双重视角下无陪护病房的多维效应与优化策略研究

注册号:

Registration number:

ChiCTR2600121784 

最近更新日期:

Date of Last Refreshed on:

2026-04-02 17:19:30 

注册时间:

Date of Registration:

2026-04-02 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

双重视角下无陪护病房的多维效应与优化策略研究

Public title:

A Study on the Intervention of the Three-Level Prevention Management Model on Negative Emotions of Nurses in Tertiary Public Hospitals in Ankang City

注册题目简写:

English Acronym:

研究课题的正式科学名称:

双重视角下无陪护病房的多维效应与优化策略

Scientific title:

Research on the Multi-Dimensional Effects and Optimization Strategies of No-Accompanying-Care Wards from a Dual Perspective

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:

庞丽 

研究负责人:

张婷 

Applicant:

Pang Li 

Study leader:

Zhang Ting 

申请注册联系人电话:

Applicant telephone:

+86 915 3284290

研究负责人电话:

Study leader's
telephone:

+86 915 3284209

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:

2453881795@qq.com

研究负责人电子邮件:

Study leader's E-mail:

869392424@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:

陕西省安康市汉滨区金州南路85号

研究负责人通讯地址:

金州南路85号

Applicant address:

No. 85 Jinzhou South Road, Hanbin District, Ankang City, Shaanxi Province

Study leader's address:

No. 85, South Jinzhou Road, Ankang, Shaanxi province

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:

安康市中心医院

Applicant's institution:

Ankang Central Hospital

研究负责人所在单位:

安康市中心医院

Affiliation of the Leader:

Ankang Central 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:

AKZXEC-SC-KY2026-009-01

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:

安康市中心医院临床研究伦理委员会

Name of the ethic committee:

Clinical Research Ethics Committee, Ankang Central Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2026-02-10 00:00:00

伦理委员会联系人:

王慧姣

Contact Name of the ethic committee:

Wang Huijiao

伦理委员会联系地址:

金州南路85号

Contact Address of the ethic committee:

No. 85, South Jinzhou Road, Ankang, Shaanxi province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 915 3283401

伦理委员会联系人邮箱:

Contact email of the ethic committee:

664739426@qq.com

研究实施负责(组长)单位:

安康市中心医院

Primary sponsor:

Ankang Central Hospital

研究实施负责(组长)单位地址:

金州南路85号

Primary sponsor's address:

No. 85, South Jinzhou Road, Ankang, Shaanxi province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

陕西省

市(区县):

Country:

China

Province:

Shaanxi

City:

单位(医院):

安康市中心医院

具体地址:

金州南路85号

Institution
hospital:

Ankang Central Hospital

Address:

No. 85, South Jinzhou Road, Ankang, Shaanxi province

经费或物资来源:

自选课题

Source(s) of funding:

Self-funded project

研究疾病:

无  

Target disease:

NA

研究疾病代码:

Target disease code:

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

探索性研究/预试验 

Study phase:

0

研究设计:

队列研究 

Study design:

Cohort study 

研究目的:

本研究旨在通过医患双重视角,系统评估无陪护病房在患者康复、经济负担、满意度及医护人员工作负荷、医护协作等多维度的综合效应。通过实证研究识别影响模式运行的关键因素与潜在问题,并构建“患者需求-医护效能”双导向的优化模型,最终形成一套标准化、可推广的无陪护病房建设与管理策略,为缓解社会照护压力、推动护理服务创新及公立医院高质量发展提供实践依据与政策参考。  

Objectives of Study:

This study aims to systematically evaluate the comprehensive effects of the no-accompanying-care ward on multiple dimensions such as patient recovery, economic burden, satisfaction, and the workload and collaboration of medical staff from both the perspectives of doctors and patients. By conducting empirical research to identify key factors and potential issues affecting the operation of the model, a dual-oriented optimization model focusing on "patient needs - medical staff efficiency" will be constructed. Ultimately, a set of standardized and replicable strategies for the construction and management of no-accompanying-care wards will be developed, providing practical evidence and policy references for alleviating social care pressures, promoting nursing service innovation, and driving the high-quality development of public hospitals.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1.患有严重精神疾病; 2.无法配合完成问卷/访谈。

Exclusion criteria:

1.Suffering from severe mental illness; 2.Unable to cooperate in completing the questionnaire/ interview.

