ChiCTR2300078829 版本V1.1 版本创建时间2024/04/22 09:15:29 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：

 ChiCTR2300078829 

最近更新日期：

Date of Last Refreshed on：

 2023-12-19 16:11:22 

注册时间：

Date of Registration：

 2023-12-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

专科临床医师参与的基层病例讨论会议干预策略在基层糖尿病管理中的应用效果——整群随机对照实验研究

Public title：

Effectiveness of case discussion conferences involving specialists on the management of Type 2 diabetes patients in primary healthcare settings: a cluster randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

专科临床医师参与的基层病例讨论会议干预策略在基层糖尿病管理中的应用效果——整群随机对照实验研究

Scientific title：

Effectiveness of case discussion conferences involving specialists on the management of Type 2 diabetes patients in primary healthcare settings: a 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：

李佳 

研究负责人：

袁蓓蓓 

Applicant：

Li Jia 

Study leader：

Yuan Beibei 

申请注册联系人电话：

Applicant telephone：

 +86 188 1155 5217

研究负责人电话：

Study leader's
telephone：

+86 186 1829 5166

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：

 jiali@bjmu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 beibeiyuan@bjmu.edu.cn

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：

北京海淀区学院路38号北京大学医学部

研究负责人通讯地址：

北京海淀区学院路38号北京大学医学部

Applicant address：

Xueyuan Road 38, Haidian District, Beijing

Study leader's address：

Xueyuan Road 38, Haidian District, Beijing

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：

北京大学公共卫生学院卫生政策与管理系

Applicant's institution：

Department of Health Policy and Management, School of Public Health, Peking University

研究负责人所在单位：

北京大学中国卫生发展研究中心

Affiliation of the Leader：

China Center for Health Development Studies, Peking 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：

 IRB00001052-23126

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：

北京大学生物医学伦理委员会

Name of the ethic committee：

Peking University Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-10-24 00:00:00

伦理委员会联系人：

李洁

Contact Name of the ethic committee：

Li Jie

伦理委员会联系地址：

北京市海淀区学院路38号北京大学医学部

Contact Address of the ethic committee：

Xueyuan Road 38, Haidian District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 8280 5751

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：

北京大学中国卫生发展研究中心

Primary sponsor：

China Center for Health Development Studies, Peking University

研究实施负责（组长）单位地址：

北京海淀区学院路38号北京大学医学部

Primary sponsor's address：

Xueyuan Road 38, Haidian District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京市

市(区县)：

海淀区

Country：

China

Province：

Beijing

City：

Haidian

单位(医院)：

北京大学中国卫生发展研究中心

具体地址：

北京海淀区学院路38号

Institution
hospital：

China Center for Health Development Studies, Peking University

Address：

Xueyuan Road 38, Haidian District, Beijing

经费或物资来源：

国家自然科学基金72274006

Source(s) of funding：

China National Nature Science Fund 72274006

研究疾病：

糖尿病  

Target disease：

diabetes mellitus

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：

本研究借鉴国际做法和以往研究经验，利用东西部两个市正在开展基层卫生综合改革的机会，组建基层家庭医生团队和二三级医院专科医师之间多学科团队，计划在寿光潍坊市寿光市和广西防城港市上思县开展基层家庭医生团队与二三级医院专科医师的定期病例讨论会议，借助定期沟通落实和推进全科和专科在基层医疗服务中的合作。家庭医生团队和专科医师在会议中共同讨论复杂病例，交流经验并为家庭医生提供专家建议。本研究为整群随机对照试验，探究糖尿病病例讨论会议在基层糖尿病管理中的有效性，并为加强基层全科和上级医院专科之间的协作、改善服务模式、最终改善患者健康结果提供潜在有效的策略经验。本研究的目的如下： 1）评估病例讨论会议干预措施的可行性和参与者的依从性。 2）评估病例讨论会议对控制2型糖尿病患者血糖水平的有效性。  

Objectives of Study：

Given the identified health needs and research gaps, we have formulated this protocol for a cluster randomized trial aimed at examining the effectiveness of case discussion conferences within Chinese PHIs. The purpose is to offer a potentially effective strategy for strengthening the collaboration between primary care and specialty care, enhancing patient care delivery, and ultimately improving patient health outcomes. The specific objectives of this cluster randomized trial are outlined as follows: 1) To evaluate the feasibility of the intervention and the extent of participant adherence. 2) To assess the effectiveness of the case conference intervention on the health outcomes of patients with Type 2 diabetes mellitus (T2DM).

