ChiCTR2600126621 版本V1.0 版本创建时间2026/06/12 11:54:41 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：

 ChiCTR2600126621 

最近更新日期：

Date of Last Refreshed on：

 2026-06-12 11:54:29 

注册时间：

Date of Registration：

 2026-06-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

门诊TARE沟通模式对护患沟通质量和护士职业心理负荷影响的研究

Public title：

A study of the TARE communication model for improving outpatient nurse–patient communication and nurse work-related burnout

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于服务补救理论的门诊TARE模式构建与实证研究

Scientific title：

Development and empirical evaluation of a service recovery theory-based TARE model in outpatient departments: a multi-campus stepped-wedge 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：

吴俊 

研究负责人：

吴俊 

Applicant：

Jun Wu 

Study leader：

WU JUN 

申请注册联系人电话：

Applicant telephone：

 +86 13738138313

研究负责人电话：

Study leader's
telephone：

+86 137 3813 8313

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：

 junco0311@163.com

研究负责人电子邮件：

Study leader's E-mail：

 wujun1985@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)：

申请注册联系人通讯地址：

浙江省杭州市余杭区文一西路1367号

研究负责人通讯地址：

浙江省杭州市余杭区文一西路1367号

Applicant address：

1367 Wenyi Rd., Yuhang District, Hangzhou

Study leader's address：

1367 Wenyi Rd., Yuhang District, Hangzhou

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：

浙江大学医学院附属第一医院

Applicant's institution：

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

研究负责人所在单位：

浙江大学医学院附属第一医院

Affiliation of the Leader：

The FIrst Affiliated Hospital, College of Medicine, Zhejiang 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：

 浙大一院伦审2026研第104号-会（[2026C]IIT Ethics Approval No.104）

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：

浙江大学医学院附属第一医院IIT伦理审查委员会

Name of the ethic committee：

The IIT Ethics Review Board of the First Affiliated Hospital, Zhejiang University School of Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-05-20 00:00:00

伦理委员会联系人：

吕朵

Contact Name of the ethic committee：

Lv Duo

伦理委员会联系地址：

浙江省杭州市余杭区文一西路1367号

Contact Address of the ethic committee：

1367 Wenyi Rd., Yuhang District, Hangzhou

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 571 87236596

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 lvduo8905@foxmail.com

研究实施负责（组长）单位：

浙江大学医学院附属第一医院

Primary sponsor：

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

研究实施负责（组长）单位地址：

浙江省杭州市余杭区文一西路1367号

Primary sponsor's address：

1367 Wenyi Rd., Yuhang District, Hangzhou

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江省

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

浙江大学医学院附属第一医院

具体地址：

浙江省杭州市余杭区文一西路1367号

Institution
hospital：

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

Address：

1367 Wenyi Rd., Yuhang District, Hangzhou

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

This study is self-funded by the investigators and received no external grant funding.

研究疾病：

工作相关倦怠  

Target disease：

Work-related burnout

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

研究设计：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

1. 构建适用于门诊高压场景的 TARE 短程沟通模式，并形成配套实施工具。 2. 评价 TARE 模式对不良护患沟通事件、护士职业心理负荷及沟通质量的影响。  

Objectives of Study：

1.To develop a short-course TARE communication model suitable for high-pressure outpatient settings and to establish supporting implementation tools. 2.To evaluate the effects of the TARE model on adverse nurse–patient communication events, nurses’ occupational psychological burden, and communication quality.

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.持有中华人民共和国有效的《护士执业证书》及《护士资格证书》，并在我院门诊部注册执业的在职 护士。
2.在本研究纳入随机化的 53 个护理功能单元内定岗工作，且在该岗位连续工作时长≥6 个月。
3.直接从事一线临床护理或窗口服务工作（包括但不限于分诊咨询、采血注射、伤口造口治疗、综合服 务台接待等），即日常工作中需直接与患者或家属进行面对面沟通的人员。
4.对本研究知情同意，自愿参与TARE模型培训及后续随访，并签署书面知情同意书。

Inclusion criteria

1.Currently employed nurses who hold valid Nurse Qualification Certificates and Nurse Practicing Certificates issued by the People's Republic of China, and are registered to practice in the outpatient department of our hospital.
2.Participants were required to be assigned to designated positions within the 53 randomized nursing functional units, with a continuous working duration of ≥ 6 months in their current roles.
3.Participants must be directly engaged in frontline clinical nursing or patient-facing service roles (including but not limited to triage and consultation, phlebotomy and injections, wound and ostomy care, and general service desk reception), defined as personnel who require direct, face-to-face communication with patients or their families in their daily work.
4.Voluntarily gave informed consent to participate in this study, agreed to attend the TARE model training and subsequent follow-ups, and signed the written informed consent form.

