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

IF 22.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL JAMA Internal Medicine Pub Date : 2024-12-01 DOI:10.1001/jamainternmed.2024.5632
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
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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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痴呆症患者的高风险药物治疗:随机临床试验。
重要性:阿尔茨海默病(AD)和阿尔茨海默病相关性痴呆(ADRD)患者可能会因某些高风险药物(包括抗精神病药、镇静催眠药和强抗胆碱能药)处方不当而增加不良后果的风险:目的:评估患者/护理者和开药者邮寄的教育干预措施对AD或ADRD患者潜在不适当处方的影响:这项前瞻性、开放标签、务实的随机临床试验于 2022 年 4 月至 2023 年 6 月在 2 个大型国家医疗计划中进行。试验对象包括患有注意力缺失症(AD)或注意力缺失性精神障碍(ADRD)并使用3类目标减量药物(抗精神病药、镇静催眠药或强抗胆碱能药)中任何一类药物的患者:患者被随机分配到 3 个干预组中的 1 个:(1) 向患者及其开处方的临床医生邮寄针对停药目标药物的教育材料;(2) 仅向开处方的临床医生邮寄教育材料;或 (3) 常规护理组:采用改良的意向治疗法进行分析。主要研究结果是在为期 6 个月的研究观察期内,针对取消处方的药物的配发情况。次要结果包括特定药物平均日剂量和医疗服务利用率的变化:在纳入修正意向治疗分析的 12 787 名患者中,有 8 742 人(68.4%)为女性,平均(标清)年龄为 77.3(9.4)岁。在患者和处方医生邮寄组中,被处方为取消处方目标药物的累计发生率为 76.7% (95% CI, 75.4-78.0);在仅处方医生邮寄组中,发生率为 77.9% (95% CI, 76.5-79.1);在常规护理组中,发生率为 77.5% (95% CI, 76.2-78.8)。与常规护理组相比,患者和开处方者组的危险比为 0.99(95% CI,0.94-1.04),仅开处方者组的危险比为 1.00(95% CI,0.96-1.06)。在次要结果方面,各组之间没有差异:这些研究结果表明,针对AD或ADRD患者及其临床医生的特定药物教育邮件并不能有效减少高风险药物的使用:试验注册:ClinicalTrials.gov Identifier:NCT05147428。
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来源期刊
JAMA Internal Medicine
JAMA Internal Medicine MEDICINE, GENERAL & INTERNAL-
CiteScore
43.50
自引率
1.30%
发文量
371
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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