Dissemination and Implementation of Evidence-Based Dementia Care Using Embedded Pragmatic Trials

There are many nonpharmacologic interventions tested in randomized clinical trials that demonstrate significant benefits for people living with Alzheimer's disease (AD) and AD-related dementia, their care partners, or professional care providers. Nevertheless, with few exceptions, proven interventions have not been translated for delivery in real-world settings, such as home care, primary care, hospitals, community-based services, adult day services, assisted living, nursing homes, or other healthcare systems (HCSs). Using embedded pragmatic clinical trial (ePCT) methods is one approach that can facilitate dissemination and implementation (D&I) of dementia care interventions. The science of D&I can inform the integration of evidence-based dementia care in HCSs by offering theoretical frameworks that capture field complexities and guiding evaluation of implementation processes. Also, D&I science can suggest evidence-based strategies for implementing dementia care in HCSs. Although D&I considerations can inform each stage of dementia care intervention development, it is particularly critical when designing ePCTs. This article examines fundamental considerations for implementing dementia-specific interventions in HCSs and how best to prepare for successful dissemination upstream in the context of ePCTs, thereby illustrating the critical role of the D&I Core of the National Institute on Aging Imbedded Pragmatic Alzheimer's Disease and AD-Related Dementias Clinical Trials Collaboratory. The scientific premise of the D&I Core is that having the “end” in mind, upfront in the design and testing of dementia care programs, can lead to decision-making that optimizes the ultimate goal of wide-scale D&I of evidence-based dementia care programs in HCSs. J Am Geriatr Soc 68:S28–S36, 2020 .     

Embedded Pragmatic Trials in Dementia Care: Realizing the Vision of the NIA IMPACT Collaboratory

Close to 6 million Americans have Alzheimer's disease (AD) or Alzheimer's disease and related dementia (AD/ADRD). These high-need, high-cost patients are vulnerable to receiving poor quality uncoordinated care, ultimately leading to adverse health outcomes, poor quality of life, and misuse of resources. Improving the care of persons living with dementia (PLWD) and their caregivers is an urgent public health challenge that must be informed by high-quality evidence. Although prior research has elucidated opportunities to improve AD/ADRD care, the adoption of promising interventions has been stymied by the lack of research evaluating their effectiveness when implemented under real-world conditions. Embedded pragmatic clinical trials (ePCTs) in healthcare systems have the potential to accelerate the translation of evidence-based interventions into clinical practice. Building from the foundation of the National Institutes of Healthcare Systems Collaboratory, in September 2019 the National Institute on Aging Imbedded Pragmatic AD/ADRD Clinical Trials (IMPACT) Collaboratory was launched. Its mission is to build the nation's capacity to conduct ePCTs within healthcare systems for PLWD and their caregivers by (1) developing and disseminating best practice research methods, (2) supporting the design and conduct of ePCTs including pilot studies, (3) building investigator capacity through training and knowledge generation, (4) catalyzing collaboration among stakeholders, and (5) ensuring the research includes culturally tailored interventions for people from diverse backgrounds. This report presents the rationale, structure, key activities, and markers of success for the overall NIA IMPACT Collaboratory. The articles that follow in this special Issue describe the specific work of its 10 core working groups and teams. J Am Geriatr Soc 68:S1–S7, 2020 .     

Using Healthcare Data in Embedded Pragmatic Clinical Trials among People Living with Dementia and Their Caregivers: State of the Art

Embedded pragmatic clinical trials (ePCTs) are embedded in healthcare systems as well as their data environments. For people living with dementia (PLWD), settings of care can be different from the general population and involve additional people whose information is also important. The ePCT designs have the opportunity to leverage data that becomes available through the normal delivery of care. They may be particularly valuable in Alzheimer's disease and Alzheimer's disease-related dementia (AD/ADRD), given the complexity of case identification and the diversity of care settings. Grounded in the objectives of the Data and Technical Core of the newly established National Institute on Aging Imbedded Pragmatic Alzheimer's Disease and AD-Related Dementias Clinical Trials Collaboratory (IMPACT Collaboratory), this article summarizes the state of the art in using existing data sources (eg, Medicare claims, electronic health records) in AD/ADRD ePCTs and approaches to integrating them in real-world settings. J Am Geriatr Soc 68:S49–S54, 2020 .     

