ePCT Planning Grant Program

ePCT Planning Grant Program

Program Overview

The goal of this 12-month Embedded Pragmatic Clinical Trials (ePCT) Planning Grant is to support the activities required to collaboratively plan and develop a feasible, fully specified protocol for a Stage IV effectiveness ePCT in dementia care. Projects must be conducted in partnership with a nursing home organization and include at least two nursing home sites (either within a single organization or across multiple organizations).

This mechanism is intended for Stage IV effectiveness trials (based on the NIH Stage Model). It does not support early-stage intervention development (Stages 0-I) or protocol development for efficacy trials (Stages II-III).

This award emphasizes strong partnerships among investigators, nursing home partners, and an advisory board of residents, care partners, and other caregivers. By working together, this opportunity is to ensure the intervention and its implementation align with real-world operational contexts, are feasible, and are ready for future testing in an ePCT.

By the end of the award period, awardees are expected to produce a fully specified trial protocol for either a pilot or full-scale ePCT. The protocol should incorporate core design components, including the level of randomization, an approach to participant identification and enrollment, intervention structure and implementation, specification of clinical outcomes, and plans for data access and transfer.

With a well-developed protocol in place, awardees are expected to be strongly positioned to pursue subsequent funding to conduct either a pilot ePCT (e.g., IMPACT Pilot Grant, NIH R21, R34) or a full-scale ePCT (e.g., IMPACT Demonstration Project Grant, R01, or equivalent).

Funding Opportunity Description

This is a focused planning grant for a Stage IV ePCT in nursing home settings. Please review the full RFA to determine whether this opportunity is a fit for your work.

The IMPACT Collaboratory will fund up to two 12-month awards for up to $150,000 (total direct costs). Applicants must partner with a nursing home organization, with participation from at least two nursing homes (within a single organization or across multiple organizations) and include a resident-care partner advisory board.

This funding opportunity supports planning activities necessary to design trial protocols for ePCTs (Stage IV on the NIH Stage Model) that will evaluate the effectiveness of non-pharmacological interventions to improve the management of behavioral and psychological symptoms of dementia (BPSD) in nursing home settings. Proposed projects must emphasize nursing home-level approaches suitable for evaluation in future pilot or full-scale ePCTs.

The award is structured to provide sufficient resources to support meaningful engagement with nursing home partners, the resident-care partner advisory board, and other engaged partners, including relationship-building and collaborative planning for developing and finalizing the ePCT protocol, intervention and implementation strategy, participant and outcome selection, and plans for data access and transfer. The planning activities should ensure that the ePCT protocol is well-aligned with the operational workflows, staffing, and care delivery needs and constraints.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this funding opportunity.

Request for Applications | RFA-IMPACT-PG2026

 

 

Home Time as a Patient-Centered Outcome in Pragmatic Trials: Promise, Pitfalls, and the Path Forward

January 2026 – Grand Rounds 62, Drs. Hanson, Kim, Ankuda, and Van Houtven discuss home time as a patient-centered outcome in pragmatic trials.

Webinar Slides

Laura Hanson, MD, MPH

Professor, Division of Geriatric Medicine and Director, UNC Palliative Care Program, University of North Carolina School of Medicine

 

Claire Ankuda, MD, MPH

Associate Professor, Icahn School of Medicine at Mount Sinai

Dae Hyun Kim, MD, MPH, ScD

Associate Director of Marcus Institute for Aging Research, Associate Professor of Medicine, Harvard Medical School

Courtney Van Houtven, PhD

Professor, Population Health Sciences, Duke University School of Medicine and Duke-Margolis Institute for Health Policy

Learning Objectives

  • Understand the concept of home time as a patient‑centered, system‑relevant outcome measure and how it is operationalized across different clinical contexts.
  • Recognize the limitations, measurement challenges, and equity concerns associated with using home time as an outcome or performance metric in pragmatic clinical trials.
  • Reflect on emerging evidence and future directions for developing more person‑centered home time measures that better capture quality of life for older adults and caregivers.

The IMPACT Collaboratory Lived Experience Panel: Reflections on Accomplishments and Recommendations for Continued Work

This extended summary report, authored by Yaideliz M. Romero-Ramos, a Brown University graduate student and Health Equity Scholar, describes feedback from Lived Experience Panel members about their involvement with the panel to date and recommendations for future work. The report details discussions from a series of meetings where members revisited and shared perspectives on previously discussed topics. Additionally, the report highlights members' reflections on their experience with the panel and their suggestions for future initiatives.

