Using Learning Teams for Reflective Adaptation for Diabetes and Depression

NCT00414986 | Completed

• 3 other identifiers: 05-0457R18DK067083MH069806
• Study Type: interventional
• Target: 1,565
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Hyperlipidemia; Hypertension; Depression

Outcome Measures

Primary Outcomes (2)

• Surveillance of Hemoglobin A1c, blood pressure, lipids, depression process of care

  Baseline, 9, and 18 month

• HEDIS-like measures of acute phase management of depression

  Baseline, 9, and 18 months

Secondary Outcomes (1)

• Patient report (by survey) of their primary care experience

  baseline, 9-months, 18-months

Study Arms (3)

1

EXPERIMENTAL

Practice in this arm will receive the Chronic Care Improvement intervention

Behavioral: Chronic Care Improvement (CCI) Intervention

2

EXPERIMENTAL

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

3

ACTIVE COMPARATOR

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

Standard CQI intervention BEHAVIORAL

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

2

Chronic Care Improvement (CCI) Intervention BEHAVIORAL

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.

1

Self-directed practice comparison BEHAVIORAL

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

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Under primary care for type 2 diabetes

You may not qualify if:

• Are not minimally literate in either English or Spanish

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Colorado Health Sciences Center

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperlipidemias; Hypertension; Depression

Interventions

Methods

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• David West, PhD

  Department of Family Medicine, University of Colorado Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 22, 2006
• Study Start: September 1, 2005
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 22, 2012

Record last verified: 2012-11

Locations

US (1)