The program will fund up to 2 Demonstration Projects, each providing up to $800,000 in total direct costs over a 24-month period. The awards will support full-scale embedded pragmatic clinical trials. Projects must evaluate the effectiveness of nonpharmacological interventions embedded within healthcare systems for people living with dementia and their care partners.
More than 5 million Americans are living with Alzheimer disease and related dementias. They are particularly vulnerable to receiving uncoordinated and poor-quality care, which contributes to adverse health outcomes and misuse of resources. The mission of the IMPACT Collaboratory is to advance care for persons with dementia and their caregivers in real-world settings by building national capacity to conduct pragmatic clinical trials that test interventions embedded in healthcare systems.
The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging.
In a survey of pragmatic clinical trials across 3 NIH research networks, the complexity of delivering nonpharmacological interventions was similar between pain-related trials and non–pain-related trials. However, pain trials tended to have more intervention components, add more new tasks, and require modifications to existing workflows.
The researchers surveyed study team members from trials in the NIH Pragmatic Trials Collaboratory, the IMPACT Collaboratory, and the Pain Management Collaboratory. All 3 programs support pragmatic clinical trials embedded in healthcare systems, including trials of nonpharmacological interventions for pain.
Though the trials examined in the study had similar intervention complexity, pain trials had slightly greater complexity overall, and the study teams for these trials reported needing to make more adaptations in workflows during the trial to improve the intervention’s fit or effectiveness in real-world settings.
“Change in workflow was an important consideration for intervention delivery for all trials in our study,” wrote lead author Lindsay Ballengee and her coauthors. “Future research should capture detailed, real-time information about the nature of intervention delivery complexity, adaptations, and implementation success to help improve delivery of nonpharmacologic pain interventions,” she wrote. Ballengee is a research fellow with the NIH Pragmatic Trials Collaboratory.
The NIA IMPACT Collaboratory, a program to advance pragmatic clinical trials of interventions for people living with dementia and their care partners, announced a new collection of statistical tools for researchers. The tools are available on a new Statistical Tools webpage that will be updated as new resources become available.
The program’s Design and Statistics Core developed the statistical tools and related resources to aid in the design and analyses of pragmatic trials embedded in healthcare systems. These methods, manuscripts, statistical programs, and interactive web applications are available to help researchers calculate sample sizes, intracluster correlations, and statistical power for stepped-wedge and other cluster randomized designs.
The tools and other resources include:
Tool to calculate intracluster correlation coefficients for designing cluster randomized trials
Tool to simulate intracluster correlation coefficients among Medicare beneficiaries with dementia for hospitalizations, emergency department visits, and deaths across US hospital referral areas
Power analyses for stepped-wedge designs with multivariate continuous outcomes
Power and sample size requirements for generalized estimating equation analyses of cluster randomized crossover trials
Information content of stepped-wedge designs when treatment effect heterogeneity and/or implementation periods are present
More than 5 million Americans are living with Alzheimer disease and related dementias. They are particularly vulnerable to receiving uncoordinated and poor-quality care, which contributes to adverse health outcomes and misuse of resources. The mission of the IMPACT Collaboratory is to advance care for persons with dementia and their caregivers in real-world settings by building national capacity to conduct pragmatic clinical trials that test interventions embedded in healthcare systems.
The NIA IMPACT Collaboratory announced a new online certificate program designed to empower researchers at all levels in integrating health equity considerations into embedded pragmatic clinical trials (ePCTs) for people living with dementia and their care partners.
Program Overview
This comprehensive training program, aligned with the IMPACT Collaboratory's "Best Practices for Integrating Health Equity into ePCTs for Dementia Care" document, equips researchers with the knowledge and skills to incorporate health equity considerations into design and research activities at every level of ePCTs for people living with dementia. The program covers 6 essential topic areas:
Getting started
Community Partner Engagement
Design and Analysis
Intervention Design and Implementation
Healthcare System and Participant Selection
Selecting Outcomes
Key Features
Free, accessible online training
Six courses, each including 2 to 5 brief and engaging videos
Self-paced learning, typically completed in 3 hours or less
Certificate upon successful completion of the program
Access the Training
Visit the IMPACT Collaboratory website for details and links to set up your free learning account. This account not only provides access to the health equity training program but also to other certificate programs and training materials.
The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging.
The 1.5-day virtual workshop features all new material to build a foundation in practical aspects of designing and conducting embedded pragmatic trials in Alzheimer disease and related dementias. The workshop will include a combination of activities, including panel discussions, small group sessions, and networking opportunities with experts in the field.
The IMPACT Collaboratory is inviting applications from early- to midcareer researchers who are seeking to develop competence in designing and conducting pragmatic trials of nonpharmacological interventions embedded in healthcare systems for people living with dementia and their care partners. Applications are due on October 20.
