Depression Clinical Trial
Official title:
Care Management Technology to Facilitate Depression Care in Safety Net Diabetes Clinics
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.
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?
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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