title: Clinic-based versus outsourced implementation of a diabetes health literacy intervention.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Health Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine at Northwestern University, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL, 60611, USA, mswolf@northwestern.edu.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Wolf
authors.forename: Hilary
authors.initials: H
authors.lastname: Seligman
authors.forename: Terry C
authors.initials: TC
authors.lastname: Davis
authors.forename: David A
authors.initials: DA
authors.lastname: Fleming
authors.forename: Laura M
authors.initials: LM
authors.lastname: Curtis
authors.forename: Anjali U
authors.initials: AU
authors.lastname: Pandit
authors.forename: Ruth M
authors.initials: RM
authors.lastname: Parker
authors.forename: Dean
authors.initials: D
authors.lastname: Schillinger
authors.forename: Darren A
authors.initials: DA
authors.lastname: Dewalt
mesh_terms: D000328:Adult; D000368:Aged; D000554:Ambulatory Care Facilities / Q000458:organization & administration; D003151:Community Health Centers / Q000458:organization & administration*; D003376:Counseling; D003695:Delivery of Health Care / Q000458:organization & administration*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000523:psychology / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D057220:Health Literacy; D006801:Humans; D008297:Male; D008875:Middle Aged; D008923:Missouri; D017060:Patient Satisfaction; D012648:Self Care; D020377:Self Efficacy; D012959:Socioeconomic Factors; D013689:Telephone
chemical_list: D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human