Clinical trial NCT02011529: TEAMcare for Diabetes in Mental Health Centers
Official title: A Team Approach to Improve the Quality of Diabetes Care for Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-12-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 6 months
Secondary outcomes:
measure: Blood Pressure
timeFrame: 6 months
measure: LDL cholesterol
timeFrame: 6 months
Other outcomes:
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: 6 months
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Lydia Chwastiak, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.