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临床试验/NCT01916876
NCT01916876撤回不适用

A Randomised Controlled Trial of an Integrated Post-discharge Transitional Care Package for General Medical In-patients in Cape Town, South Africa

University of Cape Town4 个研究点 分布在 1 个国家开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
4
主要终点
All cause mortality

研究概览

简要总结

The post discharge time is a vulnerable time for general medical in-patients, with high rates of adverse events that may cause unnecessary readmissions and even death. A recent study of 415 patients discharged from the general medical wards at Groote Schuur Hospital, demonstrated a very high 12 month mortality of 35%. The majority of these deaths were classified as "unexpected". The reasons for this were not further examined, but it was speculated, given the authors' knowledge of the public sector in Cape Town, that three related factors contribute significantly to this early mortality: i) a lack of continuity of care, with patients not necessarily accessing the primary care support treatment that they need or being able to access early post discharge follow-up (for example for anti-retroviral or anti-tuberculous care); ii) the inability of primary care to deal with the complex nature of the discharged patients, most whom have significant co-morbid disease; iii) A lack of optimisation of therapy for chronic disease after acute discharge.

The investigators hypothesise that an integrated post-discharge transitional care package, which includes an early medical specialist follow-up in the first 3 months after hospital discharge will decrease the 6- and 12-month mortality and re-admission rate amongst general medical hospital admissions in Cape Town, South Africa. Our study will compare an integrated package, suitable to implementation if effective, with current standard discharge packages.

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 (Care Provider)

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

  • Patients referred for admission to general medical wards (including within hospital transfer e.g. ICU discharge)
  • >18 years and willing to give informed consent

排除标准

  • Patient admitted directly to intensive care unit
  • Patient refusing consent or <18 years old
  • Patients electively admitted
  • Patients without phone numbers who cannot provide any telephone contact details for a co-habitant, relative or neighbour.

结局指标

主要结局

All cause mortality

时间窗: 12 months

All cause 12-month mortality will be evaluated at 12-months post enrolment. Data on mortality will be acquired through telephonic patient/family contact and review of provincial death registry

次要结局

  • All cause mortality(6 months)
  • Hospital readmission rate(12 months)
  • Bartel index(12 months)
  • Karnofsky performance score(12 months)

研究者

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

Jonathan Peter

Honorary Consultant, Department of Medicine

University of Cape Town

研究点 (4)

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