Division of Research, Kaiser Permanente Northern California, Oakland.
Pharmacy Operations, Kaiser Permanente Northern California, Oakland.
JAMA Netw Open. 2023 Jul 3;6(7):e2322505. doi: 10.1001/jamanetworkopen.2023.22505.
Older patients using many prescription drugs (hyperpolypharmacy) may be at increased risk of adverse drug effects.
To test the effectiveness and safety of a quality intervention intended to reduce hyperpolypharmacy.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial allocated patients 76 years or older who used 10 or more prescription medications to a deprescribing intervention or to usual care (1:1 ratio) at an integrated health system with multiple preexisting deprescribing workflows. Data were collected from October 15, 2020, to July 29, 2022.
Physician-pharmacist collaborative drug therapy management, standard-of-care practice recommendations, shared decision-making, and deprescribing protocols administered by telephone over multiple cycles for a maximum of 180 days after allocation.
Primary end points were change in the number of medications and in the prevalence of geriatric syndrome (falls, cognition, urinary incontinence, and pain) from 181 to 365 days after allocation compared with before randomization. Secondary outcomes were use of medical services and adverse drug withdrawal effects.
Of a random sample of 2860 patients selected for potential enrollment, 2470 (86.4%) remained eligible after physician authorization, with 1237 randomized to the intervention and 1233 to usual care. A total of 1062 intervention patients (85.9%) were reached and agreed to enroll. Demographic variables were balanced. The median age of the 2470 patients was 80 (range, 76-104) years, and 1273 (51.5%) were women. In terms of race and ethnicity, 185 patients (7.5%) were African American, 234 (9.5%) were Asian or Pacific Islander, 220 (8.9%) were Hispanic, 1574 (63.7%) were White (63.7%), and 257 (10.4%) were of other (including American Indian or Alaska Native, Native Hawaiian, or >1 race or ethnicity) or unknown race or ethnicity. During follow-up, both the intervention and usual care groups had slight reductions in the number of medications dispensed (mean changes, -0.4 [95% CI, -0.6 to -0.2] and -0.4 [95% CI, -0.6 to -0.3], respectively), with no difference between the groups (P = .71). There were no significant changes in the prevalence of a geriatric condition in the usual care and intervention groups at the end of follow-up and no difference between the groups (baseline prevalence: 47.7% [95% CI, 44.9%-50.5%] vs 42.9% [95% CI, 40.1%-45.7%], respectively; difference-in-differences, 1.0 [95% CI, -3.5 to 5.6]; P = .65). No differences in use of medical services or adverse drug withdrawal effects were observed.
In this randomized clinical trial from an integrated care setting with various preexisting deprescribing workflows, a bundled hyperpolypharmacy deprescribing intervention was not associated with reduction in medication dispensing, prevalence of geriatric syndrome, utilization of medical services, or adverse drug withdrawal effects. Additional research is needed in less integrated settings and in more targeted populations.
ClinicalTrials.gov Identifier: NCT05616689.
使用多种处方药(多重用药)的老年患者可能面临更多的药物不良反应风险。
测试旨在减少多重用药的质量干预措施的有效性和安全性。
设计、地点和参与者:这是一项随机临床试验,纳入了在综合医疗系统中使用 10 种或以上处方药且年龄在 76 岁及以上的患者,这些患者分为药物减量干预组或常规护理组(1:1 比例),该系统有多种预先存在的药物减量工作流程。数据于 2020 年 10 月 15 日至 2022 年 7 月 29 日收集。
医生-药剂师合作药物治疗管理、标准护理实践建议、共同决策以及通过电话进行的药物减量方案,最多在分配后 180 天内进行多个周期。
与随机分组前相比,分配后 181 至 365 天内药物数量和老年综合征(跌倒、认知、尿失禁和疼痛)的发生率变化。次要结局为医疗服务的使用和药物撤药不良反应。
在随机抽样的 2860 名潜在入组患者中,2470 名(86.4%)在医生授权后仍符合入选条件,其中 1237 名随机分配至干预组,1233 名分配至常规护理组。共有 1062 名干预组患者(85.9%)接受了联系并同意入组。人口统计学变量平衡。2470 名患者的中位年龄为 80 岁(范围为 76-104 岁),1273 名(51.5%)为女性。在种族和民族方面,185 名(7.5%)为非裔美国人,234 名(9.5%)为亚洲或太平洋岛民,220 名(8.9%)为西班牙裔,1574 名(63.7%)为白人(63.7%),257 名(10.4%)为其他种族(包括美洲印第安人或阿拉斯加原住民、夏威夷原住民或多种种族或民族)或未知种族或民族。在随访期间,干预组和常规护理组的药物处方数量均略有减少(平均变化分别为-0.4[95%CI:-0.6 至-0.2]和-0.4[95%CI:-0.6 至-0.3]),两组之间无差异(P=0.71)。在随访结束时,常规护理组和干预组老年疾病的发生率均无显著变化,两组之间也无差异(基线发生率:47.7%[95%CI:44.9%-50.5%]与 42.9%[95%CI:40.1%-45.7%],差异为 1.0[95%CI:-3.5 至 5.6];P=0.65)。未观察到医疗服务使用或药物撤药不良反应的差异。
在这项来自具有各种预先存在的药物减量工作流程的综合护理环境的随机临床试验中,捆绑的多重用药药物减量干预措施与减少药物配给、老年综合征的流行率、医疗服务的使用或药物撤药不良反应无关。在不那么整合的环境中和更有针对性的人群中,需要进一步研究。
ClinicalTrials.gov 标识符:NCT05616689。