Wien Katharina, Klein Jan Philipp, Rodenstein Niels, Vogler Julia, Tilz Roland Richard, Thern Julia, Borgwardt Stefan
Hospital Pharmacy, University Hospital Schleswig-Holstein, Lübeck, Germany.
Department of Psychiatry, Psychosomatics and Psychotherapy, University of Lübeck, Lübeck, Germany.
Front Psychiatry. 2025 Aug 28;16:1606497. doi: 10.3389/fpsyt.2025.1606497. eCollection 2025.
Many psychotropic drugs potentially prolong the QTc interval. The aim of this study was to investigate the feasibility of the pharmacist-supported implementation of a new local guideline for QTc monitoring at a psychiatric department and to gather preliminary data on the effectiveness of this intervention.
The study was conducted as a prospective, randomized-controlled feasibility study at the inpatient service of a department of psychiatry. In the intervention group (IG), guideline-based monitoring of QTc intervals was supported by a clinical pharmacist. The control group (CG) was solely monitored by the treating physicians. The primary effectiveness outcome was the mean change in the QTc interval between admission (T) and 30 days after admission (T). The implementation ratio of guideline recommendations and the acceptability of the pharmacist support based on an online employee satisfaction survey were assessed as secondary outcomes.
160 patients were recruited and randomly allocated to the IG ( = 75) or CG ( = 85). A total of 102 patients completed the trial (IG: = 42, CG: = 60). There was no significant difference in the mean change of the QTc interval from T to T between the two groups ( = 0.582). Guideline recommendations were significantly more often implemented in the IG than in the CG (78% vs. 37%, = 0.004). 4 out of 15 (26.7%) physicians and 9 out of 45 (20%) nurses working on the wards responded to the online survey. Physicians and nurses were very satisfied with the pharmaceutical support.
Pharmacist support of the implementation of a new guideline for QTc monitoring led to a higher rate of uptake of guideline recommendations but did not have a significant effect on the QTc interval. The responding physicians and nurses were very satisfied with this intervention. Future research using an adapted study design would be required to assess guideline adherence as the primary outcome and, secondarily, determine the effect of pharmacist support on cardiac outcomes.
German Clinical Trials Register: DRKS00033127, https://drks.de/search/de/trial/DRKS00033127.
许多精神药物可能会延长QTc间期。本研究的目的是探讨在精神科由药剂师支持实施一项关于QTc监测的新地方指南的可行性，并收集有关该干预措施有效性的初步数据。
本研究作为一项前瞻性、随机对照可行性研究，在一个精神科的住院服务部门进行。在干预组（IG）中，临床药剂师支持基于指南的QTc间期监测。对照组（CG）仅由主治医生进行监测。主要有效性结局是入院时（T）至入院后30天（T）QTc间期的平均变化。基于在线员工满意度调查评估指南建议的实施率以及药剂师支持的可接受性作为次要结局。
招募了160名患者并随机分配至IG（n = 75）或CG（n = 85）。共有102名患者完成试验（IG：n = 42，CG：n = 60）。两组之间从T到T的QTc间期平均变化无显著差异（P = 0.582）。IG中指南建议的实施频率显著高于CG（78%对37%，P = 0.004）。在病房工作的15名医生中有4名（26.7%）和45名护士中有9名（20%）回复了在线调查。医生和护士对药学支持非常满意。
药剂师支持实施新的QTc监测指南导致指南建议的采纳率更高，但对QTc间期没有显著影响。回复的医生和护士对该干预措施非常满意。未来需要采用适应性研究设计进行研究，以评估指南依从性作为主要结局，并其次确定药剂师支持对心脏结局的影响。
德国临床试验注册中心：DRKS00033127，https://drks.de/search/de/trial/DRKS00033127 。
