跳至主要内容
临床试验/NCT01767883
NCT01767883已完成不适用

Improving Evidence-Based Primary Care for Chronic Kidney Disease

American Academy of Family Physicians2 个研究点 分布在 1 个国家目标入组 27,000 人开始时间: 2011年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
27,000
试验地点
2
主要终点
Degree of evidence-based guideline-concordant care for CKD

研究概览

简要总结

Background: Chronic Kidney Disease (CKD) is under-recognized and under-treated in primary care offices and primary care physicians are generally not familiar with treatment guidelines. Even when diagnosed properly, as a chronic condition CKD is frequently associated with co-morbidities that make effective treatment difficult due to complexity of care. Availability of Clinical Decision Support (CDS) for CKD may help promote effective, evidence-based care, but evidence suggests that CDS alone may not be sufficient for quality improvement and other interventions such as CDS plus practice facilitation may be needed.

Purpose: The project aims to: 1) assess the viability of CDS in implementing evidence-based guidelines for Primary Care Practices (PCPs) and 2) to develop evidence-based practice guidelines that PCPs may use to enhance the care they provide to a difficult to manage segment of the healthcare population.

Methods: This is a randomized controlled trial of point-of-care CDS plus full TRANSLATE model of practice change, versus CDS alone. The study aims to analyze differences in promoting evidence-based care in primary care practices. Thirty-six practices will be recruited for this study. Patient inclusion criteria: adult patients with estimated Glomerular Filtration Rate (eGFR) of <60 and >15ml/min/1.73m2 confirmed with repeat testing over three or more months. A process evaluation will be conducted between the CDS practices with facilitation and the CDS only practices to assess clinical outcomes of CKD progression and all-cause mortality. Lastly, a cost-effective analysis will compare the cost-to-benefit ratio of CDS alone to that of CDS plus TRANSLATE (i.e. practice facilitation) in relation to cost per quality adjusted years of life. This study is funded by NIH NIDDK under R01 mechanism starting on 07/01/2011 and ending on 06/30/2016.

详细描述

The proposed trial tests the extent to which CDS plus facilitation promotes evidence-based care and improves the clinical outcomes of reduced disease progression and mortality in primary care practices. We also conduct an observational comparative effectiveness analysis of data from a larger database of electronic medical records in order to identify the most successful components of evidence-based care with respect to disease progression and all-cause mortality.

Specific Aim 1: Conduct a group randomized controlled trial of point-of-care computer decision support plus the full TRANSLATE model of practice change, versus computer decision support alone in promoting evidence-based care in primary care practices for all patients with an eGFR <60 and > 15 ml/min/1.73m2 confirmed with repeat testing over three or more months. (CKD stages 3 and 4) Hypothesis 1.1: CDS practices using the TRANSLATE model will provide a greater degree of evidence-based guideline-concordant care for CKD than CDS only practices.

Specific Aim 2: Conduct an intent-to-treat and process analysis between the CDS practices with facilitation versus the CDS only practices of the clinical outcomes of CKD progression and all-cause mortality.

Hypothesis 2.1: Patients with stage 3 and 4 CKD in facilitated practices will have slower CKD progression than patients in CDS only practices.

Hypothesis 2.2: Patients with stage 3 and 4 CKD in facilitated practices will have significantly lower all-cause mortality than stage 3 and 4 patients in CDS only practices.

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 (Participant)

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

  • all individuals whose primary care provider offices participate in the study who is over the age of 18 with a diagnosis of stages 2-4 of CKD and/or diabetes and/or hypertension and/or one eGFR <60 and/or one urine albumin/creatinine ratio >30

排除标准

  • individual patients whose primary care provider's practice has not signed practice and data use agreements with the AAFP NRN to participate in this practice improvement project at the practice level

研究组 & 干预措施

Facilitated Clinical Decision Support

Experimental

The primary care practices in this arm will receive:

  • CKD decision support algorithms added to their Clinical Decision Support
  • System Academic detailing concerning the rationale for the algorithms
  • On-going mentoring and practice facilitation

干预措施: Facilitated Clinical Decision Support (Other)

Clinical Decision Support Only

Active Comparator

The primary care practices in this arm will receive:

  • CKD decision support algorithms added to their Clinical Decision Support System
  • Academic detailing concerning the rationale for the algorithms

干预措施: Clinical Decision Support Only (Other)

结局指标

主要结局

Degree of evidence-based guideline-concordant care for CKD

时间窗: up to 3 years

Percentage of patients at goal for: Control Blood Pressure Control LDL Control HbA1C Use ACE/ARB Eliminate NSAID/Cox-2 use Refer to Nephrologist Eliminate Smoking

次要结局

  • CKD Management Process Measures(upt to 3 years)
  • Cost of intervention(up to 3 years)
  • All-cause mortality(up to 3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验