Diabetes-Depression Care-management Adoption Trial (DCAT)

University of Southern California

Status: Completed

Conditions: Diabetes Mellitus; Depression

Treatments: Other: Technology-supported care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01781013

RFA-AE-10-001

Details and patient eligibility

About

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.

Full 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?

Enrollment: 1,485 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,485 participants in 3 patient groups

Technology-supported care

Experimental group

Description:

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.

Treatment:

Other: Technology-supported care

Supported-Care

No Intervention group

Description:

This arm consists of CRM (Clinic Resource Management) clinics and serves as one of the two control arms in the study.

Usual Care

No Intervention group

Description:

This arm consists of non-CRM (Clinic Resource Management) clinics and serves as one of the two control arms in the study.