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| Name | Class |
|---|---|
| Brown University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Medication Reconciliation Completed | 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. | 24 hours |
| Participants With Deprescribed Medications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Dresden, Dr. | Northwestern University- Department of Emergency Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States | ||
| Northwestern Medicine Lake Forest Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23390181 | Background | 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. | |
| 29355877 | Background | 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. |
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Emergency Department pharmacists approached patients with prior diagnosis of dementia or MCI to perform medication reconciliation
Emergency Department patients with dementia at three different EDs within one health system were recruited from June 1, 2024 - 6/30/2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | PRIDE Patients | 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. Patients had medication reconciliation conducted by the clinical pharmacist. Patients who were previously prescribed CNS PIMs had deprescribing recommendations communicated by the clinical pharmacist to the outpatient prescriber. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PRIDE Patients | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants With 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. | Posted | Count of Participants | Participants | 24 hours |
|
90 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ED Deprescribing Recommendation | Patients who had pharmacists' deprescribing recommendations communicated to out patient prescribers |
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The study originally planned to track medication supply of central nervous system active potentially inappropriate medications (CNS PIMs), however those data were unavailable. Therefore we tracked deprescribing activity as documented in the outpatient electronic health record.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott M Dresden | Northwestern Memorial Hospital | 312-926-6494 | sdresden@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2024 | Apr 29, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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|
this will be determined through outpatient pharmacy records at day 90. Deprescribing defined as reduction in dose, quantity, or elimination of the prescription
| 90 days |
| Participants With Repeat ED Visits or Hospitalization | Repeat emergency department visits or hospitalizations within 90 days of deprescribing intervention | 90 days |
| Lake Forest |
| Illinois |
| 60045 |
| United States |
| Northwestern Medicine Palos Hospital | Palos Heights | Illinois | 60463 | United States |
| 31403717 | Background | 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. |
| 26523710 | Background | 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. |
| 23177603 | Background | 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. |
| 24890806 | Background | 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. |
| 35247358 | Background | 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. |
| 31732374 | Background | 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. |
| 31663245 | Background | 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. |
| 33646311 | Background | 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. |
| 29318583 | Background | 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. |
| 32223601 | Background | 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. |
| 30180821 | Background | 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. |
| 30535930 | Background | 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. |
| 35343999 | Background | 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. |
| 32012721 | Background | 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. |
| 34919686 | Background | 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. |
| 34282638 | Background | 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. |
| 30693946 | Background | 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. |
| 28851459 | Background | 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. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Site | Count of Participants | Participants |
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| Secondary | Participants With Medication Reconciliation Completed | 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. | Posted | Count of Participants | Participants | 24 hours |
|
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| Secondary | Participants With Deprescribed Medications | this will be determined through outpatient pharmacy records at day 90. Deprescribing defined as reduction in dose, quantity, or elimination of the prescription | Posted | Count of Participants | Participants | 90 days |
|
|
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| Secondary | Participants With Repeat ED Visits or Hospitalization | Repeat emergency department visits or hospitalizations within 90 days of deprescribing intervention | Posted | Count of Participants | Participants | 90 days |
|
|
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| 2 |
| 79 |
| 0 |
| 79 |
| 0 |
| 79 |
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| D001523 | Mental Disorders |