Project Background: The co-occurrence of diabetes and depressive symptoms is highly prevalent and has dramatic consequences on the quality of life and health of affected patients. Due to the complex interrelation between these conditions, patients often experience both psychological and physiological difficulties. Furthermore, veterans with diabetes and depressive symptoms in rural settings have limited access to care. Interventions that reach veterans in rural / community-based primary care are needed, especially those that blend treatment strategies for physical and emotional health. Project Objectives: Specific (Primary) Aim (1): Compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) at 6 and 12 month follow-up. Hypothesis 1a: After 6 months (active treatment phase), HOPE will produce greater improvements in diabetes control (measured by hemoglobin A1c levels) and depression (measured by PHQ-9 scores) than will EUC. Hypothesis 1b: At 12 months (6-month active phase plus 6-month maintenance phase), HOPE participants will continue to evidence significant greater improvements in HbA1c and PHQ-9 compared with EUC participants. Exploratory Specific Aim (2): To examine the role of moderators and mediators on intervention effectiveness Exploratory Aim 2a. To evaluate factors that mediate or moderate effectiveness at 6 and 12 months for all enrolled patients (regardless of intervention group assignment). Potential mediating and moderating variables include patient-level (clinical factors-diabetes distress and self-efficacy and sociodemographics) and facility- level factors (availability of medical and mental health services by clinical site). Exploratory Aim 2b. To evaluate factors that mediate or moderate effectiveness at 6 and 12 months for patients enrolled in the HOPE intervention arm. Intervention factors include adherence (e.g. session attendance), fidelity (ratings of coach effectiveness), and treatment implementation (e.g., goal setting quality and self-management behaviors) as well as any significant predictors obtained from Aim 1a. Exploratory Specific Aim (3): Evaluate the potential for embedding the HOPE intervention processes within a VA CBOC using the RE-AIM framework for evaluating effectiveness of behavioral interventions. Exploratory Aim 3a - Reach. Compare clinical and demographic characteristics of enrolled study participants with the characteristics of all potentially eligible patients at each CBOC. Exploratory Aim 3b - Adoption. Qualitatively elicit clinicians'perceptions of behavioral coaches, patients'use of action plans, and responses to coaches'recommendations in preparation for future implementation Project Methods: The proposed study is a randomized controlled trial enrolling 242 largely rural veterans with uncontrolled diabetes and clinically-significant depressive symptoms. Both groups will receive screening, education, and notification of clinical findings along with follow-up in usual primary care. HOPE participants will also receive 8 behavioral coaching telephone sessions and four booster sessions over a six month period. Coaches will use a standardized, theory-based process for conducting the sessions with the aim of creating patient-centered and articulated goals and behavioral action plans. Participants'primary care providers will be notified about session discussions and the resultant goals and action plans. Both groups will receive only usual primary care during the subsequent 6 months maintenance period. Hemoglobin A1c and PHQ-9 measurements along with self-report questionnaires will also be collected at baseline, 6 and 12 months follow- up. Changes in measurements from baseline will be compared between groups. Analytic evaluations of intervention mediators/moderators and implementation will also be conducted at 6 and 12 months follow-up. 1. Significance of the Specific Aims Proposed. Criterion Score: 1.5 Co-occurring major depression is common among diabetic patients (11%) and potentially significant depressive symptoms are evident in up to a third of patients with diabetes. Diabetic patients with co-occurring depression have higher health care costs, poorer self management, and poorer glycemic control than diabetics without depression. Thus, the problem is highly significant for VHA and society in general. 2. Impact / Innovation / Contribution to VHA. Criterion Score: 1.6 Previous trials targeting co-occurring depression and diabetes have largely focused on depression management and while they have produced clinically significant decreases in depression outcomes they've resulted in no change in HbA1c values. If the proposed intervention is successful, it could make a significant contribution toward reducing morbidity associated with diabetes. 3. Approach. Criterion Score: 1.5 The application now includes some pilot data from an open pilot study of 9 enrolled patients. The observed attrition rate appears to be 22%. Pre-post statistical effect sizes were moderate for HbA1c values (9.7 vs. 8.6;Cohen's D=0.35) and large for PHQ-9 . Note that although the effect on the PHQ-9 was statistically large, it actually reflects the """"""""minimally clinically signifiant change"""""""" of 5 points (2 standard errors of the measurement) on the PHQ-9. While pilot data that included a control group would have been preferable to those presented (e.g., as it is possible that observed treatment effects are a result of regression to the mean), they at least provide some data showing an effect of the proposed intervention. The proposed randomized controlled design is appropriate, as is the quantitative approach applied to testing the primary aim of the project. The qualitative approach for the exploratory aim 3 investigating providers'perceptions of the intervention as a first step toward implementation is a strength. The application and conceptualization of interventions are well grounded and driven by relevant theoretical models including the transactional model of stress and coping, the Re-Aim framework to evaluate impact, and the 5 A's model for behavioral goal setting. Inclusion criteria have been changed to avoid complications with overly aggressive treatment as seen in the ACCORD trial. The primary outcomes appear adequately measured. The majority of potential moderating and mediating variables (Aim 2) are also assessed with well validated self-report measures or with variables attained from the medical record (e.g., prescribed medications;receipt of other related treatments). There is better specificity on how psychiatric outcomes will be assessed and modeled. The use of both 6 month and 12-month endpoints is a strength. The analysis plan is improved and there is now a plan to test whether there is a group difference in clinically significant changes (e.g., difference in HbA1c of 0.5;proportion of patients with PHQ-9 scores <4). While the proposal includes information on ensuring reliability and fidelity of intervention, a relative weakness that remains is that the analysis plan does not account for the fact that patients will be nested within therapist/behavioral coach. So called non-specific factors of psychotherapy may be a strong predictor of outcome and may differ across coach. A strength of the application is that data will be collected via use of validated self-report measures or from medical and pharmacy record sources. The investigators have experience with the proposed measures from their previous work. The monitoring of intervention fidelity is a strength. 4. Investigator Qualifications / Resources and Environment. Criterion Score: 1.5 The investigative team seems well qualified to complete the proposed project. The co-PIs, while relatively junior, have complementary expertise and are both grant funded investigators. Dr. Kunik's effort on the project is a strength. 5. Feasibility. The revised application includes additional data on the feasibility of the proposed enrollment, which is a strength. 6. Project Organization and Management. The proposed project will be led by both Drs. Naik and Cully at 25% effort each. The leadership plan for multiple PIs is convincing. Dr. Kunik currently mentors both Drs. Naik and Cully and has time on this project. The project management plan which includes weekly meetings of the core study team (PIs, RA, project coordinator, statistician, data analyst), quarterly meetings with Dr. Haidet (a consultant who is chairing the data safety monitoring committee), and bi-annual meetings of the full advisory board is sound. The dissemination and implementation plan is innovative and is a major strength. The investigators have experience working with local medical center management on implementation of quality improvement efforts and will partner with the VISN 16 MIRECC to disseminate results. Included in these efforts will be staff training in HOPE methodology and refinement of behavioral coaching methods to enhance adaption by VA staff. These efforts will be informed and guided by results of qualitative analyses (AIM 3). A concern is whether individuals without a psychology/behavioral science background could implement the intervention. 7. Human Subject Protections. Acceptable. The primary risks associated with this study are risks to confidentiality and possible psychological distress associated with questionnaires or the content of the intervention. The plan to minimize risks is appropriate. A plan to deal with patients expressing suicidal ideation has been developed. Respondent burden is reasonable. A minor point, the human subjects section has not been updated to include the inclusion criteria of >20 miles from MEDVAMC. 8. Inclusion of Women and Minorities. Acceptable. Women and minorities will be represented proportionally to their population representation. 9. Response to Previous Review. The applicants appear to have been highly responsive to previous feedback by HSR&D and have implemented a number of important changes including: (1) Inclusion of pilot data from an open-label pilot of HOPE. (2) Changes in inclusion criteria based on VA/DoD guidelines for lowering A1c. (3) Addressed missingness of A1c values. (4) Changed inclusion criteria to >20 miles away from Houston VAMC to increase representativeness of rural veterans. (5) Better specified analytic plan in relation to moderating/mediating variables in exploratory aims. 10. Budget. The budget is reasonable. Dr. Naik is not 5/8ths VA and thus an eligibility waiver will be submitted. 11. Overall Impression. The proposed project addresses a highly significant, high priority area and may contribute to advancing Veteran health. The research plan is clearly stated and generally appropriate to the aims of the study. The project and dissemination plan are innovative and if successful are likely to reduce morbidity associated with diabetes. The investigators and environment are strengths of the application. Pilot data that provide an estimate of the effect of the intervention now strengthen the application. (Summary Points) 1. The primary aim of the study is clear, highly relevant to the VA mission and has the potential to contribute to VHA and beyond. 2. The investigators have been responsive to previous concerns and now include pilot data to provide some estimate of the effect of the intervention. 12. Key Strengths. There are a number of notable strengths to this application including: 1. The study addresses an important topic associated with two HSR&D priority areas. 2. Excellent team of investigators. 3. Innovative intervention and dissemination plan. 4. Pilot data providing some evidence of treatment efficacy. 13. Key Weaknesses. 1. Proposed analyses don't account for potential therapist effects 2. As therapists are all advanced psychology graduate students, it is unclear whether individuals without such previous training can implement the intervention. This may hamper implementation efforts.
Anticipated Impact on Veterans'Care: Diabetes mellitus is the third most common diagnosis within VHA, affecting one in six veterans. One-third of these patients experience clinically significant symptoms of depression. Diabetic veterans with depressive symptoms have greater health services utilization, functional impairment, morbidity and mortality compared to diabetics without depressive symptoms. Depressive symptoms are associated with greater non-adherence to diabetes self-care activities. This study evaluates a feasible method of reaching veterans, living in rural areas or at a distance from a VA hospital, to support existing primary care services in treating veterans with complex yet common morbid conditions. If this model of behavioral coaching is proven effective, it may be applicable for other chronic conditions that require physical and psychological treatment to improve patient-centered health outcomes.
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