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.

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, 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 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.

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.

Figure 1:

Registration, randomization and follow-up of study participants (CONSORT diagram) Abbreviations: HbA1c (glycated haemoglobin), BP (Blood pressure), LDLc (low density lipoprotein cholesterol)

Figure 2:

Multiple and single risk factor control by Treatment group during study follow-up Figure 2.A Proportion change in primary study outcome (multiple risk factor control) Figure 2.B-2.D: Proportion change in secondary outcomes (single risk factor control: HbA1c<7.0%, BP<130/80 mmHg, LDLc<100 mg/dl, respectively) by treatment group during follow-up. Overall relative risk was obtained via log binomial models using generalised estimating equations. Estimates combine all non-missing values collected at baseline, months 12, 24, and end-of-study. Model terms included treatment, time, treatment*time interaction, baseline value, and site. 95% CΙ: indicates 95% confidence interval Difference (p value): the difference (p value) between Intervention and Usual care at each time point Study time points: baseline, 12m (12 month), 24m (24 month), EOS (End of Study) Abbreviations: HbA1c (glycated haemoglobin), BP (blood pressure), LDL-c (low density lipoprotein cholesterol)

Figure 3:

Primary outcome of achieving multiple risk factor targets by subgroups Abbreviations: HbA1c (glycated hemoglobin), SBP (Systolic blood pressure), LDL (low density lipoprotein cholesterol), H/O (history of), CVD (cardiovascular disease), Microvascular complications (retinopathy, neuropathy and renal failure), BMI (body mass index), Rs (Indian rupees), US$ (United States dollar), CI (confidence intervals) The primary outcome of multiple risk factor control is shown by prespecified baseline subgroups. Error bars indicate 95%CIs; P values are for the test of homogeneity for each subgroup.