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Comparing Quality of Primary Health Care between Public and Private Providers in China: a Cross-sectional Study Using Unannounced Standardized Patients in Seven Provinces of China
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注册号:

Registration number:

ChiCTR2000032773 

最近更新日期:

Date of Last Refreshed on:

2020-05-10 

注册时间:

Date of Registration:

2020-05-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于标准化病人方法的中国公立和民营基层卫生保健质量比较研究  

Public title:

Comparing Quality of Primary Health Care between Public and Private Providers in China: a Cross-sectional Study Using Unannounced Standardized Patients in Seven Provinces of China 

注册题目简写:

ACACIA Study - PvP 

English Acronym:

ACACIA Study - PvP 

研究课题的正式科学名称:

中国基层卫生保健质量公立民营比较研究 

Scientific title:

Quality of Primary Health Care in China: public versus private 

研究课题代号(代码):

Study subject ID:

CMB公开竞标项目(16-260, 18-300 and 18-301)); 国家自然科学基金 (71974211) 

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:

杨伊里 

研究负责人:

徐东 

Applicant:

YILI YANG 

Study leader:

Dong (Roman) Xu 

申请注册联系人电话:

Applicant telephone:

+86 18782492873 

研究负责人电话:

Study leader's telephone:

+86 13910988979 

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:

yyl115@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

roman.xu@gmail.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):

https://www.researchgate.net/profile/Dong_Xu58 

申请注册联系人通讯地址:

四川省成都市人民南路三段十六号 

研究负责人通讯地址:

广东省广州市海珠区新港西路135号中山大学南校区文科楼524室  

Applicant address:

16 Third Section, South Renmin Road, Chengdu, Sichuan, China 

Study leader's address:

135 West Xin'gang Road, Haizhu District, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

610041 

研究负责人邮政编码:

Study leader's postcode:

510275 

申请人所在单位:

四川大学华西公共卫生学院 

Applicant's institution:

West China School of Public Health,Sichuan University 

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:

中大公卫医伦[2017]第011号,[2017]第007号,[2019]第24号,  

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:

中山大学公共卫生学院生物医学研究伦理审查委员会 

Name of the ethic committee:

Ethical Review Committee for Biomedical Research, School of Public Health, Sun Yat-sen University  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-02-28 

伦理委员会联系人:

郝元涛 

Contact Name of the ethic committee:

Yuantao Hao 

伦理委员会联系地址:

广东省广州市越秀区中山二路74号中山大学北校区公共卫生学院 

Contact Address of the ethic committee:

School of Public Health, North Campus, Sun Yat-sen University, 74 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

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:

中山大学公共卫生学院 

Primary sponsor:

School of Public Health, Sun Yat-sen University  

研究实施负责(组长)单位地址:

广东省广州市越秀区中山二路74号中山大学北校区公共卫生学院  

Primary sponsor's address:

74 Secon Zhongshan Road, Yuexiu District, Guangzhou, 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):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学公共卫生学院

具体地址:

广东省广州市越秀区中山二路74号中山大学北校区公共卫生学院

Institution
hospital:

School of Public Health, Sun Yat-sen University

Address:

74 Secon Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China

经费或物资来源:

CMB公开竞标项目(16-260, 18-300 and 18-301)); 国家自然科学基金 (71974211) 

Source(s) of funding:

CMB Open Competition programme (16-260, 18-300 and 18-301); National Natural Science Foundation of China (71974211) 

研究疾病:

糖尿病,高血压,中风,腰背痛,心绞痛,哮喘,腹泻,肺结核,抑郁,跌倒,痴呆,胃炎,偏头痛等  

Target disease:

Diabetes, hypertension, stroke, back pain, angina, asthma, diarrhea, tuberculosis, depression, falls, dementia, gastritis, migraine, and so on 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health Services Research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本研究的目的是探索基础卫生机构所有制形式对医疗质量的影响。具体分两步: (1)通过利用未经事先告知的标准化患者,比较公立和民营基层卫生保健质量,进而探索所有制形式和质量之间的关系;(6)通过排除其他相关干扰因素,从而单独研究民营医疗机构本身对卫生服务质量的影响。 

Objectives of Study:

The purpose of the study is to explore the association of the ownership types of the providers to the quality of primary health care (PHC), which includes two steps: (1) raw comparison of the quality of care between the private and public PHC providers using unannounced standardized patients (USPs) so as to expose any objective quality differences between the two groups; and (2) comparison after adjusting for potential confounding so as to isolate the relations between the intrinsic natures of the private ownership to quality of PHC.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

机构的纳入标准:一级和二级医院、社区卫生中心(站)和诊所,以及乡镇卫生院及村卫生室。 医务人员的纳入标准:在符合以上条件的医疗机构内工作的执业(助理)医师和乡村医生,执业范围仅包括全科、内科、外科,妇产科和儿科。  

Inclusion criteria

Inclusion criteria of institutions: level 1 and level II hospitals, community health centers and stations and clinics, as well as township health centers and village clinics. Inclusion criteria for clinicians: (1) licensed doctors and assistant doctors; or (2) rural health practitioners who have a certificate for rural practice; (3) scope of practice must be one of the following: general practice, internal medicine, surgery, obstetrics and gynecology, and pediatrics.  

