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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG059815-01 | U.S. NIH Grant/Contract | View source | |
| R01AG059815-01S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The goal of this study will be to design, implement and test the impact of a quality improvement (QI) intervention that uses an EHR CDS tool among physicians newly ordering an antipsychotic medication for older adults with ADRD. The study team hypothesizes that the intervention will reduce each participating clinician's pill days per patient prescribed.
Importance: Among patients with Alzheimer's disease and its related dementias (ADRD) with behavioral disturbances, antipsychotic prescriptions have limited efficacy and substantially increase risk of death. Despite an FDA 2005 "black box" warning and multiple professional physician society guidelines discouraging their use, physicians continue to frequently prescribe antipsychotic medications as first-line therapy for behavioral disturbances among patients with ADRD.
Objective: This study will measure the impact of a multi-pronged electronic health record (EHR) clinical decision support (CDS) tool intervention to reduce physician prescriptions of new antipsychotic medications among older adults with ADRD.
Design, Setting, and Participants: Utilizing a pragmatic parallel cluster-randomized trial design, the study will randomize eligible physicians from a large urban academic medical center to either receive an EHR CDS tool (intervention) or not (control) when they prescribe a new antipsychotic medication during a visit with a patient with ADRD. The intervention will include three components: (1) alerts the prescriber that antipsychotic prescriptions increase mortality; (2) offers non-pharmacological behavioral resources for caregivers; and if the prescriber does not cancel the order (3) auto-defaults the prescription to contain the lowest dose and number of pills (n=30) without refills. In addition, the PI will email all providers randomized to the intervention arm in order to make them aware of the components of this intervention and its motivation. Acknowledging the clinical complexity of this vulnerable patient population, the multidisciplinary study team attempted to design the intervention to maximize impact while minimizing clinician burden. Over a one-year timeframe, the study team will compare the cumulative total of new antipsychotic pill-days prescribed (primary outcome) by physicians in the intervention group versus in the control group.
Hypothesis: This pragmatic trial will advance understanding of how a multi-pronged EHR CDS tool can potentially reduce harmful, low-value care among older adults with ADRD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EHR CDS tool | Experimental | Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the EHR CDS tool. Multi-pronged electronic health record (EHR) clinical decision support (CDS) tool intervention to reduce physician prescriptions of new antipsychotic medications among older adults with ADRD |
|
| Control | Experimental | Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the control. Physicians will not receive intervention and perform duties as usual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EHR CDS | Behavioral | When a clinician initiates a new antipsychotic prescription for a patient with dementia, a three-pronged electronic health record clinical decision support tool "pops up": (1) Alerting clinicians that antipsychotic prescriptions increase patient mortality; (2) Offering non-pharmacological behavioral resources for caregivers via a link to the IDEA! strategy resources on how caregivers can best manage a patient's behavioral disturbance non-pharmacologically, which will be available in the EHR to include in the patient's after visit summary; and (3) Defaulting prescriptions to a low supply of pills in to order to minimize harm. In addition, the PI will email all providers randomized to the intervention arm in order to make them aware of the components of this intervention and its motivation. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Total of New Antipsychotic Pill-days Prescribed | Cumulative total of new antipsychotic prescription days supplied by clinicians per eligible patient in the 12 months after the intervention rollout date compared to the prior 12-months | 12 month time point |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Receive Handout | Number of patients who receive the non-Pharmacologic IDEA Strategy handout at 12 month time point comparing the intervention vs. control | 12 month time point |
