TEAMcare for Diabetes in Mental Health Centers
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Team Approach to Improve the Quality of Diabetes Care for Patients With Schizophrenia|
- Hemoglobin A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- LDL cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02011529
|Contact: Jessica Lowe, BSfirstname.lastname@example.org|
|Contact: Lydia Chwastiak, MD, MPHemail@example.com|
|United States, Washington|
|Harborview Medical Center||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Jessica Lowe 206-744-4565|
|Sub-Investigator: Brent Wisse, MD|
|Sub-Investigator: Michael McDonell, PhD|
|Sub-Investigator: Wayne Katon, MD|
|Principal Investigator:||Lydia Chwastiak, MD, MPH||University of Washington|