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

根据研究设计，本干预的研究人群包括基层医疗卫生机构（社区卫生服务中心/乡镇卫生院）的家庭医生团队、二三级级医院专科医师、以及在纳入基层医疗机构管理的糖尿病患者。 基层医疗卫生机构及其家庭医生团队 纳入的基层医疗卫生机构应满足如下条件：①按照国家卫生健康委员会2018 年发布的《关于规范家庭医生签约服务管理的指导意见中的要求，以团队服务形式开展家庭医生签约服务；②注册的每个家庭医生团队至少配备3名成员（1 名医生、1 名护理人员和1 名公共卫生医师或健康管理师）；③信息系统完善，可以导出每位患者的健康档案信息、并记录基层医务人员提供治疗性服务和预防性服务的工作情况；④没有参与到其他临床研究中；⑤至少有413名登记在册并进行管理的糖尿病患者。纳入的社区卫生服务中心或乡镇卫生院中的所有家庭医生团队自动参与到本研究中。 二三级医院专科医师 每个家庭医生团队分配一名二三级医院专科医师，在专科医师意愿参与到本研究的基础上，满足以下条件即可纳入：①专业类型与糖尿病紧密相关，所在科室应为内分泌科或者糖尿病专科科室；②累计工作年份在五年及以上；③未来一年内工作岗位稳定，无调岗或岗位变动等计划。 基层医疗卫生机构管理的糖尿病患者 基层医疗卫生机构登记在册并进行管理的所有2 型糖尿病患者自动参与到研究中。

Inclusion criteria

The participants in the study consist of primary healthcare institutions (PHIs), family doctor teams of PHIs, specialists, and patients with T2DM. PHIs and family doctor teams In the study, six PHIs at each of the two trial centers, which are responsible for managing T2DM patients within the community, will be selected. A typical team composition comprises a minimum of three individuals with distinct roles, such as a doctor, a nurse, and a public health worker. Regarding the inclusion criteria, in each PHI (cluster), family doctor contract services must be carried out in the form of team services within the community. Furthermore, these institutions should not be concurrently involved in any other clinical trial, and they should possess an information system facilitating access to patients' health records. All family doctor teams within the selected institutions will participate in this study. Eligible family doctor teams will be included in this study under the agreement of all team members. Specialists of secondary or tertiary hospitals The specialists assigned to PHIs will be chosen from a pool of endocrinologists or diabetes specialists working in secondary or tertiary hospitals. Inclusion criteria for these specialist physicians, contingent upon their willingness to participate in this study, are as follows: (1) specialization closely related to diabetes mellitus, with their working department being either Endocrinology or a specialized Diabetes Department; (2) accumulated work experience of five years or longer; (3) stable employment status within their current position for the upcoming year, without any plans for job changes. To assess potential sources of variance stemming from individual specialists, we will conduct a baseline evaluation encompassing their demographic details, medical capabilities, and specialty expertise. Patients All patients diagnosed with T2DM who received care directly from the participating family doctor teams will be eligible to participate in this trial, regardless of age.

排除标准：

根据研究目的和研究设计，排除出现以下情况的糖尿病患者：①患有绝症或严重的合并症，预期寿命不足12 个月；②患有痴呆或其他疾病，严重影响正常沟通和交流；③同时在参与其他临床研究，对其糖尿病情况产生影响。

Exclusion criteria：

Patients will be excluded if they: (1) have a terminal illness with a life expectancy of fewer than 12 months; (2) are suffering from dementia or other diseases that impair their ability to communicate; (3) are concurrently enrolled in other intervention projects that may influence their health conditions regarding diabetes.

研究实施时间：

Study execute time：

从 From 2023-12-20 00:00:00至 To 2025-02-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-12-27 00:00:00 至 To 2024-02-01 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 1239

Group：

Intervention group

Sample size：

干预措施：

对于进入到干预组的基层医疗机构，在常规的合作策略之外，其家庭医生团队与对应的专科医师开展每月2 次的病例讨论会议。会议的参与人员为家庭医生团队所有成员和1 名二三级专科医师。 每次病例讨论会议持续约120 分钟，讨论6-8个糖尿病病例。会议前，家庭医生根据标准和日常工作中的需求选出会议中所需讨论的病例。会议中，专科医师负责整体会议流程的推进，针对每个病例，讨论过程包括病例的简要介绍、以往治疗方案及其疗效评估、诊疗及健康管理策略的制定或改进、转诊需求以及糖尿病健康知识的分享。会议后，由会议协调者上传会议记录，家庭医生团队和专科医师填写讨论反馈问卷。后续患者管理中，根据讨论形成的一致意见，由家庭医生团队进行患者管理方案的实施，并在下一次会议中给出实施效果的反馈意见。

