Clinical trial NCT06273917: Deprescribing Potentially Inappropriate Medications in the Emergency Department for Persons Living with Dementia
Official title: Deprescribing Potentially Inappropriate Medications in the Emergency Department for Persons Living with Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Keywords: Depresribing Medication
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
Collaborators: name: Brown University
First posted: 2024-02-23
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pharmacist communication of deprescribing recommendation
timeFrame: 24 hours
Secondary outcomes:
measure: Medication reconciliation
timeFrame: 24 hours
measure: Medication supply of CNS PIMs
timeFrame: 90 days
measure: Outpatient follow up
timeFrame: 90 days
measure: Repeat Emergency Department visits
timeFrame: 90 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Lake Forest
country: United States
facility: Northwestern Medicine Lake Forest Hospital
state: Illinois
city: Palos Heights
country: United States
facility: Northwestern Medicine Palos Hospital
state: Illinois
Study officials:
affiliation: Northwestern University- Department of Emergency Medicine
name: Scott Dresden, Dr.
role: PRINCIPAL_INVESTIGATOR
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