Effectiveness of a multicomponent quality improvement strategy to improve achievement of diabetes care goals a randomized, controlled trial

Mohammed K. Ali, Kavita Singh, Dimple Kondal, Raji Devarajan, Shivani A. Patel, Roopa Shivashankar, Vamadevan S. Ajay, A. G. Unnikrishnan, V. Usha Menon, Premlata K. Varthakavi, Vijay Viswanathan, Mala Dharmalingam, Ganapati Bantwal, Rakesh Kumar Sahay, Muhammad Qamar Masood, Rajesh Khadgawat, Ankush Desai, Bipin Sethi, Dorairaj Prabhakaran, K. M. Venkat NarayanNikhil Tandon

Research output: Contribution to journalArticlepeer-review

79 Citations (Scopus)


Background: Achievement of diabetes care goals is suboptimal globally. Diabetes-focused quality improvement (QI) is effective but remains untested in South Asia. Objective: To compare the effect of a multicomponent QI strategy versus usual care on cardiometabolic profiles in patients with poorly controlled diabetes. Design: Parallel, open-label, pragmatic randomized, controlled trial. (ClinicalTrials.gov: NCT01212328) Setting: Diabetes clinics in India and Pakistan. Patients: 1146 patients (575 in the intervention group and 571 in the usual care group) with type 2 diabetes and poor cardiometabolic profiles (glycated hemoglobin [HbA1c] level ≥8% plus systolic blood pressure [BP] ≥140 mm Hg and/or low-density lipoprotein cholesterol [LDLc] level ≥130 mg/dL). Intervention: Multicomponent QI strategy comprising nonphysician care coordinators and decision-support electronic health records. Measurements: Proportions achieving HbA1c level less than 7% plus BP less than 130/80 mm Hg and/or LDLc level less than 100 mg/dL (primary outcome); mean risk factor reductions, healthrelated quality of life (HRQL), and treatment satisfaction (secondary outcomes). Results: Baseline characteristics were similar between groups. Median diabetes duration was 7.0 years; 6.8% and 39.4% of participants had preexisting cardiovascular and microvascular disease, respectively; mean HbA1c level was 9.9%; mean BP was 143.3/81.7mmHg; and mean LDLc level was 122.4 mg/dL. Over a median of 28 months, a greater percentage of intervention participants achieved the primary outcome (18.2% vs. 8.1%; relative risk, 2.24 [95% CI, 1.71 to 2.92]). Compared with usual care, intervention participants achieved larger reductions in HbA1c level (-0.50% [CI, -0.69% to -0.32%]), systolic BP (-4.04 mm Hg [CI, -5.85 to -2.22 mm Hg]), diastolic BP (-2.03 mm Hg [CI, -3.00 to -1.05 mm Hg]), and LDLc level (-7.86 mg/dL [CI, -10.90 to -4.81 mg/dL]) and reported higher HRQL and treatment satisfaction. Limitation: Findings were confined to urban specialist diabetes clinics. Conclusion: Multicomponent QI improves achievement of diabetes care goals, even in resource-challenged clinics. Primary Funding Source: National Heart, Lung, and Blood Institute and UnitedHealth Group.

Original languageEnglish
Pages (from-to)399-408
Number of pages10
JournalAnnals of Internal Medicine
Issue number6
Publication statusPublished - 20 Sept 2016


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