干预措施代码：

Intervention：

In the intervention group, healthcare professionals participating in the trial will engage in monthly case discussion conferences within the PHIs. The case discussion conferences will be conducted twice every month. Teams in the intervention arm will receive electronic reminders from the information system every 2-4 weeks, which will include details about the conference arrangements. Each conference is expected to last approximately 120 minutes with 6-8 diabetes cases to be discussed. The selection of cases for each discussion will be at the discretion of the family doctor teams within the same PHI by turns. Defined case selection criteria will be made available to guide their decisions. Furthermore, family doctor teams have the flexibility to include any cases they believe require clinical advice and guidance from specialists. During the conference, participants will be required to present fundamental information about each case, exhibit clinical indicators from the medical records, assess the effectiveness of current treatment plans, offer suggestions for improvement, identify necessary referrals, deliberate on health management strategies, and share the latest clinical guidelines. To ensure the consistency and comparability of each conference's procedure, checklists and guidelines for the discussion process will be made available to the team. Following the end of each conference, a coordinator will complete record checklists, which will then be uploaded to the information system. Health records for individual cases within the system should also be updated. In addition, all attendants will be required to submit an online feedback questionnaire that includes several questions about their participation in and perceptions of the conference. Moreover, the information system will automatically generate regular implementation reports. These reports will be based on attendance records, feedback from discussion participants, and health records of the cases discussed. They will be made available to all team members, enabling ongoing monitoring of the implementation and the tracking of progress in patient management. After the case discussion conference, the family doctor teams assume responsibility for the implementation of treatment and health management plans that are collectively agreed upon during the conference. This includes actions such as prescription adjustments, patient education, referrals, and any other decisions made regarding the discussed cases. Based on the insights gained during the conference, the family doctor teams may also contemplate adjustments to the diabetes care provided to other patients who were not specifically addressed during the discussion.

Intervention code：

组别：

对照组

样本量：

 1239

Group：

Control group

Sample size：

干预措施：

对照组基层医疗机构的每个家庭医生团队配备一名二三专科医师，根据现有规定和策略，进行常规的转诊和咨询等相关服务的合作，不开展病例讨论会议。

干预措施代码：

Intervention：

In the control group, PHIs and family doctor teams will continue their regular collaboration with specialists from secondary or tertiary hospitals.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

 潍坊市寿光市 

Country：

China

Province：

Shandong

City：

Shouguang, Weifang

单位(医院)：

 侯镇中心卫生院 

单位级别：

 乡镇卫生院 

Institution
hospital：

Hou Township Healthcare Center

Level of the institution：

Township Healthcare Center

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

 潍坊市寿光市 

Country：

China

Province：

Shandong

City：

Shouguang, Weifang

单位(医院)：

 洛城街道卫生院 

单位级别：

 乡镇卫生院 

Institution
hospital：

Luocheng Street Healthcare Center

Level of the institution：

Township Healthcare Center

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

 潍坊市寿光市 

Country：

China

Province：

Shandong

City：

Shouguang, Weifang

单位(医院)：

 田柳镇卫生院 

单位级别：

 乡镇卫生院 

Institution
hospital：

Tianliu Township Healthcare Center

Level of the institution：

Township Healthcare Center

国家：

 中国

省(直辖市)：

 广西省 

市(区县)：

 防城港市上思县 

Country：

China

Province：

Guangxi

City：

Shangsi, Fangchengang

单位(医院)：

 思阳镇卫生院 

单位级别：

 乡镇卫生院 

Institution
hospital：

Siyang Township Healthcare Center

Level of the institution：

Township Healthcare Center

国家：

 中国

省(直辖市)：

 广西省 

市(区县)：

 防城港市上思县 

Country：

China

Province：

Guangxi

City：

Shangsi, Fangchengang

单位(医院)：

 那琴乡卫生院 

单位级别：

 乡镇卫生院 

Institution
hospital：

Naqin Township Healthcare Center

Level of the institution：

Township Healthcare Center

国家：

 中国

省(直辖市)：

 广西省 

市(区县)：

 防城港市上思县 

Country：

China

Province：

Guangxi

City：

Shangsi, Fangchengang

单位(医院)：

 在妙镇卫生院 

单位级别：

 乡镇卫生院 

Institution
hospital：

Zaimiao Township Healthcare Center

Level of the institution：

Township Healthcare Center

测量指标：

Outcomes：

指标中文名：

空腹血糖

指标类型：

主要指标

Outcome：

fasting blood glucose (FBG)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

收缩压

指标类型：

次要指标

Outcome：

systolic blood pressure

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

舒张压

指标类型：

次要指标

Outcome：

diastolic blood pressure

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生命质量

指标类型：

次要指标

Outcome：

quality of life

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

月门诊次数

指标类型：

次要指标

Outcome：

frequency of outpatients within a month

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

年住院次数

指标类型：

次要指标

Outcome：

frequency of inpatients within a year

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者满意度

指标类型：

次要指标

Outcome：

patient satisfaction

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：

NA

组织：

Sample Name：

NA

Tissue：

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age NA 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）：

