Pharmacist-guided, patient-driven management of high blood pressure in CKD: A Novel Approach

药剂师指导、以患者为主导的 CKD 高血压管理：一种新方法

• 批准号: 10535326
• 负责人: Diana I Jalal
• 金额: --
• 依托单位: IOWA CITY VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-10-01 至 2026-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10535326
• 关键词: Address; Adherence; Affect; Albuminuria; Ambulatory Care; Appointment; Blood Pressure; Cardiovascular Diseases; Caring; Characteristics; Chronic Disease; Chronic Kidney Failure; Cities; Clinic Visits; Clinical; Clinical Pharmacists; Clinical Trials; Complex; Consolidated Framework for Implementation Research; Data; Dialysis procedure; Disease Progression; End stage renal failure; Evaluation; Exercise; Feasibility Studies; Funding; General Population; Goals; Health Care Surveys; Healthcare Systems; Home; Home Blood Pressure Monitoring; Hypertension; Instruction; Intervention; Interview; Iowa; Learning; Measurement; Methods; Modality; Modeling; Monitor; Morbidity - disease rate; Outcome; Outpatients; Participant; Patients; Performance; Pharmaceutical Preparations; Pharmacists; Pharmacy facility; Prevalence; Provider; Quality of Care; Randomized; Reporting; Research; Research Personnel; Risk; Risk Factors; Sampling; Self Management; Service delivery model; Services; Standardization; Structure; System; Testing; Time; Titrations; United Kingdom; United States National Institutes of Health; Universities; Veterans; Veterans Health Administration; arm; base; blood pressure control; blood pressure medication; blood pressure reduction; cardiovascular disorder risk; cardiovascular risk factor; care providers; care systems; design; experience; health care delivery; health care model; high risk; hypertension control; implementation evaluation; implementation facilitation; implementation framework; improved; innovation; mortality; mortality risk; novel; novel strategies; patient engagement; primary outcome; programs; shared decision making; standard care; tool; traditional care

Background. Chronic kidney disease (CKD) associates with high morbidity and mortality due to CKD progression and cardiovascular disease (CVD). Blood pressure (BP) lowering reduces the risk of CVD and CKD progression. In spite of the large number of BP medications available, a significant proportion of Veterans with CKD have BP above the goal. The current practice involves licensed providers performing medication titrations to achieve BP goals and is associated with limited patient engagement. Our preliminary data indicate that the implementation of pharmacist-guided patient-driven titration of BP medications is effective and feasible in CKD. In this model, Veterans self-manage their BP medications under the guidance of the clinical pharmacist based on a pre-determined medication titration plan. Significance. The prevalence of CKD is extremely high among Veterans, with some studies reporting a prevalence of 47% (vs 11% in the general population). Here, we propose a novel interdisciplinary care model that engages the Veterans as an active participant in their care with the goal of improving BP control to improve long term outcomes. The application addresses a key HSR&D priority (management of complex chronic disease). Innovation and Impact. First, the proposed care model is one that has not been tested and includes the clinical pharmacist working with the provider and the Veterans so that Veterans with CKD can self-manage their hypertension. While self-management is exercised in CKD once patients are on dialysis (via home dialysis modalities), the self-management approach is not utilized in the earlier stages of CKD. Second, in the approach, we will utilize a transdisciplinary approach to evaluate the implementation of pharmacist-guided self- management of BP medications and we will apply constructs of an implementation science framework, Consolidated Framework for Implementation Research (CFIR), to understand Veteran and system factors that may either facilitate or impede the implementation and sustainment of the pharmacist-guided self-management approach. Specific aims. Specific aim 1 will evaluate if pharmacist-guided self-management of BP medications is more effective than self-monitoring of home BP + the standard care amongst Veterans with CKD. Specific aim 2 will identify and understand Veteran factors that may influence the acceptability of and the adherence to the self- management approach whereas specific aim 3 will focus on understanding system factors that may facilitate or impede the implementation of the self-management approach. Methods. One hundred and sixty Veterans with uncontrolled hypertension and either stage 2 CKD with albuminuria or stage 3 and 4 CKD will be randomized to either pharmacist-guided self-management or to self- monitoring + the standard practice for 12 months. Aim 1 will evaluate change in [standardized] office systolic BP at 12 months as the primary outcome. Aim 2 will utilize a mixed methods approach including semi- structured interviews to evaluate a sample of 20 Veterans in each of the study arms. We will further design data abstraction tools to evaluate the adherence to the intervention. In aim 3, we will utilize CFIR constructs to guide our qualitative semi-structured interviews with key organizational stakeholders including PACT clinical pharmacists, PCPs, and CKD providers (20 key stakeholders). Implementation. The PI will implement the pharmacist-guided self-management approach with the Pharmacy and Ambulatory care services as operational partners. The implementation of this approach will improve the patient experience (Survey of Healthcare Experiences of Patients) and the quality of care (Clinical Performance Measurement Program and the Strategic Analytics for Improvement and Learning).

