Stratified Patient-Centered Care in Type 2 Diabetes

A cluster-randomized, controlled clinical trial of effectiveness and cost-effectiveness

  1. Louis W. Niessen, MD, PHD2,5
  1. 1Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands
  2. 2Institute of Health Policy and Management, Institute for Medical Technology Assessment, Erasmus MC, Erasmus University Rotterdam, Rotterdam, the Netherlands
  3. 3University of Michigan Medical Center, Ann Arbor, Michigan
  4. 4Dutch College of General Practitioners, Utrecht, the Netherlands
  5. 5Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
  1. Corresponding author: Annabelle S. Slingerland, annabelle.s.slingerland{at}gmail.com.

Abstract

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 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 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).

RESULTS Patient-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 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 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).

CONCLUSIONS Patient-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.

  • Received September 12, 2012.
  • Accepted April 10, 2013.

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