Learning Implementation of Guideline-based Decision Support System for Hypertension Treatment (LIGHT)

Not Applicable

• Conditions: Hypertension
• Interventions: Behavioral: Computer-based decision support system

• Registration Number: NCT03636334
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-17
• Study Start: 2019-08-21
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-15
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer-based decision support system	Computer-based decision support system	Computer-based decision support system for BP management, with appropriate training of local PHC doctors.

Primary Outcome Measures

Name	Time	Method
The proportion of visits with ideal appropriate treatment provided among all the eligible hypertension visits within the period of observational follow-up	Baseline; 1 year	ideal appropriate treatment means guideline-accordant treatment

Secondary Outcome Measures

Name	Time	Method
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.	Baseline; 1 year	the average change in SBP from first visit after randomization to the last visit among enrolled patients.
The proportion of visits with acceptable appropriate treatment among all the eligible hypertension visits.	Baseline; 1 year	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.
The percentage of participants with BP<140/90 mmHg at the last visit among the eligible participants during the period of 9-month observation.	Baseline; 1 year	The individuals' last blood pressure measurement during the 9-month observation phase will be used for assessment

Trial Locations

Locations (3)

Yankuang Hospital; 🇨🇳 Zoucheng, Shandong, China

Center for chronic disease control; 🇨🇳 Shenzhen, Shenzhen, China

Luoyang Oriental hospital; 🇨🇳 Beijing, Henan, China