中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2000029369
最近更新日期： Date of Last Refreshed on：	2020-01-26 10:29:42
注册时间： Date of Registration：	2020-01-25 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	A specific criteria-based guideline improves compliance with General Surgery ambulatory care standards and reduces overcrowding in “Hot Clinic”: Quality Improvement Study
Public title：	A specific criteria-based guideline improves compliance with General Surgery ambulatory care standards and reduces overcrowding in “Hot Clinic”: Quality Improvement Study
注册题目简写：
English Acronym：
研究课题的正式科学名称：	A specific criteria-based guideline improves compliance with General Surgery ambulatory care standards and reduces overcrowding in “Hot Clinic”: Quality Improvement Study
Scientific title：	A specific criteria-based guideline improves compliance with General Surgery ambulatory care standards and reduces overcrowding in “Hot Clinic”: Quality Improvement Study
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：	Shahab Hajibandeh	研究负责人：	Shahab Hajibandeh
Applicant：	Shahab Hajibandeh	Study leader：	Shahab Hajibandeh
申请注册联系人电话： Applicant telephone：	+44 77 66106423	研究负责人电话： Study leader's telephone：	+44 77 66106423
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：	shahab_hajibandeh@yahoo.com	研究负责人电子邮件： Study leader's E-mail：	shahab_hajibandeh@yahoo.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：	Rhuddlan Road, Bodelwyddan, Rhyl, Denbighshire LL18 5UJ, UK	研究负责人通讯地址：	Rhuddlan Road, Bodelwyddan, Rhyl, Denbighshire LL18 5UJ, UK
Applicant address：	Rhuddlan Road, Bodelwyddan, Rhyl, Denbighshire LL18 5UJ, UK	Study leader's address：	Rhuddlan Road, Bodelwyddan, Rhyl, Denbighshire LL18 5UJ, UK
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：	英国格兰克莱德医院
Applicant's institution：	Glan Clwyd Hospital, UK
研究负责人所在单位：	英国格兰克莱德医院
Affiliation of the Leader：	Glan Clwyd Hospital, UK