Achieving Health Equity in Embedded Pragmatic Trials for People Living with Dementia and Their Family Caregivers

Embedded pragmatic clinical trials (ePCTs) advance research on Alzheimer's disease/Alzheimer's disease and related dementias (AD/ADRD) in real-world contexts; however, health equity issues have not yet been fully considered, assessed, or integrated into ePCT designs. Health disparity populations may not be well represented in ePCTs without special efforts to identify and successfully recruit sites of care that serve larger numbers of these populations. The National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer's disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory's Health Equity Team will contribute to the overall mission of the collaboratory by developing and implementing strategies to address health equity in the conduct of ePCTs and ensure the collaboratory is a national resource for all Americans with dementia. As a first step toward meeting these goals, this article reviews what is currently known about the inclusion of health disparities populations of people living with dementia (PLWD) and their caregivers in ePCTs, highlights unique challenges related to health equity in the conduct of ePCTs, and suggests priority areas in the design and implementation of ePCTs to increase the awareness and avoidance of pitfalls that may perpetuate and magnify healthcare disparities. J Am Geriatr Soc 68:S8–S13, 2020 .     

Latino Caregivers of Relatives with Alzheimer's Disease

Abstract

This review of the literature discusses the experience of Latinos who provide care to a family member with Alzheimer's Disease and Related Disorders (ADRD). This discussion is imperative in light of the present demographic changes and in light of current findings suggesting that the risk for dementia is significantly higher for Hispanic elderly. All studies reviewed reported that the ADRD Latino caregiver is most likely to be a female caring for her parents or her parents-in-law. Despite the relatively low availability of informal support and the high levels of depression among ADRD Latino caregivers, most studies reported that ADRD Latino caregivers underutilize formal services. The major implications of the present review are that a heterogeneous perspective of the Latino community should be adopted by taking into consideration within group differences. In addition, systematic study of outreach and therapeutic interventions aimed specifically towards ADRD Latino caregivers is recommended.     

Alzheimer's Disease: Individuals,Dyads, Communities,and Costs

Alzheimer's disease and related dementias (ADRD) affect over 5 million Americans. Over a typical disease course of 5–10 years, family caregivers provide the majority of the day‐to‐day hands‐on on care for persons with dementia. Most caregivers enter this complex role with little training and inadequate household resources and they are tasked to navigate a fragmented health care system as well as a patchwork of community services. Our nation can and should do more to help family caregivers provide care in the home to their loved ones who suffer from dementia. We will all benefit if we design and implement a better system of care for persons with dementia. We will benefit financially as a nation, we will benefit morally as a community, and in case we have forgotten, we stand to benefit ourselves as we age and face our own aging brain. Building a system of care requires excellent science and engineering, but we also need creative approaches that design systems of care that are available nationwide because they are scalable and affordable. Most importantly, families need our help now. We need to move faster.     

Program design and evaluation strategies for the Special Projects of National Significance Outreach Initiative

Through its Targeted HIV Outreach and Intervention Model Development (Outreach Initiative), the Health Resources and Services Administration's Special Projects of National Significance (SPNS) program funded ten demonstration sites to implement and evaluate strategies to engage and retain underserved populations living with HIV/AIDS (PLWHA) in HIV primary medical care. The 10 sites were located in urban areas across the United States. Target populations were women, youth, people of color, and people with histories of incarceration, substance use, homelessness, or mental illness. Program interventions included outreach, motivational interventions, case management, and other ancillary services to connect and sustain people in HIV medical care. To evaluate outcomes from this initiative, a multisite study consisting of client interviews administered at 6-month intervals, documentation of program contacts, and medical chart abstractions of CD4 and viral load values and HIV primary care visits was conducted. This paper describes the study design and methods used to implement and evaluate this large multisite initiative. Strengths and limitations of the study design are discussed.     

