Sonal Singh, Xiaojuan Li, Noelle M Cocoros, Mary T Antonelli, Ramya Avula, Sybil L Crawford, Inna Dashevsky, Hassan Fouayzi, Thomas P Harkins, Kathleen M Mazor, Ashley I Michnick, Lauren Parlett, Mark Paullin, Richard Platt, Paula A Rochon, Cassandra Saphirak, Mia Si, Yunping Zhou, Jerry H Gurwitz
{"title":"痴呆症患者的高风险药物治疗：随机临床试验。","authors":"Sonal Singh, Xiaojuan Li, Noelle M Cocoros, Mary T Antonelli, Ramya Avula, Sybil L Crawford, Inna Dashevsky, Hassan Fouayzi, Thomas P Harkins, Kathleen M Mazor, Ashley I Michnick, Lauren Parlett, Mark Paullin, Richard Platt, Paula A Rochon, Cassandra Saphirak, Mia Si, Yunping Zhou, Jerry H Gurwitz","doi":"10.1001/jamainternmed.2024.5632","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>To evaluate the effect of a patient/caregiver and prescriber-mailed educational intervention on potentially inappropriate prescribing to patients with AD or ADRD.</p><p><strong>Design, setting, and participants: </strong>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).</p><p><strong>Interventions: </strong>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.</p><p><strong>Main outcomes and measures: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions and relevance: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT05147428.</p>","PeriodicalId":14714,"journal":{"name":"JAMA Internal Medicine","volume":" ","pages":"1426-1433"},"PeriodicalIF":22.5000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11581620/pdf/","citationCount":"0","resultStr":"{\"title\":\"High-Risk Medications in Persons Living With Dementia: A Randomized Clinical Trial.\",\"authors\":\"Sonal Singh, Xiaojuan Li, Noelle M Cocoros, Mary T Antonelli, Ramya Avula, Sybil L Crawford, Inna Dashevsky, Hassan Fouayzi, Thomas P Harkins, Kathleen M Mazor, Ashley I Michnick, Lauren Parlett, Mark Paullin, Richard Platt, Paula A Rochon, Cassandra Saphirak, Mia Si, Yunping Zhou, Jerry H Gurwitz\",\"doi\":\"10.1001/jamainternmed.2024.5632\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>To evaluate the effect of a patient/caregiver and prescriber-mailed educational intervention on potentially inappropriate prescribing to patients with AD or ADRD.</p><p><strong>Design, setting, and participants: </strong>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).</p><p><strong>Interventions: </strong>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.</p><p><strong>Main outcomes and measures: </strong>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.</p><p><strong>Results: </strong>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. 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High-Risk Medications in Persons Living With Dementia: A Randomized Clinical Trial.
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.
期刊介绍：
JAMA Internal Medicine is an international, peer-reviewed journal committed to advancing the field of internal medicine worldwide. With a focus on four core priorities—clinical relevance, clinical practice change, credibility, and effective communication—the journal aims to provide indispensable and trustworthy peer-reviewed evidence.
Catering to academics, clinicians, educators, researchers, and trainees across the entire spectrum of internal medicine, including general internal medicine and subspecialties, JAMA Internal Medicine publishes innovative and clinically relevant research. The journal strives to deliver stimulating articles that educate and inform readers with the latest research findings, driving positive change in healthcare systems and patient care delivery.
As a member of the JAMA Network, a consortium of peer-reviewed medical publications, JAMA Internal Medicine plays a pivotal role in shaping the discourse and advancing patient care in internal medicine.
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