Elsevier

American Heart Journal

Volume 238, August 2021, Pages 45-58
American Heart Journal

Trial designs
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

https://doi.org/10.1016/j.ahj.2021.04.009Get rights and content

Background

Diabetes has become a major public health challenge worldwide, especially in low- and middle-income countries (LMICs). Uncontrolled hyperglycemia, hypertension, and dyslipidemia single bond major risk factors for all-cause mortality and cardiovascular disease (CVD) single bond 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.

Methods

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.

Conclusion

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.

Section snippets

Global health challenge of diabetes and related cardiovascular diseases

The prevalence of diabetes is rapidly increasing worldwide, especially in low- and middle-income countries (LMIC).1 Approximately 463 million adults aged 20 to 79 years had diabetes in 2019 and 79% of them were living in LMIC.2 For example, the prevalence of diabetes in the general population aged 20 years and older in China increased from 2.5% in 1994 to 11.6% in 2010.3,4 It was estimated that 113.9 million Chinese adults had diabetes in 2010.4 More troublesome, only 25.8% of patients with

Overview of study design

The Diabetes Complication Control in Community Clinics (D4C) study is a cluster-randomized trial conducted in 38 CHCin Xiamen City, China (Figure 1). D4C aims to test whether implementation of team-based care with CDSS compared to team-based care alone will further reduce CVD risk factors over 18 months (phase 1) and major CVD events over 3 years (phase 2) among 11,584 patients with uncontrolled diabetes and at increased risk for CVD. Nineteen CHC were randomly assigned to the intervention

Conclusion

The D4C study is the first cluster-randomized trial to test the effectiveness of the implementation of a team-based care plus CDSS strategy compared to only team-based care on multiple CVD risk factors and CVD events among patients with diabetes and co-morbidities in LMICs. The CDSS tested in this study applies the core elements of multi-condition integrated care and protocol-based treatment to major CVD risk factors that benefits patients with diabetes, hypertension, and dyslipidemia. This

Acknowledgments

We are thankful for the contributions of all primary care providers, health coaches, research nurses, and other clinic staff from the 38 Community Health Centers in Xiamen City, China. This study was supported by Xiamen Municipal Health Commission, Xiamen, China. However, the US investigators did not receive any financial support from this study.

References (72)

  • X Li et al.

    Evaluation of the three-in-one team-based care model on hierarchical diagnosis and treatment patterns among patients with diabetes: a retrospective cohort study using Xiamen's regional electronic health records

    BMC health services research

    (2017)
  • DC Goff et al.

    2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines

    Journal of the American College of Cardiology

    (2014)
  • AK O'Sullivan et al.

    Collection of health-economic data alongside clinical trials: is there a future for piggyback evaluations?

    Value Health

    (2005)
  • NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in diabetes since 1980: a pooled analysis of 751...
  • XR Pan et al.

    Prevalence of diabetes and its risk factors in China, 1994. National Diabetes Prevention and Control Cooperative Group

    Diabetes Care

    (1997)
  • Y Xu et al.

    Prevalence and control of diabetes in Chinese adults

    Jama

    (2013)
  • J Lu et al.

    Predictive Value of Fasting Glucose, Postload Glucose, and Hemoglobin A(1c) on Risk of Diabetes and Complications in Chinese Adults

    Diabetes care

    (2019)

  • GBD 2019 Risk Factors Collaborators. Global burden of 87 risk factors in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019

    Lancet

    (2020)
  • SM Grundy et al.

    Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement

    Circulation

    (2005)
  • D Gu et al.

    Prevalence of cardiovascular disease risk factor clustering among the adult population of China: results from the International Collaborative Study of Cardiovascular Disease in Asia (InterAsia)

    Circulation

    (2005)
  • D Giugliano et al.

    Glycemic control, preexisting cardiovascular disease, and risk of major cardiovascular events in patients with type 2 diabetes mellitus: systematic review with meta-analysis of cardiovascular outcome trials and intensive glucose control trials

    J Am Heart Assoc

    (2019)
  • TN Kelly et al.

    Systematic review: glucose control and cardiovascular disease in type 2 diabetes

    Annals of internal medicine

    (2009)
  • M Brunström et al.

    Effect of antihypertensive treatment at different blood pressure levels in patients with diabetes mellitus: systematic review and meta-analyses

    BMJ (Clinical research ed)

    (2016)
  • CA Emdin et al.

    Blood pressure lowering in type 2 diabetes: a systematic review and meta-analysis

    Jama

    (2015)
  • PM Kearney et al.

    Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis

    Lancet (London, England)

    (2008)
  • P Gaede et al.

    Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes

    N Engl J Med

    (2003)
  • P Gaede et al.

    Effect of a multifactorial intervention on mortality in type 2 diabetes

    N Engl J Med

    (2008)
  • JB Brown et al.

    The role of patient, physician and systemic factors in the management of type 2 diabetes mellitus

    Family practice

    (2002)
  • RW Grant et al.

    Overcoming barriers to evidence-based diabetes care

    Curr Diabetes Rev

    (2006)
  • B Rushforth et al.

    Barriers to effective management of type 2 diabetes in primary care: qualitative systematic review

    Br J Gen Pract

    (2016)
  • JC Crosson et al.

    Physicians' perceptions of barriers to cardiovascular disease risk factor control among patients with diabetes: results from the translating research into action for diabetes (TRIAD) study

    Journal of the American Board of Family Medicine: JABFM

    (2010)
  • JA Schmittdiel et al.

    Why don't diabetes patients achieve recommended risk factor targets? Poor adherence versus lack of treatment intensification

    Journal of general internal medicine

    (2008)
  • RR Rubin

    Adherence to pharmacologic therapy in patients with type 2 diabetes mellitus

    Am J Med

    (2005)
  • IL Piña et al.

    Medication adherence: Importance, issues and policy: A policy statement from the American Heart Association

    Prog Cardiovasc Dis

    (2020)
  • H Bekele et al.

    Barriers and Strategies to Lifestyle and Dietary Pattern Interventions for Prevention and Management of TYPE-2 Diabetes in Africa, Systematic Review

    J Diabetes Res

    (2020)
  • P Mitchell et al.

    Core principles & values of effective team-based health care

    (2012)

    • Cited by (0)

    Trial registration: clinicaltrials.gov Identifier: NCT02835287

    Disclosures: The authors declare that they have no conflicts of interest.

    1

    Contributed to this work equally.

    View full text
    © 2021 Elsevier Inc. All rights reserved.