Evaluation of Quality of Care - Multi-disciplinary Risk Assessment and Management Programme for Patients With Hypertension, HA (QoC RAMP-HT)

Hypertension Clinical Trial

Official title:

Evaluation of Quality of Care - Multi-disciplinary Risk Assessment and Management Programme for Patients With Hypertension, HA (QoC RAMP-HT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219958
• Other study ID #: HKCTR-1685
• Status: Completed
• Phase: N/A
• First received: August 14, 2014
• Last updated: September 5, 2017
• Start date: September 2012
• Est. completion date: April 2017

Study information

• Verified date: September 2017
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2496
• Est. completion date: April 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong Island

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Hospital Authority, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

Yu EY, Wan EY, Chan KH, Wong CK, Kwok RL, Fong DY, Lam CL. Evaluation of the quality of care of a multi-disciplinary Risk Factor Assessment and Management Programme for Hypertension (RAMP-HT). BMC Fam Pract. 2015 Jun 19;16:71. doi: 10.1186/s12875-015-0291 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of clinics that have satisfied each of the structure criteria	Final analysis will evaluate the period from August, 2012 to December, 2014.	Three years
Primary	The proportion of patients who have complied with the criterion process of care.	Final analysis will evaluate the period from August, 2012 to December, 2014.	Three years
Primary	The proportion of patients who have achieved a BP level <140/90mmHg.	Final analysis will evaluate the period from August, 2012 to December, 2014.	Three years
Secondary	LDL	Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.	Three years
Secondary	BMI (Body Mass Index)	Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.	Three years
Secondary	Occurrence of First Cardiovascular Complication	Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.	Three years
Secondary	The change in SF-12v2 scores	Baseline and 6-month/12-month/24-month/36-month after the first administration of questionnaire.	Three years
Secondary	PEI (Patient Enablement Index)	6-month/12-month/24-month/36-month after the first administration of questionnaire.	Three years
Secondary	GRS (Global Rating of Change Scale) scores	6-month/12-month/24-month/36-month after the first administration of questionnaire.	Three years