Diabetes-Depression Care-management Adoption Trial

Depression Clinical Trial

— DCAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781013
• Other study ID #: RFA-AE-10-001
• Status: Completed
• Phase: N/A
• First received: January 29, 2013
• Last updated: December 3, 2014
• Start date: June 2010
• Est. completion date: September 2013

Study information

• Verified date: December 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1485
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Diabetes Mellitus

Intervention

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)..

Locations

Country	Name	City	State
United States	El Monte Comprehensive Health Center	El Monte	California
United States	High Desert Comprehensive Health Center	Lancaster	California
United States	Long Beach Comprehensive Health Center	Long Beach	California
United States	H. Claude Hudson Comprehensive Health Center	Los Angeles	California
United States	Roybal Comprehensive Health Center	Los Angeles	California
United States	Olive View-UCLA Medical Center Diabetes Clinic	Sylmar	California
United States	Mid-Valley Comprehensive Health Center	Van Nuys	California
United States	Harbor Comprehensive Health Center	Wilmington	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

References & Publications (10)

Anderson RJ, Freedland KE, Clouse RE, Lustman PJ. The prevalence of comorbid depression in adults with diabetes: a meta-analysis. Diabetes Care. 2001 Jun;24(6):1069-78. — View Citation

Anderson RJ, Gott BM, Sayuk GS, Freedland KE, Lustman PJ. Antidepressant pharmacotherapy in adults with type 2 diabetes: rates and predictors of initial response. Diabetes Care. 2010 Mar;33(3):485-9. doi: 10.2337/dc09-1466. Epub 2009 Dec 23. — View Citation

Cabassa LJ, Hansen MC, Palinkas LA, Ell K. Azúcar y nervios: explanatory models and treatment experiences of Hispanics with diabetes and depression. Soc Sci Med. 2008 Jun;66(12):2413-24. doi: 10.1016/j.socscimed.2008.01.054. Epub 2008 Mar 12. — View Citation

Ell K, Xie B, Quon B, Quinn DI, Dwight-Johnson M, Lee PJ. Randomized controlled trial of collaborative care management of depression among low-income patients with cancer. J Clin Oncol. 2008 Sep 20;26(27):4488-96. doi: 10.1200/JCO.2008.16.6371. — View Citation

Golden SH, Lazo M, Carnethon M, Bertoni AG, Schreiner PJ, Diez Roux AV, Lee HB, Lyketsos C. Examining a bidirectional association between depressive symptoms and diabetes. JAMA. 2008 Jun 18;299(23):2751-9. doi: 10.1001/jama.299.23.2751. — View Citation

Katon W, Robinson P, Von Korff M, Lin E, Bush T, Ludman E, Simon G, Walker E. A multifaceted intervention to improve treatment of depression in primary care. Arch Gen Psychiatry. 1996 Oct;53(10):924-32. — View Citation

Katon WJ. The comorbidity of diabetes mellitus and depression. Am J Med. 2008 Nov;121(11 Suppl 2):S8-15. doi: 10.1016/j.amjmed.2008.09.008. — View Citation

Lin EH, Katon W, Von Korff M, Rutter C, Simon GE, Oliver M, Ciechanowski P, Ludman EJ, Bush T, Young B. Relationship of depression and diabetes self-care, medication adherence, and preventive care. Diabetes Care. 2004 Sep;27(9):2154-60. — View Citation

U.S. Preventive Services Task Force. Screening for depression in adults: U.S. preventive services task force recommendation statement. Ann Intern Med. 2009 Dec 1;151(11):784-92. doi: 10.7326/0003-4819-151-11-200912010-00006. — View Citation

