Deprescribing Potentially Inappropriate Medications in the Emergency Department for Persons Living with Dementia

Last updated: January 23, 2025
Sponsor: National Institute on Aging (NIA)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Treatment

PRIDE

Clinical Study ID

NCT06273917
FY23_Pilot2_Dresden
  • Ages 18-120
  • All Genders

Study Summary

Aim 1: To demonstrate the feasibility by determining proportion of completed medication reconciliation, Central Nervous System active Potentially Inappropriate Medication (CNS PIM) use among patients with Alzheimer's Disease and Related Dementias (ADRD) and Mild Cognitive Impairment (MCI) in the emergency department (ED), and communication between ED clinical pharmacists and outpatient prescribers.

Aim 2: To demonstrate the feasibility of collecting the primary and secondary outcomes for a subsequent study. The future primary outcome will be reduction in CNS PIMs 90 days after an ED visit. Secondary outcomes will include outpatient follow-up, repeat ED visits, and hospitalizations during the 90 days following an ED visit.

Aim 3: To demonstrate the acceptability of the PRIDE intervention to outpatient clinicians using the Acceptability of Intervention Measure and qualitative analysis of responses.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Community dwelling

  • 18 years of age or older

  • History of dementia or mild cognitive impairment in the problem list in the NM EHR.A history of mild cognitive impairment will be identified using the ICD-10 codeG31.84 (mild cognitive impairment) or ICD-10 codes suggestive of ADRD as describedin the Bynum-standard algorithm: F01.50-F01.51 (vascular dementia), F02.80-F02.81 (dementia), F03.90-F03.91 (unspecified dementia), F04 (amnestic disorder),G30.0/30.1/30.8/G30.9 (Alzheimer's disease), G31.01 (Pick's disease), G31.09 (frontotemporal dementia), G31.83 (dementia with Lewy bodies), G31.1 (seniledegeneration), G31.2 (degeneration of nervous system), R41.81 (age-related cognitivedecline).

  • Able to participate in medication reconciliation as determined by the pharmacist perusual care OR a care partner with knowledge of the patient's current medications ispresent in the ED or is available by phone.

  • Has had prior outpatient care performed at Northwestern Medicine location(s)

  • Arrives to the emergency department between 7am and 7pm, Monday-Friday

Exclusion

Exclusion Criteria:

  • Emergency Severity Index (ESI) of 1 (critical)

  • ICU consult placed in the ED

  • Reside in nursing facility or assisted living facility

Study Design

Total Participants: 290
Treatment Group(s): 1
Primary Treatment: PRIDE
Phase:
Study Start date:
July 09, 2024
Estimated Completion Date:
June 30, 2025

Study Description

This is an embedded pragmatic clinical trial (ePCT) of the Pharmacist Reconciliation of Inappropriate medications and Deprescribing in the Emergency department (PRIDE) intervention which will be implemented as standard care for all community-dwelling adults (age 18+) in the ED with prior outpatient visits within the Northwestern Medicine (NM) healthcare system who have been diagnosed with Alzheimer's Disease and Related Dementias (ADRD) or Mild Cognitive Impairment (MCI) as clinical pharmacist availability allows. The PRIDE program did not exist prior to the initiation of this study. PRIDE is in the process of being implemented at all three hospitals and will continue beyond the end of the research study.

This study will take place at 3 hospital emergency departments within the Northwestern Medicine (NM) Healthcare System. Community-dwelling adults (age 18+) in the ED with prior outpatient visits within the NM system and a history of dementia or mild cognitive impairment recorded in the NM EHR will be eligible for the study.

The primary outcome is the number and percent of patients taking central nervous system potentially inappropriate medications (CNS PIMs) who have documented communication of pharmacist's recommendations for deprescribing on the day of the ED visit. The key secondary outcome is the number and percent of patients with ADRD or MCI in the ED who have documented medication reconciliation by the clinical pharmacist on the day of the ED visit.

Pharmacists present in the ED will perform medication reconciliation for eligible patients. This will be done to demonstrate the feasibility of the PRIDE intervention in the ED for patients with ADRD and MCI. Patients eligible for medication reconciliation will be enrolled in Aim 2 of the study.

Outpatient prescribers of these patients who are discharged from the ED will be contacted by the ED pharmacist on the date of ED discharge and will receive a medication report including fill data 90-100 days after the ED visit.

At the completion of the study, the outpatient clinicians will also receive a questionnaire about the acceptability of the PRIDE program including the Acceptability of Intervention Measure to complete electronically.

Community-dwelling adults (age 18+) in the ED with prior outpatient visits within the NM system and a history of dementia or mild cognitive impairment recorded in the NM EHR will be eligible for inclusion. We will include 290 patients across 3 sites to have medication reconciliation conducted by the clinical pharmacist. Patients who were previously prescribed CNS PIMs will have deprescribing recommendations communicated by the clinical pharmacist to the outpatient prescriber.

Connect with a study center

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois 60045
    United States

    Active - Recruiting

  • Northwestern Medicine Palos Hospital

    Palos Heights, Illinois 60463
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.