排除标准：

1.虽定岗在门诊，但从事纯行政管理、库房后勤管理或科研档案整理等无患者直接接触性质岗位的护士。
2.处于轮转期的实习护士、进修护士或未取得独立执业资格的见习期护士。
3.在研究周期（24 周）内，有明确计划申请产假、长期病假、外出进修或离职，且预期脱岗时间超过 4 周者。
4.既往有确诊的严重精神心理疾病史（如重度抑郁、双相情感障碍），或目前正在接受精神类药物治疗 及心理危机干预的护士。

Exclusion criteria：

1.Nurses were excluded if they were assigned to the outpatient department but engaged in positions without direct patient contact, such as purely administrative duties, inventory and logistics management, or research archive organization.
2.Nurses were excluded if they were nursing interns on clinical rotation, visiting nurses, or probationary nurses who had not yet obtained independent practice qualifications.
3.Nurses were excluded if they had definitive plans to take maternity leave, extended sick leave, off-site training, or to resign during the 24-week study period, resulting in an expected absence from duty of more than 4 weeks.
4.Nurses were excluded if they had a documented history of severe psychiatric disorders (e.g., major depressive disorder, bipolar disorder), or if they were currently receiving psychotropic medication or psychological crisis intervention.

研究实施时间：

Study execute time：

从 From 2026-05-10 00:00:00至 To 2027-08-10 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-25 00:00:00 至 To 2026-11-10 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 200

Group：

Control group

Sample size：

干预措施：

常规模式

干预措施代码：

Intervention：

Standard care

Intervention code：

组别：

TARE实验组

样本量：

 200

Group：

Experimental group

Sample size：

干预措施：

TARE结构化门诊护患沟通模式干预

干预措施代码：

Intervention：

TARE structured outpatient nurse-patient communication model intervention

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China

Province：

Zhejiang

City：

单位(医院)：

 浙江大学医学院附属第一医院 

单位级别：

 三级甲等 

Institution
hospital：

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

护士工作相关倦怠评分，CBI评分

指标类型：

次要指标

Outcome：

Nurse work-related burnout score (CBI score)

Type：

Secondary indicator

测量时间点：

T0基线期及T1–T5各干预周期末；每4周测量1次

测量方法：

采用哥本哈根倦怠量表，重点使用工作相关倦怠维度，通过电子问卷对所有在岗受试护士进行测评。得分越高表示工作相关倦怠程度越重，干预后评分下降提示职业心理负荷减轻。

Measure time point of outcome：

Assessed at baseline (T0) and at the end of each intervention cycle (T1–T5) at 4-week intervals.

Measure method：

This was measured using the Copenhagen Burnout Inventory (CBI), specifically focusing on the work-related burnout dimension, and was administered to all participating on-duty nurses via electronic questionnaires. Higher scores indicate a more severe degree of work-related burnout, while a reduction in scores post-intervention suggests an alleviation of occupational psychological burden.

指标中文名：

门诊患者负向评价率

指标类型：

次要指标

Outcome：

Rate of negative outpatient evaluations

Type：

Secondary indicator

测量时间点：

T0–T5，全研究周期24周；每4周采集1次

测量方法：

基于医院小程序、满意度评价或门诊反馈系统中常规采集的就诊后评价数据，统计患者在“护理服务/沟通态度”维度评价为“不满意”或“非常不满意”的比例。

Measure time point of outcome：

Assessed across the entire 24-week study period (T0–T5) with data collected at 4-week intervals.

Measure method：

This was calculated using routine post-visit evaluation data retrieved from the hospital's mini-program, satisfaction surveys, or outpatient feedback system, specifically defining the rate as the proportion of patients who rated the 'nursing service/communication attitude' dimension as 'dissatisfied' or 'very dissatisfied'.

指标中文名：

不良护患沟通事件复合发生率

指标类型：

主要指标

Outcome：

Composite incidence rate of adverse nurse-patient communication events

Type：

Primary indicator

测量时间点：

T0–T5，全研究周期24周；每4周采集1次

测量方法：

统计每个护理功能单元在对应周期内发生的一级事件、二级事件和三级事件总数，并按同期门诊接诊总人次计算。公式：不良护患沟通事件复合发生率 =（一级事件数+二级事件数+三级事件数）/同期该单元门诊接诊总人次 × 10000。数据来源于医院医疗质量管理系统、安保调度记录、门诊反馈系统等后台记录。

Measure time point of outcome：

Assessed throughout the 24-week study period (T0–T5) with data collected at 4-week intervals.

