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Evaluation of Quality of Care - Patient Empowerment Programme, HA (QoC PEP)

2017年9月5日 更新者:Professor Cindy L.K. Lam、The University of Hong Kong

Diabetes mellitus (DM) and hypertension (HT) are major causes of morbidity and among the top 10 causes of deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority (HA) has initiated service improvement through introducing the patient empowerment programme (PEP) to improve the quality of care (QOC) for DM and HT patients. The evaluation on the QOC is an essential part of the programme in order to inform future policy. The Family Medicine Unit (FMU) of the University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the QOC of the programme.

The Action Learning and Audit Spiral methodologies to measure whether the target standard of care intended by the PEP programme is achieved. Each PEP participating clinic and non-government organization (NGO) will be invited to complete a structured evaluation questionnaire. The data of all patients who have enrolled into the PEP for more than one year will be included in the evaluation on the process and outcomes of care. A hundred and thirty participants will be followed up by telephone to evaluate the effect of the programme in quality of life (QOL), patient enablement, and global rating of change in health condition at baseline and 6 months after enrolment. Data on the process of care will be retrieved from the HA medical records. Main Outcome Measures: The primary outcomes are the proportion of participants who have received the planned process of care and achieved the target HbA1c and blood pressure levels.

Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be calculated. The changes in clinical, service, and patient reported outcomes at 6 and 12 months will assessed by paired sample t-test. The audit cycle will be repeated annually over a period of 5 years.

Results: The QOC of the PEP programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified. Conclusion: The results of this study will provide empirical evidence on whether the HA's PEP programme can enhance QOC for patients with diabetes mellitus (DM) or hypertension (HT). The information will be used to guide service planning and policy decision making.

研究概览

地位

完全的

研究类型

观察性的

注册 (实际的)

2496

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Hong Kong Island、香港
        • The University of Hong Kong

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

All patients who have been enrolled into the PEP programme will be included in the evaluation on process of care; whereas all enrolled subjects who have been recruited for more than 12 months in the programme will be included in the evaluation on the clinical outcomes of care. An equal number of a random sample of eligible subjects who refused to take part in the PEP will be used as controls for the evaluation on the clinical outcomes of care.

描述

Inclusion Criteria:

  • Eligible patients who are ambulatory, have stable mental and emotional conditions, and follow up at general outpatients clinics (GOPC) and family medicine specialist clinics (FMSC) regularly will be recruited for the PEP programme.

Exclusion Criteria:

  • Patients will be excluded if they have severe heart failure, end stage renal failure (ESRF) or advanced eye diseases, are unable to understand or communicate in Chinese language, or refuse to give consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
Diabetes mellitus (DM) and hypertension (HT)
Diabetes mellitus (DM) and/or hypertension (HT) patients in Hong Kong

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The proportion of clinics/NGO that have satisfied each of the set structure criteria.
大体时间:Five years
Interim analysis will evaluate the period from August, 2009 to December, 2010; to December, 2011; to December, 2012; to December, 2013. Final analysis will evaluate the period from August, 2009 to December, 2014.
Five years
符合标准护理程序的患者比例。
大体时间:5年
中期分析将评估2009年8月至2011年6月期间;至 2011 年 12 月;至 2012 年 12 月;至 2013 年 12 月。 最终分析将评估2009年8月至2014年12月期间。
5年
The proportion of DM patients who have achieved a HbA1c level <7%.
大体时间:Five years
Interim analysis will evaluate the period from August, 2009 to June, 2011; to December, 2011; to December, 2012; to December, 2013. Final analysis will evaluate the period from August, 2009 to December, 2014.
Five years
The proportion of HT/ DM patients who have achieved the target blood pressure.
大体时间:Five years
Interim analysis will evaluate the period from August, 2009 to June, 2011; to December, 2011; to December, 2012; to December, 2013. Final analysis will evaluate the period from August, 2009 to December, 2014.
Five years

次要结果测量

结果测量
措施说明
大体时间
Clinical outcomes including LDL, BMI, and cardiovascular complications.
大体时间:Five years
Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 5 years.
Five years
Patient reported outcomes (PRO) measured by the change in SF-12v2 scores, the Patient Enablement Index (PEI) and Global Rating of Change Score (GRS) at 6 months, and change in patient's knowledge on disease at 12 months.
大体时间:Five years
Baseline and 6-month/12-month/24-month/36-month after the first administration of questionnaire.
Five years
GOPC consultation, SOPC, A&E and hospital attendance rates in the past 12 months.
大体时间:Five years
Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 5 years.
Five years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Cindy L.K. Lam, MD、Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
  • 首席研究员:William C.W. Wong, MD、Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年9月1日

初级完成 (实际的)

2016年9月1日

研究完成 (实际的)

2017年4月1日

研究注册日期

首次提交

2013年8月28日

首先提交符合 QC 标准的

2013年8月30日

首次发布 (估计)

2013年9月5日

研究记录更新

最后更新发布 (实际的)

2017年9月6日

上次提交的符合 QC 标准的更新

2017年9月5日

最后验证

2017年9月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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