• Ann. Intern. Med. · Sep 2016

    Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial

    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 Narayan, Nikhil Tandon, and CARRS Trial Group.
    • From the Rollins School of Public Health, Emory University, Atlanta, Georgia; All India Institute of Medical Sciences, New Delhi, India; Public Health Foundation of India, Gurgaon, India; Chellaram Diabetes Institute, Pune, India; Amrita Institute of Medical Sciences, Kochi, India; Topiwala National Medical College & BYL Nair Charity Hospital, Mumbai, India; M.V. Hospital for Diabetes and Diabetes Research Centre, Chennai, India; Bangalore Endocrinology & Diabetes Research Centre and St. John's Medical College and Hospital, Bangalore, India; Osmania General Hospital and CARE Hospital, Hyderabad, India; Aga Khan University, Karachi, Pakistan; and Goa Medical College, Bambolim, India.
    • Ann. Intern. Med. 2016 Sep 20; 165 (6): 399408399-408.

    BackgroundAchievement of diabetes care goals is suboptimal globally. Diabetes-focused quality improvement (QI) is effective but remains untested in South Asia.ObjectiveTo compare the effect of a multicomponent QI strategy versus usual care on cardiometabolic profiles in patients with poorly controlled diabetes.DesignParallel, open-label, pragmatic randomized, controlled trial. (ClinicalTrials.gov: NCT01212328).SettingDiabetes clinics in India and Pakistan.Patients1146 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).InterventionMulticomponent QI strategy comprising nonphysician care coordinators and decision-support electronic health records.MeasurementsProportions 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, health-related quality of life (HRQL), and treatment satisfaction (secondary outcomes).ResultsBaseline 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 143.3/81.7 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 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.LimitationFindings were confined to urban specialist diabetes clinics.ConclusionMulticomponent QI improves achievement of diabetes care goals, even in resource-challenged clinics.Primary Funding SourceNational Heart, Lung, and Blood Institute and UnitedHealth Group.

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