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Aged Care Clinical Mentoring Model of Change in Nursing Homes in China: A Cluster Randomized Controlled Trial
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注册号:

Registration number:

ChiCTR-IOC-17013109 

最近更新日期:

Date of Last Refreshed on:

2017-10-25 

注册时间:

Date of Registration:

2017-10-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

临床导师模式对养老机构的照护质量改进研究 

Public title:

Aged Care Clinical Mentoring Model of Change in Nursing Homes in China: A Cluster Randomized Controlled Trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

临床导师模式对养老机构的照护质量改进研究 

Scientific title:

Aged Care Clinical Mentoring Model of Change in Nursing Homes in China: A Cluster Randomized Controlled Trial 

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:

冯辉 

研究负责人:

冯辉 

Applicant:

Feng Hui 

Study leader:

Feng Hui 

申请注册联系人电话:

Applicant telephone:

+86 15173121969 

研究负责人电话:

Study leader's telephone:

+86 15173121969 

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:

1637981533@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1637981533@qq.com 

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:

湖南省长沙市岳麓区桐梓坡路172号 

研究负责人通讯地址:

湖南省长沙市岳麓区桐梓坡路172号 

Applicant address:

172 Tongzipo Road, Yuelu District, Changsha, Hu'nan, China 

Study leader's address:

172 Tongzipo Road, Yuelu District, Changsha, Hu'nan, 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:

中南大学湘雅护理学院 

Applicant's institution:

Xiangya School of Nursing of Central South University Nursing and Behavioral Medicine 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2017035 

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:

中南大学护理学院护理与行为医学研究伦理审查委员会 

Name of the ethic committee:

Xiangya School of Nursing of Central South University Nursing and Behavioral Medicine Institutional Review Boards 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

孙玫 

Contact Name of the ethic committee:

Sun Mei 

伦理委员会联系地址:

中南大学湘雅护理学院 

Contact Address of the ethic committee:

Xiangya School of Nursing of Central South University 

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:

中南大学湘雅护理学院 

Primary sponsor:

Xiangya School of Nursing of Central South University 

研究实施负责(组长)单位地址:

湖南省长沙市岳麓区桐梓坡路172号 

Primary sponsor's address:

172 Tongzipo Road, Yuelu District, Changsha, Hu'nan, 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):

湖南省

市(区县):

长沙市

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

中南大学湘雅护理学院

具体地址:

湖南省长沙市岳麓区桐梓坡路172号

Institution
hospital:

Xiangya School of Nursing of Central South University

Address:

172 Tongzipo Road, Yuelu District, Changsha, Hu'nan, China

经费或物资来源:

美国中华医学基金会、湖南省慈爱老年评估与健康促进中心 

Source(s) of funding:

China Medical Board, Hunan Ciai geriatric assessment and health promotion center 

研究疾病:

养老机构质量 

Target disease:

care quality in nursing home 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

通过在湖南省的养老机构中建立临床导师模式来提升和维持养老机构的照护质量:(1)通过改善领导力、团队合作关系、团队交流等工作环境来提高照护人员的工作满意度和降低员工的离职率;(2)照护质量越高,发生的不良事件越少;(3)减少由于跌倒、跌倒相关损伤、压疮、尿路感染引起的额外花费。 

Objectives of Study:

The goal of this project is to create and sustain quality improvement in nursing homes by implementing the Aged Care Clinical Mentoring (ACCM) Model in Hunan Province. The objectives are: (1) better work environment by improving leadership, teamwork, relationships, communication among team members, job satisfaction, and to reduced staff intention to leave; (2) higher quality of care by reducing adverse events; and (3) lower costs by reducing unplanned hospital admissions and total medical costs, due to falls, fall-related injuries, pressure ulcers, and urinary tract infections. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

整群随机分组 

Study design:

Cluster randomization 

纳入标准:

1.经湖南民政部门认证的养老机构; 2.养老机构的每个单元都必须有注册护士; 3.自愿参加 

Inclusion criteria

1. Nursing homes that have been accredited by the Department of Civil Affairs, Hunan Province; 2. Nursing homes that have RNs in each unit to lead quality improvement; 3. Nursing homes that are willing to participate in the project on a voluntary basis. 