Engaging Stakeholders in the Design and Conduct of Embedded Pragmatic Clinical Trials for Alzheimer’s Disease and Alzheimer’s Disease–Related Dementias

Embedded pragmatic clinical trials (ePCTs) of nondrug interventions for Alzheimer’s disease and Alzheimer’s disease–related dementias (AD/ADRD) are conducted in real-world clinical settings and designed to generate an evidence base to inform clinical and policy decisions about care for this vulnerable population. The ePCTs exist within a complex ecosystem of relationships between researchers, payors, policymakers, healthcare systems, direct care staff, advocacy groups, families, caregivers, and people living with dementia (PLWD). Because the rapid increase of the number of Americans with AD/ADRD outpaces curative treatments, there is an urgent need to mobilize the power of these relationships to improve dementia care and address a mounting public health crisis. Stakeholder engagement in ePCTs is essential to generate research questions, establish the relevancy of trials to the intended end users, and understand the factors that influence dissemination and implementation in real-world clinical settings. The process of including stakeholders in ePCTs for dementia is similar to stakeholder engagement in ePCTs for other diseases and conditions; however, the unique nature of embedded research, prevalence of caregiver and provider burden, and the progressive worsening of cognitive impairment in PLWD must be approached with additional strategies. This article presents key considerations of stakeholder engagement for ePCTs in AD/ADRD and main activities of the stakeholder engagement team in the National Institute on Aging IMPACT Collaboratory to move the field forward. J Am Geriatr Soc 68:S62–S67, 2020 .     

Transforming Dementia Care Through Pragmatic Clinical Trials Embedded in Learning Healthcare Systems

The current evidence base for testing nonpharmacological interventions for people living with dementia (PLWD) and their caregivers is limited, especially within care settings such as ambulatory care, assisted living communities, nursing homes, hospitals, and hospices. There has been even less attention to translation of effective interventions for PLWD into delivery of care. Thus, there is an urgent need for researchers to partner with these care settings, especially those that follow a learning healthcare systems (LHSs) model, and vice versa to conduct embedded pragmatic clinical trials (ePCTs). These trials are conducted within sites that offer routine care and are designed to answer important, relevant clinical questions and leverage existing electronic health and administrative data. ePCTs set in LHSs create a unique opportunity for researchers, healthcare providers, and PLWD and their families to work and learn together as potentially effective interventions are studied and stress tested in real-world situations. Healthcare settings that embrace research or quality improvement as part of a culture of continuous learning are ideal settings for ePCTs. In this article, we summarize what we have learned from the National Institutes of Health's Health Care Systems Research Collaboratory–funded ePCTs, discuss challenges of ePCTs within settings that serve PLWD, and describe the work of the Health Care Systems Core within the National Institute on Aging's IMbedded Alzheimer's Disease and Related Dementias Clinical Trials Collaboratory that will occur over the next 5 years. J Am Geriatr Soc 68:S43–S48, 2020 .     

Associations of sex,Alzheimer's disease and related dementias,and days alive and at home among older Medicare beneficiaries recovering from hip fracture

Background

Males constitute 25% of older adults who experience hip fractures in the United States; a concerning upward trend given poorer health and outcomes among male survivors. Male sex is associated with worse cognitive performance after hip fracture, impacting participation in rehabilitation and long-term outcomes especially for those with Alzheimer's disease or related dementias (ADRD). However, little research has evaluated whether sex differences in post-fracture recovery are greater among those living with ADRD.

Methods

Data were drawn from 2010 to 2017 Medicare fee-for-service beneficiaries aged 65 years and older who survived hospitalization for hip fracture (n = 69,581). The primary outcome was days alive and at home (DAAH), a validated patient-centered claims-based outcome calculated as 365 days from fracture minus days in hospital, nursing home, rehabilitation facility, emergency department, or time after death. Multivariable Poisson regressions with an interaction term between sex and ADRD status were to model the association between DAAH and ADRD in the 12 months post hip fracture, adjusting for demographics, injury severity, chronic disease burden, and hospital-level fixed effects.

Results

Compared to females, males were younger and had more comorbidities at the time of fracture. Among survivors, males with ADRD spent a mean of 160.7 DAAH compared to 228.4 for males without ADRD, 177.8 for females with ADRD, and 248.0 for females without ADRD. In adjusted analyses, males without ADRD spent 8.2% fewer DAAH compared to females (rate ratio [RR] = 0.92, 95% CI 0.92–0.92). This relative sex difference increased significantly when comparing those living with ADRD, with males spending an additional 3.3% fewer DAAH (interaction RR = 0.96, 95% CI 0.96–0.97).

