Back to resultsLearning Implementation of Guideline-based Decision Support System for Hypertension Treatment (LIGHT) (LIGHT)
Primary Purpose
Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Computer-based decision support system
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Decision support system, Staged cluster randomized controlled trial
Eligibility Criteria
Inclusion Criteria for Sites:
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: β-blockers (e.g., atenolol and metoprolol)
- C: Calcium antagonists (e.g., nitrendipine, nifedipine, and amlodipine)
- D: Diuretics (e.g., hydrochlorothiazide and indapamide)
- 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:
- Scheduled or unscheduled visit for hypertension treatment or prescription for antihypertensive medications
- Visit for elevated blood pressure or adverse effect of antihypertensive medications
- 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:
- Age ≥18 years
- Local resident of the community/township who attend the PHC clinic for hypertension management
- 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)
- Taking 0-2 types of antihypertensive medications (not including B)
Exclusion Criteria for participants:
- Patients with SBP≥180 mmHg and/or DBP≥110 mmHg
- 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)
- Physician- diagnosed heart failure
- 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
- Physician-diagnosed secondary hypertension
- Intolerance to at least two classes of antihypertensive medications among A, C or D
- Other serious medical illness such as malignant cancer, hepatic dysfunction, et al
- Currently at the acute phase of any disease
- Subject is pregnant or breast feeding, or planning to become pregnant or breast feeding during study period
Sites / Locations
- Luoyang Oriental hospital
- Yankuang Hospital
- Center for chronic disease controlRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Computer-based decision support system
Control
Arm Description
Computer-based decision support system for BP management, with appropriate training of local PHC doctors.
After site randomization, physicians at the control sites will manage their patients with hypertension by usual care.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
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.
Full Information
NCT ID
NCT03636334
First Posted
July 3, 2018
Last Updated
April 14, 2021
Sponsor
China National Center for Cardiovascular Diseases
1. Study Identification
Unique Protocol Identification Number
NCT03636334
Brief Title
Learning Implementation of Guideline-based Decision Support System for Hypertension Treatment (LIGHT)
Acronym
LIGHT
Official Title
Learning Implementation of Guideline-based Decision Support System for Hypertension Treatment (LIGHT): A Staged Cluster Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
March 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Decision support system, Staged cluster randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Computer-based decision support system
Arm Type
Experimental
Arm Description
Computer-based decision support system for BP management, with appropriate training of local PHC doctors.
Arm Title
Control
Arm Type
No Intervention
Arm Description
After site randomization, physicians at the control sites will manage their patients with hypertension by usual care.
Intervention Type
Behavioral
Intervention Name(s)
Computer-based decision support system
Intervention Description
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.
Primary Outcome Measure Information:
Title
The proportion of visits with ideal appropriate treatment provided among all the eligible hypertension visits within the period of observational follow-up
Description
ideal appropriate treatment means guideline-accordant treatment
Time Frame
Baseline; 1 year
Secondary Outcome Measure Information:
Title
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.
Description
the average change in SBP from first visit after randomization to the last visit among enrolled patients.
Time Frame
Baseline; 1 year
Title
The percentage of participants with BP<140/90 mmHg at the last visit among the eligible participants during the period of 9-month observation.
Description
The individuals' last blood pressure measurement during the 9-month observation phase will be used for assessment
Time Frame
Baseline; 1 year
Title
The proportion of visits with acceptable appropriate treatment among all the eligible hypertension visits.
Description
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
Other Pre-specified Outcome Measures:
Title
The proportion of individuals with a vascular event (defined as cardiac death, non-fatal stroke and non-fatal MI) at 1 year.
Description
Measure the proportion of individuals who complicate with a vascular event.
Time Frame
Baseline; 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Sites:
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: β-blockers (e.g., atenolol and metoprolol)
C: Calcium antagonists (e.g., nitrendipine, nifedipine, and amlodipine)
D: Diuretics (e.g., hydrochlorothiazide and indapamide)
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:
Scheduled or unscheduled visit for hypertension treatment or prescription for antihypertensive medications
Visit for elevated blood pressure or adverse effect of antihypertensive medications
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:
Age ≥18 years
Local resident of the community/township who attend the PHC clinic for hypertension management
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)
Taking 0-2 types of antihypertensive medications (not including B)
Exclusion Criteria for participants:
Patients with SBP≥180 mmHg and/or DBP≥110 mmHg
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)
Physician- diagnosed heart failure
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
Physician-diagnosed secondary hypertension
Intolerance to at least two classes of antihypertensive medications among A, C or D
Other serious medical illness such as malignant cancer, hepatic dysfunction, et al
Currently at the acute phase of any disease
Subject is pregnant or breast feeding, or planning to become pregnant or breast feeding during study period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Zheng, MD, PhD
Phone
+86 60866813
Email
xin.zheng@fwoxford.org
First Name & Middle Initial & Last Name or Official Title & Degree
Harlan M Krumholz, MD, SM
Phone
+86 60866813
Email
harlan.krumholz@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Zheng, MD, PhD
Organizational Affiliation
National Center for Cardiovascular Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luoyang Oriental hospital
City
Beijing
State/Province
Henan
Country
China
Individual Site Status
Completed
Facility Name
Yankuang Hospital
City
Zoucheng
State/Province
Shandong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Center for chronic disease control
City
Shenzhen
State/Province
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Zheng
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35578345
Citation
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.
Results Reference
derived
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Learning Implementation of Guideline-based Decision Support System for Hypertension Treatment (LIGHT)
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