Stratified patient-centered care in type 2 diabetes: A cluster-randomized, controlled clinical trial of effectiveness and cost-effectiveness

OBJECTIVE Diabetes treatment should be effective and cost-effective. HbA1c-associated complications are costly.Would patient-centered care be more (cost-) effective if it was targeted to patients within specific HbA1c ranges? RESEARCH DESIGN AND METHODSdThis prospective, cluster-randomized, controlled trial involved 13 hospitals (clusters) in the Netherlands and 506 patients with type 2 diabetes randomized to patient-centered (n = 237) or usual care (controls) (n = 269). Primary outcomes were change in HbA1c and quality-adjusted life years (QALYs); costs and incremental costs (USD) after 1 year were secondary outcomes. We applied nonparametric bootstrapping and probabilistic modeling over a lifetime using a validated Dutch model. The baseline HbA1c strata were ,7.0% (53 mmol/mol), 7.0-8.5%, and .8.5% (69 mmol/mol). RESULTSdPatient-centered care was most effective and cost-effective in those with baseline HbA1c >8.5% (69 mmol/mol). After 1 year, the HbA1c reduction was 0.83% (95% CI 0.81- 0.84%) (6.7 ol/mol [6.5-6.8]), and the incremental cost-effectiveness ratio (ICER) was 261 USD (235-288) per QALY. Over a lifetime, 0.54 QALYs (0.30-0.78) were gained at a cost of 3,482 USD (2,706-4,258); ICER 6,443 USD/QALY (3,199-9,686). For baseline HbA1c 7.0- 8.5% (53-69 mmol/mol), 0.24 QALY (0.07-0.41) was gained at a cost of 4,731 USD (4,259- 5,205); ICER 20,086 USD (5,979-34,193). Care was not cost-effective for patients at a baseline HbA1c <7.0% (53 mmol/mol). CONCLUSIONSdPatient-centered care is more valuable when targeted to patients with HbA1c >8.5% (69 mmol/mol), confirming clinical intuition. The findings support treatment in those with baseline HbA1c 7-8.5% (53-69 mmol/mol) and demonstrate little to no benefit among those with HbA1c >7% (53 mmol/mol). Further studies should assess different HbA1c strata and additional risk profiles to account for heterogeneity among patients.