NCT04851691

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

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

April 2, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

August 3, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

1.7 years

First QC Date

April 2, 2021

Results QC Date

May 29, 2024

Last Update Submit

August 19, 2024

Conditions

Keywords

Low Value CareAntipsychotic medication

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Number of Patients Who Receive Handout

    12 month time point

  • Number of Patients With ER Visit

    90 days

  • Number of Patients With Hospitalization

    90 days

  • Hospitalizations (Including Psychiatric Hospitalizations)

    90 days

  • Death Within 90 Days After Enrollment

    90 days

Study Arms (2)

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

Behavioral: EHR CDS

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.

Other: Usual Care

Interventions

EHR CDSBEHAVIORAL

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.

EHR CDS tool

Patients will receive usual care from their physicians.

Control

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Health

Los Angeles, California, 90095, United States

Location

Related Publications (19)

  • 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.

    PMID: 17035647BACKGROUND
  • 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.

    PMID: 25133360BACKGROUND
  • 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.

    PMID: 21954480BACKGROUND
  • 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.

    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.

    PMID: 27133416BACKGROUND
  • 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.

    PMID: 15914734BACKGROUND
  • 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.

    PMID: 32808997BACKGROUND
  • 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.

    PMID: 28459906BACKGROUND
  • 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.

    PMID: 25271601BACKGROUND
  • 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.

    PMID: 29331955BACKGROUND
  • 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.

    PMID: 24282310BACKGROUND
  • 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.

    PMID: 22949639BACKGROUND
  • 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.

    PMID: 27159011BACKGROUND
  • 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.

    PMID: 30073273BACKGROUND
  • 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.

    PMID: 12202343BACKGROUND
  • 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.

    PMID: 28631001BACKGROUND
  • 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.

    PMID: 28583965BACKGROUND
  • 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.

    PMID: 30653247BACKGROUND
  • 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.

    PMID: 25373832BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Project Manager
Organization
University of California Los Angeles, Division of General Internal Medicine and Health Services Research

Study Officials

  • Catherine A Sarkisian, MD, MSPH

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2021

First Posted

April 20, 2021

Study Start

August 3, 2021

Primary Completion

April 11, 2023

Study Completion

August 14, 2023

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-08

Locations