Upon completion of the workshop, participants will be able to:
Transmit knowledge about designing and conducting pragmatic trials among people living with dementia and their care partners in healthcare systems that integrates considerations related to estimating sample size requirements and establishing and sustaining key partnerships
Problem-solve common challenges in designing and conducting pragmatic trials for people living with dementia and their care partners
Apply the acquired knowledge to move their current and future research in pragmatic trials forward, including applying for competitive funding
Successful applicants will be expected to complete selected readings and online training prior to the workshop. All participants are expected to attend and participate in the entire 1.5-day event.
More than 5 million Americans are living with Alzheimer disease and related dementias. They are particularly vulnerable to receiving uncoordinated and poor-quality care, which contributes to adverse health outcomes and misuse of resources. The mission of the IMPACT Collaboratory is to advance care for persons with dementia and their caregivers in real-world settings by building national capacity to conduct pragmatic clinical trials that test interventions embedded in healthcare systems.
The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging.
A focus of the 2023 NIH Pragmatic Trials Collaboratory Annual Steering Committee Meeting was health equity in embedded pragmatic clinical trials (ePCTs). In an interview during the meeting, Drs. Anne Trontell and Ana Quiñones reflected on health equity in the ePCT landscape.
Trontell, who is the associate director for comparative clinical effectiveness research at the Patient-Centered Outcomes Research Institute (PCORI), said that health equity is a key component of the patient-centered efforts underlying all of PCORI’s research.
“From its beginning, PCORI has dedicated research funding to address the unique needs of historically underserved populations. The achievement of health equity is one of PCORI’s 5 guiding National Priorities for Health,” said Trontell.
As a funder, PCORI directs funds to those who pursue health equity goals and targets specific requirements that are important to the development of equity-focused research, such as working with communities and emphasizing inclusivity and diversity in the institutions and participants in research.
“It is a multipronged effort, and one that we are very excited to participate in,” said Trontell.
Quiñones, who is the core lead for the NIA IMPACT Collaboratory Health Equity Team and an associate professor at Oregon Health & Science University, said she agrees that bringing health equity into ePCTs requires a team-based approach.
“We’ve learned that leaning on ‘health equity experts’ or relying on individuals to provide answers for big gaps in the research evidence base isn’t just unrealistic, it is probably not great practice either,” said Quiñones.
One thing the NIA IMPACT Collaboratory has done is ask everyone involved in the program to think about and contribute to the process. A resulting product of this requirement is a series of best-practice recommendations for integrating health equity into ePCTs for dementia that were created by asking experts from areas across the IMPACT Collaboratory to apply a health equity perspective to their area of expertise to collectively develop recommendations for some of the issues and hidden pitfalls.
“This doesn’t mean that you don’t need people who are deeply embedded and knowledgeable about the [health equity] work, and knowledgeable about the best scientific principles, asking questions, but it does mean that everybody is a participant in solving the problem, not just the health equity expert,” said Quiñones.
Trontell said that one way PCORI is supporting health equity is by funding the groundwork that can help researchers be successful, such as building relationships with diverse communities through its engagement awards. In addition, PCORI’s Phased Large Awards for Comparative Effectiveness Research (PLACER) opportunities fund a feasibility phase that supports study refinement, infrastructure establishment, stakeholder engagement, and feasibility testing of study operations, including the ability to recruit and enroll participants successfully.
“We have heard from our investigators that meaningful engagement deserves attention, effort, and time, so our engagement awards and PLACER funding opportunity offer upstream support for strong and diverse engagement to occur,” said Trontell.
Networks such as the NIA IMPACT Collaboratory and the NIH Pragmatic Trials Collaboratory have an important role to play in these efforts as well. Quiñones said these large research networks have opportunities to build synergies around common goals related to health equity and share knowledge and best practices.
Trontell agrees. “I’m a big fan of bringing people together to figure out something and to listen to each other, particularly when they have a shared goal and excitement around trading ideas and tips. That creates a real learning community.”
The Long-Term Care (LTC) Data Cooperative this week announced a request for applications for the newly established 2023 Real World Data Scholars Program. This program supports the development of advanced graduate students, postdoctoral fellows, and early-career faculty who are interested in developing their expertise and experience in working with electronic health record (EHR) data.
The program offers a unique opportunity to be among the first users of the LTC Data Cooperative’s EHR data and to characterize the data for future users through validation and analyses. It is available for investigators at all levels who are interested in developing their expertise and experience working with EHR data.
The Real World Data Scholars Program will fund up to 3 investigators for a 12-month training grant. Selected scholars will work with the designers of the LTC Data Cooperative to test and establish the validity or reliability of key measures within this new data resource. Accepted scholars will be partnered with a mentor who is well-versed in analyzing EHR data and can provide support and direction for scholars.