本研究为整群随机对照试验，在整群（基层医疗卫生机构）层面进行随机分配。纳入本研究的6 家基层医疗卫生机构由对研究内容和设计隐藏的统计人员使用随机数生成器进行1:1 随机分配，3 家机构进入干预组，另外3 家机构进入对照组。研究者根据分组结果进行干预的分配。

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

To eliminate any effects originating from organizational or professional factors other than case discussion conferences, the six selected PHIs will be randomly assigned to the intervention group or the control group. This random allocation will be executed using a computer-generated sequence of random numbers, which will be generated by a researcher uninvolved in data collection or analysis before the commencement of the trial.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

根据本研究设计，对糖尿病患者使用盲法，干预组和对照组的患者均接受家庭医生团队的服务，不清楚其分配。对于参与本研究的基层医疗卫生机构、家庭医生团队和专科医师，由于干预组需要其参与到病例讨论中，与对照组策略存在明显不同，因此无法采用盲法。由课题组研究成员进行结局指标资料的收集和分析。由于评价的主要结局指标为客观指标，因此无需应用盲法。对于其他主观评价指标则采取第三方评价，由对研究内容和设计隐藏的其他研究人员进行资料收集和分析。

Blinding：

We anticipate that the patients enrolled in the study will remain unaware of their group allocation, ensuring blinding. However, it is essential to note that primary healthcare providers and specialists participating in the trial will not be blinded to their respective allocations since they are cognizant of whether they will be attending the care discussion conferences or not. Precaution to minimize potential bias resulting from the lack of blinding includes the blinding of participants to the study hypothesis and the use of standardized protocols for the training of data collectors and assessment of study outcomes.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

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）：

预计2025年3月1日后公开原始数据，可通过邮件联系研究主要负责人寻求原始数据

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

IPD is expected to be available after March 1, 2025, and can be requested by contacting the principal investigator by email.

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：

本研究相关数据来源于电子健康档案系统和电子问卷。使用电子健康档案系统数据得到患者健康结果指标，并测量干预的实施情况和医务人员的反馈情况；使用电子问卷测量医患满意度、家庭医生团队成员服务能力等指标，将通过相应的逻辑控制及核查程序，在调查员进行问卷填写时及时指出存在的错误并予以改正，从而有效控制数据质量。同时也避免了二次数据录入和核查产生的可能错误，保证数据的准确性。按要求对电子健康档案系统中的数据进行导出，并归档保存。所有调查问卷在按要求完成数据录入和核查后，将按编号的顺序归档保存，并填有检索目录等，以备查考。电子数据文件包括数据库、检查程序、分析程序、分析结果、编码本和说明文件等，将分类保存，并有多个备份保存于不同磁盘或记录介质上，妥善保存，防止损坏。所有原始档案应按相应规定内的期限保存。

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

The data relevant to this study were sourced from electronic health records (EHR) systems and electronic questionnaires. EHR data were utilized to derive patient health outcome indicators, assess the implementation of interventions, and gather feedback from healthcare personnel. Electronic questionnaires were employed to measure metrics such as patient satisfaction, and service capabilities of primary care team members, among others. In accordance with the prescribed procedures for logical control and verification, any errors identified during questionnaire completion by investigators were promptly highlighted and corrected, thus effectively ensuring data quality. Simultaneously, this approach mitigated the potential for errors resulting from secondary data entry and verification, thereby guaranteeing data accuracy. In compliance with the specified requirements, data from the EHR system were exported and archived for preservation. All survey questionnaires, upon completion of data entry and verification as stipulated, were archived in sequential order and included retrieval indices, facilitating subsequent reference. Electronic data files encompassed databases, inspection procedures, analytical programs, analysis results, codebooks, and explanatory documents, all systematically categorized and securely stored with multiple backups on different disks or recording media to prevent damage. Original records were maintained for the duration stipulated by the relevant 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：

  2023-12-19 16:10:59