- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02219958
Evaluation of Quality of Care - Multi-disciplinary Risk Assessment and Management Programme for Patients With Hypertension, HA (QoC RAMP-HT)
Hypertension (HT) 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 HT 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 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 HT patients. The information will be used to guide service planning and policy decision making.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Hong Kong Island, Hong Kong
- The University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- HT
- aged <80
- Suboptimal BP control (average systolic blood pressure (SBP) ≥ 140mmHg or average diastolic blood pressure (DBP) ≥ 90mmHg)
Exclusion Criteria:
- Patients will be excluded if they are unable to understand or communicate in Chinese language, or refuse to give consent.
- Patients will be excluded if they had prior history of diabetes and existing cardiovascular diseases
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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RAMP-HT and Non-RAMP-HT
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of clinics that have satisfied each of the structure criteria
Time Frame: Three years
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Final analysis will evaluate the period from August, 2012 to December, 2014.
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Three years
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The proportion of patients who have complied with the criterion process of care.
Time Frame: Three years
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Final analysis will evaluate the period from August, 2012 to December, 2014.
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Three years
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The proportion of patients who have achieved a BP level <140/90mmHg.
Time Frame: Three years
|
Final analysis will evaluate the period from August, 2012 to December, 2014.
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Three years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LDL
Time Frame: Three years
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Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.
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Three years
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BMI (Body Mass Index)
Time Frame: Three years
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Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.
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Three years
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Occurrence of First Cardiovascular Complication
Time Frame: Three years
|
Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.
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Three years
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The change in SF-12v2 scores
Time Frame: Three years
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Baseline and 6-month/12-month/24-month/36-month after the first administration of questionnaire.
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Three years
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PEI (Patient Enablement Index)
Time Frame: Three years
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6-month/12-month/24-month/36-month after the first administration of questionnaire.
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Three years
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GRS (Global Rating of Change Scale) scores
Time Frame: Three years
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6-month/12-month/24-month/36-month after the first administration of questionnaire.
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Three years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Cindy L.K. Lam, MD, Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
- Principal Investigator: Esther Y.T. Yu, MBBS, Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HKCTR-1685
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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