ChiCTR2500102930 版本V1.0 版本创建时间2025/05/21 17:16:17 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500102930 

最近更新日期：

Date of Last Refreshed on：

2025-05-21 17:16:07 

注册时间：

Date of Registration：

2025-05-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

智慧医院背景下三级综合医院护理信息能力提升策略研究

Public title：

Research on Strategies for Enhancing Nursing Information Competency in Tertiary General Hospitals under the Background of Smart Hospitals

注册题目简写：

English Acronym：

研究课题的正式科学名称：

智慧医院背景下三级综合医院护理信息能力提升策略研究

Scientific title：

Research on Strategies for Enhancing Nursing Information Competency in Tertiary General Hospitals under the Background of Smart Hospitals

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：

秦丽丽 

研究负责人：

秦丽丽 

Applicant：

Lili Qin 

Study leader：

Lili Qin 

申请注册联系人电话：

Applicant telephone：

+86 139 2103 7628

研究负责人电话：

Study leader's telephone：

+86 139 2103 7628

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：

lili_qin@cmu.ac.th

研究负责人电子邮件：

Study leader's E-mail：

lili_qin@cmu.ac.th

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：

江苏省常州市滆湖中路68号

研究负责人通讯地址：

江苏省常州市滆湖中路68号

Applicant address：

No. 68, Juhu Middle Road, Changzhou City, Jiangsu Province

Study leader's address：

No. 68, Juhu Middle Road, Changzhou City, Jiangsu Province

申请注册联系人邮政编码：

Applicant postcode：

213003

研究负责人邮政编码：

Study leader's postcode：

213003

申请人所在单位：

南京医科大学第三附属医院(常州市第二人民医院)

Applicant's institution：

The Third Affiliated Hospital of Nanjing Medical University (Changzhou No. 2 People's Hospital)

研究负责人所在单位：

南京医科大学第三附属医院(常州市第二人民医院)

Affiliation of the Leader：

The Third Affiliated Hospital of Nanjing Medical University (Changzhou No. 2 People's Hospital)

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

[2024]-KY009-01

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：

南京医科大学第三附属医院(常州市第二人民医院)

Name of the ethic committee：

The Third Affiliated Hospital of Nanjing Medical University (Changzhou No. 2 People's Hospital)

伦理委员会批准日期：

Date of approved by ethic committee：

2024-03-28 00:00:00

伦理委员会联系人：

李辰凯

Contact Name of the ethic committee：

Chenkai Li

伦理委员会联系地址：

江苏省常州市滆湖中路68号,常州市第二人民医院科技处

Contact Address of the ethic committee：

Science and Technology Department, Changzhou No. 2 People's Hospital 68 Gehu Middle Road, Wujin District, Changzhou City, Jiangsu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 519 8108 7655

伦理委员会联系人邮箱：

Contact email of the ethic committee：

czeykjc@njmu.edu.cn

研究实施负责（组长）单位：

南京医科大学第三附属医院（常州市第二人民医院）

Primary sponsor：

The Third Affiliated Hospital of Nanjing Medical University, Changzhou Second People's Hospital

研究实施负责（组长）单位地址：

江苏省常州市武进区滆湖中路68号

Primary sponsor's address：

No. 68 Gehu Middle Road, Wujin District, Changzhou City, Jiangsu Province, China, 213003

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏

市(区县)：

常州

Country：

China

Province：

Jiangsu

City：

Changzhou

单位(医院)：

南京医科大学第三附属医院（常州市第二人民医院）

具体地址：

江苏省常州市武进区滆湖中路68号

Institution
hospital：

The Third Affiliated Hospital of Nanjing Medical University, Changzhou Second People's Hospital

Address：

No. 68 Gehu Middle Road, Wujin District, Changzhou City, Jiangsu Province, China, 213003

经费或物资来源：

常州市卫健委科技项目立项项目(重大项目)

Source(s) of funding：

Changzhou Municipal Health Commission Scientific Research Project (Major Project)

