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Developing and Implementing a Quality Measure for Glycemic Control

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00012675
  Purpose

Many patients with diabetes are under sub-optimal glycemic control. Central to the clinician�s task in improving glycemic control is the management of hypoglycemic medication therapy, including the use of drugs such as insulin and sulfonylureas. Clinical trials have demonstrated that more intensive hypoglycemic medication therapy results in improved glycemic control. Yet quality measures for this critical process of care have not been developed and we know little about how physicians actually manage hypoglycemic medications.


Condition
Diabetes

MedlinePlus related topics:   Diabetes   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Retrospective
Official Title:   Developing and Implementing a Quality Measure for Glycemic Control

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:   0
Study Completion Date:   December 2003

Groups/Cohorts
1

Detailed Description:

Background:

Many patients with diabetes are under sub-optimal glycemic control. Central to the clinician�s task in improving glycemic control is the management of hypoglycemic medication therapy, including the use of drugs such as insulin and sulfonylureas. Clinical trials have demonstrated that more intensive hypoglycemic medication therapy results in improved glycemic control. Yet quality measures for this critical process of care have not been developed and we know little about how physicians actually manage hypoglycemic medications.

Objectives:

We propose to develop a quality measure that describes the intensity of physicians� hypoglycemic medication therapy. We will then provide feedback to VA physicians regarding their practices and access to experts in diabetes care to determine whether this intervention leads to improvements in glycemic control.

Methods:

The study is divided into two phases. During the first phase we will use existing data to model the decision to increase hypoglycemic medications. At each medical visit, we will determine whether an increase in medication therapy occurred. We will use recursive partitioning to develop a model that identifies patient characteristics at the visit, such as recent laboratory results and diagnoses, associated with the decision to increase therapy. This model assigns a predicted probability of an increase in therapy to each visit. We then use these predictions to define an intensity of hypoglycemic medication therapy for each physician that compares the actual to predicted number of increases over all patient-visits. The second phase will be a randomized trial in which clinicians at experimental sites receive feedback on performance and access to expert opinion while usual care is provided at control sites. Feedback on performance will be provided twice over 6 months. The change in intensity of treatment scores and glycosylated hemoglobin levels pre- and post-intervention at these sites will be compared to performance of primary care physicians at control sites not receiving the intervention.

Status:

Project is ongoing. Phase 1 analyses have been completed. Clinicians have now received two rounds of feedback on their performance and we will be performing the final data collection shortly. One VA site unexpectedly dropped out after they decided to discontinue their research program.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

Clinic patients with diabetes

Exclusion Criteria:

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012675

Locations
United States, Massachusetts
Bedford VA Medical Center    
      Bedford, Massachusetts, United States, 01730

Sponsors and Collaborators

Investigators
Principal Investigator:     Dan R. Berlowitz, MD MPH     Bedford VA Medical Center    
  More Information


Publications of Results:

Responsible Party:   Department of Veterans Affairs ( Berlowitz, Dan - Principal Investigator )
Study ID Numbers:   DII 99-205
First Received:   March 14, 2001
Last Updated:   October 31, 2008
ClinicalTrials.gov Identifier:   NCT00012675
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Diabetes Mellitus

ClinicalTrials.gov processed this record on November 20, 2008




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