Jimenez Elvira E, Rosland Ann-Marie, Stockdale Susan E, Reddy Ashok, Wong Michelle S, Torrence Natasha, Huynh Alexis, Chang Evelyn T
Center for the Study of Healthcare Innovation, Implementation & Policy (CSHIIP), VA Greater Los Angeles Healthcare System, 11301 Wilshire Blvd, Los Angeles, CA, 90073, USA.
Department of Neurology, David Gefen School of Medicine, University of California Los Angeles (UCLA), 760 Westwood Plaza, Los Angeles, CA, 90095, USA.
Implement Sci Commun. 2024 Jul 15;5(1):75. doi: 10.1186/s43058-024-00613-9.
Patients with significant multimorbidity and other factors that make healthcare challenging to access and coordinate are at high risk for poor health outcomes. Although most (93%) of Veterans' Health Administration (VHA) patients at high risk for hospitalization or death ("high-risk Veterans") are primarily managed by primary care teams, few of these teams have implemented evidence-based practices (EBPs) known to improve outcomes for the high-risk patient population's complex healthcare issues. Effective implementation strategies could increase adoption of these EBPs in primary care; however, the most effective implementation strategies to increase evidence-based care for high-risk patients are unknown. The high-RIsk VETerans (RIVET) Quality Enhancement Research Initiative (QUERI) will compare two variants of Evidence-Based Quality Improvement (EBQI) strategies to implement two distinct EBPs for high-risk Veterans: individual coaching (EBQI-IC; tailored training with individual implementation sites to meet site-specific needs) versus learning collaborative (EBQI-LC; implementation sites trained in groups to encourage collaboration among sites). One EBP, Comprehensive Assessment and Care Planning (CACP), guides teams in addressing patients' cognitive, functional, and social needs through a comprehensive care plan. The other EBP, Medication Adherence Assessment (MAA), addresses common challenges to medication adherence using a patient-centered approach.
We will recruit and randomize 16 sites to either EBQI-IC or EBQI-LC to implement one of the EBPs, chosen by the site. Each site will have a site champion (front-line staff) who will participate in 18 months of EBQI facilitation.
We will use a mixed-methods type 3 hybrid Effectiveness-Implementation trial to test EBQI-IC versus EBQI-LC versus usual care using a Concurrent Stepped Wedge design. We will use the Practical, Robust Implementation and Sustainability Model (PRISM) framework to compare and evaluate Reach, Effectiveness, Adoption, Implementation, and costs. We will then assess the maintenance/sustainment and spread of both EBPs in primary care after the 18-month implementation period. Our primary outcome will be Reach, measured by the percentage of eligible high-risk patients who received the EBP.
Our study will identify which implementation strategy is most effective overall, and under various contexts, accounting for unique barriers, facilitators, EBP characteristics, and adaptations. Ultimately this study will identify ways for primary care clinics and teams to choose implementation strategies that can improve care and outcomes for patients with complex healthcare needs.
ClinicalTrials.gov, NCT05050643. Registered September 9th, 2021, https://clinicaltrials.gov/study/NCT05050643 PROTOCOL VERSION: This protocol is Version 1.0 which was created on 6/3/2020.
患有多种严重疾病以及存在其他导致医疗服务获取和协调困难因素的患者，健康结局不佳的风险很高。尽管退伍军人健康管理局（VHA）中大多数（93%）有住院或死亡高风险的患者（“高风险退伍军人”）主要由初级保健团队管理，但这些团队中很少有实施已知能改善高风险患者群体复杂医疗问题结局的循证实践（EBP）。有效的实施策略可以增加这些EBP在初级保健中的采用；然而，提高对高风险患者循证护理的最有效实施策略尚不清楚。高风险退伍军人（RIVET）质量提升研究计划（QUERI）将比较循证质量改进（EBQI）策略的两种变体，以为高风险退伍军人实施两种不同的EBP：个体辅导（EBQI-IC；针对各个实施地点进行量身定制的培训，以满足特定地点的需求）与学习协作组（EBQI-LC；对各实施地点进行分组培训，以鼓励各地点之间的协作）。一种EBP是综合评估与护理计划（CACP），它通过全面的护理计划指导团队满足患者的认知、功能和社会需求。另一种EBP是药物依从性评估（MAA），它采用以患者为中心的方法解决药物依从性方面的常见挑战。
我们将招募16个地点并将其随机分为EBQI-IC组或EBQI-LC组，以实施由该地点选择的一种EBP。每个地点将有一名现场负责人（一线工作人员），其将参与为期18个月的EBQI促进工作。
我们将使用混合方法3型混合有效性-实施试验，采用并行阶梯楔形设计测试EBQI-IC与EBQI-LC与常规护理的效果。我们将使用实用、稳健实施与可持续性模型（PRISM）框架来比较和评估覆盖范围、有效性、采用情况、实施情况和成本。然后，我们将评估在18个月的实施期后，这两种EBP在初级保健中的维持/持续情况和推广情况。我们的主要结局将是覆盖范围，通过接受EBP的符合条件的高风险患者的百分比来衡量。
我们的研究将确定哪种实施策略总体上最有效，以及在各种情况下最有效，同时考虑到独特的障碍、促进因素、EBP特征和适应性。最终，本研究将确定初级保健诊所和团队选择能够改善复杂医疗需求患者护理和结局的实施策略的方法。
ClinicalTrials.gov，NCT05050643。于2021年9月9日注册，https://clinicaltrials.gov/study/NCT05050643 方案版本：本方案是2020年6月3日创建的1.0版。