| Number of Patients With ER Visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine A Sarkisian, MD, MSPH | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Health | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17035647 | Background | Schneider LS, Tariot PN, Dagerman KS, Davis SM, Hsiao JK, Ismail MS, Lebowitz BD, Lyketsos CG, Ryan JM, Stroup TS, Sultzer DL, Weintraub D, Lieberman JA; CATIE-AD Study Group. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer's disease. N Engl J Med. 2006 Oct 12;355(15):1525-38. doi: 10.1056/NEJMoa061240. | |
| 25133360 | Background | Hwang YJ, Dixon SN, Reiss JP, Wald R, Parikh CR, Gandhi S, Shariff SZ, Pannu N, Nash DM, Rehman F, Garg AX. Atypical antipsychotic drugs and the risk for acute kidney injury and other adverse outcomes in older adults: a population-based cohort study. Ann Intern Med. 2014 Aug 19;161(4):242-8. doi: 10.7326/M13-2796. |
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Patients were enrolled into the study when an eligible provider initiated a new antipsychotic prescription (e.g., Quetiapine, Olanzapine, Risperidone, Aripiprazole, Haloperidol, Clozapine) during a patient visit. Eligible providers were assigned an arm of the study based on their 2019 new antipsychotic orders for this population. Patients were enrolled into each arm based on the providers arm assignment. Healthcare Providers were not enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | EHR CDS Tool | Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the EHR CDS tool. The three-pronged electronic health record clinical decision support tool "pops up": (1) Alerting clinicians that antipsychotic prescriptions increase patient mortality; (2) Offering non-pharmacological behavioral resources for caregivers via a link to the IDEA! strategy resources on how caregivers can best manage a patient's behavioral disturbance non-pharmacologically, which will be available in the EHR to include in the patient's after visit summary; and (3) Defaulting prescriptions to a low supply of pills in to order to minimize harm. In addition, the PI will email all providers randomized to the intervention arm in order to make them aware of the components of this intervention and its motivation. |
| FG001 | Control | Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the control. Usual Care: Patients will receive usual care from their physicians. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Providers were not assessed for baseline
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| ID | Title | Description |
|---|---|---|
| BG000 | EHR CDS Tool | Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the EHR CDS tool. Multi-pronged electronic health record (EHR) clinical decision support (CDS) tool intervention to reduce physician prescriptions of new antipsychotic medications among older adults with ADRD EHR CDS: When a clinician initiates a new antipsychotic prescription for a patient with dementia, a three-pronged electronic health record clinical decision support tool "pops up": (1) Alerting clinicians that antipsychotic prescriptions increase patient mortality; (2) Offering non-pharmacological behavioral resources for caregivers via a link to the IDEA! strategy resources on how caregivers can best manage a patient's behavioral disturbance non-pharmacologically, which will be available in the EHR to include in the patient's after visit summary; and (3) Defaulting prescriptions to a low supply of pills in to order to minimize harm. In addition, the PI will email all providers randomized to the intervention arm in order to make them aware of the components of this intervention and its motivation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Cumulative Total of New Antipsychotic Pill-days Prescribed | Cumulative total of new antipsychotic prescription days supplied by clinicians per eligible patient in the 12 months after the intervention rollout date compared to the prior 12-months | Patients that received a new antipsychotic prescription (e.g., Quetiapine, Olanzapine, Risperidone, Aripiprazole, Haloperidol, Clozapine) from an eligible provider. | Posted | Number | New antipsychotic prescription days | 12 month time point |
|
Participants were tracked for adverse events 3 months after their first encounter with a randomized physician during which a new antipsychotic medication order is initiated.
An adverse event is defined as an Emergency Department visit that did not require hospitalization.
Serious adverse events include hospitalization or death.