背景。慢性肾脏疾病（CKD）与CKD相关的高发病和死亡率 进展和心血管疾病（CVD）。血压（BP）降低了CVD的风险和 CKD进展。尽管有大量的BP药物，但很大一部分退伍军人 CKD的BP高于目标。当前的实践涉及执照的提供者进行药物治疗 滴定以实现BP目标，并与患者参与度有限有关。我们的初步数据表示 药剂师指导的患者驱动的BP药物的实施是有效且可行的 在CKD中。在这种模型中，退伍军人在临床指导下自我管理其BP药物 基于预定的药物滴定计划的药剂师。 意义。在退伍军人中，CKD的患病率极高，一些研究报告了 患病率为47％（普通人群为11％）。在这里，我们提出了一种新颖的跨学科护理模型 这使退伍军人成为积极参与者的照顾，目的是将BP控制改善到 改善长期结果。该应用程序解决了关键的HSR＆D优先级（复杂的管理 慢性病）。 创新和影响。首先，拟议的护理模型是尚未经过测试的模型，包括 与提供者和退伍军人一起工作的临床药剂师，以便拥有CKD的退伍军人可以自我管理 他们的高血压。一旦患者进行透析，在CKD中行使自我管理（通过家里 透析模式），自我管理方法在CKD的早期阶段不使用。第二，在 方法，我们将利用一种跨学科的方法来评估药剂师指导的自我实施 BP药物的管理，我们将应用实施科学框架的结构， 合并实施研究框架（CFIR），以了解老兵和系统因素 可以促进或阻碍药剂师指导的自我管理的实施和维持 方法。 具体目标。具体目标1将评估药剂师指导的BP药物的自我管理是否更多 比自我监控的家庭BP + CKD退伍军人的标准护理。具体目标2将 识别并理解可能影响自我的可接受性和遵守性的退伍军人因素 管理方法，而特定的目标3将专注于理解可能有助于或 阻碍实施自我管理方法。 方法。一百六十名退伍军人患有不受控制的高血压，任一阶段2 CKD 蛋白尿或第3阶段和4 CKD将随机分为药剂师指导的自我管理或自我 监视 +标准练习12个月。 AIM 1将评估[标准化]办公室收缩期的变化 BP在12个月作为主要结果。 AIM 2将利用混合方法方法，包括半 结构化访谈评估每个研究组中20名退伍军人的样本。我们将进一步设计 数据抽象工具以评估遵守干预措施。在AIM 3中，我们将利用CFIR构造 指导我们与关键组织利益相关者（包括协议临床）的定性半结构化访谈 药剂师，PCP和CKD提供商（20个主要利益相关者）。 执行。 PI将使用药房实施药剂师指导的自我管理方法 作为运营伙伴的门诊护理服务。这种方法的实施将改善 患者经验（对患者的医疗保健经验的调查）和护理质量 （临床绩效测量计划和改进和学习的战略分析）。