SUMMARY¹

Throughout the United States and around the world, millions of people are living with dementia, with impacts on their health and quality of life, on their families, and on society. The signs and symptoms of dementia can be a significant source of fear and distress for persons living with dementia, and many desire support in leading meaningful and rewarding lives, maintaining independence and agency, enjoying activities of interest, maintaining social relationships with others, and being connected to familiar environments and communities. To live well with dementia, people need care, services, and supports that reflect their values and preferences, build on their strengths and abilities, promote well-being, and address needs that evolve as cognitive impairment deepens. First may come support for decision making and engagement in pleasurable activities; followed by more extensive support in basic activities of daily living, such as eating and bathing; and potentially then by complete supportive care.

Persons living with dementia co-manage their care with or rely on the support of a wide range of care partners² and caregivers, including

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¹ This Summary does not include references. Citations for the discussion presented in this Summary appear in the subsequent report chapters.

² “Care partner” is a term that refers to someone—often a family member, friend, neighbor, or group of individuals—with whom a person living with mild cognitive impairment (MCI) or early-stage dementia has a reciprocal relationship in co-managing the demands of MCI/dementia in such ways as providing emotional support and participating in decision making. Care partners may or may not live with the person or be involved in the provision of hands-on assistance with daily activities as a caregiver. Some persons living with MCI or dementia prefer the term “care partner” as it acknowledges the reciprocal contributions of and the partnership between both individuals.

spouses, other family members and friends, and direct care workers in homes or residential care settings, with the intensity of co-management changing over time. Those who provide care often experience positive aspects of caregiving, including a deeper appreciation for life, satisfaction with living according to one’s values and sense of duty, and strengthening of their relationship with the person living with dementia. At the same time, however, caregivers also face higher risks to their physical and mental health, family conflict, social isolation, and negative consequences for their finances and jobs. Together, persons living with dementia and their care partners and caregivers need supports and services to help them live in a rewarding way.

Significant progress has been made in dementia care, services, and supports since the 1970s, when late-life dementia was not widely recognized as the consequence of a disease; diagnosis and treatment received little attention in the health care system; and care for persons living with dementia was largely considered a private family matter or, as a last resort, provided by state welfare systems in asylums and “old age homes.” This progress is reflected in a rapidly expanding body of research; the 2011 National Alzheimer’s Project Act; and the establishment of National Research Summits on Care, Services, and Supports for Persons with Dementia and Their Caregivers. Unfortunately, while there are places where persons living with dementia are receiving high-quality care, services, and supports, many lack access and are struggling and unable to live as well as they might. One study found that 99 percent of persons living with dementia living in the community and 97 percent of caregivers had at least one unmet need; the average number of unmet needs was 7.7 and 4.6, respectively, for persons living with dementia and caregivers. Deep and persistent inequities also characterize the care, services, and supports available to persons from disadvantaged groups, especially racial and ethnic minorities.

To help address this long-standing and deeply urgent need to better support persons living with dementia and their care partners and caregivers, there is a corresponding urgent need for evidence to guide effective action. In this context, the National Institute on Aging (NIA) requested that the National Academies of Sciences, Engineering, and Medicine convene an ad hoc committee of experts to assist NIA and the broader Alzheimer’s disease and Alzheimer’s disease–related dementias (AD/ADRD) community in assessing the body of evidence on care interventions for persons living with dementia and caregivers, inform decision making about which interventions should be broadly disseminated and implemented, and guide future actions and research.

ASSESSING THE STATE OF THE EVIDENCE

The body of evidence on care interventions, services, and supports (referred to here collectively as interventions for the sake of brevity) for persons living with dementia and their care partners and caregivers is large and complex. These interventions can be implemented at multiple levels—from individuals and families, to the community, to policy, to society—and delivered in diverse settings. Persons living with dementia and their care partners and caregivers are as diverse as the overall population, representing different ages, genders, races, ethnicities, sexual orientations, gender identities, and disabilities. In addition to the changes in needs that result from the progression of cognitive impairment, dementia care interventions themselves are often complex—they involve multiple components addressing aspects of daily life, health, planning and decision making, and relationships, and they interact with each other and with the context and system in which they are implemented. Hundreds of care interventions have been tested in randomized controlled trials (RCTs). While some interventions have been tested in large RCTs and are beginning to be implemented more broadly in various communities, many more have been tested only in academic settings with smaller numbers of participants. Thus, it is challenging to assess the current state of the evidence and understand what is effective, for whom, and under what circumstances.

