Diabetes-Depression Care-management Adoption Trial (DCAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01781013
First received: January 29, 2013
Last updated: July 22, 2013
Last verified: August 2012
  Purpose

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.

Condition Intervention
Depression
Diabetes Mellitus
Other: Technology-supported care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Care Management Technology to Facilitate Depression Care in Safety Net Diabetes Clinics

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Change from baseline in depression outcome at 6-months [ Time Frame: 6-months from enrollment ] [ Designated as safety issue: No ]
    Depression is measured using depression scales Patient Health Questionnaire (PHQ)-9. Major depression is classified as PHQ-9>=10.


Secondary Outcome Measures:
  • Change from baseline in diabetes self-care score in 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    Diabetes self-care is measured using the Toolbert diabetes self-care scale.


Other Outcome Measures:
  • Change from baseline in physical functional status in 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    Physical functional status is measured using the physical component score of the SF-12 scale

  • Change from baseline in mental functional status in 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    Mental functional status is measured using the mental component score of the SF-12 scale

  • Change from baseline in physical functional status in 12 months [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    Physical functional status is measured using the physical component score of the SF-12 scale

  • Change from baseline in mental functional status in 12 months [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
    Mental functional status is measured using the mental component score of the SF-12 scale

  • Change from baseline of mental health-related functional impairment in 12 months [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    Assessed using the Sheehan disability scale

  • Change from baseline of mental health-related functional impairment in 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    Assessed using the Sheehan disability scale

  • Change from baseline in depression outcome in 12 months [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    Depression is measured using depression scales Patient Health Questionnaire (PHQ)-9. Major depression is classified as PHQ-9>=10.

  • Change from baseline in diabetes self-care score in 12 months [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
    Diabetes self-care is measured using Toolbert diabetes self-care scale.

  • Change from baseline of diabetes symptoms in 12 months [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    Assessed using the Whitty-9 diabetes symptoms scale

  • Change from baseline of diabetes symptoms in 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    Assessed using the Whitty-9 diabetes symptoms scale

  • Change from baseline in percentage of patients who receive HbA1C lab test in 12 months [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    This is one of our diabetes care processes measure. We are going to analyze the percentage of patients who receive the requisite lab tests, including HbA1C, microalbumin, and lipid panel.

  • Change from baseline in percentage of patients who receive the lipid panel lab test in 12 months [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    This is one of our diabetes care processes measure. We are going to analyze the percentage of patients who receive the requisite lab tests, including HbA1C, microalbumin, and lipid panel.

  • Change from baseline in percentage of patients who receive microalbumin lab test in 12 months [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    This is one of our diabetes care processes measure. We are going to analyze the percentage of patients who receive the requisite lab tests, including HbA1C, microalbumin, and lipid panel.

  • Change from baseline in percentage of patients who receive HbA1C lab test in 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    This is one of our diabetes care processes measure. We are going to analyze the percentage of patients who receive the requisite lab tests, including HbA1C, microalbumin, and lipid panel.

  • Change from baseline in percentage of patients who receive the lipid panel lab test in 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    This is one of our diabetes care processes measure. We are going to analyze the percentage of patients who receive the requisite lab tests, including HbA1C, microalbumin, and lipid panel

  • Change from baseline in percentage of patients who receive microalbumin lab test in 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    This is one of our diabetes care processes measure. We are going to analyze the percentage of patients who receive the requisite lab tests, including HbA1C, microalbumin, and lipid panel.

  • Change from baseline in percentage of patients whose HbA1C is in control in 12 months [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our diabetes outcome measure. We would like to know the percentage of patients whose HbA1C is in control pre- and post-intervention. HbA1C is considered controlled if it is <7%.

  • Change from baseline in percentage of patients whose microalbumin is in control in 12 months [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our diabetes outcome measure. We would like to know the percentage of patients whose microalbumin is in control pre- and post-intervention. Microalbumin is considered controlled if it is <30 microg/mg.

  • Change from baseline in percentage of patients whose total cholesterol is in control in 12 months [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our diabetes outcome measure. We would like to know the percentage of patients whose total cholesterol is in control pre- and post-intervention. Total cholesterol is considered controlled if it is <200mg/dL.

  • Change from baseline in percentage of patients whose LDL cholesterol is in control in 12 months [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our diabetes outcome measure. We would like to know the percentage of patients whose LDL cholesterol is in control pre- and post-intervention. LDL cholesterol is considered controlled if it is <100mg/dL.

  • Change from baseline in percentage of patients whose HDL cholesterol is in control in 12 months [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our diabetes outcome measure. We would like to know the percentage of patients whose HDL cholesterol is in control pre- and post-intervention. HDL cholesterol is considered controlled if it is <40mg/dL.

  • Change from baseline in percentage of patients whose triglycerides is in control in 12 months [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our diabetes outcome measure. We would like to know the percentage of patients whose triglycerides is in control pre- and post-intervention. Triglycerides is considered controlled if it is >200mg/dL.

  • Change from baseline in percentage of patients whose HbA1C is in control in 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our diabetes outcome measure. We would like to know the percentage of patients whose HbA1C is in control pre- and post-intervention. HbA1C is considered controlled if it is <7%.