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：	2018 226	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：	Pennine Acute Trust, The Northern Care Alliance NHS Group
Name of the ethic committee：	Pennine Acute Trust, The Northern Care Alliance NHS Group
伦理委员会批准日期： Date of approved by ethic committee：	2018-11-17 00:00:00
伦理委员会联系人：	Paul Carr
Contact Name of the ethic committee：	Paul Carr
伦理委员会联系地址：	Pennine Acute Trust, The Northern Care Alliance NHS Group
Contact Address of the ethic committee：	Pennine Acute Trust, The Northern Care Alliance NHS Group
伦理委员会联系人电话： Contact phone of the ethic committee：	0161 922 (4) 3027	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：	N/A
Primary sponsor：	Not applicable
研究实施负责（组长）单位地址：	N/A
Primary sponsor's address：	Not applicable
试验主办单位(项目批准或申办者)： Secondary sponsor：
经费或物资来源：	No
Source(s) of funding：	None received
研究疾病：	Acute presentation to General Surgery
Target disease：	Acute presentation to General Surgery
研究疾病代码：
Target disease code：
研究类型：	卫生服务研究
Study type：	Health Services Research
研究所处阶段：	其它
Study phase：	N/A
研究设计：	单臂
Study design：	Single arm
研究目的：	The number of emergency General surgery admissions has been increasing steadily over the past decades resulting in a significant strain on National Health Service (NHS) clinical and financial resources.1 In order to reduce the costs to the healthcare provider and the inpatient burden to the acute surgical team, General surgery Hot Clinic has been introduced.2 Hot clinic is designed for assessment and management of acute General surgical patients in ambulatory setting. It has been argued that up to 30% of acute General surgical patients could be managed via ambulatory pathway where unnecessary hospital admissions can be avoided.3 Although General surgery hot clinic can help to improve patient flow in acute General surgical setting, lack of specific criteria-based guideline for identifying eligible patients for ambulatory care could have contrary effects. Overcrowding in Hot Clinic is a major issue in many General surgical settings, negatively affecting the efficiency of ambulatory care and patient satisfaction. Overcrowding mainly occurs for two reasons. Firstly, due to lack of specific criteria-based guideline for including a patient in Hot Clinic, many patients not meeting the criteria for ambulatory care who can be managed in outpatient setting are inappropriately booked in Hot Clinic. Secondly, the increasing number of daily referrals to emergency General surgery team from community, accident and emergency, and other specialities can easily tempt the on-call General Surgery clinician to utilise the Hot Clinic as an excuse for not reviewing the referred patient on the same day as referral and booking the patient in Hot Clinic. The second reason also contributes to the problem caused by the first reason making a vicious circle resulting in overcrowding in Hot Clinic. We believe that the criteria specified in Table 1 would help to prevent the overcrowding in General Surgery Hot Clinic. Booking a patient in Hot Clinic without reviewing the patient is not acceptable and contributes to including ineligible patients for review in Hot Clinic; therefore, in order to decide whether a patient is eligible for ambulatory care, as an absolute requirement the patient must be reviewed clinically by the on-call General Surgery team on the same day as referral. Once the referred patient is reviewed, the on-call General Surgery team should decide to investigate and manage the patient as an inpatient, ambulatory patient, or outpatient. The patient should be booked in Hot clinic as an ambulatory patient only for the following reasons: review of already organised investigations for a patient who has already been seen; reassessment of a patient who has already been seen; and reassessment of a recently discharged inpatient. We aimed to perform a prospective baseline audit to assess on average how many patients are seen in General Surgery Hot Clinic and what proportion of Hot Clinic patients meet the criteria for ambulatory care. Our second objective was to implement a specific criteria-based guideline and monitoring programme to improve the compliance with the ambulatory care criteria.
Objectives of Study：	The number of emergency General surgery admissions has been increasing steadily over the past decades resulting in a significant strain on National Health Service (NHS) clinical and financial resources.1 In order to reduce the costs to the healthcare provider and the inpatient burden to the acute surgical team, General surgery Hot Clinic has been introduced.2 Hot clinic is designed for assessment and management of acute General surgical patients in ambulatory setting. It has been argued that up to 30% of acute General surgical patients could be managed via ambulatory pathway where unnecessary hospital admissions can be avoided.3 Although General surgery hot clinic can help to improve patient flow in acute General surgical setting, lack of specific criteria-based guideline for identifying eligible patients for ambulatory care could have contrary effects. Overcrowding in Hot Clinic is a major issue in many General surgical settings, negatively affecting the efficiency of ambulatory care and patient satisfaction. Overcrowding mainly occurs for two reasons. Firstly, due to lack of specific criteria-based guideline for including a patient in Hot Clinic, many patients not meeting the criteria for ambulatory care who can be managed in outpatient setting are inappropriately booked in Hot Clinic. Secondly, the increasing number of daily referrals to emergency General surgery team from community, accident and emergency, and other specialities can easily tempt the on-call General Surgery clinician to utilise the Hot Clinic as an excuse for not reviewing the referred patient on the same day as referral and booking the patient in Hot Clinic. The second reason also contributes to the problem caused by the first reason making a vicious circle resulting in overcrowding in Hot Clinic. We believe that the criteria specified in Table 1 would help to prevent the overcrowding in General Surgery Hot Clinic. Booking a patient in Hot Clinic without reviewing the patient is not acceptable and contributes to including ineligible patients for review in Hot Clinic; therefore, in order to decide whether a patient is eligible for ambulatory care, as an absolute requirement the patient must be reviewed clinically by the on-call General Surgery team on the same day as referral. Once the referred patient is reviewed, the on-call General Surgery team should decide to investigate and manage the patient as an inpatient, ambulatory patient, or outpatient. The patient should be booked in Hot clinic as an ambulatory patient only for the following reasons: review of already organised investigations for a patient who has already been seen; reassessment of a patient who has already been seen; and reassessment of a recently discharged inpatient. We aimed to perform a prospective baseline audit to assess on average how many patients are seen in General Surgery Hot Clinic and what proportion of Hot Clinic patients meet the criteria for ambulatory care. Our second objective was to implement a specific criteria-based guideline and monitoring programme to improve the compliance with the ambulatory care criteria.