In accordance with the study charge, the committee’s primary source of evidence was a systematic review of the available RCT evidence on care interventions for persons living with dementia and their care partners and caregivers commissioned and overseen by the Agency for Healthcare Research and Quality (AHRQ) and conducted by the Minnesota Evidence-based Practice Center. The committee also considered additional evidence and stakeholder input, including perspectives from persons living with dementia, care partners, and caregivers, as described later in this summary.

The AHRQ systematic review provides a thorough review of available RCT evidence on care interventions for persons living with dementia and their care partners and caregivers. The literature search conducted for the AHRQ review also included prospective studies with concurrent comparator arms and interrupted time series with at least three measures both pre- and postintervention, but no such studies met the review criteria, and therefore these studies did not contribute to the review analysis. The AHRQ review is the product of a systematic and extensive effort to survey the body of literature and summarize the state of the evidence; it used clear criteria for including and excluding studies; it sheds light on the question of whether any interventions are supported by such conclusive and consistent evidence as to be immediately recommended for broad use

without qualification or further study; and it provides a helpful overview of the evidence landscape.

It is important to emphasize that the AHRQ systematic review was designed specifically to inform the question of which interventions, if any, are ready for broad dissemination and implementation, and the AHRQ systematic review authors made decisions through this lens that inform the interpretation of the review findings and conclusions. The AHRQ systematic review excluded studies judged to be in Stages 0–II of the National Institutes of Health Stage Model for Behavioral Intervention Development (small-sample or pilot studies) and those judged to have high risk of bias.³ Stages 0–II describe early-stage research that has not yet included testing of interventions in real-world settings. Excluding studies that have small sample sizes or high risk of bias is standard in systematic reviews. However, the exclusion of the heterogeneous category of pilots is important to interpreting the systematic review findings. While many pilots are small and preliminary, the review also excluded some studies that are described by the study authors as pilots although they used relatively large sample sizes (i.e., hundreds of participants), and in some cases were conducted in the community with longer follow-up times. Had the review targeted specific interventions in more depth and included research-setting efficacy studies without applying the lens of readiness for dissemination and implementation, the analysis and conclusions might have looked different. Because these pilot studies were not analyzed in the systematic review, it is unknown what portion of them could potentially be informative for efficacy and what portion would be excluded because of sample size or quality concerns.

The committee concluded that the evidence needed to inform decisions about policy and the implementation of specific interventions broadly—including prioritization of the many interventions that could be helpful but require resources—is limited. The AHRQ systematic review and this committee’s analysis highlight limitations of the existing research base that can be addressed, such as a lack of diversity among study participants, underpowered and limited-duration studies, heterogeneity of outcome measures that precludes aggregation of results, lack of reporting on contextual factors that may facilitate or impede the effectiveness of interventions, and research that is divorced from practical implementation needs. Over time,

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³ Of the 627 unique studies eligible for analysis, 409 were excluded because they had small sample sizes or were pilots, and an additional 218 were assessed as having high risk of bias. Recognizing the challenges of conducting research in this area, the AHRQ systematic review authors set the sample size criterion generously: studies were excluded only if they had fewer than 10 participants per arm. Similarly, the review authors characterize their approach to assessing risk of bias as “generous, relative to how risk of bias is assessed in more targeted systematic review topics.” For example, studies were assessed as having high risk of bias due to attrition only if attrition was greater than 40 percent.

standards for research are becoming more rigorous, but this progress is not yet fully reflected in the overall body of literature assessed in the AHRQ systematic review.

The inherent complexity of this area of study—including the importance of assessing interventions that target communities, policy, and society in addition to those that target individuals and families directly—also presents challenges to the evaluation of interventions and limited the AHRQ systematic review with respect to drawing conclusions. Mixed results observed across RCTs may reflect heterogeneity among enrolled populations, settings, or other contextual factors. Reflecting the wide range of needs, values, preferences, and desires of persons living with dementia, many interventions in this domain appropriately begin from the premise of individualization. It is to be expected that the effectiveness of interventions will vary across different populations and settings. Furthermore, many factors beyond effectiveness that are critical for successful implementation, such as integration into workflow, may vary across settings, but these differences may be obscured as results are synthesized in a broad-scope systematic review. Thus, it is currently impossible to determine through a high-level systematic review whether an intervention is ineffective, whether it is effective but only for some people or in certain settings, or whether only some of its elements are effective.

Consistent with its charge, the committee relied heavily on the findings from the AHRQ systematic review. That review identified no interventions that met its criteria for high-strength or moderate evidence of benefit and just two types of interventions supported by low-strength evidence of benefit: (1) collaborative care models, which use multidisciplinary teams that integrate medical and psychosocial approaches to the care of persons living with dementia; and (2) a multicomponent intervention aimed at supporting family caregivers known as REACH (Resources for Enhancing Alzheimer’s Caregiver Health) II, along with associated adaptations.

