NCT06273917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

July 9, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

November 4, 2025

Status Verified

October 1, 2025

Enrollment Period

1.3 years

First QC Date

February 5, 2024

Last Update Submit

November 3, 2025

Conditions

Keywords

Depresribing Medication

Outcome Measures

Primary Outcomes (1)

  • Pharmacist communication of deprescribing recommendation

    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.

    24 hours

Secondary Outcomes (4)

  • Medication reconciliation

    24 hours

  • Medication supply of CNS PIMs

    90 days

  • Outpatient follow up

    90 days

  • Repeat Emergency Department visits

    90 days

Study Arms (1)

PRIDE Patients

EXPERIMENTAL

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.

Other: PRIDE

Interventions

PRIDEOTHER

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.

PRIDE Patients

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community dwelling
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045, United States

Location

Northwestern Medicine Palos Hospital

Palos Heights, Illinois, 60463, United States

Location

Related Publications (20)

  • Hebert LE, Weuve J, Scherr PA, Evans DA. Alzheimer disease in the United States (2010-2050) estimated using the 2010 census. Neurology. 2013 May 7;80(19):1778-83. doi: 10.1212/WNL.0b013e31828726f5. Epub 2013 Feb 6.

    PMID: 23390181BACKGROUND
  • Hunt LJ, Coombs LA, Stephens CE. Emergency Department Use by Community-Dwelling Individuals With Dementia in the United States: An Integrative Review. J Gerontol Nurs. 2018 Mar 1;44(3):23-30. doi: 10.3928/00989134-20171206-01. Epub 2018 Jan 23.

    PMID: 29355877BACKGROUND
  • Kent T, Lesser A, Israni J, Hwang U, Carpenter C, Ko KJ. 30-Day Emergency Department Revisit Rates among Older Adults with Documented Dementia. J Am Geriatr Soc. 2019 Nov;67(11):2254-2259. doi: 10.1111/jgs.16114. Epub 2019 Aug 12.

    PMID: 31403717BACKGROUND
  • LaMantia MA, Stump TE, Messina FC, Miller DK, Callahan CM. Emergency Department Use Among Older Adults With Dementia. Alzheimer Dis Assoc Disord. 2016 Jan-Mar;30(1):35-40. doi: 10.1097/WAD.0000000000000118.

    PMID: 26523710BACKGROUND
  • Han JH, Wilber ST. Altered mental status in older patients in the emergency department. Clin Geriatr Med. 2013 Feb;29(1):101-36. doi: 10.1016/j.cger.2012.09.005.

    PMID: 23177603BACKGROUND
  • Carpenter CR, Bromley M, Caterino JM, Chun A, Gerson LW, Greenspan J, Hwang U, John DP, Lyons WL, Platts-Mills TF, Mortensen B, Ragsdale L, Rosenberg M, Wilber S; ACEP Geriatric Emergency Medicine Section; American Geriatrics Society; Emergency Nurses Association; Society for Academic Emergency Medicine Academy of Geriatric Emergency Medicine. Optimal older adult emergency care: introducing multidisciplinary geriatric emergency department guidelines from the American College of Emergency Physicians, American Geriatrics Society, Emergency Nurses Association, and Society for Academic Emergency Medicine. J Am Geriatr Soc. 2014 Jul;62(7):1360-3. doi: 10.1111/jgs.12883. Epub 2014 Jun 2.

    PMID: 24890806BACKGROUND
  • Gettel CJ, Falvey JR, Gifford A, Hoang L, Christensen LA, Hwang U, Shah MN; GEAR 2.0-ADC Network. Emergency Department Care Transitions for Patients With Cognitive Impairment: A Scoping Review. J Am Med Dir Assoc. 2022 Aug;23(8):1313.e1-1313.e13. doi: 10.1016/j.jamda.2022.01.076. Epub 2022 Mar 2.

    PMID: 35247358BACKGROUND
  • Southerland LT, Lo AX, Biese K, Arendts G, Banerjee J, Hwang U, Dresden S, Argento V, Kennedy M, Shenvi CL, Carpenter CR. Concepts in Practice: Geriatric Emergency Departments. Ann Emerg Med. 2020 Feb;75(2):162-170. doi: 10.1016/j.annemergmed.2019.08.430. Epub 2019 Nov 13.

    PMID: 31732374BACKGROUND
  • Dresden SM, Hwang U, Garrido MM, Sze J, Kang R, Vargas-Torres C, Courtney DM, Loo G, Rosenberg M, Richardson L. Geriatric Emergency Department Innovations: The Impact of Transitional Care Nurses on 30-day Readmissions for Older Adults. Acad Emerg Med. 2020 Jan;27(1):43-53. doi: 10.1111/acem.13880. Epub 2019 Dec 1.

