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

NCT03636334 | Unknown

• 1 other identifier: 2016-I2M-1-006-1
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypertension

Keywords

Hypertension; Decision support system; Staged cluster randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 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 proportion of visits with acceptable appropriate treatment among all the eligible hypertension visits.

  Baseline; 1 year

Other Outcomes (1)

• The proportion of individuals with a vascular event (defined as cardiac death, non-fatal stroke and non-fatal MI) at 1 year.

  Baseline; 1 year

Study Arms (2)

Computer-based decision support system

EXPERIMENTAL

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

Behavioral: Computer-based decision support system

Control

NO INTERVENTION

After site randomization, physicians at the control sites will manage their patients with hypertension by usual care.

Interventions

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.

Computer-based decision support system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (3)

Luoyang Oriental hospital

Beijing, Henan, China

COMPLETED

Yankuang Hospital

Zoucheng, Shandong, China

ACTIVE NOT RECRUITING

Center for chronic disease control

Shenzhen, Shenzhen, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 39043397 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.

  PMID: 38555240 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.

  PMID: 35578345 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xin Zheng, MD, PhD

  National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Zheng, MD, PhD

CONTACT

+86 60866813; xin.zheng@fwoxford.org

Harlan M Krumholz, MD, SM

CONTACT

+86 60866813; harlan.krumholz@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: August 17, 2018
• Study Start: August 21, 2019
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: April 15, 2021

Record last verified: 2021-04

Locations

CN (3)