药物成份或治疗方案详述：	Methods Upon gaining approval from the Clinical Governance Development Unit, a prospective clinical audit was conducted in the General surgery department of a district general hospital located in the North West of England. As this was an audit, approval was not sought from the ethics committee. The audit included three cycles: baseline audit (30 days in September 2018), first re-audit (30 days in January 2019), and second re-audit (30 days in May 2019). During each cycle, all consecutive patients who attended General surgery Hot Clinic were included. The audit loop was completed after the first re-audit; the second re-audit was performed to assess whether the compliance is maintained. Outcome measures and standards Compliance with the Hot Clinic standards was considered as the outcome measure. The standards for the audit are shown in Table 2. We considered compliance of 100% as target for each standard. Data Collection For each patient, a data collection proforma was completed. The proforma included the following items: 1) Had the patient been seen by the on-call team before appointment?; 2) Did the patient meet the criteria for Hot Clinic review?; 3) What was the criterion for Hot Clinic Review?”. Data collection was performed by the on-call General Surgery junior clinician based at Surgical Triage Unit (STU) where the Hot Clinic was located. The clinical review documented in the medical notes by the General surgery team prior to Hot Clinic appointment was considered as the evidence to complete the proforma. Implementation of criteria-based guideline for Hot Clinic A specific criteria-based guideline for Hot Clinic was developed (Table 1). A briefing session was organised for all General surgery clinicians which involved clarification about the inclusion and exclusion criteria for Hot Clinic review and case-based discussion to practice the criteria. The on-line version of the guideline was provided to all clinicians and hard copies of the guideline were displayed as wall poster in STU and Hot Clinic. The clinicians were also informed about the monitoring programme via which lack of compliance with the guideline would be detected and the corresponding clinician would be notified. Sustaining the improved compliance with Hot Clinic Guideline A monitoring programme was designed in order to monitor and maintain the compliance with the Hot Clinic guideline. The on-call General Surgery junior clinician based at STU where the Hot Clinic was located was responsible to assess the clinical notes of the patients attending the Hot Clinic to ensure compliance with the guideline. In case that a deviation from the guideline was detected, the clinician who booked the patient for assessment in Hot Clinic was identified and notified to improve their practice. This monitoring programme was a continuous programme and was incorporated into normal commitments of on-call General Surgery junior clinician. Data analysis We hypothesized that the baseline compliance with the Hot Clinic criteria was 50% and the target compliance in this study was 100%; therefore, it was estimated that a minimum number of 15 patients per cycle would be required to achieve 80% power with 95% confidence level. Simple descriptive statistics was applied to present outcome data. Data were summarized with median and interquartile range (IQR) for continuous variables, and frequencies/percentages for categorical variables. Differences between the baseline audit and re-audits were tested for statistical significance using the Mann-Whitney U test for continuous variables and the χ2 test for categorical variables. All statistical tests were two-tailed and statistical significance was assumed at P < 0.05. The MedCalc 13.0 software was used for statistical analyses.
Description for medicine or protocol of treatment in detail：	Methods Upon gaining approval from the Clinical Governance Development Unit, a prospective clinical audit was conducted in the General surgery department of a district general hospital located in the North West of England. As this was an audit, approval was not sought from the ethics committee. The audit included three cycles: baseline audit (30 days in September 2018), first re-audit (30 days in January 2019), and second re-audit (30 days in May 2019). During each cycle, all consecutive patients who attended General surgery Hot Clinic were included. The audit loop was completed after the first re-audit; the second re-audit was performed to assess whether the compliance is maintained. Outcome measures and standards Compliance with the Hot Clinic standards was considered as the outcome measure. The standards for the audit are shown in Table 2. We considered compliance of 100% as target for each standard. Data Collection For each patient, a data collection proforma was completed. The proforma included the following items: 1) Had the patient been seen by the on-call team before appointment?; 2) Did the patient meet the criteria for Hot Clinic review?; 3) What was the criterion for Hot Clinic Review?”. Data collection was performed by the on-call General Surgery junior clinician based at Surgical Triage Unit (STU) where the Hot Clinic was located. The clinical review documented in the medical notes by the General surgery team prior to Hot Clinic appointment was considered as the evidence to complete the proforma. Implementation of criteria-based guideline for Hot Clinic A specific criteria-based guideline for Hot Clinic was developed (Table 1). A briefing session was organised for all General surgery clinicians which involved clarification about the inclusion and exclusion criteria for Hot Clinic review and case-based discussion to practice the criteria. The on-line version of the guideline was provided to all clinicians and hard copies of the guideline were displayed as wall poster in STU and Hot Clinic. The clinicians were also informed about the monitoring programme via which lack of compliance with the guideline would be detected and the corresponding clinician would be notified. Sustaining the improved compliance with Hot Clinic Guideline A monitoring programme was designed in order to monitor and maintain the compliance with the Hot Clinic guideline. The on-call General Surgery junior clinician based at STU where the Hot Clinic was located was responsible to assess the clinical notes of the patients attending the Hot Clinic to ensure compliance with the guideline. In case that a deviation from the guideline was detected, the clinician who booked the patient for assessment in Hot Clinic was identified and notified to improve their practice. This monitoring programme was a continuous programme and was incorporated into normal commitments of on-call General Surgery junior clinician. Data analysis We hypothesized that the baseline compliance with the Hot Clinic criteria was 50% and the target compliance in this study was 100%; therefore, it was estimated that a minimum number of 15 patients per cycle would be required to achieve 80% power with 95% confidence level. Simple descriptive statistics was applied to present outcome data. Data were summarized with median and interquartile range (IQR) for continuous variables, and frequencies/percentages for categorical variables. Differences between the baseline audit and re-audits were tested for statistical significance using the Mann-Whitney U test for continuous variables and the χ2 test for categorical variables. All statistical tests were two-tailed and statistical significance was assumed at P < 0.05. The MedCalc 13.0 software was used for statistical analyses.
纳入标准：	All consecutive patients who attended General surgery Hot Clinic were included. (As above)
Inclusion criteria	All consecutive patients who attended General surgery Hot Clinic were included. (As above)
排除标准：	None
Exclusion criteria：	None

