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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04851691
• Other study ID #: R01AG059815-01S1
• Secondary ID: 1R01AG059815-01R
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 3, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 117
• Est. completion date: July 31, 2024
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia Alzheimers
• Dementia of Alzheimer Type

Intervention

Behavioral:
• 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.

Other:
• Usual Care
Patients will receive usual care from their physicians.

Locations

Country	Name	City	State
United States	UCLA Health	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (19)

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.

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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	12 month time point
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	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	90 days
Secondary	Number of patients with hospitalization	Number of patients with at least one hospitalization within 90 days of being exposed to the intervention	90 days
Secondary	Hospitalizations (including psychiatric hospitalizations)	Hospitalizations (including psychiatric hospitalizations) within 90 days of being exposed to the intervention	90 days
Secondary	Death within 90 days after enrollment	Death within 90 days after enrollment	90 days