Measure method：

This was determined by calculating the total number of Level 1, Level 2, and Level 3 events occurring within each nursing functional unit during the corresponding period, relative to the total number of outpatient visits during the same timeframe. Data were retrieved from back-end records, including the hospital's medical quality management system, security dispatch logs, and the outpatient feedback system. The rate was calculated using the following formula:Composite incidence rate = [(Level 1

指标中文名：

临床沟通质量指数，CCQI

指标类型：

次要指标

Outcome：

Clinical Communication Quality Index (CCQI)

Type：

Secondary indicator

测量时间点：

T0基线期及T1–T5各干预周期末；或干预前后测量

测量方法：

依据TARE标准作业程序制定结构化评分表，由非本项目组成员的护理质控专家、科室护士长或高年资护士，对真实沟通案例或去标识化案例记录进行盲法评分。满分100分，得分越高表示TARE执行越完整、沟通质量越好。

Measure time point of outcome：

Evaluated at baseline (T0) and at the end of each intervention cycle (T1–T5), or measured pre- and p

Measure method：

A structured scoring scale, developed in accordance with the TARE standard operating procedures (SOPs), was utilized. Blinded evaluations of real-time communication scenarios or de-identified case records were independently conducted by nursing quality control experts, head nurses, or senior nurses unaffiliated with the research team. The scale has a maximum score of 100 points, with higher scores indicating greater adherence to the TARE model and superior communication quality.

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：

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）：

本研究采用多院区阶梯楔形整群随机对照设计（SW-RCT）。由不参与具体培训实施和结局统计的非课题组统计人员，采用分层区组随机化法，利用 PASS 15.0 软件生成随机化分配序列。随机化单位为门诊护理功能单元，随机化前按院区及岗位功能类型进行分层，在各层内将53个护理功能单元分配至5个干预启动波次。

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

This study uses a multi-center stepped wedge cluster randomized controlled design (SW-RCT). A stratified block randomization method was employed by an independent statistician—unaffiliated with the research team, training implementation, or outcome assessment—to generate the allocation sequence using PASS 15.0 software. Using the outpatient nursing functional unit as the unit of randomization, the 53 units were stratified by hospital campus and functional role type prior to being allocated into five intervention initiation waves within each stratum.

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：

开放标签，对评估者隐藏分组

Blinding：

Open-label study with blinded-evaluators

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：

本研究针对受试护士统一制定了结构化的数据采集工具。基线期采集护士一般资料 ；干预及随访期通过电子问卷采集哥本哈根倦怠量表（CBI）工作相关倦怠维度得分 ；由独立评价小组依据标准作业程序对沟通案例进行盲法评分，记录临床沟通质量指数（CCQI） 。主要终点指标（一、二、三级不良护患沟通事件数）及门诊接诊总人次，统一采用数据提取字段清单，直接提取自医院医疗质量与安全管理系统、安保调度记录等后台行政记录 。同时构建了完善的电子数据管理流程 。护士心理效能指标通过在线电子问卷系统进行流转与收集 ；医院后台客观计次数据由不参与干预的独立数据员遵循盲法原则定期导出 ，统一录入并集成至研究专项数据库中。整个采集过程严格执行去标识化处理，隐去患者姓名及护士工号，仅保留唯一受试者鉴认编码 。

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

A standardized, structured data collection tool was developed for all participating nurses in this study. General demographic and professional data of the nurses were collected at baseline; during the intervention and follow-up periods, scores for the work-related burnout dimension of the Copenhagen Burnout Inventory (CBI) were collected via electronic questionnaires; and the Clinical Communication Quality Index (CCQI) was recorded by an independent evaluation panel through blinded scoring of communication cases in accordance with standard operating procedures (SOPs). Primary endpoint indicators (the number of Level 1, 2, and 3 adverse nurse-patient communication events) and the total number of outpatient visits were retrieved using a standardized data extraction checklist directly from back-end administrative records, including the hospital's medical quality and safety management system and security dispatch logs. Furthermore, a comprehensive electronic data management workflow was established. Nurses' psychological efficacy indicators were distributed and collected via an online electronic questionnaire system; objective count data from the hospital's back-end systems were regularly exported by an independent data manager uninvolved in the intervention, adhering to blinding principles, and were uniformly entered and integrated into a dedicated study database. The entire data collection process strictly complied with de-identification protocols; patient names and nurse identification numbers were masked, retaining only a unique participant identification code.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-06-12 11:54:29