  • Change from baseline in percentage of patients whose microalbumin is in control in 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our diabetes outcome measure. We would like to know the percentage of patients whose microalbumin is in control pre- and post-intervention. Microalbumin is considered controlled if it is <20mg/L.

  • Change from baseline in percentage of patients whose total cholesterol is in control in 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our diabetes outcome measure. We would like to know the percentage of patients whose total cholesterol is in control pre- and post-intervention. Total cholesterol is considered controlled if it is >240mg/dL

  • Change from baseline in percentage of patients whose LDL cholesterol is in control in 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our diabetes outcome measure. We would like to know the percentage of patients whose LDL cholesterol is in control pre- and post-intervention. LDL cholesterol is considered controlled if it is >160mg/dL.

  • Change from baseline in percentage of patients whose HDL cholesterol is in control in 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our diabetes outcome measure. We would like to know the percentage of patients whose HDL cholesterol is in control pre- and post-intervention. HDL cholesterol is considered controlled if it is >60mg/dL.

  • Change from baseline in percentage of patients whose triglycerides is in control in 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our diabetes outcome measure. We would like to know the percentage of patients whose triglycerides is in control pre- and post-intervention. Triglycerides is considered controlled if it is <150mg/dL

  • Change from baseline to 12 months in number of outpatient visits during the past 6 months [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our utilization measure. We would like to know the number of outpatient visits during 6-months before baseline and between 6- and 12-months after enrollment.

  • Change from baseline to 6 months in number of outpatient visits during the past 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our utilization measure. We would like to know the number of outpatient visits during 6-months before baseline and during the 6-months after enrollment.

  • Change from baseline to 12 months in percentage of patients who were hospitalized during the past 6 months [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our utilization measure. We would like to know the percentage of hospitalized patients during 6-months before baseline and between 6- and 12-months after enrollment.

  • Change from baseline to 6 months in percentage of hospitalized patients during the past 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our utilization measure. We would like to know the percentage of hospitalized patients during 6-months before baseline and during the 6-months after enrollment.

  • Change from baseline to 12 months in percentage of patients with ER visits during the past 6 months [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our utilization measure. We would like to know the percentage of patients with ER visits during 6-months before baseline and between 6- and 12-months after enrollment.

  • Change from baseline to 6 months in percentage of patients with ER visits during the past 6 months [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    This is part of our utilization measure. We would like to know the percentage of patients with ER visits during 6-months before baseline and during the 6-months after enrollment.

  • Difference between cost of care management in the intervention group and the control groups over a 12-month period per patient [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Cost of care management includes automated phone calls, provider time, costs associated with reviewing tasks and follow-ups.

  • Change from baseline to 12 months in percentage of patients satisfied with care received for diabetes [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    Measured by the percentage of patients who answered "satisfied" or "very satisfied" to the question "How satisfied / dissatisfied are you with the overall health care available to you for your diabetes?" (with a 5-point Likert scale response option)

  • Change from baseline to 6 months in percentage of patients satisfied with care received for diabetes [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    Measured by the percentage of patients who answered "satisfied" or "very satisfied" to the question "How satisfied / dissatisfied are you with the overall health care available to you for your diabetes?" (with a 5-point Likert scale response option)

  • Change from baseline to 12 months in percentage of patients satisfied with care received for depression [ Time Frame: 12 months from enrollment ] [ Designated as safety issue: No ]
    Measured by the percentage of patients who answered "satisfied" or "very satisfied" to the question "How satisfied / dissatisfied are you with the clinical help received with your emotional problem?" (with a 5-point Likert scale response option)

  • Change from baseline to 6 months in percentage of patients satisfied with care received for depression [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    Measured by the percentage of patients who answered "satisfied" or "very satisfied" to the question "How satisfied / dissatisfied are you with the clinical help received with your emotional problem?" (with a 5-point Likert scale response option)


Enrollment: 1485
Study Start Date: June 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: Technology-supported care
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)..
No Intervention: Supported-Care
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
This arm consists of non-CRM (Clinic Resource Management) clinics and serves as one of the two control arms in the study.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781013

Locations
United States, California
El Monte Comprehensive Health Center
El Monte, California, United States, 91731
High Desert Comprehensive Health Center
Lancaster, California, United States, 93536
Long Beach Comprehensive Health Center
Long Beach, California, United States, 90813
H. Claude Hudson Comprehensive Health Center
Los Angeles, California, United States, 90007
Roybal Comprehensive Health Center
Los Angeles, California, United States, 90022
Olive View-UCLA Medical Center Diabetes Clinic
Sylmar, California, United States, 91342
Mid-Valley Comprehensive Health Center
Van Nuys, California, United States, 91405
Harbor Comprehensive Health Center
Wilmington, California, United States, 90744
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Shinyi Wu, PhD University of Southern California
  More Information

Publications:

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01781013     History of Changes
Other Study ID Numbers: RFA-AE-10-001
Study First Received: January 29, 2013
Last Updated: July 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Depression screening
Depression monitoring
Chronic illness
Behavioral health
Care management
Automatic telephone assessment
Clinical decision support
Suicide alert

Additional relevant MeSH terms:
Depression
Depressive Disorder
Diabetes Mellitus
Behavioral Symptoms
Mood Disorders
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014