Diabetes-Depression Care-management Adoption Trial - Full Text View

Purpose

The specific aims of the proposed study are to:

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;
Conduct the quasi-experiment in eight Los Angeles County Department of Health Services (LAC-DHS) clinics to test the interventions;
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
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:

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).
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.
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.
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.
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	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: Screening
Official Title:	Care Management Technology to Facilitate Depression Care in Safety Net Diabetes Clinics

Resource links provided by NLM:

MedlinePlus related topics: Adoption Depression Diabetes

U.S. FDA Resources

Further study details as provided by University of Southern California:

Primary Outcome Measures:

Change from baseline in depression outcome at 6-months [ Time Frame: 24-months ] [ 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:

Diabetes outcome [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Measured using Whitty-9 diabetes symptoms, presence of diabetes complications, number of diabetes complications, Toolbert diabetes self-care, and BMI.

Other Outcome Measures:

Health and functional status [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Measured using self-rated health, self-rated comorbid illnesses, and Sheehan disability scale
Patient satisfaction with care [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Satisfaction with care available for diabetes and depression

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:

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?

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 nine 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

Department of Health and Human Services

Investigators

Principal Investigator:

Shinyi Wu, PhD

University of Southern California

More Information

Publications:

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.

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.

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.

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.

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.

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: 10.1059/0003-4819-151-11-200912010-00006.

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.

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.

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.

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.

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:	January 29, 2013
Health Authority:	United States: Institutional Review Board

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 May 22, 2013

Diabetes-Depression Care-management Adoption Trial (DCAT)