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DRG支付体系下老年慢病患者护理管理的研究
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注册号：

Registration number：

 ChiCTR2500105422 

最近更新日期：

Date of Last Refreshed on：

 2025-07-03 09:30:44 

注册时间：

Date of Registration：

 2025-07-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

DRG支付体系下老年慢病患者护理管理的研究

Public title：

A Qualitative Study on the Nursing Management Challenges of Elderly Patients with Chronic Comorbidities under the DRG Payment System

注册题目简写：

English Acronym：

研究课题的正式科学名称：

DRG支付体系下老年慢病患者护理管理的研究

Scientific title：

A Qualitative Study on the Nursing Management Challenges of Elderly Patients with Chronic Comorbidities under the DRG Payment System

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：

鄢红玉 

研究负责人：

鄢红玉 

Applicant：

Yan Hongyu 

Study leader：

Yan Hongyu 

申请注册联系人电话：

Applicant telephone：

 +86 13871316473

研究负责人电话：

Study leader's
telephone：

+86 27 85351536

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：

 13871316473@163.com

研究负责人电子邮件：

Study leader's E-mail：

 13871316473@163.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：

华中科技大学同济医学院附属协和医院

研究负责人通讯地址：

湖北省武汉市江汉区解放大道1277号

Applicant address：

Geriatrics Department,Union Hospital,Tongji Medical College,Huazhong University of Science and Techn

Study leader's address：

NO.1277 Jiefang Avenue, Wuhan, Hubei

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：

华中科技大学同济医学院附属协和医院V6综合内科

Applicant's institution：

Geriatrics Department,Union Hospital,Tongji Medical College,Huazhong University of Science and Techn

研究负责人所在单位：

华中科技大学同济医学院附属协和医院

Affiliation of the Leader：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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：

 [2025]伦审字(0607)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：

华中科技大学同济医学院附属协和医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of Union Hospital of Tongji Medical College Huazhong University of Science and Technology

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-06-23 00:00:00

伦理委员会联系人：

褚圆圆

Contact Name of the ethic committee：

Chu Yuanyuan

伦理委员会联系地址：

湖北省武汉市江汉区解放大道1277号

Contact Address of the ethic committee：

NO.1277 Jiefang Avenue, Wuhan, Hubei

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 27 85726375

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 994877373@qq.com

研究实施负责（组长）单位：

华中科技大学同济医学院附属协和医院

Primary sponsor：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究实施负责（组长）单位地址：

湖北省武汉市江汉区解放大道1277号

Primary sponsor's address：

NO.1277 Jiefang Avenue, Wuhan, Hubei

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖北省

市(区县)：

Country：

China

Province：

Hubei

City：

单位(医院)：

华中科技大学同济医学院附属协和医院

具体地址：

湖北省武汉市江汉区解放大道1277号

Institution
hospital：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address：

NO.1277 Jiefang Avenue, Wuhan, Hubei

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-financed

研究疾病：

老年慢性病共病  

Target disease：

Multiple Chronic Conditions

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：

 其它 

Study phase：

N/A

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

探讨DRG支付体系下老年慢性病共病患者护理管理困境，为完善慢性病DRG支付体系提供依据。  

Objectives of Study：

This study explores the challenges in nursing management of elderly patients with comorbid chronic diseases under the DRG payment system, aiming to provide a basis for improving the chronic disease DRG payment system.

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.实习生、规培生、进修生；
2.因病假、事假、产假或外出进修等原因不在岗的护理人员；

Exclusion criteria：

1. Interns, standardized training students, advanced study students; 2. Nursing staff absent from duty due to sick leave, personal leave, maternity leave, or external training, among other reasons;

研究实施时间：

Study execute time：

从 From 2025-06-19 00:00:00至 To 2025-08-19 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-07-19 00:00:00 至 To 2025-08-19 00:00:00

干预措施：

Interventions：

组别：

观察组

样本量：

 15

Group：

Observer group

Sample size：

干预措施：

无

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)：

 湖北省 

市(区县)：

  

Country：

China

Province：

Hubei

City：

单位(医院)：

 华中科技大学同济医学院附属协和医院 

单位级别：

 三级甲等 

Institution
hospital：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

DRG支付体系下老年慢病患者护理管理的研究

指标类型：

主要指标

Outcome：

Research on Nursing Management of Elderly Patients with Chronic Diseases under the DRG Payment System

Type：

Primary indicator

测量时间点：

测量方法：

采用半结构式深度访谈法收集资料，并运用Colaizzi七步分析法对访谈文本进行编码、分类和主题提炼，以识别和归纳出影响护理质量和患者安全的系统性困境。

Measure time point of outcome：

Measure method：

Data were collected using semi-structured in-depth interviews, and the Colaizzi seven-step analysis method was applied to code, categorize, and extract themes from the interview texts in order to identify and summarize the systemic dilemmas affecting nursing quality and patient safety.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 27 岁 years
最大 Max age 54 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

