Clinical trial NCT02219958: Evaluation of Quality of Care - Multi-disciplinary Risk Assessment and Management Programme for Patients With Hypertension, HA (QoC RAMP-HT)
Official title: Evaluation of Quality of Care - Multi-disciplinary Risk Assessment and Management Programme for Patients With Hypertension, HA (QoC RAMP-HT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hospital Authority, Hong Kong
First posted: 2014-08-19
Enrollment: 2496
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All HT patients aged \<80, without prior history of diabetes and existing cardiovascular diseases, with suboptimal BP control (average systolic blood pressure (SBP) ≥ 140mmHg or average diastolic blood pressure (DBP) ≥ 90mmHg) who were enrolled into RAMP-HT.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The proportion of clinics that have satisfied each of the structure criteria
timeFrame: Three years
measure: The proportion of patients who have complied with the criterion process of care.
timeFrame: Three years
measure: The proportion of patients who have achieved a BP level <140/90mmHg.
timeFrame: Three years
Secondary outcomes:
measure: LDL
timeFrame: Three years
measure: BMI (Body Mass Index)
timeFrame: Three years
measure: Occurrence of First Cardiovascular Complication
timeFrame: Three years
measure: The change in SF-12v2 scores
timeFrame: Three years
measure: PEI (Patient Enablement Index)
timeFrame: Three years
measure: GRS (Global Rating of Change Scale) scores
timeFrame: Three years
Other outcomes:
Locations:
city: Hong Kong Island
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
name: Cindy L.K. Lam, MD
role: STUDY_CHAIR
affiliation: Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
name: Esther Y.T. Yu, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/s12875-015-0291-0.