跳至主要内容
临床试验/NCT01203813
NCT01203813已完成3 期

A Risk Based Approach to Improving Chronic Kidney Disease Management

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
10,000
试验地点
2
主要终点
Annual Nephrology Evaluation

研究概览

简要总结

Aim 1: To assess whether quality of care for stage 3 chronic kidney disease can be substantially improved over 18 months by:

  • Point of care electronic alerts to primary care physicians recommending risk-appropriate care, and
  • Quarterly mailings to patients providing self management support materials, including tailored recommendations based on personalized data from an electronic disease registry

Aim 2: To assess the relationship between utilization of the intervention components and primary care physician attitudes towards both chronic kidney disease management and electronic reminder systems.

详细描述

Specific Aim 1 We will develop software to calculate the estimated glomerular filtration rates for all patients presenting to primary care physicians randomized to the intervention arm, and identify patients with an estimated glomerular filtration rates in the range of 30 to 59. We will create three electronic alerts that intervention clinicians will receive upon accessing the patient chart based on whether the patient is high risk or low risk. These alerts will focus on recommending overdue laboratory tests (urine protein, blood cholesterol, etc), as well as recommending guideline appropriate medications (ACE inhibitors), and nephrology referral when appropriate.

We will provide self management support materials to patients of primary care physicians randomized to the intervention arm. We will rely on primary care physicians to enroll patients by first recommending referral via the electronic alerts. On a monthly basis, we will identify patient visits during which an alert fired and no referral was placed. We will distribute a list of these patients to each physician via inter-office mail at least every other month. The mailing will ask physicians to return the list indicating which patients should be enrolled in the program, and our project manager will place the referrals. For non-responding physicians, we will follow up with a reminder email. The patient mailings will include recent clinical results and guideline-recommended targets, encouraging patients to become more proactive in the management of their kidney disease. Once a patient is enrolled in the program, they will receive similar mailings with updated personalized data and recommendations every 3 months.

Electronic referrals placed by primary care physicians for management of chronic kidney disease will first be routed to the renal nurse, who will then initiate contact with the patient. A total of two telephone calls followed by a letter will be made to contact the patient. The nephrology visits will occur per standard clinical operations, including evaluation by an attending nephrologist, as well as educational sessions with the renal nurse and nutritionist. We will create new template notes within the electronic record for use by the nephrologists to communicate clinical care recommendations back to the primary care physicians.

Prior to starting the intervention, the study team will travel to each of the 14 health centers to conduct orientation sessions with the primary care physicians. These sessions will provide general information regarding the goals and scope of the upcoming intervention, including demonstrations of the electronic alerts and the self management support outreach program. A similar overview will also be provided to the HVMA Division of Nephrology.

We will randomize approximately 170 physicians into the intervention and control groups. Physicians in the intervention group will receive patient-specific alerts at the time of office visits for patients with Stage 3 kidney disease. Physicians in the control group will not receive active alerts.

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

入选标准

  • Stage 3 chronic kidney disease based on at least 2 eGFR 30-60 (separated by 90 days) within the prior 5 years
  • Must be at least 18 years of age
  • Must have a primary care visit at one of 15 of the HVMA health centers within the last 18 months

排除标准

  • Age > 85 years

结局指标

主要结局

Annual Nephrology Evaluation

时间窗: At 18 months

Patients with high risk chronic kidney disease (eGFR 30 to 45; or eGFR 45 to 60 with concurrent diabetes or proteinuria) should receive a nephrology office evaluation within the prior 12 months

Appropriate ACE/ARB Use

时间窗: At 18 months

Patients with chronic kidney disease (eGFR 30 to 60) with concurrent diabetes, proteinuria, or hypertension should receive a prescription for ACE/ARB within the prior 12 months

Annual lab monitoring for CKD

时间窗: At 18 months

Patients with chronic kidney disease (eGFR 30 to 60) should have the following labs checked within the prior 12 months: 1. eGFR/ creatinine 2. Lipid profile 3. Calcium 4. Vitamin D 5. Parathyroid hormone 6. Phosphorous 7. Hemoglobin 8. Urine microalbumin

次要结局

  • Outcomes According to Primary Care Use(At 18 months)
  • Outcomes According to Physician Attitudes(At 18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Dean Sequist, MD

Associate Professor

Brigham and Women's Hospital

研究点 (2)

Loading locations...

相似试验