Hypertension Clinical Trial
Official title:
In-depth Study of the Cost-effectiveness of the Risk Assessment and Management Programme for Hypertension (RAMP-HT) for Patients With Uncontrolled Hypertension in Primary Care in Hong Kong
NCT number | NCT03301194 |
Other study ID # | HKUCTR-2233 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2016 |
Est. completion date | January 31, 2019 |
Verified date | May 2019 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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:
1. RAMP-HT is effective in reducing HT complications, based on previous results showing
RAMP-HT was effective in improving patients' blood pressure
2. RAMP-HT is cost-effective
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:
1. 5-year incidence of cardiovascular complications
2. Direct medical costs of RAMP-HT and usual care HT patients
3. Incremental cost-effectiveness ratio (ICER) of cost per quality-adjusted life year
(QALY) gained by RAMP-HT compared to usual care
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.
Status | Completed |
Enrollment | 158322 |
Est. completion date | January 31, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility |
Inclusion criteria: 1. Age = 18 years old and < 80 years old 2. Coded with ICPC-2 of K86 on or before baseline* 3. Had uncontrolled blood pressure (i.e. average Systolic Blood Pressure (SBP) = 140mmHg OR Diastolic Blood Pressure (DBP) = 90mmHg between 6 months before and 3 months after baseline*) Exclusion criteria: 1. Patients who had a diagnosis of any HT complications defined by relevant ICPC-2 and/or ICD-9-CM diagnosis codes on or before baseline* 2. Patients diagnosed to have Diabetes Mellitus (DM) on or before 31 March 2017, defined by ICPC-2 codes of T89 or T90 3. Patients exclusively managed by Specialist Out-Patient Clinic (SOPC) on or before baseline* - Baseline: date of RAMP-HT enrolment for RAMP-HT cohort, and 31 March 2012 for usual care cohort |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 60-month | |
Primary | 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. |
12-month before baseline, baseline, 12, 24, 36, 48 and 60-month | |
Primary | 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. | 60-month | |
Secondary | 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. | 60-month | |
Secondary | 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. | 60-month | |
Secondary | 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. | 60-month |
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