(Video) In this Grand Rounds, Monica Taljaard, PhD, focuses on the use of stepped wedge design in cluster randomized trials (SW-CRT). SW-CRT is a novel research design embraced by clinical researchers. It is unique from conventional parallel arm CRTs in that all clusters receive the intervention. The three main types of SW-CRT designs are presented, along with common justifications for employing these designs and their implications.

(Video) In this Grand Rounds, Jason Karlawish, MD, discusses waivers and alterations of written informed consent in pragmatic clinical trials, focusing on regulatory criteria addressing acceptable levels of research risk, the practicability of conducting the research with vs without informed consent, and efforts to respect the rights and welfare of people living with dementia.

(External Resource) Inclusion of patients in research activities has increased in the United States, but no guidelines for inclusion of individuals with cognitive impairment exist. The experiences from the Persons Living with Dementia (PLWD) Stakeholder Group that formed to support the first National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers provided a test of feasibility of this type of participation for a major research meeting and an opportunity to understand specific contributions of the Group.

In this podcast, IMPACT Collaboratory PI Vince Mor, PhD, continues the Grand Rounds discussion with Monica Taljaard, PhD, about stepped wedge cluster randomized trials.

(Video) In this special Grand Rounds, three experts in dementia care and pragmatic clinical trials--David Grabowski, PhD, Susan Mitchell, MD, MPH, and Vince Mor, MD--provide an update on how COVID-19 is impacting nursing homes and share preliminary data for research related to COVID-19.

(Video) The National Institute on Aging (NIA) has awarded a five-year grant expected to total $53.4 million to Brown University and Boston-based Hebrew SeniorLife (HSL) to lead a nationwide effort to improve health care and quality of life for people living with Alzheimer’s disease and related dementias, as well as their caregivers.

(Article) 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.

(Article) 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, they 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.

(Article) In this report, the Regulation and Ethics Core of the IMPACT Collaboratory discusses key ethical and regulatory challenges for ePCTs in PLWD. A central thesis is that researchers should strive to anticipate and address these challenges early in the design of their ePCTs as a means of both ensuring compliance and advancing science.

(Article) 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 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.

(Article) This article describes approaches to stakeholder engagement in ePCTs for AD/ADRD. It begins with an overview of the origins of stakeholder engagement in research and its emerging evidence base in ePCTs, then describes how current frameworks for stakeholder engagement are underspecified and must be adapted for use in AD/ADRD. The authors detail the unique considerations and complexities of stakeholder engagement in ePCTs for AD/ADRD and conclude with what they consider to be important stakeholder groups, engagement processes for ePCTs on AD/ADRD, and the approach to stakeholder engagement to be used by the IMPACT Collaboratory.

(External Resource) A stakeholder group for people living with dementia (PLWD) was convened to support the work of a major US dementia research meeting. The objectives of this examination are to present the steps used to implement the Group and guidance for both PLWD and researchers for partnering on research conference planning and participation.

(Video) In this Grand Rounds, Laura Hanson, MD, MPH, and Sheryl Zimmerman, PhD, discuss the unique challenges in the use of patient and caregiver reported outcomes (PCROs) in Alzheimer’s Disease (AD) and AD Related Dementias (AD/ADRD) ePCTs. The PCRO Core aims to encourage the use of outcome assessments that are clearly matched to the priorities and lived experience of PLWD and their caregivers and are appropriate for use in ePCTs. This presentation will describe person and caregiver-centered outcome measurement in AD/ADRD ePCTs, give an overview of how outcomes are mapped to care domains, and highlight the methodological challenges present in AD/ADRD and pragmatic research.

(Slides) In this Grand Rounds, Jason Karlawish, MD, discusses waivers and alterations of written informed consent in pragmatic clinical trials, focusing on regulatory criteria addressing acceptable levels of research risk, the practicability of conducting the research with vs without informed consent, and efforts to respect the rights and welfare of people living with dementia.

(Slides) In this Grand Rounds, Ellen McCreedy, PhD, MPH, uses a case example to describe how a pilot can be used to test the adequacy of existing data for evaluating an ePCT outcome. Dr. McCreedy also describes a potentially efficient ePCT design that accommodates under-detection in existing data while maintaining large-scale implementation and evaluation.