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Completed

NCT Number: NCT01781013

Diabetes-Depression Care-management Adoption Trial

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Chronic Disease Diabetes Mellitus Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

El Monte Comprehensive Health Center, El Monte, California, United States

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About this study

In addition, the study will aim to answer the secondary research questions listed below:

  • What is medical provider satisfaction with the technology used in the TC (Technology Care) group?
  • What is patient acceptance with the technology used in the TC group?
  • What factors are identified by medical providers and clinic administrators as related to satisfaction, barriers, and sustaining the intervention post-trial?
  • What are patients' reported satisfaction and facilitating factors and barriers to receipt and acceptance of depression care?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Technology-supported care

Other

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)..

Primary outcomes

  1. Change from baseline in depression outcome at 6-months

    Time frame: 6-months from enrollment

    Depression is measured using depression scales Patient Health Questionnaire (PHQ)-9. Major depression is classified as PHQ-9>=10.

Secondary outcomes

  1. Change from baseline in diabetes self-care score in 6 months

    Time frame: 6 months from enrollment

    Diabetes self-care is measured using the Toolbert diabetes self-care scale.

Other outcomes

  1. Change from baseline in physical functional status in 6 months

    Time frame: 6 months from enrollment

    Physical functional status is measured using the physical component score of the SF-12 scale

  2. Change from baseline in mental functional status in 6 months

    Time frame: 6 months from enrollment

    Mental functional status is measured using the mental component score of the SF-12 scale

  3. Change from baseline in physical functional status in 12 months

    Time frame: 12 months from enrollment

    Physical functional status is measured using the physical component score of the SF-12 scale

  4. Change from baseline in mental functional status in 12 months

    Time frame: 12 months after enrollment

    Mental functional status is measured using the mental component score of the SF-12 scale

  5. Change from baseline of mental health-related functional impairment in 12 months

    Time frame: 12 months from enrollment

    Assessed using the Sheehan disability scale

  6. Change from baseline of mental health-related functional impairment in 6 months

    Time frame: 6 months from enrollment

    Assessed using the Sheehan disability scale

  7. Change from baseline in depression outcome in 12 months

    Time frame: 12 months from enrollment

    Depression is measured using depression scales Patient Health Questionnaire (PHQ)-9. Major depression is classified as PHQ-9>=10.

  8. Change from baseline in diabetes self-care score in 12 months

    Time frame: 12 months after enrollment

    Diabetes self-care is measured using Toolbert diabetes self-care scale.

  9. Change from baseline of diabetes symptoms in 12 months

    Time frame: 12 months from enrollment

    Assessed using the Whitty-9 diabetes symptoms scale

  10. Change from baseline of diabetes symptoms in 6 months

    Time frame: 6 months from enrollment

    Assessed using the Whitty-9 diabetes symptoms scale

  11. Change from baseline in percentage of patients who receive HbA1C lab test in 12 months

    Time frame: 12 months from enrollment

    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.

  12. Change from baseline in percentage of patients who receive the lipid panel lab test in 12 months

    Time frame: 12 months from enrollment

    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.

  13. Change from baseline in percentage of patients who receive microalbumin lab test in 12 months

    Time frame: 12 months from enrollment

    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.

  14. Change from baseline in percentage of patients who receive HbA1C lab test in 6 months

    Time frame: 6 months from enrollment

    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.

  15. Change from baseline in percentage of patients who receive the lipid panel lab test in 6 months

    Time frame: 6 months from enrollment

    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

  16. Change from baseline in percentage of patients who receive microalbumin lab test in 6 months

    Time frame: 6 months from enrollment

    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.

  17. Change from baseline in percentage of patients whose HbA1C is in control in 12 months

    Time frame: 12 months from enrollment

    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%.

  18. Change from baseline in percentage of patients whose microalbumin is in control in 12 months

    Time frame: 12 months from enrollment

    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.

  19. Change from baseline in percentage of patients whose total cholesterol is in control in 12 months

    Time frame: 12 months from enrollment

    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.

  20. Change from baseline in percentage of patients whose LDL cholesterol is in control in 12 months

    Time frame: 12 months from enrollment

    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.

  21. Change from baseline in percentage of patients whose HDL cholesterol is in control in 12 months

    Time frame: 12 months from enrollment

    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.

  22. Change from baseline in percentage of patients whose triglycerides is in control in 12 months

    Time frame: 12 months from enrollment

    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.

  23. Change from baseline in percentage of patients whose HbA1C is in control in 6 months

    Time frame: 6 months from enrollment

    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%.

  24. Change from baseline in percentage of patients whose microalbumin is in control in 6 months

    Time frame: 6 months from enrollment

    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.

  25. Change from baseline in percentage of patients whose total cholesterol is in control in 6 months

    Time frame: 6 months from enrollment

    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

  26. Change from baseline in percentage of patients whose LDL cholesterol is in control in 6 months

    Time frame: 6 months from enrollment

    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.

  27. Change from baseline in percentage of patients whose HDL cholesterol is in control in 6 months

    Time frame: 6 months from enrollment

    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.

  28. Change from baseline in percentage of patients whose triglycerides is in control in 6 months

    Time frame: 6 months from enrollment

    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

  29. Change from baseline to 12 months in number of outpatient visits during the past 6 months

    Time frame: 12 months from enrollment

    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.

  30. Change from baseline to 6 months in number of outpatient visits during the past 6 months

    Time frame: 6 months from enrollment

    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.

  31. Change from baseline to 12 months in percentage of patients who were hospitalized during the past 6 months

    Time frame: 12 months from enrollment

    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.

  32. Change from baseline to 6 months in percentage of hospitalized patients during the past 6 months

    Time frame: 6 months from enrollment

    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.

  33. Change from baseline to 12 months in percentage of patients with ER visits during the past 6 months

    Time frame: 12 months from enrollment

    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.

  34. Change from baseline to 6 months in percentage of patients with ER visits during the past 6 months

    Time frame: 6 months from enrollment

    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.

  35. 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

    Cost of care management includes automated phone calls, provider time, costs associated with reviewing tasks and follow-ups.

  36. Change from baseline to 12 months in percentage of patients satisfied with care received for diabetes

    Time frame: 12 months from enrollment

    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)

  37. Change from baseline to 6 months in percentage of patients satisfied with care received for diabetes

    Time frame: 6 months from enrollment

    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)

  38. Change from baseline to 12 months in percentage of patients satisfied with care received for depression

    Time frame: 12 months from enrollment

    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)

  39. Change from baseline to 6 months in percentage of patients satisfied with care received for depression

    Time frame: 6 months from enrollment

    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)

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

Care Management Technology to Facilitate Depression Care in Safety Net Diabetes Clinics

Acronym: DCAT

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 31, 2013
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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