Continuous Quality Improvement for Diabetes

Diabetes Clinical Trial

Official title:

Continuous Quality Improvement for Diabetes: Unique Care Delivery Design's Effect on Quality of Care and Utilization of Resources

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00838825
• Other study ID #: SCVMC 2/8/08-10
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: February 5, 2009
• Last updated: February 5, 2009
• Start date: April 2006
• Est. completion date: April 2010

Study information

• Verified date: December 2008
• Source: Santa Clara Valley Health & Hospital System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare health care delivery outcomes and costs achieved by two different approaches to health care delivery. The investigators will compare health outcomes for groups of adult patents with diabetes. One group will be managed by our traditional approach to diabetes care. The second group's care delivery is structured according to a design consistent with the Chronic Care Model (CCM).

Description:

The study is comparing the effect of an intervention targeting a subset of the diabetic patients within a primary care practice on the resource utilization of resources and disease outcomes on the entire population of patients with diabetes in that practice. The effect will also be compared across the entire panel of patients assigned to the physicians in the 2 arms of the study.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: April 2010
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Primary care physicians practicing in a designated site with > 200 patients assigned to their panel who have been diagnosed with diabetes

Exclusion Criteria:

• Refusal to give informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes

Intervention

Other:
• introduction of the chronic care model
The care management team is organized according to the chronic care model for health care delivery. They are supported by an information registry for diabetes, receive instruction in self-management, have redesigned their work flow to include delegation of functions to care managers who follow specific guidelines and protocols for managing diabetes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santa Clara Valley Health & Hospital System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resource utilization		baseline compared to 2 years intervention	No
Secondary	compliance with process measures		3 years	No
Secondary	metabolic outcome		3 years	No