Conclusions

Males spend fewer DAAH after hip fracture than females, and this difference increases modestly for males living with ADRD compared to females. This suggests that cognitive impairment may be a small but significant contributor to sex-based differences observed during hip fracture recovery.     

Career development in pragmatic clinical trials to improve care for people living with dementia

The growing number of people living with dementia (PLWD) requires a coordinated clinical response to deliver pragmatic, evidence-based interventions in frontline care settings. However, infrastructure to support such a response is lacking. Moreover, there are too few researchers conducting rigorous embedded pragmatic clinical trials (ePCTs) to make the vision of high quality, widely accessible dementia care a reality. National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer's disease and Related Dementias Clinical Trials (IMPACT) Collaboratory seeks to improve the pipeline of early career researchers qualified to lead ePCTs by funding career development awards. Even with support from the Collaboratory, awardees face practical and methodological challenges to success, recently exacerbated by the COVID-19 pandemic. We first describe the training opportunities and support network for the IMPACT CDA recipients. This report then describes the unique career development challenges faced by early-career researchers involved in ePCTs for dementia care. Topics addressed include challenges in establishing a laboratory, academic promotion, mentoring and professional development, and work-life balance. Concrete suggestions to address these challenges are offered for early-career investigators, their mentors, and their supporting institutions. While some of these challenges are faced by researchers in other fields, this report seeks to provide a roadmap for expanding the work of the IMPACT Collaboratory and initiating future efforts to recruit, train, and retain talented early-career researchers involved in ePCTs for dementia care.     

Optimizing coding and reimbursement to improve management of Alzheimer's disease and related dementias

The objectives of this study were to review the diagnostic, International Classification of Disease, 9th Revision, Clinical Modification (ICD-9-CM), diagnosis related groups (DRGs), and common procedural terminology (CPT) coding and reimbursement issues (including Medicare Part B reimbursement for physicians) encountered in caring for patients with Alzheimer's disease and related dementias (ADRD); to review the implications of these policies for the long-term clinical management of the patient with ADRD; and to provide recommendations for promoting appropriate recognition and reimbursement for clinical services provided to ADRD patients. Relevant English-language articles identified from MEDLINE about ADRD prevalence estimates; disease morbidity and mortality; diagnostic coding practices for ADRD; and Medicare, Medicaid, and managed care organization data on diagnostic coding and reimbursement were reviewed. Alzheimer's disease (AD) is grossly undercoded. Few AD cases are recognized at an early stage. Only 13% of a group of patients receiving the AD therapy donepezil had AD as the primary diagnosis, and AD is rarely included as a primary or secondary DRG diagnosis when the condition precipitating admission to the hospital is caused by AD. In addition, AD is often not mentioned on death certificates, although it may be the proximate cause of death. There is only one ICD-9-CM code for AD-331.0-and no clinical modification codes, despite numerous complications that can be directly attributed to AD. Medicare carriers consider ICD-9 codes for senile dementia (290 series) to be mental health codes and pay them at a lower rate than medical codes. DRG coding is biased against recognition of ADRD as an acute, admitting diagnosis. The CPT code system is an impediment to quality of care for ADRD patients because the complex, time-intensive services ADRD patients require are not adequately, if at all, reimbursed. Also, physicians treating significant numbers of AD patients are at greater risk of audit if they submit a high frequency of complex codes. AD is grossly undercoded in acute hospital and outpatient care settings because of failure to diagnose, limitations of the coding system, and reimbursement issues. Such undercoding leads to a lack of recognition of the effect of AD and its complications on clinical care and impedes the development of better care management. We recommend continuing physician education on the importance of early diagnosis and care management of AD and its documentation through appropriate coding, expansion of the current ICD-9-CM codes for AD, more appropriate use of DRG coding for ADRD, recognition of the need for time-intensive services by ADRD patients that result in a higher frequency of use of complex CPT codes, and reimbursement for CPT codes that cover ADRD care management services.     

