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Grand Rounds 1: Are You Ready for a Pragmatic Trial? The RAPT Model and Implementation Considerations (Video)11/21/2019Grand Rounds/Webinars
(Video) This Grand Rounds webinar focuses on using the Readiness Assessment for Pragmatic Trials (RAPT) model to assess an intervention’s readiness for an embedded pragmatic clinical trial (ePCT). RAPT includes nine domains that reflect a range of considerations regarding the feasibility of successfully employing pragmatic methods and the prospect of an intervention’s widespread adoption, if proven effective. Researchers using RAPT to evaluate an intervention are asked to qualitatively assess each domain from low to high readiness and can use the results to inform team discussion about when and how to proceed with an ePCT. In this session, we describe the model’s creation, domains, and scoring criteria, and then provide an example of its application to iterative phases of a pragmatic study.
Grand Rounds 2: Stepped Wedge Cluster Randomized Trials: What, How, And When? (Video)12/19/2019Grand Rounds/Webinars
(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.
Grand Rounds 3: Using a Pilot to Test and Refine Your Measurement Strategy (Video)1/23/2020Grand Rounds/Webinars
(Video) 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.
Grand Rounds 4: Modifications and waivers of informed consent in pragmatic clinical trials (Video)2/20/2020Grand Rounds/Webinars
(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.
Readiness assessment for pragmatic trials (RAPT): a model to assess the readiness of an intervention for testing in a pragmatic trial7/18/2019Publications/Articles
(External Resource) Pragmatic randomized, controlled trials (PCTs) test the effectiveness of interventions implemented in routine clinical practice. Because PCT findings are generalizable, this approach is gaining momentum among interventionists and funding agencies seeking to accelerate the testing and adoption of evidence-based strategies to improve care and outcomes. Particular attention is being paid to non-pharmacological interventions, which are often complex and may be difficult to uniformly implement across multiple sites. While many such non-pharmacological interventions have proven efficacious in small trials, most have not been widely adopted. PCTs could accelerate effectiveness testing and adoption, yet there are no established criteria to identify interventions ready for testing in a PCT.
Contributions of Persons Living With Dementia to Scientific Research Meetings. Results From the National Research Summit on Care, Services, and Supports for Persons With Dementia and Their Caregivers.10/28/2019Publications/Articles
(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.
Podcast 1: Continuing the discussion of the RAPT Model12/10/2019Podcasts
In this podcast, IMPACT Collaboratory PI Susan Mitchell, MD, MPH, continues the Grand Rounds discussion with Rosa Baier, MPH, and Eric Jutkoqitz, PhD, about the RAPT Model and how it can help researchers determine a project’s readiness for a pragmatic trial.
Podcast 2: Continuing the conversation on stepped wedge cluster trials: what, how and when?1/6/2020Podcasts
In this podcast, IMPACT Collaboratory PI Vince Mor, PhD, continues the Grand Rounds discussion with Monica Taljaard, PhD, about stepped wedge cluster randomized trials.
Grand Rounds 5: Health equity as foundational to the design of pragmatic trials (Video)4/16/2020Grand Rounds/Webinars
(Video) In this Grand Rounds, Ana Quiñones, PhD, MS, and Jonathan Jackson, PhD, discuss health equity issues within ePCTs. Minoritized 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 Health Equity Team (HET) will contribute to the IMPACT Collaboratory's overall mission by developing and implementing strategies to address health equity in the conduct of ePCTs and ensure that the Collaboratory is a national resource for all Americans with dementia.
Special Grand Rounds: COVID-19 in Nursing Homes: Pragmatic Research Responses to the Crisis (Video)5/7/2020Grand Rounds/Webinars
(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.
Grand Rounds 6: Stakeholder Engagement in ePCTs for People Living with Dementia (Video)5/21/2020Grand Rounds/Webinars
(Video) In this Grand Rounds, Ellen Tambor, MA, discussed the unique considerations for engaging stakeholders in ePCTs for people living with dementia. Stakeholders including PLWD, family caregivers, direct care staff, clinicians, health system leaders, and payors must be strategically included in ePCTs for Alzheimer’s disease (AD) and AD Related Dementias (AD/ADRD) in order to ensure the success of trials embedded in everyday care settings and adoption of effective interventions. The overarching goal of the Stakeholder Engagement Team is to ensure robust stakeholder engagement throughout the IMPACT Collaboratory and the pilot projects it funds.
IMPACT on Alzheimer's (Video)9/10/2019Featured Videos
(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.
Embedded Pragmatic Trials in Dementia Care: Realizing the Vision of the NIA IMPACT Collaboratory6/26/2020Publications/Articles
(Article) An introductory article for the JAGS special issue, describing the mission and vision of the IMPACT Collaboratory, including articles from each of the 10 IMPACT Cores and Teams describing how they are working to improve the quality and effectiveness of ePCTs in PLWD and their care partners.
Achieving Health Equity in Embedded Pragmatic Trials for People Living with Dementia and Their Family Caregivers6/26/2020Publications/Articles
(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.