研究实施时间:

Study execute time:

From 2025-10-01 00:00:00 To 2027-09-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-04-02 00:00:00 To 2026-07-31 00:00:00

干预措施:

Interventions:

组别:

普通病房组

样本量:

200

Group:

General ward group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

无陪护病房组

样本量:

200

Group:

Unaccompanied ward group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

陕西省 

市(区县):

 

Country:

China

Province:

Shaanxi

City:

单位(医院):

安康市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Ankang Central Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

医护人员满意度

指标类型:

主要指标

Outcome:

Medical staff satisfaction

Type:

Primary indicator

测量时间点:

每个月动态调研

测量方法:

依据研究目的自行设计《医护人员对无陪护病房实施效果评估调查》量表,在验证信效度后,对开展无陪护病房科室的医护人员进行多维度问卷调查,并利用统计软件进行描述性分析、推断性检验和多元回归分析。

Measure time point of outcome:

Dynamic surveys conducted every month

Measure method:

Based on the research objectives, the "Evaluation Survey on the Implementation Effect of No-Accompanying-Care Wards by Medical Staff" was designed. After verifying its reliability and validity, a multi-dimensional questionnaire survey was conducted among medical staff in departments where no-accompanying-care wards were implemented, and statistical software was used for descriptive analysis, inferential testing, and multiple regression analysis.

指标中文名:

患者满意度

指标类型:

主要指标

Outcome:

Patient satisfaction

Type:

Primary indicator

测量时间点:

每个月动态调研

测量方法:

依据研究目的自行设计《住院患者陪护情况问卷调查》和《医护人员对无陪护病房实施效果评估调查》两份量表,在验证信效度后,对无陪护病房及普通病房的患者与医护人员进行大样本问卷调查,定量收集经济负担、照护专业性、满意度等多维度数据。 充分利用医院信息系统,从HIS系统及数据上报平台中追溯提取住院天数、次均费用、治愈率等客观临床指标,并与问卷数据相结合,利用统计软件进行描述性分析、推断性检验和多元回归分析。

Measure time point of outcome:

Dynamic surveys conducted every month

Measure method:

Based on the research objectives, two questionnaires were designed: the "Survey on the Accompanying Care Situation of Inpatients" and the "Inpatient Satisfaction Survey on No-Accompanying-Care Wards." After verifying their reliability and validity, questionnaire surveys were conducted among patients in departments where no-accompanying-care wards were implemented to quantitatively collect multi-dimensional data such as economic burden, professionalism of care, and satisfaction. Statistical softw

指标中文名:

平均住院日

指标类型:

主要指标

Outcome:

average length of stay

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者住院期间并发症发生率

指标类型:

次要指标

Outcome:

Incidence of complications during hospitalization of patients

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

次均住院总费用

指标类型:

次要指标

Outcome:

Average hospitalization total cost per visit

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者/家属对生活照护专业性的评分

指标类型:

次要指标

Outcome:

Rating of patients/family members on the professionalism of life care

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

家庭照护负担评分

指标类型:

次要指标

Outcome:

Family care burden rating

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

区环境与 秩序管理评分

指标类型:

次要指标

Outcome:

District Environment and Order Management Score

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:

标本中文名:

组织:

Sample Name:

NA

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

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):

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:

不公开/Private

盲法:

Blinding:

None

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):

本研究数据涉及患者的个人健康信息、医疗记录及隐私数据,根据医疗伦理规范和患者隐私保护原则,不便对外公开共享。所有数据仅限本项目研究团队内部用于统计分析,确保患者信息安全。

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

The data in this study involve patients' personal health information, medical records, and private data. In accordance with medical ethics regulations and patient privacy protection principles, the data are not suitable for public sharing. All data are limited to internal use by the research team of this project for statistical analysis only, ensuring the security of patient information.

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:

本研究数据采集采用多源整合方式。客观临床数据(如住院天数、费用、并发症)经授权从医院信息系统(HIS)匿名提取;主观体验数据通过标准化问卷,从患者/家属及医护人员处收集,问卷已进行信效度检验。所有数据通过唯一研究编码链接,在采集后立即进行去标识化处理,并加密存储于医院安全服务器,实施严格的访问权限控制,确保数据安全、真实、可溯。数据管理遵循预定的标准操作规程,直至研究结束并按规定期限保存。

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

The data collection in this study adopts a multi-source integration approach. Objective clinical data (such as length of hospital stay, costs, complications) are anonymously extracted from the Hospital Information System (HIS) with authorization. Subjective experience data are collected through standardized questionnaires from patients/families and medical staff, and the questionnaires have been tested for reliability and validity. All data are linked through a unique study code. After collection, the data are immediately de-identified and encrypted for storage on the hospital's secure server, with strict access control measures in place to ensure data security, authenticity, and traceability. Data management follows the predetermined standard operating procedures until the end of the study and is retained for the specified period.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2026-04-02 17:19:13