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. HbA(1c)-associated complications are costly. Would patient-centered care be more (cost-) effective if it was targeted to patients within specific HbA(1c) ranges? RESEARCH DESIGN AND METHODS: This 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 HbA(1c) 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 HbA(1c) strata were <7.0% (53 mmol/mol), 7.0–8.5%, and >8.5% (69 mmol/mol). RESULTS: Patient-centered care was most effective and cost-effective in those with baseline HbA(1c) >8.5% (69 mmol/mol). After 1 year, the HbA(1c) reduction was 0.83% (95% CI 0.81–0.84%) (6.7 mmol/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 HbA(1c) 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 HbA(1c) <7.0% (53 mmol/mol). CONCLUSIONS: Patient-centered care is more valuable when targeted to patients with HbA(1c) >8.5% (69 mmol/mol), confirming clinical intuition. The findings support treatment in those with baseline HbA(1c) 7–8.5% (53–69 mmol/mol) and demonstrate little to no benefit among those with HbA(1c) <7% (53 mmol/mol). Further studies should assess different HbA(1c) strata and additional risk profiles to account for heterogeneity among patients.