The MedSafer Study-Electronic Decision Support for Deprescribing in Hospitalized Older Adults: A Cluster Randomized Clinical Trial.

The MedSafer Study-Electronic Decision Support for Deprescribing in Hospitalized Older Adults: A Cluster Randomized Clinical Trial.
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DOI:
10.1001/jamainternmed.2021.7429
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发表时间:
2022-03-01
影响因子:
39
通讯作者:
Lee TC
Lee TC
中科院分区:
医学1区
文献类型:
--
作者:
McDonald EG;Wu PE;Rashidi B;Wilson MG;Bortolussi-Courval É;Atique A;Battu K;Bonnici A;Elsayed S;Wilson AG;Papillon-Ferland L;Pilote L;Porter S;Murphy J;Ross SB;Shiu J;Tamblyn R;Whitty R;Xu J;Fabreau G;Haddad T;Palepu A;Khan N;McAlister FA;Downar J;Huang AR;MacMillan TE;Cavalcanti RB;Lee TC

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在急性护理住院期间提供临床决策支持是否能改善老年人潜在不适当药物的停药和出院后30天的不良药物事件(ADE)?这项对5698名住院参与者进行的整群随机多中心试验发现,尽管出院时停药次数增加,但提供电子生成的停药报告在30天内对ADE没有显著影响。这项随机临床试验的结果表明,住院期间的临床决策支持改善了停药,但在短期内对药物危害几乎没有影响。可扩展的停药干预措施可能会减少多药联用和潜在不适当药物(PIM)的使用;然而,很少有研究大到足以评估停药可能对不良药物事件(ADE)的影响。目的:评价电子停药决策支持工具对多药联用老年患者出院后不良反应的影响。这是一项整群随机临床试验,研究对象为预期生存期超过3个月的老年(≥65岁)住院患者,这些患者于2017年8月22日至2020年1月13日期间住进加拿大11家急性护理医院中的1家。入院时,参与者每天服用5种或更多药物。数据分析从2021年1月3日到2021年9月23日进行。由MedSafer软件生成的关于停药机会的个性化报告,以解决常见的家庭药物以及预后和虚弱的衡量标准。将提供给治疗组的停药报告与常规护理(药物调节)进行比较。主要结果是通过结构化电话调查获得的出院后前30天内ADE的减少(包括不良药物停药事件),并对干预状态进行盲判。次要结果是出院时停药1次或1次以上的患者比例和不良停药事件(ADWE)患者的比例。共有5698名参与者(年龄中位数78[范围],78[72-85]岁;2858[50.2%]女性;没有收集种族和民族数据)被登记在3个组中,并根据主要结果进行评判(对照组,3204;干预,2494)。尽管进行了整群随机分组,但仍存在组内不平衡现象,例如,干预组的参与者年龄较大,基线时的PIM处方较多。出院后,4989人(87.6%)完成了ADE访谈。出院30天内的ADE差异无统计学意义(2742名对照组中138名[5.0%]对2247名干预者中111名[4.9%];调整后的风险差异−为0.8%;95%CI,−为2.9%至1.3%)。停药从2667名对照组的795名(29.8%)增加到2256名干预者中的1249名(55.4%)[ARD,22.2%;95%CI,16.9%到27.4%]。两组ADWE差异无统计学意义。一些特别后的敏感性分析,包括使用非参数检验来解决低聚类数、组不平衡和潜在的偏差,并没有改变研究结论。这一整群随机临床试验表明,在急性住院期间提供停药临床决策支持对ADE没有明显影响,尽管干预是安全的,并导致停药情况的改善。ClinicalTrials.gov标识:NCT03272607这项随机临床试验考察了电子决策支持对加拿大11家医院65岁或以上住院患者出院后不良药物事件和停药的影响。
Does providing clinical decision support during an acute care hospitalization improve deprescribing of potentially inappropriate medications and 30-day postdischarge adverse drug events (ADEs) in older adults? This cluster randomized multicenter trial of 5698 hospitalized participants found that providing electronically generated deprescribing reports did not have a significant impact on ADEs within 30 days despite increased deprescribing at discharge. The findings of this randomized clinical trial indicate that clinical decision support during hospitalization improves deprescribing but has little impact on medication harms in the short term. Scalable deprescribing interventions may reduce polypharmacy and the use of potentially inappropriate medications (PIMs); however, few studies have been large enough to evaluate the impact that deprescribing may have on adverse drug events (ADEs). To evaluate the effect of an electronic deprescribing decision support tool on ADEs after hospital discharge among older adults with polypharmacy. This was a cluster randomized clinical trial of older (≥65 years) hospitalized patients with an expected survival of more than 3 months who were admitted to 1 of 11 acute care hospitals in Canada from August 22, 2017, to January 13, 2020. At admission, participants were taking 5 or more medications per day. Data analyses were performed from January 3, 2021, to September 23, 2021. Personalized reports of deprescribing opportunities generated by MedSafer software to address usual home medications and measures of prognosis and frailty. Deprescribing reports provided to the treating team were compared with usual care (medication reconciliation). The primary outcome was a reduction of ADEs within the first 30 days postdischarge (including adverse drug withdrawal events) captured through structured telephone surveys and adjudicated blinded to intervention status. Secondary outcomes were the proportion of patients with 1 or more PIMs deprescribed at discharge and the proportion of patients with an adverse drug withdrawal event (ADWE). A total of 5698 participants (median [range] age, 78 [72-85] years; 2858 [50.2%] women; race and ethnicity data were not collected) were enrolled in 3 clusters and were adjudicated for the primary outcome (control, 3204; intervention, 2494). Despite cluster randomization, there were group imbalances, eg, the participants in the intervention arm were older and had more PIMS prescribed at baseline. After hospital discharge, 4989 (87.6%) participants completed an ADE interview. There was no significant difference in ADEs within 30 days of discharge (138 [5.0%] of 2742 control vs 111 [4.9%] of 2247 intervention participants; adjusted risk difference [aRD] −0.8%; 95% CI, −2.9% to 1.3%). Deprescribing increased from 795 (29.8%) of 2667 control to 1249 (55.4%) of 2256 intervention participants [aRD, 22.2%; 95% CI, 16.9% to 27.4%]. There was no difference in ADWEs between groups. Several post hoc sensitivity analyses, including the use of a nonparametric test to address the low cluster number, group imbalances, and potential biases, did not alter study conclusions. This cluster randomized clinical trial showed that providing deprescribing clinical decision support during acute hospitalization had no demonstrable impact on ADEs, although the intervention was safe and led to improvements in deprescribing. ClinicalTrials.gov Identifier: NCT03272607 This randomized clinical trial examines the impact of electronic decision support on postdischarge adverse drug events and deprescribing among hospitalized patients 65 years or older at 11 hospitals in Canada.
DOI: 10.1111/j.1525-1497.2005.30390.x
发表时间: 2005-04-01
影响因子: 5.7
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通讯作者: Bates, DW
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影响因子: 2.5
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