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临床试验/NCT01290614
NCT01290614已完成4 期

A Chronic Care Model Based QI Program to Improve the Care of Patients With CKD

University of Minnesota1 个研究点 分布在 1 个国家目标入组 2,199 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
2,199
试验地点
1
主要终点
Systolic Blood Pressure (SBP)

研究概览

简要总结

The goal of this study is to evaluate the impact of a chronic care model (CCM) based quality improvement program on 1) outcomes for patients with chronic kidney disease (CKD) and 2) adherence to CKD guidelines. This pilot study will evaluate the feasibility of a CCM based quality improvement program for patients with CKD and assess potential mechanisms for the intervention's effect.

Hypothesis: Implementing a CCM based quality improvement program including system level support in the form of collaborative care, a CKD registry, and provider education will 1) reduce systolic BP in patients with poorly controlled hypertension, 2) increase the percentage of patients appropriately monitored for metabolic complications, and 3) decrease the rate of catheter use in patients initiating dialysis.

详细描述

Research Plan:

The experimental design is a prospective, randomized controlled trial evaluating the impact of a Chronic Care Model (CCM) based quality improvement program on CKD guideline adherence. The intervention will focus on three main goals: 1) reduction of BP to target levels, 2) appropriate monitoring of patients for metabolic complications of CKD, and 3) reduced use of dialysis catheters in patients initiating dialysis. The CKD CCM QI program will include a lecture on CKD guidelines and hypertension to all CBOC providers and a centrally located pharmacist with access to the CKD registry.

Methodology:

Veterans receive primary care at Community Based Outpatient Centers (CBOCs) throughout Northeast Ohio. Patients with CKD who receive their primary care at a Northeast Ohio CBOC will be eligible for the study. The hypothesis was formulated before data collection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •receipt of primary care at a VISN 10 Northeast Ohio CBOC
  • •GFR (calculated according to the 4 variable Modification of Diet in Renal Disease study equation) less than 45 mL/min per 1.73m2 with a second GFR less than 60 at least 90 to 730 days prior to the index GFR (26); and
  • •at least one primary care visit in the year prior to study initiation.

排除标准

  • •ESRD as defined by chronic renal replacement therapy,
  • •receipt of a renal transplant,
  • •hospice care, and
  • •age greater than 85 years or less than 18 years at the time of study initiation.

研究组 & 干预措施

Control - usual care

Active Comparator

Patients assigned to control will continue to receive care from their VA provider.

干预措施: Usual Care (Other)

Pharmacist intervention

Experimental

干预措施: Pharmacist based QI program (Other)

结局指标

主要结局

Systolic Blood Pressure (SBP)

时间窗: one year

Average SBP for those with a baseline BP \> 130/80

次要结局

  • Number of Participants With PTH Measurement During the Study Period(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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