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

Abstract

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. 1146 patients (575 in the intervention group and 571 in the usual care group) with type 2 diabetes and poor cardiometabolic profiles (glycated hemoglobin [HbA_1c] 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 HbA_1c 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, Health-Related 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 HbA_1c level was 9.9%; mean BP was 143.3/81.7 mm Hg; 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 HbA_1c 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.