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临床试验/NCT03890588
NCT03890588已完成不适用

A Technology-Driven Intervention to Improve Identification and Management of Chronic Kidney Disease in Primary Care

HealthPartners Institute2 个研究点 分布在 1 个国家目标入组 6,295 人开始时间: 2019年4月17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
6,295
试验地点
2
主要终点
Number of Patients With Optimal Blood Pressure Control

研究概览

简要总结

To prevent serious chronic kidney disease (CKD) complications such as end-stage renal disease and cardiovascular events, better strategies are needed to identify, treat, and refer CKD patients seen in primary care clinics. This project expands an existing and successful Web-based clinical decision support (CDS) system to include key elements of CKD care and rigorously assesses the impact of this intervention on quality of CKD care for patients seen in primary care settings, including better recognition of CKD, better management of blood pressure and glucose, and more timely referral to nephrologists when appropriate. This low-cost and highly scalable intervention has high potential to improve CKD care and translate massive public and private sector investments in health informatics into tangible health benefits for large numbers of patients with CKD.

详细描述

Clinics are randomly allocated 1:1 through a computer-generated program to either control or intervention.

Control Clinics. All control clinics will continue to use the basic Electronic Medical Record (EMR)-linked CDS for cardiovascular (CV) risk factor management. This CDS includes algorithmically derived identification of high CV risk patients and prioritized treatment suggestions for lipids, Blood Pressure (BP), glycemic control, weight, tobacco, and aspirin use based on distance from goal, current medications, labs, allergies, and safety considerations. The basic CDS does not include information specific to CKD care.

Intervention Clinics. The CKD-CDS intervention provides updated clinical recommendations at any primary care visit for patients meeting inclusion and exclusion criteria. This presents patients and their primary care providers (PCPs) multiple opportunities to consider an evolving array of timely, evidence-based treatment options to improve CKD care. The CKD-CDS intervention is rooted in a series of antecedent studies that developed more limited but successful forms of CDS. From an operational point of view, implementing CKD-CDS at intervention clinics requires a series of 4 distinct steps that occur at every encounter:

Step 1: Data exchange and evaluation: The EMR securely exchanges data with the Web Service at every encounter of patients aged 18-75 triggered by BP entry.

Step 2: Recognition of CKD and presence of care deficits: Patients with stage 3-4 CKD are automatically identified by the Web Service and evaluated using algorithms maintained in the Web service for identification of CKD and for the 5 emphasized care gaps (identification of CKD, BP control, glucose control, Angiotensin converting enzyme inhibitor (ACEI)/Angiotensin receptor blocker (ARB) use if appropriate, and nephrology consultation if appropriate). If the patient has a care gap, the rooming staff receives an immediate best practice advisory (BPA) prompt to print CDS materials for the patient and the provider to review and use for shared decision making. Using a sequence of steps successfully implemented in previous studies, the rooming staff will print the materials and give the lay version to the patient to review while waiting for the provider. A professional version is left on the door for the provider to review before entering the exam room. This approach has been well-liked by our providers to help them be prepared and to engage patients in their care needs before the clinician-patient interaction. PCPs can also optionally view an electronic version of the CDS materials. The CDS can be viewed in real time for any patient by clicking on a button programmed in the EMR encounter display.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 75 years, inclusive. The evidence-based guidelines on which the CDS intervention is based are not applicable outside this age range.
  • Have confirmed CKD based on 2 or more estimated glomerular filtration rate (eGFR) values <60 cc/min/1.73m2, including the most recent eGFR value and a previous eGFR at least one week prior
  • Have a CKD care component suboptimally managed as defined by one or more of the following:
  • Have two or more BP values from separate encounter dates of >=130/80 including the most recent BP to the index visit
  • Have an individualized A1C over goal as determined by CDS algorithm criteria of most recent glycated hemoglobin (A1C) > 7% OR > 8% if any of the following conditions are identified: cardiovascular disease (CVD) or calculated 10-yr atherosclerotic cardiovascular disease (ASCVD) risk >30%, cancer, hypoglycemia, cognitive impairment, on 2 or more glycemia medications with insulin, or on 3 or more non-insulin glycemia medications
  • Have most recent eGFR 30-59 with hypertension identified or albumin to creatinine ratio (ACR) > 30 mg/g and not on an ACEI or ARB
  • Have non-steroidal anti-inflammatory drug (NSAID) other than aspirin on the active medication list
  • Have a eGFR 15-29 or ACR > 300 mg/g without a nephrology visit in the last 12 months

排除标准

  • An individual who meets any of the following criteria will be excluded from receiving the
  • Patients enrolled in hospice,
  • Patients with active cancer or undergoing chemotherapy
  • Patients with pregnancy in the last year
  • Patients with end stage renal disease
  • Individuals who meet all inclusion and exclusion criteria at an index visit and have at least one post-index visit in the following 12 months will be included in the primary analyses.

结局指标

主要结局

Number of Patients With Optimal Blood Pressure Control

时间窗: 18-month period post index

Number of patients for whom the average of the two most recent blood pressures prior to 18 months post index was \<130/80.

Number of Participants With CKD Diagnosis

时间窗: 18-month period post index

Number of patients who had a CKD diagnosis document in the 18 months post index.

Number of Patients With Optimal Glucose Control

时间窗: 1 to 18-month period post index

Number of patients whose last A1c was \<7% in the 1-18 months post index.

Number of Patients With Orders for Angiotensin-converting Enzyme Inhibitors (ACEI) or Angiotension II Reception Blockers (ARB)

时间窗: 18-month period post index

Number of patients who had an Angiotensin-converting enzyme inhibitors (ACEI) or Angiotension II reception blockers (ARB) order in the 18 months post index.

Number of Patients With Referral to Nephrology

时间窗: 18-month period post index

Number of patients who have a referral to nephrology in the 18 months post index.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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