Diabetes-Depression Care-management Adoption Trial
- Conditions
- Diabetes MellitusDepression
- Interventions
- Other: Technology-supported care
- Registration Number
- NCT01781013
- Lead Sponsor
- University of Southern California
- Brief Summary
The specific aims of the proposed study are to:
1. 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;
2. Conduct the quasi-experiment in eight Los Angeles County Department of Health Services (LAC-DHS) clinics to test the interventions;
3. 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
4. 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:
1. 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).
2. 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.
3. 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.
4. 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.
5. 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
In addition, the study will aim to answer the secondary research questions listed below:
1. What is medical provider satisfaction with the technology used in the TC (Technology Care) group?
2. What is patient acceptance with the technology used in the TC group?
3. What factors are identified by medical providers and clinic administrators as related to satisfaction, barriers, and sustaining the intervention post-trial?
4. What are patients' reported satisfaction and facilitating factors and barriers to receipt and acceptance of depression care?
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1485
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Technology-supported care Technology-supported care 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.
- Primary Outcome Measures
Name Time Method Change from baseline in depression outcome at 6-months 6-months from enrollment Depression is measured using depression scales Patient Health Questionnaire (PHQ)-9. Major depression is classified as PHQ-9\>=10.
- Secondary Outcome Measures
Name Time Method Change from baseline in diabetes self-care score in 6 months 6 months from enrollment Diabetes self-care is measured using the Toolbert diabetes self-care scale.
Trial Locations
- Locations (8)
El Monte Comprehensive Health Center
🇺🇸El Monte, California, United States
High Desert Comprehensive Health Center
🇺🇸Lancaster, California, United States
Long Beach Comprehensive Health Center
🇺🇸Long Beach, California, United States
H. Claude Hudson Comprehensive Health Center
🇺🇸Los Angeles, California, United States
Mid-Valley Comprehensive Health Center
🇺🇸Van Nuys, California, United States
Roybal Comprehensive Health Center
🇺🇸Los Angeles, California, United States
Harbor Comprehensive Health Center
🇺🇸Wilmington, California, United States
Olive View-UCLA Medical Center Diabetes Clinic
🇺🇸Sylmar, California, United States