Clinical trial NCT01781013: Diabetes-Depression Care-management Adoption Trial
Official title: Care Management Technology to Facilitate Depression Care in Safety Net Diabetes Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Diabetes Mellitus
Keywords: Depression screening
Depression monitoring
Chronic illness
Behavioral health
Care management
Automatic telephone assessment
Clinical decision support
Suicide alert
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2013-01-31
Enrollment: 1485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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?

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in depression outcome at 6-months
timeFrame: 6-months from enrollment
Secondary outcomes:
measure: Change from baseline in diabetes self-care score in 6 months
timeFrame: 6 months from enrollment
Other outcomes:
measure: Change from baseline in physical functional status in 6 months
timeFrame: 6 months from enrollment
measure: Change from baseline in mental functional status in 6 months
timeFrame: 6 months from enrollment
measure: Change from baseline in physical functional status in 12 months
timeFrame: 12 months from enrollment
measure: Change from baseline in mental functional status in 12 months
timeFrame: 12 months after enrollment
measure: Change from baseline of mental health-related functional impairment in 12 months
timeFrame: 12 months from enrollment
measure: Change from baseline of mental health-related functional impairment in 6 months
timeFrame: 6 months from enrollment
measure: Change from baseline in depression outcome in 12 months
timeFrame: 12 months from enrollment
measure: Change from baseline in diabetes self-care score in 12 months
timeFrame: 12 months after enrollment
measure: Change from baseline of diabetes symptoms in 12 months
timeFrame: 12 months from enrollment
measure: Change from baseline of diabetes symptoms in 6 months
timeFrame: 6 months from enrollment
measure: Change from baseline in percentage of patients who receive HbA1C lab test in 12 months
timeFrame: 12 months from enrollment
measure: Change from baseline in percentage of patients who receive the lipid panel lab test in 12 months
timeFrame: 12 months from enrollment
measure: Change from baseline in percentage of patients who receive microalbumin lab test in 12 months
timeFrame: 12 months from enrollment
measure: Change from baseline in percentage of patients who receive HbA1C lab test in 6 months
timeFrame: 6 months from enrollment
measure: Change from baseline in percentage of patients who receive the lipid panel lab test in 6 months
timeFrame: 6 months from enrollment
measure: Change from baseline in percentage of patients who receive microalbumin lab test in 6 months
timeFrame: 6 months from enrollment
measure: Change from baseline in percentage of patients whose HbA1C is in control in 12 months
timeFrame: 12 months from enrollment
measure: Change from baseline in percentage of patients whose microalbumin is in control in 12 months
timeFrame: 12 months from enrollment
measure: Change from baseline in percentage of patients whose total cholesterol is in control in 12 months
timeFrame: 12 months from enrollment
measure: Change from baseline in percentage of patients whose LDL cholesterol is in control in 12 months
timeFrame: 12 months from enrollment
measure: Change from baseline in percentage of patients whose HDL cholesterol is in control in 12 months
timeFrame: 12 months from enrollment
measure: Change from baseline in percentage of patients whose triglycerides is in control in 12 months
timeFrame: 12 months from enrollment
measure: Change from baseline in percentage of patients whose HbA1C is in control in 6 months
timeFrame: 6 months from enrollment
measure: Change from baseline in percentage of patients whose microalbumin is in control in 6 months
timeFrame: 6 months from enrollment
measure: Change from baseline in percentage of patients whose total cholesterol is in control in 6 months
timeFrame: 6 months from enrollment
measure: Change from baseline in percentage of patients whose LDL cholesterol is in control in 6 months
timeFrame: 6 months from enrollment
measure: Change from baseline in percentage of patients whose HDL cholesterol is in control in 6 months
timeFrame: 6 months from enrollment
measure: Change from baseline in percentage of patients whose triglycerides is in control in 6 months
timeFrame: 6 months from enrollment
measure: Change from baseline to 12 months in number of outpatient visits during the past 6 months
timeFrame: 12 months from enrollment
measure: Change from baseline to 6 months in number of outpatient visits during the past 6 months
timeFrame: 6 months from enrollment
measure: Change from baseline to 12 months in percentage of patients who were hospitalized during the past 6 months
timeFrame: 12 months from enrollment
measure: Change from baseline to 6 months in percentage of hospitalized patients during the past 6 months
timeFrame: 6 months from enrollment
measure: Change from baseline to 12 months in percentage of patients with ER visits during the past 6 months
timeFrame: 12 months from enrollment
measure: Change from baseline to 6 months in percentage of patients with ER visits during the past 6 months
timeFrame: 6 months from enrollment
measure: Difference between cost of care management in the intervention group and the control groups over a 12-month period per patient
timeFrame: 12 months
measure: Change from baseline to 12 months in percentage of patients satisfied with care received for diabetes
timeFrame: 12 months from enrollment
measure: Change from baseline to 6 months in percentage of patients satisfied with care received for diabetes
timeFrame: 6 months from enrollment
measure: Change from baseline to 12 months in percentage of patients satisfied with care received for depression
timeFrame: 12 months from enrollment
measure: Change from baseline to 6 months in percentage of patients satisfied with care received for depression
timeFrame: 6 months from enrollment
Locations:
city: El Monte
country: United States
facility: El Monte Comprehensive Health Center
state: California
city: Lancaster
country: United States
facility: High Desert Comprehensive Health Center
state: California
city: Long Beach
country: United States
facility: Long Beach Comprehensive Health Center
state: California
city: Los Angeles
country: United States
facility: H. Claude Hudson Comprehensive Health Center
state: California
city: Los Angeles
country: United States
facility: Roybal Comprehensive Health Center
state: California
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center Diabetes Clinic
state: California
city: Van Nuys
country: United States
facility: Mid-Valley Comprehensive Health Center
state: California
city: Wilmington
country: United States
facility: Harbor Comprehensive Health Center
state: California
Study officials:
affiliation: University of Southern California
name: Shinyi Wu, PhD
role: PRINCIPAL_INVESTIGATOR
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