Read the full report here.

2023-2024 LEP Report Reflections (1)

Citation: Yaideliz M. Romero-Ramos, Carolyn A. Malone, Kerry Finegan, Willetha Barnette, Bart Brammer, Katie Brandt, Roberta Cruz, Monica Downer, Darrell Foss, Ying-Ling Jao, LuPita Gutierrez-Parker, Freddye G. James, Joan Monin, Emily Mroz, Maria Mora Pinzon, Judith S. Rocha, Lauren Stratton, Mark Toles, Anthony Wagner, Monica Moreno, Gary Epstein-Lubow. The IMPACT Collaboratory Lived Experience Panel: Reflections on Accomplishments and Recommendations for Continued Work. NIA IMPACT Collaboratory; 2024.

IMPACT community members seek improvements in post-acute care in SNFs

IMPACT community members, Joan Carpenter, PhD, CRNP, Nancy Hodgson, PhD, RN, and Laura  Hanson, MD, MPH share the results of their recent pilot pragmatic trial which was supported by the National Institute of Nursing Research of the National Institutes of Health under Award Number K23NR017663 and the Rita & Alex Hillman Foundation, New York.

The trial explores the feasibility of implementing a palliative care intervention during post-acute care to improve outcomes and reduce the need for rehospitalizations.

The two-group, multisite feasibility pilot pragmatic clinical trial, which was conducted at 12 SNFs co-located in continuing care retirement communities in the Northeast and Mid-Atlantic United States, evaluated the feasibility of implementing the primary palliative care in post-acute care (PPC-PAC) intervention in the post-acute care skilled nursing facility (SNF) setting.

Implementation of the PPC-PAC intervention proved feasible and acceptable among older adults and clinicians. Future research is needed to focus on testing the effectiveness of PPC-PAC and explore strategies for optimal intervention implementation and SNF staff engagement.

Read the full article here.

NORC Dementia DataHub

Button to access NORC Dementia DataHub

The Dementia DataHub (R01 AG075730), created by NORC at the University of Chicago, provides interactive dashboards and maps to view dementia diagnoses among Medicare beneficiaries, with results available at the national, state, and county levels. NORC Dementia DataHub uses the term “dementia” to refer broadly to Alzheimer’s disease dementia and Alzheimer’s disease related dementias (AD/ADRD) and other diagnoses that are sometimes used to indicate these conditions.

 

NIA Outreach Pro: Building Better AD/ADRD Clinical Trial Outreach Materials

The National Institute on Aging developed OutreachPro to help researchers create customized outreach materials for clinical trials on Alzheimer’s and related dementias. Choose from a suite of audience-specific images, headlines and text, available in multiple languages and tested for maximum recruiting impact. Then add your own content, apply your own logo, and brand colors. Watch the video to the right for an overview of how to use OutreachPro.

Bynum and team publish findings from research into geographic disparities in Alzheimer’s disease diagnosis

Congratulations to Julie Bynum, MD, MPH from the University of Michigan‘s Institute for Healthcare Policy and Innovation and the team for their newest research findings reflecting the disparities in Alzheimer’s disease diagnosis based on geographic location!

Highlights from the research:

  • The rate of new Alzheimer’s disease and related dementias (ADRD) case identification varies geographically across the United States.
  • Variation in case identification is greatest in Black, Hispanic, and young-old groups.
  • Intensity of diagnosis (i.e., case identification) unrelated to population risk differs across place.
  • Likelihood of receiving an ADRD diagnosis varies 2-fold based on place of residence.

