatic pilot studies to investigate promising interventions for people living with Alzheimer’s disease and related dementias.
Goldfeld shares what we can expect to learn from a relatively small pilot study of a new intervention. The blog shares two articles addressing small pilot studies, and provides simulations to see how a small pilot study could potentially lead to poor design decisions with respect to sample size. Read the full post on Goldfeld’s blog here.
Richard Platt, MD, MS, a member of the Executive Committee for the NIA IMPACT Collaboratory Technical Data Core, was among the presenters at the NIH Health Care Systems Research Collaboratory Grand Rounds on Friday, December 6th. Details are below:
Topic
Millions More People, Stronger Collaborations: The New and Improved NIH Collaboratory Distributed Research Network
Date
Friday, December 6, 2019, 1:00-2:00 p.m. ET
Speakers
Richard Platt, MD, MS
Professor and Chair
Harvard Medical School
Department of Population Medicine
Kevin Haynes, PharmD, MSCE
Principal Scientist
HealthCore
Denise Boudreau, PhD
Senior Scientific Investigator
Kaiser Permanente Washington Health Research Institute
Jerry H. Gurwitz, MD
Professor of Medicine, Family Medicine and Community Health, and Population & Quantitative Health Sciences
University of Massachusetts Medical School
Executive Director, Meyers Primary Care Institute
Christopher B. Granger, MD
Professor of Medicine
Duke University
The NIA IMPACT Collaboratory’s Stakeholder Engagement Team (SET) conducted an all-day meeting on December 3, 2019 at Hebrew SeniorLife in Boston, MA. Attendees included the SET, the Stakeholder Advisory Committee (SAC), and additional participants relevant to the IMPACT Collaboratory’s efforts regarding stakeholder engagement. Click here to see the full list of participants. .
The objectives were to:
1) Review the role of the SAC;
2) Provide advice to the IMPACT Collaboratory on how to integrate stakeholder engagement into its mission;
3) Strategize about the optimal way to assist the selection and guidance of pilot project; and
4) Discuss priority topics to address in guidance materials.
After a welcome from Gary Epstein-Lubow, MD, and Katie Maslow, MSW, Susan Mitchell, MD, MPH, presented an overview of the IMPACT Collaboratory. This was followed by personal messages about the importance of research to address aspects of the lived experience of dementia presented by a person living with dementia, Louise Phillips, MD, and a family caregiver and dementia care clinician, Katie Brandt, MIM.
Historic definitions of SE as prepared by the Patient-Centered Outcomes Research Institute were provided by Lori Frank, PhD, MA. Ellen Tambor, MA, presented SE work from the original NIH Collaboratory; this was followed by information from Katie Maslow about SE specific to dementia care research in the U.S. The NIA IMPACT Collaboratory’s process for supporting pilot ePCTs was reviewed by Laurie Herndon, MSN, followed by suggestions from Jill Harrison, PhD, as to how stakeholders can be integrated into the pilot study processes.
In the afternoon, pilot study expectations were further explored as they relate to the involvement and engagement of people with lived experiences of dementia as well as a wide array of clinicians, service providers, health care system leaders, and payers.
Antonia Bennett, PhD, of the Collaboratory’s Patient and Caregiver Reported Outcomes (PCRO) Core and Monica Moreno, BS, of the Alzheimer’s Association described the development of a “Lived Experience Panel”. This was followed by a discussion of engaging health systems leaders which was led by Alice Bonner, PhD, RN, and included Lee Jennings, MD, MSHS, David Gifford, MD, MPH, and others. The final session was an overview of selected advice from the SAC emanating from the day.
Outcomes of the meeting included:
1) Successful orientation of SAC members;
2) Preliminary plans for clarifying definitions and processes regarding SE within the Collaboratory;
3) Review of SE activities related to pilot study investigators; and
4) Discussion of SE activities including development of a Lived Experiences Panel, guidance documents for investigators, a logic model for SE activities within the Collaboratory, and methods for evaluation of SE activities.
Federal grant from the National Institute on Aging will fund a collaborative research incubator to support trials across the nation aimed at improving care for people living with dementia.
PROVIDENCE, R.I.[Brown University] — The National Institute on Aging (NIA) has awarded a five-year grant expected to total $53.4 million to Brown University and Boston-based Hebrew SeniorLife (HSL) to lead a nationwide effort to improve health care and quality of life for people living with Alzheimer’s disease and related dementias, as well as their caregivers.
Together, the institutions will create a massive collaborative research incubator to develop trials aimed at evaluating interventions for Alzheimer’s disease or Alzheimer's-related dementia (AD/ADRD).
“This grant will revolutionize the national infrastructure for research into how care is delivered to people living with dementia and their caregivers,” said Vincent Mor, co-leader of the collaboration and a professor of health services, policy and practice at Brown’s School of Public Health. “The key is figuring out how to take an idea that worked in an ideal situation and adapt it so it can be piloted in the messy real-world system of care providers that exists across the U.S.”
