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Evaluation of Quality of Care - Shared-Care Programme, HA (QoC SCP)

2017年11月2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 shared-care (SC) programme 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 SC programme is achieved. Each SC participating clinic and private medical practitioner (PMP) will be invited to complete a structured evaluation questionnaire. The data of all patients who have enrolled into the programme 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 received the criterion process of care and achieved a HbA1c level <7.5%.

Data Analysis: Descriptive statistics on proportions of clinics or subjects meeting the quality of care criteria will be calculated. The outcomes of SC patients will be compared at 6, 12, 24, 36 and 48 months by paired sample t-test. The outcomes between SC patients and control group will be compared by independent sample t-test or Chi-square test.

Hypothesis: The QOC of the SC programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified. The results of this study will provide empirical evidence on whether the HA's SC programme can achieve equivalent QOC as the usual HA care for diabetes mellitus (DM) patients. The information will be used to guide service planning and policy decision making.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

620

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

  • 香港
    • Hksar
      • Hong Kong、Hksar、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

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients with diabetes mellitus who have received care at the specialist outpatient clinic (SOPC) for at least 2 years, stratified to be of low risk and have normal renal function as defined by the plasma creatinine level would be offered the option of being followed up by a private medical practitioner (PMP) in primary care with a financial subsidy and continuing support from the original SOPC. Each patient in the SC programme will receive an annual assessment and complication screening at the SOPC. The programme encourages long-term patient-doctor relationships in order to develop continuous and holistic care for CD patients. Patients will be excluded if they are stratified to be at high cardiovascular risk or are suffering end stage renal failure, on dialysis or after transplantation, or on insulin, or do not give consent to be transferred.

描述

Inclusion Criteria:

  • Patients with diabetes mellitus who have received care at the specialist outpatient clinic (SOPC)for at least 2 years, stratified to be of low risk and have normal renal function as defined by the plasma creatinine level.

Exclusion Criteria:

  • Patients will be excluded if they are stratified to be at high cardiovascular risk or are suffering end stage renal failure, on dialysis or after transplantation, or on insulin, or do not give consent to be transferred.

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

队列和干预

团体/队列
DM subjects in Hong Kong

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Change of the proportion of clinics that have satisfied each of the structure criteria.
大体时间：December, 2010; December, 2011; December, 2012; December, 2013; December, 2014
December, 2010; December, 2011; December, 2012; December, 2013; December, 2014
Change of the proportion of patients who have received with the SC criterion process of care.
大体时间：June, 2011; December, 2011; December, 2012; December, 2013; December, 2014
June, 2011; December, 2011; December, 2012; December, 2013; December, 2014
Change of the proportion of patients who have achieved a HbA1c <7.5%.
大体时间：June, 2011; December, 2011; December, 2012; December, 2013; December, 2014
June, 2011; December, 2011; December, 2012; December, 2013; December, 2014

次要结果测量

结果测量
大体时间
Low-density lipoprotein (LDL)
大体时间：Baseline, 6, 12, 24, 36 and 48 months after enrollment.
Baseline, 6, 12, 24, 36 and 48 months after enrollment.
Blood pressure (BP)
大体时间：Baseline, 6, 12, 24, 36 and 48 months after enrollment.
Baseline, 6, 12, 24, 36 and 48 months after enrollment.
Body mass index (BMI)
大体时间：Baseline, 6, 12, 24, 36 and 48 months after enrollment.
Baseline, 6, 12, 24, 36 and 48 months after enrollment.
Cardiovascular complications
大体时间：Baseline, 6, 12, 24, 36 and 48 months after enrollment.
Baseline, 6, 12, 24, 36 and 48 months after enrollment.
Patient reported outcomes (PRO) measured by the change in Short Form-12 version 2 (SF-12v2) scores at 6 months.
大体时间：Baseline and 6 months after the first administration of questionnaire.
Baseline and 6 months after the first administration of questionnaire.
Patient reported outcomes (PRO) measured by the change in the Patient Enablement Instrument (PEI) scores at 6 months.
大体时间：Baseline and 6 months after the first administration of questionnaire.
Baseline and 6 months after the first administration of questionnaire.
Patient reported outcomes (PRO) measured by the change in the Global Rating Scale (GRS) at 6 months.
大体时间：Baseline and 6 months after the first administration of questionnaire.
Baseline and 6 months after the first administration of questionnaire.
Service utilization outcomes measured by General Outpatient Clinics (GOPC) attendance rates at baseline and 12, 24, 36 and 48 months after enrollment.
大体时间：Baseline, 12, 24, 36 and 48 months after enrollment
Baseline, 12, 24, 36 and 48 months after enrollment
Service utilization outcomes measured by specialist outpatient clinic (SOPC) attendance rates at baseline and 12, 24, 36 and 48 months after enrollment.
大体时间：Baseline, 12, 24, 36 and 48 months after enrollment
Baseline, 12, 24, 36 and 48 months after enrollment
Service utilization outcomes measured by accident & emergency (A&E) attendance rates at baseline and 12, 24, 36 and 48 months after enrollment.
大体时间：Baseline, 12, 24, 36 and 48 months after enrollment
Baseline, 12, 24, 36 and 48 months after enrollment
Service utilization outcomes measured by hospital attendance rates at baseline and 12, 24, 36 and 48 months after enrollment.
大体时间：Baseline, 12, 24, 36 and 48 months after enrollment
Baseline, 12, 24, 36 and 48 months after enrollment

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。

赞助

The University of Hong Kong

合作者

Hospital Authority, Hong Kong

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)

2015年9月1日

研究完成 (实际的)

2015年9月1日

研究注册日期

首次提交

2017年10月24日

首先提交符合 QC 标准的

2017年11月2日

首次发布 (实际的)

2017年11月7日

研究记录更新

最后更新发布 (实际的)

2017年11月7日

上次提交的符合 QC 标准的更新

2017年11月2日

最后验证

2017年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HKCTR-1185

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