The relative effect of Alzheimer's disease and related dementias, disability, and comorbidities on cost of care for elderly persons

OBJECTIVES: Our primary objectives were (a) to determine the relative impact of Alzheimer's disease and related dementias (ADRD), disability, and common comorbid health conditions on the cost of caring for community-dwelling elderly person and (b) to determine whether ADRD serves as an effect modifier for the effect of disability and common comorbidities on costs. METHODS: Participants were drawn from community respondents to the 1994 National Long Term Care Survey. The authors compared total cost of caring for persons without ADRD with that of those who had moderate and severe ADRD. Using regression analysis, the author identified the adjusted effect of ADRD, limitations in activities of daily living (ADLs), and common comorbidities on total costs. RESULTS: Persons with severe ADRD had higher median total costs ($10,234) than did persons with moderate ADRD ($4,318) and those without ADRD ($2,268, p <.001). However, disability measured by ADL limitations was a more important predictor of total cost than was ADRD status in both stratified and multivariate analyses. Comorbidities such as heart attack, stroke, and chronic obstructive pulmonary disease also increased costs. Severe ADRD was an effect modifier for ADL limitations, increasing the positive impact of disability on total costs among persons with severe ADRD, but not for comorbidities. DISCUSSION: Disability, severe ADRD, and comorbidity all had independent effects that increased total costs. Thus, any risk adjustment procedure should account for disability and comorbidity and not just ADRD status.     

Models, Strategies, and Tools

This paper presents a case for careful consideration of theory in planning to implement evidence-based practices into clinical care. As described, theory should be tightly linked to strategic planning through careful choice or creation of an implementation framework. Strategies should be linked to specific interventions and/or intervention components to be implemented, and the choice of tools should match the interventions and overall strategy, linking back to the original theory and framework. The thesis advanced is that in most studies where there is an attempt to implement planned change in clinical processes, theory is used loosely. An example of linking theory to intervention design is presented from a Mental Health Quality Enhancement Research Initiative effort to increase appropriate use of antipsychotic medication among patients with schizophrenia in the Veterans Health Administration.     

Pragmatic Trials in Long-Term Care: Implementation and Dissemination Challenges and Opportunities

Randomized controlled trials are considered the most rigorous research design in efficacy and effectiveness research; however, such trials present numerous challenges that limit their applicability in real-world settings. As a consequence, pragmatic trials are increasingly viewed as a research design that overcomes some of these barriers with the potential to produce findings that are more reproducible. Although pragmatic methodology in long-term care is receiving increasing attention as an approach to improve successful dissemination and implementation, pragmatic trials present complexities of their own. To address these complexities and related issues, experts with experience conducting pragmatic trials, developing nursing home policy, participating in advocacy efforts, and providing clinical care in long-term care settings participated in a virtual consensus conference funded by the National Institute on Aging in Spring 2021. Participants identified 4 cross-cutting principles key to dissemination and implementation of pragmatic trial interventions: (1) stakeholder engagement, (2) diversity and inclusion, (3) organizational strain and readiness, and (4) learn from adaptations. Participants emphasized that implementation processes must be grounded in the perspectives of the people who will ultimately be responsible for implementing the intervention once it is proven to be effective. In addition, messaging must speak to long-term care staff and all others who have a stake in its outcomes. Although our understanding of dissemination and implementation strategies remains underdeveloped, this article is designed to guide long-term care researchers and community providers who are increasingly aware of the need for pragmatism in disseminating and implementing evidence-based care interventions.     

Models,strategies, and tools

This paper presents a case for careful consideration of theory in planning to implement evidence-based practices into clinical care. As described, theory should be tightly linked to strategic planning through careful choice or creation of an implementation framework. Strategies should be linked to specific interventions and/or intervention components to be implemented, and the choice of tools should match the interventions and overall strategy, linking back to the original theory and framework. The thesis advanced is that in most studies where there is an attempt to implement planned change in clinical processes, theory is used loosely. An example of linking theory to intervention design is presented from a Mental Health Quality Enhancement Research Initiative effort to increase appropriate use of antipsychotic medication among patients with schizophrenia in the Veterans Health Administration.     