The findings of the AHRQ systematic review with regard to intervention effectiveness were used to identify the above two types of interventions as potentially ready for broad dissemination and implementation. In addition to effectiveness, however, many factors need to be considered in determining whether broad implementation of an intervention is appropriate. To inform the development of its recommendations on these two types of interventions, the committee applied the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision (EtD) framework to the interventions identified by the systematic review as being supported by low-strength evidence of benefit. Factors taken into account in this framework include the priority of the problem, how substantial the benefits and harms of the intervention are, the certainty of the evidence, the value of the outcomes to stakeholders, how the intervention

compares with others, resource requirements, cost-effectiveness relative to comparable options, the impact on health equity, the acceptability of the intervention to stakeholders, and the feasibility of implementation. Information for the application of this framework was culled from studies of various adaptations and implementations of the two types of intervention. The AHRQ review authors rated some of these implementation studies as having high risk of bias and excluded others because they used methodologies that failed to meet the review’s inclusion criteria, such as studies with a single pre–posttest. Nevertheless, these studies provide such information as feasibility, equity, and resources required, which is important for making decisions about implementation in the real world. The committee identified these additional studies by reference mining the studies that met the AHRQ review inclusion criteria, reviewing studies mentioned in the AHRQ review that did not meet the inclusion criteria, conducting PubMed and hand searches, and reviewing the Best Practice Caregiving database and Center for Medicare & Medicaid Innovation evaluations of dementia care interventions.

Taken together, these studies provide a rich source of evidence beyond the outcomes on which the AHRQ review was able to draw conclusions. Thus, without negating the AHRQ review’s conclusions regarding the low strength of evidence or the uncertainties that prevented the review from reaching conclusions on many outcomes, the committee deemed that compiling the comprehensive set of available evidence on effectiveness could be informative for those considering implementing these two types of interventions in a range of settings.

Finally, to inform its conclusions about gaps in the current evidence base and opportunities for moving forward, the committee considered input and information beyond that included in the AHRQ systematic review. A systematic review is necessarily limited to existing literature, and therefore reflects past research priorities. In particular, the perspectives of persons living with dementia, care partners, and caregivers have historically not been central in guiding research. Recognizing the importance of changing this situation, the committee sought to identify opportunities to expand the evidence base for interventions deemed important by persons living with dementia, care partners, and caregivers. The committee also considered other expert and stakeholder input presented during a public workshop and such resources as the Best Practice Caregiving database, which aided in the identification of types of interventions already being implemented in real-world practice settings but for which the AHRQ systematic review found insufficient evidence of effectiveness.

MOVING TOWARD BETTER DEMENTIA CARE, SERVICES, AND SUPPORTS

The charge to this committee was to examine the available evidence on specific interventions for providing dementia care, services, and supports to inform policy, institutional/community decisions about broadly implementing interventions, and prioritization of the many interventions that could be helpful but require resources that are limited. Unfortunately, the evidence to inform this task is lacking. This does not mean, however, that fundamental principles or core components of dementia care, services, and supports are called into question. Rather, it points to the need for additional research to fill gaps in information about specific interventions. In the interim, organizations, agencies, communities, and individuals can use the guiding principles in Box S-1 and the core components of care in Box S-2 to guide their actions toward improving dementia care, services, and supports. Given the critical need for improvements in the current situation, access to care, services, and supports that followed these principles and included these components would represent a significant advance for persons living with dementia and their care partners and caregivers.

Furthermore, there are many activities, such as listening to music and dancing, that provide pleasure for many people living with or without dementia and likely have little potential harm apart from opportunity and financial costs. At an individual or family level, persons living with dementia and their care partners and caregivers may want to experiment with these types of activities, tailored to their personal interests and preferences, to see what works for them, knowing this may change as the condition progresses.

INTERVENTIONS READY FOR IMPLEMENTATION IN REAL-WORLD SETTINGS WITH MONITORING, EVALUATION, QUALITY IMPROVEMENT, AND INFORMATION SHARING

Together, the two types of interventions identified by the AHRQ systematic review as supported by low-strength evidence of benefit—collaborative care models and REACH II and associated adaptations—incorporate many, although not all, of the core components of care, services, and supports listed in Box S-2.

