A Multicenter RCT of Pharmacist-Directed Transitional Care to Reduce Post-Hospitalization Utilization

药剂师指导的过渡护理以减少出院后使用的多中心随机对照试验

• 批准号: 10458906
• 负责人: Joshua M Pevnick
• 金额: $ 17.17万
• 依托单位: CEDARS-SINAI MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10458906
• 关键词: Address; Adopted; Adverse drug event; Adverse event; American; Budgets; Businesses; Caring; Cessation of life; Clinical Research; Communities; Complex; Counseling; Country; Disease Management; Dissemination and Implementation; Doctor of Pharmacy; Doctor of Philosophy; Drug Prescriptions; Economics; Elderly; Emergency department visit; Ensure; Face; Funding; Geriatrics; Goals; Grant; Health; Health Care Costs; Health system; Hospitalization; Hospitals; Human Resources; Institution; Intervention; Knowledge; Lead; Light; Literature; Measures; Medical; Medication Errors; Medication Management; Methodology; Methods; Modeling; Monitor; Morbidity - disease rate; Older Population; Organizational Change; Outcome; Outpatients; Patients; Pharmaceutical Preparations; Pharmacists; Pharmacy facility; Physiological; Polypharmacy; Prevalence; Process; Publishing; Qualitative Methods; Randomized Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Regimen; Reporting; Research; Research Personnel; Resources; Review Literature; Risk; Sample Size; Secondary to; Services; Site; Societies; Surrogate Endpoint; Telephone; Testing; Time; Training; Update; attributable mortality; cost; design; evidence base; experience; health care service utilization; high risk; hospital readmission; implementation cost; improved; information organization; innovation; intervention effect; member; mortality; multidisciplinary; patient subsets; pragmatic trial; prevent; randomized trial; side effect; social; success

The sickest patients in the community are recently hospitalized elders. A substantial component of their morbidity and mortality is caused by adverse drug events (ADEs). ADEs account for 70% of adverse events occurring after discharge, which occur at a rate of 0.30 ADEs per patient. The oldest, sickest patients are at highest risk for ADEs because they have the most complex and hazardous medication regimens yet the least physiologic reserve and the fewest social and economic resources. Several studies, including our own, have demonstrated the efficacy of pharmacist-led post-discharge interventions to improve medication management. Most prominent among these have been post-discharge phone calls from pharmacists to patients. However, despite demonstrated efficacy, these interventions have not been widely implemented. In this proposal, we use the RE-AIM model to understand and address gaps in existing research that have hindered implementation. The central knowledge gap is that most research focuses on process or surrogate endpoint measures (like medication discrepancies) that we now understand to be insufficient to motivate organizational change. In contrast, we will measure the effect on utilization, a closely-tracked outcome that strongly motivates hospital leaders. We will use a large randomized controlled trial to rigorously assess the effect of PHARM-DC on this outcome. We will also study the barriers and facilitators of adopting these interventions, about which little is known. Finally, although implementation costs are critically important information for organizations considering pharmacist-led discharge (PHARM-DC) interventions, evidence on this topic is scarce. We thus aim to measure the impact of PHARM-DC interventions on post-discharge utilization within 30 days. We will also identify patient sub-populations most likely to benefit from PHARM-DC. Finally, we will estimate the incremental net cost of PHARMs from the health system perspective. To study these aims, we have selected two sites that: 1) are already proficient at in-hospital medication reconciliation, a prerequisite for implementing and evaluating PHARM-DC; 2) have a Chief Pharmacy Officer committed to using operational resources to provide PHARM-DC to patients during the study period; and 3) have investigators experienced in the research content and methodologies needed to study the aforementioned aims. This project will generate new knowledge allowing for increased implementation and dissemination of research already known to be efficacious, thus reducing the substantial morbidity and mortality attributable to ADEs among seniors in the high risk post-discharge time period.

社区中病情最严重的患者是最近住院的老年人。他们的一个重要组成部分 发病率和死亡率是由药物不良事件（ADE）引起的。 ADE 占不良事件的 70% 发生在出院后，每名患者发生 0.30 ADE 的比率。最年长、病情最严重的患者在 ADE 的风险最高，因为它们具有最复杂和危险的药物治疗方案，但又最少 生理储备和最少的社会经济资源。 包括我们自己在内的几项研究已经证明了药剂师主导的出院后治疗的功效 改善药物管理的干预措施。其中最突出的是出院后 药剂师给患者打电话。然而，尽管这些干预措施已被证明有效，但 没有得到广泛实施。在本提案中，我们使用 RE-AIM 模型来理解和解决 现有的研究阻碍了实施。核心知识差距是大多数研究 重点关注我们现在了解的过程或替代终点指标（如药物差异） 不足以推动组织变革。相反，我们将衡量对利用率的影响， 密切跟踪的结果强烈激励医院领导。我们将使用大型随机对照 试验严格评估 PHARM-DC 对此结果的影响。我们还将研究障碍和 采取这些干预措施的推动者，对此我们知之甚少。最后，尽管实施成本 对于考虑由药剂师主导出院的组织 (PHARM-DC) 来说是至关重要的信息 干预措施，有关该主题的证据很少。因此，我们的目标是衡量 PHARM-DC 的影响 出院后 30 天内的利用干预。我们还将确定最常发生的患者亚群 可能会从 PHARM-DC 中受益。最后，我们将估计 PHARM 的增量净成本 卫生系统视角。 为了研究这些目标，我们选择了两个站点：1) 已经精通院内药物治疗 协调，是实施和评估 PHARM-DC 的先决条件； 2）有一名首席药房官 致力于在研究期间利用运营资源向患者提供 PHARM-DC；和 3) 研究人员在研究所需的研究内容和方法方面是否有经验 上述目标。 该项目将产生新知识，从而加强实施和传播 已知有效的研究，从而大大降低了由以下原因引起的发病率和死亡率 出院后高风险时期老年人的 ADE。