Improving diabetes care: multi-component cardiovascular disease risk reduction strategies for people with diabetes in South Asia--the CARRS multi-center translation trial

Abstract

Aims: Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in people with diabetes in South Asia. The CARRS Translation Trial tests the effectiveness, cost-effectiveness, and sustainability of a clinic-based multi-component CVD risk reduction intervention among people with diabetes in India and Pakistan.

Methods: We randomly assigned 1146 adults with diabetes recruited from 10 urban clinic sites, to receive usual care by physicians or to receive an integrated multi-component CVD risk reduction intervention. The intervention involves electronic health record management, decision-support prompts to the healthcare team, and the support of a care coordinator to actively facilitate patient and provider adherence to evidence-based guidelines. The primary outcome is a composite of multiple CVD risk factor control (blood glucose and either blood pressure or cholesterol, or all three). Other outcomes include control of the individual CVD risk factors, process and patient-centered measures, cost-effectiveness, and acceptability/feasibility.

Conclusion: The CARRS Translation Trial tests a low-cost diabetes care delivery model in urban South Asia to achieve comprehensive cardio-metabolic disease case-management of high-risk patients (clinicaltrials.gov number: NCT01212328).

Figure 1. CARRS Translation Trial Schematic: design, participant flow and study measures

HbA1c=glycated hemoglobin, SBP=systolic blood pressure, LDLc=low density lipoprotein cholesterol, Ht=height, Wt=weight, WC=waist circumference, BP=blood pressure, HR=heart rate, FBG=fasting blood glucose, ECG=electrocardiogram, DSS=decision-support software

Figure 2. Intervention arm: care coordinator functions and electronic health record/decision-support software interactions for patient case-management

txt msg = text message, call = phone call, DSS=decision-support software, EHR= electronic health records, CC=care coordinator

1. CC checks EHR to track which patients have upcoming visits. CC sends reminder (text message or phone call) to patient to visit clinic and get needed lab tests done for visit evaluation.

2. During clinic visit, CC first takes the patient’s intake (history, labs, measurements) and enters the information into the EHR to patient-specific DSS prompts.

3. CC takes patient to physician and conveys the patient’s status and the treatment DSS prompts to the physician. Physician conducts any exam, updates the plan accounting for the DSS prompts, and provides patient education and needed prescriptions/referrals. The CC updates the response to the DSS prompts (accepted or rejected) and treatment plan in the EHR, including any reminders to schedule.

4. CC checks EHR to track and send patient reminders for referrals, lab tests, or pharmacy.

5. CC checks EHR to track and send patient reminders for self-care and motivation.