Read the full article to learn more about their insightful findings: https://doi.org/10.1002/alz.14092

The 2023-2024 Lived Experience Panel Report: Perspectives on Evaluating and Measuring Goal-Concordant Care for People Living with Dementia

July 10, 2024

Authors: Joshua Niznik, PharmD, PhD, Antonia Bennett, PhD, Natalie C. Ernecoff, PhD, MPH, Sheryl Zimmerman, PhD, Kathryn Wessell, MPH, Laura Hanson, MD, Gary Epstein-Lubow, MD, MPH, Carolyn Malone, MPH, Willetha Barnette, Bart Brammer, Katie Brandt, Roberta Cruz, Monica Downer, Darrell Foss, LuPita Gutierrez-Parker, Freddye G. James, Judith S. Rocha, Anthony Wagner

Description: This report describes the major lessons learned from a series of discussions between people living with dementia, care partners, researchers, healthcare providers, and other community members about ways to improve the quality of healthcare for people living with dementia. The main topic of these discussions was ‘goal-concordant care’ which means ensuring that healthcare treatments and decisions are in line with what matters most to patients and families. Panel members were asked to discuss their experiences talking about goals with their healthcare providers and how thinking about their goals could help with making healthcare decisions. Some key takeaway points are:

  1. Decision-making for people living with dementia is more often driven by needs and priorities, than by healthcare “goals.”
  2. Decision-making for people living with dementia involves many people, which is not often reflected in research.
  3. It can be difficult for people living with dementia and care partners to feel actively involved in healthcare decision-making.

Further study is needed to identify strategies to ensure that people living with dementia and care partners are actively involved in decision-making and in identifying the best ways to measure whether the needs and priorities of people living with dementia and care partners are being met.

Read the full report here.

Citation: Niznik J, Bennett A, Ernecoff NC, Zimmerman S, Wessell K, Hanson L, Epstein-Lubow G, Malone C, Barnette W, Brammer B, Brandt K, Cruz R, Downer M, Foss D, Gutierrez-Parker L, James FG, Rocha JS, Wagner A. 2023-2024 Lived Experience Panel Report: Perspectives on Evaluating and Measuring Goal-Concordant Care for People Living with Dementia. NIA IMPACT Collaboratory; 2024. doi: 10.58234/35429703
Click to view LEP Report | PCRO Goal-Concordant Care

The GUIDE Model: A CMS payment model test to support people living with dementia and their family caregivers

May 2024 – In Grand Rounds 47, Drs. Epstein-Lubow and Lees-Haggerty, along with Tonya Saffer, Director of the Division of Healthcare Payment Models with the Centers for Medicare & Medicaid Services (CMS), share the GUIDE Model. GUIDE is a CMS payment model that tests whether dementia care programs can improve quality of life for people living with dementia and their caregivers.

Download Webinar Slides

Headshot photo of Dr. Gary Epstein-Lubow

 

 

 

 

 

Gary Epstein-Lubow, MD
Team Lead, Engaging Partners Team
Distinguished Medical Scholar, EDC
Associate Professor, Brown University

Headshot photo of Dr. Kristin Lees-Haggerty

 

 

 

 

 

Kristin Lees-Haggerty, PhD
Project Director
Natl. Collaboratory to Address Elder Mistreatment
Education Development Center

Headshot photo of Tonya Saffer

 

 

 

 

 

Tonya Saffer, MPH
Director
Division of Healthcare Payment Models
Centers for Medicare & Medicaid Services

Learning Objectives

  • Review the historical context of the CMS GUIDE Model and its potential for transforming the delivery, quality and outcomes of dementia care in the United States.
  • Learn the requirements for participating health systems regarding care delivery and outcomes reporting.
  • Understand how the GUIDE Model requirements align with evidence-based comprehensive dementia care, including new opportunities and challenges for pragmatic evaluation of dementia service delivery related to GUIDE-participating health systems.

Guidance for Proxy Data and Dyadic Analysis

May 17, 2024

Authors: Katie Newkirk, PhD and Joan Monin, PhD

Description: This document provides guidance on what dyadic data is, how it is different from proxy data, and what information can be gained by collecting and analyzing dyadic data compared to proxy data when conducting embedded pragmatic clinical trials (ePCTs) that include people living with dementia and care partners. Topic covered:

  • Dyadic Data
  • Proxy Data
  • Constructs Often Measured for Both People Living with Dementia and Care Partners
  • Analyzing Dyadic Data
  • When Data Don’t Require Dyadic Analysis
  • Proxy Data
  • Do I Have Dyadic Data?
Citation: Newkirk K, Monin J. Guidance for Proxy Data and Dyadic Analysis. NIA IMPACT Collaboratory; 2024. doi: 10.58234/236781742
Click to view PDF of Guidance for Proxy Data and Dyadic Analysis