Background: We compared two implementation approaches for a health literacy diabetes intervention designed for community health centers.
Methods: A quasi-experimental, clinic-randomized evaluation was conducted at six community health centers from rural, suburban, and urban locations in Missouri between August 2008 and January 2010. In all, 486 adult patients with type 2 diabetes mellitus participated. Clinics were set up to implement either: 1) a clinic-based approach that involved practice re-design to routinely provide brief diabetes education and counseling services, set action-plans, and perform follow-up without additional financial resources [CARVE-IN]; or 2) an outsourced approach where clinics referred patients to a telephone-based diabetes educator for the same services [CARVE-OUT]. The fidelity of each intervention was determined by the number of contacts with patients, self-report of services received, and patient satisfaction. Intervention effectiveness was investigated by assessing patient knowledge, self-efficacy, health behaviors, and clinical outcomes.
Results: Carve-out patients received on average 4.3 contacts (SD = 2.2) from the telephone-based diabetes educator versus 1.7 contacts (SD = 2.0) from the clinic nurse in the carve-in arm (p < 0.001). They were also more likely to recall setting action plans and rated the process more positively than carve-in patients (p < 0.001). Few differences in diabetes knowledge, self-efficacy, or health behaviors were found between the two approaches. However, clinical outcomes did vary in multivariable analyses; carve-out patients had a lower HbA1c (β = -0.31, 95 % CI -0.56 to -0.06, p = 0.02), systolic blood pressure (β = -3.65, 95 % CI -6.39 to -0.90, p = 0.01), and low-density lipoprotein (LDL) cholesterol (β = -7.96, 95 % CI -10.08 to -5.83, p < 0.001) at 6 months.
Conclusion: An outsourced diabetes education and counseling approach for community health centers appears more feasible than clinic-based models. Patients receiving the carve-out strategy also demonstrated better clinical outcomes compared to those receiving the carve-in approach. Study limitations and unclear causal mechanisms explaining change in patient behavior suggest that further research is needed.