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

Hypertension Clinical Trial

— LIGHT  

Official title:

Learning Implementation of Guideline-based Decision Support System for Hypertension Treatment (LIGHT): A Staged Cluster Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03636334
• Other study ID #: 2016-I2M-1-006-1
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2019
• Est. completion date: March 30, 2022

Study information

• Verified date: April 2021
• Source: China National Center for Cardiovascular Diseases
• Contact: Xin Zheng, MD, PhD
• Phone: +86 60866813
• Email: xin.zheng[@]fwoxford.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Sites:

1. At least one drug available from each of the four classes of recommended antihypertensive drugs are provided at clinic:

• A: Angiotensin-converting enzyme inhibitors (ACEI; e.g., captopril and nalapril) or angiotensin receptor blockers (ARB; e.g., losartan and valsartan)

• B: ß-blockers (e.g., atenolol and metoprolol)

• C: Calcium antagonists (e.g., nitrendipine, nifedipine, and amlodipine)

• D: Diuretics (e.g., hydrochlorothiazide and indapamide)

2. Has an outpatient clinic for hypertension treatment and staff willing to take part in the study

3. Electronic data collection system is routinely used at clinic for hypertension management

4. At least 100 individuals with hypertension can attend the clinic every 3 months.

Inclusion Criteria for Visits:

1. Scheduled or unscheduled visit for hypertension treatment or prescription for antihypertensive medications

2. Visit for elevated blood pressure or adverse effect of antihypertensive medications

3. Visit for other cardiovascular diseases such as diabetes, stroke, PAD, or newly diagnosed of CKD, CAD and heart failure regardless of individuals' blood pressure level.

Inclusion Criteria for Participants:

1. Age =18 years

2. Local resident of the community/township who attend the PHC clinic for hypertension management

3. Established diagnosis of essential hypertension (defined as systolic blood pressure=140 mmHg, diastolic blood pressure =90 mmHg, or both, measured on at least 3 separate visits; or currently taking antihypertensive medications)

4. Taking 0-2 types of antihypertensive medications (not including B)

Exclusion Criteria for participants:

1. Patients with SBP=180 mmHg and/or DBP=110 mmHg

2. History of coronary heart disease (i.e., angina, MI, coronary artery bypass grafting [CABG], percutaneous coronary intervention [PCI], >50% stenosis of coronary artery, or positive stress test)

3. Physician- diagnosed heart failure

4. Physician-diagnosed or self-reported CKD, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (if serum creatinine is available), or currently on dialysis

5. Physician-diagnosed secondary hypertension

6. Intolerance to at least two classes of antihypertensive medications among A, C or D

7. Other serious medical illness such as malignant cancer, hepatic dysfunction, et al

8. Currently at the acute phase of any disease

9. Subject is pregnant or breast feeding, or planning to become pregnant or breast feeding during study period

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Computer-based decision support system
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.

Locations

Country	Name	City	State
China	Luoyang Oriental hospital	Beijing	Henan
China	Center for chronic disease control	Shenzhen	Shenzhen
China	Yankuang Hospital	Zoucheng	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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
Secondary	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	Baseline; 1 year
Secondary	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