Author: Sonya Sutton

IMPACT Collaboratory announces the 2023 Health Care Systems Scholars Program Awardees

Posted on by Sonya Sutton

The National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer’s Disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory (U54AG063546) is pleased to announce the 2023 Health Care Systems (HCS) Scholars Program awardees.

This program offers investigators an opportunity to work directly with health care systems interested in improving the care provided to people living with dementia (PLWD) and their care partners. The goals of the HCS Scholars Program are to embed investigators in health care systems to:

  • Establish mutually beneficial partnerships to improve the care of PLWD and their care partners.
  • Train investigators about health care settings’ needs and how new programs are successfully introduced at all levels of the organization.
  • Engage HCS in learning more about what it means to conduct ePCTs and provide resources for understanding opportunities for improvement in dementia care or evaluation of related quality improvement projects.
  • Strengthen collaborations between investigators and HCS that may lead to pilot studies or demonstration projects.

Recipients of this year’s HCS Scholar awards are:

Co-Designing Care Transition Support for Dementia Patients and Care Partners             

Building an Academic Long-Term Care System Coalition to Improve Palliative Care

Goldfeld develops a simple way to simulate setting sample size for variable cluster sizes in randomized trials

Posted on by Sonya Sutton

Keith Goldfeld, DrPH, MS, MPA, member of the executive committee of the IMPACT Design & Statistics Core, recently published a blog post inspired by discussions with collborators from the IMPACT Collaboratory.

Goldfeld discussed how the question of variable cluster sizes has come up a number of times in recent discussion with IMPACT Collaborators about setting the sample sizes for proposed cluster randomized trials, Goldfeld explains that when working with  a fixed overall sample size, it is generally better (in terms of statistical power) if the sample is equally distributed across the different clusters. Highly variable cluster sizes increase the standard errors of effect size estimates and reduce the ability to determine if an intervention or treatment is effective.

Goldfeld realized that there is no easy way to generate the desired variable cluster sizes while holding the total sample size constant using simstudy, his preferred simulation package. In response to this, he developed a simple solution that is available for download on the blog.

Read the full post here.

Clapp to present at Society for Clinical Trials 44th Annual Meeting

Posted on by Sonya Sutton

The Society for Clinical Trials (SCT) will hold its 44th Annual Meeting May 21-24 in Baltimore, MD. The theme is “Championing High-quality Evidence to Optimize Human Health.” Justin Clapp, PhD, MPH, member of the executive committee of the Ethics & Regulation Core, will be presenting, “Physician Gatekeeping in Pragmatic Trials: A Qualitative Study of Clinical Reasoning about Patient Randomization” during the conference.

Learn more at this link.

NIH Pragmatic Trials Collaboratory Chapter: ETHICAL CONSIDERATIONS OF DATA SHARING IN PRAGMATIC CLINICAL TRIALS

Posted on by Sonya Sutton

Published on the NIH Pragmatic Trials Collaboratory website April 3 2023, this new chapter of the living textbook presents the human subjects research regulations that may impact data sharing and examines the intersection of enabling critical ePCT research, and respecting the interest of patients who become ePCT participants.

The scientific motivations for data sharing are clear: health information can enable scientific discovery, as well as enhance transparency and reproducibility in trial results. However, the ethical considerations of sharing data from embedded pragmatic clinical trials (ePCTs) are less well defined, especially when data are collected with a waiver or alteration of informed consent, as is often the case in ePCTs. Therefore, in this chapter, we describe the human subjects research regulations that may impact such data sharing and examine the intersection of enabling critical ePCT research, and respecting the interests of patients who become ePCT participants.