排除标准:

机构的排除标准:专科医疗机构(如专科医院、牙医诊所)、公共卫生防治机构(如结核病防治所),民族医学机构(如蒙医院、藏医院等)、二级以上的医院,以及尚未定级的医院。 医务人员的排除标准:其他专科医生(如心脏科、内分泌科医生)。  

Exclusion criteria:

Exclusion criteria for institutions: specialized medical institutions (such as specialist hospitals and dental clinics ), public health prevention and control institutions (such as tuberculosis prevention and control institutes), ethnic medical institutions (such as Mongolian Hospital, Tibetan Hospital, etc.), hospitals above Level 2 and hospital not yet been graded; Exclusion criteria for medical staff: other specialists (such as cardiologists and endocrinologists).  

研究实施时间:

Study execute time:

From2020-01-01To 2023-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

2200

Group:

Case series

Sample size:

干预措施:

不适用

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东、湖南、内蒙古、四川、贵州、陕西、甘肃 

市(区县):

 

Country:

China 

Province:

Guangdong, Hunan,Inner Monglia,Sichuan、 Guizhou、Shanxi、Gansu 

City:

 

单位(医院):

1226家基础医疗卫生机构 

单位级别:

一级和二级医院以及基层卫生保荐机构(乡镇卫生院,村卫生室,诊所,社区卫生服务中心站等) 

Institution
hospital:

1226 PHC institutes  

Level of the institution:

Level 1 and Level 2 Hospitals and prmary healthcare institutions 

测量指标:

Outcomes:

指标中文名:

指南规定的问诊和检查条目的完成率

指标类型:

主要指标 

Outcome:

Completion rate of inquiry and examination items specified in the clinical guidelines

Type:

Primary indicator 

测量时间点:

标准化病人就诊后15分钟内

测量方法:

标准化病人质量清单

Measure time point of outcome:

within 15 minutes of SP-clinican encounter

Measure method:

Standardized Patient recall quality checklist

指标中文名:

诊断准确率

指标类型:

主要指标 

Outcome:

Diagnostic accuracy rate

Type:

Primary indicator 

测量时间点:

标准化病人就诊后15分钟内

测量方法:

标准化病人质量清单

Measure time point of outcome:

within 15 minutes of SP-clinican encounter

Measure method:

Standardized Patient recall quality checklist

指标中文名:

治疗准确率

指标类型:

主要指标 

Outcome:

Management/treatment accuracy rate

Type:

Primary indicator 

测量时间点:

标准化病人就诊后15分钟内

测量方法:

标准化病人质量清单

Measure time point of outcome:

within 15 minutes of SP-clinican encounter

Measure method:

Standardized Patient recall quality checklist

指标中文名:

以患者为中心服务质量评分

指标类型:

次要指标 

Outcome:

Patient centered care score

Type:

Secondary indicator 

测量时间点:

标准化病人就诊后15分钟内

测量方法:

患者角度以患者为中心服务量表

Measure time point of outcome:

within 15 minutes of SP-clinican encounter

Measure method:

Patient perspective patient centeredness scale (PPPC)

指标中文名:

就诊及时性

指标类型:

次要指标 

Outcome:

Timelines of care

Type:

Secondary indicator 

测量时间点:

标准化病人就诊后15分钟内

测量方法:

机构营业时间和诊疗等待时间

Measure time point of outcome:

within 15 minutes of SP-clinican encounter

Measure method:

Opening hours of the provider & wait time to seek care

指标中文名:

诊疗的公平性

指标类型:

次要指标 

Outcome:

Equity of care

Type:

Secondary indicator 

测量时间点:

标准化病人就诊后15分钟内

测量方法:

同一病例不同社会经济类别SP就医质量的一致性

Measure time point of outcome:

within 15 minutes of SP-clinican encounter

Measure method:

Concordance of quality between SPs with different social-econical status for a same SP case

指标中文名:

诊疗效率

指标类型:

次要指标 

Outcome:

Efficiency of care

Type:

Secondary indicator 

测量时间点:

标准化病人就诊后15分钟内

测量方法:

诊疗费用

Measure time point of outcome:

within 15 minutes of SP-clinican encounter

Measure method:

expenses of care

指标中文名:

药物滥用

指标类型:

附加指标 

Outcome:

drug abuse

Type:

Additional indicator 

测量时间点:

标准化病人就诊后15分钟内

测量方法:

医生处方(抗生素,激素,止痛片,中成药等)

Measure time point of outcome:

within 15 minutes of SP-clinican encounter

Measure method:

physician prescription (antibiotics, TCM medicine, pain killer, and sterioids)

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

不适用

组织:

不适用

Sample Name:

N/A

Tissue:

N/A

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):

本研究不是RCT研究,但抽样为随机抽样

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

数据公开网址:https://www.researchgate.net/project/ACACIA-Study。在项目数据完全清理完毕,并完成本登记所指定的数据分析6个月后,研究者可申请使用本研究数据。

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

Researchers can apply to obtain access to the data 6-month after the conclusion of the afore-specified analyses through the web: https://www.researchgate.net/project/ACACIA-Study

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:

用RedCap采集和管理数据。

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

RedCap will be used for data collection and management.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-05-10
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