排除标准:

No 

Exclusion criteria:

No 

研究实施时间:

Study execute time:

From2018-01-01To 2022-01-01 

征募观察对象时间:

Recruiting time:

From2018-01-01To 2018-04-01 

干预措施:

Interventions:

组别:

对照组

样本量:

450

Group:

usual care arm

Sample size:

干预措施:

常规培训

干预措施代码:

Intervention:

routine training

Intervention code:

组别:

干预组

样本量:

450

Group:

intervention arm

Sample size:

干预措施:

老年照护临床导师模式

干预措施代码:

Intervention:

Aged Care Clinical Model

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南省 

市(区县):

岳阳市 

Country:

China 

Province:

Hunan 

City:

Yueyang 

单位(医院):

岳阳市国泰养老颐养院 

单位级别:

大型 

Institution
hospital:

Guotai Sunshine Nursing Home of Yueyang City  

Level of the institution:

Elder Center 

国家:

中国 

省(直辖市):

湖南省 

市(区县):

长沙市 

Country:

China 

Province:

Hunan 

City:

Changsha 

单位(医院):

长沙市红枫康乐养老中心 

单位级别:

大型 

Institution
hospital:

Red Maple Recreation Elderly Center of Changsha City  

Level of the institution:

Elder Center 

国家:

中国 

省(直辖市):

湖南省 

市(区县):

长沙市 

Country:

China 

Province:

Hunan 

City:

Changsha 

单位(医院):

康乃馨老年养护中心 

单位级别:

大型 

Institution
hospital:

Carnation Elderly Care Center of Changsha City  

Level of the institution:

Elder Center 

国家:

中国 

省(直辖市):

湖南省 

市(区县):

汨罗市 

Country:

China 

Province:

Hunan 

City:

Miluo 

单位(医院):

汨罗市泰康福利院 

单位级别:

大型 

Institution
hospital:

Taikang Welfare Home of Miluo City  

Level of the institution:

Elder Center 

国家:

中国 

省(直辖市):

湖南省 

市(区县):

长沙市 

Country:

China 

Province:

Hunan 

City:

Changsha 

单位(医院):

雨花区社会福利中心 

单位级别:

大型 

Institution
hospital:

Social Welfare Center of Yuhua District of Changsha City  

Level of the institution:

Elder Center 

国家:

中国 

省(直辖市):

湖南省 

市(区县):

长沙市 

Country:

China 

Province:

Hunan 

City:

Changsha 

单位(医院):

长沙市第一社会福利院 

单位级别:

大型 

Institution
hospital:

The 1st Social Welfare Home of Changsha City  

Level of the institution:

Elder Center 

国家:

中国 

省(直辖市):

湖南省 

市(区县):

湘潭市 

Country:

China 

Province:

Hunan 

City:

Xiangtan 

单位(医院):

湘潭市老年康复中心 

单位级别:

大型 

Institution
hospital:

Elderly Rehabilitation Center of Xiangtan City  

Level of the institution:

Elder Center 

国家:

中国 

省(直辖市):

湖南省 

市(区县):

株洲市 

Country:

China 

Province:

Hunan 

City:

Zhuzhou 

单位(医院):

株洲市攸县颐宁园老年公寓 

单位级别:

大型 

Institution
hospital:

Yining Garden Elderly Apartment of Zhuzhou City  

Level of the institution:

Elder Center 

国家:

中国 

省(直辖市):

湖南省 

市(区县):

长沙市 

Country:

China 

Province:

Hunan 

City:

Changsha 

单位(医院):

永济老年养护院 

单位级别:

大型 

Institution
hospital:

Yongji Elderly Nursing home of Changsha City  

Level of the institution:

Elder Center 

国家:

中国 

省(直辖市):

湖南省 

市(区县):

长沙市 

Country:

China 

Province:

Hu'nan 

City:

Changsha 

单位(医院):

长沙市康怡老年护养院 

单位级别:

大型 

Institution
hospital:

Kangyi elderly Nursing Home of Changsha City  

Level of the institution:

Elder Center 

测量指标:

Outcomes:

指标中文名:

养老机构质量提升与改进的能力

指标类型:

主要指标 

Outcome:

Aged care facility's capacity to create and sustain quality improvement

Type:

Primary 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:

标本中文名:

组织:

Sample Name:

non

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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 years
最大 Max age 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):

对自愿参加的养老机构,根据其报名顺序依次编号,按照随机数字表法产生10个随机数(遇到重复弃去不计),即产生10家养老机构。

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

The voluntary nursing home are numbered 1,2,3......N,then randomly select 10 numbers according random number table(encountered repeated abandonment), the 10 random numbers represent 10 nursing home.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

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):

2022年7月1日,在中南大学湘雅护理学院官网上公布:http://nursing.csu.edu.cn/

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

Public on official website (http://nursing.csu.edu.cn/) on May 1, 2022

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:

采用纸质问卷收集,SPSS18.0整理记录分析

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

Collect data by questionnaire,and use SPSS18.0 to sort out,record and analyze.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2017-10-25
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