■导致不良健康结果的高风险药物经常被处方给老年人。取消处方的干预措施减少了它们的使用,但研究的目的往往不是为了检查对患者相关健康结局的影响.
■为了测试针对老年人及其初级保健临床医生的医疗系统嵌入式处方干预措施的效果,以减少中枢神经系统活性药物的使用并防止药物治疗的跌倒。
■在这个随机分组中,平行组,临床试验,从2021年4月1日至2022年6月16日,从华盛顿州的综合医疗保健提供系统中招募了18个初级保健实践,以及他们符合条件的病人。随机化发生在临床水平。患者为60岁或以上的社区居住成年人,从5种靶向药物类别中的任何一种中开出至少1种药物(阿片类药物,镇静催眠药,骨骼肌松弛剂,三环抗抑郁药,和第一代抗组胺药)至少连续3个月。
■患者教育和临床医生决策支持。控制臂参与者接受常规护理。
■主要结果是药物治疗的跌倒。次要结果包括停药,持续停药,减少任何和每种目标药物的剂量。涉及阿片类药物或镇静催眠药的严重不良停药事件是主要的安全性结果。使用意向治疗分析进行分析。
■在2367名患者参与者中(平均[SD]年龄,70.6[7.6]岁;1488名妇女[63%]),干预组18个月时首次接受药物治疗的跌倒的校正累积发生率为0.33(95%CI,0.29-0.37),常规护理组为0.30(95%CI,0.27-0.34)(估计的校正风险比,1.11(95%CI,0.94-1.31)(P=.11)。干预组在停药方面存在显著差异,持续停药,并在6个月时减少三环抗抑郁药的剂量(停药调整率:干预组,0.23[95%CI,0.18-0.28]与常规护理组相比,0.13[95%CI,0.09-0.17];调整后相对风险,1.79[95%CI,1.29-2.50];P=.001)和次要时间点(9、12和15个月)。
■在这项针对社区居住的老年人的医疗系统嵌入处方干预的随机临床试验中,规定了中枢神经系统活性药物及其初级保健临床医生,在减少药物治疗的跌倒方面,干预没有比常规治疗更有效.对于将处方作为常规临床实践一部分的卫生系统,额外的干预措施可能会给处方带来适度的益处,而不会对临床结局产生可测量的影响.
■ClinicalTrials.gov标识符:NCT05689554。
UNASSIGNED: High-risk medications that contribute to adverse health outcomes are frequently prescribed to older adults. Deprescribing interventions reduce their use, but studies are often not designed to examine effects on patient-relevant health outcomes.
UNASSIGNED: To test the effect of a health system-embedded deprescribing intervention targeting older adults and their primary care clinicians for reducing the use of central nervous system-active drugs and preventing medically treated falls.
UNASSIGNED: In this cluster randomized, parallel-group, clinical trial, 18 primary care practices from an integrated health care delivery system in Washington state were recruited from April 1, 2021, to June 16, 2022, to participate, along with their eligible patients. Randomization occurred at the clinic level. Patients were community-dwelling adults aged 60 years or older, prescribed at least 1 medication from any of 5 targeted medication classes (opioids, sedative-hypnotics, skeletal muscle relaxants, tricyclic antidepressants, and first-generation antihistamines) for at least 3 consecutive months.
UNASSIGNED: Patient education and clinician decision support. Control arm participants received usual care.
UNASSIGNED: The primary outcome was medically treated falls. Secondary outcomes included medication discontinuation, sustained medication discontinuation, and dose reduction of any and each target medication. Serious adverse drug withdrawal events involving opioids or sedative-hypnotics were the main safety outcome. Analyses were conducted using intent-to-treat analysis.
UNASSIGNED: Among 2367 patient participants (mean [SD] age, 70.6 [7.6] years; 1488 women [63%]), the adjusted cumulative incidence rate of a first medically treated fall at 18 months was 0.33 (95% CI, 0.29-0.37) in the intervention group and 0.30 (95% CI, 0.27-0.34) in the usual care group (estimated adjusted hazard ratio, 1.11 (95% CI, 0.94-1.31) (P = .11). There were significant differences favoring the intervention group in discontinuation, sustained discontinuation, and dose reduction of tricyclic antidepressants at 6 months (discontinuation adjusted rate: intervention group, 0.23 [95% CI, 0.18-0.28] vs usual care group, 0.13 [95% CI, 0.09-0.17]; adjusted relative risk, 1.79 [95% CI, 1.29-2.50]; P = .001) and secondary time points (9, 12, and 15 months).
UNASSIGNED: In this randomized clinical trial of a health system-embedded deprescribing intervention targeting community-dwelling older adults prescribed central nervous system-active medications and their primary care clinicians, the intervention was no more effective than usual care in reducing medically treated falls. For health systems that attend to deprescribing as part of routine clinical practice, additional interventions may confer modest benefits on prescribing without a measurable effect on clinical outcomes.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT05689554.