Using Learning Teams for Reflective Adaptation for Diabetes and Depression

Hypertension Clinical Trial

— ULTRA-DM/MDD  

Official title:

Using Learning Teams for Reflective Adaptation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414986
• Other study ID #: 05-0457
• Secondary ID: R18DK067083MH069
• Status: Completed
• Phase: N/A
• First received: December 21, 2006
• Last updated: November 21, 2012
• Start date: September 2005
• Est. completion date: February 2012

Study information

• Verified date: November 2012
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 diabetes and depression. One intervention is based on complexity science and the other is a traditional QI intervention.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1565
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Under primary care for type 2 diabetes

Exclusion Criteria:

• Are not minimally literate in either English or Spanish

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Depression
• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Type 2 Diabetes

Intervention

Behavioral:
• Standard CQI intervention
In-practice change facilitator assists the practice in implementing a chronic disease registry
• 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.
• Self-directed practice comparison
Practices will have access to all tools used in Arm 1 via a project website

Locations

Country	Name	City	State
United States	University of Colorado Health Sciences Center	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surveillance of Hemoglobin A1c, blood pressure, lipids, depression process of care		Baseline, 9, and 18 month	No
Primary	HEDIS-like measures of acute phase management of depression		Baseline, 9, and 18 months	No
Secondary	Patient report (by survey) of their primary care experience		baseline, 9-months, 18-months	No