Collaborative Care Models

Collaborative care models use multidisciplinary teams to integrate medical and psychosocial approaches to the care of persons living with dementia. These programs—such as ACCESS, Dementia Care Management,

Care Ecosystem, and the Indiana University/Purdue University Model—have multiple common components, including coordination of psychosocial interventions, medical management, and other services through a care manager; the development of care plans; case tracking; and collaboration with care providers. Aggregating results across collaborative care interventions to draw conclusions regarding particular outcomes, the AHRQ systematic review found sufficient evidence to support conclusions of low-strength evidence that collaborative care models are effective for three outcomes for persons living with dementia: (1) quality of life, (2) quality indicators,

and (3) emergency room visits. In addition to the outcomes for which the AHRQ systematic review found low-strength evidence of benefit, both the systematic review and original study authors identified evidence of benefit for other outcomes in individual studies, including decreasing neuropsychiatric symptoms and nursing home placement for persons living with dementia, and reducing caregiver strain and depression. The evidence was not sufficient to warrant reaching conclusions on effectiveness for these outcomes, generally because of inconsistent findings across studies.

A Multicomponent Intervention for Family Caregivers: REACH II and Adaptations

REACH II is a multicomponent intervention that provides support for family care partners/caregivers through a combination of strategies that include problem solving, skills training, stress management, support groups, provision of information and education, and role playing. It has

been adapted for different populations and for delivery in different settings across the United States and elsewhere, including Germany and Hong Kong.

The AHRQ systematic review found that there is low-strength evidence that REACH II and its adaptations reduce caregiver depression. Although the available evidence was insufficient to draw a conclusion, the systematic review also identified a reduction in caregiver strain. Additional studies of adaptations of REACH II that did not meet the AHRQ review inclusion criteria illustrate trends in benefits on a wide range of other outcomes, including challenging behaviors of persons living with dementia, caregiver frustration or bother, and physical symptoms of psychiatric conditions. Studies of adaptations of REACH II also found improvements in self-reported social support, self-reported caregiver health, caregiver reactions to challenging behaviors, positive aspects of caregiving, and safety of persons living with dementia. Although the AHRQ systematic review did not find sufficient evidence to support conclusions about these outcomes, the trends of benefit across many outcomes in these implementation and adaptation studies complement the AHRQ systematic review findings.

Recommendations

Collaborative care models and REACH II and its adaptations have demonstrated some effectiveness under clinical trial conditions. Both—but especially REACH II and its adaptations—are already being implemented in a variety of community settings with promising results. Of particular note, REACH II has been studied in and adapted for diverse populations to a greater extent than is usual in the field. The original trial studied the intervention in a study population that was one-third Black or African American, one-third white or Caucasian, and one-third Hispanic or Latino, although it did not include Asian participants. Later adaptation studies have also been conducted with racially and ethnically diverse study populations, with linguistic and cultural adaptations, and with low-income participants and communities. A moderate amount of evidence is available with respect to intervention acceptability, feasibility, and resource requirements. Collaborative care models and REACH II and its adaptations are ready for the next stage of field testing to support their widespread adoption in and adaptation to the variety of settings where people seek care, and to enhance understanding and information dissemination regarding key factors beyond effectiveness that are important for determining whether and how to implement such an intervention.

The state of the evidence base for these two intervention types as assessed by the AHRQ review complicates making recommendations for a path forward. The AHRQ finding of low-strength evidence of effectiveness suggests limited confidence in the effectiveness of these interventions

and indicates that additional evidence is likely to change the estimate of effect. Nevertheless, the committee recommends a path forward based on the following argument. First, given the inherent challenges of studying this topic—including the complexity of dementia care interventions, the diversity of populations affected, and the importance of contextual effects—the fact that these two interventions produced low-strength evidence of effectiveness is important. Second, there is a notable trend in benefits across multiple outcomes beyond those for which the AHRQ review was able to draw a conclusion, and the consistency of evidence of benefit across sources of evidence is encouraging. Third, there is a moderate amount of evidence to inform implementation as assessed against the EtD criteria. Particularly important, these interventions have been studied in diverse populations, although additional evidence is needed to expand understanding of their use in all populations.

Taken together, these considerations led the committee to conclude that the evidence is sufficient to justify implementation of these two types of interventions in a broad spectrum of community settings, with evaluation conducted to continue expanding the evidence base to inform future implementation. The committee believes that this approach to expanding the evidence base is likely to bring greater gains and better inform real-world implementation relative to focusing on additional large RCTs aimed at generating moderate- or high-strength evidence in a future systematic review before any further dissemination can be supported.

It is important to stress that these recommendations should not be taken to imply that these are the only two types of interventions that should be pursued. As discussed next, additional research on a full range of interventions should be undertaken to continue to innovate and develop better ways of meeting the urgent needs of persons living with dementia and their care partners and caregivers.

