跳至主要内容
临床试验/NCT07435662
NCT07435662招募中不适用

Optimizing Heart Failure Therapies Among Patients With Limited Access in Denver

Denver Health and Hospital Authority0 个研究点目标入组 40 人开始时间: 2025年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
主要终点
Proportion of visits with initiation or intensification of heart failure medications

研究概览

简要总结

Numerous pharmacotherapies have been proven to reduce mortality and hospitalization rates for heart failure with reduced ejection fraction (HFrEF) patients. However, these are underutilized clinically, preventing realization of proven benefits. Simplified patient education tools and multidisciplinary teams including pharmacists have been used to improve medication optimization but in predominantly private payer groups. This study will translate these evidence-based interventions to patients with limited access to care. In this randomized, prospective study, patients with HFrEF at a local hospital dedicated to care for participants with limited access will receive either pharmacist-directed medication adjustment visits with patient education materials or standard of care. This study will assess the hypothesis that the implementation of the intervention is feasible in this population, as demonstrated by the number of visits and proportion of visits with medication adjustments. Further, medication dosing in each arm will be evaluated via the Kansas City Medication Optimization (KCMO) score, which will average the percentage of maximal doses of appropriate HFrEF medication classes a patient is on. The change in KCMO scores over the course of the pilot in the two arms will then be compared to assess the hypothesis that the intervention will better increase patients' KCMO scores than the standard of care. The findings of this study will help address knowledge gaps in the care of patients not well represented previously in the literature. This proposal addresses the translational science roadblock of recruitment and engagement of participants with limited access to care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Diagnosis of HFrEF (EF ≤ 40%)
  • Receiving care within DHHA system

排除标准

  • Estimated glomerular filtration rate (eGFR) < 25 mL/min/1.73 m² or receiving dialysis.
  • Cirrhosis
  • Inability to consent
  • Non-English or non-Spanish speaking

结局指标

主要结局

Proportion of visits with initiation or intensification of heart failure medications

时间窗: This will be assessed at each visit up to 3 months after enrollment.

次要结局

  • Change in Kansas City Medical Optimization (KCMO) score from baseline.(Calculated at enrollment and at 3 months.)

研究者

申办方类型
Other
责任方
Sponsor

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