An observational study in Hypertension and Cost Effectiveness, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-03.
Sponsored by The University of Hong Kong · Observational
Hypertension (HT) is an important risk factor for stroke, coronary heart disease (CHD), heart failure and renal diseases, and the leading risk factor of global disease burden. A multitude of interventions have proven efficacy in lowering blood pressure and reducing long term HT complications, including pharmacologic treatment, DASH diet (Dietary Approaches to Stop Hypertension), exercise, weight reduction, smoking cessation, alcohol moderation and self-monitoring of blood pressure.
Objectives:
To evaluate long-term effectiveness and cost-effectiveness of Risk-Assessment-and-Management-Programme-for-Hypertension (RAMP-HT), a multi-disciplinary structured service to enhance quality of hypertension care in primary care compared to usual care
Hypotheses:
Design and Subjects:
Retrospective study of 5-year longitudinal data on matched cohorts of public primary care patients with uncontrolled HT under RAMP-HT and usual care will be conducted to evaluate long-term effectiveness and direct medical costs. Results from the long-term effectiveness and costing analyses will be applied to Markov modeling to determine the life time cost-effectiveness of RAMP-HT.
Main outcome measures:
Data analysis:
Cox regression will be performed to estimate the effect of RAMP-HT on the development of HT complication adjusted for baseline covariates. Descriptive statistics will be used to calculate costs of RAMP-HT and annual direct medical costs for HT patients. Markov modeling will be used to simulate 2 patient cohorts (RAMP-HT versus usual care) to estimate the respective lifetime direct medical costs and QALY gained/person. Cost/QALY of RAMP-HT will be compared to that of usual care to determine the ICER.
Expected results:
The results can provide evidence on the effectiveness and cost-effectiveness of RAMP-HT for primary care patients with uncontrolled HT, which can inform health policy and service planning.
Aim and objectives:
The aim of this study is to evaluate the cost-effectiveness of the RAMP-HT of the HA in primary care patients with uncontrolled hypertension.
The objectives are to:
Hypotheses:
All patients who have enrolled into the RAMP-HT between 1 October 2011 and 31 March 2012, fulfilled the inclusion criteria and without any exclusion criterion will be included in the RAMP-HT cohort. The same number of matched patients receiving usual care in general outpatient clinics (GOPCs) who have never enrolled into RAMP-HT on or before 31 March 2017, fulfilled the inclusion criteria and without any exclusion criterion will be randomly selected from the HA clinical management system (CMS) to form the usual care cohort.
Exclusion criteria:
Patients exclusively managed by Specialist Out-Patient Clinic (SOPC) on or before baseline*
HT patients who have enrolled into the RAMP-HT between 1 October 2011 and 31 March 2012 and fulfilled the inclusion criteria and without any exclusion criteria
Other: RAMP-HT
HT patients receiving usual care in GOPCs who have never enrolled into RAMP-HT on or before 31 March 2017 and fulfilled the inclusion criteria and without any exclusion criteria
RAMP-HT was launched since October 2011 by the Hospital Authority with the support from the Food and Health Bureau. Standardized cardiovascular risk factor assessment, hypertensive complication screening and assessment on patient adherence to treatment are carried out on enrolled patients. Patients are stratified into low, medium or high risk groups according to the 10-year cardiovascular disease (CVD) risk calculated from their relevant risk factors by the Joint British Society 2005 Equation. A multidisciplinary team comprised of doctors, nurses, dieticians, physiotherapists and/or occupational therapists would then deliver individualized management targeted to the patient's risk factors according to standardized risk-stratified guidelines.
The 5-year incidence of CVD among RAMP-HT and usual care HT patients
CVD is defined as the presence of any of coronary heart disease (CHD), heart failure or stroke. CHD includes all ischaemic heart disease, myocardial infarction, coronary death or sudden death as indicated by the ICPC-2 K74 to K76 or ICD-9-CM 410.x, 411.x to 414.x, 798.x codes. Heart failure is defined as the ICPC-2 K77 or ICD-9-CM 428.x codes. Stroke (fatal and non-fatal stroke) is defined by the ICPC-2 K89 to K91 or ICD-9-CM 430.x to 438.x codes.
Time frame: 60-month
The direct medical costs of RAMP-HT and usual care HT patients with and without complications
Public medical costs will be estimated from products of the unit costs (published in the HKSAR Government Gazette and Hospital Authority (HA) ordinance (Chapter 113) of charges for non-entitled persons) and the utilization rates of 1) dispensed drugs, 2) laboratory tests and investigations, 3) healthcare services including general outpatient clinics (GOPC), specialist outpatient clinics (SOPC), allied health services (e.g. dietician, physiotherapist or occupational therapist), accident and emergency (A\&E) department and 4) admissions to hospital in the 12 months before baseline and at 12, 24, 36, 48 and 60 months after study enrolment for each patient in the study cohorts. Private direct medical costs include the cost of all private Western doctor and Chinese medicine practitioner consultations, private hospitalisation and self-medications inclusive of self-financed medications prescribed by the HA.
Time frame: 12-month before baseline, baseline, 12, 24, 36, 48 and 60-month
The ICER of cost per QALY gained by RAMP-HT compared to usual care group
The ICER was the ratio of the incremental costs of RAMP-HT group over the incremental effectiveness compared to those of the usual care group. In this study, the ICER referred to 1) program cost per HT-related complication reduced by RAMP-HT, and 2) program cost per event-free year in the RAMP-HT group, compared to the usual care group.
Time frame: 60-month
The 5-year incidence of end stage renal disease (ESRD) and all-cause mortality among RAMP-HT and usual care HT patients
ESRD is defined by any of ICD-9-CM 250.3x, 585.x, 586.x, or an estimated Glomerular Filtration Rate (eGFR) \< 15mL/min/1.73m2, according to the definition of the National Kidney Foundation. Mortality is defined by a documented death in the Hong Kong Death Registry.
Time frame: 60-month
The hazard ratio of CVD, ESRD and all-cause mortalities between RAMP-HT and usual care group
Multivariable Cox proportional hazards regression will be performed to estimate the adjusted effect of RAMP-HT on the dependent variable of each first HT complication event, adjusting for all baseline covariates of patients.
Time frame: 60-month
The Number-Need-to-Treat (NNT) to reduce one CVD, ESRD and mortality in 5 years by RAMP-HT
NNT is the average number of patients who need to be treated to prevent one additional outcome event. It is defined as the inverse of the absolute risk reduction.
Time frame: 60-month
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The University of Hong Kong