研究实施时间：

Study execute time：

从 From 2019-09-01 00:00:00至 To 2019-05-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2019-09-01 00:00:00 至 To 2019-05-31 00:00:00

干预措施：

Interventions：

组别：	General Surgery Ambulatory Patients	样本量：	306
Group：	General Surgery Ambulatory Patients	Sample size：	306
干预措施：	A specific criteria-based ambulatory care guideline	干预措施代码：
Intervention：	A specific criteria-based ambulatory care guideline	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	英国	省(直辖市)：	曼彻斯特	市(区县)：
Country：	UK	Province：	Manchester	City：	Manchester
单位(医院)：	North Manchester General Hospital	单位级别：	District General hospital
Institution hospital：	North Manchester General Hospital	Level of the institution：	District General hospital

测量指标：

Outcomes：

指标中文名：	Compliance with the Hot Clinic standards	指标类型：	主要指标
Outcome：	Compliance with the Hot Clinic standards	Type：	Primary 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：	No	组织：
Sample Name：	Not applicable	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：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	90	岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

N/A

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

Not applicable The study is not randomised

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：	N/A
Blinding：	Not applicable

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）：	N/A
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Not applicable
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：	For each patient, a data collection proforma was completed. The proforma included the following items: 1) “Had the patient been seen by the on-call team before appointment?”; 2) “Did the patient meet the criteria for Hot Clinic review?”; 3) “What was the criterion for Hot Clinic Review?”. Data collection was performed by the on-call General Surgery junior clinician based at Surgical Triage Unit (STU) where the Hot Clinic was located. The clinical review documented in the medical notes by the General surgery team prior to Hot Clinic appointment was considered as the evidence to complete the proforma.
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	For each patient, a data collection proforma was completed. The proforma included the following items: 1) “Had the patient been seen by the on-call team before appointment?”; 2) “Did the patient meet the criteria for Hot Clinic review?”; 3) “What was the criterion for Hot Clinic Review?”. Data collection was performed by the on-call General Surgery junior clinician based at Surgical Triage Unit (STU) where the Hot Clinic was located. The clinical review documented in the medical notes by the General surgery team prior to Hot Clinic appointment was considered as the evidence to complete the proforma.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2020-01-26 10:29:42