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The NIA IMPACT Collaboratory: History, impact, challenges, and the future of conducting ePCTs to improve dementia care

2024; Wiley; Volume: 72; Issue: 5 Linguagem: Inglês

10.1111/jgs.18803

1532-5415

Jill Harrison, Susan L. Mitchell, Ellen P. McCarthy, Vincent Mor,

Palliative Care and End-of-Life Issues

In recognition of the 50th anniversary of the National Institute on Aging (NIA), we commemorate the NIA's response to the charge from Congress to identify effective and comprehensive programs to meet the urgent and complex public health needs of Americans impacted by Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD), a group of irreversible and progressive brain disorders that destroy a person's memory and thinking skills. Currently, more than 6 million people in the United States are living with ADRD.1 By 2050, 13 million Americans are projected to live with the disease, overwhelming care partners and healthcare systems, and costing the nation nearly $1 trillion dollars.1 People living with dementia (PLWD) are at high risk of receiving uncoordinated and poor-quality care, ultimately leading to adverse health outcomes, poor quality of life, and misuse of resources.1-3 Given the challenges with detection and diagnosis, intersecting with health disparities, the proportion of Americans impacted by AD/ADRD is likely undercounted and underreported.4 Still, according to the Centers for Disease Control and Prevention, while deaths from other common diseases, such as heart disease and cancer, have declined, deaths from AD/ADRD are increasing in every race, sex, and ethnicity category.4 The Alzheimer's Association reports that one in every three older adults dies with a diagnosis of AD/ADRD in the United States.1 Until recently, advances in AD/ADRD were disproportionate to the magnitude of this growing public health crisis. For example, the majority of drug trials for AD/ADRD do not show positive results,5 and the adoption of promising non-drug interventions into routine clinical practice has been stymied by the lack of research evaluating their effectiveness when implemented under real-world conditions in busy everyday healthcare systems (HCS).3 Embedded pragmatic clinical trials (ePCTs) of non-drug interventions have the potential to generate high-quality evidence to inform decisions about dementia care interventions that are effective in the real world by connecting what have traditionally been two siloed worlds, scientific research and actual healthcare delivery. We commend the NIA for emphasizing ePCTs of non-pharmacological approaches in HCS as part of a multi-faceted national strategy to rethink clinical trials and advance progress in dementia care. In 2012, the National Institutes of Health (NIH) invested in infrastructure via the NIH Pragmatic Trials Collaboratory to strengthen the national capacity to conduct ePCTs in partnership with HCS.3 Leveraging this foundation and lessons learned from a 2017 NIA conference on the "State of the Science for Pragmatic Trials of Non-Pharmacological Interventions for Persons with Dementia,"6 which concluded that conducting ePCTs with PLWD and their CPs had special considerations that merited a focused and coordinated initiative, the NIA announced a request for applications for a dementia-focused Collaboratory.3 This resulted in a cooperative agreement (U54) of the National Institute on Aging (NIA) IMbedded Pragmatic Alzheimer's disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory.3 The mission of IMPACT is to build the nation's capacity to conduct ePCTs of interventions for PLWD and their CPs.3 Unlike traditional clinical trials that typically test interventions in well-controlled, ideal environments, and conditions, ePCTs are designed to inform clinical and policy-level decisions by testing whether an intervention actually works when it is embedded into everyday healthcare settings under, often messy, real-world conditions. As such, ePCTs to improve dementia care have unique challenges. For example, investigators must develop competencies in brokering relationships with collaborating HCS. With the methodology of ePCTs still evolving, investigators must learn how to prioritize scientific rigor and health equity, while balancing complex issues related to design, ethics, implementation, and the pragmatic assessment of clinical outcomes. IMPACT's resources fill these important training and knowledge gaps. The first Collaboratory of its kind to focus solely on dementia, the IMPACT Collaboratory achieves its mission by supporting the conduct of ePCTs, developing and disseminating knowledge, building investigator capacity, and catalyzing partnerships. Since its inception in 2019, IMPACT's goal has been to build the field of ePCTs to improve dementia care. In its first 5 years, it has done so by establishing and operationalizing a robust national infrastructure that has funded 30 project and 24 training grants through national competitions created an innovative scientific consultation program for investigators by experts from its Scientific Cores,7 developed robust training opportunities and resources,8 established real world data infrastructures,9 and integrated health equity10 throughout all its activities and funded science. IMPACT's accomplishments in these areas are summarized in Figure 1. Transforming dementia care using ePCTs, a new and developing field for researchers, is a social enterprise that requires a shared vision and tremendous coordination. IMPACT is the only national infrastructure of its kind to bring together HCS, researchers, community partners, funders, and regulators to transform the delivery, quality, and outcomes of care provided to Americans living with dementia and their CPs by accelerating the testing and adoption of evidence-based non-drug dementia care interventions using ePCTs within HCS. The NIA's vision to fund a dementia-focused Collaboratory to address the urgent needs of PLWD and their CPs is leading to innovation in the field of ePCTs to improve dementia care and will undoubtedly be part of the NIA legacy to advance population health for Americans. Jill Harrison is the lead author. The additional authors contributed equally. The authors have no conflicts. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. This work was supported by the National Institute on Aging (NIA) of the National Institutes of Health under Award Number U54AG063546, which funds NIA Imbedded Pragmatic Alzheimer's Disease and AD-Related Dementias Clinical Trials Collaboratory (NIA IMPACT Collaboratory).