Providers were not assessed for adverse events
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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 | EHR CDS Tool | Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the EHR CDS tool. Multi-pronged electronic health record (EHR) clinical decision support (CDS) tool intervention to reduce physician prescriptions of new antipsychotic medications among older adults with ADRD EHR CDS: When a clinician initiates a new antipsychotic prescription for a patient with dementia, a three-pronged electronic health record clinical decision support tool "pops up": (1) Alerting clinicians that antipsychotic prescriptions increase patient mortality; (2) Offering non-pharmacological behavioral resources for caregivers via a link to the IDEA! strategy resources on how caregivers can best manage a patient's behavioral disturbance non-pharmacologically, which will be available in the EHR to include in the patient's after visit summary; and (3) Defaulting prescriptions to a low supply of pills in to order to minimize harm. In addition, the PI will email all providers randomized to the intervention arm in order to make them aware of the components of this intervention and its motivation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient Admission | General disorders | Systematic Assessment | All cause inpatient admissions of enrolled participants were chart reviewed when admitted up to 30 days following enrollment encounter. All reasons for visit were considered eligible for review |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Department visits that did not require admissions | General disorders | Systematic Assessment | All cause emergency department visits of enrolled participants were chart reviewed when visit occurred up to 30 days following enrollment encounter. All reasons for visit were considered eligible for review |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | University of California Los Angeles, Division of General Internal Medicine and Health Services Research | 310-825-8253 | cvillaflores@mednet.ucla.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 | Aug 3, 2021 | May 28, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Usual Care | Other | Patients will receive usual care from their physicians. |
|
Number of patients with at least one emergency department visit within 90 days of being exposed to the intervention
| 90 days |
| Number of Patients With Hospitalization | Number of patients with at least one hospitalization within 90 days of being exposed to the intervention | 90 days |
| Hospitalizations (Including Psychiatric Hospitalizations) | Hospitalizations (including psychiatric hospitalizations) within 90 days of being exposed to the intervention | 90 days |
| Death Within 90 Days After Enrollment | Death within 90 days after enrollment | 90 days |
| 21954480 | Background | Maher AR, Maglione M, Bagley S, Suttorp M, Hu JH, Ewing B, Wang Z, Timmer M, Sultzer D, Shekelle PG. Efficacy and comparative effectiveness of atypical antipsychotic medications for off-label uses in adults: a systematic review and meta-analysis. JAMA. 2011 Sep 28;306(12):1359-69. doi: 10.1001/jama.2011.1360. |
| Background | American Geriatrics Society. Ten things clinicians and patients should question. Choosing wisely: an initiative of the ABIM foundation. http://www.choosingwisely.org/societies/american-geriatrics-society/. Accessed Revised April 23, 2015. |
| 27133416 | Background | Reus VI, Fochtmann LJ, Eyler AE, Hilty DM, Horvitz-Lennon M, Jibson MD, Lopez OL, Mahoney J, Pasic J, Tan ZS, Wills CD, Rhoads R, Yager J. The American Psychiatric Association Practice Guideline on the Use of Antipsychotics to Treat Agitation or Psychosis in Patients With Dementia. Am J Psychiatry. 2016 May 1;173(5):543-6. doi: 10.1176/appi.ajp.2015.173501. No abstract available. |
| 15914734 | Background | Kuehn BM. FDA warns antipsychotic drugs may be risky for elderly. JAMA. 2005 May 25;293(20):2462. doi: 10.1001/jama.293.20.2462. No abstract available. |
| 32808997 | Background | Maust DT, Strominger J, Bynum JPW, Langa KM, Gerlach LB, Zivin K, Marcus SC. Prevalence of Psychotropic and Opioid Prescription Fills Among Community-Dwelling Older Adults With Dementia in the US. JAMA. 2020 Aug 18;324(7):706-708. doi: 10.1001/jama.2020.8519. |
| 28459906 | Background | Morgan DJ, Leppin AL, Smith CD, Korenstein D. A Practical Framework for Understanding and Reducing Medical Overuse: Conceptualizing Overuse Through the Patient-Clinician Interaction. J Hosp Med. 2017 May;12(5):346-351. doi: 10.12788/jhm.2738. |
| 25271601 | Background | Colla CH. Swimming against the current--what might work to reduce low-value care? N Engl J Med. 2014 Oct 2;371(14):1280-3. doi: 10.1056/NEJMp1404503. No abstract available. |