Critical Workforce Gaps in Dementia Education and Training

The US Department of Health and Human Services and the Foundation for the National Institutes of Health, through private sector support, sponsored the National Research Summit on Dementia Care: Building Evidence for Services and Supports (Summit) in 2017. Various workgroups were asked to address topics of interest in dementia care and develop recommendations addressing the goals of the Summit. Workforce education and training was identified to be a key issue. As a result, a Workforce Development Workgroup (the Workgroup) was created and addressed two of the Summitʼs goals. The first goal is to improve the quality of care and support provided to persons living with dementia and those who care for them. The second goal is to accelerate the development, evaluation, translation, implementation, and scaling-up of evidence-based and evidence-informed services for persons living with dementia, their families, and caregivers. In this article, the Workgroup identified gaps in educating and training a dementia-capable workforce. The Workgroup consisted of an interprofessional team with expertise in dementia workforce development from academia, professional organizations, and the federal government. Four recommendations are presented concerning research topics that will advance the education and training of a dementia-capable workforce, which includes health professions students, faculty, practitioners, direct care workers, persons living with dementia, and those who care for them. J Am Geriatr Soc 68:625–629, 2020     

Models, strategies, and tools. Theory in implementing evidence-based findings into health care practice

This paper presents a case for careful consideration of theory in planning to implement evidence-based practices into clinical care. As described, theory should be tightly linked to strategic planning through careful choice or creation of an implementation framework. Strategies should be linked to specific interventions and/or intervention components to be implemented, and the choice of tools should match the interventions and overall strategy, linking back to the original theory and framework. The thesis advanced is that in most studies where there is an attempt to implement planned change in clinical processes, theory is used loosely. An example of linking theory to intervention design is presented from a Mental Health Quality Enhancement Research Initiative effort to increase appropriate use of antipsychotic medication among patients with schizophrenia in the Veterans Health Administration.     

Training the Workforce to Conduct Embedded Pragmatic Clinical Trials to Improve Care for People Living with Dementia and Their Caregivers

The National Institute on Aging IM bedded P ragmatic A lzheimer's Disease and Alzheimer's Disease–Related Dementias C linical T rials (IMPACT) Collaboratory serves as a national resource for the conduct of embedded pragmatic clinical trials to improve the care of people living with dementia (PLWD) in partnership with the healthcare systems that serve them. Inherent in this objective is the need to train and support a cadre of investigators prepared to conduct this work now and in the future. The Training Core of the IMPACT Collaboratory supports the training of investigators to become experts in this field through three objectives: (1) curricula development and dissemination; (2) network generation and navigation; and (3) a career development award program. The innovative approach of the Training Core will require developing content and providing training experiences that recognize the unique challenges of research at the intersection of health systems, pragmatic trials, and PLWD and their caregivers. Ultimately, we seek to build the nation's capacity to conduct research that bridges the gaps between efficacy studies to effectiveness research to implementation science. Although foundational resources in the methods of each of these areas are already available, few actually focus on pragmatic trials embedded within healthcare systems that focus on PLWD. To bring new interventions for PLWD from efficacy to widespread implementation, researchers must build diffusability, adaptability, heterogeneity, and scalability into the design of the intervention. In achieving these objectives, the Training Core will utilize the network of investigators, institutions, and stakeholders represented in the IMPACT Collaboratory. J Am Geriatr Soc 68:S21–S27, 2020 .     

Digital Health Approaches for the Assessment and Optimisation of Hypertension Care Provision

Although many aspects of our lives have been transformed by digital innovation, widespread adoption of digital health advancements within the health care sector in general, and for hypertension care specifically, has been limited. However, it is likely that, over the next decade, material increases in the uptake of digital health innovations for hypertension care delivery will be seen. In this narrative review, we summarise those innovations thought to have the greatest chance for impact in the next decade. These include provision of virtual care combined with home blood pressure (BP) telemonitoring, use of digital registries and protocolised care, leveraging continuous BP measurement to collect vast amounts of individual and population-based BP data, and adoption of digital therapeutics to provide low-cost scalable interventions for patients with or at risk for hypertension. Of these, home BP telemonitoring is likely the most ready for implementation, but it needs to be done in a way that enables efficient guideline-concordant care in a cost-effective manner. In addition, efforts must be focused on implementing digital health solutions in a manner that addresses the major challenges to digital adoption. This entails ensuring that innovations are accessible, usable, secure, validated, evidence based, cost-effective, and integrated into the electronic systems that are already used by patients or providers. Increasing the use of broader digital innovations such as artificial/augmented intelligence, data analytics, and interactive voice response is also critically important. The digital revolution holds substantial promise, but success will depend on the ability of collaborative stakeholders to adopt and implement innovative, usable solutions.