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

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

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.

Publication types

  • Pragmatic Clinical Trial
  • Comment

MeSH terms

  • Aged
  • Aged, 80 and over
  • Alzheimer Disease / drug therapy
  • Antipsychotic Agents / therapeutic use
  • Cholinergic Antagonists / administration & dosage
  • Cholinergic Antagonists / therapeutic use
  • Dementia* / drug therapy
  • Deprescriptions
  • Female
  • Humans
  • Hypnotics and Sedatives / administration & dosage
  • Hypnotics and Sedatives / therapeutic use
  • Inappropriate Prescribing* / prevention & control
  • Inappropriate Prescribing* / statistics & numerical data
  • Male
  • Patient Education as Topic / methods
  • Prospective Studies

Substances

  • Antipsychotic Agents
  • Cholinergic Antagonists
  • Hypnotics and Sedatives

Associated data

  • ClinicalTrials.gov/NCT05147428