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High-Risk Medications in Persons Living With Dementia: A Randomized Clinical Trial
Singh S, Li X, Cocoros NM, Antonelli MT, Avula R, Crawford SL, Dashevsky I, Fouayzi H et al.. JAMA internal medicine, 2024-12-01
Topic: Risk, prevention and care in population studies
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.
Key findings
- 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.
- 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.
- 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.
- 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.
Why it matters
Mailing educational materials to patients and their prescribers did not reduce dispensing of high-risk medications such as antipsychotics, sedative-hypnotics, or strong anticholinergics. This means this type of educational mailing alone did not change prescribing for people with Alzheimer's disease or related dementias.
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Study details
- Study designopen-label trial
- Participants787
- Effect size68.4%; 76.7%; 77.9%
- Evidence strengthHigh
How this study scored 71/100
Published in a leading specialty journal, and it is a randomised controlled trial.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (JAMA internal medicine) |
| Journal's citation record | 3 / 4 | JAMA Internal Medicine: journal h-index 258 (OpenAlex, 2026-10-29) |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 4 / 5 | 2024 — within 3 year(s) of the newest study here |
| Sample size | 2 / 4 | 787 participants |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 1 / 2 | Randomised (as stated in the record) |
| Times cited | 3 / 7 | Cited 20 times (OpenAlex, 2026-10-10) |
| Citations per year | 2 / 5 | 5.0 citations a year over 4 year(s) since 2024 |
| Impact for its field and year | 3 / 6 | Cited 4.7× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 1 / 6 | Cited by 2 other studies in this library |
| Still being cited | 2 / 4 | Cited 20 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 3 / 4 | Last-listed author Jerry H. Gurwitz: h-index 95 (OpenAlex, whole career) |
| Institution's track record | 3 / 3 | Harvard University: institution h-index 3,235 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 6 institution(s) in 2 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 39432286) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 71 / 100 | — |
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Read the original
- DOI: 10.1001/jamainternmed.2024.5632
- PubMed: 39432286
- Original source →
- Free full text: PubMed Central →
Full text: free to read — PubMed Central lists this copy as free to read: the link above (checked 10 Oct 2026).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record's author list ends in “et al.”, so not every author is named. Check the citation against the original before you use it.
APA 7th
Singh, S., Li, X., Cocoros, N. M., Antonelli, M. T., Avula, R., Crawford, S. L., et al. (2024). High-Risk Medications in Persons Living With Dementia: A Randomized Clinical Trial. JAMA internal medicine. https://doi.org/10.1001/jamainternmed.2024.5632
Vancouver
Singh S, Li X, Cocoros NM, Antonelli MT, Avula R, Crawford SL, et al. High-Risk Medications in Persons Living With Dementia: A Randomized Clinical Trial. JAMA internal medicine. 2024. doi:10.1001/jamainternmed.2024.5632. PMID: 39432286.
BibTeX
@article{singh2024-39432286,
author = {Singh, S. and Li, X. and Cocoros, N. M. and Antonelli, M. T. and Avula, R. and Crawford, S. L. and Dashevsky, I. and Fouayzi, H. and others},
title = {{High-Risk Medications in Persons Living With Dementia: A Randomized Clinical Trial}},
journal = {JAMA internal medicine},
year = {2024},
doi = {10.1001/jamainternmed.2024.5632},
pmid = {39432286},
url = {https://doi.org/10.1001/jamainternmed.2024.5632}
}
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