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An Electronic Clinical Decision Support Tool to Reduce Low-value Antipsychotic Prescriptions

Primary Purpose

Alzheimer Disease, Dementia Alzheimers, Dementia of Alzheimer Type

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EHR CDS
Usual Care
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alzheimer Disease focused on measuring Low Value Care, Antipsychotic medication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Physicians who will be eligible to receive the EHR CDS tool intervention include those who provide ambulatory care in the UCLA health system and have newly prescribed antipsychotics (e.g., Quetiepine, Olanzapine, Risperidone, Aripiprazole, Haloperidol, Clozapine) for eligible patients (described below) at the medical center in the last 24 months.
  • Eligible patients will be enrolled in the study during their first encounter with one of the randomized physicians (see above) during which a new antipsychotic medication order will be initiated. Inclusion criteria for patients will include: 1) having an assigned primary care physician (PCP) and/or assignment to an Accountable Care Organization (ACO) at UCLA Health, and: 2) being part of the health system's EHR-based dementia registry.

Exclusion Criteria:

  • Patients who have diagnosis codes for schizophrenic disorders, delusion disorders, bipolar disorders, or other non-organic psychoses on their problem list.
  • Patients with Parkinson's disease on their problem list
  • Patients who have been prescribed antipsychotics in the prior 12 months

Sites / Locations

  • UCLA Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

EHR CDS tool

Control

Arm Description

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

Physicians will not receive intervention and perform duties as usual.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Number of patients with hospitalization
Number of patients with at least one hospitalization within 90 days of being exposed to the intervention
Hospitalizations (including psychiatric hospitalizations)
Hospitalizations (including psychiatric hospitalizations) within 90 days of being exposed to the intervention
Death within 90 days after enrollment
Death within 90 days after enrollment

Full Information

First Posted
April 2, 2021
Last Updated
May 16, 2023
Sponsor
University of California, Los Angeles
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04851691
Brief Title
An Electronic Clinical Decision Support Tool to Reduce Low-value Antipsychotic Prescriptions
Official Title
A Pragmatic Randomized-controlled Trial of a Multi-pronged Electronic Health Record-based Clinical Decision Support Tool to Reduce Low-value Antipsychotic Prescriptions Among Older Adults With Alzheimer's and Related Dementias
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 3, 2021 (Actual)
Primary Completion Date
April 11, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia Alzheimers, Dementia of Alzheimer Type
Keywords
Low Value Care, Antipsychotic medication

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
117 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EHR CDS tool
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Experimental
Arm Description
Physicians will not receive intervention and perform duties as usual.
Intervention Type
Behavioral
Intervention Name(s)
EHR CDS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Patients will receive usual care from their physicians.
Primary Outcome Measure Information:
Title
Cumulative total of new antipsychotic pill-days prescribed
Description
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
Time Frame
12 month time point
Secondary Outcome Measure Information:
Title
Number of patients who receive handout
Description
Number of patients who receive the non-Pharmacologic IDEA Strategy handout at 12 month time point comparing the intervention vs. control
Time Frame
12 month time point
Title
Number of patients with ER visit
Description
Number of patients with at least one emergency department visit within 90 days of being exposed to the intervention
Time Frame
90 days
Title
Number of patients with hospitalization
Description
Number of patients with at least one hospitalization within 90 days of being exposed to the intervention
Time Frame
90 days
Title
Hospitalizations (including psychiatric hospitalizations)
Description
Hospitalizations (including psychiatric hospitalizations) within 90 days of being exposed to the intervention
Time Frame
90 days
Title
Death within 90 days after enrollment
Description
Death within 90 days after enrollment
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Physicians who will be eligible to receive the EHR CDS tool intervention include those who provide ambulatory care in the UCLA health system and have newly prescribed antipsychotics (e.g., Quetiepine, Olanzapine, Risperidone, Aripiprazole, Haloperidol, Clozapine) for eligible patients (described below) at the medical center in the last 24 months. Eligible patients will be enrolled in the study during their first encounter with one of the randomized physicians (see above) during which a new antipsychotic medication order will be initiated. Inclusion criteria for patients will include: 1) having an assigned primary care physician (PCP) and/or assignment to an Accountable Care Organization (ACO) at UCLA Health, and: 2) being part of the health system's EHR-based dementia registry. Exclusion Criteria: Patients who have diagnosis codes for schizophrenic disorders, delusion disorders, bipolar disorders, or other non-organic psychoses on their problem list. Patients with Parkinson's disease on their problem list Patients who have been prescribed antipsychotics in the prior 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine A Sarkisian, MD, MSPH
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17035647
Citation
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.
Results Reference
background
PubMed Identifier
25133360
Citation
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.
Results Reference
background
PubMed Identifier
21954480
Citation
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. Erratum In: JAMA. 2012 Jan 11;307(2):147.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
27133416
Citation
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.
Results Reference
background
PubMed Identifier
15914734
Citation
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.
Results Reference
background
PubMed Identifier
32808997
Citation
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.
Results Reference
background
PubMed Identifier
28459906
Citation
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.
Results Reference
background
PubMed Identifier
25271601
Citation
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.
Results Reference
background
PubMed Identifier
29331955
Citation
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.
Results Reference
background
PubMed Identifier
24282310
Citation
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.
Results Reference
background
PubMed Identifier
22949639
Citation
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.
Results Reference
background
PubMed Identifier
27159011
Citation
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.
Results Reference
background
PubMed Identifier
30073273
Citation
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.
Results Reference
background
PubMed Identifier
12202343
Citation
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.
Results Reference
background
PubMed Identifier
28631001
Citation
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.
Results Reference
background
PubMed Identifier
28583965
Citation
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.
Results Reference
background
PubMed Identifier
30653247
Citation
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. Erratum In: Mov Disord. 2019 May;34(5):765.
Results Reference
background
PubMed Identifier
25373832
Citation
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. Erratum In: J Gen Intern Med. 2016 Apr;31(4):450.
Results Reference
background

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An Electronic Clinical Decision Support Tool to Reduce Low-value Antipsychotic Prescriptions

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