Improving Transplant Medication Safety through a TEchnology and Pharmacist (ISTEP) Intervention in Veterans

通过技术和药剂师 (ISTEP) 干预退伍军人提高移植药物安全

• 批准号: 10376773
• 负责人: David J. Taber
• 金额: --
• 依托单位: RALPH H JOHNSON VA 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: 2018-03-01 至 2022-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10376773
• 关键词: Acute; Adverse drug event; Adverse event; Allografting; Applications Grants; Award; Books; Caring; Cessation of life; Characteristics; Clinical; Cluster randomized trial; Communication; Complex; Computerized Medical Record; Control Groups; Coupled; Data; Drug Interactions; Effectiveness; Emergency department visit; Event; Goals; Gold; Grant; Health; Health Care Costs; Health system; Healthcare; Healthcare Systems; Heart Diseases; Hospitalization; Immunosuppression; Immunosuppressive Agents; Incidence; Informatics; Intervention; Kidney Diseases; Learning; Liver diseases; Lung diseases; Measures; Medication Errors; Methods; Monitor; Multicenter Studies; Organ; Organ Transplantation; Outcome; Patients; Pharmaceutical Preparations; Pharmacists; Phase; Population; Population Surveillance; Protocols documentation; Provider; Quality of Care; Quality of life; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Regimen; Research; Risk; Safety; Service delivery model; Severities; Site; Survival Rate; System; Technology; Testing; Therapeutic immunosuppression; Time; Toxic effect; Transplant Recipients; Transplantation; Veterans; allograft rejection; arm; care coordination; care delivery; clinical care; clinically relevant; cost; dashboard; drug testing; effectiveness measure; graft failure; group intervention; health organization; high risk; hospital readmission; hospitalization rates; improved; innovation; innovative technologies; medication safety; military veteran; mortality; organ transplant recipient; prospective; safety outcomes; side effect; standard care; transplant centers; treatment as usual; trend

Anticipated Impacts on Veterans Health Care: The first three essential strategies listed within the VA's Blueprint for Excellence encompass plans to improve care to vulnerable Veterans, deliver high quality care through achieving the “Triple Aim” and leverage the use of technology to improve the efficiency of care delivery. The intervention this grant proposes focuses on improving medication safety and care coordination within a high risk vulnerable Veteran population, leverages the use of informatics and analytics to support this intervention, and aims to demonstrate improved care at reduced costs through the pharmacist intervention; thus, perfectly aligning with these three essential components of the Blueprint. The overarching goal of this study is to develop a feasibly deployable, technology-enabled intervention that will demonstrate substantial improvements in immunosuppressant medication safety, clinical outcomes and health care costs in Veteran organ transplant recipients; demonstrating this through a randomized controlled trial will provide sufficient evidence to further develop a VA-specific pharmacist learning collaborative aimed at improving care and reducing costs for Veteran organ transplant recipients across the entire VA system. Background: Organ transplant is the gold-standard treatment for patients with end organ diseases of the kidney, liver, heart and lungs, as it substantially improves survival and quality of life. Over the past 20 years, the use of contemporary immunosuppression has reduced the risk of acute rejection rates by upwards of 80%; yet long-term allograft survival remains suboptimal. Studies have demonstrated that causes of late graft loss is predominantly driven by immunosuppression adverse events and late allograft rejection episodes from medication errors and non-adherence, which encompass issues directly related to medication safety. Our research demonstrates that medication errors occur in nearly two-thirds of transplant recipients, leading to hospitalization in 1 in 8 recipients. Recipients that develop significant medication errors are at considerably higher risk of graft loss, leading to higher costs and mortality. Thus, in order to improve medication safety and long-term outcomes in transplant recipients, enhancements in immunosuppressant therapy management is needed. Objectives: The central hypothesis for the ISTEP study (Improving Transplant Medication Safety through a TEchnology and Pharmacist Intervention) is that pharmacist-led immunosuppressant therapy management, facilitated through the use of innovative technology, will significantly improve immunosuppressant safety and clinical outcomes in Veteran transplant recipients. Methods: This is a 24-month, prospective, multicenter, cluster-randomized controlled clinical trial at 10 sites, randomizing 5 sites to standard clinical care and 5 to standard care and the technology-enabled pharmacist intervention. The technology component of this intervention consists of the use of an expanded dashboard system that has already demonstrated effectiveness in improving immunosuppression monitoring. The dashboard performs population-level surveillance of transplant recipients and identifies those with potential drug-related problems, including non-adherence, drug interactions, missing and worrisome trends in labs; then providing a real-time alert to the pharmacist, who will determine its relevance and intervene in an appropriate protocol-guided manner. Effectiveness will be determined by comparing the rates of hospitalizations and ER visits between groups, while adjusting for baseline patient, provider and facility characteristics. Secondary measures include comparing healthcare costs and determining dashboard functionality, dashboard actionability and pharmacist intervention types and acceptance rates. We will also assess the overall incidence and severity of drug-related problems and graft and patient survival rates and compare these between the intervention and control sites.

对退伍军人医疗保健的预期影响：VA列出的前三个基本策略