深圳市三级医院肿瘤中心建立临终关怀示范单元的需求以及与二级、社区医院双向转诊机制的可行性分析

注册号:

Registration number:

ChiCTR-HOC-17012856 

最近更新日期:

Date of Last Refreshed on:

2017-10-01 16:32:20 

注册时间:

Date of Registration:

2017-10-01 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

深圳市三级医院肿瘤中心建立临终关怀示范单元的需求以及与二级、社区医院双向转诊机制的可行性分析

Public title:

The needs of establishment for the end-of-life care demonstration unit in level 3 hospital and feasibility study dual referral between level 3 and level 2 or community hospital in ShenZhen City

注册题目简写:

English Acronym:

研究课题的正式科学名称:

深圳市三级医院肿瘤中心建立临终关怀示范单元的需求以及与二级、社区医院双向转诊机制的可行性分析

Scientific title:

The needs of establishment for the end-of-life care demonstration unit in level 3 hospital and feasibility study dual referral between level 3 and level 2 or community hospital in ShenZhen City

研究课题代号(代码):

Study subject ID:

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

申请注册联系人:

李济时 

研究负责人:

李济时 

Applicant:

LI JISHI 

Study leader:

LI JISHI 

申请注册联系人电话:

Applicant telephone:

+86 13828752599

研究负责人电话:

Study leader's
telephone:

+86 13828752599

申请注册联系人传真 :

Applicant Fax:

研究负责人传真:

Study leader's fax:

申请注册联系人电子邮件:

Applicant E-mail:

lijs@hku-szh.org

研究负责人电子邮件:

Study leader's E-mail:

lijs@hku-szh.org

申请单位网址(自愿提供):

Applicant website(voluntary supply):

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

申请注册联系人通讯地址:

深圳市福田区海园1路1号

研究负责人通讯地址:

深圳市福田区海园1路1号

Applicant address:

1 The First Haiyuan Road, Futian District, Shenzhen, Guangdong, China

Study leader's address:

1 The First Haiyuan Road, Futian District, Shenzhen, Guangdong, China

申请注册联系人邮政编码:

Applicant postcode:

研究负责人邮政编码:

Study leader's postcode:

申请人所在单位:

香港大学深圳医院

Applicant's institution:

The University of Hong Kong-Shenzhen Hospital

研究负责人所在单位:

香港大学深圳医院

Affiliation of the Leader:

The University of Hong Kong-Shenzhen Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2017-85

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

香港大学深圳医院医学研究伦理委员会

Name of the ethic committee:

Ethics committee of the medical research of The University of Hong Kong-Shenzhen Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2017-04-13 00:00:00

伦理委员会联系人:

Contact Name of the ethic committee:

伦理委员会联系地址:

Contact Address of the ethic committee:

伦理委员会联系人电话:

Contact phone of the ethic committee:

伦理委员会联系人邮箱:

Contact email of the ethic committee:

研究实施负责(组长)单位:

香港大学深圳医院

Primary sponsor:

The University of Hong Kong-Shenzhen Hospital

研究实施负责(组长)单位地址:

深圳市福田区海园1路1号

Primary sponsor's address:

1 The First Haiyuan Road, Futian District, Shenzhen, Guangdong, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

深圳

Country:

China

Province:

Guangdong

City:

ShenZhen

单位(医院):

香港大学深圳医院

具体地址:

深圳市福田区海园1路1号

Institution
hospital:

The University of Hong Kong-Shenzhen Hospital

Address:

1 The First Haiyuan Road, Futian District, Shenzhen, Guangdong, China

国家:

中国

省(直辖市):

广东

市(区县):

深圳

Country:

China

Province:

Guangdong

City:

单位(医院):

深圳市龙岗中心医院

具体地址:

龙岗区龙岗大道6082号

Institution
hospital:

LongGang District Central Hospital of ShenZhen

Address:

6082 Longgang Avenue, Longgang District, Shenzhen

经费或物资来源:

深圳市卫生和计划生育委员会

Source(s) of funding:

Health and family planning commission of ShenZhen municipality

研究疾病:

癌症  

Target disease:

cancer

研究疾病代码:

Target disease code:

研究类型:

卫生服务研究

Study type:

Health services reaserch

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

本研究旨在面向深圳市公立三级医院为代表的肿瘤中心病房开展舒缓治疗质量调查,同时调研患者的就医文化、对舒缓治疗的认知度、死亡观,评估三级医院内晚期癌症患者临终关怀的需求,寻找可以优化的因素,建立三级医院临终关怀示范单元,预期通过示范效应、通过增强与二级、社区医院的示范与效仿关联、提高二级与社区医院临终关怀的诊疗技术,作为适宜技术推广并探索灵活的双向转诊机制,促进医疗资源的合理配置以及死亡质量的提高。  

Objectives of Study:

To investigate the needs and quality of end of life care for advanced cancer patients in level 3 public hospital in Shenzhen, including the death view, the needs of establishment of the end of life care demonstration unit in level 3 hospital and explore the mechanism of dual referral between level 3 and level 2 or community hospital, to promote the reasonable allocation of medical resources and improve the quality of end of life care.

药物成份或治疗方案详述:

无 

Description for medicine or protocol of treatment in detail:

none 

纳入标准:

Inclusion criteria

排除标准:

不符合纳入标准者。

Exclusion criteria:

who not indicated to the inclusion criteria.

研究实施时间:

Study execute time:

From 2017-10-01 00:00:00 To 2020-09-28 00:00:00  

征募观察对象时间:

Recruiting time:

From 2017-11-01 00:00:00 To 2019-12-31 00:00:00

干预措施:

Interventions:

组别:

1

样本量:

400

Group:

1

Sample size:

干预措施:

问卷

干预措施代码:

Intervention:

quastranaire

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

广东 

市(区县):

深圳 

Country:

China

Province:

Guangdong

City:

ShenZhen

单位(医院):

香港大学深圳医院 

单位级别:

三级 

Institution
hospital:

The University of Hong Kong-Shenzhen Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

广东 

市(区县):

深圳 

Country:

China

Province:

Guangdong

City:

ShenZhen

单位(医院):

深圳市龙岗中心医院 

单位级别:

三级 

Institution
hospital:

LongGang District Central Hospital of ShenZhen

Level of the institution:

Tertiary A hospital

测量指标:

Outcomes:

指标中文名:

舒缓治疗质量

指标类型:

主要指标

Outcome:

quality of end of life care

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

对舒缓治疗的认知度、死亡观

指标类型:

次要指标

Outcome:

death view, the needs of establishment of the end of life care demonstration unit

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 100 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

Randomization Procedure (please state who generates the random number sequence and by what method):

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

临床试验公共管理平台

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Resman research manager

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

电子采集和管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Electronic Data Capture, EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

注册人:

Name of Registration:

 2017-10-01 16:32:20