This trial aims to evaluate the effectiveness of a guideline-based decision support system for hypertension management by physicians at primary health care (PHC) centers in China in order to improve the delivery of appropriate treatment and blood pressure (BP) control for hypertensive individuals.
The LIGHT trial aims to assess the effectiveness of decision support system (DSS) for hypertension treatment in cluster clinics. At each stage, the main randomization will occur at the PHC center level. During the first 3 months (baseline period), the physicians at all sites will use an electronic data collection system to collect information about the individuals who attend the clinic. After site randomization, physicians at control sites will continue to deliver usual care, and physicians at intervention sites will receive training and support on the use of the DSS. And the DSS will recommend antihypertensive medications according to the assigned protocol. All individuals will be asked to attend the clinic at least once every 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
10,000
At intervention sites, physicians will receive training and support on use of the DSS, which will be installed on their local IT system. Individuals eligible for DSS at Intervention sites will be randomized or assigned to different drug sequence protocols for BP-lowering therapy using their current antihypertensive medications, co-morbidities, and intolerance to medications and according to the assignment plan in the Algorithm. If the protocol is not suitable for the patient because of new co-morbidities, medication intolerance or contraindication, the DSS will recommend switching to a new protocol.
Luoyang Oriental hospital
Beijing, Henan, China
COMPLETEDYankuang Hospital
Zoucheng, Shandong, China
ACTIVE_NOT_RECRUITINGCenter for chronic disease control
Shenzhen, Shenzhen, China
RECRUITINGThe proportion of visits with ideal appropriate treatment provided among all the eligible hypertension visits within the period of observational follow-up
ideal appropriate treatment means guideline-accordant treatment
Time frame: Baseline; 1 year
The average change in SBP from first visit after randomization to the last visit among the eligible participants during the period of 9-month observation.
the average change in SBP from first visit after randomization to the last visit among enrolled patients.
Time frame: Baseline; 1 year
The percentage of participants with BP<140/90 mmHg at the last visit among the eligible participants during the period of 9-month observation.
The individuals' last blood pressure measurement during the 9-month observation phase will be used for assessment
Time frame: Baseline; 1 year
The proportion of visits with acceptable appropriate treatment among all the eligible hypertension visits.
Acceptable appropriate treatments is defined as the recommendations offered by the doctors who are not following DSS on reasonable conditions, such as patient-reported normal home-measured blood pressure, hypotension or syncope before the visit.
Time frame: Baseline; 1 year
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