TEAMcare for Diabetes in Mental Health Centers

A Team Approach to Improve the Quality of Diabetes Care for Patients With Schizophrenia

This proposal aims to demonstrate the feasibility and acceptability of adapting TEAMcare for patients with schizophrenia. The aim of this innovative mental health center-based team intervention is to improve diabetes, cardiovascular and psychiatric outcomes among patients with poorly controlled type 2 diabetes. The study will be conducted in two phases over the 2-year grant period.

Phase 1. Development of the adapted TEAMcare intervention and training of team members.

Phase 2. During year 2, we will implement the intervention on the caseload of 40 outpatients at Harborview Mental Health Services with schizophrenia and poorly controlled type 2 diabetes. The intervention involves the management of subjects' diabetes, hypertension, and hyperlipidemia by a CMHC diabetes team for 6 months (advanced nurse specialist on-site at supervised in weekly meetings by a psychiatrist and a UW Diabetes Center endocrinologist).

The primary aim of this pilot research grant is to evaluate the feasibility of implementing this complex intervention, in order to guide the design of a larger scale efficacy study (R01). Both process and outcome measures will be evaluated at baseline, and at 3- and 6-month follow-up visits for the 40 subjects enrolled in this feasibility trial.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Other: TEAMcare treatment of diabetes

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult (18-70 years);
• enrolled to receive mental health treatment at Harborview Mental Health Services or Downtown Emergency Services Mental Health center
• a diagnosis of type 2 diabetes mellitus or cardiovascular disease
• Hemoglobin A1c >8 or BP > 140/90

Exclusion Criteria:

• cognitive, hearing, or language impairment that would preclude a subject from providing informed consent;
• current suicidality, homicidality, or grave disability that requires psychiatric hospitalization;
• current substance abuse or dependence, as defined by SCID.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: TEAMcare treatment of diabetes	Other: TEAMcare treatment of diabetes; TEAMcare is an evidence-based collaborative care approach to the treatment of diabetes and psychiatric illness. It involves structured visits with a study nurse to monitor psychiatric symptoms, control of medical disease, and self-care activities. The nurses use motivational coaching to help patients solve problems and set goals for improved self-care and medication adherence. Medications for diabetes, hypertension, and hyperlipidemia are monitored and therapy intensified based on treat-to-target guidelines. All of these process and outcome measures are tracked in a registry designed for the study, and the nurses receive weekly supervision with a psychiatrist, an endocrinologist and a psychologist in order to review new cases and to track progress. Once a patient achieves targeted levels for relevant measures, the patient and the nurse develop a maintenance plan.
NO_INTERVENTION: Treatment as usual; Participants randomized to treatment as usual will receive their usual mental health treatment and primary care treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin A1c	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
LDL cholesterol	6 months
Blood Pressure	6 months

Other Outcome Measures

Outcome Measure	Time Frame
Brief Psychiatric Rating Scale (BPRS)	6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Lydia Chwastiak, MD, MPH, University of Washington

Publications and helpful links

General Publications

• Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955.
• Chwastiak LA, Luongo M, Russo J, Johnson L, Lowe JM, Hoffman G, McDonell MG, Wisse B. Use of a Mental Health Center Collaborative Care Team to Improve Diabetes Care and Outcomes for Patients With Psychosis. Psychiatr Serv. 2018 Mar 1;69(3):349-352. doi: 10.1176/appi.ps.201700153. Epub 2017 Dec 1.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (ESTIMATE): December 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 5, 2015
• Last Update Submitted That Met QC Criteria: October 1, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 44422-G; R21DK096286-01A1 (NIH)