Willeboordse F, Schellevis F G, Meulendijk M C, Hugtenburg J G, Elders P J M
Department of General Practice & Elderly Care Medicine, Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam, The Netherlands.
NIVEL, Netherlands Institute for Health Services Research, Utrecht, The Netherlands.
Int J Clin Pharm. 2018 Jun;40(3):550-565. doi: 10.1007/s11096-018-0615-y. Epub 2018 Mar 20.
Background Implementation of clinical medication reviews in daily practice is scarcely evaluated. The Opti-Med intervention applied a structured approach with external expert teams (pharmacist and physician) to conduct medication reviews. The intervention was effective with respect to resolving drug related problems, but did not improve quality of life. Objective The objective of this process evaluation was to gain more insight into the implementation fidelity of the intervention. Setting Process evaluation alongside a cluster randomized trial in 22 general practices and 518 patients of 65 years and over. Method A mixed methods design using quantitative and qualitative data and the conceptual framework for implementation fidelity was used. Implementation fidelity is defined as the degree to which the various components of an intervention are delivered as intended. Main outcome measure Implementation fidelity for key components of the Opti-Med intervention. Results Patient selection and preparation of the medication analyses were carried out as planned, although mostly by the Opti-Med researchers instead of practice nurses. Medication analyses by expert teams were performed as planned, as well as patient consultations and patient involvement. 48% of the proposed changes in the medication regime were implemented. Cooperation between expert teams members and the use of an online decision-support medication evaluation facilitated implementation. Barriers for implementation were time constraints in daily practice, software difficulties with patient selection and incompleteness of medical files. The degree of embedding of the intervention was found to influence implementation fidelity. The total time investment for healthcare professionals was 94 min per patient. Conclusion Overall, the implementation fidelity was moderate to high for all key components of the Opti-Med intervention. The absence of its effectiveness with respect to quality of life could not be explained by insufficient implementation fidelity.
临床药物审查在日常实践中的实施情况鲜有评估。Opti-Med干预措施采用结构化方法，由外部专家团队（药剂师和医生）进行药物审查。该干预措施在解决药物相关问题方面有效，但并未改善生活质量。目的：本过程评估的目的是更深入地了解该干预措施的实施保真度。背景：在22家普通诊所对518名65岁及以上患者进行的一项整群随机试验中进行过程评估。方法：采用混合方法设计，使用定量和定性数据以及实施保真度的概念框架。实施保真度定义为干预措施的各个组成部分按预期实施的程度。主要结局指标：Opti-Med干预措施关键组成部分的实施保真度。结果：患者选择和药物分析准备按计划进行，不过大多是由Opti-Med研究人员而非执业护士完成。专家团队进行的药物分析、患者咨询和患者参与均按计划进行。药物治疗方案中48%的建议更改得到了实施。专家团队成员之间的合作以及在线决策支持药物评估的使用促进了实施。实施的障碍包括日常实践中的时间限制、患者选择的软件困难以及医疗档案不完整。发现干预措施的融入程度会影响实施保真度。医疗专业人员为每位患者投入的总时间为94分钟。结论：总体而言，Opti-Med干预措施所有关键组成部分的实施保真度为中等至高。生活质量方面缺乏有效性不能用实施保真度不足来解释。
