Using Learning Teams for Reflective Adaptation for Diabetes and Depression

NCT ID: NCT00414986

Last Updated: 2012-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1565 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2012-02-29

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.

Conditions

Type 2 Diabetes; Hyperlipidemia; Hypertension; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

1

Practice in this arm will receive the Chronic Care Improvement intervention

Group Type: EXPERIMENTAL

Chronic Care Improvement (CCI) Intervention

Intervention Type: 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.

2

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.

Group Type: EXPERIMENTAL

Standard CQI intervention

Intervention Type: BEHAVIORAL

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

3

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

Group Type: ACTIVE_COMPARATOR

Self-directed practice comparison

Intervention Type: BEHAVIORAL

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

Interventions

Standard CQI intervention

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Self-directed practice comparison

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Under primary care for type 2 diabetes

Exclusion Criteria

• Are not minimally literate in either English or Spanish

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David West, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Family Medicine, University of Colorado Health Sciences Center

Locations

University of Colorado Health Sciences Center

Denver, Colorado, United States

Countries

United States

Other Identifiers

R18DK067083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MH069806

Identifier Type: -

Identifier Source: secondary_id

05-0457

Identifier Type: -

Identifier Source: org_study_id