Background: Despite evidence that diabetes is costly and devastating, the health care system is poorly equipped to meet the challenges of chronic disease care. The Penn State Institute of Diabetes & Obesity is evaluating a model of managing type 2 DM which includes nurse case management (NCM) and motivational interviewing (MI) to foster behavior change. The primary care intervention is designed to improve patients' self care and to reduce clinical inertia through provider use of standardized clinical guidelines to achieve better diabetes outcomes.
Methods: This RCT tests the efficacy of an enhanced NCM intervention on type 2 DM (n=549) patient outcomes mediated by changes in self-care behavior and diabetes management. Outcome measures include: (a) effect on clinical parameters such as HbA1c (<7), BP (<130/80), and LDL (<100), depression scores and weight; (b) process measures such as complication screening; (c) patient psychological and behavioral outcomes as measured by emotional distress (PAID), diabetes-specific quality of life (ADDQoL), patient satisfaction (DTSQ), self-care activities (SDSCA); and (d) physician satisfaction and cost-effectiveness of the intervention.
Conclusions: Baseline includes (mean) age=58; BMI=34.4; 57% females; 47% Caucasian, and 39% Hispanic. Patients had elevated HbA1c (8.4), BP (137/77) and LDL (114). Overall, patients were depressed (CES-D=21.6) and had an extremely negative quality of life (ADDQoL=-1.58). We believe that enhanced NCM will both improve self-care and reduce emotional distress for patients with diabetes. If proven effective, enhanced NCM may be translated to other chronic illnesses.
Trial registration: ClinicalTrials.gov NCT00308386.