Abstract
Depression symptoms are present in one-third of patients with diabetes, contributing to significant adverse consequences. Population screening of high-risk patients coupled with telephone delivery of evidence-based therapies for comorbid diabetes may address barriers to care. To evaluate the effectiveness of proactive population screening plus telephone delivery of a collaborative goal-setting intervention among high-risk patients with uncontrolled diabetes and depression. In this randomized clinical trial, 225 participants (intervention [n = 136] and control [n = 89]) were enrolled from a regional Veterans Healthcare System serving Southeast Texas from November 1, 2012, through June 24, 2016. Data were gathered at baseline and 6 and 12 months after intervention. Patients selected had uncontrolled diabetes (hemoglobin A1c [HbA1c] >7.5%]) and clinically significant depression (Patient Health Questionnaire-9 scores [PHQ-9] ≥10) and were living more than 20 miles from the Veterans Affairs medical center. Data collection was completed on December 6, 2016, and final analyses were completed by January 25, 2018. All analyses were intent to treat. Healthy Outcomes Through Patient Empowerment (HOPE) included 9 telephone sessions with 24 trained health care professionals using collaborative goal-setting and behavioral activation methods. The control group received enhanced usual care (EUC) and notification of high-risk status. Change in depression symptoms using PHQ-9 and glycemic control using HbA1c from baseline to 6 months and to 12 months. Secondary analyses evaluated clinically significant responses for these measures. Among 225 participants, 202 (89.8%) were men, the mean (SD) age was 61.9 (8.3) years, 145 (64.4%) were married, and 156 (69.3%) had some education beyond high school. For the overall study, 38 participants (16.9%) were lost to follow-up or withdrew at 6 months and another 21 (9.3%) were lost to follow-up or withdrew at 12 months. Repeated-measures analysis with multiple imputation for missing data assessing the interaction of treatment group (HOPE vs EUC) and time (baseline, 6 months, and 12 months) found no significant improvement in PHQ-9 (β, 1.56; 95% CI, -0.68 to 3.81; P = .17) or HbA1c (β, -0.005; 95% CI, -0.73 to 0.72; P = .82). Analyses using t test for change from baseline to 12 months showed a HOPE vs EUC between-group mean difference for PHQ-9 of 2.14 (95% CI, 0.18 to 4.10; P = .03) and for HbA1c of -0.06% (95% CI, -0.61% to 0.50%; P = .83). A secondary analysis of patients experiencing a clinical response found that 52.1% of HOPE participants had clinically significant responses in PHQ-9 at 12 months vs 32.9% in EUC (difference, 0.19; 95% CI, 0.04-0.33; P = .01). Telephone-delivered, collaborative goal setting produced clinically significant reductions in depression symptoms but not glycemic control among patients who remained engaged at 12 months compared with EUC among a population screened sample of high-risk patients with diabetes and depression. Although the intervention created some lasting effect for depression, additional strategies are needed to maintain engagement of this high-risk population within an interprofessional team approach to primary care. ClinicalTrials.gov identifier: NCT01572389.
Highlights
One-third of patients with diabetes have clinically significant depression symptoms, contributing to substantial adverse consequences.[1]
Repeated-measures analysis with multiple imputation for missing data assessing the interaction of treatment group (HOPE vs enhanced usual care (EUC)) and time found no significant improvement in Patient Health Questionnaire–9 (PHQ-9) (β, 1.56; 95% CI, –0.68 to 3.81; P = .17) or hemoglobin A1c (HbA1c) (β, –0.005; 95% CI, –0.73 to 0.72; P = .82)
Telephone-delivered, collaborative goal setting produced clinically significant reductions in depression symptoms but not glycemic control among patients who remained engaged at 12 months compared with EUC among a population screened sample of high-risk patients with diabetes and depression
Summary
One-third of patients with diabetes have clinically significant depression symptoms, contributing to substantial adverse consequences.[1] Patients with diabetes and depression use more health services and have greater functional impairment and morbidity compared with those without depression.[2,3,4] Depression increases mortality risks among patients with diabetes, especially older adults and those who have had recent cardiovascular events.[5] there are correlations between the number of diabetes-related symptoms and the number of depression symptoms, suggesting a magnification of physical and affective symptoms in patients with comorbidities.[6]. Identification of at-risk patients is often difficult using customary screening methods.[11,12] Learning health care systems using electronic health records linked to large data repositories provide digital infrastructure for screening high-risk populations using more efficient and reliable methods.[13] Learning health care systems can use structured clinical, billing, and outcomes data to identify clusters of patients with persistently uncontrolled diabetes and depression risk factors before they present with more serious illness.[14]
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