Unit for Medication Outcomes Research and Education, School of Pharmacy, University of Tasmania, Hobart, Tasmania, Australia.
BMC Health Serv Res. 2011 Jan 25;11:16. doi: 10.1186/1472-6963-11-16.
Shorter periods of hospitalisation and increasing warfarin use have placed stress on community-based healthcare services to care for patients taking warfarin after hospital discharge, a high-risk period for these patients. A previous randomised controlled trial demonstrated that a post-discharge service of 4 home visits and point-of-care (POC) International Normalised Ratio (INR) testing by a trained pharmacist improved patients' outcomes. The current study aims to modify this previously trialled service model to implement and then evaluate a sustainable program to enable the smooth transition of patients taking warfarin from the hospital to community setting.
METHODS/DESIGN: The service will be trialled in 8 sites across 3 Australian states using a prospective, controlled cohort study design. Patients discharged from hospital taking warfarin will receive 2 or 3 home visits by a trained 'home medicines review (HMR)-accredited' pharmacist in their 8 to 10 days after hospital discharge. Visits will involve a HMR, comprehensive warfarin education, and POC INR monitoring in collaboration with patients' general practitioners (GPs) and community pharmacists. Patient outcomes will be compared to those in a control, or 'usual care', group. The primary outcome measure will be the proportion of patients experiencing a major bleeding event in the 90 days after discharge. Secondary outcome measures will include combined major bleeding and thromboembolic events, death, cessation of warfarin therapy, INR control at 8 days post-discharge and unplanned hospital readmissions from any cause. Stakeholder satisfaction will be assessed using structured postal questionnaire mailed to patients, GPs, community pharmacists and accredited pharmacists at the completion of their study involvement.
This study design incorporates several aspects of prior interventions that have been demonstrated to improve warfarin management, including POC INR testing, warfarin education and home visits by trained pharmacists. It faces several potential challenges, including the tight timeframe for patient follow-up in the post-discharge period. Its strengths lie in a strong multidisciplinary team and the utilisation of existing healthcare frameworks. It is hoped that this study will provide the evidence to support the national roll-out of the program as a new Australian professional community pharmacy service.
Australian New Zealand Clinical Trials Registry Number 12608000334303.
住院时间缩短和华法林使用量增加，给社区医疗服务带来了压力，需要在出院后照顾这些患者，这是他们的高风险时期。先前的一项随机对照试验表明，由经过培训的药剂师进行 4 次家访和即时检测（POC）国际标准化比值（INR）测试的出院后服务可以改善患者的预后。本研究旨在改进之前试验过的服务模式，实施并评估一项可持续的计划，使服用华法林的患者能够从医院顺利过渡到社区环境。
方法/设计：该服务将在澳大利亚 3 个州的 8 个地点进行试点，采用前瞻性、对照队列研究设计。从医院出院后开始服用华法林的患者，在出院后 8 至 10 天内，将由经过培训的“家庭用药审查（HMR）-认证”药剂师进行 2 至 3 次家访。家访将包括 HMR、全面的华法林教育以及与患者的全科医生（GP）和社区药剂师合作进行 POC INR 监测。将比较患者的预后与对照组（常规护理）的预后。主要结局指标是出院后 90 天内发生大出血事件的患者比例。次要结局指标包括大出血和血栓栓塞事件的综合发生率、死亡、停止华法林治疗、出院后 8 天 INR 控制以及任何原因导致的非计划住院再入院。将通过向患者、GP、社区药剂师和认证药剂师邮寄结构化的邮政问卷，评估利益相关者的满意度。
该研究设计结合了一些先前干预措施的方面，这些措施已被证明可以改善华法林管理，包括 POC INR 测试、华法林教育和经过培训的药剂师家访。它面临一些潜在的挑战，包括患者在出院后期间随访的时间紧张。其优势在于有一个强大的多学科团队和利用现有的医疗保健框架。希望这项研究能够提供证据，支持该计划在全国范围内推出，成为澳大利亚新的专业社区药房服务。
澳大利亚新西兰临床试验注册中心编号 12608000334303。
