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Support From Hospital to Home for Elders: A Randomized Controlled Study (SHHE)

2013年7月5日 更新者:University of California, San Francisco

The investigators will randomize 700 non-psychiatric, non-obstetric, non-surgical patients aged 55 years and older at San Francisco General Hospital (SFGH) to usual care (ten days of prescription medication, discharge summary sent to primary care provider (PCP), and outpatient appt made for patient, and patient's nurse reviews discharge plan,) or usual care plus a peridischarge intervention (a visit with specialized in-hospital discharge nurse, development of personalized discharge plan, two phone calls from a nurse practitioner(NP)/physician assistant (PA) after discharge and availability of additional calls back from NP/PA, upon patient request, to help answer questions and assist patient's transition to outpatient care, and communication with primary care/subspecialty providers). The usual care and usual care plus intervention groups will be assessed for differences in mortality and rates of rehospitalization and emergency department use 30, 90 and 180 days following discharge from the hospital.

The discharge process from the hospital to home is frequently marked by poor quality and high risk of adverse events and readmissions. It has been hypothesized that better coordinated care, personalized patient education, and follow-up calls to identify potential sources of adverse events, such as medical complications and medication errors can reduce rehospitalization and emergency room visits following discharge from the hospital. Although these interventions have been shown to reduce combined hospital readmissions and emergency department visits in English-speaking patients, none has focused on elderly patients in a diverse urban public hospital setting that includes non-English-speakers, who might benefit more than other populations from enhanced services during and after discharge from the hospital. Further, these labor-intensive interventions are costly to implement, and it is unknown whether opportunity cost of providing additional services in a limited-resource environment such as San Francisco General Hospital (SFGH) outweighs the unknown clinical benefits.

研究概览

地位

完全的

条件

研究类型

介入性

注册 (实际的)

699

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • San Francisco、California、美国、94110
        • San Francisco General Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

55年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • patients age 55 and older
  • admitted to the general medicine, family medicine, cardiology, and neurology services at San Francisco General Hospital,
  • able to communicate in either English, Spanish, Mandarin or Cantonese,
  • attending physicians agree to the patient's participation.
  • Patients must be able to demonstrate an understanding of the study's goals through a set of teach back questions included in the consent process.

Exclusion Criteria:

  • transferred from an outside hospital;
  • admitted for a planned hospitalization (e.g. chemotherapy, a planned surgery)
  • requiring hospice, nursing home, rehab or other institutional settings (i.e. expected by the physician team to be discharged to skilled nursing facilities) - those unable to independently consent (i.e. severely cognitively impaired, delirious, deaf, or involuntarily hospitalized because of severe mental illness)
  • unable to understand English, Spanish or Cantonese (as reported by medical teams or unable to complete the consent teach-back process)
  • less than age 55
  • aphasic
  • otherwise excluded by the medical team
  • participated in the pilot project of this intervention.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:日常护理
实验性的:SHHE Peridischarge intervention
Patients receive the Support from Hospital to Home (SHHE) Peridischarge Intervention plus usual care

Support from Hospital to Home (SHHE) Peridischarge Intervention patients will receive Usual care plus

  1. a visit with in-hospital registered nurse, who provides additional patient education, assesses patient's needs post-hospitalization, communicates with the medical team, and develops a personalized discharge plan;
  2. two phone calls from a nurse practitioner(NP)/physician assistant (PA) after discharge, in which adherence to medications, treatment plan, and access to outpatient care, and other issues identified during the hospitalization will be explored;
  3. the provision of a phone support line, on which an NP/PA will call patients back within 24 hours to answer questions and assist transition to outpatient care.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Combined Emergency Department Visits and Inpatient Readmissions
大体时间:30 days after discharge from hospital
30 days after discharge from hospital
Combined Emergency Department Visits and Inpatient Readmissions
大体时间:90 days after discharge from hospital
90 days after discharge from hospital
Combined Emergency Department Visits and Inpatient Readmissions
大体时间:180 days after discharge from hospital
180 days after discharge from hospital

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jeffrey M Critchfield, MD、University of California, San Francisco
  • 首席研究员:Sue Currin, RN、San Francisco General Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年7月1日

初级完成 (实际的)

2012年2月1日

研究完成 (实际的)

2013年7月1日

研究注册日期

首次提交

2010年7月13日

首先提交符合 QC 标准的

2010年10月13日

首次发布 (估计)

2010年10月15日

研究记录更新

最后更新发布 (估计)

2013年7月9日

上次提交的符合 QC 标准的更新

2013年7月5日

最后验证

2013年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • SHHE2010

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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