Implementation trial of a coaching intervention to increase the use of transradial PCI

实施指导干预试验以增加经桡动脉 PCI 的使用

• 批准号: 10186494
• 负责人: Christian D Helfrich
• 金额: --
• 依托单位: VA PUGET SOUND HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-02-01 至 2021-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10186494
• 关键词: Academic Detailing; Accountability; Address; Adopted; Adoption; Affect; Anatomy; Atmosphere; Businesses; Cardiac Catheterization Procedures; Cardiology; Catheterization; Clinical; Complex; Coronary artery; Cost Analysis; Cost Savings; Dangerousness; Data; Ensure; Expectancy; Feedback; Fellowship; Fostering; Goals; Health Care Costs; Healthcare Systems; Hemorrhage; Image; Industry; Inguinal region; Intervention; Interview; Knowledge; Lead; Leadership; Learning; Measures; Medical; Methods; Minority; Modeling; Observational Study; Operative Surgical Procedures; Participant; Patients; Perception; Persons; Procedures; Promoting Action on Research Implementation in Health Services framework; Reporting; Resources; Role; Safety; Savings; Self Efficacy; Site; Source; Specialist; Structure; Surgical Specialties; Surveys; Testing; Time; Training; Update; Veterans; Work; Wrist; base; budget impact; care episode; contextual factors; continuing medical education; cost; cost estimate; design; effectiveness testing; efficacy outcomes; evidence base; femoral artery; follow-up; formative assessment; hands on instruction; implementation trial; improved; intervention cost; intervention effect; medical specialties; primary outcome; psychologic; radial artery; secondary outcome; skills; symposium

Background: Of the two approaches to performing cardiac catheterization, cardiologists in the VA and US overwhelmingly choose the approach that is known to be less comfortable and more dangerous to patients and more costly to the health care system. The trans-radial approach (TRA), which is accessed via the wrist, is more comfortable for patients; is much safer with half the rate of bleeding complications; and has lower overall costs per episode of care than the trans-femoral approach (TFA), which is accessed via the groin. Yet, today in the US TRA is used in only 25%-30% of cardiac catheterizations, and in the VA is used for just over 40% of catheterizations. The reasons are that TFA predominates in the fellowships where cardiologists train to perform catherizations; certain aspects of TRA, such as the anatomy of the radial artery, make it initially more challenging than TFA; and there is a lack of training resources that address the needs for hands-on training, feedback from an expert, and training of the team. This challenge is common to many medical and surgical specialties where new, superior procedures emerge regularly. We previously developed and piloted a coaching intervention to help cath labs become “TRA-dominant.” The coaching intervention was team-based, included hands-on instruction with multiple opportunities for corrective feedback, and included a period of support and accountability beyond a training session. The pilot test garnered positive reports from participating teams; however, we do not know if it successfully increases use of TRA. Nor do we know if the coaching intervention works the way we believe it does, through creating a non-punitive atmosphere where participants develop self- efficacy with TRA, overcome the steep learning curve and become proficient. Finally, we do not know the budget impact of the coaching intervention, and whether the costs may be offset by the savings from reduced complications and associated costs. Objectives: Our objective is to improve the VA’s ability to systematically implement new technically challenging, evidence-based clinical procedures. We have 3 aims. Aim 1: Test the effectiveness of a successfully-piloted, team-based coaching intervention in increasing implementation of radial-artery access cardiac catheterization. Aim 2: Adapt, test and refine a conceptual model of team-based coaching for implementation of new procedures based on the Promoting Action on Research Implementation in Health Services framework. Aim 3: Perform a cost analysis of the coaching intervention and effects on costs per episode of care. Methods: We will use a stepped wedge design (i.e., graduated participation) to maximize validity and permit formative evaluation of the coaching intervention to improve it in real time. The primary outcome will be change in number of TRAs as a function of all catheterizations. Secondary outcomes will include improvements in complications, and cost per catheterization. We will conduct qualitative interviews and structured surveys at baseline, again just after the coaching intervention and a third time at 6 months follow-up to adapt, test and refine a conceptual model of team-based implementation that can inform modifying the coaching intervention to other clinical procedures and settings by understanding how the coaching intervention affects factors such as different types of perceived evidence related to TRA, contextual factors related to psychological safety, and team self-efficacy and outcome expectancy. Aim 3 will include two components: 1) estimate the costs of the organizational efforts needed to implement the coaching intervention, and 2) assess the effect of the coaching intervention aimed to increase adoption of TRA on healthcare costs. This will help establish the business case for the coaching intervention cost. Trial data suggests TRA leads to substantial cost savings. By developing a VA business case for the coaching intervention, we will help foster support for dissemination of the proctoring intervention.

背景：在进行心导管插入术的两种方法中，退伍军人管理局和美国的心脏病专家 绝大多数人选择已知对患者来说不太舒服且更危险的方法， 通过手腕进入的经桡动脉入路 (TRA) 的成本更高。 患者感到舒适；更安全，出血并发症发生率降低一半；并且总体成本更低； 每一次护理比经股动脉入路 (TFA) 更有效，而经股动脉入路是通过腹股沟进入的。 US TRA 仅用于 25%-30% 的心导管检查，而 VA 则用于略高于 40% 的心导管检查 原因是 TFA 在心脏病专家培训的研究中占主导地位。 导管插入；TRA 的某些方面，例如桡动脉的解剖结构，使其最初更容易 比 TFA 更具挑战性；并且缺乏满足实践培训需求的培训资源， 专家的反馈以及团队的培训这一挑战对于许多医疗和外科手术来说都是常见的。 我们之前开发并试点了一种新的、更先进的程序的专业。 帮助导管实验室成为“TRA 主导”的干预措施是以团队为基础的，包括 具有多次纠正反馈机会的实践指导，包括一段时间的支持和 试点测试获得了参与团队的积极报告； 然而，我们不知道它是否成功地增加了 TRA 的使用，也不知道教练干预是否成功。 正如我们所相信的那样，通过营造一种非惩罚性的氛围，使参与者能够自我发展 TRA 的功效，克服陡峭的学习曲线并变得熟练，最后，我们不知道。 辅导干预的预算影响，以及成本是否可以通过减少培训所节省的费用来抵消 并发症和相关费用。 目标：我们的目标是提高 VA 系统实施新技术的能力 我们有 3 个目标：测试一项具有挑战性的、基于证据的临床程序。 成功试点、基于团队的辅导干预，以增加桡动脉通路的实施 目标 2：调整、测试和完善基于团队的指导概念模型。 根据卫生领域研究实施促进行动实施新程序 目标 3：对辅导干预及其对成本的影响进行成本分析。 护理情节。 方法：我们将使用阶梯式楔形设计（即分级参与）来最大化有效性并允许 对教练干预进行形成性评估以实时改进它的主要结果将是改变。 TRA 数量作为所有导管插入术的函数，次要结果将包括改善。 我们将进行定性访谈和结构化调查。 基线，在教练干预后再次进行，第三次是在 6 个月的随访中进行适应、测试和 完善基于团队的实施的概念模型，可以为修改辅导干预提供信息 通过了解教练干预如何影响其他临床程序和环境，例如 作为与 TRA 相关的不同类型的感知证据、与心理安全相关的背景因素，以及 团队自我效能和结果预期包括两个部分：1）估计成本。 实施辅导干预工作所需的组织，以及 2) 评估辅导的有效性 旨在提高 TRA 在医疗保健成本方面的采用率的干预措施这将有助于建立商业案例。 试验数据表明，通过制定 TRA 可以节省大量成本。 VA 辅导干预商业案例，我们将帮助促进对督导传播的支持 干涉。