| 29331955 | Background | Mafi JN, Parchman M. Low-value care: an intractable global problem with no quick fix. BMJ Qual Saf. 2018 May;27(5):333-336. doi: 10.1136/bmjqs-2017-007477. Epub 2018 Jan 13. No abstract available. |
| 24282310 | Background | Bourdeaux CP, Davies KJ, Thomas MJ, Bewley JS, Gould TH. Using 'nudge' principles for order set design: a before and after evaluation of an electronic prescribing template in critical care. BMJ Qual Saf. 2014 May;23(5):382-8. doi: 10.1136/bmjqs-2013-002395. Epub 2013 Nov 26. |
| 22949639 | Background | Davidai S, Gilovich T, Ross LD. The meaning of default options for potential organ donors. Proc Natl Acad Sci U S A. 2012 Sep 18;109(38):15201-5. doi: 10.1073/pnas.1211695109. Epub 2012 Sep 4. |
| 27159011 | Background | Patel MS, Day SC, Halpern SD, Hanson CW, Martinez JR, Honeywell S Jr, Volpp KG. Generic Medication Prescription Rates After Health System-Wide Redesign of Default Options Within the Electronic Health Record. JAMA Intern Med. 2016 Jun 1;176(6):847-8. doi: 10.1001/jamainternmed.2016.1691. No abstract available. |
| 30073273 | Background | Sacarny A, Barnett ML, Le J, Tetkoski F, Yokum D, Agrawal S. Effect of Peer Comparison Letters for High-Volume Primary Care Prescribers of Quetiapine in Older and Disabled Adults: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Oct 1;75(10):1003-1011. doi: 10.1001/jamapsychiatry.2018.1867. |
| 12202343 | Background | Roddy E, Jones E. On Hippocrates. Hippocratic ideals are alive and well in 21st century. BMJ. 2002 Aug 31;325(7362):496. doi: 10.1136/bmj.325.7362.496/a. No abstract available. |
| 28631001 | Background | Liao JM, Schapira MS, Navathe AS, Mitra N, Weissman A, Asch DA. The Effect of Emphasizing Patient, Societal, and Institutional Harms of Inappropriate Antibiotic Prescribing on Physician Support of Financial Penalties: A Randomized Trial. Ann Intern Med. 2017 Aug 1;167(3):215-216. doi: 10.7326/L17-0102. Epub 2017 Jun 20. No abstract available. |
| 28583965 | Background | Schpero WL, Morden NE, Sequist TD, Rosenthal MB, Gottlieb DJ, Colla CH. For Selected Services, Blacks And Hispanics More Likely To Receive Low-Value Care Than Whites. Health Aff (Millwood). 2017 Jun 1;36(6):1065-1069. doi: 10.1377/hlthaff.2016.1416. |
| 30653247 | Background | Seppi K, Ray Chaudhuri K, Coelho M, Fox SH, Katzenschlager R, Perez Lloret S, Weintraub D, Sampaio C; the collaborators of the Parkinson's Disease Update on Non-Motor Symptoms Study Group on behalf of the Movement Disorders Society Evidence-Based Medicine Committee. Update on treatments for nonmotor symptoms of Parkinson's disease-an evidence-based medicine review. Mov Disord. 2019 Feb;34(2):180-198. doi: 10.1002/mds.27602. Epub 2019 Jan 17. |
| 25373832 | Background | Colla CH, Morden NE, Sequist TD, Schpero WL, Rosenthal MB. Choosing wisely: prevalence and correlates of low-value health care services in the United States. J Gen Intern Med. 2015 Feb;30(2):221-8. doi: 10.1007/s11606-014-3070-z. Epub 2014 Nov 6. |
| BG001 | Control | Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the control. Physicians will not receive intervention and perform duties as usual. Usual Care: Patients will receive usual care from their physicians. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Control | Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the control. Physicians will not receive intervention and perform duties as usual. Usual Care: Patients will receive usual care from their physicians. |
|
|
| Secondary | Number of Patients Who Receive Handout | Number of patients who receive the non-Pharmacologic IDEA Strategy handout at 12 month time point comparing the intervention vs. control | All participants enrolled in the study were eligible to receive the non-Pharmacologic IDEA Strategy handout | Posted | Count of Participants | Participants | 12 month time point |
|
|
|
| Secondary | Number of Patients With ER Visit | Number of patients with at least one emergency department visit within 90 days of being exposed to the intervention | Not Posted | 90 days | Participants |
| Secondary | Number of Patients With Hospitalization | Number of patients with at least one hospitalization within 90 days of being exposed to the intervention | Not Posted | 90 days | Participants |
| Secondary | Hospitalizations (Including Psychiatric Hospitalizations) | Hospitalizations (including psychiatric hospitalizations) within 90 days of being exposed to the intervention | Not Posted | 90 days | Participants |
| Secondary | Death Within 90 Days After Enrollment | Death within 90 days after enrollment | Not Posted | 90 days | Participants |
| 1 |
| 67 |
| 2 |
| 67 |
| 4 |
| 67 |
| EG001 | Control | Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the control. Physicians will not receive intervention and perform duties as usual. Usual Care: Patients will receive usual care from their physicians. | 2 | 91 | 12 | 91 | 6 | 91 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |