Diabetes-Depression Care-management Adoption Trial

Study Overview
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Brief Summary
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The specific aims of the proposed study are to: Develop the innovative depression care management technology, including the speech recognition technology for automated monitoring and patient prompts over time, automatic integration of the responses into the patient registry, and evidence-based decision-support algorithms for care actions; Conduct the quasi-experiment in eight Los Angeles County Department of Health Services (LAC-DHS) clinics to test the interventions; Use mixed-method evaluation to assess the extent of the implementation of the interventions, the acceptance to the providers and to the patients, and the impact on adoption of depression screening and treatment management over time, utilization, and cost of healthcare services, and patient health outcomes; and Conduct a cost-effectiveness analysis of the three study arms. Successful completion of the study will demonstrate which Comparative Effectiveness Research (CER) adoption strategies are successful and why, their comparative cost-effectiveness, as well as which strategies are successful under which circumstances to inform system-wide implementation of same. Hypotheses of the Proposed Study The following are the main hypotheses of the study: There will be statistically significant difference in the adoption of depression care screening and management over time among the three study groups. 1.1. The adoption rate will be Technology-supported care (TC) > Supported Care (SC) > Usual Care (UC). There will be statistically significant difference in the depression symptom reduction, and better functional status, and quality of life among the three study groups. 2.1. The difference between the TC and the SC will not be statistically significant, but both will be greater than the UC group. There will be statistically significant difference in the diabetes care process and outcomes among the three study groups. 3.1. The difference between the TC and the SC will not be statistically significant, but both will be greater than the UC group. There will also be statistically significant differences in healthcare utilization among the three study groups, with least utilization in the TC group where the greatest level of technology is applied. Of the three groups compared, the TC group will be the most cost-effective approach for accelerating adoption of the CER depression care results.

Detailed Description
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In addition, the study will aim to answer the secondary research questions listed below: What is medical provider satisfaction with the technology used in the TC (Technology Care) group? What is patient acceptance with the technology used in the TC group? What factors are identified by medical providers and clinic administrators as related to satisfaction, barriers, and sustaining the intervention post-trial? What are patients' reported satisfaction and facilitating factors and barriers to receipt and acceptance of depression care?

Official Title
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Care Management Technology to Facilitate Depression Care in Safety Net Diabetes Clinics

Conditions
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Depression, Diabetes Mellitus

Intervention / Treatment
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* Other: Technology-supported care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age equal to or greater than 18 years receiving primary care at DHS safety net clinics having a current diagnosis of type 2 diabetes mellitus (non-gestational). have a working telephone or cellular phone. Exclusion Criteria: current suicidal ideation; inability to speak either English or Spanish; a score of 2 or greater on the CAGE (4M) alcohol assessment; having schizophrenia, schizoaffective disorder, manic-depressive, or needing lithium; and cognitive impairment precluding ability to give informed consent or participating in the intervention, i.e., Short Portable Mental Status Questionnaire(SPMSQ) score of 6 or more errors. Provider and administrator inclusion criteria are: practicing or managing at one of the eight study sites; involved with diabetes or depression care No specific exclusion criteria will be applied to providers and administrators.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Technology-supported care<br>This arm consists of Clinic Resource Management (CRM) clinics and serves as our intervention arm where the tested technology is implemented. Our overarching aim in these comparisons is to assess the potential effects of technology-facilitated depression symptom monitoring, relapse prevention, and medication adjustments and to examine depression care receipt and symptom improvement, patient/provider acceptance, and cost. | Other: Technology-supported care<br>* The depression care-management technology that will interact with patients is the Automated Speech Recognition (ASR) for remote monitoring data collection. The ASR will use automated telephone calls to reach out to patients to repeat depression screening using PHQ-9, triggered either by calendar date or upcoming appointments, and to remind patients of their appointments in pre-determined time. In addition, the ASR will apply a structured script to conduct automatic follow-up with patients regarding their depression treatment adherence and side effects in order to provide data to help primary medical providers promptly and optimally adapt treatment. The ASR script will also include structured relapse prevention prompts. For providers and administrators, the depression care-management technology aimed to improve their workflow regarding depression care is Enhanced Disease Registry (EDR)..<br>|
| No Intervention: Supported-Care<br>This arm consists of CRM (Clinic Resource Management) clinics and serves as one of the two control arms in the study. | |
| No Intervention: Usual Care<br>This arm consists of non-CRM (Clinic Resource Management) clinics and serves as one of the two control arms in the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in depression outcome at 6-months | Depression is measured using depression scales Patient Health Questionnaire (PHQ)-9. Major depression is classified as PHQ-9>=10. | 6-months from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diabetes self-care score in 6 months | Diabetes self-care is measured using the Toolbert diabetes self-care scale. | 6 months from enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic illness, Behavioral health, Care management, Automatic telephone assessment, Clinical decision support, Suicide alert, Depression screening, Depression monitoring