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Type 2 DiabetesULTRA-DM/MDDNCT00414986

Using Learning Teams for Reflective Adaptation for Diabetes and Depression

A study testing Standard CQI intervention, Chronic Care Improvement (CCI) Intervention and Self-directed practice comparison in people with Type 2 Diabetes and Hyperlipidemia, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes, Hyperlipidemia, Hypertension
What is being tested?
Standard CQI intervention, Chronic Care Improvement (CCI) Intervention and Self-directed practice comparison
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,565 participants
Where
1 siteUnited States
Study dates
Sep 2005to Feb 2012
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Under primary care for type 2 diabetes

Who cannot join

  • Are not minimally literate in either English or Spanish

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Colorado Health Sciences Center

    Denver, Colorado, 80045

Other trials in United States

About this study

Official title: Using Learning Teams for Reflective Adaptation

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.

Being tested
Standard CQI intervention, Chronic Care Improvement (CCI) Intervention, Self-directed practice comparison
Medical subject headings
Diabetes Mellitus, Type 2, Hyperlipidemias, Hypertension, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard CQI interventionBehavioural

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

  • Chronic Care Improvement (CCI) InterventionBehavioural

    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.

  • Self-directed practice comparisonBehavioural

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

Study groups in NCT00414986
Study groupRoleWhat they receive
1ExperimentalPractice in this arm will receive the Chronic Care Improvement intervention
Receives: Behavioral: Chronic Care Improvement (CCI) Intervention
2ExperimentalPractices in this arm will receive the standard CQI intervention. An in-practice CQI coordinator will assist the practices in implement a chronic disease registry.
Receives: Behavioral: Standard CQI intervention
3Active comparatorPractice in this arm will have access to all chronic care tools, but will not have an in-practice change agent.
Receives: Behavioral: Self-directed practice comparison

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surveillance of Hemoglobin A1c, blood pressure, lipids, depression process of care

    Measured: Baseline, 9, and 18 month

  2. HEDIS-like measures of acute phase management of depression

    Measured: Baseline, 9, and 18 months

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

    Measured: baseline, 9-months, 18-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2006 (estimated)
  2. Study startSep 2005
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,565 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00414986
Sponsor's protocol ID
05-0457
Other IDs
R18DK067083, MH069806
Acronym
ULTRA-DM/MDD
Status last verified
Nov 2012
First submitted
21 Dec 2006
Last updated
22 Nov 2012
Results posted
No
Data monitoring committee
No

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