Target disease：

None

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

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

本研究旨在开发和评估适用于中国三级医院注册护士的护理信息能力培训方案的效果。具体研究目标包括以下三个方面: 1. 开发适用于中国三级医院注册护士的护理信息能力培训方案。本研究将基于ADDIE模型(分析、设计、开发、实施、评估)系统化开发一套完整的护理信息能力培训方案。该方案将全面涵盖知识、技能和态度三个维度,并针对中国三级医院护理工作的实际需求进行定制化设计。 2. 比较中国三级医院注册护士参与培训方案前后的护理信息能力水平变化。通过标准化的评估工具,对参与培训的护士在培训前后的护理信息能力水平进行量化比较。重点评估知识掌握程度、技能操作水平以及工作态度三个维度的变化情况,以验证培训方案的即时效果。 3. 比较接受护理信息能力培训与常规培训的注册护士在能力水平上的差异。采用随机对照研究设计,比较实验组(接受本研究开发的护理信息能力培训)与对照组(接受医院常规信息化培训)在培训后的护理信息能力水平差异。通过两组比较,验证本研究开发培训方案的优越性和有效性。 本研究将通过上述三个目标的实现,为中国三级医院提供一套科学、系统、有效的护理信息能力培训方案,以提升护士的信息化素养,适应智慧医院建设的发展需求。  

Objectives of Study：

This study aims to develop and evaluate the effectiveness of a nursing informatics competency training program for registered nurses in Chinese tertiary hospitals. The specific research objectives include the following three aspects: 1.To develop a nursing informatics competency training program tailored for registered nurses in Chinese tertiary hospitals. Based on the ADDIE model (Analysis, Design, Development, Implementation, Evaluation), this study will systematically develop a comprehensive training program that fully covers the three dimensions of knowledge, skills, and attitudes, while being customized to meet the practical needs of nursing work in tertiary hospitals. 2.To compare changes in nursing informatics competency levels among registered nurses in Chinese tertiary hospitals before and after participating in the training program. Using standardized assessment tools, the study will quantitatively compare nurses' competency levels pre- and post-training, with a focus on evaluating improvements in knowledge acquisition, operational skills, and professional attitudes to validate the immediate effectiveness of the program. 3.To compare differences in competency levels between nurses receiving the nursing informatics training and those undergoing conventional training. A randomized controlled trial (RCT) design will be employed to compare the post-training competency levels of the intervention group (receiving the newly developed training program) and the control group (receiving standard hospital IT training). This comparison will verify the superiority and effectiveness of the developed training program. Through the achievement of these three objectives, this study will provide Chinese tertiary hospitals with a scientific, systematic, and effective nursing informatics competency training program, enhancing nurses' digital literacy and supporting the development needs of smart hospital construction.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 常州市第二人民医院在岗注册护士,且已通过医院规定的定级考核(未通过考核者不得独立执业); 2. 目前从事患者护理工作的一线护士; 3. 自愿签署知情同意书并参与研究。

Inclusion criteria

1.Registered nurses currently employed at Changzhou No. 2 People's Hospital who have passed the hospital's competency assessment (those who fail cannot practice independently); 2.Frontline nurses currently engaged in direct patient care; 3.Voluntary signing of informed consent and participation in the study.

排除标准：

1. 研究启动时处于外出进修或休假的护士; 2. 护理管理人员(因其工作内容与临床护理信息操作差异显著)。

Exclusion criteria：

1.Nurses who are on external training or leave when the study begins; 2.Nursing administrators (due to significant differences in their work content compared to clinical nursing informatics operations).