无

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：

无

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）：

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：

数据采集：本研究采用目的抽样法，于2024年10—12月在湖北省某三级甲等综合医院老年科开展研究对象筛选工作。纳入标准：①具备5年以上老年科临床护理工作经验；②持有效护士执业证书;③沟通能力良好，能有效参与访谈；④知情，同意参与本研究；⑤参与实施DRG支付5年以上，且在护理管理决策方面积累了一定经验；排除标准：①实习生、规培生、进修生;②因病假、事假、产假或外出进修等原因不在岗的护理人员。样本规模以达到信息的理论饱和为原则。最终纳入15名访谈对象（编号N1～N15），均为女性；年龄27～54（41.40±8.30）岁；工作年限5～35（20.47±9.66）年。学历为本科13名，硕士2名；职称包括护师2名，主管护师11名，副主任护师1名，主任护师1名；护理层级为初级2名，中级4名，高级4名，护理管理5名；职务包括护士10名，护士长3名，科护士长1名，护理部主任1名。 本研究采用一对一半结构化访谈法收集资料。实施访谈前，研究者均向受访者充分说明研究目的、内容、保密原则及录音用途，并签署知情同意书。访谈地点均在访谈者楼层的会议室，环境安静、私密，无干扰。访谈由两名研究者共同执行，一人担任主访者引导访谈，另一人负责记录和观察非言语反应。访谈时认真倾听，记录关键信息并鼓励受访者充分表达个人情感和想法。访谈者保持中立态度避免诱导性提问，关注表情、语气、肢体语言，并及时记录受访者的非语言信息。当访谈过程中出现有价值、深刻的观点和理念时进行追问、复述和总结，每次访谈时间在30～40min。 管理：采用Colaizzi七步法进行资料分析：①反复阅读所有访谈文本，获取整体感知；②提炼与研究问题相关的重要陈述；③归纳提炼重要陈述的意义并进行初步解释；④将意义归类，形成主题或亚主题；⑤综合各主题内容，写成详细描述；⑥提炼核心主题，对描述加以凝练；⑦回访部分参与者，对分析结果进行验证与补充，确保结果的真实性和代表性。分析全程由2名研究者共同阅读、分析、编码、分类、提炼资料，并就分歧部分进行讨论，必要时请第三位研究者协助一致性判断，最终确定主题。

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

This study employed purposive sampling to screen research subjects from October to December 2024 in the geriatrics department of a tertiary Grade A general hospital in Hubei Province. Inclusion criteria: ① more than 5 years of clinical nursing experience in geriatrics; ② possession of a valid nurse practitioner license; ③ good communication skills, capable of effectively participating in interviews; ④ informed and consenting to participate in this study; ⑤ more than 5 years of experience implementing DRG payment and accumulated experience in nursing management decision-making. Exclusion criteria: ① interns, standardized trainees, and advanced study nurses; ② nursing staff absent from duty due to sick leave, personal leave, maternity leave, or external training. The sample size was determined based on the principle of achieving theoretical saturation of information. Ultimately, 15 interviewees (coded N1–N15) were included, all female; aged 27–54 years (41.40 ± 8.30); with work experience ranging from 5 to 35 years (20.47 ± 9.66). Educational background included 13 with a bachelor's degree and 2 with a master's degree; professional titles comprised 2 nurse practitioners, 11 senior nurse practitioners, 1 associate chief nurse, and 1 chief nurse; nursing levels included 2 junior, 4 intermediate, 4 senior, and 5 nursing management; positions included 10 nurses, 3 head nurses, 1 department head nurse, and 1 director of the nursing department. This study employed one-on-one semi-structured interviews to collect data. Prior to conducting the interviews, the researchers fully explained the research objectives, content, confidentiality principles, and the purpose of audio recording to the participants, and obtained signed informed consent. All interviews were conducted in a conference room on the interviewers' floor, providing a quiet, private, and disturbance-free environment. The interviews were carried out jointly by two researchers: one served as the primary interviewer guiding the conversation, while the other was responsible for note-taking and observing nonverbal responses. During the interviews, careful listening was practiced, key information was recorded, and participants were encouraged to fully express their personal emotions and thoughts. The interviewers maintained a neutral stance to avoid leading questions, paid attention to facial expressions, tone, and body language, and promptly documented the participants' nonverbal cues. When valuable and profound viewpoints or ideas emerged during the interviews, follow-up questions, paraphrasing, and summarization were conducted. Each interview lasted between 30 and 40 minutes. Management: Data analysis was conducted using Colaizzi's seven-step method: ① repeatedly reading all interview transcripts to gain an overall understanding; ② extracting significant statements related to the research questions; ③ formulating meanings from the significant statements and providing preliminary interpretations; ④ categorizing the meanings to form themes or subthemes; ⑤ integrating the content of each theme to write detailed descriptions; ⑥ distilling core themes and refining the descriptions; ⑦ revisiting some participants to verify and supplement the analysis results, ensuring the authenticity and representativeness of the findings. Throughout the analysis, two researchers collaboratively read, analyzed, coded, categorized, and extracted data, discussing any discrepancies, and involving a third researcher when necessary to assist in achieving consensus, ultimately finalizing the themes

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-07-03 09:30:08
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