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NCT Number: NCT02034695

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

  1. Clinical outcomes including, LDL, BP, body mass index (BMI), and cardiovascular complications.

    Time frame: Five years

    Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 5 years.

  2. Patient reported outcomes (PRO) measured by the change in SF-12v2 scores, the PEI and GRS scores at 6 months.

    Time frame: Five years

    Baseline and 6-month/12-month/24-month/36-month after the first administration of questionnaire.

  3. Service utilization outcomes measured by GOPC consultation, SOPC consultation, A&E and hospital attendance rates in the past 12 months.

    Time frame: Five years

    Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 5 years.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Hospital Authority, Hong Kong

Registry information

Acronym: QoC RAMP

Important dates

Study start
2010
Primary completion
2016
Study completion
2017
First posted
Jan 13, 2014
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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