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Open Access Study protocol

Behavioral health coaching for rural veterans with diabetes and depression: a patient randomized effectiveness implementation trial

Jeffrey A Cully1234*, Jessica Y Breland12, Suzanne Robertson13, Anne E Utech2, Natalie Hundt1234, Mark E Kunik1234, Nancy J Petersen123, Nicholas Masozera23, Radha Rao12 and Aanand D Naik123

Author Affiliations

1 Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, (MEDVAMC 152), 2002 Holcombe Blvd., Houston, TX 77030, USA

2 Michael E. DeBakey VA Medical Center, 2002 Holcombe Blvd., Houston, TX 77030, USA

3 Baylor College of Medicine, Houston, TX, USA

4 VA South Central Mental Illness, Education, Research and Clinical Center, Virginia, USA

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BMC Health Services Research 2014, 14:191  doi:10.1186/1472-6963-14-191

Published: 28 April 2014

Abstract

Background

Depression and diabetes cause significant burden for patients and the healthcare system and, when co-occurring, result in poorer self-care behaviors and worse glycemic control than for either condition alone. However, the clinical management of these comorbid conditions is complicated by a host of patient, provider, and system-level barriers that are especially problematic for patients in rural locations. Patient-centered medical homes provide an opportunity to integrate mental and physical health care to address the multifaceted needs of complex comorbid conditions. Presently, there is a need to not only develop robust clinical interventions for complex medically ill patients but also to find feasible ways to embed these interventions into the frontlines of existing primary care practices.

Methods/design

This randomized controlled trial uses a hybrid effectiveness-implementation design to evaluate the Healthy Outcomes through Patient Empowerment (HOPE) intervention, which seeks to simultaneously address diabetes and depression for rural veterans in Southeast Texas. A total of 242 Veterans with uncontrolled diabetes and comorbid symptoms of depression will be recruited and randomized to either the HOPE intervention or to a usual-care arm. Participants will be evaluated on a host of diabetes and depression-related measures at baseline and 6- and 12-month follow-up. The trial has two primary goals: 1) to examine the effectiveness of the intervention on both physical (diabetes) and emotional health (depression) outcomes and 2) to simultaneously pilot test a multifaceted implementation strategy designed to increase fidelity and utilization of the intervention by coaches interfacing within the primary care setting.

Discussion

This ongoing blended effectiveness-implementation design holds the potential to advance the science and practice of caring for complex medically ill patients within the constraints of a busy patient-centered medical home.

Trial registration

Behavioral Activation Therapy for Rural Veterans with Diabetes and Depression: NCT01572389.

Keywords:
Behavioral medicine; Diabetes mellitus; Depression; Veterans’ health