LeadingAge Magazine · January-February 2020 • Volume 10 • Number 01

New Effort Marries Research and Quality Dementia Care

January 17, 2020 | by Mark Crawford

The IMPACT Collaboratory is designed to encourage evaluation of care innovations to benefit those living with dementia and their caregivers.

Alzheimer’s disease is the 6th-leading cause of death in the United States and the only top-10 deadly disease that does not have a treatment or cure.

According to the Alzheimer’s Association, about 5.8 million Americans live with the disease. By 2050, this number is expected to more than double to 14 million. Although some progress has been made regarding treatments, it is still an incurable condition. People live into the most advanced stages of the disease, which require a very high level of care. Currently, total annual cost for treating Alzheimer’s disease and other dementias in the U.S. is nearly $300 billion; by 2050 this figure could rise to $1 trillion or more.

People living with Alzheimer’s and dementia (PLWD) are especially vulnerable to receiving uncoordinated and poor-quality care, which ultimately leads to higher rates of hospitalization, more emergency department visits, adverse health outcomes, premature institutionalization, and wasted resources.

To address this pressing health crisis, in September 2019 the National Institute on Aging (NIA) awarded a 5-year, $53.4 million grant to Brown University and Hebrew SeniorLife (HSL) to lead a major initiative focused on improving health care and quality of life for PLWD. The goal is to develop effective new treatments for PLWD that are based on high-quality trials carried out in real-world settings.

IMPACT Collaboratory artwork
Image courtesy of Brown University.

 

Called the Imbedded Pragmatic Alzheimer’s Disease and AD-Related Dementias Clinical Trials (IMPACT) Collaboratory, the initiative plans to improve quality of care for PLWD by:

  • Developing best-practice research methods.
  • Designing and implementing pragmatic trials in the field.
  • Training researchers and investigators.
  • Building collaborative relationships among researchers, health care providers, senior living communities, and other stakeholders.
  • Ensuring people in the studies are culturally diverse and include under-represented backgrounds.

IMPACT is led by 2 principal investigators: Susan Mitchell, professor of medicine at Harvard Medical School and senior scientist at HSL’s Hinda and Arthur Marcus Institute for Aging Research, and Vincent Mor, professor of health services, policy, and practice at Brown’s School of Public Health. Both have worked together on previous projects.

Other staff include 2 executive directors, advisory panel and steering committee members, and more than 60 investigators representing over 30 academic institutions.

“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.

Embedded Clinical Trials

“There is a need for studies conducted in realistic settings that can provide evidence for system-wide benefits,” says John Haaga, director of the division of behavioral and social research at NIA.

This can be accomplished using embedded pragmatic clinical trials, which often speed up the translation of evidence-based interventions into clinical practice.

Unlike traditional clinical studies, which are conducted with carefully selected subjects under highly controlled conditions, embedded pragmatic clinical trials test intervention ideas in real-life settings, such as hospitals, clinics, and senior-living communities. In those sites, subjects and their day-to-day living conditions are more representative of general patient populations. In addition, embedded trials can be based on simple study designs, which makes them easy to implement, without sacrificing scientific rigor.

IMPACT plans to launch up to 40 year-long pilot trials that will test non-drug, care-based interventions for PLWD. Many of the ideas to be tested will come from professionals within the participating health care systems, rather than just academic researchers. Data generated by encouraging trials will then be used to plan larger-scale, more definitive trials supported with federal funding. The hope is that some of these trials will result in the development of new interventions and best practices for Alzheimer’s and dementia care that can be shared with the greater research community.

Informed, Evidence-Based Decision-Making

NIA awarded the IMPACT grant to Brown University and Hebrew SeniorLife on Sept. 1, 2019. By Sept. 6, Mitchell and Mor had announced they were seeking letters of intent for pilot projects to test the implementation of interventions embedded with at least 2 providers (physician offices, nursing homes, day centers, etc.).

“Within one month we had selected 17 letters of intent from around the country to proceed to full proposals,” says Mor. “We will select 4 or 5 of these by the end of January 2020 and each investigator will implement the intervention within their health care system partners over the next year or more. This process will be repeated for each of the next 4 years, when we expect to be funding 8-10 pilots.”

After the pilot trials are accepted, IMPACT will actively guide and support the proposal development process. This support will come from cores specializing in statistics and research design, data management, regulatory and ethical issues, outcomes measurement, and engagement with stakeholders and health care system partners, followed by how to disseminate findings and get the intervention embedded into the daily operations of the health care systems. “Thus, this is a very activist approach to funding and supporting these pilot projects,” says Mor.

IMPACT screen grab

Success, he notes, will be achieved when positive results from pilot trials will make the health care system want to deploy them more broadly, and in a manner that makes it possible to more rigorously evaluate their impacts on the lives of PLWD and their caregivers, as well as the impacts to the operations and performance of the health care system. The ultimate sign of success will be when the feasibility of an intervention is confirmed by the health care system and implemented across the system as a new, effective approach to care for those with Alzheimer’s disease.

Mor stresses that the IMPACT Collaboratory is very excited to work with, and learn from, senior living communities. IMPACT researchers are counting on representatives from these communities to share their experiences from the front line regarding key issues and approaches, and what works and what doesn’t.

“One of our core groups is charged with identifying and cultivating health care systems, including senior living communities, to engage them as potential sites where these kinds of studies can be done cooperatively,” says Mor. “Communities often have challenges that some evidence-based programs can help solve, if they can be modified in such a way that they are acceptable to the community.”

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.”

Mark Crawford is a writer who lives in Madison, WI.