Impact of a Multidisciplinary Intensive Management Clinic on Outcomes in Multi-Ethnic Asian Incident Hemodialysis Patients
Impact of a Multidisciplinary Intensive Management Clinic on Clinical, Patient-Reported and Economic Outcomes in Multi-Ethnic Asian Incident Hemodialysis Patients
Patients with end-stage renal disease are most vulnerable in the early months following hemodialysis (HD) initiation. Data from the United States Renal Data System and Singapore Renal Registry showed high mortality rates in the first 3-12 months of dialysis. Comprehensive multidisciplinary intervention programs implemented in the initial 3-4 months of dialysis showed reduction in mortality and morbidity in incident dialysis patients in the United States.
Based on these models, the Hemodialysis Initiation and Transition (HIT) Clinic involving a renal physician, clinical pharmacist and coordinator was set up. The main aim of the clinic is to provide multidisciplinary, intensive and consistent care to patients in the first 3 to 4 months after HD initiation to focus on and streamline the management of dialysis issues and complications. These interventions would help patients achieve goal therapeutic targets, as well as reduce hospitalization rates and mortality, thereby improving their clinical outcomes and self-reported quality of life, and could result in economic and cost savings for the patients and healthcare system. The purpose of this study is to determine if the multidisciplinary, intensive and collaborative management of our multiethnic Asian patients newly-initiated on HD improves laboratory, clinical, economic and patient-reported outcomes.
Adult incident HD patients from NUH will be randomized to the HIT clinic or to conventional management. Information on demographics, medical/medication histories, laboratory data (dialysis adequacy, iron-deficiency anemia, mineral/bone disorder, malnutrition and diabetes), hospitalizations, deaths and medical costs will be obtained and compared between the 2 groups. Patient-reported outcomes will be measured using the Kidney Disease Quality of Life-Short Form, EuroQol 5 Dimensions, Family Functioning Measure, Oslo-3 Social Support Scale and Health Services Utilization questionnaires. Data collection will take place at baseline, 3 to 4 months and 12 months after the first visit, with a total study duration and follow-up period of 1 year.
研究概览
研究类型
注册 (预期的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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Singapore、新加坡
- 招聘中
- National University Hospital
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接触:
- Priscilla P How, Pharm.D., BCPS
- 电话号码:(65)6516-4906
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首席研究员:
- Priscilla P How, Pharm.D., BCPS
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- all patients who are newly-initiated on HD and who meet the following criteria will be included in the study:
- male or female 21 years of age or older with stage 5 CKD (eGFR < 15 ml/min/1.73m2)
- newly-initiated on HD within the past 4-8 weeks of being seen in the NUH outpatient renal clinic
Exclusion Criteria:
- transient HD patients
- patients with poor cognitive function or are not able to complete the PRO questionnaires.
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical (mortality and morbidity)
大体时间:One year
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Mortality and morbidity (hospitalization from uncontrolled hypertension, anemia and fluid overload)
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One year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Laboratory outcomes
大体时间:One year
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Lab results
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One year
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Economic outcomes
大体时间:One year
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Direct and indirect medical costs
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One year
|
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Patient-reported outcomes
大体时间:One-year
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KDQOL and other social support questionnaires
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One-year
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合作者和调查者
调查人员
- 首席研究员:Priscilla P How, Pharm.D., BCPS、National University of Singapore
研究记录日期
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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