Department of Hospital Pharmacy, Academic Medical Centre, Amsterdam, The Netherlands.
BMC Health Serv Res. 2011 Mar 7;11:55. doi: 10.1186/1472-6963-11-55.
Preventable adverse drug events (pADEs) are widely known to be a health care issue for hospitalized patients. Surgical patients are especially at risk, but prevention of pADEs in this population is not demonstrated before. Ward-based pharmacy interventions seem effective in reducing pADEs in medical patients. The cost-effectiveness of these preventive efforts still needs to be assessed in a comparative study of high methodological standard and also in the surgical population. For these aims the SUREPILL (Surgery & Pharmacy in Liaison) study is initiated.
METHODS/DESIGN: A multi-centre controlled trial, with randomisation at ward-level and preceding baseline assessments is designed. Patients admitted to the surgical study wards for elective surgery with an expected length of stay of more than 48 hours will be included. Patients admitted to the intervention ward, will receive ward-based pharmacy care from the clinical pharmacy team, i.e. pharmacy practitioners and hospital pharmacists. This ward-based pharmacy intervention includes medication reconciliation in consultation with the patient at admission, daily medication review with face-to-face contact with the ward doctor, and patient counselling at discharge. Patients admitted in the control ward, will receive standard pharmaceutical care.The primary clinical outcome measure is the number of pADEs per 100 elective admissions. These pADEs will be measured by systematic patient record evaluation using a trigger tool. Patient records positive for a trigger will be evaluated on causality, severity and preventability by an independent expert panel. In addition, an economic evaluation will be performed from a societal perspective with the costs per preventable ADE as the primary economic outcome. Other outcomes of this study are: severity of pADEs, number of patients with pADEs per total number of admissions, direct (non-)medical costs and indirect non-medical costs, extra costs per prevented ADE, number and type of pharmacy interventions, length of hospital stay, complications registered in a national complication registration system for surgery, number of readmissions within three months after initial admission (follow-up), quality of life and number of non-institutionalized days during follow-up.
This study will assess the cost-effectiveness of ward-based pharmacy care on preventable adverse drug events in surgical patients from a societal perspective, using a comparative study design.
Netherlands Trial Register (NTR): NTR2258.
可预防的药物不良事件(pADEs)是住院患者的一个众所周知的医疗保健问题。手术患者尤其处于风险之中,但目前尚未证明在这一人群中可以预防 pADEs。基于病房的药学干预措施似乎可以有效减少医疗患者中的 pADEs。这些预防措施的成本效益仍需要在具有高方法学标准的比较研究中进行评估,并且还需要在手术人群中进行评估。为此,启动了 SUREPILL(外科和药学联络)研究。
方法/设计:这是一项多中心对照试验,在病房层面进行随机化,并进行基线评估设计。将纳入接受择期手术且预计住院时间超过 48 小时的外科研究病房的患者。入住干预病房的患者将接受临床药剂师团队提供的基于病房的药学护理,即药剂师和医院药剂师。这种基于病房的药学干预措施包括在入院时与患者一起进行药物调整,每天与病房医生进行面对面的药物审查,并在出院时对患者进行咨询。入住对照病房的患者将接受标准的药物治疗。主要的临床结局指标是每 100 例择期入院患者中 pADE 的数量。这些 pADE 将通过使用触发工具对系统的患者记录评估进行测量。记录在案的触发患者的记录将由独立专家小组评估因果关系、严重程度和可预防程度。此外,将从社会角度进行经济评估,以可预防 ADE 的成本为主要经济结局。该研究的其他结局包括:pADE 的严重程度、每例入院患者中 pADE 的数量、直接(非)医疗费用和间接非医疗费用、每例预防 ADE 的额外费用、药学干预的数量和类型、住院时间、在国家手术并发症登记系统中登记的并发症数量、初始入院后三个月内的再入院次数(随访)、生活质量和随访期间的非住院天数。
这项研究将使用比较研究设计,从社会角度评估基于病房的药学护理对手术患者可预防药物不良事件的成本效益。
荷兰试验注册处(NTR):NTR2258。