TEAMcare for Diabetes in Mental Health Centers

NCT ID: NCT02011529

Last Updated: 2015-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-09-30

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TEAMcare treatment of diabetes

Group Type: ACTIVE_COMPARATOR

TEAMcare treatment of diabetes

Intervention Type: OTHER

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.

Treatment as usual

Participants randomized to treatment as usual will receive their usual mental health treatment and primary care treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Lydia Chwastiak

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lydia Chwastiak, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21190455 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29191136 (View on PubMed)

Other Identifiers

R21DK096286-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

44422-G

Identifier Type: -

Identifier Source: org_study_id