Diabetes-Depression Care-management Adoption Trial

NCT01781013 | Completed DMC

• 1 other identifier: RFA-AE-10-001
• Study Type: interventional
• Target: 1,485
• Locations: 1 country
• Sites: 8

Brief Summary

The specific aims of the proposed study are to:

1. 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. 2.Conduct the quasi-experiment in eight Los Angeles County Department of Health Services (LAC-DHS) clinics to test the interventions;
3. 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. 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.
5. 5.There will be statistically significant difference in the adoption of depression care screening and management over time among the three study groups.
6. 6.There will be statistically significant difference in the depression symptom reduction, and better functional status, and quality of life among the three study groups.
7. 7.There will be statistically significant difference in the diabetes care process and outcomes among the three study groups.
8. 8.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.
9. 9.Of the three groups compared, the TC group will be the most cost-effective approach for accelerating adoption of the CER depression care results.

Conditions

Depression; Diabetes Mellitus

Keywords

Depression screening; Depression monitoring; Chronic illness; Behavioral health; Care management; Automatic telephone assessment; Clinical decision support; Suicide alert

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change from baseline in diabetes self-care score in 6 months

  6 months from enrollment

Other Outcomes (39)

• Change from baseline in physical functional status in 6 months

  6 months from enrollment

• Change from baseline in mental functional status in 6 months

  6 months from enrollment

• Change from baseline in physical functional status in 12 months

  12 months from enrollment

Study Arms (3)

Technology-supported care

EXPERIMENTAL

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

Supported-Care

NO INTERVENTION

This arm consists of CRM (Clinic Resource Management) clinics and serves as one of the two control arms in the study.

Usual Care

NO INTERVENTION

This arm consists of non-CRM (Clinic Resource Management) clinics and serves as one of the two control arms in the study.

Interventions

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)..

Technology-supported care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• Department of Health and Human Services: collaborator

Study Sites (8)

El Monte Comprehensive Health Center

El Monte, California, 91731, United States

Location

High Desert Comprehensive Health Center

Lancaster, California, 93536, United States

Location

Long Beach Comprehensive Health Center

Long Beach, California, 90813, United States

Location

H. Claude Hudson Comprehensive Health Center

Los Angeles, California, 90007, United States

Location

Roybal Comprehensive Health Center

Los Angeles, California, 90022, United States

Location

Olive View-UCLA Medical Center Diabetes Clinic

Sylmar, California, 91342, United States

Location

Mid-Valley Comprehensive Health Center

Van Nuys, California, 91405, United States

Location

Harbor Comprehensive Health Center

Wilmington, California, 90744, United States

Location

Related Publications (16)

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• 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.

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• 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. doi: 10.2337/diacare.24.6.1069.

  PMID: 11375373 BACKGROUND

• 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.

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• 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. doi: 10.2337/diacare.27.9.2154.

  PMID: 15333477 BACKGROUND

• 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.

  PMID: 19949144 BACKGROUND

• 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.

  PMID: 20032276 BACKGROUND

• 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.

  PMID: 18802161 BACKGROUND

• Cabassa LJ, Hansen MC, Palinkas LA, Ell K. Azucar 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.

  PMID: 18339466 BACKGROUND

• 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. doi: 10.1001/archpsyc.1996.01830100072009.

  PMID: 8857869 BACKGROUND

• Jin H, Wu S. Text Messaging as a Screening Tool for Depression and Related Conditions in Underserved, Predominantly Minority Safety Net Primary Care Patients: Validity Study. J Med Internet Res. 2020 Mar 26;22(3):e17282. doi: 10.2196/17282.

  PMID: 32213473 DERIVED

• Hay JW, Lee PJ, Jin H, Guterman JJ, Gross-Schulman S, Ell K, Wu S. Cost-Effectiveness of a Technology-Facilitated Depression Care Management Adoption Model in Safety-Net Primary Care Patients with Type 2 Diabetes. Value Health. 2018 May;21(5):561-568. doi: 10.1016/j.jval.2017.11.005. Epub 2017 Dec 6.

  PMID: 29753353 DERIVED

• Ramirez M, Wu S, Jin H, Ell K, Gross-Schulman S, Myerchin Sklaroff L, Guterman J. Automated Remote Monitoring of Depression: Acceptance Among Low-Income Patients in Diabetes Disease Management. JMIR Ment Health. 2016 Jan 25;3(1):e6. doi: 10.2196/mental.4823.

  PMID: 26810139 DERIVED

• Ell K, Katon W, Lee PJ, Guterman J, Wu S. Demographic, clinical and psychosocial factors identify a high-risk group for depression screening among predominantly Hispanic patients with Type 2 diabetes in safety net care. Gen Hosp Psychiatry. 2015 Sep-Oct;37(5):414-9. doi: 10.1016/j.genhosppsych.2015.05.010. Epub 2015 May 29.

  PMID: 26059979 DERIVED

• Wu S, Vidyanti I, Liu P, Hawkins C, Ramirez M, Guterman J, Gross-Schulman S, Sklaroff LM, Ell K. Patient-centered technological assessment and monitoring of depression for low-income patients. J Ambul Care Manage. 2014 Apr-Jun;37(2):138-47. doi: 10.1097/JAC.0000000000000027.

  PMID: 24525531 DERIVED

• Wu S, Ell K, Gross-Schulman SG, Sklaroff LM, Katon WJ, Nezu AM, Lee PJ, Vidyanti I, Chou CP, Guterman JJ. Technology-facilitated depression care management among predominantly Latino diabetes patients within a public safety net care system: comparative effectiveness trial design. Contemp Clin Trials. 2014 Mar;37(2):342-54. doi: 10.1016/j.cct.2013.11.002. Epub 2013 Nov 8.

  PMID: 24215775 DERIVED

MeSH Terms

Conditions

Depression; Diabetes Mellitus; Chronic Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Shinyi Wu, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: January 31, 2013
• Study Start: June 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

US (8)