Access the chapter: https://rethinkingclinicaltrials.org/chapters/ethics-and-regulatory/ethical-considerations-of-data-sharing-in-pragmatic-clinical-trials/introduction-to-ethical-considerations-of-data/ 

 

The Center for Aging and Serious Illness accepting applications for second cohort of participants in Dementia Palliative Care Clinical Trials Training Program

Posted on by Sonya Sutton

The Center for Aging and Serious Illness Dementia Palliative Care Clinical Trials Training Program provides a foundation in practical aspects involving the design and conduct of randomized clinical trials in dementia palliative care. The Program is appropriate for early career researchers or other mid-career researchers interested in developing competence in the planning, design, and execution of randomized clinical trials among persons with Alzheimer’s Disease or Related Dementias (ADRD) and their caregivers. The 10-month-long Program includes a combination of virtual small group sessions and a 5-day in-person Institute where learners will work together to design a trial and learners will develop their own grant application addressing ADRD. The research training team includes a diverse group of faculty members who are dedicated to developing investigators in dementia palliative care clinical trials research.

The Institute is scheduled for October 2 – 6, 2023 in Chapel Hill, North Carolina. It is critical that the candidate be able to attend the Institute in its entirety. To be eligible, participants must be US citizens, have a doctoral-level degree, and be at least two years from their terminal degree with a demonstrated commitment to geriatric palliative care or dementia research. International applicants are not eligible for this opportunity.

Applications are due May 15, 2023. Complete this form to apply for the program.

Multiple IMPACT members present at NIA Dementia Care & Caregiving Summit March 20-22

Posted on by Sonya Sutton

IMPACT members will participate in the three-day 2023 National Research Summit on Care, Services, and Supports for Persons Living with Dementia (PLWD) and Their Care Partners/Caregivers. Daily sessions will explore the latest research for PLWD and their partners and caregivers, as well as facilitated sessions with the Lived Experience and Stakeholder panels.

Registration is now open. The Summit will be held virtually on March 20-22, from 11 a.m. to 4 p.m. Eastern Time each day. Submitting the registration form will enable you to join any or all three days of the Summit proceedings.

Register for the event.

 

IMPACT Collaboratory announces release of funding opportunity RFA for Cycle 5A of Pilot Program

Posted on by Sonya Sutton

The National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer’s Disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory is pleased to announce a Request for Applications for the Pilot Grants Program Cycle 5A.

 In this cycle, the IMPACT Collaboratory will fund up to five 1-year awards for pilot pragmatic clinical trials (ePCTs) that test non-pharmacological interventions embedded in health care system(s) for people living with Alzheimer’s Disease (AD) and AD-related dementias (ADRD) and their care partners. All applications should make a convincing case that the pilot ePCT proposed can take the next step to a full-scale Stage IV effectiveness ePCT, as defined by the National Institutes of Health (NIH). It is anticipated that Pilot Studies will be funded for up to $200,000 in direct costs for a maximum of 12-months (direct costs were raised from $175,000 to $200,000). Applicants from under-represented racial and ethnic groups as well as individuals with disabilities are strongly encouraged to apply for funding. For more information, please see our Pilot Grants Program page.

All applications for pilot ePCTs that evaluate non-pharmacological interventions to improve the care of people living with AD/ADRD and their care partners will be considered. However, this grant cycle will prioritize applications for interventions in these populations that aim to:

  • Improve care through behavioral economics “nudge” interventions;
  • Reduce inequities in health care;
  • Reduce potentially inappropriate medications through de-prescribing; or
  • Improve care in emergency departments.

The goal of the pilot projects is to generate the preliminary data necessary to design and conduct a future full-scale Stage IV effectiveness ePCT (based on the NIH Stage Model) funded through other grant mechanisms (NIH or other sources). Preference will be given to applications that address dementia care for populations traditionally marginalized or underrepresented in clinical trials and those that promote health equity.

Informational Webinar

An optional informational webinar will be hosted to provide investigators with an overview of application details and an opportunity to ask questions. Pre-registration is required using the link below.

Tuesday, February 14, 2023, at 12:00pm ET: Registration closed.