Building a National Program for Pilot Studies of Embedded Pragmatic Clinical Trials in Dementia Care6/26/2020Publications/Articles
(Article) The Pilot Core of the IMPACT Collaboratory seeks to provide funds for upward of 40 pilots for ePCTs to accelerate the testing of nonpharmacologic interventions with the goal that these pilots lead to full‐scale ePCTs and eventually the embedding of evidence‐based care into healthcare systems. The first two challenges for the Pilot Core in building the pilot study program were (1) to develop a transparent, ethical, and open nationwide process for soliciting, reviewing, and selecting pilot studies; and (2) to begin the process of describing the necessary components of a pilot study for an ePCT. During the initial funding cycle, the Core received 35 letters of intent, of which 17 were accepted for a full proposal and 14 were submitted. This process illustrated that investigators lack knowledge in ePCTs, many interventions lack readiness for an ePCT pilot study, and many proposed studies lack key pragmatic design elements. The Pilot Core therefore has set three key criteria that future pilot studies must meet at a minimum to be considered viable and discuss key design decisions investigators should consider in designing a pilot study for an ePCT.
Training the Workforce to Conduct Embedded Pragmatic Clinical Trials to Improve Care for People Living with Dementia and Their Caregivers6/26/2020Publications/Articles
(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.
Dissemination and Implementation of Evidence‐Based Dementia Care Using Embedded Pragmatic Trials6/26/2020Publications/Articles
(Article) This article examines fundamental considerations for implementing dementia‐specific interventions in Health Care Systems and how best to prepare for successful dissemination upstream in the context of ePCTs, thereby illustrating the critical role of the Dissemination and Implementation Core of the IMPACT 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.
Ethical and Regulatory Issues for Embedded Pragmatic Trials Involving People Living with Dementia6/26/2020Publications/Articles
(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.
Transforming Dementia Care Through Pragmatic Clinical Trials Embedded in Learning Healthcare Systems6/26/2020Publications/Articles
(Article) ePCTs set in Learning Healthcare Systems (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. This article summarizes what the authors learned from the NIH's Health Care Systems Research Collaboratory-funded ePCTs, discusses challenges of ePCTs within settings that serve PLWD, and describes the work of the Health Care Systems Core within the IMPACT Collaboratory.
Using Healthcare Data in Embedded Pragmatic Clinical Trials among People Living with Dementia and Their Caregivers: State of the Art6/26/2020Publications/Articles
(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.
Selecting Outcomes to Ensure Pragmatic Trials Are Relevant to People Living with Dementia6/26/2020Publications/Articles
(Article) The PCRO Core of the IMPACT Collaboratory will address key scientific challenges limiting outcome measurement, such as gaps in existing measures, methodologic constraints, and burdensome data capture. PCRO Core investigators will create a searchable library of AD/AD‐related dementias (ADRD) clinical outcome measures, including measures in existing data sources with potential for AD/ADRD ePCTs, and will support best practices in measure development, including pragmatic adaptation of PCROs. Working together with other Cores and Teams within the IMPACT Collaboratory, the PCRO Core will support investigators to select from existing outcome measures, and to innovate in methods for measurement and data capture. In the future, the work of the IMPACT Collaboratory may galvanize broader embedded use of outcomes that matter to PLWD and their care partners in large health systems.
Engaging Stakeholders in the Design and Conduct of Embedded Pragmatic Clinical Trials for Alzheimer’s Disease and Alzheimer’s Disease–Related Dementias6/26/2020Publications/Articles
(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.
Statistical Considerations for Embedded Pragmatic Clinical Trials in People Living with Dementia6/26/2020Publications/Articles
(Article) 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. This article discusses some of the contemporary methodological challenges in this area and develops a set of research priorities the Design and Statistics Core will undertake to meet these goals.
The Experiences of Persons Living with Dementia Planning for a Dementia Research Meeting. Lessons Learned From the National Research Summit on Care, Services, and Supports for Persons With Dementia and Their Caregivers4/28/2020Publications/Articles
(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.
Overview of the 2019 Pilot Awards RFA (Video)10/2/2019Grand Rounds/Webinars
(Video) This webinar describes the goals and requirements to submit a proposal for 2019 NIA IMPACT Collaboratory Pilot Awards.
Grand Rounds 7: Finding Pragmatic and Relevant Outcomes for AD/ADRD ePCTs (Video)6/18/2020Grand Rounds/Webinars
(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.
Special Grand Rounds: COVID-19 Among Older Persons in Health Care Systems: Pragmatic Responses to the Crisis (Video)6/11/2020Grand Rounds/Webinars
(Video) In this special Grand Rounds, Lew Lipsitz, MD, James Rudolph, MD, and Elizabeth While, PhD, ARPN, present on three ongoing projects to meet the unique challenges COVID-19 presents managing care of older persons.
Grand Rounds 4: Modifications and waivers of informed consent in pragmatic clinical trials (Slides)2/20/2020Grand Rounds/Webinars
(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.
Grand Rounds 2: Stepped Wedge Cluster Randomized Trials: What, How, And When? (Slides)12/19/2019Grand Rounds/Webinars
(Slides) 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.
Grand Rounds 3: Using a Pilot to Test and Refine Your Measurement Strategy (Slides)1/23/2020Grand Rounds/Webinars
(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.
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