Continuous Quality Improvement for Diabetes

May 6, 2016 updated by: Patrick Kearns, Santa Clara Valley Health & Hospital System

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

10

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • chronic care model
  • self-management
  • care manager
  • health care delivery
  • registry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
resource utilization
Time Frame: baseline compared to 2 years intervention
baseline compared to 2 years intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
compliance with process measures
Time Frame: 3 years
3 years
metabolic outcome
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santa Clara Valley Health & Hospital System

Investigators

  • Principal Investigator: Patrick J Kearns, MD, Santa Clara Valley Health & Hospital System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

February 5, 2009

First Submitted That Met QC Criteria

February 5, 2009

First Posted (Estimate)

February 6, 2009

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 6, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCVMC 2/8/08-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shared in a peer review journal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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