Clinical Trial Summary
Objective: to evaluate the efficacy of the American College of Physicians Foundation (ACPF)
Diabetes Guide (Living with Diabetes: An Everyday Guide for You and Your Family) to improve
diabetes self-management.
Study Sites: Nine Federally-qualified health centers or safety-net clinics at three sites in
Missouri. Sites are urban (St. Louis), midsize (Columbia) and rural (Kirksville). Three FQHCs
or safety net clinics are located at each of the sites.
Methods Overview and Design: A randomized controlled trial will be conducted. Patients will
be recruited from identified health centers. As the intervention itself is directed to the
clinic and not patient, the clinics will be randomly assigned to either 1) usual care (no
treatment), 2) "Carve-In" - patients receive the Diabetes Guide and clinic staff follow-up
and work with patients to create and complete action plans or 3)"Carve-Out" - patients
receive the Diabetes Guide and a diabetes educator in Chicago follows up and works with
patients to create and complete action plans. Recruited subjects will be administered a
baseline assessment, and 3-month and 1-year follow-up assessments.
Sample: The investigators will recruit a total of 1,080 patients (n=120 per clinic)
anticipating 80 percent retention through both follow-up assessments (final estimated number
of patients = 720). Eligibility to participate will be defined as patients 1) ages 30 and
older (to better represent disease distribution), 2) English or Spanish-speaking, 3) a
confirmed (by chart) diagnosis of uncontrolled diabetes (HBA1c 7.0 or more).