Wells KB, Stewart A, Hays RD, Burnam MA, Rogers W, Daniels M, Berry S, Greenfield S, Ware J. The functioning and well-being of depressed patients. Results from the Medical Outcomes Study. JAMA. 1989 Aug 18;262(7):914-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in physical functional status in 6 months	Physical functional status is measured using the physical component score of the SF-12 scale	6 months from enrollment	No
Other	Change from baseline in mental functional status in 6 months	Mental functional status is measured using the mental component score of the SF-12 scale	6 months from enrollment	No
Other	Change from baseline in physical functional status in 12 months	Physical functional status is measured using the physical component score of the SF-12 scale	12 months from enrollment	No
Other	Change from baseline in mental functional status in 12 months	Mental functional status is measured using the mental component score of the SF-12 scale	12 months after enrollment	No
Other	Change from baseline of mental health-related functional impairment in 12 months	Assessed using the Sheehan disability scale	12 months from enrollment	No
Other	Change from baseline of mental health-related functional impairment in 6 months	Assessed using the Sheehan disability scale	6 months from enrollment	No
Other	Change from baseline in depression outcome in 12 months	Depression is measured using depression scales Patient Health Questionnaire (PHQ)-9. Major depression is classified as PHQ-9>=10.	12 months from enrollment	No
Other	Change from baseline in diabetes self-care score in 12 months	Diabetes self-care is measured using Toolbert diabetes self-care scale.	12 months after enrollment	No
Other	Change from baseline of diabetes symptoms in 12 months	Assessed using the Whitty-9 diabetes symptoms scale	12 months from enrollment	No
Other	Change from baseline of diabetes symptoms in 6 months	Assessed using the Whitty-9 diabetes symptoms scale	6 months from enrollment	No
Other	Change from baseline in percentage of patients who receive HbA1C lab test in 12 months	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 months from enrollment	No
Other	Change from baseline in percentage of patients who receive the lipid panel lab test in 12 months	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 months from enrollment	No
Other	Change from baseline in percentage of patients who receive microalbumin lab test in 12 months	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 months from enrollment	No
Other	Change from baseline in percentage of patients who receive HbA1C lab test in 6 months	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.	6 months from enrollment	No
Other	Change from baseline in percentage of patients who receive the lipid panel lab test in 6 months	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	6 months from enrollment	No
Other	Change from baseline in percentage of patients who receive microalbumin lab test in 6 months	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.	6 months from enrollment	No
Other	Change from baseline in percentage of patients whose HbA1C is in control in 12 months	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%.	12 months from enrollment	No
Other	Change from baseline in percentage of patients whose microalbumin is in control in 12 months	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.	12 months from enrollment	No
Other	Change from baseline in percentage of patients whose total cholesterol is in control in 12 months	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.	12 months from enrollment	No
Other	Change from baseline in percentage of patients whose LDL cholesterol is in control in 12 months	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.	12 months from enrollment	No
Other	Change from baseline in percentage of patients whose HDL cholesterol is in control in 12 months	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.	12 months from enrollment	No
Other	Change from baseline in percentage of patients whose triglycerides is in control in 12 months	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.	12 months from enrollment	No
Other	Change from baseline in percentage of patients whose HbA1C is in control in 6 months	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%.	6 months from enrollment	No
Other	Change from baseline in percentage of patients whose microalbumin is in control in 6 months	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.	6 months from enrollment	No
Other	Change from baseline in percentage of patients whose total cholesterol is in control in 6 months	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	6 months from enrollment	No
Other	Change from baseline in percentage of patients whose LDL cholesterol is in control in 6 months	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.	6 months from enrollment	No
Other	Change from baseline in percentage of patients whose HDL cholesterol is in control in 6 months	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.	6 months from enrollment	No
Other	Change from baseline in percentage of patients whose triglycerides is in control in 6 months	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	6 months from enrollment	No
Other	Change from baseline to 12 months in number of outpatient visits during the past 6 months	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.	12 months from enrollment	No
Other	Change from baseline to 6 months in number of outpatient visits during the past 6 months	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.	6 months from enrollment	No
Other	Change from baseline to 12 months in percentage of patients who were hospitalized during the past 6 months	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.	12 months from enrollment	No
Other	Change from baseline to 6 months in percentage of hospitalized patients during the past 6 months	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.	6 months from enrollment	No
Other	Change from baseline to 12 months in percentage of patients with ER visits during the past 6 months	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.	12 months from enrollment	No
Other	Change from baseline to 6 months in percentage of patients with ER visits during the past 6 months	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.	6 months from enrollment	No
Other	Difference between cost of care management in the intervention group and the control groups over a 12-month period per patient	Cost of care management includes automated phone calls, provider time, costs associated with reviewing tasks and follow-ups.	12 months	No
Other	Change from baseline to 12 months in percentage of patients satisfied with care received for diabetes	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)	12 months from enrollment	No
Other	Change from baseline to 6 months in percentage of patients satisfied with care received for diabetes	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)	6 months from enrollment	No
Other	Change from baseline to 12 months in percentage of patients satisfied with care received for depression	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)	12 months from enrollment	No
Other	Change from baseline to 6 months in percentage of patients satisfied with care received for depression	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)	6 months from enrollment	No
Primary	Change from baseline in depression outcome at 6-months	Depression is measured using depression scales Patient Health Questionnaire (PHQ)-9. Major depression is classified as PHQ-9>=10.	6-months from enrollment	No
Secondary	Change from baseline in diabetes self-care score in 6 months	Diabetes self-care is measured using the Toolbert diabetes self-care scale.	6 months from enrollment	No