Viewing Study NCT00414986



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Study NCT ID: NCT00414986
Status: COMPLETED
Last Update Posted: 2012-11-22
First Post: 2006-12-21

Brief Title: Using Learning Teams for Reflective Adaptation for Diabetes and Depression
Sponsor: University of Colorado Denver
Organization: University of Colorado Denver

Study Overview

Official Title: Using Learning Teams for Reflective Adaptation
Status: COMPLETED
Status Verified Date: 2012-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ULTRA-DMMDD
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 practices 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 practices 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 andor 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R18DK067083 NIH None None
MH069806 US NIH GrantContract None httpsreporternihgovquickSearchR18DK067083