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

Primary Purpose

Type 2 Diabetes, Hyperlipidemia, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard CQI intervention
Chronic Care Improvement (CCI) Intervention
Self-directed practice comparison
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Under primary care for type 2 diabetes

Exclusion Criteria:

  • Are not minimally literate in either English or Spanish

Sites / Locations

  • University of Colorado Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Practice in this arm will receive the Chronic Care Improvement intervention

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.

Practice in this arm will have access to all chronic care tools, but will not have an in-practice change agent.

Outcomes

Primary Outcome Measures

Surveillance of Hemoglobin A1c, blood pressure, lipids, depression process of care
HEDIS-like measures of acute phase management of depression

Secondary Outcome Measures

Patient report (by survey) of their primary care experience

Full Information

First Posted
December 21, 2006
Last Updated
November 21, 2012
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00414986
Brief Title
Using Learning Teams for Reflective Adaptation for Diabetes and Depression
Acronym
ULTRA-DM/MDD
Official Title
Using Learning Teams for Reflective Adaptation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Hyperlipidemia, Hypertension, Depression

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1565 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Practice in this arm will receive the Chronic Care Improvement intervention
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Arm Title
3
Arm Type
Active Comparator
Arm Description
Practice in this arm will have access to all chronic care tools, but will not have an in-practice change agent.
Intervention Type
Behavioral
Intervention Name(s)
Standard CQI intervention
Intervention Description
In-practice change facilitator assists the practice in implementing a chronic disease registry
Intervention Type
Behavioral
Intervention Name(s)
Chronic Care Improvement (CCI) Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-directed practice comparison
Intervention Description
Practices will have access to all tools used in Arm 1 via a project website
Primary Outcome Measure Information:
Title
Surveillance of Hemoglobin A1c, blood pressure, lipids, depression process of care
Time Frame
Baseline, 9, and 18 month
Title
HEDIS-like measures of acute phase management of depression
Time Frame
Baseline, 9, and 18 months
Secondary Outcome Measure Information:
Title
Patient report (by survey) of their primary care experience
Time Frame
baseline, 9-months, 18-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Under primary care for type 2 diabetes Exclusion Criteria: Are not minimally literate in either English or Spanish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David West, PhD
Organizational Affiliation
Department of Family Medicine, University of Colorado Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Using Learning Teams for Reflective Adaptation for Diabetes and Depression

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