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 .     

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 .     

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 .     

Pragmatic Trials in Long-Term Care: Research Challenges and Potential Solutions in Relation to Key Areas of Care

As a method of research, pragmatic trials are recommended so as to generate results that are applicable to real-world care. This intent is especially important for the millions of older adults who receive long-term care in thousands of nursing homes and assisted living communities across the country—and many millions more around the globe. This article presents key points raised by experts participating in a conference funded by the National Institute of Aging held at the 2021 conference of the Society for Post-Acute and Long-term Care Medicine. The purpose of the conference was to convene leading clinicians, researchers, and industry partners to address special considerations of pragmatic trials in long-term care. Cross-cutting and unique challenges and solutions to conducting pragmatic trials were discussed focusing on 3 areas of clinical relevance to long-term care: (1) functional care and outcomes, (2) psychosocial care and quality of life, and (3) medical care and outcomes, with a special focus on persons with dementia. Challenges and innovative solutions were organized across the 9 domains of the revised Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) Tool, and future research recommendations for pragmatic trials in long-term care were identified.     

Supporting the delivery of cost-effective interventions in primary health-care systems in low-income and middle-income countries: an overview of systematic reviews

Strengthening health systems is a key challenge to improving the delivery of cost-effective interventions in primary health care and achieving the vision of the Alma-Ata Declaration. Effective governance, financial and delivery arrangements within health systems, and effective implementation strategies are needed urgently in low-income and middle-income countries. This overview summarises the evidence from systematic reviews of health systems arrangements and implementation strategies, with a particular focus on evidence relevant to primary health care in such settings. Although evidence is sparse, there are several promising health systems arrangements and implementation strategies for strengthening primary health care. However, their introduction must be accompanied by rigorous evaluations. The evidence base needs urgently to be strengthened, synthesised, and taken into account in policy and practice, particularly for the benefit of those who have been excluded from the health care advances of recent decades.     

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 .     

Diabetes translation research: where are we and where do we want to be?

Translation research transforms currently available knowledge into useful measures for everyday clinical and public health practice. We review the progress in diabetes translation research and identify future challenges and opportunities in this field. Several promising interventions to optimize implementation of efficacious diabetes treatments are available. Many of these interventions, singly or in combination, need to be more formally tested in larger randomized or quasi-experimental practical trials using outcomes of special interest to patients (for example, patient satisfaction and quality of life) and policymakers (for example, cost and cost-effectiveness). The long-term outcomes (such as morbidity, mortality, quality of life, and costs) of strategies aimed at improving diabetes care must be assessed. Translation research also needs to incorporate ways of studying complex systems of care. The challenges and opportunities offered by translation research are tremendous.     

Preparing for pragmatic trials in dementia care: Health equity considerations for nonpharmacological interventions

Inequities with regard to brain health, economic costs, and the evidence base for dementia care continue. Achieving health equity in dementia care requires rigorous efforts that ensure disproportionately affected populations participate fully in—and benefit from—clinical research. Embedding-proven interventions under real-world conditions and within existing healthcare systems have the potential to examine the effectiveness of an intervention, improve dementia care, and leverage the use of existing resources. Developing embedded pragmatic controlled trials (ePCT) research designs for nonpharmacological dementia care interventions involves a plethora of a priori assumptions and decisions. Although frameworks exist to determine whether interventions are “ready” for ePCT, there is no heuristic to assess health equity-readiness. We discuss health equity considerations, case examples, and research strategies across ePCT study domains of evidence, risk, and alignment. Future discussions regarding health equity considerations across other domains are needed.     

Statistical Considerations for Embedded Pragmatic Clinical Trials in People Living with Dementia

There is overwhelming need for nonpharmacological interventions to improve the health and well-being of people living with dementia (PLWD). The National Institute on Aging Imbedded Pragmatic Alzheimer's Disease (AD) and AD-Related Dementias Clinical Trials (IMPACT) Collaboratory supports clinical trials of such interventions embedded in healthcare systems. The embedded pragmatic clinical trial (ePCT) is ideally suited to testing the effectiveness of complex interventions in vulnerable populations at the point of care. These trials, however, are complex to conduct and interpret, and face challenges in efficiency (i.e., statistical power) and reproducibility. In addition, trials conducted among PLWD present specific statistical challenges, including difficulty in outcomes ascertainment from PLWD, necessitating reliance on reports by caregivers, and heterogeneity in measurements across different settings or populations. These and other challenges undercut the reliability of measurement, the feasibility of capturing outcomes using pragmatic designs, and the ability to validly estimate interventions' effectiveness in real-world settings. To address these challenges, the IMPACT Collaboratory has convened a Design and Statistics Core, the goals of which are: to support the design and conduct of ePCTs directed toward PLWD and their caregivers; to develop guidance for conducting embedded trials in this population; and to educate quantitative and clinical scientists in the design, conduct, and analysis of these trials. In this article, we discuss some of the contemporary methodological challenges in this area and develop a set of research priorities the Design and Statistics Core will undertake to meet these goals. J Am Geriatr Soc 68:S68–S73, 2020 .     