    PMID: 31663245BACKGROUND
  • Hwang U, Dresden SM, Vargas-Torres C, Kang R, Garrido MM, Loo G, Sze J, Cruz D, Richardson LD, Adams J, Aldeen A, Baumlin KM, Courtney DM, Gravenor S, Grudzen CR, Nimo G, Zhu CW; Geriatric Emergency Department Innovations in Care Through Workforce, Informatics, and Structural Enhancement (GEDI WISE) Investigators. Association of a Geriatric Emergency Department Innovation Program With Cost Outcomes Among Medicare Beneficiaries. JAMA Netw Open. 2021 Mar 1;4(3):e2037334. doi: 10.1001/jamanetworkopen.2020.37334.

    PMID: 33646311BACKGROUND
  • Hwang U, Dresden SM, Rosenberg MS, Garrido MM, Loo G, Sze J, Gravenor S, Courtney DM, Kang R, Zhu CW, Vargas-Torres C, Grudzen CR, Richardson LD; GEDI WISE Investigators. Geriatric Emergency Department Innovations: Transitional Care Nurses and Hospital Use. J Am Geriatr Soc. 2018 Mar;66(3):459-466. doi: 10.1111/jgs.15235. Epub 2018 Jan 10.

    PMID: 29318583BACKGROUND
  • Martinez AI, Abner EL, Jicha GA, Rigsby DN, Eckmann LC, Huffmyer MJ, Moga DC. One-Year Evaluation of a Targeted Medication Therapy Management Intervention for Older Adults. J Manag Care Spec Pharm. 2020 Apr;26(4):520-528. doi: 10.18553/jmcp.2020.26.4.520.

    PMID: 32223601BACKGROUND
  • Wilchesky M, Mueller G, Morin M, Marcotte M, Voyer P, Aubin M, Carmichael PH, Champoux N, Monette J, Giguere A, Durand P, Verreault R, Arcand M, Kroger E. The OptimaMed intervention to reduce inappropriate medications in nursing home residents with severe dementia: results from a quasi-experimental feasibility pilot study. BMC Geriatr. 2018 Sep 4;18(1):204. doi: 10.1186/s12877-018-0895-z.

    PMID: 30180821BACKGROUND
  • Harrison SL, Cations M, Jessop T, Hilmer SN, Sawan M, Brodaty H. Approaches to Deprescribing Psychotropic Medications for Changed Behaviours in Long-Term Care Residents Living with Dementia. Drugs Aging. 2019 Feb;36(2):125-136. doi: 10.1007/s40266-018-0623-6.

    PMID: 30535930BACKGROUND
  • Bayliss EA, Shetterly SM, Drace ML, Norton JD, Maiyani M, Gleason KS, Sawyer JK, Weffald LA, Green AR, Reeve E, Maciejewski ML, Sheehan OC, Wolff JL, Kraus C, Boyd CM. Deprescribing Education vs Usual Care for Patients With Cognitive Impairment and Primary Care Clinicians: The OPTIMIZE Pragmatic Cluster Randomized Trial. JAMA Intern Med. 2022 May 1;182(5):534-542. doi: 10.1001/jamainternmed.2022.0502.

    PMID: 35343999BACKGROUND
  • Houlind MB, Andersen AL, Treldal C, Jorgensen LM, Kannegaard PN, Castillo LS, Christensen LD, Tavenier J, Rasmussen LJH, Ankarfeldt MZ, Andersen O, Petersen J. A Collaborative Medication Review Including Deprescribing for Older Patients in an Emergency Department: A Longitudinal Feasibility Study. J Clin Med. 2020 Jan 27;9(2):348. doi: 10.3390/jcm9020348.

    PMID: 32012721BACKGROUND
  • McCarthy EP, Chang CH, Tilton N, Kabeto MU, Langa KM, Bynum JPW. Validation of Claims Algorithms to Identify Alzheimer's Disease and Related Dementias. J Gerontol A Biol Sci Med Sci. 2022 Jun 1;77(6):1261-1271. doi: 10.1093/gerona/glab373.

    PMID: 34919686BACKGROUND
  • Allore HG, Gnjidic D, Skanderson M, Han L. Association Between Potentially Inappropriate Medications and 30-Day Post-Hospital Discharge Outcomes in US Veterans. Ann Pharmacother. 2022 Mar;56(3):256-263. doi: 10.1177/10600280211032072. Epub 2021 Jul 20.

    PMID: 34282638BACKGROUND
  • By the 2019 American Geriatrics Society Beers Criteria(R) Update Expert Panel. American Geriatrics Society 2019 Updated AGS Beers Criteria(R) for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2019 Apr;67(4):674-694. doi: 10.1111/jgs.15767. Epub 2019 Jan 29.

    PMID: 30693946BACKGROUND
  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

    PMID: 28851459BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Scott Dresden, Dr.

    Northwestern University- Department of Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Scott Dresden

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 23, 2024

Study Start

July 9, 2024

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

November 4, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations