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: 9655230
• 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/9655230
• 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; Health Services; Healthcare Systems; Hemorrhage; Image; Industry; Inguinal region; Intervention; Interview; Knowledge; Lead; Leadership; Learning; Measures; Medical; Methods; Minority; Modeling; Observational Study; Operative Surgical Procedures; Outcome; Participant; Patients; Perception; Persons; Procedures; 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; evidence base; femoral artery; follow-up; formative assessment; hands on instruction; implementation research; 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：在执行心脏导管插入术的两种方法中，弗吉尼亚州和美国的心脏病学家 绝大多数选择的方法对患者的舒适和危险较差，并且 医疗保健系统的成本更高。通过手腕访问的跨雷亚方法（tra）更多 适合患者；比出血并发症发生率的一半要安全得多。总成本较低 通过腹股沟访问的跨女性方法（TFA）而不是跨女性方法（TFA）。然而，今天 美国TRA仅用于25％-30％的心脏导管插入术，而在VA中，使用了40％以上 导管插入。原因是TFA在心脏病学家训练表演的奖学金中占主导地位 收缩; TRA的某些方面，例如径向动脉的解剖结构，最初使其更大 比TFA具有挑战性；而且缺乏培训资源来满足动手培训的需求， 专家的反馈和团队培训。这个挑战对于许多医学和外科手术都是常见的 新的，卓越的程序定期出现的专业。我们以前开发并驾驶教练 干预措施以帮助Cath Labs成为“ Tra-Driminant”。教练干预是基于团队的，包括 动手指导有多种纠正反馈的机会，并包括一段时间的支持和 超越培训课程的问责制。飞行员测试获得了参与团队的积极报告； 但是，我们不知道它是否成功地增加了TRA的使用。我们也不知道教练干预是否 通过我们的信念，通过营造一种非义务的氛围，参与者发展自我 TRA的功效，克服钢制学习曲线并熟练。最后，我们不知道 教练干预的预算影响，以及是否可以减少成本的费用 并发症和相关成本。 目标：我们的目标是提高VA系统地实施新的新型能力 具有挑战性的基于证据的临床程序。我们有3个目标。目标1：测试一个 成功训练，基于团队的教练干预，以增加径向动脉访问的实施 心脏导管插入术。目标2：适应，测试和完善基于团队教练的概念模型 基于促进健康研究行动的新程序的实施 服务框架。 AIM 3：对教练干预和对每项成本的影响进行成本分析 护理的情节。 方法：我们将使用梯级楔形设计（即毕业参与）来最大化有效性和许可 对教练干预的形成性评估，以实时改进。主要结果将是改变 在所有导管插入的函数中，TRA数量。次要结果将包括改进 并发症和每导导管的成本。我们将在 基准，在教练干预后再次，第三次在6个月后进行调整，测试和 完善基于团队的实施的概念模型，该模型可以告知修改教练干预 通过了解教练干预如何影响此类因素，以了解其他临床程序和环境 作为与TRA有关的不同类型的感知证据，与心理安全有关的上下文因素以及 团队自我效能和预期结果。 AIM 3将包括两个组成部分：1）估计 实施教练干预所需的组织努力，2）评估教练的影响 干预旨在增加TRA对医疗保健成本的采用。这将有助于建立业务案例 用于教练干预费用。试验数据表明，TRA可节省大量成本。通过开发一个 VA业务案例用于教练干预，我们将帮助促进支持批准的支持 干涉。