Evaluation of telephone care management intervention designed to improve outcomes among depressed diabetes patients.
Research Plan: 382 patients ages 21-80, including 177 women, and 123 Blacks from the Ann Arbor VA HCS, UM, and the Genesys Health Care System in Flint. Patients will be randomized to: (1) brief education about depression, diabetes self-care, and physical activity; or (2) telephone care management including antidepressant medication care management (MCM) and/or cognitive behavioral therapy (CBT). The MCM module uses a standard algorithm to identify efficacious antidepressants and promote adherence. The CBT module addresses symptoms, exercise, and communication skills. Methods: Surveys: Patients will complete clinic-based surveys at baseline and 12-months to measure their health status, self-care, provider-patient communication, and resource use. At 4 months, they will complete a mailed questionnaire to capture short-term changes in depressive symptoms, walking, patient-provider communication, medication adherence, and quality-of-life. Physiologic Measures: At baseline and 12-months, patients' A1c and cholesterol will be measured via a fingerstick blood test. We also will measure blood pressure, height, and weight. With patients' 4-month mailed surveys, they will complete fingerstick A1c tests and return the results via mail. The blood tests are identical to those diabetes patients use to self-monitor their blood glucose. Pedometers: We will measure distance walked at baseline, 4 months, and 12 months using a pedometer. Patients will record their walk distances for one week and return the results via mail. Electronic data: Utilization and billing databases will be used to identify health service utilization (ER visits, outpatient care, hospitalizations) occurring during patients' participation and the prior 12 months. Physician feedback. At patients' 12-month assessment, the physician will complete a brief survey about the patient's communication style. All patients will provide written consent administered prior to their face-to-face screening and baseline interviews. Physician 12-month surveys about patients' communication style will be anonymous.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
339
* Basic physical activity counseling * Notify PCP and facilitate initiation of antidepressants * Medication monitoring calls at 1, 2, 4, 6, 8, 10, and 12 weeks\* * 1/mo monitoring in continuation phase (mos. 4-12)\* * Report \& recommendations to PCP after each patient call * Note: \*average of 10 minutes of telephone time each (series is repeated if second antidepressant trial is needed)
* Notify PCP * CBT Manual * Weekly CBT focused counseling for 12 weeks\*\* * Monthly CBT in months 4-12\*\* * Behavioral physical activity counseling * Report \& recommendations to PCP after each patient call * Note: \*\*average of 50 minutes of telephone time each
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Participant HbA1c levels
Time frame: one year
Participant cardiovascular risk index
Time frame: one year
Proximal intervention targets
(e.g., depressive symptoms, physical activity levels, and provider-patient communication)
Time frame: one year
Other self-care behaviors
Time frame: one year
Health-related quality of life
Time frame: one year
Treatment satisfaction
Time frame: one year
Resource use
Time frame: one year
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