Continuous Quality Improvement for Diabetes

NCT00838825 | Completed Phase 2 DMC

• 1 other identifier: SCVMC 2/8/08-10
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Diabetes

Keywords

diabetes; chronic care management; resource utilization; outcome; glycohemoglobin; hospitalization

Outcome Measures

Primary Outcomes (1)

• resource utilization

  baseline compared to 2 years intervention

Secondary Outcomes (2)

• compliance with process measures

  3 years

• metabolic outcome

  3 years

Study Arms (2)

traditional

NO INTERVENTION

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.

care management

EXPERIMENTAL

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

Interventions

introduction of the chronic care model OTHER

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

Also known as: care manager, chronic care model, health care delivery, self-management, registry

care management

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Refusal to give informed consent

Sponsors & Collaborators

• Santa Clara Valley Health & Hospital System: lead

Related Publications (1)

• Kearns P. Diabetes Care Management Teams Did Not Reduce Utilization When Compared With Traditional Care: A Randomized Cluster Trial. Manag Care. 2017 Oct;26(10):33-40.

  PMID: 29068297 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Case Managers; Chronic Care Model; Delivery of Health Care; Self-Management; Registries

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services; Delivery of Health Care, Integrated; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation; Rehabilitation; Health Services; Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health

Study Officials

• Patrick J Kearns, MD

  Santa Clara Valley Health & Hospital System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Chronic Care Mangement

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: April 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: April 1, 2011
• Last Updated: May 10, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share