ChiCTR2500113083 版本V1.0 版本创建时间2025/11/24 18:08:01 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：

 ChiCTR2500113083 

最近更新日期：

Date of Last Refreshed on：

 2025-11-24 18:07:55 

注册时间：

Date of Registration：

 2025-11-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

An evidence-based advance care planning programme to promote end-of-life care planning among patients with advanced diseases in the Emergency Department – a feasibility randomised controlled trial

Public title：

An evidence-based ACP programme to promote EOL planning among patients with advanced diseases in the ED – a feasibility randomised controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

An evidence-based advance care planning programme to promote end-of-life care planning among patients with advanced diseases in the Emergency Department – a feasibility randomised controlled trial

Scientific title：

An evidence-based advance care planning programme to promote end-of-life care planning among patients with advanced diseases in the Emergency Department – a feasibility randomised 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：

LEUNG Po Shan Melissa 

研究负责人：

LEUNG Po Shan Melissa 

Applicant：

LEUNG Po Shan Melissa 

Study leader：

LEUNG Po Shan Melissa 

申请注册联系人电话：

Applicant telephone：

 +852 9121 3016

研究负责人电话：

Study leader's
telephone：

+852 9121 3016

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：

 1155005007@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 1155005007@link.cuhk.edu.hk

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：

2-10 Princess Margaret Hospital Road, Kowloon, HKSAR

研究负责人通讯地址：

2-10 Princess Margaret Hospital Road, Kowloon, HKSAR

Applicant address：

2-10 Princess Margaret Hospital Road, Kowloon, HKSAR

Study leader's address：

2-10 Princess Margaret Hospital Road, Kowloon, HKSAR

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：

The Chinese University of Hong Kong, The Nethersole School of Nursing

Applicant's institution：

The Chinese University of Hong Kong, The Nethersole School of Nursing

研究负责人所在单位：

The Chinese University of Hong Kong, The Nethersole School of Nursing

Affiliation of the Leader：

The Chinese University of Hong Kong, The Nethersole School of Nursing

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：

 Central IRB - Research Ethics Application (Ref: CIRB-2025-303-1)

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：

Hospital Authority Central Institutional Review Board

Name of the ethic committee：

Hospital Authority Central Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-10-30 00:00:00

伦理委员会联系人：

Ms Mandy LUK

Contact Name of the ethic committee：

Ms Mandy LUK

伦理委员会联系地址：

A 503, 5/F, Block A, Centre for Health Protection, 143a Argyle Street, Kowloon

Contact Address of the ethic committee：

A 503, 5/F, Block A, Centre for Health Protection, 143a Argyle Street, Kowloon

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2300 6431

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 hacco@ha.org.hk

研究实施负责（组长）单位：

The Nethersole School of Nursing, The Chinese University of Hong Kong

Primary sponsor：

The Nethersole School of Nursing, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

The Nethersole School of Nursing 6-8/F, Esther Lee Building The Chinese University of Hong Kong Shatin, N.T., Hong Kong

Primary sponsor's address：

The Nethersole School of Nursing 6-8/F, Esther Lee Building The Chinese University of Hong Kong Shatin, N.T., Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

Princess Margaret Hospital

具体地址：

2-10 Princess Margaret Hospital Road, Kowloon, HKSAR

Institution
hospital：

Princess Margaret Hospital

Address：

2-10 Princess Margaret Hospital Road, Kowloon, HKSAR

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

Patients with advanced disease with a need for end-of-life care  

Target disease：

Patients with advanced disease with a need for end-of-life care

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：

随机平行对照 

Study design：

Parallel 

研究目的：

The study aims to examine the feasibility and acceptability of an evidence-based ACP programme among patients with advanced diseases in the Emergency Department. The objectives of the study are to determine the feasibility of conducting an ACP programme in the ED based on recruitment and attrition rate, to examine the acceptability of the intervention based on satisfaction survey and qualitative comments on patient’s experiences, and to examine the preliminary effect of the programme on patient reported ACP readiness and evidence of ACP documentation on medical record.  

Objectives of Study：

The study aims to examine the feasibility and acceptability of an evidence-based ACP programme among patients with advanced diseases in the Emergency Department. The objectives of the study are to determine the feasibility of conducting an ACP programme in the ED based on recruitment and attrition rate, to examine the acceptability of the intervention based on satisfaction survey and qualitative comments on patient’s experiences, and to examine the preliminary effect of the programme on patient reported ACP readiness and evidence of ACP documentation on medical record.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Subjects will be recruited from Emergency Medicine Wards, ED of two public hospitals in Kowloon West Cluster, Hong Kong. One of the ED is in Kwai Tsing District providing tertiary care while the other ED is located on Lantau Island providing tertiary and rehabilitation service.Participants are adult (18 years old or above) admitted to the EMW, Chinese-speaking, fulfill the two general and one clinical criterion stipulated in the Supportive and Palliative Care Indicator Tools (SPICT?) (The University of Edinburgh, 2025). SPICT was developed as an instrument to identify patients at risk of dying within one year (Paulik et al., 2024). It has a sensitivity of 0.65 (95% CI) and a specificity of 0.72 (95% CI) in detecting life-limiting conditions (Paulik et al., 2024).By using this dual indicators approach, it allows a more comprehensive and personalized model of care for patients with advanced illnesses (Paulik et al., 2024).