Strategies for promoting adherence to antiretroviral therapy: A review of the literature

The success of antiretroviral therapy (ART) for HIV infection, though widespread and resounding, has been limited by inadequate adherence to its unforgiving regimens, especially over the long term. This article summarizes the literature on behavioral interventions to promote ART adherence and highlights some of the most recent and innovative research on patient education and case management, modified directly observed therapy, contingency management, interventions emphasizing social support, and novel technologies to promote awareness. Research in the area of adherence in pediatric HIV infection and in resource-constrained international settings also is considered. Although adherence interventions have been successful in experimental trials, they may not be feasible or adaptable given the constraints of real-world clinics and community-based settings. Implementation and dissemination of adherence interventions needs increased attention as ART adherence research moves beyond its first decade. We conclude with suggestions for incorporating research findings into clinical practice.     

The Mixed Evidence for Brief Intervention in Emergency Departments,Trauma Care Centers,and Inpatient Hospital Settings: What Should We Do?

Background: This qualitative review is based on a symposia presented at the 2009 annual conference of the Research Society on Alcoholism (Baird et al., 2009; Field et al., 2009; Monti et al., 2009; Saitz et al., 2009a). The purpose is to describe the mixed evidence supporting brief interventions in the emergency department, trauma care, and in‐patient medical care settings; examine potential moderators of treatment outcome in light of the mixed evidence; and identify methods to move the research and practice of brief interventions beyond their current state. Methods: By drawing upon existing reviews and selected individual studies, we provide examples that reflect the current complexity of research in this area and propose steps for advancing the field. Results: Emergency departments, inpatient hospital settings, and trauma care settings represent three unique contexts within which brief interventions have been tested. While the general efficacy of brief alcohol interventions in these settings has been recognized, the evidence is increasingly mixed. Recent studies investigating potential moderators of treatment outcomes suggest that a more sophisticated approach to evaluating the effectiveness of brief interventions across varying patient populations is needed to further understand its effectiveness. Conclusions: Current dissemination efforts represent a significant advance in broadening the base of treatment for alcohol problems by providing an evidence‐based intervention in health care settings and should not be curtailed. However, additional research is required to enhance treatment outcomes, refine current practice guidelines, and continue to bridge the gap between science and practice. Given the current state of research, a multisetting clinical trial is recommended to account for potential contextual differences while controlling for study design.     

Prospects and pitfalls: use of the RAI-HC assessment by the Department of Veterans Affairs for home care clients

PURPOSE: The U.S. Department of Veterans Affairs has adopted two functional assessment systems that guide care planning: one for nursing home residents (the Resident Assessment Instrument [RAI]) and a compatible one for home care clients (RAI-HC). The purpose of this article is to describe the RAI-HC (often referred to as the Minimum Data Set-Home Care or MDS-HC) and its uses and offer lessons learned from implementation experiences in other settings. DESIGN AND METHODS: We reviewed implementation challenges associated both with the RAI and the RAI-HC in the United States, Canada, and other adopter countries, and drew on these to suggest lessons for the Department of Veterans Affairs as well as other entities implementing the RAI-HC. RESULTS: Beyond its clinical utility, there are a number of evidence-based uses for the assessment system. The resident-level data can be aggregated and analyzed, and scales identify clinical conditions and risk for various types of negative outcomes. In addition, the data can be used for other programmatic and research purposes, such as determining eligibility, setting payment rates for contract care, and evaluating clinical interventions. At the same time, there are a number of implementation challenges the Department of Veterans Affairs and other organizations may face. IMPLICATIONS: Policy makers and program managers in any setting, including state long-term-care programs, who wish to implement an assessment system must anticipate and address a variety of implementation problems with a clear and consistent message from key leadership, adequate training and clinical support for assessors, and appropriate planning and resources for data systems.     

Dying patients in the intensive care unit: forgoing treatment, maintaining care

End-of-life care of patients in the intensive care unit (ICU) often requires dramatic shifts in attitudes and interventions, from traditional intensive rescue care to intensive palliative care. The care of patients dying in ICUs raises both clinical and ethical difficulties. Because fewer ICU patients are able to make decisions about withdrawing treatment, careful attention must be paid to previously expressed preferences and surrogate input. Cultural and spiritual values of patients and families may differ markedly from those of clinicians. Although prognostic models are increasingly able to predict mortality rates for groups of ICU patients, their usefulness in guiding specific decisions to forego treatment has not been established. When a decision to forego treatment is made, the focus should be on specifying the patient's goals of care and assessing all treatments in light of these goals; interventions that do not contribute to the patient's goals should be discontinued. Symptoms accompanying withdrawal of life support can almost always be controlled with appropriate palliative measures. After ICU interventions are foregone, patient comfort must be the paramount objective. Whether in the ICU or elsewhere, hospitals have an ethical obligation to provide settings that offer dignified, compassionate, and skilled care.     