研究实施时间：

Study execute time：

从 From 2024-04-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-06-15 00:00:00 至 To 2025-10-14 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

42

Group：

Intervention grop

Sample size：

干预措施：

接受本研究开发的护理信息能力培训

干预措施代码：

 01

Intervention：

Receive training in nursing information competencies developed in this study

Intervention code：

组别：

对照组

样本量：

42

Group：

Control group

Sample size：

干预措施：

接受医院常规信息化培训

干预措施代码：

 02

Intervention：

Receive routine informatization training in hospitals

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

 常州 

Country：

China 

Province：

Jiangsu 

City：

Changzhou 

单位(医院)：

南京医科大学第三附属医院（常州市第二人民医院） 

单位级别：

三甲 

Institution
hospital：

The Third Affiliated Hospital of Nanjing Medical University, Changzhou Second People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

护士信息能力水平

指标类型：

主要指标

Outcome：

Nursing informatics competency score

Type：

Primary indicator

测量时间点：

培训前、培训结束后当天、培训结束后一个月

测量方法：

NICS量表

Measure time point of outcome：

Before training, the day and 1 month after training

Measure method：

NICS scale

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

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 岁 years
最大 Max age 岁 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）：

本研究采用分层整群随机抽样法,确保样本的代表性并避免组间污染。首先按护理单元类型将全院护士分为普通病区、重症监护单元和特殊单元三个层次。通过医院人力资源系统获取符合纳入标准的护士名单后,使用SPSS随机数生成器对每类护理单元进行整群随机分配,确保同一单元的所有护士均进入同一组别(干预组或对照组)。在各组单元中,按员工ID编号采用系统抽样法抽取所需样本量,最终每组纳入42名护士(考虑10%的脱落率)。该设计既保证了各组基线特征的均衡性,又符合临床工作实际,有效控制了混杂因素对研究结果的影响。

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

This study employs a stratified cluster randomization approach to ensure sample representativeness and prevent intergroup contamination. First, all hospital nurses are stratified into three categories based on unit type: general wards, intensive care units, and specialized units. After obtaining the list of eligible nurses meeting inclusion criteria through the hospital HR system, SPSS random number generator is used to perform cluster randomization within each unit category, ensuring all nurses from the same unit are assigned to the same group (either intervention or control). Within each grouped unit, systematic sampling is conducted based on employee ID numbers to achieve the target sample size, ultimately enrolling 42 nurses per group (accounting for a 10% attrition rate). This design maintains baseline characteristic balance across groups while aligning with clinical workflow realities, effectively controlling for confounding factors that may impact study outcomes.

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：

无

Blinding：

None

是否共享原始数据：

IPD sharing

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）：

无

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

None

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：

在本研究中收集的所有信息将被记录或存储在电子文件中。该信息将保持机密,仅对授权的研究人员可访问。研究伦理委员会和指定的监督机构可能会出于监督目的访问您的数据。参与者有法律权利访问个人信息,如果希望行使此权利,请通知研究人员。任何研究收益将根据清迈大学的相关规定提供。数据收集将分为两部分:与研究相关的信息和仅用代码标识的个人信息。所有编码数据将安全地存储在研究者的密码保护计算机上。此数据的访问将仅限于授权人员。此外,数据将被加密,以防止未经授权的访问。 数据将在研究完成并发表结果后的三年内保留,在此期间可能需要验证信息的准确性或重复分析以确认研究结果的有效性。在此时期结束后,所有数据将根据适用规定安全销毁。

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

All information collected in this study will be recorded and stored in electronic files. These data will remain strictly confidential and accessible only to authorized research personnel. The Institutional Review Board (IRB) and designated regulatory authorities may access your data for monitoring purposes. Participants retain the legal right to access their personal information; those wishing to exercise this right should notify the research team. Any study-related benefits will be provided in accordance with the relevant regulations of Chiangmai University.Data collection will involve two components:Research-related information and Personally identifiable information (coded for anonymity). All coded data will be securely stored on password-protected computers accessible exclusively to authorized personnel. Additional encryption measures will be implemented to prevent unauthorized access. The data will be retained for three years following study completion and publication of results, during which time it may be required for verification of accuracy or replication of analyses to confirm findings. Upon expiration of this period, all data will be securely destroyed in compliance with applicable regulations.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-05-21 17:16:07