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. 2024 Dec 1;184(12):1426-1433.
doi: 10.1001/jamainternmed.2024.5632.

High-Risk Medications in Persons Living With Dementia: A Randomized Clinical Trial

Sonal Singh  1 , Xiaojuan Li  2 , Noelle M Cocoros  2 , Mary T Antonelli  3 , Ramya Avula  4 , Sybil L Crawford  5 , Inna Dashevsky  2 , Hassan Fouayzi  6 , Thomas P Harkins  7 , Kathleen M Mazor  6 , Ashley I Michnick  2 , Lauren Parlett  4 , Mark Paullin  4 , Richard Platt  2 , Paula A Rochon  8 , Cassandra Saphirak  6 , Mia Si  4 , Yunping Zhou  7 , Jerry H Gurwitz  9
Affiliations

High-Risk Medications in Persons Living With Dementia: A Randomized Clinical Trial

Sonal Singh et al. JAMA Intern Med. .

Abstract

Importance: Individuals with Alzheimer disease (AD) and Alzheimer disease-related dementias (ADRD) may be at increased risk for adverse outcomes relating to inappropriate prescribing of certain high-risk medications, including antipsychotics, sedative-hypnotics, and strong anticholinergic agents.

Objective: To evaluate the effect of a patient/caregiver and prescriber-mailed educational intervention on potentially inappropriate prescribing to patients with AD or ADRD.

Design, setting, and participants: This prospective, open-label, pragmatic randomized clinical trial, embedded in 2 large national health plans, was conducted from April 2022 to June 2023. The trial included patients with AD or ADRD and use of any of 3 drug classes targeted for deprescribing (antipsychotics, sedative-hypnotics, or strong anticholinergics).

Interventions: Patients were randomized to 1 of 3 arms: (1) a mailing of educational materials specific to the medication targeted for deprescribing to both the patient and their prescribing clinician; (2) a mailing to the prescribing clinician only; or (3) a usual care arm.

Main outcomes and measures: Analysis was performed using a modified intention-to-treat approach. The primary study outcome was the dispensing of the medication targeted for deprescribing during a 6-month study observation period. Secondary outcomes included changes in medication-specific mean daily dose and health service utilization.

Results: Among 12 787 patients included in the modified intention-to-treat analysis, 8742 (68.4%) were female, and the mean (SD) age was 77.3 (9.4) years. The cumulative incidence of being dispensed a medication targeted for deprescribing was 76.7% (95% CI, 75.4-78.0) in the patient and prescriber mailing group, 77.9% (95% CI, 76.5-79.1) in the prescriber mailing only group, and 77.5% (95% CI, 76.2-78.8) in the usual care group. Hazard ratios were 0.99 (95% CI, 0.94-1.04) for the patient and prescriber group and 1.00 (95% CI, 0.96-1.06) for the prescriber only group compared with the usual care group. There were no differences between the groups for secondary outcomes.

Conclusions and relevance: These findings suggest medication-specific educational mailings targeting patients with AD or ADRD and their clinicians are not effective in reducing the use of high-risk medications.

Trial registration: ClinicalTrials.gov Identifier: NCT05147428.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Li reported grants from the National Institute on Aging outside the submitted work. Dr Cocoros reported grants from the National Institutes of Health during the conduct of the study. Ms Avula reported stock ownership from Elevance Health and grants from UMass Chan Medical School during the conduct of the study. Dr Crawford reported grants from the National Institute on Aging during the conduct of the study. Dr Fouayzi reported grants from the National Institute on Aging during the conduct of the study. Dr Mazor reported grants from the National Institute on Aging during the conduct of the study. Dr Parlett reported stock ownership from Elevance Health and grants from UMass Chan Medical School during the conduct of the study as well as grants from Pfizer and Sanofi outside the submitted work. Mr Paullin reported grants from UMass Chan Medical School during the conduct of the study. Dr Platt reported grants from GlaxoSmithKline, Janssen Pharmaceuticals, and Pfizer paid to his academic institution outside the submitted work. Ms Saphirak reported grants from the National Institute on Aging during the conduct of the study. Ms Si reported grants from UMass Chan Medical School during the conduct of the study as well as grants from Harvard Pilgrim Healthcare Institute outside the submitted work. Ms Zhou reported grants from UMass Chan Medical School during the conduct of the study. Dr Gurwitz reported grants from the National Institute on Aging during the conduct of the study as well as personal fees from United Healthcare outside the submitted work. No other disclosures were reported.

Comment in

References

    1. Hukins D, Macleod U, Boland JW. Identifying potentially inappropriate prescribing in older people with dementia: a systematic review. Eur J Clin Pharmacol. 2019;75(4):467-481. doi:10.1007/s00228-018-02612-x - DOI - PubMed
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    1. Pokorney SD, Cocoros N, Al-Khalidi HR, et al. . Effect of mailing educational material to patients with atrial fibrillation and their clinicians on use of oral anticoagulants: a randomized clinical trial. JAMA Netw Open. 2022;5(5):e2214321. doi:10.1001/jamanetworkopen.2022.14321 - DOI - PMC - PubMed

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