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临床试验/NCT02915575
NCT02915575已完成不适用

Advancing Community Care and Access to Follow-up After Acute Kidney Injury Hospitalization

University of Alberta3 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2018年3月19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
155
试验地点
3
主要终点
Proportion of patients develop Chronic kidney disease after Acute kidney injury

研究概览

简要总结

The purpose of this trial is to test the clinical benefit and feasibility of structured risk based post discharge care for hospital acquired Acute kidney injury survivors.This is a Pragmatic randomized controlled trial. It will be conducted at 2 hospitals in Alberta. 166 participants will be enrolled in this Randomized controlled trial..

详细描述

Research Objective:

To evaluate the impact of risk based decision support on processes of care for high-risk patients following discharge after hospitalization with Acute Kidney injury.

Experimental Strategy- rationale and considerations:

International guidelines for Chronic Kidney disease diagnosis and management provide a stage-based management approach to reduce the risk of adverse cardiovascular and renal outcomes based on estimated glomerular filtration rate (eGFR) and proteinuria. Identified key quality indicators for CKD care include the use of statins in CKD patients greater than age 50, or with diabetes or cardiovascular disease, use of ACEi (angiotensin-converting enzyme inhibitor) and ARB (angiotensin receptor blocker) in patients with proteinuria and referral to nephrology care with a sustained eGFR <30/ml/min/1.73m2. patients at low risk of CKD can be effectively managed by primary care given appropriate support. Study investigator will evaluate the identification of CKD by providing lab requisitions to all study participants. Those in the medium and high risk groups for CKD based on our risk index will be further guided to either a primary care web-based CKD care pathway which helps Primary care Physicians identify, treat and refer CKD patients using best practices, or nephrology care, respectively. Transitional care interventions have been shown to be effective preventing readmission in chronic conditions such as heart failure. Specialist care delivery often through multidisciplinary clinics has been found to improve prescription of proven efficacious medications and outcomes in a number of chronic disease settings including heart failure, Myocardial infarction,asthma and CKD. As there is no specific intervention for treating Acute kidney injury ensuring high adherence to CKD care in affected individuals is a feasible, sustainable strategy.

Participants The trial population will be comprised of consenting adult patients admitted to general medical or surgical teaching wards at 2 centers, the University of Alberta Hospital in Edmonton and the Foothills Hospital in Calgary.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

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

  • Age ≥ 18 yrs
  • At least a doubling of serum creatinine during hospitalization (including need for dialysis)
  • Have a primary care physician (PCP)
  • No nephrologist follow up arranged after hospital discharge

排除标准

  • Baseline GFR<30ml/min/1.73m2(CKD-EPI) or requiring chronic dialysis on admission
  • Renal transplant recipients
  • Poor prognosis not expected to survive > 6 months
  • Residence at a nursing home facility

研究组 & 干预措施

Control Arm (usual care)

Other

Participants will be discharged as per usual ward discharge protocols.

干预措施: Usual Care (Other)

Risk guided follow-up

Other

Participant will be stratified for risk of CKD in three groups: Low (<1% risk of CKD), medium (1-10 % risk of CKD) and high (≥10 % risk of CKD). Specific follow-up will be guided by risk status

干预措施: Risk guided follow-up (Other)

结局指标

主要结局

Proportion of patients develop Chronic kidney disease after Acute kidney injury

时间窗: 90 days

The primary (process based) outcome of this trial is the proportion of patients with CKD meeting all three quality of care indicators (statin use, ACEi/ARB use in those with proteinuria (ACR\>30mg/mmol) or diabetes, nephrologist visit if sustained eGFR\<30ml/min/1.73m2) within 90 days of hospital

次要结局

  • Feasibility(one year)
  • Proportion of patients completed the lab and seen by PCP(90 days)
  • check eGFR(one year)
  • Hospitalization(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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