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OpenTrials
Completed

NCT Number: NCT06273917

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

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.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 code G31.84 (mild cognitive impairment) or ICD-10 codes suggestive of ADRD as described in 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 (senile degeneration), G31.2 (degeneration of nervous system), R41.81 (age-related cognitive decline).
  • Able to participate in medication reconciliation as determined by the pharmacist per usual care OR a care partner with knowledge of the patient's current medications is present 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 criteria

  • Emergency Severity Index (ESI) of 1 (critical)
  • ICU consult placed in the ED
  • Reside in nursing facility or assisted living facility

Treatment and study plan

PRIDE

Other

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.

Primary outcomes

  1. Participants With Pharmacist Communication of Deprescribing Recommendation

    Time frame: 24 hours

    This will be determined if the ED pharmacist sends an electronic message through the EHR to the outpatient prescriber with de-prescribing recommendations for patients who are taking CNS PIMs. This will be performed on Day 0 in the Emergency Department.

Secondary outcomes

  1. Participants With Medication Reconciliation Completed

    Time frame: 24 hours

    This will be determined if the ED pharmacist enters a medication reconciliation document into the EHR. This will occur on Day 0 in the ED.

  2. Participants With Deprescribed Medications

    Time frame: 90 days

    this will be determined through outpatient pharmacy records at day 90. Deprescribing defined as reduction in dose, quantity, or elimination of the prescription

  3. Participants With Repeat ED Visits or Hospitalization

    Time frame: 90 days

    Repeat emergency department visits or hospitalizations within 90 days of deprescribing intervention

Sponsors and collaborators

Lead sponsor

National Institute on Aging (NIA)

Nih

Collaborators

  • Brown University

Registry information

Acronym: IMPACT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2024
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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