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临床试验/NCT02034695
NCT02034695已完成不适用

Evaluation of Quality of Care - Risk Assessment Management Programme, HA

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 2,496 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,496
试验地点
1
主要终点
The proportion of clinics that have satisfied each of the structure criteria

研究概览

简要总结

Diabetes mellitus (DM) is one of the major cause 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 risk assessment and management programme (RAMP) to improve the quality of care (QOC) for DM patients in general outpatient clinics (GOPC). The evaluation on the QOC is an essential part of the programme in order to inform future policy. The Department of Family Medicine and Primary Care (FMPC) 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 RAMP programme is achieved. Each RAMP participating clinic and hospital will be invited to complete a structured evaluation questionnaire. The data of all patients who have enrolled into the RAMP for more than one year will be included in the evaluation on the process and outcomes of care.

One thousand two hundred and forty-eight age and disease matched control patients who have not been enrolled into the RAMP programme will be selected for the comparison in the 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 criterion process of care, and achieved the target HbA1c and blood pressure levels.

Data Analysis: Descriptive statistics on proportions of centers or subjects meeting the QOC criteria will be calculated. The changes in the clinical and patient reported outcomes of RAMP subjects will be compared at 12, 24, 36 and 48 months will be compared by paired sample t-test. The clinical outcomes between RAMP subjects and control group will be compared by independent sample t-test or Chi-square test.

Results: The QOC of the RAMP 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 RAMP programme can achieve improvement in QOC for DM patients. The information will be used to guide service planning and policy decision making.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with DM who are mostly independent in their activities of daily living and being followed up at GOPC regularly will be recruited.

排除标准

  • Patients will be excluded if they are unable to understand or communicate in Chinese language, or refuse to give consent.

结局指标

主要结局

The proportion of clinics that have satisfied each of the structure criteria

时间窗: 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.

The proportion of patients who have complied with the criterion process of care.

时间窗: 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.

The proportion of patients who have achieved a HbA1c level <7%.

时间窗: 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.

次要结局

  • Clinical outcomes including, LDL, BP, body mass index (BMI), and cardiovascular complications.(Five years)
  • Patient reported outcomes (PRO) measured by the change in SF-12v2 scores, the PEI and GRS scores at 6 months.(Five years)
  • Service utilization outcomes measured by GOPC consultation, SOPC consultation, A&E and hospital attendance rates in the past 12 months.(Five years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Cindy L.K. Lam

Clinical Professor

The University of Hong Kong

研究点 (1)

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