 Letters of Intent (LOI) – Required
Interested applicants are required to submit an LOI. LOIs are accepted on a rolling basis through:

March 3, 2023 @5PM ET

Full Proposals (By invitation only)

Applications selected for further consideration will be invited to submit a full proposal due:

June 16, 2023 @ 5pm ET

IMPACT Collaboratory funds two career development awards

Posted on by Sonya Sutton

The IMPACT Collaboratory is pleased to announce two new recipients of the IMPACT Career Development Award Program. Recipients were selected from an impressive group of competitive applications.

2022 Cycle 4 NIA IMPACT Career Development Award Recipients

Andrew Kiselica, PhD, University of Missouri
Technology Assistance in Dementia (Tech- AiD)

Komal Patel Murali, PhD, New York University Rory Meyers College of Nursing
Barriers to Hospice Care Transitions for Diverse Persons Living with Dementia

About the NIA IMPACT Career Development Award Program

NIA IMPACT Collaboratory funds two to four Career Development Awards annually. These awards support the development of early-stage MD, PhD, or equivalent researchers who seek careers conducting ePCTs for people living with AD/ADRD and their care partners. The IMPACT Collaboratory prioritizes applications that address dementia care for people of all backgrounds and promote health equity.

IMPACT Collaboratory included in NIH 2022 progress report on dementia research

Posted on by Sonya Sutton

The National Institutes of Health (NIH) recently released their 2022 Scientific Progress Report on Advancing Alzheimer’s Disease and Related Dementias and included the IMPACT Collaboratory as a highlight of real word applications of dementia research.

The NIH is working toward the ambitious goal of preventing and effectively treating Alzheimer’s disease and related dementias by 2025. The progress report features scientific advances and related efforts between April 2021 and early 2022 in areas including drug development, lifestyle interventions, biomarker research, and more. The report provides an overview of the meaningful progress researchers are making to address Alzheimer’s disease, which impacted more than 6 million Americans in 2022, and other dementias.

The IMPACT Collaboratory’s efforts to test interventions in real world settings was commended in the progress report, with special focus on the research conducted during COVID-19 to study the impact of the pandemic on nursing home residents. Members of the IMPACT Collaboratory received five supplement awards for intervention studies and three supplement awards to develop infrastructure systems to monitor the effects of COVID-19 vaccines.

Read the full report at this link.

IMPACT to host webinar to introduce the Long Term Care Data Cooperative

Posted on by Sonya Sutton

The IMPACT Collaboratory will host a special webinar event featuring leaders from the Long-Term Care (LTC) Data Cooperative, who will provide an introduction and overview to this powerful new resource. The webinar will be December 7 from 12:00 pm- 1:00 pm EST and will feature IMPACT’s Vince Mor, PhD, David Dore, PharmD, PhD, from Exponent, and David Gifford, MD, MPH from the American Health Care Association (AHCA).  Participants will learn more about the Data Cooperative, its membership, how to join, and options for data access.

The LTC Data Cooperative is a nationwide effort funded by the National Institute on Aging, to assemble resident health records to improve treatment outcomes and be better prepared for public health events in the future. An outgrowth of work led by Vince Mor in response to COVID-19, this initiative brings together healthcare systems and data management resources to create the largest integrated database of detailed, normalized, electronic health record (EHR) data from nursing homes (NH) in the United States. The EHR data can also be linked to Medicare claims data.

The LTC Data Cooperative will:

  • Assist providers with health care operations, including care coordination, risk stratification and quality performance reporting.
  • Support public health monitoring for medical conditions and infections, including COVID-19.
  • Enable observational studies of the LTC population, ranging from comparative treatment effectiveness studies, to epidemiological studies of risk to pharmaco-epidemiological studies.
  • Facilitate provider and patient recruitment into clinical research studies, including stage 3 and 4 embedded pragmatic clinical trials.

The LTC Data Cooperative’s comprehensive data set will facilitate researchers’ ability to test the impact of treatments and other interventions intended to improve the lives of NH residents through observational studies and pragmatic clinical trials. This will enable researchers to generate real-world evidence on the effectiveness of different treatments and care practices for older adults, individuals with disabilities, and people living with dementia in nursing homes.

 

Registration closed.