Continuous Quality Improvement for Diabetes - Full Text View

Purpose

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	Intervention	Phase
Diabetes	Other: introduction of the chronic care model	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Choosing a Doctor or Health Care Service Diabetes

U.S. FDA Resources

Further study details as provided by Santa Clara Valley Health & Hospital System:

Primary Outcome Measures:

resource utilization [ Time Frame: baseline compared to 2 years intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

compliance with process measures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
metabolic outcome [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	April 2006
Estimated Study Completion Date:	April 2010
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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
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

Arms

Assigned Interventions

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.

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

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

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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838825

Sponsors and Collaborators

Santa Clara Valley Health & Hospital System

Investigators

Principal Investigator:

Patrick J Kearns, MD

Santa Clara Valley Health & Hospital System

More Information

No publications provided

Responsible Party:	Patrick Kearns, MD, Director, Chronic Care Managament, Santa Clara Valley Health and Hospital System
ClinicalTrials.gov Identifier:	NCT00838825 History of Changes
Other Study ID Numbers:	SCVMC 2/8/08-10
Study First Received:	February 5, 2009
Last Updated:	February 5, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on June 18, 2013