Cost-effectiveness of RAMP-HT for Patients With Uncontrolled Hypertension in Hong Kong

NCT03301194 | Completed

• 1 other identifier: HKUCTR-2233
• Study Type: observational
• Target: 158,322
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.RAMP-HT is effective in reducing HT complications, based on previous results showing RAMP-HT was effective in improving patients' blood pressure
2. 2.RAMP-HT is cost-effective
3. 3.5-year incidence of cardiovascular complications
4. 4.Direct medical costs of RAMP-HT and usual care HT patients
5. 5.Incremental cost-effectiveness ratio (ICER) of cost per quality-adjusted life year (QALY) gained by RAMP-HT compared to usual care

Conditions

Hypertension; Cost Effectiveness

Keywords

Hypertension; Effectiveness; Cost Effectiveness; Cost; Multi-disciplinary; Risk Stratification

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• The 5-year incidence of end stage renal disease (ESRD) and all-cause mortality among RAMP-HT and usual care HT patients

  60-month

• The hazard ratio of CVD, ESRD and all-cause mortalities between RAMP-HT and usual care group

  60-month

• The Number-Need-to-Treat (NNT) to reduce one CVD, ESRD and mortality in 5 years by RAMP-HT

  60-month

Study Arms (2)

RAMP-HT patients

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

Usual care patients

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

Interventions

RAMP-HT OTHER

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.

RAMP-HT patients

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Age ≥ 18 years old and \< 80 years old
• Coded with ICPC-2 of K86 on or before baseline\*
• 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\*)

You may not qualify if:

• 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\*
• Patients diagnosed to have Diabetes Mellitus (DM) on or before 31 March 2017, defined by ICPC-2 codes of T89 or T90
• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Esther Yee Tak Yu

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 4, 2017
• Study Start: August 1, 2016
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: May 3, 2019

Record last verified: 2019-05

Locations

HK (1)