IMPACT authors publish commentary on medical therapies in nursing homes

IMPACT members Kathleen Unroe, MD, MHA, MS, Debra Saliba, MD, MPH, Sheryl Zimmerman, PhD and Jerry Gurwitz, MD, contribute commentary in the Journal of the American Geriatrics Society citing IMPACT and the Long Term Data Cooperative as National Institute on Aging (NIA) initiatives that provide foundational work addressing the identification and capture of important clinical outcomes, laying the groundwork for a nursing home clinical trials network. The commentary is based on the article Evaluation of medical therapies in the nursing home population: Gaps, challenges, and next steps.

Read the full commentary.

Health care use pattern data brief shows expanding need for dementia planning and care

IMPACT’s Cameron Gettel, MD and Julie Bynum, MD, MPH are among the authors of the CAPRA Data Brief on health care use patterns among older adults with dementia. The brief was developed by the Center to Accelerate Population Research on Alzheimer’s (CAPRA) at the University of Michigan.

Authors demonstrated the use of Medicare claims to examine healthcare use patterns among older adults with ADRD using datasets provided by the Impact Collaboratory. The brief cites the increase in emergency care, hospitalization, and skilled nursing facility admissions for Medicare recipients and an increased need for planning and care for people with Alzheimer’s Disease and Related Dementias (ADRD) in the U.S.

Read the brief here.

Study shows how music can improve verbal agitation behaviors of nursing home residents with dementia

IMPACT multiple principal investigator Vince Mor, PhD, and members Roee Gutman, PhD, James Rudolph, MD, SM, Rosa Baier, MPH and executive committee member, Ellen McCreedy, PhD, are among authors sharing observed effects of music on nursing home residents with dementia. In a randomized controlled trial, patients were observed to express more pleasure and fewer signs of verbal agitation. The authors conclude that non-pharmacological interventions like personalized music exposure can temporarily relieve agitated behaviors of people living with dementia in a nursing home setting.

Read the full article.

NIH Collaboratory workshop recordings on ePCT’s effects on healthcare systems now available

Multiple principal investigator Vince Mor, PhD was part of an NIH Collaboratory workshop entitled “Getting the Right Evidence to Decision-Makers Faster” held June 20-21, 2023. Mor was part of a panel of experts addressing “How Have Health Systems Made Decisions Based on Evidence Collected in PCTs?”

The 2-day workshop explored how researchers share evidence with healthcare system decision-makers to implement the findings of pragmatic clinical trials conducted within healthcare systems.

To access the workshop summary, materials and recordings, visit the NIH Collaboratory website.

CICADA RFA Penn’s Center for Improving Care Delivery for the Aging (CICADA) is seeking applications for the 2024-2025 cohort of CICADA Scientists.

Penn’s Center for Improving Care Delivery for the Aging (CICADA) is seeking applications for the 2024-2025 cohort of CICADA Scientists. In collaboration with Penn’s Leonard Davis Institute for Health Economics (LDI), CICADA seeks to enhance the diversity of the aging research workforce by mentoring promising scientists from under-represented backgrounds interested in a career focused on improving health equity and health care delivery for older adults.

The deadline for submitting applications is 8:00 a.m. ET on January 8, 2024.

To review the full request for applications, including available resources, review criteria, and the application timeline, please click here.

For application questions, please contact CICADA@pennmedicine.upenn.edu.

Observing the impact of personalized music on agitated behaviors in dementia patients

Using Structured Observations to Evaluate the Effects of a Personalized Music Intervention on Agitated Behaviors and Mood in Nursing Home Residents With Dementia: Results From an Embedded, Pragmatic Randomized Controlled Trial

November 2, 2023

Authors, including IMPACT members, Roee Gutman, PhD, Vincent Mor, PhD, James Rudolph, MD, SM, Rosa Baier, MPH, and Ellen McCreedy, PhD, MPH explored whether implementation of a personalized music intervention decreased the frequency of agitated behaviors in nursing home residents with dementia. They measured impact by using structured observations conducted as part of a randomized controlled trial design.

The authors found that personalized music decreased the frequency of verbally agitated behaviors in residents randomized to receive the treatment compared to residents randomized to a usual care control. No effect of the intervention was found on physically agitated behaviors. The intervention also increased observed pleasure.

This study provides evidence for the effectiveness of a non-pharmacological intervention for temporary relief in verbal behaviors in nursing home residents with dementia.

Read the full article.

American Journal of Bioethics publishes special issue, includes commentary on article by IMPACT member

July 14, 2023

A previously published article by IMPACT member Emily Largent, PhD, JD, RN, and Stephanie Morain, MD, was the subject of guest commentary in a special issue of The American Journal of Bioethics (AJOB). The special issue focused on pragmatic clinical trials (PCTs). In the issue, Largent and Morain’s target article exploring investigators’ ethical obligations to patients was discussed in several peer commentaries and by two guest editorials including one co-authored by Commissioner of the Food and Drug Administration (FDA), Robert Califf, MD.

 

Access the special issue including all commentaries and the original target article.

Article advocates for advancing comprehensive dementia care for patients and caregivers beyond pharmaceuticals

A new publication co-authored by IMPACT member Eric Larson, MD, MPH, reflects on the importance of non-pharmacological interventions that promote the wellbeing of people living with dementia and their care partners as integral to dementia care. Authors comment on the contributions made by IMPACT Collaboratory on insights into real-world implementation of dementia care interventions through multiple mechanisms. The article emphasizes the need for comprehensive dementia care beyond pharmaceutical solutions, considering patients, caregivers, and care partners.

Abstract

Millions of individuals across the United States and around the world are living with dementia. Persons living with dementia can lead rewarding and fulfilling lives, and to do so, they need medical care, physical quality of life, social and emotional quality of life, and access to services and supports. To meet these needs, persons living with dementia may comanage with or rely on care partners or caregivers for adequate care and support. Many care partners and caregivers report positive benefits from assuming that role. However, the potential for negative consequences for their health, relationships, and finances necessitates a system of supports and services for the care partner and caregiver as well.

The approvals of the drugs aducanumab in 2021 and lecanemabin in 2023 for the treatment of Alzheimer’s disease have garnered a great deal of attention within the dementia community. Press releases highlighting other drugs in development aiming to reduce amyloid plaques—which are thought to contribute to dementia symptoms—such as donanemab continue to raise hope for more curative treatments. The arrival of these new drugs continues the decades-long process in search of treatments and cures for Alzheimer’s disease and related dementias. However, available treatments have the potential to cause serious side effects, and it remains unclear whether a causal relationship exists between dementia symptoms and the amyloid plaques that the drugs target.

With recent advances in research methods and infrastructure, a future in which people can live well with dementia is coming into sharper focus.

Read the full article.

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

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/