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。慢性肾脏病 (CKD) 与 CKD 导致的高发病率和死亡率相关 进展和心血管疾病（CVD）。降低血压 (BP) 可以降低心血管疾病 (CVD) 的风险 CKD 进展。尽管有大量可用的降血压药物，但很大一部分退伍军人 患有 CKD 的患者血压高于目标。目前的做法涉及有执照的提供者进行药物治疗 滴定以实现血压目标，并且与有限的患者参与相关。我们的初步数据表明 实施药剂师指导的患者驱动的血压药物滴定是有效且可行的 慢性肾病。在这个模型中，退伍军人在临床医生的指导下自我管理他们的血压药物。 药剂师根据预先确定的药物滴定计划。 意义。退伍军人中 CKD 的患病率极高，一些研究报告称 患病率为 47%（普通人群的患病率为 11%）。在这里，我们提出了一种新颖的跨学科护理模式 让退伍军人积极参与他们的护理，目标是改善血压控制 改善长期成果。该应用程序解决了 HSR&D 的一个关键优先事项（复杂的管理） 慢性病）。 创新和影响。首先，拟议的护理模式尚未经过测试，包括 临床药剂师与提供者和退伍军人合作，以便患有 CKD 的退伍军人能够自我管理 他们的高血压。虽然 CKD 患者一旦进行透析（通过家庭 透析方式），但在 CKD 早期阶段并未采用自我管理方法。其次，在 方法，我们将利用跨学科的方法来评估药剂师指导的自我管理的实施情况 血压药物管理，我们将应用实施科学框架的构建， 实施研究综合框架 (CFIR)，了解退伍军人和系统因素 可能促进或阻碍药剂师指导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血压药物自我管理是否更有效 比家庭血压自我监测+慢性肾病退伍军人的标准护理更有效。具体目标2将 识别和理解可能影响自我接受度和坚持的退伍军人因素 管理方法，而具体目标 3 将侧重于了解可能促进或 妨碍自我管理方法的实施。 方法。一百六十名患有未受控制的高血压和 2 期 CKD 的退伍军人 白蛋白尿或 3 期和 4 期 CKD 将被随机分配至药剂师指导的自我管理或自我管理 监控+12个月的标准实践。目标 1 将评估[标准化]办公室收缩压的变化 12 个月时的血压作为主要结果。目标 2 将采用混合方法，包括半 通过结构化访谈来评估每个研究组中 20 名退伍军人的样本。我们将进一步设计 数据抽象工具来评估干预的依从性。在目标 3 中，我们将利用 CFIR 结构来 指导我们与主要组织利益相关者（包括 PACT 临床）进行定性半结构化访谈 药剂师、PCP 和 CKD 提供者（20 个主要利益相关者）。 执行。 PI 将与药房一起实施药剂师指导的自我管理方法 作为运营合作伙伴的流动护理服务。该方法的实施将改善 患者体验（患者医疗体验调查）和护理质量 （临床绩效衡量计划以及改进和学习的战略分析）。