Protecting seriously ill populations during pragmatic clinical trials

Pragmatic clinical trials (PCTs) emphasize real-world effectiveness methodology to address the limitations of results from explanatory randomized clinical trials (RCTs), which often fail to translate to real-world medical practice. An inherent tension in the conduct of PCTs is that the research must impose a minimal burden on patients and health care institutions. PCTs prioritize outcome measures from existing data sources to minimize data collection burden; however, a lack of patient-reported outcomes may result in gaps in safety for vulnerable populations, such as those with serious illnesses. One proposed standard for judging the readiness of a study for a pragmatic trial is a ranking system that assigns PCTs a lower rank if they impose additional data collection burdens. However, this results in the wide use of measures of health care utilization and costs while patient experience measures, which could capture adverse unintended consequences, are omitted. In this article, we make the case for a risk-based approach to imposing additional data collection in PCTs to capture potential safety and patient experience outcomes, using examples from “real life” implemented interventions to improve end-of-life care through the Liverpool Pathway and through the implementation of Physician Orders for Life Sustaining Treatment (POLST) in Oregon.     

Family Work in a Long-Term Care Setting

ABSTRACT

Following placement of a relative in a nursing home, many family members maintain an active caregiving role. Families are often an invisible force in long-term care settings. Although they do not live or work inside the facility, their influence on resident and staff functioning is profound. Psychologists working in long-term care settings are frequently asked to intervene around issues involving family members. Understanding the interactive nature of problems both within and between the resident, the family, the staff, and the larger community facilitates the development of successful psychological interventions.

This article presents the psychologist's use of a systemic approach in guiding interventions with families of long-term care residents. Common concerns are reviewed, including family members' adjustment to long-term care placement and the challenges between families and staff. Case examples are used to illustrate these concerns and challenges. The use of a systemic model in family work in long-term care settings is described, and then illustrated with a case example. This case is presented to highlight the interactive nature of problems that can arise between staff and families, the impact of these problems on resident care, as well as the utility of systemic conceptualization in guiding family interventions in long-term care settings.     

Alcohol screening and brief intervention: dissemination strategies for medical practice and public health

This paper introduces the concept of risky drinking and considers the potential of alcohol screening and brief intervention (SBI) to reduce alcohol-related problems in medical practice and in organized systems of health care. The research evidence behind this approach is reviewed. Potential strategies for the dissemination of SBI to systems of health care are then discussed within the context of a public health model of clinical preventive services. There is an emerging consensus that SBI should be promoted in general healthcare settings, but further research is needed to determine the best ways to achieve widespread dissemination. In an attempt to provide an integrative model that is relevant to SBI, dissemination strategies are discussed for three target groups: (1) individual patients and practitioners; (2) health care settings and health systems; and (3) the communities and the general population. Dissemination strategies are considered from the fields of social change, social science, commercial marketing and education in terms of their potential for translating SBI innovations into routine clinical practice. One overarching strategy implicit in the approaches reviewed in this article is to embed alcohol SBI in the more general context of preventive health services, the utility of which is becoming increasingly recognized as a critical supplement to more traditional clinical medicine.     

Usual care as the control group in clinical trials of nonpharmacologic interventions

We discuss the pros and cons of including usual care as a control arm in clinical trials of nonpharmacologic interventions. Usual care is a term used to describe the full spectrum of patient care practices in which clinicians have the opportunity (which is not necessarily seized) to individualize care. The decision to use usual care as the control arm should be based on the nature of the research question and the uniformity of usual-care practices. The use of a usual-care arm in a two-arm trial should be considered for trials of investigational drugs or devices, for trials that propose to test interventions that lie well outside usual-care practices, or for trials where the research question per se is to compare a strategy against usual care. Examples of the latter include pragmatic effectiveness trials of clinical pathways or protocolized-care versus usual-care practices. Randomized intervention trials can be safely conducted and monitored using two treatments that lie within the range of usual-care practices if both approaches are considered prudent and good care for the target population.     

Brief alcohol intervention—where to from here? Challenges remain for research and practice

Brief intervention (BI) is intended as an early intervention for non‐treatment‐seeking, non‐alcohol‐dependent, hazardous and harmful drinkers. This text provides a brief summary of key BI research findings from the last three decades and discusses a number of knowledge gaps that need to be addressed. Five areas are described: patient intervention efficacy and effectiveness; barriers to BI implementation by health professionals; individual‐level factors that impact on BI implementation; organization‐level factors that impact on BI implementation; and society‐level factors that impact on BI implementation. BI research has focused largely upon the individual patient and health professional levels, with the main focus upon primary health care research, and studies are lacking in other settings. However, research must, to a larger degree, take into account the organizational and wider context in which BI occurs, as well as interaction between factors at different levels, in order to advance the understanding of how wider implementation of BI can be achieved in various settings and how different population groups can be reached. It is also important to expand BI research beyond its current parameters to investigate more ambitious long‐term educational programmes and new organizational models. More widespread implementation of BI will require many different interventions (efforts, actions, initiatives, etc.) at different interlinked levels, from implementation interventions targeting individual health professionals' knowledge, skills, attitudes and behaviours concerning alcohol issues, BI and behaviour change counselling to efforts at the organizational and societal levels that influence the conditions for delivering BI as part of routine health care.