Awards are for 12 months and up to $50,000 in direct costs; awardees are expected to devote 25% to 50% effort toward the goals of the program. Indirect costs are calculated at 8%. Applicants should be experienced using large-scale administrative and/or clinical data (eg, EHR data, Medicare claims, Minimum Data Set, registry data). Individuals with a background in pharmacoepidemiology, natural language processing, or clinical investigations are also encouraged to apply. Applicants from underrepresented racial and ethnic groups, as well as individuals with disabilities, are strongly encouraged to apply.
Applicants must be associated with an academic institution or academic medical center and be citizens or permanent residents of the United States. All research must be performed within the United States.
In the March 16 session of IMPACT Grand Rounds, the NIA IMPACT Collaboratory will host Dr. Eleanor Murray, who will present on the topic of causal inference in pragmatic trials.
Join us for IMPACT Grand Rounds on Thursday, March 16 at 12pm ET with Dr. Murray who will be presenting on the “Causal Inference in Pragmatic Trials.”
Eleanor (Ellie) Murray, PhD, is an assistant professor of Epidemiology at Boston University School of Public Health with expertise in causal inference. Her work focuses on improving methods for evidence-based decision-making and human-data interaction, as well as improving the translation of methodological advances into practical applied work. Application areas include HIV, HPV, cancer, cardiovascular disease, reproductive health research, tuberculosis research, access to care, psychiatric disorders, musculoskeletal disorders, social and environmental epidemiology, and maternal and adolescent health. Dr Murray also conducts meta-research evaluating bias in existing research. She has an ScD in Epidemiology and MSc in Biostatistics from Harvard TH Chan School of Public Health, where she also did her postdoctoral fellowship in the Program on Causal Inference, an MPH in Epidemiology from Columbia Mailman School of Public Health, and a BSc in Biology from McGill University. Dr Murray is the co-host of the podcast Casual Inference, an Associate Editor for Social Media at the American Journal of Epidemiology, and a science communicator under the handle @epiellie on Twitter.
Zoom Conferencing Join from PC, Mac, iOS or Android: https://hebrewseniorlife.zoom.us/j/97344810673 Dial-In: +1 312 626 6799 (US Toll) or +1 470 250 9358 (US Toll) Meeting ID: 973 4481 0673
Fan Li, PhD, is an assistant professor in the Department of Biostatistics at Yale School of Public Health, and faculty member in the Center for Methods in Implementation and Prevention Science and the Yale Center for Analytical Sciences. He is the principal investigator of a Patient-Centered Outcomes Research Institute (PCORI)–funded methods award that investigates new study planning methods and software for testing treatment effect heterogeneity in cluster randomized trials.
Zoom Conferencing Join from PC, Mac, iOS or Android: https://hebrewseniorlife.zoom.us/j/97344810673 Dial-In: +1 312 626 6799 (US Toll) or +1 470 250 9358 (US Toll) Meeting ID: 973 4481 0673
The NIA IMPACT Collaboratory is seeking letters of intent from interested applicants for Cycle 5A of its Pilot Grants Program.
The 1-year pilot grant awards will fund up to $175,000 in direct costs for pilot studies that aim to generate preliminary data for full-scale embedded pragmatic clinical trials of nonpharmacologic interventions in healthcare systems for persons living with Alzheimer disease and related dementias and/or their care partners. In this grant cycle, the program will give priority to applications aim that improve care through behavioral economics “nudge” interventions; reduce inequities in healthcare; reduce potentially inappropriate medication use through de-prescribing; or improve care in emergency departments.
More than 5 million Americans are living with Alzheimer disease and related dementias. They are particularly vulnerable to receiving uncoordinated and poor-quality care, which contributes to adverse health outcomes and misuse of resources. The mission of the IMPACT Collaboratory is to advance care for persons with dementia and their caregivers in real-world settings by building national capacity to conduct pragmatic clinical trials that test interventions embedded in healthcare systems.
The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging.
The NIA IMPACT Collaboratory announced a request for applications for its 2025 Demonstration Projects Grants Program.
The NIA IMPACT Collaboratory, a program to advance pragmatic clinical trials of interventions for people living with dementia and their care partners, announced a new collection of statistical tools for researchers. The tools are available on a new 
On January 24-25, 2024, the IMPACT Collaboratory will hold its fourth annual virtual Training Workshop entitled 
The Long-Term Care (LTC) Data Cooperative this week announced a request for applications for the newly established 
In the March 16 session of IMPACT Grand Rounds, the NIA IMPACT Collaboratory will host Dr. Eleanor Murray, who will present on the topic of causal inference in pragmatic trials.