Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computer-based decision support system | Experimental | Computer-based decision support system for BP management, with appropriate training of local PHC doctors. |
|
| Control | No Intervention | After site randomization, physicians at the control sites will manage their patients with hypertension by usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer-based decision support system | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The 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 | Baseline; 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of individuals with a vascular event (defined as cardiac death, non-fatal stroke and non-fatal MI) at 1 year. | Measure the proportion of individuals who complicate with a vascular event. | Baseline; 1 year |
Inclusion Criteria for Sites:
At least one drug available from each of the four classes of recommended antihypertensive drugs are provided at clinic:
Has an outpatient clinic for hypertension treatment and staff willing to take part in the study
Electronic data collection system is routinely used at clinic for hypertension management
At least 100 individuals with hypertension can attend the clinic every 3 months.
Inclusion Criteria for Visits:
Inclusion Criteria for Participants:
Exclusion Criteria for participants:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Zheng, MD, PhD | Contact | +86 60866813 | xin.zheng@fwoxford.org | |
| Harlan M Krumholz, MD, SM | Contact | +86 60866813 | harlan.krumholz@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Xin Zheng, MD, PhD | National Center for Cardiovascular Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luoyang Oriental hospital | Completed | Beijing | Henan | China | ||
| Yankuang Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42201734 | Derived | Song J, Liu Y, Shang Q, Liu J, Zhang H, Zhou Z, Wang W, Lu J, Zheng X. Clinical Decision Support System, Antihypertensive Treatment Intensification, and Blood Pressure Control: A Post Hoc Secondary Analysis of a Cluster Randomized Trial. JAMA Netw Open. 2026 May 1;9(5):e2614858. doi: 10.1001/jamanetworkopen.2026.14858. | |
| 39043397 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
The individuals' last blood pressure measurement during the 9-month observation phase will be used for assessment |
| 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. | Baseline; 1 year |
| Active, not recruiting |
| Zoucheng |
| Shandong |
| China |
| Center for chronic disease control | Recruiting | Shenzhen | Shenzhen | China |
|
| Song J, Wang X, Wang B, Ge Y, Bi L, Jing F, Jin H, Li T, Gu B, Wang L, Hao J, Zhao Y, Liu J, Zhang H, Li X, Li J, Ma W, Wang J, Normand ST, Herrin J, Armitage J, Krumholz HM, Zheng X; LIGHT Collaborative Group. Learning implementation of a guideline based decision support system to improve hypertension treatment in primary care in China: pragmatic cluster randomised controlled trial. BMJ. 2024 Jul 23;386:e079143. doi: 10.1136/bmj-2023-079143. |
| 38555240 | Derived | Yi J, Wang L, Song J, Liu Y, Liu J, Zhang H, Lu J, Zheng X. Development of a machine learning-based model for predicting individual responses to antihypertensive treatments. Nutr Metab Cardiovasc Dis. 2024 Jul;34(7):1660-1669. doi: 10.1016/j.numecd.2024.02.014. Epub 2024 Mar 4. |
| 35578345 | Derived | Song J, Wang X, Wang B, Gao Y, Liu J, Zhang H, Li X, Li J, Wang JG, Cai J, Herrin J, Armitage J, Krumholz HM, Zheng X; LIGHT Collaborative Group. Effectiveness of a clinical decision support system for hypertension management in primary care: study protocol for a pragmatic cluster-randomized controlled trial. Trials. 2022 May 16;23(1):412. doi: 10.1186/s13063-022-06374-x. |