Effect of a multicomponent quality improvement strategy on sustained achievement of diabetes care goals and macrovascular and microvascular complications in South Asia at 6.5 years follow-up: Post hoc analyses of the CARRS randomized clinical trial.

Background: Diabetes control is poor globally and leads to burdensome microvascular and macrovascular complications. We aimed to assess post hoc between-group differences in sustained risk factor control and macrovascular and microvascular endpoints at 6.5 years in the Center for cArdiovascular Risk Reduction in South Asia (CARRS) randomized trial. Methods and findings: This parallel group individual randomized clinical trial was performed at 10 outpatient diabetes clinics in India and Pakistan from January 2011 through September 2019. A total of 1,146 patients with poorly controlled type 2 diabetes (HbA1c ≥8% and systolic BP ≥140 mm Hg and/or LDL-cholesterol ≥130 mg/dl) were randomized to a multicomponent quality improvement (QI) strategy (trained nonphysician care coordinator to facilitate care for patients and clinical decision support system for physicians) or usual care. At 2.5 years, compared to usual care, those receiving the QI strategy were significantly more likely to achieve multiple risk factor control. Six clinics continued, while 4 clinics discontinued implementing the QI strategy for an additional 4-year follow-up (overall median 6.5 years follow-up). In this post hoc analysis, using intention-to-treat, we examined between-group differences in multiple risk factor control (HbA1c <7% plus systolic BP <130 mm Hg and/or LDL-cholesterol <100 mg/dl) and first macrovascular endpoints (nonfatal myocardial infarction, nonfatal stroke, death, revascularization [angioplasty or coronary artery bypass graft]), which were coprimary outcomes. We also examined secondary outcomes, namely, single risk factor control, first microvascular endpoints (retinopathy, nephropathy, neuropathy), and composite first macrovascular plus microvascular events (which also included amputation and all-cause mortality) by treatment group and whether QI strategy implementation was continued over 6.5 years. At 6.5 years, assessment data were available for 854 participants (74.5%; n = 417 [intervention]; n = 437 [usual care]). In terms of sociodemographic and clinical characteristics, participants in the intervention and usual care groups were similar and participants at sites that continued were no different to participants at sites that discontinued intervention implementation. Patients in the intervention arm were more likely to exhibit sustained multiple risk factor control than usual care (relative risk: 1.79; 95% confidence interval [CI], 1.45, 2.20), p < 0.001. Cumulatively, there were 233 (40.5%) first microvascular and macrovascular events in intervention and 274 (48.0%) in usual care patients (absolute risk reduction: 7.5% [95% CI: −13.2, −1.7], p = 0.01; hazard ratio [HR] = 0.72 [95% CI: 0.61, 0.86]), p < 0.001. Patients in the intervention arm experienced lower incidence of first microvascular endpoints (HR = 0.68 [95% CI: 0.56, 0.83), p < 0.001, but there was no evidence of between-group differences in first macrovascular events. Beneficial effects on microvascular and composite vascular outcomes were observed in sites that continued, but not sites that discontinued the intervention. Conclusions: In urban South Asian clinics, a multicomponent QI strategy led to sustained multiple risk factor control and between-group differences in microvascular, but not macrovascular, endpoints. Between-group reductions in vascular outcomes at 6.5 years were observed only at sites that continued the QI intervention, suggesting that practice change needs to be maintained for better population health of people with diabetes. Trial registration: ClinicalTrials.govNCT01212328. Nikhil Tandon and colleagues explore the impact of a quality improvement strategy for patients with type 2 diabetes 6.5 years after its implementation for the CARRS randomised trial. Author summary: Why was this study done?: Data on whether improvements in diabetes care goal achievement can be sustained (>5 years) with quality improvement (QI) strategies are lacking from low- and middle-income countries (LMICs). Prior studies of QI strategies to improve care goal achievement among people with diabetes from high-income countries reported modest benefits in blood glucose, blood pressure, and lipids, but the effects of these improvements on reducing vascular complications and deaths related to diabetes are unknown. What did the researchers do and find?: In the Center for cArdiovascular Risk Reduction in South Asia (CARRS) randomised trial of 1,146 patients with type 2 diabetes attending 10 diverse diabetes clinics in India and Pakistan, the QI strategy was associated with benefits on diabetes care goals (HbA1c <7% plus systolic BP <130 mm Hg and/or LDL-cholesterol <100 mg/dl) at 2.5 years after randomization. Four clinics discontinued implementation, while 6 clinics continued to implement the QI strategy for an additional 4 years. This report assesses whether benefits were sustained and reduced vascular complications and deaths associated with diabetes at 6.5 years. Patients receiving the QI strategy, compared to those receiving usual care, experienced sustained benefits on diabetes care goals and less microvascular endpoints (eye, kidney, and nerve diseases) at 6.5 years after randomization. Total macrovascular and microvascular events were also lower in those receiving the QI strategy, and this was only observed at sites that continued implementation of the QI strategy for 6.5 years. What do these findings mean?: These findings add to our knowledge of the long-term effects of multicomponent QI strategies in sustaining multiple risk factor control and reducing combined vascular events compared to usual care in resource-limited settings. In view of these findings, clinical decision support and trained nonphysician health workers may be important QI strategies to consider integrating into India's healthcare system to improve diabetes care quality and reduce morbidity and mortality. One limitation of the study is that the tertiary care facilities included in the CARRS trial may not be generalizable across LMICs. [ABSTRACT FROM AUTHOR]