Journal Article

Comparative effectiveness of team-based care with a clinical decision support system versus team-based care alone on cardiovascular risk reduction among patients with diabetes: Rationale and design of the D4C trial

Lin, Mingzhu, Yang, Shuyu, Obst, Katherine, Shi, Xiulin, Huang, Peiying, Li, Zhibin, Wang, Caihong, Yao, Guanhua, Li, Xuejun, He, Jiang, Wang, Liying, Chen, Chung-Shiuan, Huang, Yinxiang, Li, Weihua, Yan, Bing, Song, Haiqu, Zhang, Mulin, Liu, Changqin, Xiao, Fangsen

2021

Overview

Diabetes has become a major public health challenge worldwide, especially in low- and middle-income countries (LMICs). Uncontrolled hyperglycemia, hypertension, and dyslipidemia major risk factors for all-cause mortality and cardiovascular disease (CVD) are common in patients with diabetes in China. We propose to compare the effectiveness of team-based care plus a clinical decision support system (CDSS) with team-based care alone on glycemic, blood pressure (BP), and lipid control, and clinical CVD reduction among patients with type-2 diabetes and at high risk for CVD. The Diabetes Complication Control in Community Clinics (D4C) study is a cluster-randomized trial conducted among 38 community health centers in Xiamen City, China. Nineteen clinics have been randomly assigned to team-based care plus CDSS and 19 to team-based care alone. Team-based care includes primary care providers, health coaches, and diabetes specialists working collaboratively with patients to achieve shared treatment goals for CVD risk factor reduction. The CDSS integrates guideline-based treatment algorithms for glycemic, BP, and lipid control, along with a patient's medical history and insurance policy, to recommend treatment and follow-up plans. In phase 1, the co-primary outcomes are mean reduction in glycated hemoglobin (HbA1c), systolic BP (SBP), and low-density lipoprotein (LDL)-cholesterol over 18 months, and the proportion of patients with controlled HbA1c, SBP, and LDL-cholesterol at 18 months’ between the 2 comparison groups. In phase 2, the primary outcome is the difference in major CVD incidence (non–fatal stroke, non–fatal myocardial infarction, hospitalized heart failure, and CVD mortality) between the 2 comparison groups. Mean reduction in HbA1c, SBP, and LDL-cholesterol levels will be simultaneously modeled for a single overall treatment effect. The D4C trial will generate evidence on whether a CDSS will further reduce the CVD burden among patients with diabetes beyond team-based care at community clinics. If proven effective, this implementation strategy could be scaled up within primary care settings in China and other LMICs to reduce CVD incidence and mortality among patients with diabetes.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Algorithms / Blood Pressure / Cardiovascular disease / Cardiovascular diseases / Cardiovascular Diseases - epidemiology / Cardiovascular Diseases - mortality / Cardiovascular Diseases - prevention & control / Cerebral infarction / China / Cholesterol / Cholesterol, LDL - blood / Chronic illnesses / Collaboration / Congestive heart failure / Decision making / Decision support systems / Decision Support Systems, Clinical / Diabetes / Diabetes mellitus / Diabetes Mellitus, Type 2 - blood / Diabetes Mellitus, Type 2 - complications / Disease management / Drug prices / Dyslipidemia / Electronic health records / Empowerment / Female / Glucose / Glycated Hemoglobin / Health care expenditures / Health care facilities / Health care policy / Health facilities / Health risks / Health services / Heart Disease Risk Factors / Heart diseases / Heart Failure - prevention & control / Hemoglobin / Humans / Hyperglycemia / Hypertension / Incidence / Intervention / Lipids / Low density lipoprotein / Male / Medical diagnosis / Middle Aged / Mortality / Multicenter Studies as Topic / Myocardial infarction / Myocardial Infarction - prevention & control / Patient Care Team - organization & administration / Patient compliance / Patient satisfaction / Patients / Primary care / Public health / Randomized Controlled Trials as Topic / Risk analysis / Risk factors / Risk management / Risk Reduction Behavior / Stroke - prevention & control