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Continuous Quality Improvement for Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00838825
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
Patrick Kearns, Santa Clara Valley Health & Hospital System

Brief 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).

Condition or disease Intervention/treatment Phase
Diabetes Other: introduction of the chronic care model Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Continuous Quality Improvement for Diabetes: Unique Care Delivery Design's Effect on Quality of Care and Utilization of Resources
Study Start Date : April 2005
Primary Completion Date : March 2008
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
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.
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



Primary Outcome Measures :
  1. resource utilization [ Time Frame: baseline compared to 2 years intervention ]

Secondary Outcome Measures :
  1. compliance with process measures [ Time Frame: 3 years ]
  2. metabolic outcome [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838825


Sponsors and Collaborators
Santa Clara Valley Health & Hospital System
Investigators
Principal Investigator: Patrick J Kearns, MD Santa Clara Valley Health & Hospital System

Responsible Party: Patrick Kearns, Director, Chronic Care Mangement, Santa Clara Valley Health & Hospital System
ClinicalTrials.gov Identifier: NCT00838825     History of Changes
Other Study ID Numbers: SCVMC 2/8/08-10
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shared in a peer review journal

Keywords provided by Patrick Kearns, Santa Clara Valley Health & Hospital System:
diabetes
chronic care management
resource utilization
outcome
glycohemoglobin
hospitalization

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases