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Open Access Study protocol

Controlled trial of a collaborative primary care team model for patients with diabetes and depression: Rationale and design for a comprehensive evaluation

Jeffrey A Johnson12*, Fatima Al Sayah12, Lisa Wozniak2, Sandra Rees2, Allison Soprovich2, Constance L Chik3, Pierre Chue45, Peter Florence4, Jennifer Jacquier3, Pauline Lysak5, Andrea Opgenorth3, Wayne J Katon6 and Sumit R Majumdar23

Author Affiliations

1 Department of Public Health Sciences, University of Alberta, Edmonton, Canada

2 ACHORD, University of Alberta, Edmonton, Canada

3 Department of Medicine, University of Alberta, Edmonton, Canada

4 Alberta Health Services, Edmonton, Canada

5 Department of Psychiatry, University of Alberta, Edmonton, Canada

6 Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA

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BMC Health Services Research 2012, 12:258  doi:10.1186/1472-6963-12-258

Published: 16 August 2012

Abstract

Background

When depression accompanies diabetes, it complicates treatment, portends worse outcomes and increases health care costs. A collaborative care case-management model, previously tested in an urban managed care organization in the US, achieved significant reduction of depressive symptoms, improved diabetes disease control and patient-reported outcomes, and saved money. While impressive, these findings need to be replicated and extended to other healthcare settings. Our objective is to comprehensively evaluate a collaborative care model for comorbid depression and type 2 diabetes within a Canadian primary care setting.

Methods/design

We initiated the TeamCare model in four Primary Care Networks in Northern Alberta. The intervention involves a nurse care manager guiding patient-centered care with family physicians and consultant physician specialists to monitor progress and develop tailored care plans. Patients eligible for the intervention will be identified using the Patient Health Questionnaire-9 as a screen for depressive symptoms. Care managers will then guide patients through three phases: 1) improving depressive symptoms, 2) improving blood glucose, blood pressure and cholesterol, and 3) improving lifestyle behaviors. We will employ the RE-AIM framework for a comprehensive and mixed-methods approach to our evaluation. Effectiveness will be assessed using a controlled “on-off” trial design, whereby eligible patients would be alternately enrolled in the TeamCare intervention or usual care on a monthly basis. All patients will be assessed at baseline, 6 and 12 months. Our primary analyses will be based on changes in two outcomes: depressive symptoms, and a multivariable, scaled marginal model for the combined outcome of global disease control (i.e., A1c, systolic blood pressure, LDL cholesterol). Our planned enrolment of 168 patients will provide greater than 80% power to observe clinically important improvements in all measured outcomes. Direct costing of all intervention components and measurement of all health care utilization using linked administrative databases will be used to determine the cost-effectiveness of the intervention relative to usual care.

Discussion

Our comprehensive evaluation will generate evidence to reliability, effectiveness and sustainability of this collaborative care model for patients with chronic diseases and depression.

Trials registration

Clintrials.gov Identifier: NCT01328639

Keywords:
Primary care; Collaborative; Diabetes; Depression; Controlled trial; Health services research