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Continuous Quality Improvement for Diabetes

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Santa Clara Valley Health & Hospital System
ClinicalTrials.gov Identifier:
NCT00838825
First received: February 5, 2009
Last updated: NA
Last verified: December 2008
History: No changes posted

February 5, 2009
February 5, 2009
April 2006
October 2008   (final data collection date for primary outcome measure)
resource utilization [ Time Frame: baseline compared to 2 years intervention ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • compliance with process measures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • metabolic outcome [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Continuous Quality Improvement for Diabetes
Continuous Quality Improvement for Diabetes: Unique Care Delivery Design's Effect on Quality of Care and Utilization of Resources

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).

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Diabetes
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
Other Names:
  • care manager
  • chronic care model
  • health care delivery
  • self-management
  • registry
  • No Intervention: traditional
    The traditional arm is composed of primary care physicians who continue the health care delivery model existing for the 5 years prior to the study. The traditional includes the physician, a pool of resources including random assignment of diabetic educators and includes the entire panel of patients assigned to the PCP.
    Intervention: Other: introduction of the chronic care model
  • Experimental: care management
    The care management group is composed of primary care physicians who have been assigned a specific physician extender, the care manager, and an additional medical assistant and form a care manager team working together with registry support, team meetings and instruction in self-management and includes the entire panel of patients assigned to the PCP.
    Intervention: Other: introduction of the chronic care model
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
10
April 2010
October 2008   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00838825
SCVMC 2/8/08-10
Yes
Patrick Kearns, MD, Director, Chronic Care Managament, Santa Clara Valley Health and Hospital System
Santa Clara Valley Health & Hospital System
Not Provided
Principal Investigator: Patrick J Kearns, MD Santa Clara Valley Health & Hospital System
Santa Clara Valley Health & Hospital System
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP