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Research in Dementia

The network supports a variety of scholarship on deprescribing that is focused on the unique needs of people with cognitive impairment or dementia. This includes funding pilot and exploratory studies on this topic, and opportunities for funding grant planning and collaboration activities. Visit our funded investigators page to learn more. The network also supports the development of junior investigators through our 12-month Junior Investigator Intensive program, with a number of JII scholars conducting work related to deprescribing and dementia. Visit our Investigator Development page to learn more.

The network has also received supplemental funding from the National Institute on Aging to conduct dedicated research on Alzheimer’s Disease and related dementias. The following projects have been supported by this funding mechanism and provide additional opportunities to advance research on deprescribing for people with these conditions.

2023 – 2024

PRINCIPAL Investigator:

Jennifer Kim, DNP, GNP-BC, FNAP, FAANP, Vanderbilt University School of Nursing

ADRD Supplement:

Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living 

Background and Importance: Although persons living with dementia (PWD) are more likely to have polypharmacy and take unnecessary medications, few studies have assessed deprescribing attitudes in this population. A recent showed that the majority of participants with dementia were agreeable to stopping a medication if advised by their physician. Proxy respondents in this study were less agreeable to deprescribing, echoing previous findings that have shown caregiver resistance to deprescribing of antipsychotics due to concern about the management of BPSD. Sequelae associated with PIM use in PWD thus requires a better understanding of deprescribing attitudes in surrogate decision-makers.

Study Aims: The primary objective of the pilot study is to implement and evaluate a patient/surrogate-centered deprescribing intervention previously used in the Shed-MEDS clinical trial in a population of people living with dementia (PWD) who reside at Abe’s Garden, a memory care assisted living (ALF). The specific aims of the study are:

Aim 1: Determine the feasibility of implementing the Shed-MEDS deprescribing intervention among PWD residing in a dementia care ALF.

Aim 2: Document the effects of the Shed-MEDS deprescribing intervention on medication burden among PWD.

Aim 3: Document the effects of the patient-centered deprescribing intervention (Shed-MEDS) on the quality of life of PWD.

Study Design: This single-arm pilot trial will evaluate an evidence-based, patient-centered deprescribing intervention with assisted living facility (ALF) residents age 65+ who have a diagnosis of dementia. This deprescribing intervention was demonstrated to be safe and effective in reducing medication burden during the Shed-MEDS randomized clinical trial that enrolled hospitalized older adults discharging to post-acute care facilities. The intervention includes a comprehensive review of a participant’s medications by a study team licensed nurse practitioner and deprescribing recommendations using evidence-based guidelines. Deprescribing recommendations will be shared with residents/surrogate decision makers (i.e., respective family member/s) to determine their willingness to stop or reduce the dose of the targeted medications. If the resident/surrogate-decision maker agrees, deprescribing recommendations will then be communicated with the routine ALF medical providers for consideration and final deprescribing decisions. The primary outcomes measured in this intervention include: 1) the total number of medications deprescribed (defined as medication termination or dose reduction) from enrollment at 30, 60, and 90 days, and 2) Scores on the DEMQOL-Proxy scale at enrollment and 90 days.

2022 – 2023

CO-PRINCIPAL Investigators:

Aanand Naik, MD, McGovern School of Medicine, UT Health Houston 

Holly Holmes, MD, MS, AGSF, McGovern School of Medicine, UT Health Houston

ADRD Supplement:

Priorities Aligned Deprescribing for Persons Living with Dementia and their Caregivers

Background and Importance: Persons living with dementia (PlwD) have a significant burden from multiple chronic conditions and overmedication, and may benefit from deprescribing to reduce polypharmacy. Patient Priorities Care (PPC) is an evidence-based approach to identify outcome goals and care preferences (health priorities) and align care to meet those priorities. Less is known about how PPC works in the context of clinician, caregiver, and persons living with dementia (PlwD). Aligning the priorities of all three individuals is crucial for safe, priorities-guided deprescribing in the setting of dementia. To facilitate the adaptation of the PPC approach to the context of PlwD, we will address the following research aims:

Study Aims:
Aim 1:  Conduct a pilot randomized clinical trial with 50 PlwD and caregiver dyads and their clinicians to compare the PPC approach and usual care to identify differences in post-encounter medication changes, treatment burden, and shared decision making. We will also compare differences in medication changes based on documentation of care preferences and goals by patients, caregivers, or both.

Aim 2: For PPC participants, we will conduct cognitive-task-analyses with primary providers to understand their sense-making and communication approaches related to deprescribing decisions in relation to the identified health priorities.

Aim 3: For all participants, we will conduct a post-encounter follow-up televisit to identify and categorize adverse drug withdrawal events (ADWEs) that occur from deprescribing medications.

Study Design: This is a pilot controlled trial in which we will randomize 50 caregiver and community-dwelling PlwD dyads to PPC versus usual care. PPC consists of (1) an encounter with a facilitator who will identify priorities (outcome goals and care preferences) from the dyads, and (2) a follow-up encounter with their usual provider to decide upon changes in their care that align with the identified priorities. The usual care arm will consist of a usual care visit by the PlwD and their caregivers. For PPC participants, we will record dyad – facilitator encounters and analyze processes, communication, and negotiation that results in the identification of blended priorities placed in the EHR (electronic health record). We will conduct cognitive task analysis to review clinicians’ sense-making of the identified health priorities and their pre-encounter plans to change medications based on observed malalignment. We will probe clinicians about how triadic discussions of the alignment of medications with priorities affected their eventual treatment decisions. We will conduct a blinded 3-month follow-up (chart review and telephone call) to document all medication changes from baseline and identify any adverse drug withdrawal events and their clinical sequela.

2021 – 2022

PRINCIPAL Investigator:

Daniela Moga, MD, PhD, University of Kentucky College of Pharmacy

Gregory Jicha, MD, PhD (MPI), University of Kentucky College of Medicine

ADRD Supplement:

Assessment of Medication Optimization in Rural Kentucky Appalachian Patients With Mild Cognitive Impairment or Dementia: The AMOR-Kentucky Study

Background and Importance: Medication-related problems are often the cause of emergency room visits, hospitalizations, and transition to higher levels of care in older adults experiencing Alzheimer’s Disease or Related Dementias (ADRD) and related cognitive impairments. Medication complexity adds to the caregiver burden and often results in negative health outcomes and diminished quality of life for both the patient with cognitive impairment or dementia and the caregiver. These pose challenges in the best of circumstances, and even more so in the underserved, lower socioeconomic populations in rural Appalachian Kentucky. Outreach into such areas to improve healthcare has been further impacted by the current COVID-19 pandemic. Developing novel, remotely delivered, deprescribing and medication optimization strategies to such populations is an important need and a primary goal of our efforts.

Study Aims:
Aim 1:  To assess feasibility and acceptability of a novel deprescribing intervention to optimize medication regimens using a telemedicine-based approach in rural/underserved Kentucky Appalachian populations with ADRD and related cognitive impairments.

Aim 2:  To obtain preliminary data about the impact of a novel deprescribing intervention on medication appropriateness and number of potentially inappropriate medications (primary outcomes), as well as to explore the impact on cognitive outcomes and effects on caregiver burden/efficacy to be evaluated in future larger intervention studies.

Study Design: We will assess the potential use of telemedicine by performing an initial unblinded, single arm study of a medication therapy management describing intervention in rural/underserved Kentucky Appalachian populations with ADRD and related cognitive impairments using potentially inappropriate medications (n=50). Following initial recruitment and clinical evaluation, participants will have their medication list reviewed by a pharmacist-clinician team to identify targets for deprescribing intervention. After enrollment, the intervention will be delivered by the study team via telemedicine to the participant and their caregiver and then reevaluated at 4 weeks and 3-months during follow-up. Outcome measures will be evaluated 6 months after enrollment and include change in number of medications and medication appropriateness with the intervention, participant and caregiver satisfaction, and evaluation of connectivity issues, along with cognitive outcomes and effects on caregiver burden/efficacy.

PRINCIPAL Investigator:

Ariel Green, MD, MPH, PhD, Johns Hopkins University School of Medicine

SITE PRINCIPAL INVESTIGATOR AT KAISER PERMANENTE COLORADO:

Rebecca Boxer, MD, MS

ADRD Supplement:

Identifying Caregivers to Support Care and Research for Patients with Memory Disorders

Background and Importance: Few deprescribing interventions have specifically identified or engaged family and unpaid caregivers of people living with dementia (PLWD). Purposeful engagement of caregivers is critically important for implementing deprescribing for PLWD but current research is lacking. Ability to pragmatically identify dementia caregivers is a methodologic limitation for pragmatic trials.

Study Aims: Systematically identifying caregivers with responsibility for managing medications would facilitate pragmatic trial recruitment, enable tailored delivery of deprescribing interventions to caregivers and collection of caregiver-reported outcome measures through the electronic medical record. To accomplish this objective, we propose the following specific aims:

  1. To iteratively refine a tool for identifying caregivers of PLWD for future embedded pragmatic deprescribing trials through a user-centered design process involving in-depth interviews with key stakeholders (n=15-20 patient-caregiver dyads and 10-15 direct care staff, clinicians and health system leaders).
  2. To test the resultant tool with 25 patient-caregiver dyads at two healthcare systems (50 dyads in total) to establish proof of concept, feasibility and acceptability of the process.

Study Design: Aim 1 will be a qualitative study based on in-depth, semi-structured interviews. Question guides will elicit stakeholders’ perspectives on how best to identify, engage and support family or unpaid caregivers of PLWD and build their information into the EMR. Findings from Aim 1 will be synthesized and used to inform the development of a simple, scalable tool for identifying caregivers of PLWD. We will initially develop a paper version of the tool, which will allow us to explore ideas, gather feedback from users, and make changes before investing time and money into development of an EMR field. Aim 2 will be a single-arm pilot study lasting 12 weeks. Pilot outcomes will consist of feasibility and acceptability of the tool. The product of Aim 2 will be a tool for identifying caregivers of PLWD that has demonstrated proof of concept and will be applicable to future pragmatic deprescribing trials and, more broadly, to other pragmatic clinical trials of strategies to improve the care of PLWD and their caregivers.

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