The general aim of this project is to evaluate the effectiveness, safety and costs of a medication withdrawal policy compared to usual care in general practice in patients who are currently treated for hypertension and/or hypercholesterolemia, but…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Central nervous system vascular disorders
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the change in 10-year CVD risk according to the
risk table from the guideline CVRM 2011.
Secondary outcome
Secondary outcome measures are quality of life (EQ-5D + VAS), (CVD related)
mortality, cardiovascular events and side effects related to withdrawal of
medication or use of medication. Other outcome measures are related to
modifiable risk factors, such as smoking behaviour (smoking behaviour
questionnaire), physical activity (SQUASH), alcohol consumption, eating habits
(Standard nutrition questionnaire of Dutch common health services), systolic
blood pressure (SBP), ratio of total cholesterol/HDL-cholesterol (TC/HDL ratio)
in blood, Body Mass Index (body weight and height), and waist circumference.
Background summary
In the Netherlands, cardiovascular disease (CVD) is the leading cause of
mortality in women, the second leading cause in man, and is associated with
loss of quality of life and high costs for the society
(www.nationaalkompas.nl). Primary health care plays an important role in the
primary prevention of CVD.
In 2006, the former guidelines Hypertension and Cholesterol of the Dutch
College for General Practitioners (Nederlands Huisarts Genootschap (NHG)) were
replaced by a combined guideline Cardiovascular Risk Management (CVRM), which
is recently revised (2011). At the time, the transition of management of
patients treated for hypertension and/or hypercholesterolemia according to the
former guidelines Hypertension and Cholesterol into the guideline
Cardiovascular Risk Management, was not part of this new guideline. The former
guidelines recommended lower thresholds for the start of preventive medication
in patients. Therefore, there are probably many patients unnecessarily treated
with antihypertensive medication and/or lipid-lowering drugs according to the
guideline CVRM 2011. This study will evaluate a medication withdrawal policy in
these patients and will be carried out in collaboration with the Dutch College
of General Practitioners (NHG). The NHG facilitates implementation of the study
findings into routine clinical practice.
Study objective
The general aim of this project is to evaluate the effectiveness, safety and
costs of a medication withdrawal policy compared to usual care in general
practice in patients who are currently treated for hypertension and/or
hypercholesterolemia, but do not need pharmacological therapy according to the
guideline CVRM 2011
Study design
This study employs a cluster randomised controlled non-inferiority trial in
general practice, using a complete-double-consent design. The primary endpoint
for effectiveness has been chosen at 12 months and for safety and costs at 24
months.
Intervention
The general practitioners (GPs) of the practices in the intervention group will
actively withdraw medication in patients who do not need pharmacological
treatment according to the guideline CVRM 2011.
GPs will receive a half-day training program, consisting of a general
introduction about the guideline CVRM 2011, with special attention to primary
prevention of CVD, and withdrawal of medication in patients without an
indication for medication according to this guideline.
Study burden and risks
Patients will be re-evaluated by a blinded research nurse after randomisation
has taken place. Baseline measurements are performed simultaneously. After
re-evaluation and baseline measurements patients are asked to fill in a
45-minute questionnaire package. The same package is completed at 3 and 12
months. In addition, after 6 and 24 months they are asked to complete a
cost-questionnaire and EQ-5D + VAS.
After re-evaluation and baseline measurements, the research nurse will examine
the patients at 3, and 12 months, which will take about 30 minutes. Every
examination a venous blood sample will be taken.
In general practices allocated to the usual care group, patients will be given
the usual care.
The GPs in the intervention group will actively withdraw medication in the
participating patients. Based on a previous report of a relapse of high blood
pressure in the case of withdrawal(2;7-10), an individual follow-up will take
place of 1-3 visits, which involves registration of side effects of withdrawal
and measuring blood pressure, and serum lipid levels.
Laan van Nieuw Oost-Indië 334
Den Haag 2593CE
NL
Laan van Nieuw Oost-Indië 334
Den Haag 2593CE
NL
Listed location countries
Age
Inclusion criteria
• Age 40 to 70 years;
• Prescription of antihypertensive medication and/or lipid-lowering drugs for hypertension and/or hypercholesterolemia during the last 12 months (using ATC codes: C02, C03, C07, C08, C09, C10).
Exclusion criteria
• Cardiovascular disease (ICPC codes: K74, K75, K76, K89, K90.03, K91, K92.01 and K99.01);
• Use of platelet aggregation inhibitors (heparin excluded) (ATC code: B01AC);
• Use of antihypertensive medication for another reason than prevention of CVD;
• Familial hypercholesterolemia/lipidemia (ICPC code: T93.04);
• Patients with a current SBP >180 mmHg, or a SBP >180 mmHg before the start of medication;
• Patients with a current TC/HDL ratio >8, or a TC/HDL ratio >8 before the start of medication;
• Patients with a 10-year CVD risk >16%
• 10-year CVD risk of 10-16%, based on the 2011 risk table, in combination with at least one additional major risk-increasing factor;
• 10-year CVD risk of 10-16%, based on the 2011 risk table, in combination with two or more additional minor risk-increasing factors;
• 10-year CVD risk of 10-16%, based on the 2011 risk table, in combination with one additional minor risk-increasing factor and an SBP >140 mmHg and/or LDL >2.5 mmol/L.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40551.058.12 |