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Using Learning Teams for Reflective Adaptation for Diabetes and Depression (ULTRA-DM/MDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00414986
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : November 22, 2012
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The study will randomize 54 primary care practices to two intervention and a comparison groups. Both interventions will involve an on-site Improvement Facilitator who will assist the practice in forming an Improvement Team, using rapid-cycle tests of change, and implementing chronic care office systems for type 2 diabetes and depression. One intervention is based on complexity science and the other is a traditional QI intervention.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Hyperlipidemia Hypertension Depression Behavioral: Standard CQI intervention Behavioral: Chronic Care Improvement (CCI) Intervention Behavioral: Self-directed practice comparison Not Applicable

Detailed Description:
Evidence-based guidelines for primary care of diabetes have been established and disseminated, yet adoption of guidelines in community-based primary care practice has been disappointing. This effectiveness study proposes a randomized trial involving 54 community-based primary care practices to test two innovative interventions to improve diabetes and depression care. One intervention, derived from theoretically based and efficacious programs tested in other settings, adopts a broad focus and seeks to improve diabetes and depression care by a) increasing the practice's organizational capacity to manage change, and b) implementing and sustaining chronic care office systems that support clinician efforts to improve care for diabetes. The intervention will combine two integrated components. The first component will utilize an Improvement Facilitator that will assess the practice's current use of chronic care office systems and their organizational capacity to manage change, provide feedback to key stakeholders in the practice, and work with the practice over six months to form an Improvement Team that will both address organizational capacity to create and sustain improvement and implement chronic care systems. In the second component of the intervention, the practice will participate in a local Improvement Collaborative that will afford opportunities to learn and share experiences during implementation and maintenance phases of the intervention with five similar practices in their geographic area. The second intervention is based on traditional QI methods and focuses on a chronic disease registry with regular reports to the physicians. It also uses PDSA cycles to assist in implementing change. This intervention will offer tools to improve diabetes and/or asthma care. Both interventions will be evaluated in two ways. First, a randomized trial using rigorous quantitative methods will measure 2 primary and 3 secondary endpoints at 9 and 18 months, including a) the ADA Physician Recognition Program performance measures by both patient-report and review of the medical record, and b) HEDIS measures of acute phase management of depression, c) assessment of the extent to which practices implement and physicians use elements of the chronic care model in their care of diabetes and depression. Change from baseline to 9 months will assess adoption of chronic care improvements, and change from 9 to 18 months will assess sustainability of improvements. Second, a multimethod assessment process will be used to analyze all qualitative and quantitative data separately to understand how and why the intervention led to the observed effects. The practice assessment will strive to understand which components of the interventions were most effective, their relative costs for implementation, and how they might be further improved. Successful components of the intervention will be refined and made available to our collaborators in the project; the Copic Insurance Company and the Colorado Clinical Guidelines Collaborative, for use in their statewide activities to improve diabetes care.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1565 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Using Learning Teams for Reflective Adaptation
Study Start Date : September 2005
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Practice in this arm will receive the Chronic Care Improvement intervention
Behavioral: Chronic Care Improvement (CCI) Intervention
An in-practice change facilitator will assist the Improvement Team in enhancing the relationship infrastructure of the practice and in implementing diabetes and depression office systems.

Experimental: 2
Practices in this arm will receive the standard CQI intervention. An in-practice CQI coordinator will assist the practices in implement a chronic disease registry.
Behavioral: Standard CQI intervention
In-practice change facilitator assists the practice in implementing a chronic disease registry

Active Comparator: 3
Practice in this arm will have access to all chronic care tools, but will not have an in-practice change agent.
Behavioral: Self-directed practice comparison
Practices will have access to all tools used in Arm 1 via a project website

Primary Outcome Measures :
  1. Surveillance of Hemoglobin A1c, blood pressure, lipids, depression process of care [ Time Frame: Baseline, 9, and 18 month ]
  2. HEDIS-like measures of acute phase management of depression [ Time Frame: Baseline, 9, and 18 months ]

Secondary Outcome Measures :
  1. Patient report (by survey) of their primary care experience [ Time Frame: baseline, 9-months, 18-months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Under primary care for type 2 diabetes

Exclusion Criteria:

  • Are not minimally literate in either English or Spanish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00414986

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United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Mental Health (NIMH)
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Principal Investigator: David West, PhD Department of Family Medicine, University of Colorado Health Sciences Center
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Responsible Party: University of Colorado, Denver Identifier: NCT00414986    
Other Study ID Numbers: 05-0457
R18DK067083 ( U.S. NIH Grant/Contract )
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Lipid Metabolism Disorders
Metabolic Diseases