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临床试验/NCT03679247
NCT03679247已完成不适用

Electronic Tools to Increase Recognition and Improve Primary Care Management for Hypertension in Chronic Kidney Disease

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 2,026 人开始时间: 2021年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,026
试验地点
2
主要终点
Change in Systolic Blood Pressure (SBP) From Baseline to 180 Days

研究概览

简要总结

In this project the investigators will create computer reminders through user-centered design and will validate the logic using retrospective electronic health record (EHR) data. Then the investigators will test the reminders in primary care clinics to see if they improve treatment of high blood pressure in early chronic kidney disease.

Hypothesis: The mean systolic blood pressure of the chronic kidney disease (CKD) population can be decreased by an intervention with three innovative features: 1) methods to synthesize EHR data in order to identify under-diagnosed chronic conditions, 2) iterative improvement in clinical decision support (CDS) content through human factors methods to maximize the "informativeness" of the CDS, and 3) the use of behavioral economic principles to create behavioral "nudges" internal and external to the CDS.

详细描述

Specific Aim 1: To develop and validate the intervention. Specific Aim 1a: To develop and validate the CDS that will: 1) synthesize existing laboratory tests, medication orders, and vital sign data; 2) increase recognition of CKD, 3) increase recognition of uncontrolled HTN in CKD patients; and 4) deliver evidence-based CKD and hypertension (HTN) management recommendations.

Specific Aim 1b: To improve the design and content of the CDS, we will use human factors methods, specifically usability testing.

Specific Aim 1c: To develop a "wrap-around" intervention including two behavioral "nudges": 1) pre-checked default orders, and 2) an email to obtain commitment from primary care providers (PCPs) to obtain their commitment to follow the CDS recommendations.

Aim 1a Study Procedures:

Develop Rules for Evidence-based Recommendations for HTN in CKD: The investigators will leverage past work that they have done in a study that delivered recommendations based on national guidelines. An example of one of the rules is to determine whether anti-hypertensive agents have been prescribed but are not at highest potency. If so, the CDS will deliver a recommendation to increase the dosage. The investigators will also include one-click access to recommended orders.

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
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

  • 18 years or older
  • Has visit with PCP at one of the intervention practices during the 2 years before the study period
  • Chronic Kidney Disease, defined as two prior estimated glomerular filtration rate (eGFR) 16-59 mL/min/1.73m2 separated by 90 days (as calculated by CKD-EPI) or two prior urine albumin to creatinine ratio (UACR) >30 mg/g separated by 90 days

排除标准

  • Patients receiving care from residents in training
  • Patients receiving care from physicians only seeing urgent care and walk-in patients
  • Patients with a most recent eGFR ≤ 20 or two previous eGFRs within 2 years separated by at least 90 days ≤ 15

结局指标

主要结局

Change in Systolic Blood Pressure (SBP) From Baseline to 180 Days

时间窗: 180 days

Difference in SBP from baseline to 180 days

次要结局

未报告次要终点

研究者

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

Lipika Samal

Director of Brigham and Women's Primary Care Practice-based Research Network

Brigham and Women's Hospital

研究点 (2)

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