The grant from NIA, one of 27 institutes and centers of the National Institutes for Health, will support the incubator for the next five years. For Brown, the grant marks the largest federal award in University history.
“The NIA IMPACT Collaboratory will transform the delivery, quality and outcomes of care provided to Americans with dementia and their caregivers by accelerating the testing and adoption of evidence-based interventions within health care systems,” said Dr. Susan Mitchell, co-leader of the collaboration, senior scientist at HSL’s Hinda and Arthur Marcus Institute for Aging Research and professor of medicine at Harvard Medical School.The research incubator, called the NIA Imbedded Pragmatic AD/ADRD Clinical Trials (IMPACT) Collaboratory, will take on two primary objectives through eight working groups comprising experts from more than 30 top research institutions. The first objective is to fund and provide expert assistance to up to 40 pilot trials that will test non-drug, care-based interventions for people living with dementia. The second objective is to develop best practices for implementing and evaluating interventions for Alzheimer’s and dementia care and share them with the research community at large.
The 40 pilot projects will be embedded in real-world health care systems and generate the necessary data to inform larger, definitive trials supported with federal funding, the researchers said.
Projects will benefit from guidance from the collaboratory’s community of experts, who will assist with ethical concerns (such as how to secure informed consent from people living with dementia); technical support and generation of data on participant populations; statistics and project design; advice on how to measure patient- and caregiver-reported outcomes; dissemination of results and efforts to maximize the likelihood of implementation; partnering with health care systems interested in conducting trials; project administration; training for junior researchers; inclusion of and applicability to people of all backgrounds and cultures; and best practices to engage people interested in this work, including people living with dementia and their caregivers, health care systems and researchers.
Researchers at Brown and HSL have collaborated on aging research for nearly 40 years. Mor is renowned for his expertise in quality measurement and brings decades of experience running clinical trials focused on older adults within real-world health care systems, including skilled nursing centers. Mitchell, director of Palliative Care Research at the Marcus Institute and co-director of the Interventional Studies in Aging Center, has dedicated her career to research to improve the care of people living with dementia, particularly those in the later stages.
For the past four years, Mor and Mitchell have co-led a trial on the effectiveness of videos that guide patients through planning for care preferences to be employed when they become too incapacitated to make decisions. For that trial, they partnered with two large nursing center corporations.
“It’s time for Alzheimer’s and other dementias to receive the same level of research focus and investment as cancer,” said Louis Woolf, HSL president and CEO. “We’re proud to collaborate with Brown University to address this national epidemic that affects not only patients, but their families and caregivers as well.”
Brown President Christina Paxson said the grant will complement efforts across the University to devise treatments and technologies to address a wide variety of brain-related diseases and injuries.
“Alzheimer’s and dementia remain among the most vexing neurodegenerative diseases both to researchers searching for solutions and to patients and family members,” Paxson said. “This grant will harness the collective power of leading-edge scholars at Brown, Hebrew SeniorLife and across the nation to advance care and make a positive real-world impact on the individuals most directly affected by these illnesses.”
Ideally, the yearlong pilot projects will originate with professionals within the affected health care systems, rather than only academic researchers, Mor and Mitchell said. This goal builds on the mission of the Center for Long-Term Care Quality and Innovation, which will lead administration of the grant and is based at Brown’s School of Public Health. The center focuses on partnering with innovators, including health care providers, to evaluate novel practices to improve the quality of care.
“This new grant harnesses the School of Public Health’s depth of expertise and collaborative strength to investigate pioneering interventions with the potential to transform the lives of those living with dementia, along with the lives of their families and caregivers,” said Bess Marcus, the school’s dean.
Mor said that the $53.4 million grant is one among many examples of how NIA is supporting research in recognition of the urgent and growing public health need to better care for the millions of American families who face Alzheimer’s disease and related dementias. The Alzheimer’s Association estimates that while more than 5 million Americans currently live with Alzheimer’s or a related dementia, the number is expected to double by 2050. The current annual cost of dementia care exceeds $226 million a year in the U.S. alone.
“The national discourse around Alzheimer’s and other dementias is growing louder by the day as the number of Americans suffering with this disease increases exponentially,” said Dr. Lewis Lipsitz, director of the Marcus Institute and chief academic officer. “The NIA IMPACT Collaboratory will provide the research infrastructure and community of experts needed to conduct real-world clinical trials that will meet this challenge head-on.”
The work is supported by the National Institute on Aging of the National Institutes of Health under Award No. U54AG063546. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
“This grant will revolutionize the national infrastructure for research into how care is delivered to people living with dementia and their caregivers,” said 
“The NIA IMPACT Collaboratory will transform the delivery, quality and outcomes of care provided to Americans with dementia and their caregivers by accelerating the testing and adoption of evidence-based interventions within health care systems,” said