THE STATE OF THE EVIDENCE FOR OTHER DEMENTIA CARE INTERVENTIONS: GAPS AND OPPORTUNITIES

Beyond the two types of interventions discussed above that met the AHRQ systematic review’s criteria for low-strength evidence of benefit, the review found insufficient evidence to support conclusions about benefit for all other interventions. Importantly, a finding of insufficient evidence does not necessarily mean that an intervention is ineffective, but rather reflects high uncertainty given the limitations of the evidence base and of the approach used in the AHRQ systematic review to synthesize the existing evidence and assess its strength to support conclusions on readiness for broad dissemination and implementation. As described above, the limitations of the existing evidence base are due in part to the inherent complexity of this area of study, but some of these limitations can be addressed.

The evidence base for dementia care interventions appears biased toward those targeting the individual level. The gap in the evidence base for interventions targeting the community, policy, or societal level—such as organization, financing, and delivery processes—may result from the way researchers define interventions and the challenges of studying these latter kinds of interventions with rigor, which may necessitate expanded or alternative approaches to studying and assessing evidence.

In addition, there remain significant gaps in the evidence base for many individual-level interventions evaluated in the AHRQ systematic review, some of which have been identified by persons living with dementia, care partners, and caregivers as important to their health and well-being, such

as respite care, social support, late-stage care, and training and support for direct care workers. There is a lack of evidence as well regarding the effectiveness of dementia care interventions in diverse populations, such as specific racial/ethnic groups; LGBTQ populations; people with significant comorbidities; people of low socioeconomic status; and those from low-resource areas, such as rural and tribal populations. Variation in the experiences and circumstances of persons living with dementia and their care partners and caregivers may also have implications for the perceived value of interventions, the fidelity of implementation, and intervention effectiveness that need to be better understood. Consequently, the applicability of the existing evidence base to the full range of persons living with dementia, care partners, and caregivers is not supported, even for those interventions showing promise in clinical trials.

Finally, the evidence for some intervention categories—such as exercise, music, psychosocial interventions, and cognitive interventions—is insufficient to support conclusions on their readiness for broad dissemination and implementation despite a signal of benefit. Signal of benefit was determined based on the observation of benefit for a given outcome in multiple independent RCTs evaluating the same (or a similar) intervention, even if the overall body of evidence was mixed for that outcome (i.e., one or more RCTs found no benefit for that outcome). As a result of heterogeneity in study populations, intervention implementation, and measured outcomes, little is known regarding which interventions are likely to be effective for persons living with dementia experiencing different stages of disease progression and their care partners and caregivers, and how they should be optimally implemented.

A BLUEPRINT FOR FUTURE RESEARCH

To strengthen the evidence base by addressing the limitations described above, the committee offers a blueprint for future research. This blueprint includes methodological improvements aimed at limitations frequently found in the current evidence base—such as underpowered and limited-duration studies, and heterogeneity of outcome measures that precludes aggregation across studies—as well as approaches that can supplement the quantitative measures in RCTs to advance understanding in the face of the complexity of dementia care interventions and the systems in which they operate. To ensure that research is representative, generalizable across populations, and person-centered, the committee stresses the importance of prioritizing inclusive research and incorporating the priorities of persons living with dementia, care partners, and caregivers throughout the study process. Finally, the committee emphasizes the need to expand the focus on community- and policy-level interventions and to conduct research aimed at assessing key factors in determining real-world effectiveness.

To address the long-standing and urgent need to better support persons living with dementia and their care partners and caregivers in living as well as possible, there continues to be an urgent need to build a more robust and useful evidence base. Studying dementia care interventions is challenging and complex, and the body of evidence is complicated to interpret. Two types of interventions are supported by sufficient evidence for implementation in real-world settings with evaluation to continue to expand the evidence base. These interventions are practical instantiations of many of the core components of care, supports, and services discussed above, which are needed to promote the well-being of persons living with dementia and their care partners and caregivers. Given current major deficits in the care, services, and supports that are available now, providing these interventions to those who could benefit would be a step forward. Yet, this is not a final answer. It is important that research continue to develop and evaluate other potentially promising interventions, many of which have demonstrated some signal of benefit. The committee’s recommendations provide a path forward for building a more robust and useful evidence base by employing cutting-edge methods that are rigorous, most informative for this domain, inclusive, and equitable, and can yield information critical for real-world implementation. These exciting approaches can be implemented throughout this field, including by early-career researchers and others who want to harness new approaches to make a difference in addressing this critical societal need and better supporting persons living with dementia and their care partners and caregivers in living as well as possible.

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