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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Computer-based decision support system

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 Type: Interventional
• Enrollment (Anticipated): 10000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xin Zheng, MD, PhD; Phone Number: +86 60866813; Email: xin.zheng@fwoxford.org
• Study Contact Backup: Name: Harlan M Krumholz, MD, SM; Phone Number: +86 60866813; Email: harlan.krumholz@yale.edu

Study Locations

• China
  • Henan
    • Beijing, Henan, China
      • Completed
      • Luoyang Oriental hospital
  • Shandong
    • Zoucheng, Shandong, China
      • Active, not recruiting
      • Yankuang Hospital
  • Shenzhen
    • Shenzhen, Shenzhen, China
      • Recruiting
      • Center for Chronic Disease Control
      • Contact: Xin Zheng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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: β-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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Computer-based decision support system; Computer-based decision support system for BP management, with appropriate training of local PHC doctors.	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.
NO_INTERVENTION: Control; After site randomization, physicians at the control sites will manage their patients with hypertension by usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Xin Zheng, MD, PhD, National Center for Cardiovascular Diseases

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 21, 2019
• Primary Completion (ANTICIPATED): March 30, 2022
• Study Completion (ANTICIPATED): March 30, 2022

Study Registration Dates

• First Submitted: July 3, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (ACTUAL): August 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Hypertension; Decision support system; Staged cluster randomized controlled trial
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2016-I2M-1-006-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No