CClinicalTrials.gg
CompletedNCT00414986ULTRA-DM/MDDUpdated Nov 22, 2012

Using Learning Teams for Reflective Adaptation for Diabetes and Depression

An interventional study of Standard CQI intervention and Chronic Care Improvement (CCI) Intervention in Type 2 Diabetes, Hyperlipidemia and Hypertension, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-22.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
1,565
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes
  • Hyperlipidemia
  • Hypertension
  • Depression
03

In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's enrollment of 1,565 is above the median of 87 across 691 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Under primary care for type 2 diabetes

Exclusion criteria

Exclusion Criteria:

  • Are not minimally literate in either English or Spanish
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1,565 participants (actual)

Study arms

  • Experimental
    1

    Practice in this arm will receive the Chronic Care Improvement intervention

    Behavioral: Chronic Care Improvement (CCI) Intervention

  • 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

  • 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

Interventions

  • BehavioralStandard CQI intervention

    In-practice change facilitator assists the practice in implementing a chronic disease registry

  • BehavioralChronic 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.

  • BehavioralSelf-directed practice comparison

    Practices will have access to all tools used in Arm 1 via a project website

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Patient report (by survey) of their primary care experience

    Time frame: baseline, 9-months, 18-months

07

Study locations

1 site
  • University of Colorado Health Sciences Center
    Denver, Colorado 80045, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00414986
Lead sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Dec 22, 2006
Start date
Sep 2005
Primary completion
Feb 2012
Completion
Feb 2012
Last update
Nov 22, 2012

Study contacts

David West, PhD
principal investigator · Department of Family Medicine, University of Colorado Health Sciences Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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