Inclusion criteria

Subjects will be recruited from Emergency Medicine Wards, ED of two public hospitals in Kowloon West Cluster, Hong Kong. One of the ED is in Kwai Tsing District providing tertiary care while the other ED is located on Lantau Island providing tertiary and rehabilitation service.Participants are adult (18 years old or above) admitted to the EMW, Chinese-speaking, fulfill the two general and one clinical criterion stipulated in the Supportive and Palliative Care Indicator Tools (SPICT?) (The University of Edinburgh, 2025). SPICT was developed as an instrument to identify patients at risk of dying within one year (Paulik et al., 2024). It has a sensitivity of 0.65 (95% CI) and a specificity of 0.72 (95% CI) in detecting life-limiting conditions (Paulik et al., 2024).By using this dual indicators approach, it allows a more comprehensive and personalized model of care for patients with advanced illnesses (Paulik et al., 2024).

排除标准：

Patients will be excluded if they are mentally incompetent determined based on the Diagnostic assessment Confusion Assessment Method (3D-CAM) (Marcantonio et al., 2015). The Chinese version of 3D-CAM can be used as a reliable and accurate instrument for delirium assessment, its sensitivity ranges from 85.7 to 100% and the specificity from 95.7 to 96.4% (Mu et al., 2020). Patients who were non-Chinese speaking, non-communicable, refusal or unable to give consent, altered sensorium or cognitive functions, physical unwell to receive the intervention, and with previous documented ACP or AMD will be excluded from the study.

Exclusion criteria：

Patients will be excluded if they are mentally incompetent determined based on the Diagnostic assessment Confusion Assessment Method (3D-CAM) (Marcantonio et al., 2015). The Chinese version of 3D-CAM can be used as a reliable and accurate instrument for delirium assessment, its sensitivity ranges from 85.7 to 100% and the specificity from 95.7 to 96.4% (Mu et al., 2020). Patients who were non-Chinese speaking, non-communicable, refusal or unable to give consent, altered sensorium or cognitive functions, physical unwell to receive the intervention, and with previous documented ACP or AMD will be excluded from the study.

研究实施时间：

Study execute time：

从 From 2025-11-24 00:00:00至 To 2026-10-25 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-11-24 00:00:00 至 To 2026-10-25 00:00:00

干预措施：

Interventions：

组别：

Experimental Group

样本量：

 30

Group：

Experimental Group

Sample size：

干预措施：

Patients in the intervention group will receive a ACP programme which include a six-minute video on introduction toACP, followed by a 30-minute discussion guided by a trained nurse on ACP as well as a pamphlet with written information on the same topic.

干预措施代码：

Intervention：

Patients in the intervention group will receive a ACP programme which include a six-minute video on introduction toACP, followed by a 30-minute discussion guided by a trained nurse on ACP as well as a pamphlet with written information on the same topic.

Intervention code：

组别：

Control Group

样本量：

 30

Group：

Control Group

Sample size：

干预措施：

Patient in the control group will receive usual care such as ward routine and fall prevention advice.

干预措施代码：

Intervention：

Patient in the control group will receive usual care such as ward routine and fall prevention advice.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 The North Lantau Hospital 

单位级别：

 Secondary 

Institution
hospital：

The North Lantau Hospital

Level of the institution：

Secondary

测量指标：

Outcomes：

指标中文名：

Recruitment and retention rate

指标类型：

主要指标

Outcome：

Recruitment and retention rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Time spent in each intervention

指标类型：

主要指标

Outcome：

Time spent in each intervention

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

ACP engagement

指标类型：

次要指标

Outcome：

ACP engagement

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Decisional Conflict

指标类型：

次要指标

Outcome：

Decisional Conflict

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Documentation of end-of-life care preferences

指标类型：

次要指标

Outcome：

Documentation of end-of-life care preferences

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Demographics and health conditions

指标类型：

次要指标

Outcome：

Demographics and health conditions

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Qualitative Interview

指标类型：

次要指标

Outcome：

Qualitative Interview

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：

None

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 18 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）：

Eligible and consented patients will be randomised into intervention or control group in a 1:1 ratio using the Random Sequence Generator (Prachanukool et al., 2022).

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

Eligible and consented patients will be randomised into intervention or control group in a 1:1 ratio using the Random Sequence Generator (Prachanukool et al., 2022).

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：

Due to the nature of the intervention, the participants cannot be blinded to the group allocation. The outcome assessors will be blinded to the group allocation.

Blinding：

Due to the nature of the intervention, the participants cannot be blinded to the group allocation. The outcome assessors will be blinded to the group allocation.

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

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）：

None

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：

The principal investigator will identify potential participants through screening patient’s eligibility. She will then approach the eligible patient to explain the purpose and nature of the study and to obtain written consent. Patients will receive phone calls for follow-up assessment at week four post-allocation. The research assistants who are responsible for the follow-up assessment do not have knowledge to the group assignment, nor they do not have access to the randomization arrangement and the baseline data (Ouchi et al. 2025).

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

The principal investigator will identify potential participants through screening patient’s eligibility. She will then approach the eligible patient to explain the purpose and nature of the study and to obtain written consent. Patients will receive phone calls for follow-up assessment at week four post-allocation. The research assistants who are responsible for the follow-up assessment do not have knowledge to the group assignment, nor they do not have access to the randomization arrangement and the baseline data (Ouchi et al. 2025).

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-11-24 18:07:55